Federal Register Vol. 81, No.155,

Federal Register Volume 81, Issue 155 (August 11, 2016)

Page Range52969-53243
FR Document

81_FR_155
Current View
Page and SubjectPDF
81 FR 53095 - Federal Housing Administration (FHA): Strengthening the Home Equity Conversion Mortgage ProgramPDF
81 FR 53146 - Sunshine Act MeetingPDF
81 FR 53174 - In the Matter of Chang-On International, Inc., Computer Graphics International Inc., Guanwei Recycling Corp., John D. Oil and Gas Company, Legal Life Plans, Inc., Powder River Coal Corp., Reunion Industries, Inc., ThermoEnergy Corporation; Order of Suspension of TradingPDF
81 FR 53130 - Agency Information Collection Activities; Comment Request; Federal Perkins Loan Program Regulations and General Provisions RegulationsPDF
81 FR 53148 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program StandardsPDF
81 FR 53196 - Fund Availability under the Grants for Transportation of Veterans in Highly Rural AreasPDF
81 FR 53119 - Granular Polytetrafluorethylene Resin From Italy: Final Results of Sunset Review and Revocation of Antidumping Duty OrderPDF
81 FR 53121 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
81 FR 53120 - Porcelain-on-Steel Cooking Ware From the People's Republic of China: Continuation of Antidumping Duty OrderPDF
81 FR 53152 - The Privacy Act Of 1974, As Amended; Notice of New HUD Certified Housing Counselor and Client Certificate of Housing Counseling Database, System of RecordsPDF
81 FR 53120 - Multilayered Wood Flooring From the People's Republic of China: Correction to the Final Results of Antidumping Duty Administrative ReviewPDF
81 FR 52998 - Disposition of HUD-Acquired Single Family Properties; Updating HUD's Single Family Property Disposition RegulationsPDF
81 FR 53004 - Safety Zone; Pittsburgh Steelers Fireworks; Allegheny River Mile 0.0-0.25, Ohio River Mile 0.0-0.1, Monongahela River Mile 0.0-0.1, Pittsburgh, PAPDF
81 FR 53125 - Agency Information Collection Activities Under OMB ReviewPDF
81 FR 53144 - Access to Confidential Business Information by Battelle Memorial InstitutePDF
81 FR 53143 - Access to Confidential Business Information by the U.S. Consumer Product Safety CommissionPDF
81 FR 53142 - Access to Confidential Business Information by the National Institute for Occupational Safety and HealthPDF
81 FR 53167 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Coal Mine Dust Sampling DevicesPDF
81 FR 53166 - Agency Information Collection Activities; Proposed eCollection eComments Requested; United States Victims of State Sponsored Terrorism Fund Application FormPDF
81 FR 53019 - Halauxifen-methyl; Pesticide TolerancesPDF
81 FR 53012 - Aminocyclopyrachlor; Pesticide TolerancesPDF
81 FR 53167 - Workforce Innovation and Opportunity Act; Native American Employment and Training CouncilPDF
81 FR 53155 - Agency Information Collection Activities: Request for CommentsPDF
81 FR 53149 - Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment PeriodPDF
81 FR 53031 - Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017; CorrectionsPDF
81 FR 53169 - Confirmatory Order; In the Matter of AREVA, Inc.PDF
81 FR 53159 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Identification of Explosive MaterialsPDF
81 FR 53161 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Certification on Agency Letterhead Authorizing Purchase of Firearm for Official Duties of Law Enforcement OfficerPDF
81 FR 53160 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Interstate Firearms Shipment Report of Theft/Loss (ATF F 3310.6)PDF
81 FR 53165 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of an Existing Collection in Use Without an OMB Control Number Credit Card Payment Form (1-786)PDF
81 FR 53164 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Import/Export Declaration for List I and List II Chemicals-DEA Forms 486, 486APDF
81 FR 53165 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Controlled Substances Import/Export Declaration-DEA Form 236PDF
81 FR 53163 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Application for Permit To Export Controlled Substances, Application for Permit To Export Controlled Substances for Subsequent Reexport-DEA Forms 161, 161RPDF
81 FR 53155 - Endangered Species; Recovery Permit ApplicationsPDF
81 FR 53118 - Submission for OMB Review; Comment RequestPDF
81 FR 53145 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
81 FR 53144 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 53158 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 53124 - Submission for OMB Review; Comment RequestPDF
81 FR 53134 - Eastern Shore Natural Gas Company; Notice of Intent To Prepare an Environmental Assessment for the Planned 2017 Expansion Project and Request for Comments on Environmental IssuesPDF
81 FR 53137 - Alcoa Power Generating Inc., Cube Yadkin Generation LLC; Notice of Application for Transfer of License and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 53139 - Cushnie, Colin E.; Notice of FilingPDF
81 FR 53132 - HORUS Central Valley Solar 1, LLC, HORUS Central Valley Solar 2, LLC v. California Independent System Operator Corporation; Notice of ComplaintPDF
81 FR 53130 - West Deptford Energy, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 53137 - El Paso Natural Gas Company, L.L.C.; Notice of Request Under Blanket AuthorizationPDF
81 FR 53139 - ANR Pipeline Company; Notice of Request Under Blanket AuthorizationPDF
81 FR 53136 - Notice of Commission Staff AttendancePDF
81 FR 53141 - NextEra Energy Transmission West, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 53140 - Texas Eastern Transmission, LP; Notice of Intent To Prepare an Environmental Assessment for the Proposed Bayway Lateral Project, and Request for Comments on Environmental IssuesPDF
81 FR 53133 - PennEast Pipeline Company, LLC; Notice of Public Comment Meeting Location Change for the Proposed Penneast Pipeline ProjectPDF
81 FR 53142 - Combined Notice of Filings #1PDF
81 FR 53131 - Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications; Shell Energy North America (US), L.P.PDF
81 FR 53138 - Notice of Application for Temporary Variance and Soliciting Comments, Motions To Intervene, and Protests: Domtar Paper Company, LLCPDF
81 FR 53130 - Notice of Commission Staff AttendancePDF
81 FR 53131 - Notice of Request Under Blanket Authorization: Natural Gas Pipeline Company of America, LLCPDF
81 FR 53132 - Combined Notice of Filings #1PDF
81 FR 53156 - Certain Overflow and Drain Assemblies for Bathtubs and Components Thereof; Notice of the Commission's Determination Not To Review an Initial Determination Terminating Better Enterprise Co. Ltd. From the Investigation; Issuance of Consent Order; Termination of the InvestigationPDF
81 FR 53157 - Hydrofluorocarbon Blends and Components From China; DeterminationPDF
81 FR 53128 - Submission for OMB Review; Comment RequestPDF
81 FR 53127 - Submission for OMB Review; Comment RequestPDF
81 FR 53129 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
81 FR 53147 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding CompaniesPDF
81 FR 53146 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 53146 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 53118 - Notice of Public Meetings of the Virginia Advisory Committee to Plan Civil Rights ProjectPDF
81 FR 53184 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Options Fee SchedulePDF
81 FR 53180 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1, Amending NYSE Rule 49 Regarding: (1) The Exchange's Emergency Powers; (2) the Exchange's Disaster Recovery Plans; and (3) Exchange Backup Systems and Mandatory TestingPDF
81 FR 53176 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change, Rule Change, as Modified by Amendment No. 1, Amending NYSE Rule 49-Equities Regarding: (1) The Exchange's Emergency Powers; (2) the Exchange's Disaster Recovery Plans; and (3) Exchange Backup Systems and Mandatory TestingPDF
81 FR 53174 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 11.270(c) Concerning Clearly Erroneous ExecutionsPDF
81 FR 53147 - National Institute for Occupational Safety and Health Draft Immediately Dangerous to Life or Health (IDLH) Value Profile for Peracetic Acid (CAS #79-21-0)PDF
81 FR 53168 - Proposal Review; Notice of MeetingsPDF
81 FR 53125 - Fostering the Advancement of the Internet of Things WorkshopPDF
81 FR 53152 - Office of the Director; Notice of MeetingPDF
81 FR 53151 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 53151 - National Institute of Dental & Craniofacial Research; Notice of Closed MeetingPDF
81 FR 53162 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-R Consortium, Inc.PDF
81 FR 53162 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Heterogeneous System Architecture FoundationPDF
81 FR 52969 - Livestock Mandatory Reporting: Reauthorization of Livestock Mandatory Reporting and Revision of Swine and Lamb Reporting RequirementsPDF
81 FR 53163 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Open Platform for NFV Project, Inc.PDF
81 FR 53161 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Node.Js FoundationPDF
81 FR 53157 - Certain Document Cameras and Software for Use Therewith; Issuance of a Limited Exclusion Order and Cease and Desist Order Against the Respondent Found in Default; Termination of the InvestigationPDF
81 FR 53163 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-ODPI, Inc.PDF
81 FR 53162 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Medical CBRN Defense Consortium (Formerly National Chemical Biological Defense Consortium)PDF
81 FR 53006 - Technical Correction to the National Ambient Air Quality Standards for Particulate MatterPDF
81 FR 53097 - Technical Correction to the National Ambient Air Quality Standards for Particulate MatterPDF
81 FR 53109 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery Off the Southern Atlantic States; Regulatory Amendment 16PDF
81 FR 53128 - Army Education Advisory Committee Meeting NoticePDF
81 FR 53039 - Amendment of the Emergency Alert SystemPDF
81 FR 53046 - Public Transportation Safety ProgramPDF
81 FR 53098 - Approval and Promulgation of Implementation Plans; Oklahoma; Disapproval of Prevention of Significant Deterioration for Particulate Matter Less Than 2.5 Micrometers-Significant Impact Levels and Significant Monitoring ConcentrationPDF
81 FR 52995 - New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; CorrectionPDF
81 FR 52994 - Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical AmendmentPDF
81 FR 52992 - Amendment of Class E Airspace for the Following Michigan Towns; Alma, MI; Bellaire, MI; Cadillac, MI; Drummond Island, MI; Gladwin, MI; Holland, MI; and Three Rivers, MIPDF
81 FR 53093 - Proposed Amendment of Class E Airspace for the Following Wisconsin Towns; Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI; Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI, and Proposed Revocation of Class E Airspace; Wausau, WIPDF
81 FR 52991 - Establishment of Class E Airspace; Park River, NDPDF
81 FR 53091 - Proposed Amendment of Class D and E Airspace for the Following Texas Towns; Houston Sugar Land, TX; Alice, TX; Bay City, TX; Brenham, TX; Burnet, TX; Falfurrias, TX; Graford, TX; and Hamilton, TX, and Proposed Revocation of Class E Airspace; Austin Horseshoe Bay Resort Airport, TXPDF
81 FR 52974 - Operating Philosophy for Maintaining Occupational and Public Radiation Exposures as Low as Is Reasonably AchievablePDF
81 FR 53061 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Northeast Fisheries Science Center Fisheries ResearchPDF
81 FR 52975 - Airworthiness Directives; Continental Motors, Inc. Reciprocating EnginesPDF
81 FR 53045 - Defense Federal Acquisition Regulation Supplement; Technical AmendmentPDF
81 FR 53101 - Defense Federal Acquisition Regulation Supplement: Procurement of Commercial Items (DFARS Case 2016-D006)PDF
81 FR 53150 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-March Through June 2016PDF
81 FR 53008 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Prevention of Significant Deterioration and Approval of Infrastructure State Implementation Plans for Specific National Ambient Air Quality StandardsPDF
81 FR 53025 - Arkansas: Final Authorization of State Hazardous Waste Management Program RevisionPDF
81 FR 53100 - Arkansas: Final Authorization of State Hazardous Waste Management Program RevisionsPDF
81 FR 53186 - Notice of Funding Availability for the Small Business Transportation Resource Center ProgramPDF
81 FR 53191 - Notice of Funding Availability for the Small Business Transportation Resource Center ProgramPDF
81 FR 53033 - National Environmental Policy Act Implementing Procedures and Categorical ExclusionsPDF
81 FR 53204 - Amendment of Americans With Disabilities Act Title II and Title III Regulations To Implement ADA Amendments Act of 2008PDF

Issue

81 155 Thursday, August 11, 2016 Contents Agricultural Marketing Agricultural Marketing Service RULES Livestock Mandatory Reporting: Reauthorization of Livestock Mandatory Reporting and Revision of Swine and Lamb Reporting Requirements, 52969-52974 2016-19040 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Food and Nutrition Service

Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification on Agency Letterhead Authorizing Purchase of Firearm for Official Duties of Law Enforcement Officer, 53161 2016-19095 Identification of Explosive Materials, 53159-53160 2016-19096 Interstate Firearms Shipment Report of Theft/Loss, 53160-53161 2016-19094 Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: Heterogeneous System Architecture Foundation, 53162 2016-19042 Medical CBRN Defense Consortium, 53162-53163 2016-19035 NODE.JS Foundation, 53161-53162 2016-19038 ODPI, Inc., 53163 2016-19036 Open Platform for NFV Project, Inc., 53163 2016-19039 R Consortium, Inc., 53162 2016-19043 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53127-53128 2016-19062 2016-19063 Meetings: Army Education Advisory Committee, 53128-53129 2016-18975 Centers Disease Centers for Disease Control and Prevention NOTICES National Institute for Occupational Safety and Health Immediately Dangerous to Life or Health Value Profiles: Peracetic Acid; Draft, 53147-53148 2016-19051 Centers Medicare Centers for Medicare & Medicaid Services RULES Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017: Corrections, 53031-53032 2016-19108 Civil Rights Civil Rights Commission NOTICES Meetings: Virginia Advisory Committee, 53118-53119 2016-19056 Coast Guard Coast Guard RULES Safety Zones: Pittsburgh Steelers Fireworks; Allegheny River Mile 0.0-0.25, Ohio River Mile 0.0-0.1, Monongahela River Mile 0.0-0.1, Pittsburgh, PA, 53004-53005 2016-19128 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53125-53127 2016-19127 Defense Acquisition Defense Acquisition Regulations System RULES Defense Federal Acquisition Regulation Supplements: Technical Amendment, 53045 2016-18705 PROPOSED RULES Defense Federal Acquisition Regulation Supplements: Procurement of Commercial Items, DFARS Case 2016-D006, 53101-53109 2016-18704 Defense Department Defense Department See

Army Department

See

Defense Acquisition Regulations System

NOTICES Charter Amendments, Establishments or Renewals: Board of Visitors, National Defense University, 53129-53130 2016-19061
Denali Denali Commission RULES National Environmental Policy Act Implementing Procedures and Categorical Exclusions, 53033-53039 2016-18176 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Perkins Loan Program Regulations and General Provisions Regulations, 53130 2016-19166 Employment and Training Employment and Training Administration NOTICES Meetings: Native American Employment and Training Council; Workforce Innovation and Opportunity Act, 53167 2016-19112 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: West Virginia; Prevention of Significant Deterioration and Approval of Infrastructure State Implementation Plans for Specific National Ambient Air Quality Standards, 53008-53012 2016-18518 Final Authorization of State Hazardous Waste Management Program Revisions: Arkansas, 53025-53031 2016-18433 National Ambient Air Quality Standards for Particulate Matter: Technical Correction, 53006-53008 2016-19034 Pesticide Tolerances: Aminocyclopyrachlor, 53012-53019 2016-19117 Halauxifen-methyl, 53019-53025 2016-19118 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Oklahoma; Disapproval of Prevention of Significant Deterioration for Particulate Matter Less than 2.5 Micrometers: Significant Impact Levels and Significant Monitoring Concentration, 53098-53100 2016-18895 Final Authorization of State Hazardous Waste Management Programs: Arkansas, 53100-53101 2016-18432 National Ambient Air Quality Standards for Particulate Matter: Technical Correction, 53097-53098 2016-19033 NOTICES Access to Confidential Business Information: Battelle Memorial Institute, 53144 2016-19126 National Institute for Occupational Safety and Health, 53142-53143 2016-19121 U.S. Consumer Product Safety Commission, 53143-53144 2016-19124 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Continental Motors, Inc. Reciprocating Engines, 52975-52991 2016-18708 Class E Airspace; Amendments: Alma, Bellaire, Cadillac, Drummond Island, Gladwin, Holland, Three Rivers, MI, 52992-52994 2016-18777 Class E Airspace; Establishments: Park River, ND, 52991-52992 2016-18772 PROPOSED RULES Class D and E Airspace; Amendments; Class E Airspace; Revocations: Houston Sugar Land, Alice, Bay City, Brenham, Burnet, Falfurrias, Graford, Hamilton, TX; Austin Horseshoe Bay Resort Airport, TX, 53091-53093 2016-18769 Class E Airspace; Amendments and Revocations: Antigo, Ashland, Black River Falls, Cable Union, Cumberland, Eagle River, Hayward, Wausau, WI; Wausau, WI, 53093-53095 2016-18773 Federal Communications Federal Communications Commission RULES Emergency Alert System, 53039-53045 2016-18962 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53144-53146 2016-19086 2016-19087 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 53146 2016-19246 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Temporary Variance and Soliciting Comments, Motions to Intervene, and Protests, 53138-53139 2016-19069 Combined Filings, 53132-53133, 53142 2016-19066 2016-19071 Complaints: HORUS Central Valley Solar 1, LLC, et al. v. California Independent System Operator Corp., 53132 2016-19079 Environmental Assessments; Availability, etc.: Eastern Shore Natural Gas Co.; 2017 Expansion Project, 53134-53136 2016-19082 Texas Eastern Transmission, LP; Proposed Bayway Lateral Project, 53140-53141 2016-19073 Filings: Cushnie, Colin E., 53139-53140 2016-19080 License Transfer Applications: Alcoa Power Generating Inc.; Cube Yadkin Generation LLC, 53137-53138 2016-19081 Meetings: PennEast Pipeline Co. LLC; Proposed PennEast Pipeline Project; Location Change, 53133-53134 2016-19072 Permit Applications: Shell Energy North America (US), LP, 53131-53132 2016-19070 Refund Effective Dates: NextEra Energy Transmission West, LLC, 53141-53142 2016-19074 West Deptford Energy, LLC, 53130 2016-19078 Requests under Blanket Authorizations: ANR Pipeline Co., 53139 2016-19076 El Paso Natural Gas Co., LLC, 53137 2016-19077 Natural Gas Pipeline Company of America, LLC, 53131 2016-19067 Staff Attendance, 53130-53131, 53136-53137 2016-19068 2016-19075 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 53146 2016-19058 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 53146-53147 2016-19059 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 53147 2016-19060 Federal Transit Federal Transit Administration RULES Public Transportation Safety Program, 53046-53061 2016-18920 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Recovery Permit Applications, 53155 2016-19089 Food and Drug Food and Drug Administration RULES New Animal Drugs: New Animal Drug Applications; Opportunity for a Hearing; Correction, 52995-52997 2016-18809 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment, 52994-52995 2016-18787 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Manufactured Food Regulatory Program Standards, 53148-53149 2016-19165 Guidance for Industry: Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers, 53149-53150 2016-19109 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53118 2016-19088 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53155-53156 2016-19110 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Medicare Program: Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances: March through June 2016, 53150-53151 2016-18665
Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department RULES Disposition of HUD-Acquired Single Family Properties; Updating HUD's Single Family Property Disposition Regulations, 52998-53003 2016-19132 PROPOSED RULES Federal Housing Administration: Strengthening the Home Equity Conversion Mortgage Program, 53095-53097 2016-19255 NOTICES Privacy Act; Systems of Records, 53152-53155 2016-19134 Interior Interior Department See

Fish and Wildlife Service

See

Geological Survey

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Granular Polytetrafluorethylene Resin from Italy, 53119-53120 2016-19155 June Anniversary Dates, 53121-53124 2016-19152 Multilayered Wood Flooring from the People's Republic of China, 53120-53121 2016-19133 Porcelain-on-Steel Cooking Ware from the People's Republic of China, 53120 2016-19143 International Trade Com International Trade Commission NOTICES Complaints: Certain Industrial Control System Software, Systems Using Same, and Components Thereof, 53158-53159 2016-19084 Investigations; Determinations, Modifications, and Rulings, etc.: Better Enterprise Co. Ltd.; Certain Overflow and Drain Assemblies for Bathtubs and Components Thereof, 53156-53157 2016-19065 Certain Document Cameras and Software for Use Therewith, 53157-53158 2016-19037 Hydrofluorocarbon Blends and Components from China, 53157 2016-19064 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

See

Antitrust Division

RULES Amendment of Americans with Disabilities Act Regulations to Implement the Americans with Disabilities Act Amendments Act, 53204-53243 2016-17417 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Controlled Substances Import/Export Declaration; Extension, 53165-53166 2016-19091 Credit Card Payment Form, 53165 2016-19093 Import/Export Declaration for List I and List II Chemicals, 53164-53165 2016-19092 Permit to Export Controlled Substances, Subsequent Re-Export, 53163-53164 2016-19090 United States Victims of State Sponsored Terrorism Fund Application Form, 53166-53167 2016-19119
Labor Department Labor Department See

Employment and Training Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Coal Mine Dust Sampling Devices, 53167-53168 2016-19120
National Institute National Institutes of Health NOTICES Meetings: Big Data to Knowledge Multi-Council Working Group, 53152 2016-19047 National Institute of Allergy and Infectious Diseases, 53151 2016-19045 2016-19046 National Institute of Dental and Craniofacial Research Special Emphasis Panel, 53151-53152 2016-19044 National Oceanic National Oceanic and Atmospheric Administration RULES Takes and Imports of Marine Mammals: Incidental to Northeast Fisheries Science Center Fisheries Research, 53061-53090 2016-18739 PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Fishery off the Southern Atlantic States; Amendment 16, 53109-53117 2016-18998 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53124 2016-19083 National Science National Science Foundation NOTICES Meetings: Proposal Review, 53168-53169 2016-19050 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Internet Policy Task Force and the Digital Economy Leadership Team, 53125 2016-19048 Nuclear Regulatory Nuclear Regulatory Commission RULES Operating Philosophy for Maintaining Occupational and Public Radiation Exposures as Low as is Reasonably Achievable, 52974-52975 2016-18767 NOTICES Confirmatory Orders: AREVA, Inc., 53169-53173 2016-19105 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Investors Exchange LLC, 53174-53176 2016-19052 New York Stock Exchange LLC, 53180-53184 2016-19054 NYSE Arca, Inc., 53184-53186 2016-19055 NYSE MKT LLC, 53176-53180 2016-19053 Suspension of Trading Orders: Chang-On International, Inc., et al., 53174 2016-19209 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Transit Administration

NOTICES Funding Availability: Great Lakes Region Small Business Transportation Resource Center Program, 53186-53191 2016-18327 Gulf Region Small Business Transportation Resource Center Program, 53191-53196 2016-18326
Veteran Affairs Veterans Affairs Department NOTICES Funding Availability: Grants for Transportation of Veterans in Highly Rural Areas, 53196-53201 2016-19163 Separate Parts In This Issue Part II Justice Department, 53204-53243 2016-17417 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.

81 155 Thursday, August 11, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 59 [Doc. #AMS-LPS-15-0070] RIN 0581-AD45 Livestock Mandatory Reporting: Reauthorization of Livestock Mandatory Reporting and Revision of Swine and Lamb Reporting Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

On April 2, 2001, the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) implemented the Livestock Mandatory Reporting (LMR) program as required by the Livestock Mandatory Reporting Act of 1999 (1999 Act). The LMR program was reauthorized in October 2006 and September 2010. On September 30, 2015, the Agriculture Reauthorizations Act of 2015 (2015 Reauthorization Act) reauthorized the LMR program for an additional 5 years until September 30, 2020, and directed the Secretary of Agriculture (Secretary) to amend the LMR swine reporting requirements. This final rule incorporates the swine reporting revisions contained within the 2015 Reauthorization Act and a minor revision to the lamb reporting requirements under the Agricultural Marketing Act of 1946, USDA Livestock Mandatory Reporting regulations.

DATES:

This final rule is effective October 11, 2016.

FOR FURTHER INFORMATION CONTACT:

Michael Lynch, Director; Livestock, Poultry, and Grain Market News Division; Livestock, Poultry, and Seed Program; AMS, USDA, Room 2619-S, STOP 0252; 1400 Independence Avenue SW., Washington, DC 20250-0251; telephone (202) 720-4868; fax (202) 690-3732; or email [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

The 1999 Act was enacted into law on October 22, 1999, [Pub. L. 106-78; 113 Stat. 1188; 7 U.S.C. 1635-1636(i)] as an amendment to the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.). On April 2, 2001, the AMS Livestock, Poultry, and Seed Program's (LPS) Livestock, Poultry, and Grain Market News Division (LPGMN) implemented the LMR program as required by the 1999 Act. The purpose was to establish a program of easily understood information regarding the marketing of cattle, swine, lambs, and livestock products; improve the price and supply reporting services of the USDA; and encourage competition in the marketplace for livestock and livestock products. The LMR regulations (7 CFR part 59) set the requirements for packers or importers to submit purchase and sales information of livestock and livestock products to meet this purpose.

The statutory authority for the program lapsed on September 30, 2005. In October 2006, Congress passed the Livestock Mandatory Reporting Reauthorization Act (2006 Reauthorization Act) [Pub. L. 109-296]. The 2006 Reauthorization Act re-established the regulatory authority for the continued operation of LMR through September 30, 2010. On July 15, 2008, the LMR final rule became effective (73 FR 28606, May 16, 2008).

On September 28, 2010, Congress passed the Mandatory Price Reporting Act of 2010 (2010 Reauthorization Act) [Pub. L. 111-239]. The 2010 Reauthorization Act reauthorized LMR for an additional 5 years through September 30, 2015. On January 7, 2013, the LMR final rule became effective (77 FR 50561, August 22, 2012).

On September 30, 2015, the Agriculture Reauthorizations Act of 2015 (2015 Reauthorization Act) [Pub. L. 114-54] was enacted; it reauthorized the LMR program for an additional 5 years through September 30, 2020, and amended the reporting requirements for swine purchase types and late afternoon swine purchases. On February 29, 2016, AMS published a proposed rule for these swine reporting changes and for changes to lamb reporting requirements as requested by the lamb industry which included new definitions and requirements for packers to report lambs committed for future delivery to the packer and prices of pelts paid to the producer and an amendment to the definition of packer-owned lambs (81 FR 10132, February 29, 2016). The proposed rule included a 60-day comment period. AMS received 11 timely comments. Nine were substantive and relevant and two were outside the scope of regulation.

This final rule incorporates the swine reporting revisions contained within the 2015 Reauthorization Act and the lamb reporting revision to amend the definition of packer-owned lambs as requested by the lamb industry, under the USDA LMR regulations. Based on the comments received, AMS chose not to incorporate in this final rule the proposed reporting revisions concerning lambs committed for future delivery and prices of pelts paid to producers due to the burden increase on the packers affected by this rule and the possible negative implications on U.S. trade within domestic and international markets.

II. Comments and Responses

AMS received nine relevant comments from organizations representing livestock producers and meat packers and processors. A review of AMS responses to the comments follows below.

Swine

Summary of Comments: Two commenters supported reporting negotiated formula purchases and the publication of late afternoon barrow and gilt purchases in reports issued the following day. These commenters noted that these revisions should provide more information about buyer/seller interactions indicating the manner in which swine is marketed and increase the volume of barrow and gilt data able to be published in daily purchase reports.

Agency Response: AMS made no changes.

Lamb—Lambs Committed

Summary of Comments: Two commenters supported the requirement to report lambs committed, one commenter requested clarification concerning the specificity of the number of animals and the date of delivery reported, and four commenters, representing a majority of the entities affected by this requirement opposed this requirement. The opposing commenters requested AMS reconsider this revision. Of the opposing commenters, two stated that the requirement would be overly burdensome and exceed the scope of the LMR program as it could change the manner in which purchase contracts are written and implemented. One commenter stated that commitments or schedules to deliver lambs vary based on factors including feedlot performance, weather, transportation availability, feed availability, producer management, plant capacity, and customer demand for lambs and therefore would be difficult to report. This commenter also stated that the reporting requirement would require a significant amount of recordkeeping to maintain compliance. Other commenters noted that the requirement would provide too much market intelligence about the domestic lamb packing industry regarding packer buying positions and would therefore be detrimental to the U.S. lamb industry putting it at a competitive disadvantage to importers of Australian and New Zealand lamb.

Agency Response: AMS recognizes the value of information this requirement could provide for the industry; however, the domestic and international trade implications raise serious concerns. Therefore, AMS has removed the aforementioned provision for the reporting requirement concerning lambs committed from this final rule.

Lamb—Pelts

Summary of Comments: Two commenters supported the requirement to report lamb pelts noting voluntary reporting of pelt market interactions between packers and pelt processors has become static and no longer indicative of current marketing practices due to consolidation of the lamb packing and pelt processing industries. Furthermore, these commenters noted that the requirement to report volumes and prices for pelts paid to the producer by the packer, instead of the current voluntary practice of providing market interactions between the packer and pelt processor, would provide producers with market information to better determine the whole value of a slaughter lamb. One commenter requested clarification about whether the requirement would apply to each lot of animals or individual animals. Three commenters, representing a majority of the entities affected by this requirement, were opposed to the requirement, noting the increase in burden on the reporting entities with little or no benefit to the industry. These opposing commenters acknowledged the importance of reporting market information for pelts and stressed the point that AMS currently reports the pelt market on a voluntary basis; therefore, they suggested that mandatory pelt reporting would be redundant. Commenters opposing this provision noted that grouping pelts into the proposed classification categories within each lot would be difficult and time-consuming because pelts are sorted by a third-party based on quality characteristics inconsistent with the classification categories in the proposed rule. Also, the commenters opposing the revision suggested that compliance with the requirement would be subjective and difficult to verify since there are no standard pelt grades used consistently throughout the industry. Two of the opposing commenters explained that pelts are typically sent to another part of a plant after removal and therefore impossible to match pelt information with specific animals. Another commenter expressed that considering the consolidation of the U.S. pelt processing industry, this provision to require detailed pelt reporting, and thereby increase market transparency, could negatively affect trade by providing a competitive advantage to international buyers of pelts.

Agency Response: AMS recognizes the value of information on the pelt market this provision could provide for the industry. However, the concerns raised by the commenters about the burden and difficulty in meeting this requirement with limited benefit to the industry cannot be overlooked. Therefore, AMS has removed the aforementioned provision for the reporting requirement concerning pelts from this final rule.

Lamb—Packer-Owned Lambs

Summary of Comments: One commenter supported the revision of the definition of packer-owned lambs to include animals a packer owns for at least 28 days immediately before slaughter. The commenter noted this revised definition would help address the need to amend current reporting for lambs in order to provide useful market information readily understood by producers and improve AMS market reporting services.

Agency Response: AMS made no changes.

III. Final Revisions

Under the LMR regulations, certain cattle, swine and lamb packers and processors, and lamb importers are required to report purchases of livestock for slaughter and sales of meat products to AMS. This final rule amends the LMR regulations for swine reporting and lamb reporting requirements as described below.

Swine

The swine reporting requirement revisions within this final rule are authorized through the 2015 Reauthorization Act. This final rule minimally increases the reporting burden for swine packers.

Swine packers are required to report purchase data by four types of purchase: negotiated purchase, other market formula purchase, swine or pork market formula purchase, or other purchase arrangement. A `negotiated purchase' is a cash or spot market purchase by a packer under which the base price for the swine is determined by seller-buyer interaction and agreement on a delivery day; and the swine are scheduled for delivery to the packer not more than 14 days after the date on which the swine are committed to the packer. An `other market formula purchase' is a purchase of swine by a packer in which the pricing mechanism is a formula price based on any market other than the market for swine, pork, or pork product, and includes a formula purchase in a case where the price formula is based on one or more futures or options contracts. A `swine or pork market formula purchase' is a purchase of swine by a packer in which the pricing mechanism is a formula price based on a market for swine, pork, or pork product, other than a future or option for swine, pork, or pork product. An `other purchase arrangement' is a purchase of swine by a packer that is not a negotiated purchase, swine or pork market formula purchase, or other market formula purchase, and does not involve packer-owned swine.

The 2015 Reauthorization Act amended the swine reporting requirements, subpart C of part 59, by adding an additional purchase type definition for negotiated formula purchases of swine, which requires swine packers to report swine purchased on a negotiated formula basis as a separate purchase type. As defined in § 59.200, the term “negotiated formula” is a swine or pork market formula purchase under which the formula is determined by negotiation on a lot-by-lot basis, and swine are scheduled for delivery to the packer not later than 14 days after the date on which the formula is negotiated and swine are committed to the packer. Packers will be required to report any swine purchased in this manner as a negotiated formula purchase.

Adding a negotiated formula purchase type provides market participants with more specific information about the various purchase methods used in the daily marketing of swine and a better understanding of the marketplace concerning formulated prices and spot negotiated prices.

Packers are required to report purchase data for barrows and gilts for a morning report not later than 10 a.m. Central time and an afternoon report not later than 2 p.m. Central time. The information to be reported is the same for the morning and afternoon reports and includes an estimate of the total number of barrows and gilts purchased by each type of purchase, the total number of barrows and gilts purchased, the base price paid for all negotiated purchases of barrows and gilts, and the base price paid for each type of purchase of barrows and gilts other than through a negotiated purchase. This information must be submitted for all covered transactions that occur within one-half hour of each specified reporting time. Packers completing transactions during the half-hour prior to the previous reporting time report those transactions at the next prescribed reporting time.

The 2015 Reauthorization Act directed the Secretary to include in the morning and afternoon daily reports for the following day, the purchase information for any barrows and gilts purchased or priced after the afternoon reporting time of the current reporting day. Under this final rule, the required information reported remains the same for the morning and afternoon reports; however, the morning report requirements under § 59.202 now requires packers to report purchase data for barrows and gilts purchased after 1:30 p.m. Central time of the previous reporting day and up to that time of the reporting day for the total number of barrows and gilts purchased, the base price paid for all negotiated purchases of barrows and gilts, and the base price paid for each type of purchase of barrows and gilts other than through a negotiated purchase. Under this final rule, the LMR regulations for the afternoon reporting requirements remain unchanged. The inclusion of the late afternoon swine purchase information in the following day's reports increases the volume of barrows and gilts shown in the daily morning and afternoon purchase reports and better represents the daily market conditions.

Lamb

Since the implementation of LMR in 2001 and its subsequent revisions, the U.S. lamb industry has become more concentrated at all levels of the production system through consolidation, impacting AMS' ability to publish certain market information in accordance with the confidentiality provisions of the 1999 Act. To help address this issue, the Livestock Marketing Information Center, an independent provider of economic analyses concerning the livestock industry, conducted an analysis of the current LMR program for lamb reporting in 2013 at the request of the American Sheep Industry Association, an industry organization representing sheep producers throughout the U.S.1 Based on this study, recommendations were proposed to amend the current LMR regulations to improve the price and supply reporting services of AMS and better align LMR lamb reporting requirements with current industry marketing practices. These recommendations are the basis for the lamb reporting change as proposed by the lamb industry for this final rule.

1 Hearing to Review Reauthorization of the Livestock Mandatory Reporting Act: Hearing before the Subcommittee on Livestock and Foreign Agriculture of the Committee on Agriculture, House of Representatives, 114th Cong., 1st sess. (Serial No. 114-12). (2015). Retrieved from GPO's Federal Digital System: https://www.thefederalregister.org/fdsys/pkg/CHRG-114hhrg94372/pdf/CHRG-114hhrg94372.pdf.

The revision to the lamb reporting requirements, subpart D of part 59, is an amended definition under § 59.300 for the term “packer-owned lambs.” This final rule amends the definition for the term “packer-owned lambs” to cover lambs owned by a packer for at least 28 days immediately before slaughter.

Appendices

The last section of this document contains three appendices; the proposed rule contained four. As explained in section II above, based on the comments received, AMS chose not to incorporate in this final rule the proposed reporting revisions concerning lambs committed for future delivery and prices of pelts paid to producers. Therefore, AMS deleted appendix B in its entirety, removed all references to lamb forms in appendices C and D, and re-lettered appendices C and D as appendices B and C, respectively. Appendix A lists the forms used by swine packers required to report information under the LMR program. Appendix B provides a description of the forms, while appendix C contains the actual reporting forms. These appendices will not appear in the Code of Federal Regulations.

With this final rule, all form and guideline identification numbers associated with the LMR program are updated to reflect the change in the program name from the AMS Livestock and Seed Program (LS) to the AMS Livestock, Poultry, and Seed Program (LPS); therefore, form number designations are changed from LS-XXX to LPS-XXX. This change to the form numbers is included in the request for an extension of a currently approved information collection for OMB 0581-0186 (Commodities Covered by the Livestock Mandatory Reporting Act of 1999); and in the appendices of this final rule.

Amendments to two swine reporting forms, LPS-118 Swine Prior Day Report and LPS-119 Swine Daily Report, were made to include the new purchase type under this final rule, “negotiated formula purchase.” One form for swine reporting, LPS-119 Swine Daily Report, requires an amendment to the description of the form to include the reporting of the late afternoon purchased barrows and gilts from the previous reporting day in the following reporting day's daily reports, as shown in appendix B.

IV. Classification Executive Order 12866 and Executive Order 13563

This final rule is being issued by USDA with regard to the LMR program in conformance with Executive Orders 12866 and 13563.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives, and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This action has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has waived the review process for this action.

Regulatory Flexibility Act

In General. This final rule was reviewed under the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). The purpose of RFA is to consider the economic impact of a rule on small business entities. Alternatives, which would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the marketplace, have been evaluated. Regulatory action should be appropriate to the scale of the businesses subject to the action. The collection of information is necessary for the proper performance of the functions of AMS concerning the mandatory reporting of livestock information. Information is only available directly from those entities required to report under these regulations and exists nowhere else. Therefore, this final rule does not duplicate market information reasonably accessible to the USDA.

Objectives and Legal Basis. The objective of this final rule is to improve the price and supply reporting services of the USDA in order to encourage competition in the marketplace for swine and lambs as specifically directed by the 2015 Reauthorization Act and the lamb industry requested revisions as authorized through the 1999 Act and these regulations, as described in detail in the background section.

Estimated Number of Small Businesses. For this regulatory flexibility analysis, AMS utilized the North American Industry Classification System (NAICS), which is the standard used by federal statistical agencies to classify business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy. This analysis compares the size of meat packing companies to the NAICS standards to determine the percentage of small businesses within the industry affected by this final rule. Under these size standards, meat packing companies with 500 or less employees are considered small business entities.2

2 North American Industry Classification System, code 311611 for abattoirs.

This final rule amends the reporting requirements for swine packers by adding a new purchase type for negotiated formula purchases of barrows and gilts, and including late afternoon purchases of barrows and gilts from the previous reporting day in the morning and afternoon daily reports of the current reporting day. For swine packers, this final rule applies only to federally inspected swine processing facilities that slaughtered an average of at least 100,000 swine per year during the immediately preceding 5 calendar years and a person that slaughtered an average of at least 200,000 sows, boars, or combination thereof per year during the immediately preceding 5 calendar years. Additionally, in the case of a swine processing plant or person that did not slaughter swine during the immediately preceding 5 calendar years, it would be considered a packer if the Secretary determines the processing plant or person should be considered a packer under this subpart after considering its capacity.

Approximately 36 individual pork packing companies representing a total of 55 individual plants are required to report information to AMS. Based on the NAICS size standard for meat packing companies with 500 or less employees, AMS estimates that 24 of these 36 pork packing companies would be considered small businesses, representing 27 individual plants that are required to report. The figure of 55 plants required to report represents 8.9 percent of the federally inspected swine plants in the U.S. The remaining 91.1 percent of swine plants, nearly all estimated to qualify as small business, are exempt from mandatory reporting.

To implement the swine reporting changes in this final rule, AMS estimated the total annual burden on each swine packer to be $108, which includes the annual share of initial startup costs of $415. There is no annual cost increase associated with electronically submitting data or for the storage and maintenance of electronic files submitted to AMS due to this final rule.

For lamb reporting, this final rule amends the definition of the term “packer-owned lambs” to include lambs owned by a packer for at least 28 days immediately before slaughter.

Under the 2015 Reauthorization Act, a lamb packer includes any person with 50 percent or more ownership in a facility that slaughtered or processed an average of 35,000 lambs during the immediately preceding 5 calendar years, or that did not slaughter or process an average of 35,000 lambs during the immediately preceding 5 calendar years if the Secretary determines that the processing plant should be considered a packer after considering its capacity.

The LMR regulations require 10 lamb packers to report information, which is less than 2 percent of all federally inspected lamb plants. Therefore, approximately 98 percent of lamb packers are exempt from reporting information by this final rule. Based on the NAICS size standard for meat packing companies with 500 or less employees and its knowledge of the lamb industry, AMS estimates that all lamb packing companies currently required to report under LMR would be considered small businesses. As this final rule amends a definition and does not impose additional burdens, AMS estimates no costs to implement the lamb reporting changes in this final rule. There is no annual cost increase associated with electronically submitting data or for the storage and maintenance of electronic files submitted to AMS due to this final rule.

Projected Reporting. The LMR regulations require the reporting of specific market information regarding the buying and selling of livestock and livestock products. This information is reported to AMS by electronic means and this final rule does not affect this requirement. Electronic reporting involves the transfer of data from a packer's or importer's electronic recordkeeping system to a centrally located AMS electronic database. The packer or importer is required to organize the information in an AMS-approved format before electronically transmitting the information to AMS. Once the required information has been entered into the AMS database, it is aggregated and processed into various market reports which are released according to the daily and weekly time schedule set forth in the LMR regulations. As an alternative, AMS also developed and made available web-based input forms for submitting data online as AMS found that some of the smaller entities covered under mandatory price reporting would benefit from such a web-based submission system.

Each packer and importer required to report information to USDA under LMR must maintain such records as are necessary to verify the accuracy of the information provided to AMS. This includes information regarding price, class, head count, weight, quality grade, yield grade, and other factors necessary to adequately describe each transaction. These records are already kept by the industry. Reporting packers and importers are required to maintain and make available the original contracts, agreements, receipts, and other records associated with any transaction relating to the purchase, sale, pricing, transportation, delivery, weighing, slaughter, or carcass characteristics of all livestock, and to maintain these records for a minimum of two years. Packers and importers are not required to report any other new or additional information they do not generally have available or maintain. Further, they are not required to keep any information that would prove unduly burdensome to maintain.

In addition, AMS has not identified any relevant federal rules currently in effect that duplicate, overlap, or conflict with this rule. Professional skills required for recordkeeping under the LMR regulations are not different than those already employed by the reporting entities. Reporting is accomplished using computers or similar electronic means. This final rule does not affect the professional skills required for recordkeeping already employed by the reporting entities. Reporting will be accomplished using computers or similar electronic means. AMS believes the skills needed to maintain such systems are already in place in those small businesses affected by this rule.

Alternatives. This final rule requires swine and lamb packing plants of a certain size to report information to the Secretary at prescribed times throughout the day and week. The 1999 Act and these regulations exempt the vast majority of small businesses by the establishment of slaughter, processing, and import capacity thresholds.

AMS recognizes that most of the economic impact of this final rule on those small entities required to report involves the manner in which information must be reported to the Secretary. However, in developing this final rule, AMS considered other means by which the objectives of this final rule could be accomplished, including reporting the required information by telephone, facsimile, and regular mail. AMS believes electronic submission to be the only method capable of allowing AMS to collect, review, process, aggregate, and publish reports while complying with the specific time-frames set forth in the 1999 Act and regulation.

To respond to the concerns of smaller operations, AMS developed a web-based input form for submitting data online. Based on prior experience, AMS found that some of the smaller entities covered under mandatory price reporting would benefit from such a web-based submission system. Accordingly, AMS developed such a system for program implementation.

Additionally, to further assist small businesses, AMS may provide for an exception to electronic reporting in emergencies, such as power failures or loss of Internet accessibility, or in cases when an alternative is agreeable between AMS and the reporting entity.

Other than these alternatives, there are no other practical and feasible alternatives to the methods of data transmission that are less burdensome to small businesses. AMS will work actively with those small businesses required to report and minimize the burden on them to the maximum extent practicable.

Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), we included the changes in reporting and recordkeeping requirements for 7 CFR part 59 associated with this action into the program's request for an extension of a currently approved information collection for OMB 0581-0186 (Commodities Covered by the Livestock Mandatory Reporting Act of 1999).

Executive Order 12988

This final rule was reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect. Section 259 of the 1999 Act prohibits states or political subdivisions of a state to impose any requirement that is in addition to, or inconsistent with, any requirement of the 1999 Act with respect to the submission or reporting of information, or the publication of such information, on the prices and quantities of livestock or livestock products. In addition, the 1999 Act does not restrict or modify the authority of the Secretary to administer or enforce the Packers and Stockyards Act of 1921 (7 U.S.C. 181 et seq.); administer, enforce, or collect voluntary reports under the 1999 Act or any other law; or access documentary evidence as provided under Sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49, 50). There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this final rule.

Civil Rights Review

AMS reviewed the potential civil rights implications of this final rule on minorities, women, or persons with disabilities to ensure that no person or group shall be discriminated against on the basis of race, color, national origin, gender, religion, age, disability, sexual orientation, marital or family status, political beliefs, parental status, or protected genetic information. This review included persons who are employees of the entities that are subject to this regulation. This final rule does not require affected entities to relocate or alter their operations in ways that could adversely affect such persons or groups. Further, this final rule does not deny any persons or groups the benefits of the program or subject any persons or groups to discrimination.

Executive Order 13132

This final rule was reviewed under Executive Order 13132, Federalism. This Order directs agencies to construe, in regulations and otherwise, a federal statute to preempt state law only when the statute contains an express preemption provision. This final rule is required by the 1999 Act. Section 259 of the 1999 Act, Federal Preemption states, “In order to achieve the goals, purposes, and objectives of this title on a nationwide basis and to avoid potentially conflicting State laws that could impede the goals, purposes, or objectives of this title, no State or political subdivision of a State may impose a requirement that is in addition to, or inconsistent with, any requirement of this subtitle with respect to the submission or reporting of information, or the publication of such information, on the prices and quantities of livestock or livestock products.”

Prior to the passage of the 1999 Act, several states enacted legislation mandating, to various degrees, the reporting of market information on transactions of cattle, swine, and lambs conducted within that particular state. However, since the federal LMR program was implemented on April 2, 2001, these state programs are no longer in effect. Therefore, there are no federalism implications associated with this rulemaking.

Executive Order 13175

This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. AMS considered the potential implications of this final rule to ensure this regulation does not have substantial and direct effects on Tribal governments and was found to not have significant Tribal implications.

List of Subjects in 7 CFR Part 59

Cattle, Hogs, Lamb, Livestock, Sheep, Swine.

For the reasons set forth in the preamble, 7 CFR part 59 is amended as follows:

PART 59—LIVESTOCK MANDATORY REPORTING 1. The authority citation for 7 CFR part 59 continues to read as follows: Authority:

7 U.S.C. 1635-1636i.

2. Amend § 59.200 by: a. Adding a definition for “Negotiated formula purchase” in alphabetical order; b. Revising the definition of “Other purchase arrangement”; and c. Revising paragraphs (3) and (4) and adding paragraph (5) in the definition of “Type of purchase”.

The additions and revisions read as follows:

§ 59.200 Definitions.

Negotiated formula purchase. The term “negotiated formula purchase” means a swine or pork market formula purchase under which:

(1) The formula is determined by negotiation on a lot-by-lot basis; and

(2) The swine are scheduled for delivery to the packer not later than 14 days after the date on which the formula is negotiated and swine are committed to the packer.

Other purchase arrangement. The term “other purchase arrangement” means a purchase of swine by a packer that is not a negotiated purchase, swine or pork market formula purchase, negotiated formula purchase, or other market formula purchase; and does not involve packer-owned swine.

Type of purchase. * * *

(3) A swine or pork market formula purchase;

(4) Other purchase arrangement; and

(5) A negotiated formula purchase.

3. Amend § 59.202 by revising paragraphs (b)(2) through (4) to read as follows:
§ 59.202 Mandatory daily reporting for barrows and gilts.

(b) * * *

(2) The total number of barrows and gilts, and barrows and gilts that qualify as packer-owned swine, purchased since 1:30 p.m. central time of the previous reporting day and up to that time of the reporting day through each type of purchase;

(3) All purchase data for base market hogs purchased since 1:30 p.m. central time of the previous reporting day and up to that time of the reporting day through negotiated purchases;

(4) All purchase data for base market hogs purchased through each type of purchase other than negotiated purchase since 1:30 p.m. central time of the previous reporting day and up to that time of the reporting day, unless such information is unavailable due to pricing that is determined on a delayed basis. The packer shall report information on such purchases on the first reporting day or scheduled reporting time on a reporting day after the price has been determined.

4. Amend § 59.300 by revising the definition for “Packer-owned lambs” to read as follows:
§ 59.300 Definitions.

Packer-owned lambs. The term “packer-owned lambs” means lambs that a packer owns for at least 28 days immediately before slaughter.

Dated: August 5, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-19040 Filed 8-10-16; 8:45 am] BILLING CODE 3410-02-P
NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 [NRC-2015-0286] Operating Philosophy for Maintaining Occupational and Public Radiation Exposures as Low as Is Reasonably Achievable AGENCY:

Nuclear Regulatory Commission.

ACTION:

Regulatory guide; issuance.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 2 to Regulatory Guide (RG) 8.10, “Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as is Reasonably Achievable.” This revision describes methods and procedures that the NRC staff considers acceptable for maintaining radiation exposures to employees and the public as low as is reasonably achievable (ALARA).

DATES:

Revision 2 to RG 8.10 is available on August 11, 2016.

ADDRESSES:

Please refer to Docket ID NRC-2015-0286 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document using the following methods:

Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0286. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Document collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced in this notice (if that document is available in ADAMS) is provided the first time that a document is referenced. Revision 2 to RG 8.10 and the regulatory analysis may be found in ADAMS under Accession Nos. ML16105A136 and ML15203B408, respectively.

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

Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.

FOR FURTHER INFORMATION CONTACT:

Casper Sun, telephone: 301-415-1646, email: [email protected]; and Harriet Karagiannis, telephone: 301-415-2493; email: [email protected] Both are staff of the Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION: I. Introduction

The NRC is issuing a revision to an existing guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, techniques that the NRC staff uses in evaluating specific issues or postulated events, and data that the NRC staff needs in its review of applications for permits and licenses.

Revision 2 of RG 8.10 was issued with a temporary identification of Draft Regulatory Guide, DG-8033. Revision 2 addresses changes identified since Revision 1 was issued in September 1975 (the NRC issued Revision 1-R in May 1977). In 1991, the NRC promulgated amendments to part 20 of title 10 of the Code of Federal Regulations (CFR) (56 FR 23360; May 21, 1991). The 1991 rulemaking included substantive amendments to 10 CFR part 20 as well as a renumbering of those regulations. As such, this revision to the regulatory guide aligns with the regulatory structure of current 10 CFR part 20 by updating the regulatory guide's 10 CFR part 20 cross-references.

In addition, this revision includes additional guidance from operating ALARA experience since 1975. It provides more details describing management responsibilities to ensure commitment to ALARA.

II. Additional Information

The NRC published a notice of availability of DG-8033 in the Federal Register on December 24, 2015 (80 FR 80395), for a 60-day public comment period. The public comment period closed on February 22, 2016. The public comments on DG-8033 and the NRC staff responses to the public comments are available in ADAMS under Accession Number ML16105A137.

III. Congressional Review Act

This regulatory guide is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.

IV. Backfitting

This regulatory guide provides updated guidance on the methods acceptable to the NRC staff for complying with the NRC's regulations associated with ALARA. The regulatory guide applies to current and future applicants for, and holders of:

• Operating licenses for nuclear power reactors under 10 CFR part 50.

• approvals issued under subpart B, C, E, and F of 10 CFR part 52 (“protected applicants and licensees”).

• licenses issued under 10 CFR part 70 to possess or use, at any site or contiguous sites subject to licensee control, a formula quantity of strategic special nuclear material, as defined in 10 CFR 70.4.

• operating licenses for nuclear non-power reactors under 10 CFR part 50.

• specific domestic licenses to manufacture or transfer certain items containing byproduct material under 10 CFR part 32.

• specific domestic licenses of broad scope for byproduct material under 10 CFR part 33.

• licenses for industrial radiography under 10 CFR part 34.

• licenses for medical use of byproduct material under 10 CFR part 35.

• licenses for irradiators under 10 CFR part 36.

• licenses for well logging under 10 CFR part 39.

• licenses for source material under 10 CFR part 40.

• certificates of compliance for packaging of radioactive material under 10 CFR part 71.

• licenses for independent spent fuel storage installations under 10 CFR part 72.

The backfitting provisions in 10 CFR 50.109, 70.76, and 72.62, and the issue finality provisions in 10 CFR part 52 do not apply to holders of licenses under 10 CFR parts 31, 32, 33, 34, 35, 36, 39, 40, or 71, or to holders of licenses for non-power reactors under 10 CFR part 50, unless those licensees also have an NRC regulatory approval under 10 CFR parts 50 or 52 (for a nuclear power reactor), 70, or 72. In addition, the issuance of this regulatory guide would not constitute backfitting under 10 CFR 50.109, 70.76, or 72.62, and would not otherwise be inconsistent with the issue finality provisions in 10 CFR part 52. As discussed in the “Implementation” section of this regulatory guide, the NRC has no intention of initiating any regulatory action that would require the use of this regulatory guide by current holders of 10 CFR part 50 operating licenses, 10 CFR part 52, subpart B, C, E, or F approvals, 10 CFR part 70 licenses, or 10 CFR part 72 licenses.

If a licensee protected by a backfitting or issue finality provision (a “protected licensee”) voluntarily seeks a license amendment or change, and (1) the NRC staff's consideration of the request involves a regulatory issue directly relevant to this revised regulatory guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the NRC staff's determination of the acceptability of the licensee's request, then the NRC staff may request that the licensee either follow the guidance in this regulatory guide or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. Such a request by NRC staff is not considered backfitting as defined in 10 CFR 50.109(a)(1), 70.76(a)(1), or 72.62(a), or a violation of any applicable finality provisions in 10 CFR part 52.

If a protected licensee believes that the NRC is either using this regulatory guide or requesting or requiring the protected licensee to implement the methods or processes in this regulatory guide in a manner inconsistent with the discussion in the Implementation section of this regulatory guide, then the protected licensee may file a backfit appeal with the NRC in accordance with the guidance in NRC Management Directive 8.4, “Management of Facility-Specific Backfitting and Information Collection” (ADAMS Accession No. ML12059A460); and NUREG-1409, “Backfitting Guidelines” (ADAMS Accession No. ML032230247).

Dated at Rockville, Maryland, this 3rd day of August, 2016.

For the Nuclear Regulatory Commission.

Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2016-18767 Filed 8-10-16; 8:45 am] BILLING CODE 7590-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2012-0002; Directorate Identifier 2011-NE-42-AD; Amendment 39-18610; AD 2016-16-12] RIN 2120-AA64 Airworthiness Directives; Continental Motors, Inc. Reciprocating Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Continental Motors, Inc., (CMI) San Antonio (formerly known as Airmotive Engineering Corp. (AEC)), replacement parts manufacturer approval (PMA) cylinder assemblies marketed by Engine Components International Division (ECi). On July 17, 2015, AEC was purchased by CMI and is now operating as “Continental Motors—San Antonio.” These cylinder assemblies are used on all CMI model -520 and -550 reciprocating engines, and on all other CMI engine models approved for the use of model -520 and -550 cylinder assemblies, such as the CMI model -470 when modified by supplemental type certificate (STC). This AD was prompted by reports of multiple cylinder head-to-barrel separations and cracked and leaking aluminum cylinder heads. This AD requires removal of the affected cylinder assemblies, including overhauled cylinder assemblies, according to a phased removal schedule. We are issuing this AD to prevent failure of the cylinder assemblies, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.

DATES:

This AD is effective September 15, 2016.

ADDRESSES:

For service information identified in this AD, contact Continental Motors, Inc., San Antonio, 9503 Middlex Drive, San Antonio, TX 78217; phone: 210-820-8100; Internet: http://www.continentalsanantonio.com. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2012-0002.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2012-0002; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Jurgen E. Priester, Aerospace Engineer, Delegation Systems Certification Office, FAA, Rotorcraft Directorate, 10101 Hillwood Parkway, Fort Worth, TX 76177; phone: 817-222-5190; fax: 817-222-5785; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion August 12, 2013—NPRM

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain CMI San Antonio replacement PMA cylinder assemblies marketed by ECi. These assemblies are used on CMI model -520 and -550 reciprocating engines, and all other CMI engine models approved for the use of models -520 and -550 cylinder assemblies such as the CMI model -470 when modified by STC. The NPRM published in the Federal Register on August 12, 2013 (78 FR 48828) (referred to herein after as the “August 12, 2013, NPRM”). The August 12, 2013, NPRM proposed to require initial and repetitive inspections, immediate replacement of cracked cylinder assemblies, and replacement of cylinder assemblies at reduced times-in-service (TIS) since new. The August 12, 2013, NPRM also proposed to prohibit the installation of affected cylinder assemblies into any engine.

September 26, 2013-March 12, 2014—Posting Technical Documents/Extension of Comment Period/Initial Regulatory Flexibility Analysis (IRFA)

We received several hundred comments to our August 12, 2013, NPRM. In response to this high-level of public interest, we undertook several actions to help the public understand and provide further comment on our proposed rule. These actions included:

• Extending the comment period to the August 12, 2013, NPRM;

• publishing an IRFA; and

• adding several technical documents that were posted to Docket No. FAA-2012-0002 (see Addresses section of this final rule for information on locating the docket) on September 20, 2013.

Documents added to the docket include:

(1) FAA Safety Recommendations 08.365, 08.366, and 11.216, which were written against the subject ECi cylinder assemblies;

(2) NTSB Safety Recommendation A-12-7, also written against the subject ECi cylinder assemblies;

(3) The original ECi AD worksheet for 2011-NE-42-AD, which documents the reasons for the proposed rule;

(4) A list of separations of ECi cylinder assemblies;

(5) A white paper 1 on failures of ECi cylinders by the FAA Chief Scientific and Technical Adviser (CSTA) for Engine Dynamics;

1 An authoritative report that informs readers about a complex issue.

(6) Figures showing ECi Dome Separation Failures;

(7) A briefing on “ECi Cylinder Head Failures on Continental IO 520 & 550 Engines”; and

(8) FAA Policy Memorandum on “Risk Assessment for Reciprocating Engine Airworthiness Directives,” dated May 24, 1999.

We notified the public of these actions on September 26, 2013, via the Federal Register (78 FR 59293). In that notification, we extended the comment period for the August 12, 2013, NPRM to December 11, 2013. This extension allowed the public additional time to comment on our August 12, 2013, NPRM and the additional information we had added to the docket.

We also determined that we needed to add to the docket a detailed regulatory flexibility analysis to estimate the effects of the proposed rule on small business entities. We published an Initial Regulatory Flexibility Analysis in Docket FAA-2012-0002 on March 12, 2014 (79 FR 13924).

September 3-4, 2014—Challenge Team's Review of August 12, 2013, NPRM

Because the response to our August 12, 2013, NPRM was so negative—we received over 500 comments, most disagreeing with the NPRM—we established a Challenge Team to review our proposed AD. The Challenge Team was an independent, multi-disciplinary team, consisting of three FAA CSTAs, FAA Aircraft Certification Service (AIR) managers, and other FAA technical experts from all four Directorates.

The Challenge Team reviewed the technical information that formed the basis for our proposed AD and the public comments we had received concerning our proposal. The CSTA for Aircraft Safety Analysis also independently computed a new risk assessment using the earlier failure reports, and the additional failure reports that we received from the public as comments to our August 12, 2013, NPRM.

Based on their review of this data and the new risk assessment of failures of affected cylinder assemblies, the Challenge Team determined that an AD was still required. But, they suggested changes to make compliance less aggressive and substantially reduce cost. Their recommended changes included revising the compliance schedule in favor of a phased removal schedule, clarifying that overhauled cylinder assemblies are included in the proposed phased removal schedule, eliminating the reporting requirement for removed cylinder assemblies, and removing the requirement for initial and repetitive inspection.

January 8, 2015—First Supplemental Notice of Proposed Rulemaking (SNPRM)

We adopted the Challenge Team's recommendations, and we then published them as an SNPRM in the Federal Register on January 8, 2015 (80 FR 1008) (referred to herein after as the “January 8, 2015, SNPRM”). The January 8, 2015, SNPRM proposed to modify the schedule for removal of the affected cylinder assemblies, added that overhauled affected cylinder assemblies be removed within 80 hours, eliminated a reporting requirement, and removed a requirement for initial and repetitive inspections.

We also responded in our January 8, 2015, SNPRM, to the several hundred comments that we received to the August 12, 2013, NPRM. Many of these comments were repetitious, so we grouped the comments and provided our responses to the different groups, depending on the nature of the comment. For example, some comments claimed that airplanes can operate safely with a separated cylinder head; others suggested that pilot error was causing cylinder head separations; and others recommended adopting less stringent compliance requirements. Each of these groups received our response to the group's comment.

June 9, 2015—Meeting With National Transportation Safety Board (NTSB)

The NTSB, in its comments to our August 12, 2013, NPRM; January 8, 2015, SNPRM; and in its Safety Recommendation A-12-07, did not fully support our approach to resolving the unsafe condition that is the subject of this final rule. Therefore, we met with the NTSB on June 9, 2015 to understand the technical basis for their recommendation and their technical objections to our proposed AD. At this meeting, we presented the NTSB the technical information upon which we based our AD as amended. Information that was reviewed included failure reports, the risk assessment by the FAA's CSTA for Aircraft Safety Analysis, FAA safety recommendations, and the data supporting our conclusion that field inspections had an insufficient probability of cylinder failure detection.

The NTSB noted in this meeting that Safety Recommendation A-12-7, and the NTSB's comments to the August 12, 2013, NPRM and the January 8, 2015, SNPRM, were based on the information available to them at that time. The NTSB also indicated it would reassess its recommendation and comments to our proposed rule based on the presentations and the supporting data that we had presented.

June 23, 2015—Additional Technical Documents Posted

We received additional comments to our August 12, 2013, NPRM and our January 8, 2015, SNPRM, requesting that we provide additional information that supports this AD. Commenters also requested that we identify the data that we relied on in drafting this AD and to explain why that data supported our conclusion that an unsafe condition exists. Based on these comments, we concluded that further additional public participation in our proposed AD was appropriate. Specifically, we concluded that we would post to the docket the additional technical information responsive to the comments. So, on June 23, 2015, we posted the additional technical information to Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). These documents provide further technical rationale for this AD. This additional technical information included:

(1) The risk analysis process conducted by the FAA's CSTA for Aircraft Safety Analysis—referenced in Docket No. FAA-2012-0002 as the “Proposed Airworthiness Directive for ECi Cylinders Risk Analysis Process,” referred to herein as the “risk analysis”;

(2) A risk analysis using the Small Airplane Risk Analysis (SARA) methods used by the FAA's Small Airplane Directorate (SAD)—referenced in Docket No. FAA-2012-0002 as “SARA Worksheet Systems/Propulsion”;

(3) A June 2011, presentation by AEC to the FAA concerning its ECi cylinder assemblies;

(4) A list of ECi cylinder assembly failure reports consisting of only those reports where both cylinder serial number and time in service are included in the reports;

(5) A list of additional failures of ECi cylinder assemblies reported by a maintenance organization; and

(6) AEC Technical Report 1102-13, dated April 30, 2011.

August 28, 2015—2nd SNPRM

We published a second SNPRM in the Federal Register on August 28, 2015 (80 FR 52212, referred to herein after as the “August 28, 2015, SNPRM”). The August 28, 2015, SNPRM retained the compliance requirements proposed by the January 8, 2015, SNPRM. We published the August 28, 2015, SNPRM to provide the public a final opportunity to comment on the proposed AD and the additional technical documentation we had added to the docket on June 23, 2015.

Also, since many commenters had cited NTSB support for their positions, we wanted to clarify our rationale for disagreeing with the compliance actions proposed by the NTSB in its Safety Recommendation A-12-7, and the NTSB's comments to the August 12, 2013, NPRM and the January 8, 2015, SNPRM.

The NTSB did submit a final comment to our August 28, 2015, SNPRM, that was posted to the docket on November 23, 2015. In the NTSB's final comment, the NTSB indicated that it now considers that our proposed compliance actions satisfy the intent of Safety Recommendation A-12-7. The information we covered with the NTSB, including copies of FAA presentations to the NTSB, were subsequently posted to Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket) on April 6, 2016.

Comments Introduction

We have, through the August 12, 2013, NPRM; the September 26, 2013, posting of additional information; our extension of the August 12, 2013, NPRM comment period; the January 8, 2015, SNPRM; and August 28, 2015, SNPRM, given the public the opportunity to participate in developing this AD. The public, as noted already, has participated deeply in this rule making; providing hundreds of comments.

This final rule includes our responses to any previously unaddressed comments to the August 12, 2013, NPRM and to the January 8, 2015, SNPRM, that we may have left without response, and to the August 28, 2015, SNPRM.

To organize comments and facilitate their review, we again grouped like comments and responses. These groupings in this final rule's comments section are:

(1) Comments to withdraw or revise the SNPRMs for technical reasons—these comments, and the resulting groupings, were similar to those we used in responding to the August 12, 2013, NPRM. They include, for example, requests to withdraw the SNPRM because the commenters claim that ECi cylinder assemblies are not unsafe; airplanes can operate safely with a separated cylinder head; or the root cause of cylinder failure is unknown.

(2) Comments to the FAA's risk assessment processes and policies—these comments generally asserted that the SNPRMs should be withdrawn because the FAA had not appropriately followed its risk assessment processes and policies in determining that the failure of ECi cylinder assemblies represents an unsafe condition.

(3) Comments to the FAA's rulemaking processes—these comments generally requested that the SNPRMs be withdrawn, alleging that the FAA had failed to follow its rulemaking processes and was adopting a rule that is “arbitrary and capricious.”

(4) Comments to the cost of compliance—these comments indicated that the cost of compliance to this AD was higher than the FAA has estimated and will have a substantial effect on small entities.

(5) Administrative comments—these were generally comments that did not pertain to the substance of this AD, such as requests for names and phone numbers of FAA personnel involved in this rulemaking.

(6) Support for the SNPRMs—these were comments in support of issuing the SNPRMs.

A. Comments To Withdraw or Revise the SNPRMs for Technical Reasons Request To Withdraw the SNPRMs Because ECi Cylinder Assemblies Are Not Unsafe

Comment. Several organizations and individuals, commenting to the August 12, 2013, NPRM, commented also to the January 8, 2015, and August 28, 2015, SNPRMs, that the affected ECi cylinder assemblies have an equivalent, or lower, failure rate than that of cylinder assemblies manufactured by the original equipment manufacturer (OEM). The commenters also indicated that there have been no failures of ECi cylinder assemblies in the last 3 years. These commenters request the FAA withdraw this AD because they believe that the ECi cylinder assemblies are not unsafe.

Response. We disagree. The rate of separation for the affected ECi cylinder assemblies is at least 32 times greater than that of OEM cylinder assemblies over the same period. Although there are approximately four times as many OEM cylinder assemblies in service than ECi cylinder assemblies, the ECi cylinder assemblies suffered more cylinder head separations than OEM cylinder assemblies since 2004. This data is available for review in Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). In addition, we have continued to receive field reports of failures of the affected cylinders in the past three years. We did not withdraw the August 28, 2015, SNPRM.

Comment. Commenters also questioned the validity of the data that the FAA used to justify the proposed AD.

Response. We interpret the comment as suggesting that the data used to justify the rule is not valid. We disagree. We used warranty reports from ECi and RAM Aircraft, which is a major overhauler of CMI engines, STC holder for an increased horsepower version of the affected model engine, and the largest user of the affected ECi cylinders. We also used service difficulty reports (SDRs), and other field service reports regarding ECI cylinder separations. We did not withdraw the August 28, 2015, SNPRM.

Comment. The IPL Group LLC (IPL Group) commented that the FAA has mischaracterized “quality enhancements” in production as “design changes.” IPL Group noted that ECi had applied experience gained during manufacturing, as well as through service feedback, to make quality improvements in production and the changes made to the design data were not due to design deficiencies.

Response. We disagree. We correctly stated that ECi has made increases in the dome transition radius through cylinder serial number 33697, and has made incremental increases in the head-to-barrel interference fit at least through cylinder serial number 61177 (see Airmotive Engineering Technical Report 1102-13) to address the two identified inherent design deficiencies associated with the effected cylinder assemblies. These changes are design changes. We did not withdraw the August 28, 2015, SNPRM.

Comment. RAM Aircraft commented that when it submitted its December 9, 2013, comment, it calculated the likelihood of a cylinder separation. RAM Aircraft indicated it provided a significant amount of data that proves that the likelihood of a cylinder separation is “extremely remote.” RAM commented that at that time their data showed one cylinder separation for every: 21,808 multi-engine aircraft flight hours, or 172 average years of active service; and 42,057 single engine aircraft flight hours, or 455 average years of active service. Further, that the fleet of aircraft using the cylinders subject to the January 8, 2015, SNPRM have continued to fly for an additional 14 months since December 9, 2013. RAM Aircraft indicated that there is no doubt that both the 21,808 multi-engine aircraft flight hour number, and the 42,057 single engine aircraft flight hour number, would both be now much larger, thereby, further reducing the likelihood of a cylinder separation.

Response. We disagree. RAM Aircraft's data does not substantiate its claimed failure rate. Without knowing the total number of hours flown on all affected cylinders, it is not possible to accurately calculate an hours-based failure rate. This data is not available for general aviation aircraft. We, therefore, find RAM Aircraft's estimate to be unreliable. We did not withdraw the August 28, 2015, SNPRM.

Comment. RAM Aircraft also indicated that a statement by the FAA in the January 8, 2015, SNPRM regarding numbers of failures of affected cylinder assemblies was grossly misleading. RAM Aircraft assumes that the FAA is referring to reports entered via the SDR system. RAM Aircraft indicated that it has provided evidence in an earlier comment that not every piece of information in the SDR system can be taken at face value. With respect to this SNPRM, RAM suggested that it is very important to distinguish between the “SNPRM failure modes” (quotations not in original comment) and other types of “nuisance” cracks that are common occurrences in all manufacturer's air-cooled aircraft cylinders. The SNPRM failure modes do not include cracks between spark plug holes, valve seats, injector ports, etc. There is no doubt that the “hundreds of failures” referenced by the FAA were never researched to determine which were of the SNPRM failure mode and which were of the “nuisance” variety.

Response. We disagree. Our response in the January 8, 2015, SNRPM is not misleading. On the contrary, under-reporting of cylinder assembly cracks in the SDR system further reinforces the need for this AD. Further, the FAA did not include the SDR failure reports referred to by the commenter as of the “nuisance” variety in the list of separations that were used to substantiate the need for this AD. We did not base this AD on nuisance cracks in the affected cylinder assemblies. We did not withdraw the August 28, 2015, SNPRM.

Comment. One commenter stated that the separated cylinders that were determined to be the precipitating root cause events for the two fatal accidents cited by the FAA in the January 8, 2015, SNPRM were overhauled cylinders, so they therefore should not be considered in the determination as to whether or not the proposed corrective action should be implemented.

Response. We disagree. The ECi cylinder heads, P/N AEC 65385, of the separated cylinder assemblies that precipitated the two referenced fatal accidents were of the same type design and within the same affected cylinder assembly serial number range as are used in new ECi cylinder assemblies. The cast and then machined aluminum cylinder head shrink band region has the predominant features that define the final interference fit of the overall cylinder assembly, not the steel barrel. This is further supported by the fact that the design changes that ECi made to the interference fit were accomplished by modification of the cylinder head. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings commented that the FAA should withdraw the August 28, 2015 SNPRM because the FAA failed to establish that the affected product, i.e., the ECi cylinder assemblies, do not meet the established minimum safety standards established by 14 CFR part 33.

Response. We disagree. The operational history of the affected ECi cylinder assemblies established that the affected ECi cylinder assemblies present an unacceptable compromise to safety, an unsafe condition, when installed in operating aircraft engines. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings also stated that the “same unsafe condition” that is addressed by this AD is present in the cylinders of all manufacturers and that the FAA failed to consider similar failures of the OEM cylinders.

Response. We disagree. The affected ECi PMA cylinders have separated at a significantly higher rate than the OEM cylinders over the same service period since the ECi PMA cylinders entered service. ECi itself identified two root causes for the separations. See AEC Technical Report 1102-13 in Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket) which recommends withdrawal from service of the affected ECi cylinders. We compared the number of separations of these affected ECi PMA cylinders to the number of OEM separations over the same service period, since the ECi PMA cylinders entered service in meaningful numbers. Over the same period of time the affected ECi PMA cylinders and OEM cylinders were in service, the ECi cylinders experienced eight times the number of OEM separations, even though only one-quarter as many ECI cylinders were in service as the OEM's. Further, the SDR database does not reveal similar separation rates or similar failure modes for OEM cylinders. Therefore, we have no reason to regard the OEM cylinder assemblies as subject to the same or similar unsafe condition. We did not withdraw the August 28, 2015, SNPRM.

Request To Withdraw the SNPRMs Because Airplanes Can Operate Safely With a Separated Cylinder Head

Comment. Several commenters indicated that we should not issue this AD because airplanes can continue to operate safely even after a cylinder head separation.

Response. We disagree. An in-flight cylinder head separation is an unsafe condition that presents multiple secondary effects. For example, in-flight fire and loss of aircraft control. Accident data confirms that separated cylinders have also been a precipitating event in fatal accidents. Therefore, the safety consequences represented by a cylinder head separation in flight are significant, and represent an unsafe condition appropriate for an AD. We did not withdraw the August 28, 2015, SNPRM.

Comment. Several commenters added that airplane engines are designed and certified to safely operate with one failed cylinder.

Response. We disagree. Applicants are not required to show that their engines are designed to operate with one cylinder failed or with a separated cylinder, nor that doing so constitutes safe operation of an engine. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Aerospace commented that the docket contains evidence from RAM Aircraft that valid and verifiable testing establishes that a head-to-barrel separation results in less than 20 percent power loss to the engine.

Response. We disagree. The RAM Aircraft testing that is included in Docket FAA-2012-0002 only quantified the horsepower output per cylinder. The RAM Aircraft testing was of an uninstalled engine in a test cell and RAM Aircraft did not attempt to assess the impact of reduced engine horsepower output on airplane level performance. We estimate that a 20% reduction in engine horsepower on a single-engine airplane results in a nearly 40% reduction in aircraft rate of climb, which is a hazardous condition. It is also a potentially hazardous condition for twin-engine airplanes due to the resultant asymmetric thrust condition. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Aerospace indicated that FAA guidance material does not define this condition as “hazardous” in the certification process.

Response. We interpret the comment to be that the FAA has no definition of hazardous event that includes loss of one cylinder in a six-cylinder engine, within the engine certification regulations (14 CFR part 33). We agree. The certification process does not define “hazardous events.” The FAA establishes through the engine certification process the minimum standards that an engine needs to meet to be considered airworthy. For example, § 33.19 establishes durability standards that are designed to minimize the development of an unsafe condition between overhaul periods. These minimum safety standards must also be met by PMA parts, either through establishing identicality or through test and computation. FAA Policy PS-ANE100-1997-00001, provides guidance for the certification of PMA applications for reciprocating engine critical, highly stressed or complex parts, including, but not limited to crankshafts and cylinder heads. We did not withdraw the August 28, 2015, SNPRM.

Comment. RAM Aircraft commented that it has run tests that substantiate and document the power loss as a “minor power loss” in the event of a cylinder separation.

Response. We interpret the comment to be that any power loss from cylinder head separation is only minor. We disagree. The loss of one cylinder's power would equate to approximately a 17 to 20% reduction in engine horsepower output. Further, loss of a cylinder at critical phases of flight, for example, during climb-out where like here, the failure is at increased probability of occurring, produces a power loss sufficient to result in a 40% reduction in airplane rate of climb. This would constitute a hazardous condition during a critical phase of flight like departure/climb. We did not withdraw the August 28, 2015, SNPRM.

Comment. RAM Aircraft suggested that this minor power loss would be classified as a “minor hazard,” based on guidance from the FAA's “Policy Statement on Risk Assessment for Reciprocating Engine Airworthiness Directives” (PS-ANE100-1999-00006). According to the FAA policy statement, minor hazards are candidates for AD action only when the probability of the event is very high.

Response. We disagree. FAA policy classifies service problems that do not result in a significant power loss, such as a partial power loss, rough running, pre-ignition, backfire, single magneto failures, as “minor.” We found that cylinder separations results in a 17 to 20% reduction in engine horsepower output results in an approximately 40% reduction in airplane excess power, which translates into a 40% reduction in airplane rate of climb. This constitutes a hazardous condition that is not a “minor hazard.” We did not change this AD based on this comment.

Comment. RAM Aircraft commented that Appendix VI of the SAD Airworthiness Directives Manual Supplement includes examples of conditions that potentially have a “minor” affect. The loss of one engine (multi-engine aircraft) is listed as a condition with a “minor” effect. Given the “minor” effect of the loss of one engine and the likelihood of the cylinder separation being extremely remote, then this AD should not be issued against multi-engine aircraft.

Response. We disagree. By comparing the risk analysis computed by the CSTA for Aircraft Safety Analysis with either the Small Airplane Risk Analysis guidelines used by the SAD or the Engine and Propeller Directorate (E&PD) Continued Airworthiness Assessment Process (CAAP) Handbook guidelines, demonstrates that an AD is needed for both single and twin-engine aircraft. We did not withdraw the August 28, 2015, SNPRM.

Comment. RAM Aircraft commented that they are not aware of any substantiated fact of a “fire,” or any other significant consequence of a cylinder head separation. Further, RAM Aircraft noted that in its May 12, 2014, comment, it had documented the research it had done to refute the “rumor” of a fire resulting from a cylinder head separation of an ECi cylinder.

Response. We disagree. RAM Aircraft itself submitted data to the FAA indicating that a fire could occur from cylinder head separation. FAA requested to see that information. FAA's subsequent visit to RAM Aircraft confirmed that a failed cylinder caused an in-flight fire on a Cessna 414 airplane. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Aerospace cited FAA documents that indicate that the design of an aircraft engine, for reciprocating engines, should incorporate mitigating features. For example, Danbury quoted SAD Standards Staff (ACE-110) Memorandum, dated May 6, 1986, and an E&PD Standards Staff (ANE-110) memorandum, dated May 24, 1997.

Response. We agree. However, the regulatory requirement for a designer to mitigate a possible reciprocating engine failure prior to certification is different than correcting an unsafe condition found to exist after certification. This AD addresses an unsafe condition—cylinder head separation, found after certification. A regulatory requirement to mitigate in the aircraft design an engine failure is not the subject of this AD. We did not withdraw the August 28, 2015, SNPRM.

Comment. IPL Group commented that we were misusing the term “catastrophic” when describing the effects of potential cylinder failures.

Response. We disagree. As to the use of “catastrophic,” we did not use the term in the August 12, 2013, NPRM, the two SNPRMs, or in this final rule AD. We did not change the August 28, 2015, SNPRM based on this comment.

Comment. IPL Group argued that a cylinder head separation does not cause an unsafe event and that there is “zero evidence” in Docket No. FAA-2012-0002 to support the showing that a failed cylinder causes an unsafe condition.

Response. We disagree. Cylinder separations can cause partial or complete engine failure which can cause a subsequent loss of power and control of the airplane. Loss of control of the airplane may result in the loss of the airplane and injuries or death. Additionally, we note the NTSB has stated that cylinder head separations could result in a loss of control of the airplane (see NTSB's comment to “Docket No FAA-2008-0052; Directorate Identifier 2008-NE-01-AD, dated September 25, 2009”). We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings commented that the FAA had not provided any information to substantiate the FAA's position that cylinder separations have a “significant” effect on airplane safety or that cylinder separations would result in a fire.

Response. We disagree. The impact of a cylinder separation in-flight is an unacceptable compromise to safety. To clarify this point, we changed the AD to use “unacceptable.” We disagree that cylinder head separations might not result in fire. Cylinder separations can result in engine failure and/or fire. As an example, on November 29, 1987, a Piper PA-46 airplane experienced a cylinder head separation followed by an in-flight fire. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings also stated that the FAA did not issue a similar AD against the OEM cylinder assemblies because the OEM manufactured more such cylinder assemblies.

Response. We disagree. The FAA did not mandate actions similar to those specified in this AD against the OEM cylinders because the OEM cylinders do not have the inherent design deficiencies that the ECi PMA cylinders have. Also, the service history of the OEM cylinders indicates that the OEM separation rate is approximately 32 times lower than the ECi cylinders. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings further commented that ADs are never justified for any cylinder manufacturer.

Response. We interpret the comment as suggesting that we should not issue an AD when engine design deficiencies related to cylinders are found. We disagree. Cylinders are engine parts whose structural failure can result in a degradation to or total loss of, engine power output, and loss of control of an airplane. Cylinder separations aloft can also cause an in-flight fire. We will exercise our regulatory arm to issue ADs when we determine doing so is necessary to resolve an unsafe condition in a product. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Aerospace commented that 14 CFR part 33.43 requires assessment of crankshaft vibration for one cylinder not firing because the condition is not an engine failure event condition.

Response. We disagree. As we noted in our January 8, 2015, SNPRM, 14 CFR part 33 does not require continued safe operation following a cylinder separation or following any other engine structural failure. Section 33.43(d), addressing the engine vibration survey of § 33.43(a), requires assessment of crankshaft vibration for an engine that has one cylinder that “is not firing.” We require vibration testing with a critical cylinder inoperative because it is a failure condition where stresses may exceed the endurance limit of the crankshaft material. We need to know the speed ranges where the excessive stresses occur so operational information may be provided to flight crews so they can avoid these speed ranges when a cylinder is inoperative. We did not withdraw the August 28, 2015, SNPRM.

Request To Withdraw the SNPRMs Because Root Cause of Cylinder Failure Is Unknown

Comment. Several commenters indicated that the FAA has failed to identify the root cause(s) of cylinder head separations.

Response. We disagree. We have identified the root cause of cylinder failure as design deficiencies inherent in the affected ECi cylinder assemblies. These ECi cylinder assemblies have two inherent design deficiencies: Insufficient dome radius and insufficient head-to-barrel interference fit. These design deficiencies are identified in AEC Technical Report 1102-13, dated April 30, 2011, that we posted to Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). We did not withdraw the SNPRMs.

Comment. Danbury Aerospace commented that root cause analysis is absolutely essential to determining compliance with regulations and if an unsafe condition has been created. Therefore the agency has not properly identified the unsafe condition.

Response. We disagree. We identified the unsafe condition in the engine: Cylinder head separation. The purpose of this AD is to correct that unsafe condition. We also identified that cylinder head separations are due to at least two inherent design deficiencies. All cylinders prior to S/N 33697 have insufficient dome transition radius, and all cylinders prior to S/N 61177 insufficient head-to-barrel interference fit. ECi characterized both of these as “inherent design deficiencies” in its AEC Technical Report 1102-13. We did not withdraw the August 28, 2015, SNPRM.

Request To Withdraw the SNPRMs Because Pilot Error Is Causing Cylinder Head Separations

Comment. Danbury Aerospace and Danbury Holdings commented that cylinder head separations involving the ECi cylinder assemblies affected by this AD were caused by excessive CHTs, presumably caused pilot error, rather than by design deficiencies of the cylinder assemblies.

One operator observed that operators who use the ECi cylinder assemblies and operate them within limits and with good instrumentation are not having issues. This operator noted that everyone, with the exception of the FAA, believes that overheating beyond CHT limits by operators has a direct effect on cylinder head separation.

Response. We disagree. Although pilot error may cause excessive CHT, we have no data to suggest it is the cause of the unsafe condition that is the subject of this AD. If pilot error results in excessive CHT, which leads to cylinder head separation, then we would expect to see similar damage in engines with other than ECi cylinder assemblies installed where the pilots exceeded the same limitation(s). However, we do not have any such data. Also, we have no evidence that either intentional or inadvertent exceedance of CHT limits has caused cylinder separation. Further ECi identified several design deficiencies in AEC Technical Report 1102-13, dated April 30, 2011.We did not withdraw the SNPRMs.

Request To Withdraw the SNPRMs Because of the Risk of Maintenance Errors

Comment. Several commenters commented that the FAA should withdraw the SNPRMs because the removal and replacement of affected cylinder assemblies before time between overhaul (TBO) would result in maintenance errors that would adversely affect safety. For example, IPL Group indicated that replacement of the cylinder assemblies would likely result in events of main bearings losing clamp-up and turning, resulting in cylinder through-bolt and flange stud failures, which would likely result in total engine failure.

Response. We disagree. Our regulatory framework presumes that maintenance will be performed correctly by experienced personnel authorized by the FAA to return aircraft to service in an airworthy condition. Further, we have not observed any negative effects on safety due to removal of these cylinder assemblies during maintenance. Also, cylinder removal and replacement is a maintenance action addressed in engine maintenance manuals. We did not withdraw the SNPRMs.

Request To Justify 80-Hour Removal Requirement for Overhauled Cylinder Assemblies

Comment. Danbury Aerospace and Danbury Holdings requested that the FAA provide evidence (including engineering analysis) supporting its conclusion that overhauled cylinder assemblies should be removed within 80 hours after the effective date.

Response. We interpret the comment to be that the commenters disagree that the phased removal plan required by this AD is appropriate. We disagree. This AD mandates a phased removal of affected cylinders with the intent to retire all affected cylinders by initial TBO. The FAA recognizes that some cylinders in service may already have exceeded their initial TBO. Metal fatigue damage is cumulative, and the longer a cylinder head remains in service, the more likely it will fail due to one of the inherent design deficiencies. Overhauled cylinders have likely experienced more load and temperature cycles than lower time cylinders and the total time in service since new of overhauled cylinders often cannot be determined. Our determination of 80 hours is supported by our Challenge Team's findings and our risk analysis that we uploaded to FAA Docket No. FAA-2012-0002 (see Addresses section of this final rule for information on locating the docket). We did not change this AD based on this comment.

Comment. Danbury Aerospace and Danbury Holdings also stated that the FAA had not substantiated that the overhaul of a cylinder does not reduce the existing fatigue damage that a cylinder may have incurred while in service.

Response. We disagree. Fatigue strength of metal alloys operated at high temperatures continuously decreases with cycles until failure. This is particularly true for aluminum alloys, including the aluminum alloy used to cast cylinder heads. Metallic structural elements that are operated at high temperatures are more susceptible to time dependent fatigue. The overhaul of a cylinder assembly does not reverse the fatigue damage that had been previously accumulated in the aluminum cylinder head casting. We did not change the AD based on this comment.

Request To Revise Applicability

Comment. Danbury Holdings commented that the FAA has no evidence that all cylinders through S/N 61176 are at risk for separation in the first thread due to insufficient head-to-barrel interference fit.

Response. We disagree. The SDR database and other field reports document instances of first-thread failures of cylinders manufactured to design data applicable to all cylinders prior to S/N 61177. For this reason, all cylinders through S/N 61176 are subject to the corrective actions of this AD. We did not change this AD based on this comment.

Comment. One commenter stated that he has an O-470 engine converted by P. Ponk Aviation to the equivalent of an O-520 engine. He indicated that those engines should not be affected by this AD.

Response. We disagree. The affected S/N cylinders are installed on -470 engines, as well as the -520 and -550 engine models. Any engine that uses one of these affected cylinders is at risk. We have received at least one report of a separation of these affected S/N cylinders on -470 engines. Although the unmodified -470 engines have lower engine horsepower output, their brake mean effective pressure (BMEP) is actually higher than that of the -520 and -550 engines. BMEP is proportional to the ratio of horsepower per cubic inch of displacement. Therefore, the actual operating stresses in the same cylinder wall are even higher when these same cylinders are installed in an unmodified -470 engines than it would be for either the -520 or the -550 engines. The P. Ponk Aviation STC increases the displacement of the unmodified -470 engine to -520 cubic inches by installing the -520 cylinders on the -470 engine. Given that no valid sensitivity analysis exists showing the relationship of BMEP to fatigue life of these cylinders, and since the crack propagation rate is also unknown, we have included all the -470 engines, including those modified by the P. Ponk Aviation STC, in the effectivity of this AD. We did not change this AD based on this comment.

Request To Adopt Less Stringent Compliance Requirements

Comment. AOPA, RAM Aircraft, as well as operators and private citizens, requested that we adopt less stringent requirements than those in the proposed AD. The commenters indicated that the affected cylinder assemblies should be inspected at regular intervals, but removed at TBO. For example, one commenter suggested recurring inspections every 60 hours. Several commenters cited the NTSB in support of its recommendation. RAM Aircraft commented that the FAA may be jumping to conclusions by eliminating these inspections. RAM Aircraft noted that the failure of a compression/soap test to detect a particular crack in a cylinder assembly on several occasions does not mean that the test will fail to detect cracked cylinders on most occasions. By their very nature and design compromises, i.e., steel barrels to contain the forces of combustion combined with lighter cylinder head alloys to reduce weight so that aircraft engines have commercial viability and value, and the harsh conditions, altitudes, and temperatures in which they operate, reciprocating aircraft engine cylinders will inevitably crack. RAM Aircraft indicated that there is no question but that some cylinders are going to crack, and that therefore, they must be properly operated, maintained, and inspected.

Response. We disagree. Repetitive inspections until TBO, as suggested by the commenters, do not adequately address the unsafe condition in this particular case. Repetitive inspections would not detect cracks until they have already progressed completely across the cylinder head wall thickness.

Several operators and mechanics have reported that they successfully passed the compression/soap test with a partially separated cylinder. Others have reported that they successfully passed the compression/soap test and then experienced an in-flight separation before the next scheduled 50-hour inspection.

Therefore, we conclude that these tests are not sufficiently reliable. Also, engine overhaul is not a requirement for all operators. Therefore, tying the proposed recurrent inspection to engine overhaul would not resolve the unsafe condition. Based on its comment to the August 28, 2015, SNPRM, we know that the NTSB now considers this rule consistent with the rationale they have provided in the past in support of NTSB Safety Recommendation A-12-7 regarding these affected cylinder assemblies (Reference NTSB Comment FAA-2012-0002-0653, dated September 24, 2015 in Docket FAA-2012-0002). We did not change this AD based on this comment.

Comment. One commenter indicated it was incorrect to apply the same requirement to remove the cylinders at specified intervals to different CMI engine models. He noted, for example, that the TSIO-520-J engine that is allowed to produce 36 inches of manifold pressure and 310 horsepower will produce less stress on a cylinder head than a TSIO-520-NB engine that is allowed 41 inches of manifold pressure and 325 horsepower, as installed on a Cessna 414 airplane.

Response. We disagree. Service history indicates that the affected cylinder assemblies have cracked on -470, -520, and -550 engine models. The AD, therefore, applies to all affected CMI -470, -520 and -550 engine models. We have no engineering analysis or test data to justify varying compliance times by engine model or applying the corrective actions of this AD to only the higher power engines. We did not change this AD based on this comment.

Comment. Danbury Aerospace observed that the average number of cylinder assemblies, P/N AEC 631397, in the serial number range in the January 8, 2015, SNPRM that are still in operation have less than 500 hours left to TBO. Danbury Aerospace indicated that the early removal of these cylinders is not justified by a statistical analysis developed in accordance with the E&PD CAAP Handbook.

Response. We disagree. We do not know the exact number of total hours TIS for each affected cylinder assembly. We have no data to support the claim that the existing fleet of cylinder assemblies already has accumulated 1,200 or more hours TIS. Service history also shows that most of the separations occurred well before initial TBO. Therefore, removal of the affected cylinder assemblies before TBO is appropriate. We did not change this AD based on this comment.

Comment. Danbury Holdings commented that the FAA had not provided evidence that there have been separations within the originally proposed 50-hour recurrent compression test/soap inspection interval.

Response. We disagree. We received several field reports of cylinder separations occurring within 50 hours of passing either the originally proposed 50-hour recurrent compression test/soap inspection in the August 12, 2013, NPRM. SDR report No. SQP2011F00000 was submitted by a part 135 operator who operated a Cessna T210N with an affected ECi cylinder assembly installed. The operator reported that on September 9, 2011, that affected ECI cylinder head separated at the 5th cooling fin on-head. At the time of the failure, the engine and failed cylinder had 817.6 hours time since overhaul/time since new, and its last compression check inspection was at 19.2 hrs. prior. Other field reports also document separated cylinders (for example, see SDR Report 2010FA0000179) that recently passed the compression test/soap inspections. We did not change this AD based on this comment.

Comment. One commenter commented that, based on his experience, ECi has an aluminum head cracking issue and that these cylinders seem to crack more than CMI cylinders. The commenter further indicated that he believed the number of cylinder failures is underreported in the SDR database. The commenter further noted that in his 30 plus years of aircraft maintenance experience, he has never seen a cylinder failure rate this high. The commenter welcomed an AD that requires these cylinders to be inspected at around 100 hours and the reports of cracks sent to an FAA database.

Response. We note the comment. We agree that the ECi failure rate is much higher than the OEM failure rate over the same field service period and that cylinder cracks are under-reported. For example, many of the RAM failures listed in the docket were not reported under the SDR system or as required by 14 CFR 21.3. We did not change this AD based on this comment.

Comment. RAM Aircraft commented that, based on its previous comments, the FAA should withdraw the SNPRMs. RAM Aircraft recommended that the FAA consider education and requiring inspections of all reciprocating airplane engine cylinders on the terms and conditions the FAA determines to be appropriate.

Response. We disagree. Our analysis indicates that an AD is required to resolve the unsafe condition presented by installed affected ECi cylinder assemblies. We did not withdraw the SNPRMs based on this comment.

Comment. One commenter suggested that users of a JPI or other engine monitoring system should be subject to a different compliance interval.

Response. We disagree. As noted previously, the root cause of these cylinder failures are design deficiencies. The affected cylinders may fail without overtemping. Therefore, use of an engine monitoring system like JPI would be insufficient to detect the unsafe condition. We did not change this AD based on this comment.

Request To Use Mandatory Service Bulletin Instead of This AD

Comment. One commenter requested that the FAA use a mandatory service bulletin instead of this AD to implement corrective action.

Response. We disagree. Requiring a manufacturer to issue a mandatory service bulletin is outside the scope of the FAA's authority. We did not change this AD based on this comment.

B. Comments to the FAA's Risk Assessment Processes and Polices Request That the FAA Follow Its Own Risk Assessment Policies and Guidance

Comment. Multiple commenters, including Danbury Aerospace, Danbury Holdings, and the Aeronautical Repair Station Association (ARSA) commented that the FAA did not follow its own risk assessment policies and guidance, such as FAA Order 8110.107A, Monitor Safety/Analyze Data (MSAD), dated October 1, 2012, and FAA Order 8040.4A, Safety Risk Management Policy, dated April 30, 2012, and the E&PD CAAP Handbook, dated September 23, 2010.

Response. We interpret this comment as a comment that we failed to follow FAA Order 8110.107A, FAA Order 8040.4A, and the CAAP Handbook. We disagree. We performed the process as required by FAA Order 8110.107A, Monitor Safety/Analyze Data (MSAD), dated October 1, 2012, to analyze data and determine corrective action for continued operational safety issues. We acquired the failure event data from the MSAD, SDR, NTSB databases, ECi, and outside sources. We conducted a hazard criteria analysis where we filtered the data to identify relevant events. We performed a qualitative preliminary risk assessment and determined that this safety problem required corrective action. We performed risk analyses in conjunction with the E&PD risk assessment criteria. We identified that the ECi model separations have two inherent design deficiencies: Insufficient dome radius and insufficient head-to-barrel interference fit. Finally, we coordinated with our Corrective Action Review Board, which determined and agreed to the proposed corrective action in our August 12, 2013, NPRM.

Later, as part of the Challenge Team's meeting in September, 2014, the CSTA for Aircraft Safety performed a risk analysis that confirmed the need for this AD and shaped its compliance plan. We compared the results of the CSTA's risk analysis to the guidelines used by the SAD in its SARA and to the guidelines in the E&PD's CAAP Handbook and determined that an AD is required.

FAA Order 8040.4A requires a risk assessment methodology as outlined in the Order. FAA Order 8040.4A notes that the safety risk is a composite of two factors: The potential “severity” or worst possible consequence(s) or outcome of an adverse event that is assumed to occur, and also the expected frequency of occurrence or likelihood of occurrence (failure rate) for that specific adverse event. Each of these factors is assessed independent of the other and then entered as separate inputs into a risk matrix that yields an overall level of risk for the event.

We performed the risk assessment required by FAA Order 8040.4A and concluded that this AD was necessary. Therefore, our August 12, 2013, NPRM, as revised by the January 8, 2015 SNPRM, and as republished on August 28, 2015, are consistent with FAA Order 8040.4A, FAA Order 8110.107A, and the CAAP Handbook. We did not change this AD based on this comment.

Comment. Commenters, including Danbury Holdings, commented that the FAA should not have included the failure rate of the affected ECi cylinders in the FAA risk assessments that were used to substantiate the need for the corrective actions in this AD. Danbury Holdings indicated that the failure rate is irrelevant to the unsafe condition.

Response. We disagree. We did not use the failure rate in the risk analysis, however, we used the number of reported failures. A risk analysis involves using past data; both successful operation as well as failures (including cracks), to develop a relationship between part parameters, including age and usage, and risk of failure. Therefore, our use of failures was appropriate in this risk analysis. We did not change this AD based on this comment.

Comment. Danbury Aerospace commented that the FAA ignored its own standards for what constitutes an unsafe condition and therefore has failed to identify one.

Response. We disagree. The FAA followed its standard risk analysis processes in determining that the unsafe condition represented by the affected ECi cylinder assemblies exists. 14 CFR part 39 prescribes that we issue an AD when an unsafe condition exists in a product and that condition is likely to exist or develop in other products of the same type design. We did not change this AD based on this comment.

Comment. Danbury Holdings commented that the basis for the FAA's risk analysis is seriously flawed because the unsafe condition must be the basis for the failure, not one unsubstantiated fatality.

Response. We disagree. The unsafe condition in the engine presented by the presence of affected ECi cylinders is the basis of this AD. We did not change this AD based on this comment.

Comment. Danbury Holdings further commented that the FAA had failed to establish a connection between the cylinder separation issue addressed by this AD and the official reports of the two fatal accidents that the FAA references.

Response. We disagree. Reports by the Bahamas Department of Civil Aviation and the NTSB establish that these accidents in the Bahamas and in Swanzey, New Hampshire involved separated ECi cylinders (see Report AAIPU# A10-01312 and NTSB Accident Report No. NYC02FA178, respectively). We have determined that the separation of the affected ECi cylinder assemblies represents an unsafe condition. We are not required to establish any further connection with these accidents. We did not change this AD based on this comment.

Comment. Danbury Holdings added that the FAA should not have included the fatal accident in the Bahamas in the FAA's risk assessments because the NTSB full narrative for that accident (ERA11WA008) made no mention of a cylinder separation.

Response. We interpret the comment as the fatal accident in the Bahamas is not relevant to this AD. We disagree. As noted in the previous comment response, we have determined that the separation of the affected ECi cylinder assemblies, as occurred in the accident in the Bahamas, represents an unsafe condition. We did not change this AD.

Comment. Danbury Holdings also stated that the root cause of the other fatal accident, the Swanzey, New Hampshire, accident (see NTSB Accident Report No. NYC02FA178) that the FAA included in its risk assessments was unsafe and improper operation of the airplane by the pilot not cylinder separation.

Response. We disagree. As noted in the preceding comment discussion, we have determined that the separation of the affected ECi cylinder assemblies, as occurred in the accident in Swanzey, New Hampshire, represents an unsafe condition and is therefore relevant to this AD. We did not change this AD based on this comment.

Comment. Danbury Aerospace added that the accident in the Bahamas should not be included in the FAA's risk analysis because: (1) It did not concern a U.S.-registered aircraft and therefore cannot be used in this rulemaking; (2) loss of control and uncontrolled flight was cited as the cause; and (3) even if the accident could be included, it does not meet hazard level thresholds required for rulemaking.

Response. The commenter presents three comments, which have three parts. We disagree with all three parts. As to part one, the Bahamas accident involved a U.S.-type certificated product, an engine with affected ECi cylinders installed. Therefore, the product is the proper subject of this AD. As to part two, the accident involved an engine with an ECI cylinder separation, a failure of a part of the engine, during flight. A cylinder separation during flight represents an unsafe condition in the engine. Therefore, our action in issuing this AD is appropriate. As to the part three, the cylinder failure presented a hazard to the engine and an unsafe condition, and therefore, meets the threshold for an AD. The need for this AD was confirmed by comparing the result of the risk analysis to the guidelines in the SAD's SARA and the E&PD's CAAP Handbook. We did not change this AD based on this comment.

Request That the FAA Define Guidelines Used To Define an Unsafe Condition

Comment. Danbury Holdings commented that the FAA had not defined the guidelines that it used to establish the existence of an unsafe condition.

Response. We interpret the comment to be a request to identify what guidance defines an unsafe condition. The comment therefore, is not to the technical merits of this AD, but a request for general guidance. As such, a response is unnecessary per the Administrative Procedures Act (APA), and we recommend that the commenter seek his answer through a direct request to the FAA Aircraft Certification Service or Flight Standards Division. We did not change this AD based on this comment.

Request To Withdraw the August 28, 2015, SNPRM Because Supporting Documents Do Not Support Issuing This AD

Comment. Danbury Holdings commented that the documents provided by the FAA in Docket No. FAA-2012-0002 do not support issuance of this AD. The supporting documents referred to by Danbury Holdings are: (1) The risk analysis conducted by the FAA's CSTA for Aircraft Safety Analysis; (2) a risk analysis using the Small Airplane Risk Analysis (SARA) methods; (3) a June 2011, presentation by Airmotive Engineering to the FAA concerning its ECi cylinder assemblies; (4) a list of ECi cylinder assembly failure reports consisting of only those reports where both cylinder serial number and time in service are included in the reports; (5) a list of additional failures of ECi cylinder assemblies reported by a maintenance organization; and (6) Airmotive Engineering Corporation Technical Report 1102-13, dated April 30, 2011.

Response. We disagree. The supporting documents that Danbury Holdings referred to, identified above, support that the FAA followed its process and were used to help determine that an unsafe condition exists. We have also uploaded additional documents to Docket No. FAA-2012-0002 on June 23, 2015 (see ADDRESSES section of this final rule for information on locating the docket).

The risk analysis performed by the FAA's CSTA for Aircraft Safety Analysis, recommends removal and replacement of the affected ECi cylinder assemblies as specified in this AD. The SARA applied to failures of ECi cylinder assemblies confirms that an AD is necessary. AEC Technical Report 1102-13 states that a root cause for the first thread separations was an inherent design deficiency in the form of insufficient head-to-barrel design interference fit. AEC Technical Report 1102-13 recommended withdrawing these cylinder assemblies from service. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings commented that that the FAA's risk analyses and other technical information were “flawed, improperly applied, and replete with unsubstantiated conclusions.”

Response. The commenter failed to provide any examples of FAA technical information that was flawed, improperly applied, or replete with unsubstantiated conclusions. Without those details, we are unable to consider the comment as having technical merit. Accordingly, we interpret the comment as a general objection to the need for the AD. We disagree. Our Challenge Team applied the risk assessments by the FAA's CSTA for Aircraft Safety Analysis, against the SAD's SARA guidelines and the E&PD's CAAP guidelines and independently concluded that an AD is required to mitigate the unsafe condition presented by installed affected ECi cylinder assemblies. We presented both risk assessments in Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). We did not change this AD based on this comment.

Comment. Danbury Holdings commented that it found no relationship between the risk analysis using SARA methods and any analysis or conclusion provided by the agency in this rulemaking. We interpret Danbury Holding's comment as suggesting that no relationship exists between the risk analysis using SARA methods and any analysis or conclusion provided by the agency in this rulemaking.

Response. We disagree. In comments to the August 12, 2013, NPRM some commenters requested that we use the SARA to determine if an AD was warranted. We used the SARA, and it confirmed the need for an AD. We did not change this AD based on this comment.

Comment. Danbury Holdings commented that RAM Aircraft had concluded, through its own risk analysis, that “the probability of a cylinder separation is extremely remote” and that “historical data and information thus far evident leads to the conclusion that there has been no physical discomfort to pilots or passengers and no damage to any aircraft as a result of the subject cylinders.”

Response. We interpret the comment as two parts; first, that our risk assessment reached a wrong conclusion, and second, that a cylinder head separation does not result in any discomfort to pilots or passengers, or damage to the aircraft. We disagree. FAA Order 8040.4A, “Safety Risk Management Policy”, dated April 30, 2012, FAA Order 8110.107A, “Monitor Safety/Analyze Data,” and the guidance in Engine & Propeller Directorate memorandum “Risk Assessment for Reciprocating Engine Airworthiness Directives,” PS-ANE-100-1999-00006, dated May 24, 1999, direct how we do a risk assessment.

We analyze safety risk, per FAA Order 8040.4A, as a composite of two factors: The potential “severity” or worst possible consequence(s) or outcome of an adverse event that is assumed to occur, and also the “expected frequency of occurrence” for that specific adverse event. FAA Order 8040.4A directs us to assess both factors independently, then enter each as separate inputs into a risk matrix. The matrix yields an overall level of risk for the event. The overall risk is then categorized as either “Unacceptable Risk,” “Acceptable Risk with Mitigation,” or “Acceptable Risk.” The corrective action(s), if any, is driven by the assessed overall risk. Table C-1 of Appendix C of FAA Order 8040.4A defines five levels of severity and Table C-2 defines five levels of event frequency that are used in the determination of composite risk.

The FAA classification for the “severity” of an engine cylinder head separation event, per FAA Order 8040.4A, is “hazardous” for both single-engine and light-twin airplanes for several reasons. Cylinder head separations can significantly reduce the power of the airplane such that under some conditions it may not be able to safely takeoff and climb out. It could also create a dangerous asymmetric thrust condition for twin-engine airplanes. If the separation occurs in cruise flight, the airplane may have insufficient excess power to continue safe flight at any altitude. Cylinder head separations have also caused in-flight fires. These are all unsafe conditions that warrant a “hazardous” severity level for risk assessment purposes.

Table C-2 in FAA Order 8040.4A defines “extremely improbable” as “So unlikely that it is not expected to occur, but it is not impossible.” It defines “extremely remote” as “Expected to occur rarely.” It defines “Remote” as “Expected to occur infrequently.” It defines “probable” as “Expected to occur often.” Finally, it defines “frequent” as “expected to occur routinely.”

Service history failure reports indicate that in a population of 43,000 cylinders, that 1 of every 1,000 cylinders could separate on average; either in the dome radius or the first thread. A single-engine airplane has six of these cylinders, so the actual risk of a separation of any one of those six cylinders for any given airplane is 6/1,000: 1 of every 166 engines. Similarly, a twin-engine airplane will have 12 cylinders, so the risk of experiencing a separation of one cylinder on a twin-engine aircraft is twice that of a single engine, 12/1,000, 1 of every 83 twin-engine airplanes that use these model cylinders.

Separation event under-reporting occurs. This is evidenced by RAM Aircraft's submittal of 23 additional reported failures of the subject ECi cylinders after the August 12, 2013 NPRM was issued. Photos of these failures are available in Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). The calculated separation rate, therefore, is likely higher than what we used in our analysis. Also based on service experience, we expect more ECi cylinder head separations in the future. Therefore, we concluded that the most appropriate assessment for the frequency of occurrence for these cylinder separations is “Remote C”; “Expected to occur infrequently.”

Figure C-1 of FAA Order 8040.4A is a risk matrix that yields an overall risk based on the severity classification and the assessed frequency of occurrence. Using the FAA severity classification of “hazardous” and the FAA assessed frequency of occurrence “Remote C”, yields an overall risk that is “unacceptable.” The corrective actions required by this final rule AD are based on and consistent with this overall risk assessment.

We, therefore, disagree with claims by RAM Aircraft and other commenters that a cylinder head separation will have a negligible effect on airplane safety. Also, several documented in-flight fires were precipitated by a cylinder head separation. We did not change this AD based on this comment.

Comment. Danbury Holdings also commented that AEC Technical Report 1102-13 was “disavowed” by AEC [now CMI San Antonio] since it was obtained under questionable circumstances and has since been proven incorrect given its predictions did not come to fruition.

Response. We disagree. AEC originally provided the analysis to the FAA when it was considering a service bulletin for the affected ECi cylinder assemblies. ECi requested the FAA return or destroy ECi Technical Report 1102-13 after they learned the FAA was considering an AD. We found the data in this report useful in our determination of an unsafe condition. We did not change this AD based on this comment.

Comment. Danbury Holdings commented that the FAA has not substantiated that the affected ECi cylinder assemblies have separated at 32 times the rate of the OEM cylinders. Danbury Holdings stated that the FAA had not provided any supporting documentation to substantiate the FAA's estimate that the OEM has produced approximately 4 times as many cylinders as ECi did over the same period of time. Danbury Holdings further commented that that the FAA ignores separations of other cylinder manufacturers.

Response. We disagree. We uploaded supporting information, including service history, to Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). We determined the comparative failure rate of affected ECi cylinders to OEM cylinders through comparing the service history of ECi cylinders to the OEM's since ECi received their PMA. That service history shows that the affected ECi cylinders have had approximately eight times as many separations over the same period of time as that of the OEM cylinders; since ECi received its PMA. We compared the affected ECi cylinder production rates from ECi, to that of the OEM since ECi received its PMA. From ECi's and the OEM's production information, we concluded that the OEM has produced approximately four times as many cylinders as ECi since ECi received its PMA. This yields a normalized failure rate that is approximately 8 (comparative cylinder failure rate) × 4 (comparative production rate), which showed an overall failure rate 32 times higher for ECi cylinders.

Since we first published that rate information, we subsequently learned of more failures of affected ECi cylinders. Those additional failures would, if included, increase the ECi failure rate. We did not update the failure rate to higher than 32 times that of the OEM's because it did not affect our decision regarding this AD. We did not change this AD based on this comment.

The FAA has also issued ADs against other cylinder manufacturers, including mandating early retirement of cylinders to preclude cracking and separation. For example, ADs 2014-05-29 and 2007-04-19R1 both apply to certain Superior Air Parts cylinder assemblies. We did not change this AD based on this comment.

Comment. Danbury Holdings also commented that the FAA failed to place all information in its purview into the docket and that the agency had failed to link its analyses to verifiable data.

Response. We disagree. As previously noted, we have uploaded the relevant documents used in the decision-making process of this AD in Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). Our analysis shows that the FAA's actions are based on the data that we included in the docket. Our analysis is therefore linked to “verifiable data.” We did not change this AD based on this comment.

Comment. Danbury Holdings commented that the FAA had failed to provide any evidence that cylinder separations have resulted in engine failures, in-flight shutdowns, and/or loss of control of an airplane and that the agency had included accidents that were not the direct result of a cylinder separation.

Response. We disagree. A cylinder separating from its engine is an engine failure. We did not change this AD based on this comment.

Comment. RAM Aircraft commented that it assumes that the failures of ECi cylinder assemblies shown in the supporting document titled “ECi AD—Additional Failures Reported by RAM Aircraft” are based on letters RAM Aircraft sent to the FAA in 2013. RAM Aircraft, therefore, commented that this is not new information since the issuance of the January 8, 2015, SNPRM. Also, of the 38 photographs of damaged cylinder assemblies, RAM Aircraft noted that only 23 failures actually represent ECi cylinder assemblies.

Response. We partially agree. First, we agree that the failed cylinder assemblies identified in the supporting document “ECi AD—Additional Failures Reported by RAM Aircraft” do not represent new information since the issuance of the January 8, 2015, SNPRM. These failures are not represented in the SDR database but are consistent with our view that failures of these cylinder assemblies are under-reported.

Second, we agree that some of the cylinder photographs uploaded to the docket are not cylinder assemblies affected by this AD. The FAA sent a letter to RAM Aircraft specifically requesting any information that RAM Aircraft had relative to failures of ECi cylinder assemblies, P/N AEC 631397, after we learned of possible failures that had not been reported as required by 14 CFR 21.3. RAM Aircraft responded to this request with the photographs and data that we uploaded into Docket FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket). These photographs did not have any effect on our decision to issue this AD. We did not change this AD based on this comment.

Request To Describe FAA's Validation Process

Comment. Danbury Holdings requested that the FAA provide a description of the validation process that was used for each of the cylinder separations that the FAA used to substantiate the need for this AD.

Response. We interpret this comment as a request for identification of how we found out about the failures of ECi cylinder assemblies. We found out about the ECi cylinder assembly failures from the FAA SDR database and warranty information at ECi and RAM Aircraft, and failure reports from operators. Many of the operator SDR reports contained detailed information describing the nature and specific location of the separation. The findings of ECi Technical Report 1102-13 agreed with the original failure reports. We did not change this AD based on this comment.

C. Comments to the FAA's Rulemaking Processes Request To Follow the APA

Comment. IPL Group, RAM Aircraft, and Danbury Holdings commented that the FAA had failed to follow the requirements of the APA when it dispositioned previous comments to the August 12, 2013, NPRM, and the January 8, 2015, SNPRM. IPL Group indicated that the FAA had, for example, summarily discounted previous comments, failed to conduct appropriate investigations of the failed cylinder assemblies, and mischaracterized hazard levels in the proposed ADs.

RAM Aircraft also commented that its previous comments were dispositioned in general categories in the January 8, 2015, SNPRM. RAM Aircraft, however, does not believe that the specifics of its comments were adequately or properly responded to, as required by the APA.

Response. We disagree. The commenters failed to provide any examples of where we failed to comply with the APA in our handling of comments to the August 12, 2013, NPRM, and by extension, the January 8, 2015, and August 25, 2015, SNPRMs. We have in our responses to the NPRM and the SNPRMs, and herein in this final rule, fully responded to all comments, including those comments concerning our investigation of the unsafe condition, hazard levels, and conclusions.

We carefully considered all comments we received. In our January 8, 2015, SNPRM and August 28, 2015, SNPRM, we responded to several hundred comments that we had received. Many were substantively the same and, therefore, as previously discussed we grouped them into several categories and answered the comments by category. The commenters have not indicated what, if anything, is improper about doing so nor how doing as we did might have violated the requirements of the APA. In this final rule, we responded to all remaining comments. We again used categories to group and answer comments that were similar if not identical. As to improperly recognizing affected ECi cylinder assemblies, we based our applicability of this AD on the reports of failure provided by ECi, the manufacturer, the reports required by 14 CFR that form the basis for the SDR, and the reports of the commenters themselves. We did not change this AD based on this comment.

Request To Withdraw the SNPRMs Because They Are Arbitrary and Capricious

Comment. Danbury Holdings and ARSA referred to the proposed rule as “arbitrary and capricious” because it does not apply equally to cylinder assemblies manufactured by the OEM. Danbury Holdings observed that the OEM's cylinders also separate and that the FAA has singled out ECi with this AD action.

Response. We disagree. The FAA is not mandating similar corrective actions against the OEM's cylinders because OEM service history data is different. Our review of OEM service history indicates that OEM cylinder assembly failures, unlike ECi cylinder assembly failures, are not traceable to any specific design or manufacturing anomaly. In contrast, the ECi PMA cylinder separations are traceable to design deficiencies, which ECi itself identified in ECi Technical Report 1102-13. We did not find the ECi cylinder assembly design deficiencies in cylinder assemblies produced by any other manufacturer. Further, ECi's failure rate is some 32 times greater than the OEM's. We did not change this AD based on this comment.

Comment. ARSA also indicated the rule is arbitrary and capricious because the FAA has failed to “examine the relevant data and articulate a satisfactory explanation for its action including a `rational connection between the facts found and the choice made.” Further, ARSA cites the APA as requiring federal agencies to allow meaningful public participation in the rulemaking process and provide a “statement of basis and purpose” justifying a rule's issuance.” ARSA notes the obligation of the FAA to demonstrate a sound factual basis for the issuance of a rule by specifically disclosing to interested parties the material upon which a prospective rule would be fashioned.

Response. We disagree. Beyond its generalized allegation, the commenter did not identify any examples of agency shortcoming. We examined the relevant data, including the failure rate of the ECi assemblies, the ECi cylinder assembly design deficiencies, and the consequences to the engine and airplane when an ECi cylinder assembly failed. We reviewed and applied the applicable FAA Orders and policies.

The agency therefore, has articulated a satisfactory explanation for its action including a “rational connection between the facts found and the choice made.”

We provided the public several opportunities to participate in this rule making; through extending the comment period and the two supplemental notices with their comment periods. For example, we first published an NPRM on August 12, 2013 (78 FR 48828), then published an extension of the comment period on September 26, 2013 (78 FR 59293) to allow the public additional time to comment on the proposed rule. We then issued a notice of availability of an initial regulatory flexibility analysis on March 12, 2014 (79 FR 13924). We reviewed the over 500 comments to the proposed rule that we had received, determined that we needed to review how we proposed to address the unsafe condition, formed a team to review the technical basis of the proposed rule, the numerous public comments, and the additional failure information provided by commenters to the NPRM. Through this team we confirmed that an AD is needed to correct the unsafe condition represented by the subject cylinder assemblies installed in aircraft engines, but that we could do so through a lengthier compliance interval. We published that revised compliance interval in our January 8, 2015, SNPRM.

After publication of the January 8, 2015, SNRPM, we issued the August 28, 2015, SNPRM to allow us to explain the rationale for this AD action. We also added several documents to Docket No. FAA-2012-0002 (see ADDRESSES section of this final rule for information on locating the docket), including the risk analyses by our CSTA for Aircraft Safety Analysis, and one using SARA methods, and various technical documents that list failures of ECi cylinder assemblies. For each of the documents we published, we allowed the public an opportunity to provide comments. We did not change this AD based on this comment.

Comment. ARSA also commented that presentation of relevant comments is further stymied by the agency's conclusory and unsupported responses to the NPRM submissions. ARSA commented that the agency stated that it was irrelevant that the root cause of the cylinder failures is unknown and that it “disagreed” that pilot error was a factor.

Response. We disagree. The purpose of this AD is to remove an unsafe condition in aircraft engines, not to identify root cause of cylinder failure(s). This AD resolves the unsafe condition by removing the affected cylinder assemblies from service in the engine models listed in this AD. We did not change this AD based on this comment.

Comment. Danbury Holdings also commented that the FAA had not provided substantiation for a change in the design requirement that ensures safe operation with one inoperative cylinder.

Response. The comment is not germane to this AD. We direct the commenter to the regulations relevant to design requirements, as found in 14 CFR. We did not withdraw the August 28, 2015, SNPRM.

Comment. Danbury Holdings commented that the FAA has admitted that the SDR database is problematic and that the FAA picked and chose data to fit a conclusion.

Response. We disagree. The SDR database reflects input received from field reporting. The SDR database may not reflect all service difficulty problems with affected ECI cylinder assemblies, but what information it contains indicates the need for this AD. Moreover, the SDR database is only one tool in our decision-making process. We did not change this AD based on this comment.

Comment. Several commenters commented that the FAA should withdraw the January 8, 2015, SNPRM because it unfairly targets ECi.

Response. We disagree. This AD does not “target” ECi, the PMA manufacturer of the affected cylinder assemblies. The AD resolves an unsafe condition in a product. We did not change this AD based on this comment.

Request To Substantiate That This AD Does Not Affect Airplanes Operated by Federal or State Agencies

Comment. Danbury Holdings commented that the FAA had not provided documentation to substantiate that no affected airplanes are operated by federal or state agencies.

Response. The comment is not relevant to whether this AD is necessary to resolve the unsafe condition presented by the engine with the affected ECi cylinders installed. We did not change this AD based on this comment.

Request To Substantiate That Airplanes Operating in Alaska Are Not Affected

Comment. Danbury Holdings stated that the FAA had not provided documentation that substantiates that remote locations of Alaska are not served by airplanes affected by this AD.

Response. The comment is not relevant to the technical basis for this AD. Further we state that this AD will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction. We did not change this AD based on this comment.

Request To Send Proposed Rule to Office of Information and Regulatory Affairs (OIRA) and Small Business Administration (SBA)

Comment. Danbury Aerospace commented that per Executive Order (E.O.) No. 13272, the FAA should provide the draft rule to the OIRA in the Office of Management and Budget (OMB) under E.O. No. 12866 and to the SBA's Chief Counsel for Advocacy.

Response. We partially agree. We do not agree that this rule meets the criteria of a significant regulatory action under E.O. 12866. Therefore, we did not provide the draft rule to the OMB. We agree that the rule has a significant effect on a substantial number of small entities. We, therefore, provided a copy of the rule to the SBA's Chief Counsel for Advocacy for comment. We received no comments from the SBA.

D. Comments to the Cost of This AD Request To Revise and Provide Supporting Data for Number of Affected Cylinder Assemblies and Engines

Comment. Danbury Aerospace and RAM Aircraft indicated that the FAA has under-estimated the numbers of airplanes and engines affected and up to 11,000 aircraft may be affected based on the aircraft registry, or otherwise hasn't provided the data it used to determine the affected population of engines and cylinders.

Response. We disagree in part. We do not agree that 11,000 aircraft may be affected by this AD, or that we haven't provided the data used to determine the affected populations. Not all aircraft and engines on the aircraft registry use the affected ECi cylinder assemblies. Further, the commenter hasn't provided any factual basis for its assumption that all aircraft on the aircraft registry use ECi cylinder assemblies.

We agree that we could better estimate the number of engines affected by this AD. We again reviewed our estimate. We now estimate that approximately 6,200 engines are affected by this AD. That number is based on our initial estimate of approximately 43,000 affected cylinder assemblies produced by ECi from 2002 to 2011. This number is supported by AEC Technical Report 1102-13, dated April 30, 2011. We then reduced 43,000 by our estimated number of cylinder assemblies that would have been removed from service.

Our review indicates that approximately 6,000 of the 43,000 cylinder assemblies would have been retired from service by the time of the publication of this AD. Therefore, we estimate 37,000 cylinder assemblies may be in service, as of June 1, 2016. We divided this number by 6 cylinders per engine to give us an estimated 6,167 engines in service. To increase the conservatism of our cost estimate, we rounded this figure to 6,200 engines. We revised our cost estimate to reflect these updated calculations.

Request To Revise the Number of Labor Hours to Perform This AD

Comment. A few commenters, including IPL Group, indicated that the number of hours to replace 6 cylinders would be greater than the 18 hours that we estimated in our costs of compliance.

Response. We agree. In the August 12, 2013, NPRM, and the January 8, 2015, and August 28, 2015, SNPRM, we estimated 18 work hours. Although the commenters did not provide data to support increasing the number of work hours, we held discussions with manufacturers regarding the number of hours they would allow to perform this work. Based on these more recent discussions, we revised our estimate for the number of work hours to replace 6 cylinder assemblies to 32 hours.

Request To Revise Cost of Replacing a Cylinder Assembly in This AD

Comment. Danbury Aerospace, Danbury Holdings, RAM Aircraft, and IPL Group commented that the cost of a cylinder assembly, as calculated by the FAA, does not accurately represent replacement costs. The commenters indicated that the FAA's use of “pro-rated cost” allows a vast underestimation of actual expenses that would be incurred by owners. The agency must at least provide sound reasoning and facts supporting the assertion that the pro-rated cost “more accurately reflects” replacement cost. IPL Group further commented that a “pro-rated value” is inconsistent with FAA policy and the Regulatory Flexibility Act.

Response. We disagree in part. Industry, including ECi, uses pro-rated cost in its cost estimates. For example, ECi, in its MSB 05-8, Revision No. 1, dated December 29, 2005, used a similar time in service based pro-rated cost calculation to determine the discounted cost to operators for replacement cylinders, instead of providing the cylinders to the operators at no cost. Further, we typically use pro-rated cost for larger, turbofan engines when life-limited parts are involved. Operators of those engines are typically airlines and other large operators. Pro rata estimating therefore, is an acceptable method of estimating cost.

We agree however, that engines with affected ECi cylinders installed may be installed on airplanes owned by individual operators in the general aviation community, who are less familiar with the concept of pro-rated costs to ADs. In consequence, we revised our estimate to use the full replacement cost of each cylinder assembly even though this will likely result in an over-estimate of the total cost of this AD. We, therefore, used the replacement cost of 6 cylinder assemblies in this final rule. This resulted in an increase from $4,202 in the SNPRMs to $11,520 in this final rule.

Request To Include Additional Costs in the Overall Cost Estimate

Comment. IPL Group and Danbury Aerospace requested that we add additional costs to our overall cost estimate. IPL Group indicated that the FAA should include costs for loss of use of the aircraft, test flight, and break-in expenses. Danbury Aerospace commented that we should account for loss of overhauled assemblies as replacement items and new costs associated strictly with their replacement.

Response. We disagree. In constructing our cost estimate, we followed the guidance of the FAA's Airworthiness Directives Manual, FAA-IR-M-8040.1C, dated May 17, 2010, which states “Do not state any costs beyond initial work-hours and parts costs. . . .” The additional costs cited by the commenters are not appropriate to our cost estimates. We did not change this AD based on this comment.

Request To Withdraw the SNPRMs Because of Excessive Overall Cost

Comment. Several commenters commented that the FAA should withdraw the January 8, 2015, SNPRM and the August 28, 2015, SNPRMs because the FAA has underestimated the cost of compliance of this AD. These commenters represented that the true cost is too high and that the FAA has ignored the broader impact of this AD on industry. Most commenters failed to provide any data to support these claims, however, IPL Group provided some calculations to show that the total cost of this AD should be somewhere between $168,666,625 and $320,360,156.

Response. We disagree. We considered the impact that this AD would have on operators. As explained in response to the comments above, we increased our estimates of inspection costs, labor costs, and replacement costs of the cylinder assemblies. Although we increased our cost estimate, we still conclude that the unsafe condition represented by the affected cylinder assemblies requires an AD. We did not withdraw the SNPRMs based on this comment.

Request To Substantiate Record-Keeping and Time Estimates

Comment. Danbury Holdings also stated that the FAA had not provided documentation to substantiate its estimated record keeping cost and time estimates.

Response. We agree in part. We interpret this comment as a reference to both time spent on checking log books and reporting requirements. We withdrew our reporting requirement when we published the January 8, 2015, SNPRM, so we have no need to account for that cost. We added an inspection cost in this final rule for the time operators spend determining if they own an ECi cylinder assembly affected by this AD. The Costs of Compliance section now states “We estimate 0.5 hours will be needed to check log books to determine if an engine is affected by this AD.”

E. Administrative Comments Request To Clarify Address

Comment. The Continental Motors Group commented that the business at the address and telephone number listed in the August 28, 2015, SNPRM (9503 Middlex Drive, San Antonio, Texas 78217, Phone 210-820-8101) is now that of Continental Motors Inc., San Antonio. Continental Motors Group also indicated that the associated company Web site (http://www.eci.aero/pages/tech_svcpubs.aspx) listed in the August 28, 2015, SNPRM is not functional at this time.

Response. We agree. We updated the address and Web site information listed in the ADDRESSES and “Related Information” sections of this AD.

Request To Provide Names of Those Involved in the AD Process

Comment. Danbury Aerospace and Danbury Holdings commented that the FAA should provide the names and technical positions of each of the members of the multi-disciplinary/multi-directorate team that were involved in the review of this service difficulty problem, along with the dates, locations, and minutes for any meetings that were held.

Response. We disagree. The names and positions of personnel associated with reviewing this AD are not necessary to the public's participation in the development of this AD. We did not change this AD based on this comment.

F. Support for the SNPRM

Comment. The NTSB commented that it believes that the August 28, 2015, SNPRM will satisfy the intent of NTSB Safety Recommendation A-12-7. An individual commenter indicated that he had reviewed the SDR database and determined that the separation rate of ECi cylinder assemblies is approximately 10 times the rate of OEM cylinder assemblies.

Response. We note the comment.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed.

Costs of Compliance

We estimate that this AD affects about 6,200 CMI model IO-520, TSIO-520, IO-550, and IOF-550 reciprocating engines and all other CMI engine models approved for the use of CMI models -520 and -550 cylinder assemblies (such as the CMI model -470 when modified by STC), installed on airplanes of U.S. registry. The average labor rate is $85 per hour. We estimate 0.5 hours will be needed to check log books to determine if an engine is affected by this AD. We estimate that about 32 hours will be required to replace all six cylinder assemblies of an engine during overhaul. We estimate the cost of replacement of six cylinder assemblies to be, on average, about $11,520 per engine. Based on these figures, we estimate the total cost of this AD to U.S. operators to change all ECi cylinder assemblies to be $88,551,500.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Flexibility Determination

The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the RFA requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the Act. The FAA determined that this rule will have a significant economic impact on a substantial number of small entities and, accordingly, as required by Section 603(a) of the RFA, the FAA prepared and published an initial regulatory flexibility analysis (IRFA) (79 FR 13924, March 12, 2014) as part of the NPRM (79 FR 48828, August 12, 2013) and initial SNPRM (80 FR 1008, January 8, 2015) for this rule. For the second SNPRM, the FAA inadvertently stated that there would be no significant impact on a substantial number of entities. We also omitted the IRFA from the second SNPRM because we thought republication unnecessary as costs had not changed and the IRFA had already been published in the first SNPRM. In addition to the IRFA, Section 604 of the RFA also requires an agency to publish a final regulatory flexibility analysis (FRFA) in the Federal Register when issuing a final rule.

With this FRFA we correct our misstatement in the second SNPRM and restate our previous conclusions for the NPRM and in the first SNPRM that the rule will have a significant impact on a substantial number of small entities. Accordingly, in the following section we undertake the regulatory flexibility analysis.

Final Regulatory Flexibility Analysis

Under Section 604(a) of the RFA, the Final analysis must address:

(1) Statement of the need for, and objectives of, the rule.

This final rule AD was prompted by failure reports of multiple cylinder head-to-barrel separations and cracked and leaking aluminum cylinder heads. This AD will apply to certain CMI San Antonio replacement PMA cylinder assemblies marketed by ECi, used on the CMI model -520 and -550 reciprocating engines, and all other engine models approved for the use of CMI model -520 and -550 cylinder assemblies such as the CMI model -470 when modified by STC.

(2) Statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments.

Danbury Holdings commented that the FAA had not provided the raw data that was used in the IRFA. We note that the provision of raw data is not required by the FAA's rulemaking procedures or orders.

In response to comments about problems with the repetitive compression/soap test proposed by the NPRM, the FAA agrees that these tests do not always reliably detect a cracked cylinder of this failure mode and therefore the costs associated with such tests outweigh the safety benefits. In the January 8, 2015 SNPRM the FAA removed the requirement for repetitive compression/soap inspection tests.

The FAA received comments questioning the reduction of the estimated number of smaller air service businesses (in addition to the estimated 609 small part 135 operators) that would be affected by the rule, from 5,000 in the IRFA to 2,000 in the January 8, 2015, SNPRM. We note that in both cases the FAA stated that a substantial number of small entities would be affected. Given the lack of available data, the FAA is unable to make an accurate estimate of the number of smaller air service businesses that will be affected by this rule, but acknowledges that this number is substantial. In addition to the 609 small part 135 operators, we therefore estimate in this final rule that the number of smaller air service businesses affected is substantial.

After publication of the NPRM and after publication of each of the two SNPRMs, we also received comments from small businesses concerning understated compliance costs. Some commenters stated that the labor rate and the hours required to replace an affected engine's cylinders are underestimated. We agree with this comment in part and have increased our estimate of the labor hours required to replace an affected engine's six cylinder assemblies from 18 to 32 hours, with a corresponding labor cost increase from $1,530 to $2,720.

In response to comments we have also increased our cost of materials estimate from a loss-of-service estimate of $4,202 to the full cost to replace all six cylinders, which has increased to $11,520. Our estimate of the total cost to replace all six cylinders has therefore increased from $5,732 to $14,240.

After publication of the August 28, 2015, SNPRM, we received negative comments concerning the inadvertent change from our original determination of a significant economic impact on a substantial number of small entities in the IRFA (and the January 8, 2015, SNPRM) to a determination of no significant impact on a substantial number of small entities. As noted in the introductory section, we are correcting this oversight in this FRFA.

(3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments.

The SBA did not submit comments.

(4) Description and an estimated number of small entities to which the final rule will apply.

Of the 610 part 135 operators we found to be affected by this rule, we identified 609 that meet the Small Business Administration (SBA) definition of a small entity (entities with 1,500 or fewer employees) that will be affected by this final rule. On this basis alone, we conclude that the final rule will affect a substantial number of small entities. In addition, we estimate that a substantial, but undetermined number of smaller air services businesses will be affected by this final rule. The FAA is unaware of the assets or financial resources of these businesses. The affected part 135 and smaller air services fly fixed wing aircraft; employ less than 1,500 employees; and conduct a variety of air services such as fly passengers and cargo for hire.

(5) Description of the record keeping and other compliance requirements of the final rule.

Record Keeping Requirement

The FAA estimates 0.5 hours will be needed to check log books to determine if an engine is affected by this AD. At a wage rate of $85 per hour, the estimated cost will be $42.50 per engine. As the affected small part 135 operators have between one and 88 affected airplanes, the costs of this requirement range from $42.50 to $3740 per part 135 operator.

Compliance Requirement To Replace Cylinder Assemblies of Affected Engines

This AD applies to certain CMI model IO-520, TSIO-520, IO-550, and IOF-550 reciprocating engines and all other engine models approved for the use of CMI models -520 and -550 cylinder assemblies (such as the CMI model -470 when modified by STC), installed on airplanes of U.S. registry. For the affected engines the AD requires replacement of the cylinder assemblies at reduced times-in-service.

As noted above our estimate of the total cost to replace all six cylinders has increased from $5,732 to $14,240. As the number of airplanes held by affected small part 135 operators ranges from one to 88, the costs of required cylinder assembly replacement per operator range from about $14.2 thousand to about $1.3 million.

To determine whether compliance costs will have a significant economic impact, we measured the cost of replacing cylinder assemblies of affected engines relative to the value of the affected airplanes held by the small part 135 operators. The estimated asset value of the affected airplanes held by the small part 135 operators ranges from $22,000 to $19.6 million. We find that the cost of replacing cylinder assemblies relative to affected airplane asset value is greater than 5 percent for 468 of the 609 affected small part 135 operators.2 We therefore conclude that the final rule will have a significant economic impact on a substantial number of small entities.

2 This assessment does not take into account record keeping requirement costs. These costs, however, are minor and do not affect our assessment of the number of small part 121 operators significantly impacted by the final rule.

(6) Steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

In response to comments about problems with repetitive compression/soap test, the FAA agrees that these tests do not always reliably detect a cracked cylinder of this failure mode and the costs associated with such tests outweigh the safety benefit. The FAA removed that requirement for repetitive compression/soap inspection tests. We also considered these following alternatives:

(a) Do nothing—This option is not acceptable due to the number of failures of ECi cylinder head assemblies and the consequences of the failures.

(b) Periodic inspections only (no forced removals)—Though the NTSB recommended this option in its comments to the NPRM (August 12, 2013, 78 FR 48828), the service history has shown that such inspections may not reliably detect existing cracks and the rate of crack growth to separation is unknown and variable. The NTSB also submitted a later comment, in response to the August 28, 2015, SNPRM, that the revised rule as adopted in this final rule, meets the intent of its Safety Recommendations A-12-7.

(c) Forced removal with periodic inspections—Periodic inspections may not reliably detect cracks and even with removal the rate of crack growth to separation is unknown and variable. Forced removal is the only remaining option.

Regulatory Findings

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

Adoption of the Amendment

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-16-12 Continental Motors, Inc. (formerly Teledyne Continental Motors, Inc., formerly Continental): Amendment 39-18610; Docket No. FAA-2012-0002; Directorate Identifier 2011-NE-42-AD. (a) Effective Date

This AD is effective September 15, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all Continental Motors, Inc. (CMI) model -520 and -550 reciprocating engines, and to all other CMI engine models approved for the use of model -520 and -550 cylinder assemblies such as the CMI model -470 when modified by supplemental type certificate (STC), with Continental Motors Inc., San Antonio (formerly Airmotive Engineering Corp.), replacement parts manufacturer approval (PMA) cylinder assemblies, marketed by Engine Components International Division (hereinafter referred to as ECi), part number (P/N) AEC 631397, with ECi Class 71 or Class 76, serial number (S/N) 1 through S/N 61176, installed.

(d) Unsafe Condition

This AD was prompted by multiple failure reports of cylinder head-to-barrel separations and cracked and leaking aluminum cylinder heads. We are issuing this AD to prevent failure of the cylinder assemblies, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.

(e) Compliance

Comply with this AD within the compliance times specified, unless already done.

(1) Review the engine maintenance records to determine if any affected cylinder assemblies are installed.

(2) If you cannot determine based on review of engine maintenance records if any affected cylinder assemblies are installed, comply with paragraph (e)(4) of this AD.

(3) If you do not have any of the affected ECi cylinder assemblies installed on your engine, no further action is required.

(4) Cylinder Identification and Serial Number Location

(i) Check the cylinder assembly P/N and Class number. The ECi cylinder assembly, P/N AEC 631397, Class 71 or Class 76, is stamped on the bottom flange of the cylinder barrel. Guidance on the P/N and Class number description and location can be found in ECi Service Instruction No. 99-8-1, Revision 9, dated February 23, 2009.

(ii) If you cannot see the cylinder assembly P/N when the cylinder assembly is installed on the engine, you may use the following alternative method of identification:

(A) Remove the cylinder assembly rocker box cover.

(B) Find the letters ECi, cast into the cylinder head between the valve stems.

(C) Check the cylinder head casting P/N. Affected cylinder assemblies have the cylinder head casting, P/N AEC 65385, cast into the cylinder head between the valve stems.

(D) Find the cylinder assembly S/N as specified in paragraphs (e)(4)(iii) or (e)(4)(iv) of this AD, as applicable.

(iii) For ECi cylinder assemblies, P/N AEC 631397, manufactured through 2008, find the cylinder assembly S/N stamped on the intake port boss two inches down from the top edge of the head.

(iv) For ECi cylinder assemblies, P/N AEC 631397, manufactured on or after January 1, 2009, find the cylinder assembly S/N stamped just below the top edge of the head on the exhaust port side.

(5) Removal From Service

(i) For any affected cylinder assembly with 680 or fewer operating hours time-in-service (TIS) since new on the effective date of this AD, remove the cylinder assembly from service before reaching 1,000 operating hours TIS since new.

(ii) For any affected cylinder assembly with more than 680 operating hours TIS since new and 1,000 or fewer operating hours TIS since new on the effective date of this AD, remove the cylinder assembly from service within the next 320 operating hours TIS or within 1,160 operating hours TIS since new, whichever occurs first.

(iii) For any affected cylinder assembly with more than 1,000 operating hours TIS since new on the effective date of this AD, remove the cylinder assembly from service within the next 160 operating hours or at next engine overhaul, whichever occurs first.

(iv) For any affected cylinder assembly that has been overhauled, remove the cylinder assembly from service within the next 80 operating hours TIS after the effective date of this AD.

(f) Installation Prohibitions

After the effective date of this AD:

(1) Do not repair, or reinstall onto any engine, any cylinder assembly removed per this AD.

(2) Do not install any affected ECi cylinder assembly that has been overhauled, into any engine.

(3) Do not install any engine that has one or more affected overhauled ECi cylinder assemblies, onto any aircraft.

(4) Do not return to service any aircraft that has an engine installed with an ECi cylinder assembly subject to this AD, if the cylinder assembly has 1,000 or more operating hours TIS.

(g) Alternative Methods of Compliance (AMOCs)

The Manager, Delegation Systems Certification Office or Fort Worth Aircraft Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request.

(h) Related Information

(1) For more information about this AD, contact Jurgen E. Priester, Aerospace Engineer, Delegation Systems Certification Office, FAA, Rotorcraft Directorate, 10101 Hillwood Parkway, Fort Worth, TX 76177; phone: 817-222-5190; fax: 817-222-5785; email: [email protected]

(2) For ECi Service Instruction No. 99-8-1, Revision 9, dated February 23, 2009, which is not incorporated by reference in this AD, contact Continental Motors—San Antonio, 9503 Middlex Drive, San Antonio, TX 78217; phone: 210-820-8101; Internet: http://www.continentalsanantonio.com.

(3) You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

(i) Material Incorporated by Reference

None.

Issued in Burlington Massachusetts, on July 19, 2016. Colleen M. D'Alessandro, Manager, Engine & Propeller Directorate, Aircraft Certification Service.
[FR Doc. 2016-18708 Filed 8-10-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-5856; Airspace Docket No. 16-AGL-9] Establishment of Class E Airspace; Park River, ND AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace in Park River, ND. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at Park River-W C Skjerven Field, Park River, ND, for the safety and management of Instrument Flight Rules (IFR) operations at the airport. Additionally, to correct airport name to correspond with the NASR in the header and legal description.

DATES:

Effective 0901 UTC, November 10, 2016. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX, 76177; telephone (817) 222-5857.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Park River-W C Skjerven Field, Park River, ND.

History

On May 24, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E Airspace in the Park River, ND area. (81 FR 32679) FAA-2016-5856. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 7-mile radius of Park River-W C Skjerven Field, Park River, ND, to accommodate new standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport. Additionally, this corrects the airport name to coordinate with the NASR, previously listed in the NPRM header and legal description as Park River Airport-WC Skjerven Field to Park River-W C Skjerven Field.

Class E airspace areas are published in Section 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for Part 71 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, effective September 15, 2015, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL ND E5 Park River, ND [New] Park River-W C Skjerven Field (Lat. 48°23′39″ N., long. 097°46′51″ W.)

That airspace extending upward from 700 feet above the surface within a 7-mile radius of Park River-W C Skjerven Field.

Issued in Fort Worth, TX, on July 28, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2016-18772 Filed 8-10-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-4629; Airspace Docket No. 16-AGL-8] Amendment of Class E Airspace for the Following Michigan Towns; Alma, MI; Bellaire, MI; Cadillac, MI; Drummond Island, MI; Gladwin, MI; Holland, MI; and Three Rivers, MI AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action modifies Class E airspace extending upward from 700 feet above the surface at Gratiot Community Airport, Alma, MI; Antrim County Airport, Bellaire, MI; Wexford County Airport, Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C. Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr. Haines Airport, Three Rivers, MI. Decommissioning of non-directional radio beacons (NDB), cancellation of NDB approaches, or implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at the above airports. This action also updates the geographic coordinates of Three Rivers Municipal Dr. Haines Airport, and the name change of West Michigan Regional Airport (formerly Tulip City Airport) to coincide with the FAA's aeronautical database.

DATES:

Effective 0901 UTC, November 10, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Gratiot Community Airport, Alma, MI; Antrim County Airport, Bellaire, MI; Wexford County Airport, Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C. Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr. Haines Airport, Three Rivers, MI.

History

On May 3, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class E airspace at Gratiot Community Airport, Alma, MI; Antrim County Airport, Bellaire, MI; Wexford County Airport, Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C. Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr. Haines Airport, Three Rivers, MI (81 FR 26501) Docket No. FAA-2016-4629. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at the following airports:

Within a 6.5-mile radius of Gratiot Community Airport, Alma, MI;

Within a 6.5-mile radius of Antrim County Airport, Bellaire, MI, with a segment extending from the 6.5-mile radius to 6.9 miles south of the airport;

Within a 6.7-mile radius of Wexford County Airport, Cadillac, MI;

Within a 6.5-mile radius of Drummond Island Airport, Drummond Island, MI, with a segment extending from the 6.5-mile radius to 8.5 miles east of the airport;

Within a 6.5-mile radius of Charles C. Zettel Memorial Airport, Gladwin, MI;

Within a 6.5-mile radius of West Michigan Regional Airport (formerly Tulip City Airport), Holland, MI; Park Township Airport is removed as it no longer has instrument procedures and no longer requires Class E airspace; and

Within a 6.4 mile radius of Three Rivers Municipal Dr. Haines Airport, Three Rivers, MI, and updates the geographic coordinates of this airport to coincide with the FAAs aeronautical database.

These airspace reconfigurations are necessary due to the decommissioning of NDBs, cancellation of NDB approaches, or implementation of RNAV procedures at the above airports. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL MI E5 Alma, MI [Amended] Alma, Gratiot Community Airport, MI (Lat. 43°19′20″ N., long. 84°41′17″ W.) Mount Pleasant VOR/DME (Lat. 43°37′22″ N., long. 84°44′14″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Gratiot Community Airport, and within 2.0 miles either side of a 270° bearing from the airport extending from the 6.5-mile radius to 10.1 miles west of the airport, and within 1.5 miles either side of the Mount Pleasant VOR/DME 178° radial extending from the 6.5-mile radius to 10.3 miles north of the airport.

AGL MI E5 Bellaire, MI [Amended] Bellaire, Antrim County Airport, MI (Lat. 44°59′19″ N., long. 85°11′54″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Antrim County Airport, and within 1.9 miles each side of the 197° bearing from the airport extending from the 6.5-mile radius to 6.9 miles south of the airport.

AGL MI E5 Cadillac, MI [Amended] Cadillac, Wexford County Airport, MI (Lat. 44°16′31″ N., long. 85°25′08″ W.)

That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of the Wexford County Airport.

AGL MI E5 Drummond Island, MI [Amended] Drummond Island Airport, MI (Lat. 46° 00′34″ N., long. 83° 44′38″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Drummond Island Airport, and within 4 miles each side of the 072° bearing from the airport extending from the 6.5-mile radius to 8.5 miles east of the airport; that airspace extending upward from 1,200 feet above the surface bounded by long. 83° 57'00” W., on the west; long. 83° 26'00” W., on the east; lat. 46° 05'00” N., on the north; and lat. 45° 45'00” N., on the south, excluding that airspace within Canada.

AGL MI E5 Gladwin, MI [Amended] Charles C. Zettel Memorial Airport, MI (Lat. 43°58′14″ N., long. 84°28′30″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the Charles C. Zettel Memorial Airport.

AGL MI E5 Holland, MI [Amended] West Michigan Regional Airport, MI (Lat. 42°44′34″ N., long. 86°06′28″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the West Michigan Regional Airport.

AGL MI E5 Three Rivers, MI [Amended] Three Rivers Municipal Dr Haines Airport, MI (Lat. 41°57′35″ N., long. 85°35′35″ W.)

That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Three Rivers Municipal Dr Haines Airport, excluding that airspace within the Sturgis, Kirsch Municipal Airport, MI, Class E airspace area.

Issued in Fort Worth, Texas, on July 29, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2016-18777 Filed 8-10-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 16 [Docket No. FDA-2016-N-0011] Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.

DATES:

This rule is effective August 11, 2016.

FOR FURTHER INFORMATION CONTACT:

Ian Ostermiller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-5678.

SUPPLEMENTARY INFORMATION:

FDA is correcting an error in the regulations that identify the statutory and regulatory provisions that provide an opportunity for a regulatory hearing, also known as an informal hearing (§ 16.1 (21 CFR 16.1)). In the list of statutory provisions at § 16.1(b)(1), the Agency is adding a reference to subsection (b) of section 516 of the FD&C Act (21 U.S.C. 360f), which provides for a reasonable opportunity for an informal hearing when FDA proposes a medical device ban with a special effective date (21 U.S.C. 360f(b)(2)). The list of statutory provisions does not currently specify subsection (b) of section 516 of the FD&C Act, and it incorrectly refers to 21 CFR 895.21(d). An opportunity for a hearing is not required under section 516 of the FD&C Act or part 895 (21 CFR part 895) for bans that do not have a special effective date.

Further, the list of regulatory provisions at § 16.1(b)(2) does not include any reference to part 895. We are correcting this by adding a reference to § 895.30(c), which provides for an opportunity for an informal hearing under 21 CFR part 16 when FDA proposes a medical device ban with a special effective date. These corrections will align § 16.1(b) with section 516 of the FD&C Act and part 895 to avoid confusion regarding when an opportunity for hearing is required for a device ban.

Prior to the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), the FD&C Act required the Secretary of Health and Human Services to afford an opportunity for informal hearings about any proposed rule to ban a medical device, regardless of effective date. One of the SMDA's provisions removed the requirement that FDA provide an opportunity for an informal hearing when FDA does not establish a special effective date for a proposed ban.1 However, the SMDA did not eliminate the informal hearing provision for a proposed ban issued with a special effective date. Thus, section 516(b) of the FD&C Act continues to require that FDA “provide reasonable opportunity for an informal hearing” on a proposed ban with a special effective date (21 U.S.C. 360f(b)) while subsection (a), the general rule for medical device bans, does not (see 21 U.S.C. 360f(a)).

1 Specifically, the SMDA deleted the then-last sentence of section 516(a). See Public Law 101-629, section 18(d)(2) (“Section 516(a) (21 U.S.C. 360f(a)) is amended . . . by striking out the last sentence.”); 21 U.S.C. 360f(a) (1989) (stating, in the last sentence, “The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection.”).

On December 10, 1992 (57 FR 58400), FDA published a final rule implementing the SMDA. The final rule of 1992 amended § 895.21(d), which covers the procedures for issuing a ban without a special effective date, by removing the requirement that FDA provide an opportunity for an informal hearing when there is no special effective date.2 FDA incorrectly removed the same language from § 895.30, which covers the procedures for issuing bans with special effective dates; the Agency issued a technical amendment restoring this language in the Federal Register of June 2, 2015 (80 FR 31299). However, FDA did not correct the language in § 16.1 to list section 516(b) of the FD&C Act and § 895.30(c) as the provisions that provide for regulatory (informal) hearings, nor did the Agency remove the reference to § 895.21(d). FDA does so now.

2 Although the hearing provision was validly removed from § 895.21(d)(8) in 1992, the removed language erroneously reappeared in the Code of Federal Regulations beginning in 1994. On March 5, 2015 (80 FR 11865), the Office of the Federal Register published a correction document fixing this publication error.

FDA finds good cause for issuing this amendment to § 16.1(b)(1) as a final rule without notice and comment because this amendment corrects the regulations to restate the statute (5 U.S.C. 553(b)(B)). “[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary.” Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule “does no more than repeat, virtually verbatim, the statutory grant of authority,” notice-and-comment procedures are not required). Further, the change to remove the erroneous cross-reference to § 895.21(d) and add the correct cross-reference to§ 895.30(c) is merely technical, insignificant in nature and impact, and inconsequential to industry and the public. See Mack Trucks, Inc. v. EPA, 682 F.3d 87, 94 (D.C. Cir. 2012). This is because this correction in no way changes when FDA is required to provide an opportunity for a hearing, which is determined by section 516 of the FD&C Act and part 895, nor does it impact the availability of such a hearing to any entity impacted by the proposed ban. It merely corrects a citation error to avoid confusion. This amendment to § 16.1(b) thus merely corrects the references to the applicable requirements of the FD&C Act and its implementing regulations, making notice-and-comment procedures unnecessary in this case. Therefore, publication of this document constitutes final action on this change under the Administrative Procedure Act (APA) (5 U.S.C. 553).

In addition, FDA finds good cause for this amendment to become effective on the date of publication of this action. The APA allows an effective date less than 30 days after publication as “provided by the agency for good cause found and published with the rule” (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because the amendment to § 16.1 does not impose any new regulatory requirements on affected parties. As a result, affected parties do not need time to prepare before the rule takes effect. Therefore, FDA finds good cause for this correction to become effective on the date of publication of this action.

List of Subjects in 21 CFR Part 16

Administrative practice and procedure.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 16 is amended as follows:

PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION 1. The authority citation for part 16 continues to read as follows: Authority:

15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

2. Amend § 16.1 as follows: a. In paragraph (b)(1), remove from the list the entry “Section 516 of the act relating to a proposed banned device regulations (see § 895.21(d) of this chapter).” and add in its place “Section 516(b) of the act regarding a proposed regulation to ban a medical device with a special effective date.” b. In paragraph (b)(2), add an entry in numerical sequence for “§ 895.30(c), regarding a proposed regulation to ban a medical device with a special effective date.” Dated: August 3, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-18787 Filed 8-10-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2016-N-1943] New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correcting amendments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.

DATES:

This rule is effective August 11, 2016.

ADDRESSES:

For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Vernon Toelle, Center for Veterinary Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5637, v[email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents I. Background II. Legal Authority III. Effective Date IV. Economic Analysis of Impacts V. Analysis of Environmental Impact VI. Paperwork Reduction Act of 1995 VII. Federalism I. Background

This regulation is intended to make technical amendments to § 514.200 (21 CFR 514.200) to harmonize the terminology with part 12 (21 CFR part 12), as well as to update § 514.200 in accordance with plain language principles to make it easier for the public to understand and follow.

When the Agency issued procedural regulations for formal evidentiary public hearings, originally published in part 2 (21 CFR part 2) and later redesignated to part 12,1 we intended those provisions to apply to all formal evidentiary hearings on new product applications, including new animal drug applications. As explained in the proposed rule, once the specific provisions in 21 CFR parts 511 and 514 relating to investigational and marketed new animal drugs were revised in the same way as their counterpart provisions relating to investigational and marketed new drugs, to refer to the new procedural provisions in part 2, the prior procedural provisions relating to hearings would be revoked.2

1 See 41 FR 51706, November 23, 1976, and 42 FR 4680, January 25, 1977.

2 See 40 FR 40682 at 40716, September 3, 1975.

Consequently, when part 12 was finalized, we revised the regulations specific to new animal drugs. These revisions included revoking certain provisions and revising 21 CFR 514.201 to state that hearings related to new animal drugs under section 512(d) and (e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(d) and (e)) shall be governed by part 12 of this chapter. However, when we made these revisions to part 514, we neglected to update § 514.200 to match the terminology used in part 12.

Therefore, we are now revising § 514.200 to make its language and terminology consistent with the language and terminology of the procedural regulations for hearings in part 12. Specifically, we are changing the references to “administrative law judge” in current § 514.200 to the term “presiding officer”, which is defined in 21 CFR 10.3 3 and further explained in 21 CFR 12.60 as the presiding officer in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved has been delegated, or an administrative law judge qualified under 5 U.S.C. 3105. Since the term “presiding officer” is used throughout part 12, we are updating the language of § 514.200 to use the same terminology. We are also updating the language in current § 514.200 from “written appearance” to “objections and request for a hearing” since the latter terminology is used throughout part 12. Finally, we are updating the language in § 514.200 on the contents of the objections and request for hearing and the contents of the Commissioner's notice granting a hearing to match the language of part 12 and to make clear what is required. These updates will eliminate confusion that could be caused by use of different terms to refer to the same procedural requirements and allow the reader to obtain necessary information in one place. We anticipate these technical changes will make § 514.200 easier for the public to understand and follow.

3 “Presiding officer means the Commissioner or the Commissioner's designee or an administrative law judge appointed as provided in 5 U.S.C. 3105.”

Since we are revising § 514.200 to harmonize the language and terminology with part 12, we are also taking this opportunity to update the language of § 514.200 in accordance with the Plain Writing Act of 2010 (Pub. L. 111-274) and Executive Order 13563. The Plain Writing Act of 2010 requires that all Federal agencies use “clear government communication that the public can understand and use.” Executive Order 13563 mandates that all regulations be “accessible, consistent, written in plain language, and easy to understand.” Therefore, we are eliminating gender-specific pronouns, passive voice, complicated sentence structure, and archaic language, and updating the language to make it more reader-friendly and accessible. We anticipate that these changes will make § 514.200 clearer and easier to read. Additionally, we are updating the title of that section from “Contents of notice of opportunity for a hearing” to “Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing” because the latter title more accurately describes the type of information found in § 514.200. The latter title also harmonizes with an analogous section for new drug applications in 21 CFR 314.200.

All of these corrections are nonsubstantive, technical amendments designed to harmonize the language and terminology of § 514.200 with the governing regulation on formal evidentiary public hearings in part 12 and to make the language of § 514.200 easier for the public to understand and follow. We are taking this action as a part of our Retrospective Review Initiative 4 to clarify and harmonize the regulations and to update the language in accordance with the Plain Writing Act of 2010 and Executive Order 13563.

4 See E.O. 13563, section 6.

II. Legal Authority

FDA is issuing these regulations under section 512(e) of the FD&C Act. This section gives the Secretary of Health and Human Services the authority to grant approval, deny approval, or withdraw approval of new animal drug applications. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

Section 6 of Executive Order 13563 states that FDA is under a continuing obligation to review its existing regulations periodically to determine whether any such regulations should be modified, streamlined, expanded, or repealed to improve regulatory effectiveness and reduce public burden. The Plain Writing Act of 2010 mandates that all regulations be written in clear language that is easy for the public to understand and use.

This rule makes technical amendments to § 514.200 to harmonize the language and terminology with the governing regulation on administrative hearings in part 12 and to update the language in accordance with the Plain Writing Act of 2010 and Executive Order 13563. Publication of this document constitutes final action on these changes under the Agency's original intent with respect to the hearing provisions for new animal drug applications. Therefore, for good cause, FDA finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.

III. Effective Date

These regulations are effective upon publication.

IV. Economic Analysis of Impacts

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

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule is making only technical amendments, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

V. Analysis of Environmental Impact

We have determined under 21 CFR 25.31(i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore, FDA is not required to seek clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

VII. Federalism

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that 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, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 514

Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 514 is amended as follows:

PART 514—NEW ANIMAL DRUG APPLICATIONS 1. The authority citation for part 514 continues to read: Authority:

21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 379e, 381.

2. Revise § 514.200 to read as follows:
§ 514.200 Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.

(a) The notice to the applicant of opportunity for a hearing on a proposal by the Commissioner to refuse to approve an application or to withdraw the approval of an application will be published in the Federal Register together with an explanation of the grounds for the proposed action. The notice will describe how to request a hearing. An applicant has 30 days after publication of the notice to request a hearing.

(b) If the applicant fails to request a hearing within the 30-day timeframe, the Commissioner, without further notice, will publish a final order denying or withdrawing approval of the application.

(c) If the applicant desires to request a hearing:

(1) Within 30 days after publication of the notice of opportunity for hearing, the applicant must submit to the Division of Dockets Management written objections and a request for a hearing in accordance with §§ 12.20 and 12.22. This request for a hearing must include each specific objection to the proposal on which a hearing is requested, together with a detailed description and analysis of the factual information (including all relevant clinical and other investigational data) the applicant will present in support of that objection. A request for a hearing may not rest upon mere allegations or denials or general descriptions of positions or contentions, but must set forth specific reliable evidence showing there is a genuine and substantial issue of fact that requires a hearing.

(2) If the Commissioner determines upon review of the data and information submitted in the objections and request for a hearing that a hearing is not justified because no genuine and substantial issue of fact precludes the refusal to approve the application or the withdrawal of approval of the application (for example, the applicant has not identified any adequate and well-controlled clinical investigations to support the claims of effectiveness), the Commissioner will enter an order denying the hearing and stating the final findings and conclusions.

(3) If the Commissioner determines upon review of the data and information submitted in the objections and request for a hearing that a hearing is justified, the Commissioner will publish a notice setting forth the following:

(i) The regulation or order that is the subject of the hearing;

(ii) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion;

(iii) The parties to the hearing;

(iv) The specific issues of fact for resolution at the hearing;

(v) The presiding officer, or a statement that the presiding officer will be designated in a later notice; and

(vi) The date, time, and place of the prehearing conference, or a statement that the date, time, and place will be announced in a later notice. However, in the case of a denial of approval, the hearing must not occur more than 90 days after expiration of the 30-day time period in which to request a hearing, unless the presiding officer and the applicant otherwise agree; and in the case of withdrawal of approval, the hearing will occur as soon as practicable.

(d) The hearing will be open to the public; however, if the Commissioner finds that portions of the application which serve as a basis for the hearing contain information concerning a method or process entitled to protection as a trade secret, the part of the hearing involving such portions will not be public, unless the respondent so specifies in the request for a hearing.

Dated: August 3, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-18809 Filed 8-10-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 291 [Docket No. FR-5776-F-02] RIN 2502-AJ32 Disposition of HUD-Acquired Single Family Properties; Updating HUD's Single Family Property Disposition Regulations AGENCY:

Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD.

ACTION:

Final rule.

SUMMARY:

This final rule revises HUD's property disposition regulations. Specifically, this rule consolidates and reorganizes these regulations to better reflect industry standards, and allow HUD to conduct its Single Family Property Disposition Program more efficiently and effectively so that HUD can obtain the greatest value for its real estate-owned (REO) properties in different market conditions. This final rule follows publication of the October 2, 2015, proposed rule and, after considering public comments submitted in response to the proposed rule, adopts the proposed rule with minor change.

DATES:

Effective Date: September 12, 2016.

FOR FURTHER INFORMATION CONTACT:

Thomas Kumi, Director, Single Family Asset Management and Disposition Division, Office of Single Family Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 9172, Washington, DC 20410-8000, telephone number 202-708-1672 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

SUPPLEMENTARY INFORMATION: I. Background

Section 204(g) of the National Housing Act (12 U.S.C. 1710g) addresses the management and disposition of HUD-acquired single-family properties, which includes HUD-acquired real and personal property assets. HUD's implementing regulations are codified in 24 CFR part 291. Under this statutory and regulatory authority, HUD is charged with carrying out a program of sales of HUD-acquired and owned properties, along with appropriate credit terms and standards to be used in carrying out the program. Property owned by HUD as a result of acquisition includes REO properties. The goals of HUD's Single Family Property Disposition Program are to reduce the inventory of single-family properties in a manner that minimizes losses to the Mutual Mortgage Insurance Fund (MMIF); promote the expansion of homeownership opportunities for American families by, among other things, selling such properties at a discount to State and local governments and HUD-approved nonprofit entities; and help stabilize distressed communities.

Following the economic and housing crises that began in 2008, the Federal Housing Administration (FHA) determined that it needed to revise, consolidate, and reorganize its property disposition regulations so that they better reflect industry standards, provide greater efficiency in the administration of HUD's property disposition program, and, ultimately, provide HUD the ability to obtain the greatest value for its REO properties in different market conditions. As a result, on October 2, 2015 (80 FR 59690), HUD published a rule that proposed certain changes to part 291. Specifically, HUD proposed the following changes:

1. Ownership and Disposition Authority. HUD proposed revising the heading of part 291 from “Disposition of HUD-Acquired Single Family Property” to “Disposition of HUD-Acquired and -Owned Single Family Property” to reflect that HUD not only receives REO properties, but also holds and maintains them throughout the disposition process. For similar reasons, HUD proposed amending § 291.1(a) and § 291.90 to, respectively, reference HUD's authority to acquire and possess properties and prescribe methods of sale and disposal of properties.

2. Appraisal of HUD REO Properties. HUD proposed amending § 291.100(b) to clarify that the list price for HUD REO properties may be established utilizing one or more evaluation tools. In addition to aligning requirements for REO appraisers with requirements for appraisers found in 24 CFR part 200, subpart G, to ensure consistency, the rule proposed expanding valuation methods available to include alternative methods commonly used in the real estate industry, such as Broker Price Opinions (BPO) 1 and Automated Valuation Models (AVM).2

1 A Broker's Price Opinion (BPO) is the process a hired sales agent utilizes to determine the selling price of a real estate property. BPOs are popularly used in situations where lenders and mortgage companies believe the expense and delay of an appraisal to determine the value of properties is unnecessary. See https://www.brokerpriceopinion.com.

2 Automated valuation model (AVM) is the name given to a service that can provide real estate property valuations using mathematical modeling combined with a database. Most AVMs calculate a property's value at a specific point in time by analyzing values of comparable properties. Some also take into account previous surveyor valuations, historical house price movements, and user inputs (e.g., number of bedrooms, property improvements). Appraisers, investment professionals, and lending institutions use AVM technology in their analysis of residential property. It is a technology-driven report. The product of an automated valuation technology comes from analysis of public record data and computer decision logic combined to provide a calculated estimate of a probable selling price of a residential property.

3. Escrow Amount Required for Properties Needing Repairs. HUD proposed increasing to $10,000 the maximum amount that buyers would be required to place into escrow for repairs in order to qualify for FHA mortgage insurance on properties that do not meet FHA's Minimum Property Standards. In addition, to ensure that HUD can keep this amount updated, HUD proposed a provision that would allow HUD to increase or decrease the repair escrow based on changes to the Consumer Price Index 3 by issuing a Federal Register notice for comment.

3 The Consumer Price Index (CPI) is prepared by the Department of Labor's Bureau of Labor Statistics and is a measure of the average change over time in the prices paid by urban consumers for a market basket of consumer goods and services. For more information, see http://stats.bls.gov/cpi/home.htm.

4. Listings. HUD proposed amending § 291.100(h) to clarify that HUD has the statutory authority to allow for a number of listings options. Specifically, in addition to asset management and listing contracts, HUD proposed providing that it may dispose of properties using any use method that the Secretary deems appropriate. In addition, HUD proposed revising § 291.100(h)(2)(ii) to require the purchaser's broker to submit bids through HUD's designated electronic bid system rather than through the exclusive broker.

5. Settlement Cost Assistance Available to Owner-Occupant Purchasers. HUD proposed removing HUD's obligation to pay the broker's sales commission and clarifying that settlement cost assistance is only available to owner-occupant purchasers and not investor purchasers.

6. Bidding Process for Competitive Sales. HUD's October 2, 2015, rule proposed updating the bidding process established under the competitive sales procedures in § 291.205. Specifically, HUD proposed revising § 291.205(k) to provide for winning bids to be made available publicly rather than making them available for inspection at a time and place designated by the HUD local office. In addition, the rule proposed specifying that winning bidders may be notified by their brokers using electronic mail and that an executed sales contract will be deemed final when, after being signed by both parties, the executed contract is sent by email rather than via postal service delivery to the successful bidder.

7. Good Neighbor Next Door (GNND). Finally, HUD proposed revising the GNND program to provide that law enforcement officers, similar to teachers and firefighters, live in the areas they serve.

II. This Final Rule

This final rule follows publication of the October 2, 2015, proposed rule and takes into consideration the public comments received on the proposed rule. The public comment period on the proposed rule closed on December 1, 2015, and HUD received six comments. The commenters were from a retail home mortgage lender, an organization of professional real property appraisers, an organization that provides appraisals, and members of the public. This section of this preamble presents a summary of the public comments received on the proposed rule, and HUD's responses to the comments. After considering these comments, HUD has decided to adopt the final rule as final with no substantive changes.

Comment: Limiting settlement cost assistance to owner-occupied purchasers will limit broker participation in the REO program. A commenter states that the proposal at § 291.205(b) to remove HUD's obligation to pay the broker's sales commission would be a major shift from the real estate industry. The commenter describes the current process of selling HUD homes as very similar to the traditional real estate market. According to the commenter, HUD's proposal would require that the sales broker ask the buyer to pay commission. This would create a significant difference between the sale and disposition of HUD homes and traditional sales of real estate and would likely deter real estate brokers from participating in the HUD sales process. The commenter also states that such a change would be unique to the HUD property disposition program and not in conformance with industry standards. The commenter suggests an alternative to address commission payouts; specifically, that HUD pay commissions based on the net sales price (Net-to-HUD). According to the commenter, this is a common and accepted practice in the real estate industry and would save hundreds of dollars per transaction and support HUD's goals of reducing inventory and minimizing losses.

HUD Response: The provision in the rule codifies that not all REO property sales transactions are sold through brokers (e.g., auctions, third-party sales at foreclosure, direct sales and, as such, HUD will not pay a commission to brokers for sale transactions that do not involve a real estate broker. For transactions that involve the services of a broker, HUD will pay for services commensurate with the services obtained. For example, for properties that involve a listing and selling agent, HUD will continue to pay brokers a commission of up to 6 percent to market and sell the HUD REO property. Alternately, if a property is being sold through an auction at a pre-foreclosure sale, then HUD will not pay a real estate broker commission. The auction company markets the property and its fee is usually paid as part of the insurance claim.

Comment: HUD's selection of certain agencies to sell properties and provide appraisals does not provide HUD the greatest value for the properties. A commenter states that the entities with which HUD contracts for the sale of properties and for appraisals of these properties use favoritism in selecting agencies to sell the properties and provide the appraisals. According to the commenter, these practices do not benefit HUD in acquiring the greatest value for properties. The commenter recommends that HUD establish a cap that limits acquisition opportunities with these preferred groups, such that it would allow disposition through other agencies and a broader utility of approved appraisers. This, according to the commenter, would provide HUD a marked increase in return on REO properties.

HUD Response: HUD disagrees with the commenter. HUD selects its Asset Manager contractors through a competitive bidding process. HUD does not participate and is not privy to an Asset Manger's selection of its subcontractors, including appraisers. In addition, for Fiscal Years (FY) 2013, 2014, and 2015, HUD received an average of 90 percent of appraisal value for its single-family REO properties. This is a clear indication that the selection criteria used by HUD Asset Manager for selecting appraisers maximizes the recovery rates on HUD single- family REO properties.

Comment: State law may limit real estate licensees from preforming a BPO to value the property. A commenter states that Pennsylvania prohibits real estate licensees from performing a BPO under their licenses if they are not separately licensed as an appraiser. According to the commenter, all that an agent can perform in Pennsylvania is a Competitive Market Analysis (CMA). As a result, the proposed rule would bar HUD or HUD Asset Managers in Pennsylvania from paying a fee to a sales agent for a BPO unless that agent was also a licensed appraiser. The commenter also suggests that other States may have similar prohibitions.

HUD Response: The provision in the rule codifies that HUD may utilize one or more valuation tools to determine the list price on its REO single-family properties. The specific services requested will be ordered only if permitted by State law. For example, if BPOs are not permitted to be performed by a broker, an AVM, CMA, appraisal, or BPO performed by an appraiser may be ordered by HUD's Asset Manager to establish the list price on an REO property.

Comment: HUD should allow servicers to participate in second chance Claims Without Conveyance of Title program. A commenter recommends, based on HUD's goal to reduce its REO inventory, that HUD consider allowing servicers to participate in a second chance program for their properties in post-sale that may not have been part of the Claims Without Conveyance of Title (CWCOT) program at the time of the foreclosure sale. The commenter states that its understanding is that unless loans were part of the original CWCOT program, they cannot be considered for second chance auction. The commenter requests that HUD reconsider this and believes that offering this opportunity to servicers will assist in meeting HUD's goal of reducing inventory and minimizing losses. According to the commenter, such a change would also reduce HUD staffing and contract expenses, and would benefit communities and tax authorities, which would see a positive benefit as homes would be reoccupied more quickly, properties better maintained, and taxes and HOA and condominium fees paid. The commenter also states that this would also reduce the servicer's labor costs and out of pocket expenses.

HUD Response: HUD appreciates the commenter's recommendation; however, this rule does not affect CWCOT procedures. Rather, Mortgagee Letter 2014-24, Increasing Use of FHA's Claims Without Conveyance of Title (CWCOT) Procedures,4 establishes the criteria for post-foreclosure, second chance sales efforts. The Mortgagee Letter provides mortgagees with instructions on accessing and utilizing the Commissioner's Adjusted Fair Market Value, which must be used for all foreclosure sales and post-foreclosure sales efforts. The mortgagee must determine the competitive and non-competitive Commissioner's Adjusted Fair Market Value (CAFMV) at the same time. Essentially, in the event a property does not sell to a third party at the foreclosure sale, mortgagees may pursue additional sales efforts (and may utilize independent third-party providers to conduct such sales) prior to making a final decision to convey the property to HUD. A mortgagee's decision to pursue additional sales efforts, subsequent to the foreclosure sale, does not relieve the mortgagee of its responsibility to convey a property to HUD within the required timeframe stated in § 203.359, unless a sales contract has been ratified. Where a sales contract has been ratified, the mortgagee will be granted a 30-day extension of the deadline for conveyance. As such, the Department encourages mortgagees to pursue additional sales efforts concurrently with their preconveyance processes to ensure that, in the event conveyance is necessary, the mortgagee is able to fully comply with FHA's conveyance timeframe. In the event a non-competitive CAFMV is used for the foreclosure sale, as in some judicial states, the competitive CAFMV value may be utilized for the post-foreclosure sales effort, if the requirements for competitive post-foreclosure sales are met.

4 Mortgagee Letter 2014-24 is available at http://portal.hud.gov/hudportal/documents/huddoc?id=14-24ml.pdf.

Comment: HUD needs to adopt a direct conveyance model. A commenter expresses support for HUD's proposed rule, stating that the changes will equip HUD with additional tools necessary to increase the efficiency and effectiveness of its REO sales program and that the changes to HUD REO property appraisals and maximum escrow amounts for properties needing repairs will bring FHA practices a step closer to conformance with industry standards. The commenter states, however, that until FHA adopts a direct conveyance model, both its REO sales process and broader property preservation policy will continue to lag behind industry standards. Specifically, the commenter states that while creating and implementing a direct conveyance model is a significant undertaking, such a model would expand the same benefits HUD claims the proposed changes will confer on the market: FHA will be able to move properties to REO more quickly, at a reduced cost, while increasing the value of the MMIF. Ultimately, FHA will gain more flexibility in selling properties in “as-is” condition. The commenter states, however, that the changes proposed by this rule represent first steps toward such a model.

HUD Response: HUD appreciates the commenter's support of the changes proposed by HUD, but disagrees that HUD needs a direct conveyance model to increase the efficiency and effectiveness of its REO sales program. FHA does not buy, sell, or securitize FHA loans and, as such, does not own a loan secured by an FHA mortgage on the foreclosure sales date. A direct conveyance model does not ensure that HUD has marketable title on a property insured by an FHA mortgage at the foreclosure sale or the property does not have damages that should be repaired by the lender prior to conveyance.

If a property is not sold to a third party at the foreclosure sale, the lender obtains title. Once the lender ascertains that it has marketable title and the property is in conveyance condition, the lender files a claim for insurance benefits and the deed is recorded in HUD's name. HUD's current conveyance model provides HUD with reasonable assurance that there are no encumbrances to a conveyed property that will prevent HUD from efficiently and effectively maintaining and marketing an REO property until it is sold.

Comment: BPOs are unregulated and performed by individuals with little oversight or training and HUD should require one independent appraisal. A commenter, focusing on § 291.100(b), cautions that BPOs are largely unregulated and are performed with little oversight and training. More specifically, the commenter states that BPO preparers have little valuation-specific education, training, and testing requirements, and do not adhere to generally accepted valuation standards. The commenter also states that AVMs are essentially statistical algorithms, reliant on public record data, which are often outdated and/or inaccurate. According to the commenter, AVMs are also historically weak in nonconforming markets, as individual property and local market conditions are largely overlooked. As a result, the commenter states that HUD should require at least one independent appraisal. This, according to the commenter, would be generally consistent with requirements imposed by Federal bank regulatory agencies, which require a current appraisal or evaluation for REO purposes.

HUD Response: HUD disagrees. Most sellers do not obtain an appraisal to determine the list price of their properties. Generally, the listing agent prepares a CMA. Currently, HUD orders an appraisal as a valuation tool in determining the list price of its REO properties. The appraisal is not always the sole basis of determining the list price. This final rule provides HUD with the flexibility of using one or more other valuation tools to establish the list price on its REO single-family properties. Since the competitive market ultimately determines the sales price for HUD REO properties in markets where the AVM, BPOs, etc., values have historically been within a relevant range of appraisal values HUD may determine that it is not cost beneficial for HUD to order appraisals for establishing the list prices.

Comment: Independent appraisals are essential to protecting the taxpayer and the MMIF. The commenter also states that the use of an independent appraisal will protect taxpayers from distressed sales below market value and help ensure that local communities do not have properties dumped on the market at below market prices. According to the commenter, quality appraisals are essential if HUD plans to reduce the inventory of single-family properties in a manner that minimizes losses to the MMIF. The commenter recommends that the final rule include a basic requirement for at least one appraisal prepared for REO purposes to protect taxpayers and local communities.

HUD Response: HUD disagrees with the commenter. As HUD states in response to an earlier comment, most sellers do not obtain an appraisal to determine the list price of their properties. This final rule provides HUD with the flexibility of using one or more other valuation tools to establish the list price on its REO single-family properties. Since, the competitive market ultimately determines the sales price for HUD REO properties, in markets where the AVM, BPOs, etc., values have historically been within a relevant range of appraisal values, HUD may determine that it is not cost beneficial for HUD to order appraisals for establishing the list prices. Properties that are security for mortgages to be insured by FHA are appraised to protect the insurance funds. In neighborhoods where FHA has insured a significant number of mortgages, there is an incidental benefit of preventing strategic default based on inflated values. Additionally, as a by-product, HUD's strategic goal of strengthening the nation's housing market to bolster the economy and protect consumers is advanced.

Comment: HUD should require two value opinions in the case of a disposition. The commenter also states that in the case of a disposition, HUD would benefit from obtaining two value opinions from real estate appraisal professionals; one for the current market value and one for the property's liquidation value. According to the commenter, such appraisals are common throughout the real estate sector and can be capably prepared by residential appraisal professionals. The commenter suggests that the Liquidation Value Addendum, published by the Appraisal Institute, would help HUD understand the range of risk exposure, with the liquidation value helping to illustrate the worst case scenario. The commenter states that such services would provide cost-effective alternatives to less credible services such as AVMs and BPOs. The commenter also recommends that, if HUD is not utilizing them today, it considers doing so before turning to less credible alternatives.

HUD Response: HUD disagrees. As HUD states in response to an earlier comment, for FY 2013, FY 2014, and FY 2015, HUD's average sales price as a percentage of appraised value was 90 percent. HUD believes that ordering a Liquidation Value Addendum from an appraiser as an additional cost is not cost effective. A liquation value is often obtained from the listing agent through a CMA as part of the listing broker commission to support price adjustments.

BPOs, CMAs, and AVMs are widely used by various market participants. HUD believes that when two or more of these valuation tools are within a relevant range, the values are generally regarded as reliable.

Currently, HUD orders an appraisal as a valuation tool in determining the list price of its REO properties. The appraisal is not always the sole basis of determining the list price. The rule provides HUD with the flexibility of using one or more other valuation tools to establish the list price on its REO single-family properties. Since, the competitive market ultimately determines the sales price for HUD REO properties, in markets where the AVM, BPO, etc., values have historically been within a relevant range of appraisal values, HUD may determine that it is not cost beneficial for HUD to order appraisals for purposes of establishing the list prices.

Comment: HUD should expand the list of valuation services available. Finally, the commenter recommends that, HUD should insist on expanding the range of valuation services available to the agency, the list be expanded to include nontraditional valuation services performed by real estate appraisers that are commonly utilized in asset management and disposition. That list, according to the commenter, should include, at a minimum, opinions of market value and liquidation or disposition value by appraisers, drive-by appraisals, and desktop appraisals, in addition to interior inspection appraisals. According to the commenter, this would provide HUD with the full range of valuation services that are available in the conventional market.

HUD Response: The final rule provides examples of valuation methods that may be used. The list is not all-inclusive and enables HUD to use valuations tools that are currently in existence or that are developed in the future, as appropriate.

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

Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and therefore subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.

The majority of the changes made by this final rule streamline HUD's property disposition program by bringing its practices into conformance with industry standards and allowing HUD to administer its Single Family Property Disposition Program more efficiently and more effectively. These changes do not create additional significant burdens for the public. As a result, this rule was determined to not be a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and therefore was not reviewed by OMB.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This final rule does not have a significant economic impact on a substantial number of small entities. HUD defines “small supervised lenders” as those depository institutions that are regulated by the Federal Reserve, the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, or the National Credit Union Administration, and which have a depository asset base of less than $500 million.5

5 Of HUD's 1,459 supervised lenders, 598 are considered, by HUD, to be “small supervised lenders.”

This rule final rule codifies changes to the administration of HUD's property disposition and acquisition activities carried out as part of the FHA insurance program for one-to-four family homes. These changes include limiting the provision of settlement cost assistance to owner-occupants, providing HUD flexibility to run the bidding process for REO properties, changes to the direct sales process, additional flexibility to list properties electronically, changes to the required escrow amount for purchasers obtaining property not meeting HUD's property standards, and clarifications in the rule governing HUD's appraisal process. These changes streamline HUD's administration of its Single Family Property Disposition Program and reflect industry practice. For these reasons, HUD has determined that this final rule does not have a significant economic impact on a substantial number of small entities.

Paperwork Reduction Act

The information collection requirements contained in this final rule have been approved by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2502-0306. In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.

Environmental Impact

A Finding of No Significant Impact (FONSI) with respect to environment has been made at the proposed rule stage in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of National Environmental Policy Act (42 U.S.C. 4332(2)(C)). The FONSI remains applicable to this final rule and is available for public inspection between the hours of 8 a.m. and 5 p.m., weekdays, in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

Executive Order 13132, Federalism

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

Unfunded Mandates Reform Act

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

List of Subjects in 24 CFR Part 291

Community facilities, Conflict of interests, Homeless, Lead poisoning, Low and moderate income housing, Mortgages, Reporting and recordkeeping requirements, Surplus government property.

Accordingly, for the reasons stated in the preamble above, HUD amends 24 CFR part 291 as follows:

PART 291—DISPOSITION OF HUD-ACQUIRED AND -OWNED SINGLE FAMILY PROPERTY 1. The authority citation for part 291 continues to read as follows: Authority:

12 U.S.C. 1701 et seq., 42 U.S.C. 1441, 1441a, 1551a and 3535(d)

2. Revise the heading of part 291 to read as set forth above. 3. Revise § 291.1(a)(1) to read as follows:
§ 291.1 Purpose and general requirements.

(a) * * *

(1) This part governs the acquisition, possession, and disposition of one-to-four family properties acquired by the Federal Housing Administration (FHA) through foreclosure of an insured or Secretary-held mortgage or loan under the National Housing Act, or acquired by HUD under section 204(g) of the National Housing Act (12 U.S.C. 1710(g)). HUD will issue detailed policies and procedures that must be followed in specific areas.

4. Amend § 291.5 by removing paragraph (a) and the introductory text of paragraph (b), adding introductory text to the section, and adding alphabetically the definition of “Secretary” as follows:
§ 291.5 Definitions.

Terms used in this part are defined as follows:

Secretary is defined in 24 CFR 5.100.

5. Amend § 291.90 by revising the introductory text to read as follows:
§ 291.90 Sales methods.

In accordance with section 204(g) of the National Housing Act (12 U.S.C. 1710(g)), HUD will prescribe the terms and conditions for all methods of sale. HUD may dispose of assets using any method that the Secretary deems appropriate, including, but not limited to the following:

6. Amend § 291.100 by revising the section heading and paragraphs (b), (c), (d), and (h) to read as follows:
§ 291.100 General policy on HUD acquisition, ownership, and disposition of real estate assets.

(b) List price. The list price, or “asking price,” assigned to the property is based upon one or more evaluation tools (e.g., appraisal, Broker Price Opinion, Automated Valuation Model). An appraisal, when used, must be conducted by an independent real estate appraiser who meets all of the requirements of 24 CFR part 200, subpart G, and is in good standing on the appraiser roster established under that section. The appraiser must provide an opinion of the “as-is” market value using a valuation method that is commonly employed in the industry and that is consistent with FHA appraisal requirements.

(c) Insurance. When listing properties, HUD may elect to include information to indicate whether the property is eligible for FHA-insured financing under section 203(B) of the National Housing Act (12 U.S.C. 1709(b)).

(d) Financing. (1) Subject to underwriting requirements, REO properties that have not been identified as uninsurable in accordance with paragraph (c) of this section can be purchased and financed with a mortgage insured under section 203(b) or 203(k) of the National Housing Act (12 U.S.C. 1709(b), 1709(k)), if supported by an FHA appraisal, in one of the following ways:

(i) Insured. A property that meets the Minimum Property Standards (MPS), as defined in HUD Handbook 4905.1 or any successor handbook, as determined by the Secretary, for existing dwellings will be offered for sale in “as-is” condition with FHA mortgage insurance available as provided in part 203 of this chapter.

(ii) Insured with repair escrow. (A) A property that requires no more than $10,000 for repairs to meet the MPS, as defined in HUD Handbook 4905.1 or any successor handbook, as determined by the Secretary, will be offered for sale in “as-is” condition with FHA mortgage insurance available, as provided in part 203 of this chapter, provided the mortgagor establishes a cash escrow to ensure the completion of the required repairs.

(B) Changes in repair escrow. HUD may adjust the escrow balance required under this paragraph based on changes to the Consumer Price Index by publishing a Federal Register notice that provides for a public comment period of 30 calendar days for the purpose of accepting comments on the amount of the change. After comments have been considered, HUD will publish a final notice announcing the revised escrow amounts.

(iii) Insured with rehabilitation loan in accordance with section 203(k) of the National Housing Act and pursuant to § 203.50 of this chapter.

(2) REO properties that have been identified as uninsurable in accordance with paragraph (c) of this section can be purchased and financed with a mortgage insured under section 203(k) of the National Housing Act (12 U.S.C. 1709(k)), subject to underwriting requirements supported by an FHA-specified appraisal and in accordance with 24 CFR 203.50.

(3) HUD, in its sole discretion and subject to appropriations, may take back Purchase Money Mortgages (PMMs) on property purchased by governmental entities or private nonprofit organizations who buy property for ultimate resale to owner-occupant purchasers with incomes at or below 115 percent of the area median income. When offered by HUD, a PMM will be available in an amount determined by the Secretary to be appropriate, at market rate interest, for a period not to exceed 5 years. Mortgagors must meet FHA mortgage credit standards.

(i) For purposes of this section, the term “purchase money mortgage,” or PMM means a note secured by a mortgage or trust deed given by a buyer, as mortgagor, to the seller, as mortgagee, as part of the purchase price of the real estate.

(ii) Except as provided in paragraph (d)(3) of this section, the purchaser is entirely responsible for obtaining financing for purchasing a property.

(h) Any real estate broker who has agreed to comply with HUD requirements may be eligible to participate in the sales program. Purchasers participating in the competitive sales program, except government entities and nonprofit organizations, must submit bids through a participating broker. In accordance with section 204(g) of the National Housing Act (12 U.S.C. 1710(g)), HUD will prescribe the terms and conditions for all methods of listing properties. HUD may dispose of properties using any method that the Secretary deems appropriate, including, but not limited to the following:

(1) Open listings. Properties may be sold on an open listing basis with participating real estate brokers.

(2) Asset management and listing contracts. (i) HUD may invite firms experienced in property management to compete for contracts that provide for an exclusive right to manage and list specified properties in a given area.

(ii) In areas where a broker has an exclusive right to list properties, a purchaser may use a broker of his or her choice. The purchaser's broker must submit the bid through HUD's designated electronic bid system.

7. Amend § 291.205 by revising the introductory text and paragraphs (b), (k)(1), (k)(2), and (l) to read as follows:
§ 291.205 Competitive sales of individual properties.

When HUD conducts competitive sales of individual properties to individual buyers, it will generally sell the properties on an “as-is” basis, without repairs or warranties, and it will follow the sales procedures provided in this section.

(b) Net offer. (1) The net offer is calculated by subtracting from the bid price the dollar amounts for the financing and loan closing costs and the broker's sales commission, as described in paragraph (b)(2) of this section.

(2) If an owner-occupant purchaser of the property requests in the bid, HUD may pay all or a portion of the financing and loan closing costs, not to exceed the percentage of the purchase price determined appropriate by the Secretary for the area. In no event will the total amount for broker's sales commission exceed 6 percent of the purchase price, except for cash bonuses offered to brokers by HUD for the sale of hard-to-sell properties. No assistance for financing and loan closing costs or for the broker's sales commission will be provided to investor purchasers.

(k) * * *

(1) The Secretary will make all winning bids available publicly.

(2) Successful bidders will be notified through their real estate brokers by electronic mail, mail, telephone, or other means. Acceptance of a bid is final and effective only upon HUD's execution of the sales contract, signed by both the submitting real estate broker and the prospective purchaser, and sending a copy of the executed contract by electronic mail to the successful bidder or the bidder's agent.

(l) Counteroffers. HUD may present counteroffers during competitive bid periods, as it deems appropriate to minimize losses to its insurance fund. “Best and Final” offers requested by HUD are considered counteroffers.

8. Revise § 291.500 to read as follows:
§ 291.500 Purpose.

This subpart describes the policies and procedures governing the Good Neighbor Next Door (GNND) Sales Program. The purpose of the GNND Sales Program is to improve the quality of life in distressed urban communities. This is to be accomplished by encouraging law enforcement officers, teachers, and firefighters/emergency medical technicians to purchase and live in homes that are located in the same communities where they perform their daily responsibilities and duties.

9. Revise § 291.505 to read as follows:
§ 291.505 Definitions.

For purposes of this subpart:

Locality means the community, neighborhood, or jurisdiction of the unit of general local government, or Indian tribal government;

Unit of general local government means a county or parish, city, town, township, or other political subdivision of a State.

10. Amend § 291.520 by removing “and” from the end of paragraph (a), removing the period and adding “;and” in its place at the end of paragraph (b), and adding paragraph (c) to read as follows:
§ 291.520 Eligible law enforcement officers.

(c) The full-time employment in paragraph (a) of this section must, in the normal course of business, directly serve the locality in which the home is located.

11. Revise § 291.525(b) to read as follows:
§ 291.525 Eligible teachers.

(b) The full-time employment in paragraph (a) of this section must, in the normal course of business, serve students from the locality where the home is located.

12. Revise § 291.530 to read as follows:
§ 291.530 Eligible firefighter/emergency medical technicians.

A person qualifies as a firefighter/emergency medical technician for the purposes of the GNND Sales Program if the person is:

(a) Employed full-time as a firefighter or emergency medical technician by a fire department or emergency medical services responder unit of the Federal Government, a State, unit of general local government, or an Indian tribal government; and

(b) The full-time employment in paragraph (a) of this section must, in the normal course of business, directly serve the locality where the home is located.

Dated: August 5, 2016. Edward L. Golding, Principal Deputy, Assistant Secretary for Housing. Approved: August 5, 2016. Nani A. Coloretti, Deputy Secretary.
[FR Doc. 2016-19132 Filed 8-10-16; 8:45 am] BILLING CODE 4210-67-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0739] RIN 1625-AA00 Safety Zone; Pittsburgh Steelers Fireworks; Allegheny River Mile 0.0-0.25, Ohio River Mile 0.0-0.1, Monongahela River Mile 0.0-0.1, Pittsburgh, PA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for navigable waters of the Allegheny River mile 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Pittsburgh.

DATES:

This rule is effective on August 12, 2016 from 9:30 p.m. until 11:30 p.m.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0739 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard, at telephone 412-221-0807, email [email protected]

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations CFR Code of Federal Regulations NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

This safety zone and fireworks displays are included in the list of annually recurring safety zones published in 33 CFR 165.801, Table 1, No. 59 as occurring on Sunday, Monday, or Thursday from September through January each year following Pittsburgh Steelers home games. For this year, the event sponsor is conducting an additional barge-based fireworks display on August 12, 2016 and that display and required safety zone location are not included in the published regulations. This temporary final rule establishes that safety zone.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because the Coast Guard received notice on July 25, 2016 that this additional fireworks display would take place. After receiving and fully reviewing the event information, circumstances, and exact location, the Coast Guard determined that a safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based fireworks display on the navigable waterway. It would be impracticable to complete the full NPRM process for this safety zone because it needs to be established by August 12, 2016. The fireworks display has been advertised and the local community has prepared for the event.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to public interest of ensuring the safety of spectators and vessels during the event. Immediate action is necessary to prevent possible loss of life and property during the hazards created by a barge-based fireworks display near and over the navigable waterway.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Pittsburgh (COTP) has determined that a safety zone is needed on August 12, 2016.This rule is needed to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based fireworks display.

IV. Discussion of the Rule

This rule establishes a safety zone on August 12, 2016 from 9:30 p.m. until 11:30 p.m. The safety zone will cover all navigable waters on the Allegheny River mile 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1. The duration of the safety zone is intended to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based firework display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

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

This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone impacts a small portion of the waterway for a limited duration of less than two hours in the evening. Vessel traffic will be informed about the safety zone through local notices to mariners. Moreover, the Coast Guard will issue broadcast notices to mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to transit the zone.

B. Impact on Small Entities

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

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

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

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less then two hours that will prohibit entry to the Allegheny River mile 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1during the barge-based firework event. It is categorically excluded from further review under paragraph 34 (g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T08-0739 to read as follows:
§ 165.T08-0739 Safety Zone; Pittsburgh Steelers Fireworks; Allegheny River mile 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1, Pittsburgh, PA.

(a) Location. The following area is a safety zone: Pittsburgh Steelers Fireworks; Allegheny River mile 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1, Pittsburgh, PA.

(b) Enforcement. This rule will be enforced, from 9:30 p.m. until 11:30 p.m. on August 12, 2016.

(c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into this zone is prohibited unless authorized by the COTP or a designated representative.

(2) Persons or vessels requiring entry into or passage through the zone must request permission from the COTP or a designated representative. The COTP representative may be contacted at 412-221-0807.

(3) All persons and vessels shall comply with the instructions of the COTP or their designated representative. Designated COTP representatives include United States Coast Guard commissioned, warrant, and petty officers.

(d) Information Broadcasts. The COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the safety zone as well as any changes in the planned schedule.

L. McClain, Jr., Commander, U.S. Coast Guard, Captain of the Port Pittsburgh.
[FR Doc. 2016-19128 Filed 8-10-16; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 50 [EPA-HQ-OAR-2016-0408; FRL-9950-48-OAR] RIN 2060-AS89 Technical Correction to the National Ambient Air Quality Standards for Particulate Matter AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is taking direct final action to make a technical correction to an equation in an appendix in the National Ambient Air Quality Standards (NAAQS) for Particle Pollution. Equation 2 describes an intermediate step in the calculation of the design value for the annual PM2.5 (particles with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers) NAAQS. This action corrects a scrivener's error in one of the equations used to calculate an annual mean PM2.5 concentration, to properly account for cases where a site does not have four complete quarters of data and passes one of two substitution tests. This change accurately reflects the intended calculation of the annual mean PM2.5 design value and is consistent with the text elsewhere in the appendix.

DATES:

This rule is effective on October 11, 2016 without further notice, unless the EPA receives adverse comment by September 12, 2016. If the EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0408, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (e.g., on the Web, Cloud, or other file sharing system).

For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Mr. Brett Gantt, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Air Quality Analysis Group (Mail Code: C304-04), Research Triangle Park, NC 27711; telephone number: (919) 541-5274; fax number: (919) 541-3613; email address: [email protected]

SUPPLEMENTARY INFORMATION: Table of Contents I. General Information A. Why is the EPA using a direct final rule? B. Does this action apply to me? C. What should I consider as I prepare my comments for the EPA? II. This Action III. 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 (PRA) C. Regulatory Flexibility Act (RFA) 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 Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act (CRA) I. General Information A. Why is the EPA using a direct final rule?

The EPA is publishing this rule without a prior proposed rule because we view this as a non-controversial action and anticipate no adverse comment. This action corrects a scrivener's error in an intermediate equation in the calculation of the annual PM2.5 design value to properly account for cases where a site does not have four complete quarters of data in a specific year and passes the minimum quarterly value substitution test. In the “Proposed Rules” section of today's Federal Register, we are publishing a separate proposed rule to correct this scrivener's error if any adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

B. Does this action apply to me?

This action applies to you if you are calculating the annual PM2.5 design value for a site which does not have four complete quarters of data for a specific year and passes the minimum quarterly value substitution test.

C. What should I consider as I prepare my comments for the EPA?

(1) Submitting CBI. Do not submit this information to EPA through www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

(2) Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

II. This Action

On December 14, 2012, the EPA revised the NAAQS for Particle Pollution (78 FR 3086). Appendix N to part 50 of this document described the data handling conventions and computations necessary for determining when the NAAQS for PM2.5 are met. Section 4.4 described the annual PM2.5 design value calculations, with equations 1, 2, and 3 used to calculate the quarterly, annual, and 3-year average concentrations. Equation 2 erroneously described the annual mean as the average of the four quarterly values despite the availability of substitution tests for cases when quarterly values do not meet the completeness requirements in section 4.1.

Specifically, the minimum quarterly value substitution test described in section 4.1(c)(i) allows for a valid annual PM2.5 design value to be calculated when a test design value, having deficient quarters substituted with quarter-specific low values, is found to be greater than the level of the standard. If the minimum quarterly value substitution test is passed, the annual PM2.5 design value is calculated from annual means of the non-deficient quarterly values, which can range in number from one to four for a specific year.

As currently written, equation 2 is not appropriate for use during a minimum quarterly value substitution test and does not accurately reflect the intended calculation of the annual mean PM2.5 concentration in these cases.1 Therefore, this action generalizes equation 2 to account for cases that pass the minimum quarterly value substitution test, yet do not have four non-deficient quarterly values in each of the years in the 3-year design value period. This technical correction to equation 2 is currently used in the calculation of the PM2.5 annual design value, is consistent with the text of section 4.1 within appendix N to part 50, and does not affect the calculation of annual mean PM2.5 concentrations when four complete quarters of data are available.

1 If read literally with the scrivener's error, it would be erroneous to use Equation 2 to calculate the annual PM2.5 NAAQS for any year with a deficient quarter of data because the equation instructs the user to sum all four quarters when at least one of those quarters contains missing data.

III. Statutory and Executive Order Reviews

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

This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.

B. Paperwork Reduction Act (PRA)

This action does not impose an information collection burden under the PRA. This action generalizes the calculation of the annual PM2.5 NAAQS design values and does not impose additional regulatory requirements on organizations monitoring air quality.

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action corrects the calculation of annual mean PM2.5 concentrations and does not impose additional regulatory requirements on sources.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments, or the private sector.

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.

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

This action does not have tribal implications, as specified in Executive Order 13175. This regulatory action is a technical correction to a previously promulgated regulatory action and does not have any impact on human health or the environment. Thus, Executive Order 13175 does not apply to this action.

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

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

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

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

I. National Technology Transfer and Advancement Act

This rulemaking does not involve technical standards.

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

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action is a technical correction to a previously promulgated regulatory action and does not have any impact on human health or the environment.

K. Congressional Review Act

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

List of Subjects in 40 CFR Part 50

Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.

Dated: August 3, 2016. Gina McCarthy, Administrator.

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

PART 50—NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS 1. The authority citation for part 50 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

2. In appendix N to part 50, in section 4.4, Equation 2 is revised to read as follows: Appendix N to Part 50—Interpretation of the National Ambient Air Quality Standards for PM2.5

4.4 Equations for the Annual PM 2.5 NAAQS

(b) * * *

ER11AU16.002 Where: X y = the annual mean concentration for year y (y = 1, 2, or 3); n Qy = the number of complete quarters Q in year y; and X qy = the mean for quarter q of year y (result of equation 1).
[FR Doc. 2016-19034 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2015-0539; FRL-9950-29-Region 3] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Prevention of Significant Deterioration and Approval of Infrastructure State Implementation Plans for Specific National Ambient Air Quality Standards AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the West Virginia Department of Environmental Protection (WVDEP) for the State of West Virginia on June 3, 2015. This revision pertains to West Virginia's Prevention of Significant Deterioration (PSD) permit program regulations for preconstruction permitting requirements for major sources. The revision includes a change in West Virginia's PSD regulations related to emissions of fine particulate matter (PM2.5). The State's June 3, 2015 submittal satisfies its obligations pursuant to an earlier rulemaking in which EPA granted final conditional approval of West Virginia's PSD implementing regulations. This action also addresses specific infrastructure program elements specified in Clean Air Act (CAA) section 110(a)(2) necessary to implement, maintain, and enforce several national ambient air quality standards (NAAQS). This action is being taken under the CAA.

DATES:

This final rule is effective on September 12, 2016.

ADDRESSES:

EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2015-0539. All documents in the docket are listed in the www.regulations.gov Web site. Although listed in the electronic docket, some information is not publicly available, i.e., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available through www.regulations.gov or may be viewed during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the West Virginia Department of Environmental Protection, Division of Air Quality, 601 57th Street SE., Charleston, West Virginia 25304.

FOR FURTHER INFORMATION CONTACT:

Mr. Paul Wentworth, (215) 814-2183, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

On January 11, 2016 (81 FR 1133), EPA published a notice of proposed rulemaking (NPR) for the State of West Virginia. In the NPR, EPA proposed approval of a revision to West Virginia's PSD permit program regulations for preconstruction permitting requirements for major sources. The revision includes revised West Virginia PSD regulations related to emissions of PM2.5. The formal SIP revision was submitted by the State of West Virginia on June 3, 2015.

II. Summary of SIP Revision

The SIP revision submitted by WVDEP on June 3, 2015 pertains to revisions to its PSD permit program regulations at 45CSR14-16.7.c that establish a significant monitoring concentration (SMC) value of zero micrograms per cubic meter for PM2.5. The submission of this revision allows EPA to change its conditional approval of 45CSR14 to a full approval. Because this submission fulfills the commitment made by West Virginia in the final conditional approval of West Virginia's earlier submittals of revisions to 45CSR14 as discussed in the NPR, EPA is now fully approving West Virginia's PSD regulations at 45CSR14 in its entirety as 45CSR14 meets requirements in the CAA and its implementing regulations and removing the prior conditional approval. See 80 FR 36483 (final conditional approval of prior SIP submissions of revisions to 45CSR14).

With its submittal, West Virginia has made all of the changes to its PSD implementing regulations necessary to address PM2.5 as prescribed by the CAA, 40 CFR 51.166, and the May 16, 2008 new source review implementation rule for PM2.5 at 73 FR 28321. Because West Virginia's regulations at 45CSR14 fully meet the federal requirements for PSD in the CAA, EPA also found that West Virginia's PSD program now addresses specific PSD-related portions of the infrastructure program elements in section 110(a)(2) of the CAA for the 1997 ozone and PM2.5 NAAQS, the 2006 PM2.5 NAAQS, the 2008 lead and ozone NAAQS, and the 2010 nitrogen dioxide (NO2) and sulfur dioxide (SO2) NAAQS. Other specific requirements of and the rationale for EPA's approval action of West Virginia's revised PSD regulations and relevant infrastructure SIP revisions for several NAAQS are explained in the NPR and will not be restated here. No public comments were received on the NPR.

III. Final Action

EPA is approving this SIP revision submitted by WVDEP as a revision to the West Virginia SIP for its PSD program and removing a prior conditional approval on the PSD program. In this action, EPA is also approving several of West Virginia's infrastructure SIP revisions as meeting the PSD elements of section 110(a)(2) of the CAA for the 1997 ozone and PM2.5 NAAQS, the 2006 PM2.5 NAAQS, the 2008 lead and ozone NAAQS, and the 2010 NO2 and SO2 NAAQS.

IV. Incorporation by Reference

In this rule the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of 45CSR14-16.7.c, described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or may be viewed at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

V. Statutory and Executive Order Reviews A. General Requirements

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

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

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

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

C. Petitions for Judicial Review

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 11, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action which revises West Virginia's PSD regulations related to emissions of PM2.5 and which approves portions of several infrastructure SIPs as addressing PSD elements in CAA section 110(a)(2) may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Carbon monoxide, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: July 25, 2016. Shawn M. Garvin, Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart XX—West Virginia 2. In § 52.2520: a. The table in paragraph (c) is amended by revising the entries for 45CSR Series 14. b. The table in paragraph (e) is amended by revising the entries for: i. Section 110(a)(2) Infrastructure Requirements for the 1997 8-Hour Ozone NAAQS, ii. Section 110(a)(2) Infrastructure Requirements for the 1997 PM2.5 NAAQS, iii. Section 110(a)(2) Infrastructure Requirements for the 2006 PM2.5 NAAQS, iv. Section 110(a)(2) Infrastructure Requirements for the 2008 Lead NAAQS, v. Section 110(a)(2) Infrastructure Requirements for the 2008 8-Hour Ozone NAAQS, vi. Section 110(a)(2) Infrastructure Requirements for the 2010 Nitrogen Dioxide NAAQS, and vii. Section 110(a)(2) Infrastructure Requirements for the 2010 1-Hour Sulfur Dioxide NAAQS.

The revised text reads as follows:

§ 52.2520 Identification of plan.

(c) * * *

EPA-Approved Regulations in the West Virginia SIP State citation
  • [Chapter 16-20 or 45 CSR ]
  • Title/Subject State effective date EPA Approval date Additional explanation/
  • Citation at 40 CFR
  • 52.2565
  • *         *         *         *         *         *         * [45CSR] Series 14 Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration Section 45-14-1 General 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-2 Definitions 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-3 Applicability 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-4 Ambient Air Quality Increments and Ceilings 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-5 Area Classification 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-6 Prohibition of Dispersion Enhancement Techniques 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-7 Registration, Report and Permit Requirements for Major Stationary Sources and Major Modifications 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-8 Requirements Relating to Control Technology 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-9 Requirements Relating to the Source's Impact on Air Quality 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-10 Modeling Requirements 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-11 Air Quality Monitoring Requirements 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-12 Additional Impacts Analysis Requirements 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-13 Additional Requirements and Variances for Source Impacting Federal Class 1 Areas 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-14 Procedures for Sources Employing Innovative Control Technology 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-15 Exclusions From Increment Consumption 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-16 Specific Exemptions 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-17 Public Review Procedures 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-18 Public Meetings 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-19 Permit Transfer, Cancellation and Responsibility 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-20 Disposition of Permits 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-21 Conflict with Other Permitting Rules 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-25 Actual PALs 06/01/2015 08/11/2016, [Insert Federal Register citation] Section 45-14-26 Inconsistency Between Rules 06/01/2015 08/11/2016, [Insert Federal Register citation] *         *         *         *         *         *         *

    (e) * * *

    Name of non-regulatory
  • SIP revision
  • Applicable geographic area State submittal date EPA Approval date Additional explanation
    *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 1997 8-Hour Ozone NAAQS Statewide 12/3/07, 5/21/08 8/4/11, 76 FR 47062 This action addresses the following CAA elements or portions thereof: 110(a)(2)(A), (B), (C), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). 12/3/07, 12/11/07, 8/31/11 10/17/12, 77 FR 63736 Approval of the following PSD-related elements or portions thereof: 110(a)(2)(D)(i)(II), except taking no action on the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66 only as it relates to the requirement to include condensable emissions of particulate matter in that definition. See § 52.2522(i). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(D)(i)(II). See § 52.2520.
    Section 110(a)(2) Infrastructure Requirements for the 1997 PM2.5 NAAQS Statewide 4/3/08, 5/21/08, 7/9/08, 3/18/10 8/4/11, 76 FR 47062 This action addresses the following CAA elements or portions thereof: 110(a)(2)(A), (B), (C), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). 12/11/07, 4/3/08, 8/31/11 10/17/12, 77 FR 63736 Approval of the following PSD-related elements or portions thereof: 110(a)(2)(D) (i)(II), except taking no action on the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66 only as it relates to the requirement to include condensable emissions of particulate matter in that definition. See § 52.2522(i). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(D)(i)(II). See § 52.2520.
    Section 110(a)(2) Infrastructure Requirements for the 2006 PM2.5 NAAQS Statewide 10/1/09, 3/18/10 8/4/11, 76 FR 47062 This action addresses the following CAA elements or portions thereof: 110(a)(2)(A), (B), (C), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). 10/1/09, 8/31/11 10/17/12, 77 FR 63736 Approval of the following PSD-related elements or portions thereof: 110(a)(2)(D) (i)(II), except taking no action on the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66 only as it relates to the requirement to include condensable emissions of particulate matter in that definition. See § 52.2522(i). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(D)(i)(II). See § 52.2520.
    *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 2008 Lead NAAQS Statewide 10/26/11 9/10/12, 77 FR 55417 This action addresses the following CAA elements: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M), or portions thereof. 8/31/11, 10/26/11 10/17/12, 77 FR 63736 Approval of the following elements or portions thereof: 110(a)(2)(C), (D)(i)(II), and (J), except taking no action on the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66 only as it relates to the requirement to include condensable emissions of particulate matter in that definition. See § 52.2522(i). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(C), (D)(i)(II), and (J). See § 52.2520.
    Section 110(a)(2) Infrastructure Requirements for the 2008 8-Hour Ozone NAAQS Statewide 8/31/11, 2/17/12 10/17/12, 77 FR 63736 Approval of the following PSD-related elements or portions thereof: 110(a)(2)(C), (D)(i)(II), and (J), except taking no action on the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66 only as it relates to the requirement to include condensable emissions of particulate matter in that definition. See § 52.2522(i). 2/17/12 4/7/2014,
  • 79 FR 19001
  • This action addresses the following CAA elements, or portions thereof: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M).
    7/24/14 3/9/15,
  • 80 FR 12348
  • Addresses CAA element 110(a)(2)(E)(ii).
    6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(C), (D)(i)(II), and (J). See § 52.2520.
    *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 2010 Nitrogen Dioxide NAAQS Statewide 12/13/12 1/22/14, 78 FR 3504 This action addresses the following CAA elements: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M), or portions thereof. 7/24/14 3/9/15, 80 FR 12348 Addresses CAA element 110(a)(2)(E)(ii). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(C), (D)(i)(II), and (J). See § 52.2520.
    *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 2010 1-Hour Sulfur Dioxide NAAQS Statewide 6/25/13 10/16/14, 79 FR 62035 This action addresses the following CAA elements: 110(a)(2)(A), (B), (C) (enforcement and minor new source review), (D)(ii), (E)(i) and (iii), (F), (G), (H), (J) (consultation, public notification, and visibility protection), (K), (L), and (M). 7/24/14 3/9/15, 80 FR 12348 Addresses CAA element 110(a)(2)(E)(ii). 6/1/2015 8/11/2016,
  • [Insert Federal Register citation]
  • Approval of PSD-related element 110(a)(2)(C), (D)(i)(II), and (J). See § 52.2520.
    *         *         *         *         *         *         *
    [FR Doc. 2016-18518 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2011-0144; FRL-9944-48] Aminocyclopyrachlor; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of aminocyclopyrachlor in or on milk and livestock commodities imported into the United States, which are identified and discussed later in this document. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective August 11, 2016. Objections and requests for hearings must be received on or before October 11, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-0144, 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: RDFR[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/test-guidelines-pesticides-and-toxic-substances.

    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-2011-0144 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 October 11, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0144, 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 Tuesday, March 29, 2011 (76 FR 17376) (FRL-8867-4), 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 0F7817) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide aminocyclopyrachlor, 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid, and aminocyclopyrachlor methyl ester, methyl 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate, expressed as aminocyclopyrachlor, in or on grass, forage at 65 parts per million (ppm); grass, hay at 125 ppm; fat (of cattle, goat, horse, and sheep) at 0.07 ppm; meat (of cattle, goat, horse, and sheep) at 0.02 ppm; meat byproducts, excluding liver (of cattle, goat, horse, and sheep) at 0.4 ppm; liver (of cattle, goat, horse, and sheep) at 0.06 ppm; and milk at 0.035 ppm. That document referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    After issuance of the notice of filing, the registrant revised the petition by rescinding the proposed grass commodities and amending the purpose of establishing tolerances from domestic to import use (i.e. import tolerances).

    Based upon review of the data supporting the petition, EPA has lowered the proposed tolerances for milk, meat (of cattle, goat, horse, and sheep), and fat (of cattle, goat, horse, and sheep) and changed the proposed tolerances from liver and meat byproducts, except liver (of cattle, goat, horse, and sheep) to meat byproducts (of cattle, goat, horse, and sheep). The reasons for these changes are explained in Unit IV.C.

    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 aminocyclopyrachlor including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with aminocyclopyrachlor 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.

    Aminocyclopyrachlor

    Aminocyclopyrachlor (parent acid) has low acute toxicity by all routes of exposure (oral, dermal, inhalation), does not cause skin irritation or skin sensitization, but causes mild eye irritation. There are no target organs of toxicity for aminocyclopyrachlor. In the subchronic oral toxicity studies in rats, mild systemic toxicity effects of decreased body weights, body weight gains, food consumption, and food efficiency in both sexes were observed with repeated exposures at very high (limit) doses. There was no appreciable increase in the severity of these effects with time. The most sensitive species is the rat. Subchronic and chronic dietary studies in dogs and mice showed no adverse effects at all treatment doses including the limit dose. The subchronic dermal toxicity study in rat showed no evidence of toxicity at the limit dose. Subchronic inhalation toxicity studies are not available; however, based on the results of the acute inhalation studies showing low toxicity at twice the limit concentration, the likelihood of subchronic toxicity via inhalation route is expected to be low.

    In the prenatal developmental toxicity study, there were no adverse effects of aminocyclopyrachlor on prenatal development or maternal health in rats at all treatment doses including the limit dose. In the rabbit study, administration at the limit dose resulted in one treatment-related death and two abortions which were considered secondary effects to maternal weight losses which occurred over a period of 5 to 7 days. No developmental effects were observed in the offspring. There were no adverse effects of aminocyclopyrachlor on reproduction and fertility in rats at the limit dose. Toxicity in parental rats and offspring was limited to decreases in body weights at the limit dose.

    Aminocyclopyrachlor is classified as “Not Likely to be Carcinogenic to Humans.” This classification is based on no treatment-related tumors seen in male or female rats or mice at doses that were adequate to assess carcinogenicity, and no evidence of mutagenicity from a full battery of in vitro and in vivo genotoxicity studies. There was no evidence of neurotoxicity or immunotoxicity observed in the rodent studies up to the limit dose.

    Aminocyclopyrachlor-Methyl

    The toxicity database for aminocyclopyrachlor-methyl (ester) via the oral route of exposure is bridged with aminocyclopyrachlor (parent acid) based on evidence from metabolism studies, acute toxicity studies, and repeat-dose toxicity studies with common endpoints. The rat metabolism studies showed that aminocyclopyrachlor-methyl rapidly metabolizes (within 30 minutes) to aminocyclopyrachlor. A full suite of acute toxicity studies conducted with aminocyclopyrachlor and aminocyclopyrachlor-methyl resulted in the same toxicity category classifications. The subchronic oral toxicity study and the modified one-generation reproduction toxicity study in rats conducted with aminocyclopyrachlor-methyl showed effects of decreased body weights and body weight gains at the limit dose similar to those observed in the aminocyclopyrachlor studies. This one-generation reproduction study showed no evidence of reproductive, developmental, or neurotoxicity at the limit dose. There was no evidence of mutagenicity in the in vitro bacterial genotoxicity test conducted with aminocyclopyrachlor-methyl. The results of these studies show that aminocyclopyrachlor-methyl causes effects similar to aminocyclopyrachlor at the same dose levels. Therefore, studies conducted with aminocyclopyrachlor can be used to support aminocyclopyrachlor-methyl.

    Cyclopropane Carboxylic Acid

    Cyclopropane carboxylic acid (CPCA), also known as IN-V0977, is an environmental photolytic degradate of aminocyclopyrachlor present only in surface water. CPCA has a different mode of toxic action than aminocyclopyrachlor and aminocyclopyrachlor-methyl. Based on extensive pre-clinical studies of the anxiolytic drug candidate panadiplon, which metabolizes to CPCA after oral administration, the target organ is the liver, causing impairment of mitochondrial function by inhibiting the beta oxidation of fatty acids, resulting in microvesicular steatosis (accumulation of small fat droplets in cells) that is often accompanied by liver necrosis and inflammation, decreased hepatic glycogen, and decreased blood glucose levels. These effects were observed with acute (1 to 3 days) and repeated (up to 14 days) exposures. The most sensitive species is the rabbit. Hepatic microvesicular steatosis in the rabbit follows a different dose-response than body-weight decreases observed with aminocyclopyrachlor and aminocyclopyrachlor-methyl in rats, with a 100-fold lower adverse-effect level.

    There are no chronic dietary toxicity studies available to assess the carcinogenic potential of CPCA. However, structural-activity relationship (SAR) analyses on CPCA and panadiplon indicated no structural alerts for genotoxicity or carcinogenicity. Also, there were no reports of tumorigenic responses to CPCA or panadiplon in the open scientific literature.

    Specific information on the studies received and the nature of the adverse effects caused by aminocyclopyrachlor, aminocyclopyrachlor-methyl, and cyclopropane carboxylic acid, 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 Aminocyclopyrachlor: Human Health Risk Assessment for Section 3, Food Use on Rangeland/Pastures/CRP Acres at pages 15-26 in docket ID number EPA-HQ-OPP-2011-0144.

    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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    Summaries of the toxicological endpoints for aminocyclopyrachlor and cyclopropane carboxylic acid used for human health risk assessment are shown in Tables 1 and 2 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Aminocyclopyrachlor for Use in Human Health Risk Assessment Exposure/scenario Point of
  • departure and
  • uncertainty/safety
  • factors
  • RfD and PAD for
  • risk assessment
  • Study and toxicological effects
    Acute dietary (All populations) No hazard attributable to a single-exposure was identified. Chronic dietary (All populations) NOAEL= 279 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 2.79 mg/kg/day
  • cPAD = 2.79 mg/kg/day
  • Combined Chronic Toxicity/Carcinogenicity Rat Study.
  • LOAEL = 892 (males)/957 (females) mg/kg/day based on mild decreases in body weight/body weight gain.
  • Table 2—Summary of Toxicological Doses and Endpoints for Cyclopropane Carboxylic Acid for Use in Human Health Risk Assessment Exposure/scenario Point of
  • departure and
  • uncertainty/safety
  • factors
  • RfD and PAD for risk assessment Study and toxicological effects
    Acute dietary (All populations) LOAEL= 2.55 mg/kg/day CPCA
  • UFA = 10x
  • UFH = 10x
  • FQPA SF (UFDB, UFL) = 10x
  • Acute RfD = 0.026 mg/kg/day
  • aPAD = 0.0026 mg/kg/day
  • Panadiplon Subchronic Oral Rabbit Study
  • LOAEL = 10 mg/kg/day panadiplon (calculated to 2.55 mg/kg/day CPCA) based on hepatic steatosis.
  • Chronic dietary (All populations) LOAEL= 2.55 mg/kg/day CPCA
  • UFA = 10x
  • UFH = 10x
  • FQPA SF (UFDB, UFL, UFS) = 30x
  • Chronic RfD = 0.0087 mg/kg/day
  • cPAD = 0.00087 mg/kg/day
  • Panadiplon Subchronic Oral Rabbit Study
  • LOAEL = 10 mg/kg/day panadiplon (calculated to 2.55 mg/kg/day CPCA) based on hepatic steatosis.
  • FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. 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 aminocyclopyrachlor, EPA considered exposure under the petitioned-for tolerances only, as there are no registered food/feed uses. CPCA is an environmental photodegradate of aminocyclopyrachlor present only in surface water; therefore, any dietary exposure would be from drinking water only and is not expected through food or feed. EPA assessed dietary exposures from aminocyclopyrachlor 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. No such effects were identified in the toxicological studies for aminocyclopyrachlor; therefore, a quantitative acute dietary exposure assessment was not conducted.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment for aminocyclopyrachlor, 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).

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

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

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

    The importation of milk and livestock commodities containing potential residues of aminocyclopyrachlor will not increase pesticide exposure in U.S. drinking water. Therefore, the drinking water estimates are based on pesticide exposure from the existing non-food/non-feed uses of aminocyclopyrachlor.

    Based on the First Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model Ground Water (PRZM-GW) models, the estimated drinking water concentrations (EDWCs) of aminocyclopyrachlor for chronic exposures for non-cancer assessments are estimated to be 18.3 parts per billion (ppb) for surface water, and 78.0 ppb for ground water. The EDWCs of CPCA from surface water are estimated to be 1.7 ppb for acute exposure, and 1.2 ppb for chronic exposures for non-cancer assessments. Ground water EDWCs for CPCA were not calculated since CPCA is a photodegradate of aminocyclopyrachlor and is not anticipated to be present in ground water due to the absence of sunlight.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment to aminocyclopyrachlor, the water concentration value of 78.0 ppb was used to assess the contribution to drinking water. For acute dietary risk assessment to CPCA, the water concentration value of 1.7 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment to CPCA, the water concentration value of 1.2 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). Aminocyclopyrachlor is not currently registered for any specific use patterns that would result in residential exposure. In the risk assessment, EPA had assessed residential exposure based on previously-registered uses on lawn and turf, including golf courses; however, those residential use patterns are no longer registered, and therefore non-dietary residential exposure does not occur.

    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 aminocyclopyrachlor to share a common mechanism of toxicity with any other substances, and aminocyclopyrachlor does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that aminocyclopyrachlor 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA 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. As discussed in Unit III.A., there was no evidence of prenatal toxicity resulting from exposure to aminocyclopyrachlor. There was no evidence of increased susceptibility following in utero exposure in the rat and rabbit developmental toxicity studies. An increase in abortions in maternal rabbits was observed at the limit dose, but the abortions were considered secondary effects due to severe maternal body weight loss. There was also no evidence of increased susceptibility of offspring in the rat reproduction and fertility studies, with only body weight decreases observed in both maternal rats and offspring at the limit dose.

    For CPCA, there were no information available investigating developmental or offspring effects. However, there is indirect evidence in the open literature that the young may be more sensitive to the metabolic effects of CPCA, and this evidence does not allow this potential sensitivity to be ruled out. This evidence is provided by inherited conditions, specifically inborn errors of metabolism that results in compromised metabolism of fatty acids that is qualitatively similar to that of CPCA's effect of inhibition of beta oxidation of fatty acids. These inborn metabolism errors result in energy deficiencies during periods of fasting, and it is known that developing/young children are more sensitive to these effects than pregnant women or adults. The magnitude of this effect would be much more severe in the inherited case than for CPCA. This is because fatty acid oxidation is almost completely compromised in the inherited case and other cellular processes are also impacted, whereas only beta oxidation of fatty acids would be impacted for CPCA, and the magnitude of this impact is anticipated to be negligible for the estimated (low-level) dietary exposures.

    3. Conclusion. For aminocyclopyrachlor, 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.

    For the degradate cyclopropane carboxylic acid, the FQPA SF is retained at 10X for acute dietary exposures, to account for the extrapolation of data from a LOAEL to a NOAEL for hepatic steatosis/necrosis in rabbits, and to account for any potential uncertainties regarding developmental toxicity effects based on the available data. This SF is considered protective because hepatic steatosis/necrosis and any developmental toxicity effects would be caused by the same cellular mechanism. Therefore, protecting for these liver effects would protect any potential developmental toxicity resulting from very low dietary exposures to CPCA.

    For chronic dietary exposures, the FQPA SF is increased from 10X to 30X to account for the use of a short-term (acute) study to assess long-term (chronic) exposure. The additional 3X SF is considered protective since the duration of the acute study was 14 days with the dose administered as a bolus (via gavage). Because the exposure in this study was repeated and a bolus dose was used that would overestimate dietary exposure, the severity of the liver effects are not expected to vary substantially with time.

    Those decisions are based on the following findings:

    i. The toxicity database for aminocyclopyrachlor is adequate for assessing the sensitivity of infants and children under FQPA and for selecting endpoints for risk assessment.

    The database for CPCA is also adequate, as there is a substantial amount of toxicological information available in the open literature that identifies the target organ of toxicity, the mechanism of toxicity, and the most sensitive species. The FQPA SFs account for any residual uncertainties in the toxicity database for CPCA.

    ii. There is no indication that aminocyclopyrachlor is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Based on the mechanism of toxicity for CPCA that has been identified in the open scientific literature, the nervous system is not expected to be more sensitive than the liver. Although there are no studies available that directly investigate the effects of CPCA on the nervous system, there is indirect evidence that the endpoint on which the Agency is regulating CPCA (hepatic steatosis/necrosis) is protective of the nervous system. First, the molecular mechanism underlying hepatic steatosis has been identified as inhibition of the metabolic pathway of beta oxidation of fatty acids in the mitochondria. This is a major, energy producing pathway in liver but not in the brain. Since the ketone bodies generated by this process in the liver are metabolized by the brain for energy, any brain effects from inhibition of this pathway would be secondary to liver effects. Second, CPCA is a metabolite of panadiplon, a drug that was developed to target the nervous system as an anxiolytic. Panadiplon failed in preclinical development not as a result of neurotoxicity, but as a result of liver toxicity that was caused by CPCA. This further supports that adverse effects on the liver is more sensitive than the brain. Since the endpoint chosen for risk assessment is protective for liver effects, it is therefore also protective for any primary or secondary neurotoxicity that may result from CPCA exposure.

    iii. There is no evidence that aminocyclopyrachlor results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In the rabbit prenatal developmental study, an increase in abortions was observed at the limit dose, which were considered secondary effects to severe decreases in maternal body weight.

    As discussed in Unit III.D.2., there is no information available that directly investigates the developmental effects of CPCA. However, based on the known information, the magnitude of the potential impact of CPCA exposure on the inhibition of beta oxidation of fatty acids is anticipated to be negligible for the estimated dietary exposure, and less than the non-CPCA-related effects resulting from inborn metabolic errors which compromises the metabolism of fatty acids and other cellular processes.

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

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

    For CPCA, using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from drinking water only will occupy 11% of the aPAD for all infants less than 1 year 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 will utilize <1% of the cPAD for aminocyclopyrachlor (from food and water) and 7.4% of the cPAD for CPCA (from water only) for all infants less than 1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3. regarding residential use patterns, chronic residential exposure to residues of aminocyclopyrachlor and CPCA is not expected.

    3. Short- and Intermediate-term risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level).

    Short- and intermediate-term adverse effects were identified; however, aminocyclopyrachlor is no longer registered for any use patterns that would result in residential exposure. Short- and intermediate-term risks are assessed based on short-term/intermediate-term residential exposure plus chronic dietary exposure. Because there is no residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-/intermediate-term risk), no further assessment of short- and intermediate-term risks are necessary, and EPA relies on the chronic dietary risk assessments for evaluating short- and intermediate-term risks for aminocyclopyrachlor and CPCA.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, aminocyclopyrachlor is not expected to pose a cancer risk to humans. As discussed in Unit III.A., CPCA is also not expected to pose a cancer risk to humans.

    5. 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 aminocyclopyrachlor and CPCA residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology ([DuPont-27162, Revision No. 1; high-performance liquid chromatography with tandem mass spectrometry detection (HPLC/MS/MS)) is available to enforce the tolerance expression.

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

    B. International Residue Limits

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

    The Codex has not established any MRLs for aminocyclopyrachlor.

    C. Revisions to Petitioned-For Tolerances

    Based on the available residue chemistry data and EPA policy on livestock tolerances, the proposed tolerances for liver (0.06 ppm) and meat byproducts except liver (0.40 ppm) of cattle, goat, horse, and sheep are replaced by establishing tolerances for meat byproducts of cattle, goat, horse, and sheep at 0.30 ppm. Also, based on the residue data, EPA is lowering the proposed tolerances for fat of cattle, horse, goat, and sheep from 0.07 ppm to 0.05 ppm. Lastly, EPA is also lowering the proposed tolerances for milk from 0.035 ppm to 0.01 ppm, and meat of cattle, goat, horse, and sheep from 0.02 ppm to 0.01 ppm to harmonize with established Canadian MRLs.

    V. Conclusion

    Therefore, tolerances are established for residues of the herbicide aminocyclopyrachlor, 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid, including its metabolites and degradates, in or on cattle, fat at 0.05 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.30 ppm; horse, fat at 0.05 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.30 ppm; milk at 0.01 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.30 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: July 28, 2016. Jack E. Housenger, Director, 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. Add § 180.689 to subpart C to read as follows:
    § 180.689 Aminocyclopyrachlor; tolerances for residues.

    (a) General. Tolerances are established for residues of the herbicide aminocyclopyrachlor, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of aminocyclopyrachlor, 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid, and aminocyclopyrachlor methyl ester, methyl 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate, calculated as the stoichiometric equivalent of aminocyclopyrachlor.

    Commodity Parts per million Cattle, fat 1 0.05 Cattle, meat 1 0.01 Cattle, meat byproducts 1 0.30 Goat, fat 1 0.05 Goat, meat 1 0.01 Goat, meat byproducts 1 0.30 Horse, fat 1 0.05 Horse, meat 1 0.01 Horse, meat byproducts 1 0.30 Milk 1 0.01 Sheep, fat 1 0.05 Sheep, meat 1 0.01 Sheep, meat byproducts 1 0.30 1 There are no U.S. registrations as of August 11, 2016.

    (b) Section 18 emergency exemptions. [Reserved]

    (c) Tolerances with regional registrations. [Reserved]

    (d) Indirect or inadvertent residues. [Reserved]

    [FR Doc. 2016-19117 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2012-0919; FRL-9946-30] Halauxifen-methyl; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of halauxifen-methyl and its metabolite, XDE-729 acid, in or on multiple commodities which are identified and discussed later in this document. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective August 11, 2016. Objections and requests for hearings must be received on or before October 11, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0919, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0919 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 October 11, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0919, 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 February 15, 2013 (78 FR 11126) (FRL-9378-4), 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 2F8086) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide, halauxifen-methyl (methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate) and its major metabolite, XDE-729 acid, expressed as halauxifen-methyl (parent) equivalents, in or on barley, grain at 0.01 parts per million (ppm); barley, hay at 0.01 ppm; barley, straw at 0.01 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; wheat, forage at 0.5 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.04 ppm; and wheat, straw at 0.015 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA has determined that livestock commodity tolerances are not required for the proposed uses. In addition, the proposed “wheat, hay” tolerance level of 0.04 ppm will be set at a reduced tolerance level of 0.03 ppm. The reason for these changes are explained in Unit IV.C.

    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 halauxifen-methyl and its acid metabolite, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with halauxifen-methyl and its major metabolite, XDE-729 acid, 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.

    The toxicology database for halauxifen-methyl is considered adequate at this time. Following oral exposure and absorption, the liver is exposed pre-systemically to halauxifen-methyl, where it is hydrolyzed to its major metabolite, XDE-729 acid, before entering the systemic circulation. Therefore, systemic exposure to organs and tissues other than the liver is to XDE-729 acid, whereas the liver is also exposed to the parent prior to its metabolism. The guideline studies were conducted on XDE-729 acid and identified the kidney as the main target organ. Bridging studies on halauxifen-methyl identified the liver as the target organ, but the data could not bridge to the acid metabolite because liver toxicity from exposure to halauxifen-methyl occurred at lower doses than the kidney toxicity resulting from exposure to XDE-729 acid. In lieu of conducting long-term oral studies on halauxifen-methyl, mechanistic studies were performed to characterize the mode of action (MOA) for liver toxicity. These studies identified activation of the liver aryl hydrocarbon receptor (AhR) as the MOA, and the molecular initiating event (MIE), for liver toxicity, for which increased liver Cyp1a1 gene expression serves as a biomarker. In the absence of this MIE, liver toxicity from parent halauxifen-methyl, including induction of hepatocellular proliferation, will not be observed. A point of departure (POD) of 3 mg/kg/day for increased Cyp1a1 expression (observed at 10 mg/kg/day, the study NOAEL) was identified in the rat 90-day dietary study on halauxifen-methyl and was selected for chronic dietary risk assessment, since it protects for the initial step in liver toxicity, regardless of exposure duration. Therefore, the bridging and mechanistic studies were considered along with the guideline studies in selection of the dose and endpoint for halauxifen-methyl. Based on the abundance of guideline and mechanistic data available, a MOA approach was used for the identification and characterization of hazard. Due to the distinct toxicities of the two compounds and the unique MOA for liver toxicity of halauxifen-methyl, risk from the two compounds was assessed separately.

    There is no evidence of neurotoxicity or immunotoxicity for either compound. Inhalation studies (including the acute LD50 study) were waived because MOEs for inhalation exposure, calculated using a highly conservative endpoint from oral data, were high (≥2,500), and the available oral and dermal studies did not indicate the potential for portal of entry effects. In addition, halauxifen-methyl has a low vapor pressure and adequate particle sizes for test atmospheres could not be generated. Guideline rat or rabbit dermal toxicity, rat two-generation reproductive toxicity, dog chronic toxicity, rat chronic toxicity/carcinogenicity, mouse carcinogenicity, rat acute and subchronic neurotoxicity studies on halauxifen-methyl were also waived. The waivers were granted because adequate data were available for XDE-729 acid, to which systemic exposure would occur. The available data, when combined with the bridging and MOE data on halauxifen-methyl, allowed identification of a protective POD for AhR-mediated liver toxicity. Therefore, an additional database uncertainty factor (UFDB) is not required for either compound. Both are mild eye irritants (Category III) but not dermal irritants or sensitizers. XDE-729 acid is classified as “not likely to be carcinogenic to humans.” Halauxifen-methyl is classified as “not likely to be carcinogenic to humans at doses that do not induce Cyp1a1 expression,” based on the premise that AhR activation and subsequent promotion of hepatocellular tumors (via a prolonged increase in hepatocellular proliferation), a well-known non-genotoxic mechanism of liver carcinogenesis that has been previously described for other chemicals, depend upon this molecular initiating event (MIE). Moreover, based on its rapid metabolism to XDE-729 acid, halauxifen-methyl is not expected to persist in the body; therefore, progression of liver toxicity (including carcinogenic potential) from sustained AhR activation is not expected. Neither compound showed evidence of genotoxicity.

    There is no evidence of increased prenatal susceptibility to either compound in developmental toxicity studies in two species. No developmental toxicity was observed in the presence of maternal toxicity for rats exposed to halauxifen-methyl or rabbits exposed to XDE-729 acid. In rats exposed to XDE-729 acid, mild fetal effects (decreased body weight and delayed ossification of the thoracic centra) were observed in the presence of more significant maternal toxicity (moribund sacrifice due to excessively decreased body weight and food consumption, along with increased relative kidney weight). In rabbits exposed to halauxifen-methyl, the fetal effects (decreased body weight, increases in delayed ossification of the pubis) were observed in the presence of maternal liver histopathology and increased liver weight, at a dose greater than the maternal LOAEL, and were therefore not considered indicative of greater sensitivity. In a rat two-generation reproductive toxicity study on XDE-729 acid, there was no evidence of increased postnatal susceptibility. Parental toxicity in the rat two-generation reproductive toxicity study was observed at 443 mg/kg/day (NOAEL 103 mg/kg/day), but no offspring or reproductive toxicity was reported. A reproductive toxicity study was not conducted on halauxifen-methyl. Residual concerns for postnatal susceptibility to halauxifen-methyl in the absence of this study are low, due to selection of a highly conservative endpoint and assumptions for dietary exposure, as well as the low level of exposure expected from proposed use patterns.

    Specific information on the studies received and the nature of the adverse effects caused by halauxifen-methyl and its metabolite, XDE-729 acid, 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 Halauxifen-methyl—New Active Ingredient Human Health Risk Assessment for Proposed Uses on Cereal Grains (Barley, Wheat, and Triticale) at page 42 in docket ID number EPA-HQ-OPP-2012-0919.

    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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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 halauxifen-methyl used in the Agency's human health risk assessment is shown in Table 1(a) of this unit. No hazard from a single exposure was identified in the available database; therefore, no risk is expected from acute dietary exposure to halauxifen-methyl. For chronic dietary exposure, the rat 90-day oral study was selected. Although long-term oral toxicity studies are not available for halauxifen-methyl, a dose and an endpoint protective of long-term toxicity could be identified using the subchronic data together with the MOA data. The rat 90-day study NOAEL of 10.3 mg/kg/day was based on increased liver weight, hypertrophy and vacuolization consistent with fatty change at the LOAEL of 53.4 mg/kg/day. Liver effects at the LOAEL were of low severity but were considered treatment-related. A marked increase (1,500-fold above controls) in Cyp1a1 expression was also observed at the LOAEL. As previously noted, mechanistic studies on halauxifen-methyl identified activation of liver AhR as the MOA for liver toxicity, for which increased expression of Cyp1a1 in the liver is a biomarker for AhR activation, the MIE. In the absence of AhR activation, liver toxicity will not occur. Although there were no liver effects observed at the study NOAEL, a 52-fold increase in Cyp1a1 expression was observed. This increase is well below the increase that was associated which mild liver toxicity. Long-term effects on the liver from this lower level increase are not known in the absence of chronic data, but the lowest dose in the study, 3 mg/kg/day, showed essentially no Cyp1a1 activation. Cyp1a1 expression at 3 mg/kg/day was comparable to controls in both the 28- and 90-day studies (1.2- and 3.6-fold higher than controls, respectively), indicating that there is not expected to be significant activation of the AhR receptor at this dose level over time. Therefore, in order to be protective of potential adverse effects on the liver following long-term exposure, the point of departure (POD) of 3 mg/kg/day was selected, based on increased expression of liver Cyp1a1 (52-fold) at 10 mg/kg/day. The selected dose and endpoint are considered conservative, since the dose is below the study NOAEL, but protective of residual uncertainty due to the lack of chronic data because liver toxicity may not occur in the absence of the MIE, regardless of exposure duration. They are also protective of chronic effects from XDE-729 acid, which are observed at higher doses. A UF of 100 is based on the combined interspecies (10x) and intraspecies (10x) UFs. An additional 10x UF for lack of chronic data was not applied for the following reasons: (1) Progression of toxicity was not observed in the 28- and 90-day dietary studies in the rat: the NOAELs and LOAELs for both studies were the same, and the severity of the findings was minimal at both exposure durations; (2) evaluation of Cyp1a1 expression in the rat 28- and 90-day studies indicated that at the selected POD of 3 mg/kg/day, which is below the NOAELs for these studies, there is no expectation of significant AhR activation that could lead to liver toxicity. Observable liver toxicity in these studies was only associated with significantly greater levels of Cyp1a1; (3) halauxifen-methyl is rapidly metabolized to the acid, and neither bioaccumulate; and (4) based on comparative in vitro studies, humans are not anticipated to be more sensitive to liver effects of halauxifen-methyl than rats.

    Carcinogenicity studies on halauxifen-methyl were not conducted. Systemic exposure from halauxifen-methyl is primarily to XDE-729 acid, which showed no evidence of carcinogenicity. However, pre-systemic exposure of the liver to halauxifen-methyl was shown to activate the AhR receptor, an effect that induces an increase in hepatocellular proliferation and, subsequently, may promote an increased incidence of liver tumors with long-term exposure. The molecular marker for AhR activation, the MIE for liver toxicity, is increased expression of hepatic Cyp1a1, which was observed at a dose below the LOAEL for observable adverse effects of any type. The chronic dietary endpoint for halauxifen-methyl is based on the point of departure (POD) from the rat subchronic study for Cyp1a1 induction, as described above. The selected POD is considered very conservative because it is below the study NOAEL (the LOAEL was based on mild liver effects). Since Cyp1a1 induction is one of the early key events in the MOA leading to hepatotoxicity and promotion of hepatocellular proliferation, a dose that is protective of this event will be protective of the potential risk for liver cancer with chronic exposure, based on the rapid onset of AhR activation following initiation of exposure, and the lack of evidence of temporal progression of liver toxicity in the available studies (28- and 90-day). The MOA is considered relevant to human health risk assessment, but in vitro data suggest that humans are unlikely to be more sensitive than the rat. Based on a weight-of-the-evidence consideration, halauxifen-methyl is classified as “not likely to be carcinogenic to humans” at doses that do not induce liver Cyp1a1 expression.

    Table 1(a)—Summary of Toxicological Doses and Endpoints for Halauxifen-methyl 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 age 13-49) No hazard from a single exposure was identified in the available database; therefore, no risk is expected from this exposure scenario. Chronic dietary (All populations) POD = 3.0 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.03 mg/kg/day
  • cPAD = 0.03 mg/kg/day
  • 90-day oral toxicity in the rat (halauxifen-methyl).
  • NOAEL = 10 mg/kg/day.
  • At the NOAEL, increased Cyp1a1 expression was observed (endpoint selected for risk assessment). The lowest dose of 3.0 mg/kg/day was selected to be protective of potential long-term effects from increased AhR expression in the liver.1
  • LOAEL = 52 mg/kg/day based on mild liver enlargement and pathology.
  • Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans at dose levels that do not induce Cyp1a1 expression. The cRfD is considered protective of potential cancer effects because it protects for the MIE for hepatocellular proliferation (AhR activation) that, over time, may result in promotion of liver tumors. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MIE = molecular initiating event. 1. The POD selected for risk assessment was based on a non-adverse finding, increased liver Cyp1a1 expression in a rat 90-day dietary study, which was observed below the study NOAEL of 10 mg/kg/day for liver toxicity. This effect is a biomarker for activation of AhR, which causes liver toxicity and hepatocellular proliferation. The POD was selected to be protective of potential liver effects resulting from chronic dietary exposure to halauxifen-methyl. Other tissues and organs will not be exposed to halauxifen-methyl due to rapid conversion to XDE-729 acid. The POD is protective of effects from exposure to XDE-729 acid.

    A summary of the toxicological endpoints for XDE-729 acid used for human risk assessment is shown in Table 1(b) of this unit. No hazard from a single exposure was identified in the available database; therefore, no risk is expected from acute dietary exposure to XDE-729 acid. The chronic toxicity/carcinogenicity study using the rat was chosen to assess chronic dietary risk to XDE-729 acid. A NOAEL of 20.3 was chosen based on hyperplasia of the renal pelvic epithelium in females observed at 101 mg/kg/day. This NOAEL is protective of developmental effects, observed in the rat at 526 mg/kg/day (NOAEL = 140 mg/kg/day), and of maternal toxicity in both the rat (LOAEL = 526 mg/kg/day) and rabbit (LOAEL 1094 mg/kg/day).

    There was no evidence of carcinogenicity in rat and mouse cancer studies on XDE-729 acid, which is classified as “not likely to be carcinogenic to humans.”

    Table 1(b)—Summary of Toxicological Doses and Endpoints for XDE-729 Acid 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 age 13-49) No hazard from a single exposure was identified in the available database; therefore, no risk is expected from this exposure scenario. Chronic dietary (All populations) NOAEL = 20.3 mg/kg/day (females) Chronic RfD = 0.20 mg/kg/day Rat two-year dietary chronic toxicity/carcinogenicity study
  • NOAEL = 101/20.3 mg/kg/day [M/F].
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • cPAD = 0.20 mg/kg/day LOAEL = 404/101 mg/kg/day [M/F] based on increased mortality, altered urinalysis parameters, decreased body weight, increased kidney weights, adrenal zone glomerulosa hypertrophy, increased degeneration and regeneration of renal tubules and kidney stones, and bladder pathology in males; in females, hyperplasia of pelvic epithelium of the kidney.
    Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to halauxifen-methyl and the XDE-729 acid metabolite, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures to these compounds 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. No such effects were identified in the toxicological studies for halauxifen-methyl or XDE-729 acid; therefore, quantitative acute dietary exposure assessments were determined unnecessary.

    ii. Chronic exposure. In conducting individual chronic dietary exposure assessments for these two compounds, EPA used the food consumption data collected between 2003 and 2008 for USDA's National Health and Nutrition Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues and assumed 100 percent of all wheat, barley and triticale acres are treated. No processing factors were used due to the lack of residue concentration in processed commodities. Residue chemistry data indicate that halauxifen-methyl (parent compound) converts to the XDE-729 acid metabolite so quickly in the environment that dietary exposure to halauxifen-methyl is expected to be minimal.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that halauxifen-methyl does not pose a cancer risk to humans at dose levels that do not induce liver toxicity or Cypla1 expression. EPA has also concluded that its XDE-729 acid metabolite does not pose a cancer risk to humans. Therefore, separate dietary exposure assessments for the purpose of assessing cancer risk are determined to be unnecessary.

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

    2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for halauxifen-methyl and its metabolites (primarily XDE-729 acid) in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of halauxifen-methyl and its metabolites. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of halauxifen-methyl were estimated for chronic exposure in a non-cancer assessment. Based on the Screening Concentration in Groundwater (SCI-GROW) model, the EDWCs of the XDE-729 acid metabolite were estimated for chronic exposure in a non-cancer assessment. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment of halauxifen-methyl only, the water concentration value of 0.007 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment of XDE-729 acid, a drinking water concentration value of 19.5 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). Halauxifen-methyl is not used, nor is it being proposed for use in any specific use patterns that would result in residential exposure.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found halauxifen-methyl or XDE-729 acid to share a common mechanism of toxicity with any other substances, nor do they appear to produce any toxic metabolites produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that neither of these compounds 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 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. There was no evidence of increased prenatal susceptibility to either compound and no evidence of postnatal susceptibility to XDE-729 acid. Residual concerns for postnatal susceptibility to halauxifen-methyl in the absence of reproductive toxicity data are low, due to selection of a conservative endpoint and assumptions for dietary exposure, as well as the low level of exposure expected from proposed use patterns.

    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 halauxifen-methyl and XDE-729 acid are complete.

    ii. There is no indication that halauxifen-methyl or XDE-729 acid are neurotoxic chemicals and there is no need for developmental neurotoxicity studies or additional UFs to account for neurotoxicity.

    iii. There is no evidence to suggest that exposure to halauxifen-methyl or XDE-729 acid results in increased in utero susceptibility in rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

    iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was based on 100 PCT and tolerance-level residues. EPA also made conservative assumptions in the ground and surface water modeling used to assess exposure to halauxifen-methyl and XDE-729 acid in drinking water. These assessments will not underestimate the exposure and risks posed by these compounds.

    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. 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, neither halauxifen-methyl, nor XDE-729 acid are expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to halauxifen-methyl from food and water will utilize < 1% of the cPAD for all infants, the population group receiving the greatest exposure. In addition, EPA has concluded that chronic exposure to XDE-729 acid from drinking water will also utilize < 1% of the cPAD for all infants. XDE-729 is not a residue of concern in food; therefore, the chronic assessment was based on drinking water only for this acid metabolite. There are no residential uses for halauxifen-methyl being proposed at this time; therefore chronic aggregate risk reflects only dietary exposure to potential residues in food and drinking water.

    3. Short-term risk. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary.

    4. Intermediate-term risk. 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, no further assessment of intermediate-term risk is necessary.

    5. Aggregate cancer risk for U.S. population. Long-term dietary studies conducted with XDE-729 acid in the rat and the mouse showed no evidence of carcinogenicity. Based on the MOA and bridging data on halauxifen-methyl, which allowed identification of a POD for liver cancer, halauxifen-methyl is not expected to pose a cancer risk to humans at dose levels below those that induce liver Cyp1a1 expression. Genotoxicity studies were negative for both compounds.

    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 halauxifen-methyl and XDE-729 acid residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC-MS/MS) with a limit of quantitation of 0.01 ppm is available to enforce the tolerance expression. The multi-residue method, QuEChERS, is adequate for the determination of both residues of halauxifen-methyl and XDE-729 acid in crop commodities. 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.

    No MRLs have been established by Codex for halauxifen-methyl on the commodities affected by this action.

    C. Revisions to Petitioned-For Tolerances

    As noted in Unit II, the petitioned-for livestock commodity tolerances (milk; fat, meat, meat byproducts of cattle, goat, horse, and sheep) are not being established due to the lack of quantifiable residues in livestock commodities associated with the proposed uses in wheat, barley and triticale. In addition, although the petitioner proposed a tolerance of 0.04 ppm for wheat, hay, EPA has determined that a tolerance of 0.03 ppm is appropriate. When the petitioner determined the proposed tolerances, the metabolite XDE-729 acid was included as a residue of concern. EPA has subsequently determined that this metabolite is not a residue of concern for tolerance enforcement. Residues of metabolite XDE-729 acid were not quantifiable in any of the residue field trials. Therefore, the values for measuring compliance with these tolerances only include residues of halauxifen-methyl. With the exception of wheat, hay, this revision to the residues of concern for tolerance enforcement had no impact on the plant commodity tolerances.

    V. Conclusion

    Therefore, tolerances are established for residues of halauxifen-methyl, (methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl) pyridine-2-carboxylate) and its major metabolite, XDE-729 acid, expressed as halauxifen-methyl (parent) equivalents, in or on barley, (grain, hay, straw) and wheat, grain at 0.01 ppm; wheat, forage at 0.50 ppm; wheat, hay at 0.03 ppm; and wheat, straw at 0.015 ppm.

    VI. Statutory and Executive Order Reviews

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

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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 28, 2016. Jack E. Housenger, Director, 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. Add § 180.691 to subpart C to read as follows:
    §  180.691 Halauxifen-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the herbicide, halauxifen-methyl, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only halauxifen-methyl (methyl (4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-2-pyridine carboxylate).

    Commodity Parts per million Barley, grain 0.01 Barley, hay 0.01 Barley, straw 0.01 Wheat, forage 0.50 Wheat, grain 0.01 Wheat, hay 0.03 Wheat, straw 0.015

    (b) Section 18 emergency exemptions. [Reserved]

    (c) Tolerances with regional registrations. [Reserved]

    (d) Indirect or inadvertent residues. [Reserved]

    [FR Doc. 2016-19118 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R06-RCRA-2016-0176; FRL-9950-13-Region 6] Arkansas: Final Authorization of State Hazardous Waste Management Program Revision AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The State of Arkansas has applied to the United States Environmental Protection Agency (EPA) for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this direct final rule. In the “Proposed Rules” section of this Federal Register, EPA is also publishing a separate document that serves as the proposal to authorize these changes. EPA believes this action is not controversial and does not expect comments that oppose it. Unless EPA receives written comments which oppose this authorization during the comment period, the decision to authorize Arkansas' changes to its hazardous waste program will take effect. If EPA receives comments that oppose this action, EPA will publish a document in the Federal Register withdrawing this direct final rule before it takes effect, and the separate document in the “Proposed Rules” section of this Federal Register will serve as the proposal to authorize the changes.

    DATES:

    This final authorization is effective on October 11, 2016 unless the EPA receives adverse written comment by September 12, 2016. If the EPA receives such comment, EPA will publish a timely withdrawal of this direct final rule in the Federal Register and inform the public that this authorization will not take effect.

    ADDRESSES:

    Submit your comments by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    Email: [email protected]

    Fax: (214) 665-6762 (prior to faxing, please notify Alima Patterson at (214) 665-8533).

    Mail: Alima Patterson, Region 6, Regional Authorization Coordinator, RCRA Permit Section (RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas Texas 75202-2733.

    Hand Delivery or Courier: Deliver your comments to Alima Patterson, Region 6, Regional Authorization Coordinator, RCRA Permit Section (RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas Texas 75202-2733.

    Instructions: EPA must receive your comments by September 12, 2016. Direct your comments to Docket ID Number EPA-R06-RCRA-2016-0176. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov, or email. The Federal regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. (For additional information about the EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.)

    Docket: 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 hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov, or in hard copy.

    You can view and copy Arkansas' application and associated publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following locations: Arkansas Department of Environmental Quality (ADEQ), 8101 Interstate 30, Little Rock, Arkansas 72219-8913, (501) 682-0876, and EPA, Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, phone number (214) 665-8533. Interested persons wanting to examine these documents should make an appointment with the office at least two weeks in advance.

    FOR FURTHER INFORMATION CONTACT:

    Alima Patterson, Region 6 Regional Authorization Coordinator, RCRA Permit Section (RPM), Multimedia Planning and Permitting Division, (214) 665-8533, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, and email address [email protected]

    SUPPLEMENTARY INFORMATION: I. Why are revisions to State programs necessary?

    States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 CFR parts 124, 260 through 268, 270, 273, and 279.

    New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized States at the same time that they take effect in unauthorized States. Thus, the EPA will implement those requirements and prohibitions in the State of Arkansas, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.

    II. What decisions has the EPA made in this rule?

    On November 30, 2015, Arkansas submitted a final complete program revision application seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between October 4, 2005 and January 3, 2014, including the adoption of portions of RCRA Clusters XVI and XVII, and RCRA Clusters XXII and XXIII (Checklists 211, 213, 214, and 228 through 232). The EPA concludes that Arkansas' application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, the EPA grants Arkansas final authorization to operate its hazardous waste program with the changes described in the authorization application, and as outlined below in Section G of this document. The State of Arkansas has responsibility for permitting treatment, storage, and disposal facilities (TSDFs) within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of HSWA, as discussed above. New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Arkansas, including issuing permits, until the State is granted authorization to do so.

    III. What is the effect of this authorization decision?

    The effect of this decision is that a facility in Arkansas subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Arkansas has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

    • Do inspections, and require monitoring, tests, analyses, or reports;

    • Enforce RCRA requirements and suspend or revoke permits; and

    • Take enforcement actions after notice to and consultation with the State.

    This action does not impose additional requirements on the regulated community because the regulations for which Arkansas is being authorized by this action are already effective under State law, and are not changed by this action.

    IV. Why is EPA using a direct final rule?

    Along with this direct final rule, the EPA is publishing a separate document in the “Proposed Rules” section of this Federal Register that serves as the proposal to authorize these State program changes. The EPA did not publish a proposal before this rule because EPA views this as a routine program change and do not expect comments. The EPA also views the Arkansas program revisions as noncontroversial action and anticipates no adverse comment.

    EPA is providing an opportunity for public comment now, as described in Section E of this document.

    V. What happens if the EPA receives comments that oppose this action?

    If the EPA receives comments that oppose this authorization, EPA will withdraw this direct final rule by publishing a document in the Federal Register before the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous section, after considering all comments received during the comment period. EPA will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

    If EPA receives comments that oppose only the authorization of a particular change to the State hazardous waste program, EPA will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified in this document. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

    VI. For what has Arkansas previously been authorized?

    Arkansas initially received final authorization on January 25, 1985, (50 FR 1513) to implement its Base Hazardous Waste Management program. Arkansas received authorization for revisions to its program on January 11, 1985 (50 FR 1513), effective January 25, 1985; March 27, 1990 (55 FR 11192), effective May 29, 1990; September 18, 1991 (56 FR 47153), effective November 18, 1991; October 5, 1992 (57 FR 45721), effective December 4, 1992; October 7, 1994 (59 FR 51115), effective December 21, 1994; April 24, 2002 (67 FR 20038), effective June 24, 2002; and August 15, 2007 (72 FR 45663), effective October 15, 2007. The authorized Arkansas RCRA program was incorporated by reference into the Code of Federal Regulations effective December 13, 1993 (58 FR 52674); June 28, 2010 (75 FR 36538), effective August 27, 2010; August 10, 2012 (77 FR 47779), effective October 9, 2012; and October 31, 2014 (79 FR 64678), effective December 30, 2014. The authorized Arkansas RCRA program was incorporated by reference into the Code of Federal Regulations October 12, 1993 (58 FR 52674) effective December 13, 1993; June 20, 1995 (60 FR 32112) effective August 21, 1995; June 28, 2010 (75 FR 36538) effective August 27, 2010; October 2, 2014 (79 FR 59438) effective December 1, 2014; January 29, 2016 (81 FR 4961) effective March 29, 2016. On November 30, 2015, Arkansas submitted a final complete program revision application seeking authorization of its program revision in accordance with 40 CFR 271.21.

    The ADEQ has re-organized its agency and division's program areas and subunits, but all duties and responsibilities remain the same. Any differences between the State's provisions and the Federal provisions are noted on the individual revision Checklists. The official State regulations may be found in Arkansas Pollution Control and Ecology Commission Regulation Number 23 (Hazardous Waste Management), last amended September 25, 2015, effective October 18, 2015.

    The provisions for which the State is seeking authorization are documented in the Rule Revision Checklists 211, 213, 214, and 228 through 232, which are portions of RCRA Clusters XVI and XVII, and RCRA Clusters XXII and XXIII. Reference to Arkansas Code Annotate (A.C.A) of 1987, Annotated, as amended August 2015. Reference to Arkansas Pollution Control and Ecology Commission (APC&EC) Regulations Number 23, (Hazardous Waste Management) (formerly titled the Arkansas Hazardous Waste Management Code), last amended September 25, 2015, to adopt all final rules promulgated by the EPA through June 26 2014, which became, effective on October 18, 2015. Dates of enactment and adoption for other statutes or regulations are given when cited.

    VII. What changes is the EPA authorizing with this action?

    On November 30, 2015, the State of Arkansas submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make a direct final decision, subject to receipt of written comments that oppose this action, that the State of Arkansas' hazardous waste program revision is equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfies all of the requirements necessary to qualify for final authorization. Therefore, the EPA grants the State of Arkansas final authorization for portions of RCRA Clusters XVI and XVII, and RCRA Clusters XXII and XXIII (Checklists 211, 213, 214, and 228 through 232). The State of Arkansas program revisions consist of regulations which specifically govern Federal Hazardous Waste revisions promulgated October 4, 2005, April 4, 2006, July 14, 2006, April 13, 2012, and July 2013 through June 2014, which are listed in a chart below.

    Description of
  • Federal requirement
  • (include checklist #,
  • if relevant)
  • Federal Register date and page
  • (and/or RCRA statutory authority)
  • Analogous state authority
    1. Revision of Wastewater Treatment Exemptions for Hazardous Waste Mixtures (“Headworks exemptions”). (Checklist 211) 70 FR 57769-57785 October 4, 2005 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 261.3(a)(2)(iv)(A), (B), (D), (F), and (G), as amended September 25, 2015, effective on October 18, 2015. 2. Burden Reduction Initiative. (Checklist 213) 71 FR 16862-16915 April 4, 2006 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.31(b)(2)-(b)(7), 261.4(a)(9)(iii)(E), 261.4(f)(9), 264.15(b)(4), 264.16(a)(4), 264.52(b), 264.56(i), 264.73(b) introductory paragraph, (b)(1), (b)(2), (b)(6), (b)(8), (b)(10), (b)(18), and (19), 264.98(d), 264.98(g)(2) and (g)(3), 264.99(f) and (g), 264.100(g), 264.113(e)(5), 264.115 1, 264.120 1, 264.143(i) 1, 264.145(i) 1, 264.147(e) 1, 264.174, 264.191(a) 1, 264.191(b)(5)(ii) 1, 264.192(a) introductory paragraph 1 and (b) introductory paragraph 1, 264.193(a)(1) and (a)(2), 264.193(i)(2) 1, 264.195(b)-(g), 264.196(f) 1, 264.251(c) introductory paragraph, 264.280(b) 1, 264.314, 264.343(a)(2), 264.347(d), 264.554(c)(2) 1, 264.571(a)-(c) 1, 264.573(a)(4)(ii) 1, 264.573(g) 1, 264.574(a) 1, 264.1061(b)(1) and (b)(2), 264.1062(a), 264.1100 introductory paragraph, 264.1101(c)(2) 1, 265.15(b)(4), 265.16(a)(4), 265.52(b), 265.56(i), 265.73(b) introductory paragraph, 265.73(b)(1) and (b)(2), 265.73(b)(6)-(8), 265.73(b)(15), 265.90(d)(1) and (d)(3), 265.93(d)(2) and (d)(5), 265.113(e)(5), 265.115 1, 265.120 1, 265.143(h) 1, 265.145(h) 1, 265.147(e) 1, 265.174, 265.191(a) 1, 265.191(b)(5)(ii) 1, 265.192(a) introductory paragraph 1 and (b) introductory paragraph 1, 265.193(a)(1)-(2), 265.193(i)(2) 1, 265.195(a)-(c), 265.195(e)-(g), 265.196(f)  1, 265.201(c) introductory paragraph, 265.201(d), 265.201(f)-(h), 265.221(a), 265.224, 265.259(a), 265.280(e) 1, 265.301(a), 265.303(a), 265.314, 265.441(a)-(c) 1, 265.443(a)(4)(ii) 1, 265.443(g)  1, 265.444(a) 1, 265.1061(b)(1) and (b)(2), 265.1061(d), 265.1062(a), 265.1100 introductory paragraph, 265.1101(c)(2) 1, 266.102(e)(10), 266.103(d) and (k), 268.7(a)(1) and (a)(2), 268.7(b)(6), 268.9(a) and (d), 270.14(a) 1, 270.16(a) 1, 270.26(c)(15) 1, and 270.42 Appendix I, Item O except Item O.1, as amended September 25, 2015, effective on October 18, 2015. 3. Correction to Errors in the Code of Federal Regulations. (Checklist 214) 71 FR 40254-40280 July 14, 2006 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.10 “Incompatible Waste”, “Personnel or facility personnel”, “Universal waste”, and “Used oil”, 260.22(a)(1), 260.22(d)(1)(ii), 260.40(a), 260.41 introductory paragraph, 261.2(c)(1)(i), 261.3(a)(2)(i), 261.4(a)(20)(v), 261.4(b)(6)(i)(B), 261.4(b)(6)(ii) introductory paragraph, 261.4(b)(6)(ii)(D) and (F), 261.4(b)(9), 261.4(e)(2)(vi), 261.4(e)(3)(i), 261.6(a)(2)(i)-(v), 261.6(c)(2), 261.21(a)(3) and (a)(4), 261.21/Notes 1-4, 261.24(b), 261.31(a)/Table, 261.32/Table “K107” and “K069” entries, 261.33(e), 261.33(e)/Comment, 261.33(e)/Table, 261.33(f), 261.33(f)/Comment, 261.33(f)/Table, 261.38/Table 1, 261.38(c)(1)(i)(C)(4), Part 261, Appendix VII, Part 261, Appendix VIII, 262.34(a)(1)(iv), 262.53(b), 262.56(b), 262.58(a)(1), 262.70, 262.81(k), 262.82(a)(1)(ii), 262.83(b)(1)(i), 262.83(b)(2)(i), 262.84(e), 262.87(a), 262.87(a)(5) introductory paragraph, 264.1(g)(2), 264.4, 264.13(b)(7)(iii)(B), 264.17(b) introductory paragraph, 264.18(a)(2)(iii), 264.18(b)(2)(iii), 264.97(a)(1) introductory paragraph, 264.97(a)(1)(i), 264.97(i)(5), 264.98(a)(2), 264.98(g)(4)(i), 264.99(h)(2) introductory text, 264.101(d), 264.111(c), 264.112(b)(8), 264.115, 264.116, 264.118(c), 264.119(b)(1)(ii), 264.140(d)(1), 264.142(b)(2), 264.143(b)(7) and (b)(8), 264.143(e)(5), 264.145(a)(3)(i), 264.145(d)(6), 264.145(f)(11) introductory paragraph, 264.147(h)(1), 264.151(b), 264.151(f) introductory paragraph, 264.151(g), Letter From Chief Financial Officer, fifth paragraph, item 3, Part A, Alternative I, item *3, Part B, Alternative I, items 10 and 15, and Part B, Alternative II, item *7, 264.151(h)(2) Guarantee For Liability Coverage, Certification of Valid Claim Recitals, item 13.(a), and Recitals, item 14, 264.151(i), item 2.(e), 264.151(j), item 2.(d), 264.151(k), Irrevocable Standby Letter of Credit and CERTIFICATE OF VALID CLAIM, 264.151(1), 264.151(1), CERTIFICATION OF VALID CLAIM, 264.151(m)(1), CERTIFICATION OF VALID CLAIM, Section 8.(c), 264.151(n)(1), under STANDBY TRUST AGREEMENT Section 3.(c)(1), Section 3.(e)(3), and Sections 12 and 16, 264.175(b)(1),264.193(c)(4) Note, (d)(4), (e)(2)(ii) and (iii), (e)(2)(v)(A) and (B), (e)(3)(i) and (ii), (g)(1)(iii) and (iv), and (g)(2)(i)(A), 264.221(c)(1)(i)(B), (c)(2)(ii), (e)(1), and (e)(2)(i)(B) and (C), 264.223(b)(1), 264.226(a)(2), 264.251(a)(2)(i)(A),  264.252(a) and (b), 264.259(b), 264.280(c)(7) and (d) introductory paragraph, 264.283(a), 264.301(c)(2), 264.301(e)(2)(i)(B), 264.302(a), (b) and (b)(1), 264.314(e)(2), 264.317(a) introductory paragraph, 264.344(b), 264.552(e)(4)(iii), (e)(4)(iv)(F), and (e)(6)(iii)(E), 264.553(e) introductory paragraph, 264.554(a) introductory paragraph, 264.555(e)(6), 264.573(a)(1), (a)(4)(i), (a)(5), (b) introductory paragraph, and (m)(2) and (m)(3), 264.600, 264.601(a) introductory paragraph, (b)(11), and (c)(4), 264.1030(c), 264.1033(f)(2)(vii)(B), 264.1034(b)(2), 264.1035(c)(4)(i) and (ii), 264.1050(f), 264.1058(c)(1), 264.1064(c)(3), 264.1080(a) and (c), 264.1090(c), 264.1101(b)(3)(iii),(c)(3) introductory paragraph, (c)(3)(i), and (d) introductory paragraph, 264.1102(a), Part 264, Appendix I/Table 1, Part 264, Appendix I/Table 2, Section 2.(d), 265.1(c)(4)(i), 265.1(c)(6), 265.12(a)(1), 265.14(b)(1), 265.16(b), 265.19(c)(2), 265.56(b), 265.90(d) introductory paragraph, 265.110(b)(4), 265.111(c), 265.112(b)(5), 265.112(d)(4), 265.113(b) introductory paragraph, 265.113(e)(4), 265.117(b) introductory paragraph, 265.119(b)(1)(ii), 265.140(b) introductory paragraph and (b)(2), 265.142(a), 265.145(e)(11), 265.147(a)(1)(i) and (b)(1)(i) and (ii), 265.174, 265.193(e)(2)(v)(A) and (B) and (i)(2), 265.194(b)(1) and (2), 265.197(b), 265.201(c) introductory paragraph, 265.221(a) and(d)(2)(i)(A) and (B), 265.224(b)(1), 265.228(a)(2)(iii)(D) and(b)(2), 265.229(b)(2) and (b)(3), 265.255(b), 265.259(b)(1), 265.280(a)(4), 265.281(a)(1), 265.301(a), (d)(1), and (d)(2)(i)(B), 265.302(b), 265.303(b)(1), 265.312(a)(1), 265.314(e)(1)(ii) and(f)(2), 265.316 introductory paragraph, (c) and (d), 265.405(a)(1), 265.441(c), 265.443(a)(4)(i) and (b) introductory paragraph, 265.445(b), 265.1033(f)(2)(ii), 265.1035(b)(2) introductory paragraph, (b)(2)(i), and 265.1035(c)(4)(i), 265.1063(b)(4)(ii), 265.1080(a), 265.1085(h)(3) introductory paragraph, 265.1087(b), 265.1090(f)(1), 265.1100(d), 265.1101(b)(3)(i)(B), (b)(3)(iii), (c)(3) introductory paragraph, and (d) introductory paragraph, Part 265, Appendix I/Tables 1-2, Part 265, Appendix V/Table, Part 265, Appendix VI, 266.70(a), 266.80(a)/Table, 266.100(b)(2)(iv), 266.100(d)(3)(i)(A), 266.100(g) introductory paragraph, 266.102(a)(2)(vi), 266.102(e)(3)(i)(E), (e)(5)(i)(C), (e)(6)(ii)(B)(2), and (e)(8)(iii), 266.103(a)(4)(vii), 266.103(b)(2)(v)(B)(2), (b)(5)(ii)(A), and (b)(6)(viii)(A), 266.103(c)(1)(i), (c)(1)(ii)(A)(2), (c)(1)(ix) introductory paragraph, (c)(1)(ix)(A), and (c)(4)(iv)(C)(1), 266.103(g)(1)(i), 266.106(d)(1), 266.109(a)(2)(ii) and (b) introductory paragraph, Part 266, subpart N heading, Part 266, Appendices III through VI, Part 266, Appendix VIII, 3(b)(2), Part 266, Appendix XIII, 267.147(f)(2)(i)(A), 268.2(g), 268.4(a)(3) introductory paragraph, 268.6(c)(5) introductory paragraph, 268.7(a)(1), (a)(3)(ii), (a)(4)/Table entry 8, (b)(3)(ii)/Table, entry 5, (b)(4)(ii), (c)(2), (d) introductory paragraph, (d)(1) introductory paragraph, (d)(1)(i)-(iii), and (d)(2) and (d)(3), 268.14(b) and (c), 268.40(g), 268.40/Table “TREATMENT STANDARDS FOR HAZARDOUS WASTES”, 268.42/Table 1, 268.44(c), 268.45/Table 1, 268.48/Table “UNIVERSAL TREATMENT STANDARDS”, 268.49(d), 268.50(c), 268.50(g), Part 268, Appendix VIII, 270.1(a)(2)/Table, 270.1(b) introductory paragraph, 270.1(c)(1)(iii), 270.1(c)(3)(i) introductory paragraph, 270.2 “On-site” and “Publicly owned treatment works (POTW)”, 270.10(j), 270.11(d)(1) and (2), 270.13(k)(7), 270.14(a), (b)(11)(ii)(B), (b)(19)(iii), and (b)(21), 270.17(f), 270.18(b) and (g), 270.20(i)(2), 270.26(c)(15), 270.33(b) introductory paragraph, 270.41(c), 270.42(d)(2)(i), 270.42, Appendix I, 270.70(a) introductory paragraph, 270.72(b)(2), 273.9 “Universal waste”, 273.13(b) introductory paragraph, 273.14(a), 273.34(a), 279.1 “Petroleum refining facility”, 279.10(b)(2) introductory paragraph, 279.11, 279.11/Table 1, 279.43(c)(3)(i) and (c)(5), 279.44(a) and (c)(2), 279.45(a), 279.52(a) and (b), (b)(1)(ii) and (b)(6)(ii) and (iii), 279.55(a) introductory paragraph, and (b)(2)(i)(B), 279.56(a)(2), 279.57(a)(2)(ii), 279.59, 279.63(b)(3), 279.64(e), and 279.70(b)(1), as amended September 25, 2015, effective on October 18, 2015. 4. Hazardous Waste Technical Corrections and Clarification Rule. (Checklist 228) 77 FR 22229-22232 April 13, 2012 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 261.32(a), entry for K107, and 266.20(b), as amended September 25, 2015, effective on October 18, 2015. 5. Conditional Exclusions for Solvent Contaminated Wipes. (Checklist 229) 78 FR 46448-46485 July 31, 2013 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.10 “No free liquids”, 260.10 “Solvent-contaminated wipe”, 260.10 “Wipe”, 261.4(a)(26), and 261.4(b)(18), as amended September 25, 2015, effective on October 18, 2015. 6. Conditional Exclusion for Carbon Dioxide (CO2) Streams in Geologic Sequestration Activities. (Checklist 230) 79 FR 350-364 January 3, 2014 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.10 “Carbon dioxide stream”, and 261.4(h), as amended September 25, 2015, effective on October 18, 2015. 7. Hazardous Waste Electronic Manifest Rule. (Checklist 231) 79 FR 7518-7563 February 7, 2014 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.2, 260.10 “Electronic manifest (or e-manifest)”, “Electronic manifest system (or e-manifest system)”, “Manifest”, “User of the electronic manifest system”, 262.20(a)(3), 262.24, 262.25, 263.20(a), 263.25(a), 264.71(a)(2), 264.71(g)-(l), 265.71(a)(2), 265.71(g)-(l), as amended September 25, 2015, effective on October 18, 2015. (See Section I. Electronic Manifest provisions that are non-delegable to States.) 8. Revisions to the Export Provisions of the Cathode Ray Tube (CRT) Rule. (Checklist 232) 79 FR 36220-36231 June 26, 2014 Arkansas Code of 1987 Annotated (A.C.A.) Sections 8-7-201 through 8-7-226. Arkansas Pollution Control and Ecology (APC&E) Regulation Number 23, (Hazardous Waste Management) (HWM) Sections 260.10 “CRT exporter”, 261.39(a)(5)(i)(F), and (a)(5)(x) and (xi), and 261.41(a) and (b), as amended September 25, 2015, effective on October 18, 2015. 1 More stringent provisions.
    VIII. Where are the revised State rules different from the Federal rules?

    The State of Arkansas regulations that are more stringent than the Federal regulations are documented in the above chart. For enforcement purposes, the EPA does not enforce broader in scope provisions.

    IX. Electronic manifest provisions that are non-delegable to States.

    The Federal Hazardous Waste Electronic Manifest Rule (79 FR 7518; February 7, 2014) contains several provisions which are non-delegable to States. Specifically, States cannot receive authorization to establish a Federal user under the electronic manifest requirements, nor can States receive authorization for the electronic signature requirements, resulting in the States' inability to implement the provisions listed below. However, EPA strongly recommends States adopt these provisions while retaining the EPA rule language unchanged; Arkansas has adopted the Electronic Manifest Rule using this approach. The non-delegable provisions and provisions where States must retain references to “EPA” are: 40 CFR 260.10 “electronic manifest”, “electronic manifest system”, “use of the electronic manifest system”; 262.24(g); 262.25; 263.20(a)(2); 262.20(a)(3)(ii); 263.20(a)(8); 264.71(a)(2)(v); 264.71(j); 265.71(a)(2)(v); and 265.71(j).

    X. Who handles permits after the authorization takes effect?

    The State of Arkansas will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. EPA will not issue any more new permits or new portions of permits for the provisions listed in the chart in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which ADEQ is not yet authorized.

    XI. How does this action affect Indian Country (18 U.S.C. 1151) in Arkansas?

    The State of Arkansas Hazardous Program is not being authorized to operate in Indian Country.

    XII. What is codification and is the EPA codifying Arkansas' hazardous waste program as authorized in this rule?

    Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart E for this authorization of Arkansas' program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this Federal Register document.

    XIII. Administrative Requirements

    The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. The reference to Executive Order 13563 (73 FR 3821, January 21, 2011) is also exempt from review under Executive orders 12866 (56 FR 51735, October 4, 1993). This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

    Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application; to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 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 United States. Because this rule authorizes pre-existing State rules which are at least equivalent to, and no less stringent than existing federal requirements, and imposes no additional requirements beyond those imposed by State law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.

    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 document 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 in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective October 11, 2016.

    List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.

    Authority:

    This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended 42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: July 14, 2016. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2016-18433 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 144, 147, 153, 154, 155, 156, and 158 [CMS-9937-F2] RIN-0938-AS57 Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017; Corrections AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Final rule; correction and correcting amendment.

    SUMMARY:

    This document corrects technical and typographical errors that appeared in the final rule published in the March 8, 2016 Federal Register (81 FR 12204 through 12352) entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017.” The effective date for the rule was May 9, 2016.

    DATES:

    Effective Date: This correcting document is effective August 11, 2016.

    Applicability Date: The corrections indicated in this document are applicable beginning May 9, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Allison Yadsko (410) 786-1740.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In FR Doc. 2016-04439 (81 FR 12204), the final rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017” (2017 Payment Notice), there were technical errors that are identified and corrected in section IV, the Correction of Errors. These corrections are applicable as of May 9, 2016.

    II. Summary of Errors A. Summary of Errors in the Preamble

    On page 12296, the phrase “paragraphs (c)(1)(ii) and (c)(2)(iii) of this paragraph” should include a reference to “(c)(3)(ii).” This correction clarifies how the provisions are at least as stringent as the requirements of paragraph (c) and aligns with the next paragraph that clarifies we do not believe that applying timeframes less stringent than those in the current § 156.122(c) would benefit enrollees.

    On pages 12310 and 12311 the word “consecutive” should have been attached to the description of the grace period for enrollees receiving advance payments of the premium tax credit (APTC), for the description to be consistent with the regulation text that was promulgated prior to the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017; Final Rule. This correction accurately reflects the length of the grace period for enrollees receiving APTC as being 3 consecutive months.

    B. Summary of Errors in Regulation Text

    On page 12349, in § 156.122(c)(4)(i)(D), we inadvertently omitted a cross-reference to paragraph (c)(3)(ii).

    On page 12350, in § 156.270(d) introductory text, we inadvertently omitted the word “consecutive” from the language describing the length of the grace period for enrollees receiving APTC.

    III. Waiver of Proposed Rulemaking and Delay in Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Section 553(d) of the APA mandates a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(3)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements. Section 553(b)(3)(B) of the APA authorizes an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest; and includes a statement of the finding and the reasons for it in the notice. In addition, section 553(d)(3) of the APA allows the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and the agency includes in the rule a statement of the finding and the reasons for it.

    In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements. This document merely corrects typographical and technical errors in the 2017 Payment Notice. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies that were adopted subject to notice and comment procedures in the 2017 Payment Notice. As a result, the corrections made through this correcting document are intended to ensure that the 2017 Payment Notice accurately reflects the policies adopted in that rule.

    Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the 2017 Payment Notice or delaying the effective date of the corrections would be contrary to the public interest because it is in the public interest to ensure that the 2017 Payment Notice accurately reflects our final policies as soon as possible following the date they take effect. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies, but rather, we are simply correcting the Federal Register document to reflect the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the 2017 Payment Notice accurately reflects these policies. For these reasons, we believe there is good cause to waive the requirements for notice and comment and delay in effective date.

    IV. Correction of Errors in the Preamble

    In FR Doc. 2016-04439 (81 FR 12204), published March 8, 2016, make the following corrections:

    1. On page 12296, in the second column, in the first full paragraph, lines 18 and 19, the phrase “paragraphs (c)(1)(ii) and (c)(2)(iii) of this paragraph” is corrected to read “paragraphs (c)(1)(ii), (c)(2)(iii), and (c)(3)(ii) of this section”.

    2. On page 12310,

    a. In the third column, second full paragraph, line 3, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    b. In the third column, second full paragraph, line 29, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    c. In the third column, second full paragraph, line 38, the phrase “grace period of 3 months” is corrected to read “grace period of 3 consecutive months”.

    3. On page 12311,

    a. In the first column, in the first full paragraph, line 7, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    b. In the first column, in the first full paragraph, line 17, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    c. In the first column, in the first full paragraph, lines 24 through 25, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    d. In the second column, in the first full paragraph, line 8, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    e. In the second column, in the second full paragraph, line 14, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    f. In the second column, in the third full paragraph, line 13, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    g. In the second column, in the third full paragraph, line 22, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    h. In the third column, in the first partial paragraph, line 12, the phrase “3-month grace period” is corrected to read “3 consecutive month grace period”.

    List of Subjects in 45 CFR Part 156

    Administrative practice and procedure, Advertising, American Indian/Alaska Natives, Conflict of interest, Consumer protection, Cost-sharing reductions, Essential Health Benefits, Prescription drug benefit, Grant programs-health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Individuals with disabilities, Loan programs-health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Technical assistance, Women, Youth.

    Accordingly, the Department of Health and Human Services corrects 45 CFR part 156 by making the following correcting amendments:

    PART 156—HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES 1. The authority citation for part 156 continues to read as follows: Authority:

    Title I of the Affordable Care Act, sections 1301-1304, 1311-1313, 1321- 1322, 1324, 1334, 1342-1343, 1401-1402, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).

    § 156.122 [Amended]
    2. Section 156.122(c)(4)(i)(D) is amended by removing the phrase “paragraphs (c)(1)(ii) and (c)(2)(iii) of this section” and adding in its place the phrase “paragraphs (c)(1)(ii), (c)(2)(iii), and (c)(3)(ii) of this section”.
    § 156.270 [Amended]
    3. Section 156.270 is amended by amending paragraph (d) to remove the term “3 months” and add in its place the phrase “3 consecutive months”. Dated: August 5, 2016. Madhura Valverde, Executive Secretary to the Department, Department of Health and Human Services.
    [FR Doc. 2016-19108 Filed 8-10-16; 8:45 am] BILLING CODE 4120-01-P
    DENALI COMMISSION 45 CFR Chapter IX National Environmental Policy Act Implementing Procedures and Categorical Exclusions AGENCY:

    Denali Commission.

    ACTION:

    Notice of final NEPA implementation rule.

    SUMMARY:

    This document contains the final Denali Commission policies and procedures for compliance with the National Environmental Policy Act of 1969 (NEPA), as amended. This action is necessary to implement these procedures and make them available to the public on the Commission's internet site.

    DATES:

    Effective September 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Mr. John Whittington, 907-271-1414.

    SUPPLEMENTARY INFORMATION:

    General

    Established by Congress in 1998, the Denali Commission (Commission) is an innovative federal-state partnership designed to provide critical utilities, infrastructure, and economic support throughout Alaska. With the creation of the Commission, Congress acknowledged the need for increased inter-agency cooperation and focus on Alaska's remote communities. Since its first meeting in April 1999, the Commission is credited with constructing numerous cost-shared infrastructure projects across the State that exemplify effective and efficient partnership between federal and state agencies, and the private sector.

    The National Environmental Policy Act (NEPA) and implementing regulations promulgated by the Council on Environmental Quality (CEQ) (40 CFR parts 1500-1508) established a broad national policy to use all practicable means and measures, including financial and technical assistance, in a manner calculated to foster and promote the general welfare, to create and maintain conditions under which man and nature can exist in productive harmony and fulfill the social, economic, and other requirements of present and future generations of Americans. The CEQ regulations implementing the procedural provisions of NEPA are designed to ensure that this national policy, environmental considerations, and associated public concerns are given careful attention and appropriate weight in all decisions of the federal government. Sections 102(2) of NEPA and 40 CFR 1505.1 and 1507.3 require federal agencies to develop and, as needed, revise implementing procedures consistent with the CEQ regulations. The Denali Commission is issuing the following NEPA implementing procedures that comply with NEPA and supplement the CEQ regulations. The remaining sections of SUPPLEMENTARY INFORMATION will provide background. Following the SUPPLEMENTARY INFORMATION is the text of the final procedures.

    Background

    In accordance with CEQ regulations (40 CFR 1507.3), the Commission consulted with the CEQ prior to publication of the proposed rule. On August 10, 2004, the Commission published a proposed rule in the Federal Register (69 FR 48435) and invited public comment. The Commission considered the comments received on the 2004 proposed rule. On March 6, 2006, however, the Commission published a document in the Federal Register withdrawing the 2004 proposed rule (71 FR 13563). At the time, the Commission intended to adopt guidelines for implementing NEPA instead of promulgating a final rule. Since that time, however, the Commission concluded that the approach outlined in the 2004 proposed rule was appropriate and issued a revised version of the proposed rule for review and comment in the Federal Register on December 21, 2015 (80 FR 79292) that reflected the Commission's consideration of and responses to public comments received on the 2004 proposed rule.

    The final rule published today reflects the Commission's consideration of and responses to the public comments received on the revised proposed rule.

    These procedures are final and will be made available to the public in the Code of Federal Regulations (CFR) and on the Commission's internet site at https://www.denali.gov.

    Comments and Responses

    The Commission received, reviewed and considered one comment on the proposed 2015 rule. The comment, however, was not substantive and no changes were made in response to the comment. Also considered were any substantive changes resulting from consultation with the CEQ.

    Subpart A—General Section 900.106 Denali Commission Responsibility

    Paragraph (e) was added to clarify that the Approving Official will be responsible for coordinating comments with cooperating agencies and other federal agencies.

    Section 900.108 Public Involvement

    Language was added requiring hard copies of NEPA documents to be provided to local governmental and/or tribal entities in the effected communities.

    Subpart C—Environmental Assessments Section 900.302 General Considerations in Preparing Environmental Assessments

    The Commission added language clarifying the process for adoption of other environmental documents and incorporation by reference of other documents into an EA. Paragraphs (c) and (d) were eliminated because they were redundant and paragraph (e) was renumbered as paragraph (c).

    Section 900.304 Actions Resulting From Assessment

    Paragraph (c) (Mitigated FONSI) was added to clarify the distinction between a mitigated FONSI and accepting a proposal with modifications (paragraph (b)).

    Subpart D—Environmental Impact Statements Section 900.405 Proposals Normally Requiring an EIS

    The Commission identified large scale infrastructure construction projects such as the relocation of an entire community as projects normally requiring an EIS.

    List of Subjects in 45 CFR Part 900

    Administrative practice and procedure, Environmental impact statements, Environmental protection.

    For the reasons stated in the preamble, the Denali Commission is adding chapter IX, consisting of parts 900 through 999, to title 45 of the CFR to read as follows:

    CHAPTER IX—Denali Commission PART 900—NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES PARTS 901-999 [RESERVED] PART 900—NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES Subpart A—General Sec. 900.101 Purpose. 900.102 Environmental policy. 900.103 Terms and abbreviations. 900.104 Federal and intergovernmental relationships. 900.105 Applicant responsibility. 900.106 Denali Commission responsibility. 900.107 Role of lead and cooperating agencies. 900.108 Public involvement. Subpart B—Environmental Review Procedures 900.201 Environmental review process. 900.202 Emergency actions. 900.203 Determination of federal actions. 900.204 Categorical exclusions. 900.205 Environmental assessment. 900.206 Environmental impact statement. 900.207 Programmatic environmental reviews. Subpart C—Environmental Assessments 900.301 Content. 900.302 General considerations in preparing environmental assessments. 900.303 Public involvement. 900.304 Actions resulting from assessment. 900.305 Findings of no significant impact. 900.306 Proposals normally requiring an EA. Subpart D—Environmental Impact Statements 900.401 Notice of intent and scoping. 900.402 Preparation and filing of draft and final EISs. 900.403 Supplemental EIS. 900.404 Adoption. 900.405 Proposals normally requiring an EIS. Appendix A to Part 900—Categorical Exclusions Authority:

    42 U.S.C. 3121, 4321; 40 CFR parts 1500 through1508.

    Subpart A—General
    § 900.101 Purpose.

    This regulation prescribes the policies and procedures of the Denali Commission (Commission) for implementing the National Environmental Policy Act of 1969 (NEPA) as amended (42 U.S.C. 4321-4347) and the Council on Environmental Quality (CEQ) Regulations for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500 through 1508). This regulation also addresses other related federal environmental laws, statutes, regulations, and Executive Orders that apply to Commission actions. This part adopts, supplements, and is to be used in conjunction with, 40 CFR parts 1500 through 1508, consistent with 40 CFR 1507.3.

    § 900.102 Environmental policy.

    It is the policy of the Commission to:

    (a) Comply with the procedures and policies of NEPA and other related environmental laws, regulations, and orders applicable to Commission actions;

    (b) Provide guidance to applicants responsible for ensuring that proposals comply with all appropriate Commission requirements;

    (c) Integrate NEPA requirements and other planning and environmental review procedures required by law or Commission practice so that all such procedures run concurrently rather than consecutively;

    (d) Encourage and facilitate public involvement in Commission decisions that affect the quality of the human environment;

    (e) Use the NEPA process to identify and assess reasonable alternatives to proposed Commission actions to avoid or minimize adverse effects upon the quality of the human environment;

    (f) Use all practicable means consistent with NEPA and other essential considerations of national policy to restore or enhance the quality of the human environment and avoid, minimize, or otherwise mitigate any possible adverse effects of the Commission's actions upon the quality of the human environment; and

    (g) Consider and give important weight to factors including customary and traditional uses of resources, recreation, and the objectives of Federal, regional, State, local and tribal land use plans, policies, and controls for the area concerned in developing proposals and making decisions in order to achieve a proper balance between the development and utilization of natural, cultural and human resources and the protection and enhancement of environmental quality (see NEPA section 101 and 40 CFR 1508.14). In particular the Commission will consider potential effects on subsistence activities, which are critically important to the daily existence of Alaska Native villages.

    § 900.103 Terms and abbreviations.

    (a) For the purposes of this part, the definitions in the CEQ Regulations, 40 CFR parts 1500 through 1508, are adopted and supplemented as set out in paragraphs (a)(1) through (5) of this section. In the event of a conflict the CEQ Regulations apply.

    (1) Action. Action and Federal action as defined in 40 CFR 1508.18, include projects, programs, plans, or policies, subject to the Commission's control and responsibility.

    (2) Applicant. The federal, state, local government or non-governmental partner or organization applying to the Commission for financial assistance or other approval. An applicant may also be a partner organization in receipt of award funds.

    (3) Approving Official. The Denali Commission staff member designated by the Federal Co-Chair or his/her designee to fulfill the responsibilities defined in § 900.106, including overseeing development of and approval of the NEPA document.

    (4) Commission proposal (or proposal). A proposal, as defined at 40 CFR 1508.23, is a Commission proposal whether initiated by the Commission, another federal agency, or an applicant.

    (5) Federal Co-Chair. One of the seven members of the Commission, appointed by the Secretary of Commerce, as defined in the Denali Commission Act of 1998, 42 U.S.C. 3121, Public Law 105-277.

    (b) The following abbreviations are used throughout this part:

    (1) CATEX—Categorical exclusions;

    (2) CEQ—Council on Environmental Quality;

    (3) EA—Environmental assessment;

    (4) EIS—Environmental impact statement;

    (5) FONSI—Finding of no significant impact;

    (6) NEPA—National Environmental Policy Act of 1969, as amended;

    (7) NOI—Notice of intent; and

    (8) ROD—Record of decision.

    § 900.104 Federal and intergovernmental relationships.

    The Denali Commission was created to deliver the services of the federal government in the most cost-effective manner practicable. In order to reduce administrative and overhead costs, the Commission partners with federal, state and local agencies and Alaska Native villages and commonly depends on these governmental agencies for project management. Consequently, the Commission generally relies on the expertise and processes already in use by partnering agencies to help prepare Commission NEPA analyses and documents.

    (a) With federal partners, the Commission will work as either a joint lead agency (40 CFR 1501.5 and 1508.16) or cooperating agency (40 CFR 1501.6 and 1508.5). The Commission may invite other Federal agencies to serve as the lead agency, a joint lead agency, or as a cooperating agency.

    (b) Consistent with 40 CFR 1508.5, the Commission will typically invite Alaska Native villages and state and local government partners to serve as cooperating agencies.

    (c) Requests for the Commission to serve as a lead agency (40 CFR 1501.5(d)), for CEQ to determine which Federal agency shall be the lead agency (40 CFR 1501.5(e)), or for the Commission to serve as a cooperating agency (40 CFR 1501.6(a)(1)) shall be mailed to the Commission office.

    § 900.105 Applicant responsibility.

    (a) Applicants shall work under Commission direction provided by the Approving Official, and assist the Commission in fulfilling its NEPA obligations by preparing NEPA analyses and documents that comply with the provisions of NEPA (42 U.S.C. 4321-4347), the CEQ Regulations (40 CFR parts 1500 through 1508), and the requirements set forth in this part.

    (b) Applicants shall follow Commission direction when they assist the Commission with the following responsibilities, among others:

    (1) Prepare and disseminate applicable environmental documentation concurrent with a proposal's engineering, planning, and design;

    (2) Create and distribute public notices;

    (3) Coordinate public hearings and meetings as required;

    (4) Submit all environmental documents created pursuant to this part to the Commission for review and approval before public distribution;

    (5) Participate in all Commission-conducted hearings or meetings;

    (6) Consult with the Commission prior to obtaining the services of an environmental consultant; in the case that an EIS is required, the consultant or contractor will be selected by the Commission; and

    (7) Implement mitigation measures included as voluntary commitments by the applicant or as requirements of the applicant in environmental documents.

    § 900.106 Denali Commission responsibility.

    (a) The Federal Co-Chair or his/her designee shall designate an Approving Official for each Commission proposal, and shall provide environmental guidance to the Approving Official;

    (b) The Approving Official shall provide direction and guidance to the applicant as well as identification and development of required analyses and documentation;

    (c) The Approving Official shall make an independent evaluation of the environmental issues, take responsibility for the scope and content of the environmental document (EA or EIS), and make the environmental finding;

    (d) The Approving Official shall ensure mitigation measures included in environmental documents are implemented; and

    (e) The Approving official shall be responsible for coordinating communications with cooperating agencies and other federal agencies.

    § 900.107 Role of lead and cooperating agencies.

    In accordance with § 900.104, the Commission may defer the lead agency role to other federal agencies in accordance with 40 CFR 1501.5, and the Commission will then exercise its role as either a joint lead or a cooperating agency in accordance with 40 CFR 1501.6.

    § 900.108 Public involvement.

    (a) When public involvement is required pursuant to subparts C and D of this part, interested persons and the affected public shall be provided notice of the availability of environmental documents, NEPA-related hearings, and public meetings. Such notice will be made on the Commission Web site and other means such that the community is notified (e.g., community postings, newspaper, radio or television).

    (b) Applicants shall assist the Commission in providing the opportunity for public participation and considering the public comments on the proposal as described in subparts C and D of this part.

    (c) Interested persons can obtain information or status reports on EISs and other elements of the NEPA process from the Commission's office at 510 L Street, Suite 410; Anchorage, Alaska 99501; or on the Commission Web site at http://www.denali.gov. Telephone: (907) 271-1414. The Commission will provide hard copies of NEPA documents to governmental and/or tribal entities in the affected communities.

    (d) In the interests of national security or the public health, safety, or welfare, the Commission may reduce any time periods that the Commission has established and that are not required by the CEQ Regulations. The Commission shall publish a notice on the Web site at http://www.denali.gov and notify interested parties (see 40 CFR 1506.6) specifying the revised time periods for the proposed action and the rationale for the reduction.

    Subpart B—Environmental Review Procedures
    § 900.201 Environmental review process.

    (a) General. The environmental review process is the investigation of potential environmental impacts to determine the environmental process to be followed and to assist in the preparation of the environmental document.

    (b) Early coordination. Applicants will contact the Commission and work with the Approving Official to begin the environmental review process as soon as Denali Commission assistance is projected. Environmental issues shall be identified and considered early in the proposal planning process. A systematic, interdisciplinary approach that includes community involvement and intergovernmental coordination to expand the potential sources of information and identify areas of concern will be used. Environmental permits and other forms of approval, concurrence, or consultation may be required. The planning process shall include permitting and other review processes to ensure that necessary information will be collected and provided to permitting and reviewing agencies in a timely manner.

    § 900.202 Emergency actions.

    (a) General. Emergency circumstances may require immediate actions that preclude following standard NEPA processes. The Council shall limit alternative arrangements to those actions that are necessary to control the immediate impacts of the emergency. In the event of emergency circumstances, the Approving Official should coordinate with the Federal Co-Chair as soon as practicable. Immediate emergency actions necessary to protect the lives and safety of the public or prevent adverse impacts to ecological resources and functions should never be delayed in order to comply with these NEPA procedures. Alternative arrangements for NEPA compliance are permitted for emergency actions pursuant to paragraphs (b) through (d) of this section.

    (b) Categorical exclusion (CATEX). When emergency circumstances make it necessary to determine whether an extraordinary circumstance would preclude the use of a CATEX, the Approving Official shall make the determination as soon as practicable. If an extraordinary circumstance exists, the Approving Official shall comply with paragraphs (c) and (d) of this section, as applicable.

    (c) Environmental assessment (EA). When emergency circumstances make it necessary to take an action that requires an EA before the EA can be completed, the Approving Official will consult with the Federal Co-Chair to develop alternative arrangements to meet the requirements of these NEPA implementing procedures and CEQ Regulations pertaining to EAs. Alternative arrangements should focus on minimizing adverse environmental impacts of the proposed action and the emergency. To the maximum extent practicable, these alternative arrangements should include the content, interagency coordination, and public notification and involvement that would normally be undertaken for an EA for the action at issue and cannot alter the requirements of the CEQ Regulations at 40 CFR 1508.9(a)(1) and (b). The Federal Co-Chair may grant an alternative arrangement. Any alternative arrangement shall be documented. The Federal Co-Chair will inform CEQ of the alternative arrangements at the earliest opportunity.

    (d) Environmental Impact Statement (EIS). Where emergency circumstances make it necessary to take actions with significant environmental impacts without observing other provisions of these NEPA implementing procedures and the CEQ Regulations (see 40 CFR 1506.11) the Federal Co-Chair may consult with CEQ about alternative arrangements for implementation of NEPA. In these situations, the Commission may reduce processing times or, if the emergency situation warrants, abbreviate its preparation and processing of EISs. Any request for alternative arrangements must be submitted by the Federal Co-Chair to CEQ and notice of a potential request should be provided to CEQ at the earliest opportunity. For projects undertaken by an applicant, the Approving Official will inform the Federal Co-Chair about the emergency. The Federal Co-Chair will consult CEQ requesting the alternative arrangements for complying with NEPA.

    § 900.203 Determination of federal actions.

    (a) The Commission shall determine whether any Commission proposal:

    (1) Is categorically excluded from preparation of either an EA or an EIS;

    (2) Requires preparation of an EA; or

    (3) Requires preparation of an EIS.

    (b) Notwithstanding any other provision of this part, the Commission may prepare a NEPA document to assist any Commission action at any time in order to further the purposes of NEPA. This NEPA document may be done to analyze the consequences of ongoing Commission activities, to support Commission planning, to assess the need for mitigation, to disclose fully the potential environmental consequences of Commission actions, or for any other reason. Documents prepared under this paragraph shall be prepared in the same manner as Commission documents prepared under this part.

    § 900.204 Categorical exclusions.

    (a) General. A categorical exclusion (CATEX) is defined in 40 CFR 1508.4 as a category of actions which do not individually or cumulatively have a significant effect on the human environment and, for which in the absence of extraordinary circumstances or sensitive resources, neither an EA nor an EIS is required. Actions that meet the conditions in paragraph (b) of this section and are listed in section A of appendix A of this part can be categorically excluded from further analysis and documentation in an EA or EIS. Actions that meet the screening conditions in paragraph (b) of this section and are listed in section B of appendix A require satisfactory completion of a Denali Commission CATEX checklist in order to be categorically excluded from further analysis and documentation in an EA or EIS.

    (b) Conditions. The following three conditions must be met for an action to be categorically excluded from further analysis in an EA or EIS.

    (1) The action has not been segmented (too narrowly defined or broken down into small parts in order minimize its potential effects and avoid a higher level of NEPA review) and its scope includes the consideration of connected actions and, when evaluating extraordinary circumstances, cumulative impacts.

    (2) No extraordinary circumstances described in paragraph (c) of this section exist, unless resolved through other regulatory means.

    (3) One categorical exclusion described in either section of appendix A of this part encompasses the proposed action.

    (c) Extraordinary circumstances. Any action that normally would be classified as a CATEX but could involve extraordinary circumstances will require appropriate environmental review documented in a Denali Commission CATEX checklist to determine if the CATEX classification is proper or if an EA or EIS should be prepared. Extraordinary circumstances to be considered include those likely to:

    (1) Have a reasonable likelihood of significant impacts on public health, public safety, or the environment;

    (2) Have effects on the environment that are likely to be highly controversial or involve unresolved conflicts concerning alternative uses of available resources;

    (3) Have possible effects on the human environment that are highly uncertain, involve unique or unknown risks, or are scientifically controversial;

    (4) Establish a precedent for future action or represent a decision in principle about future actions with potentially significant environmental effects;

    (5) Relate to other actions with individually insignificant but cumulatively significant environmental effects;

    (6) Have a greater scope or size than is normal for the category of action;

    (7) Have the potential to degrade already existing poor environmental conditions or to initiate a degrading influence, activity, or effect in areas not already significantly modified from their natural condition;

    (8) Have a disproportionately high and adverse effect on low income or minority populations (see Executive Order 12898);

    (9) Limit access to and ceremonial use of Indian sacred sites on federal lands by Indian religious practitioners or adversely affect the physical integrity of such sacred sites (see Executive Order 13007);

    (10) Threaten a violation of a federal, tribal, state or local law or requirement imposed for the protection of the environment;

    (11) Have a reasonable likelihood of significant impact to subsistence activities; or

    (12) Have a reasonable likelihood of significant impacts on environmentally sensitive resources, such as:

    (i) Properties listed, or eligible for listing, in the National Register of Historic Places;

    (ii) Species listed, or proposed to be listed, on the List of Endangered or Threatened Species, or their habitat; or

    (iii) Natural resources and unique geographic characteristics such as historic or cultural resources; park, recreation or refuge lands; wilderness areas; wild or scenic rivers; national natural landmarks; sole or principal drinking water aquifers; prime farmlands; special aquatic sites (defined under Section 404 of the Clean Water Act); floodplains; national monuments; and other ecologically significant or critical areas.

    § 900.205 Environmental assessment.

    (a) An EA is required for all proposals, except those exempt from NEPA or categorically excluded under this part, and those requiring or determined to require an EIS. EAs provide sufficient evidence and analysis to determine whether to prepare an EIS or a finding of no significant impact (FONSI).

    (b) In addition, an EA may be prepared on any action at any time in order to assist in planning and decision making, to aid in the Commission's compliance with NEPA when no EIS is necessary, or to facilitate EIS preparation.

    (c) EAs shall be prepared in accordance with subpart C of this part and shall contain analyses to support conclusions regarding environmental impacts. If a FONSI is proposed, it shall be prepared in accordance with § 900.305.

    § 900.206 Environmental impact statement.

    An EIS is required when the project is determined to have a potentially significant impact on the human environment. EISs shall be prepared in accordance with subpart D of this part.

    § 900.207 Programmatic environmental reviews.

    (a) A programmatic NEPA review is used to assess the environmental impacts of a proposed action that is broad in reach, such as a program, plan, or policy (see 40 CFR 1502.4). Analyses of subsequent actions that fall within the program, plan, or policy may be tiered to the programmatic review, as described in 40 CFR 1502.20 and 1508.28.

    (b) Programmatic NEPA reviews may take the form of a programmatic EA or a programmatic EIS.

    (c) A programmatic EA shall meet all of the requirements for EAs in subpart C of this part, including those for content and public involvement. In order to adopt a programmatic EA prepared by another agency that did not provide the same public involvement opportunities as the Commission, the Commission shall provide notice of the availability of the programmatic EA and make it available for public comment consistent with § 900.303(b) and (c) before adopting it.

    (d) A programmatic EIS shall meet all of the requirements for EISs in subpart D of this part and in 40 CFR parts 1500 through 1508.

    Subpart C—Environmental Assessments
    § 900.301 Content.

    (a) An EA shall include brief discussions of the need for the proposal; of alternatives to the proposal as required by NEPA section 102(2)(E); and of the environmental impacts of the proposal and alternatives. The EA shall also include a listing of agencies and persons consulted in the preparation of the EA.

    (b) An EA may describe a broad range of alternatives and proposed mitigation measures to facilitate planning and decisionmaking.

    (c) The EA should also document compliance, to the extent possible, with all applicable environmental laws and Executive Orders, or provide reasonable assurance that those requirements can be met.

    (d) The EA should be a concise public document. The level of detail and depth of impact analysis will normally be limited to the minimum needed to determine the significance of potential environmental effects.

    § 900.302 General considerations in preparing environmental assessments.

    (a) Adoption of an EA. The Commission may adopt an EA prepared for a proposal before the Commission by another agency or an applicant when the EA, or a portion thereof, addresses the proposed Commission action and meets the standards for an adequate analysis under this part and relevant provisions of 40 CFR parts 1500 through 1508, provided that the Commission makes its own evaluation of the environmental issues and takes responsibility for the scope and content of the EA in accordance with 40 CFR 1506.5(b).

    (b) Incorporation by reference into the EA. Any document may be incorporated by reference in accordance with 40 CFR 1502.21 and used in preparing an EA in accordance with 40 CFR 1501.4(e) and 1506.5(a), provided that the Commission makes its own evaluation of the environmental issues and takes responsibility for the scope and content of the EA in accordance with 40 CFR 1506.5(b).

    § 900.303 Public involvement.

    (a) Commission approval is required before an EA is made available to the public and the notice of availability is published.

    (b) The public shall be provided notice of the availability of EAs and draft FONSIs in accordance with 40 CFR 1506.6 and § 900.108(a) by the Approving Official. The Approving Official is responsible for making the EA available for public inspection and will provide hard copies on request to the affected units of Alaska Native/American Indian tribal organizations and/or local government.

    (c) EAs and draft FONSIs will be available for public comment for not less than 15 calendar days but may be published for a longer period of time as determined by the Approving Official.

    (d) Final Commission action will be taken after public comments received on an EA and draft FONSI are reviewed and considered.

    § 900.304 Actions resulting from assessment.

    (a) Accepted without modification. The Commission may accept a proposal without modifications if the EA indicates that the proposal does not have significant environmental impacts and a FONSI is prepared in accordance with § 900.305.

    (b) Accepted with modification. If an EA identifies potentially significant environmental impacts, the proposal may be modified to eliminate such impacts. Proposals so modified may be accepted by the Commission if the proposed changes are evaluated in an EA and a FONSI is prepared in accordance with § 900.305.

    (c) Mitigated FONSI. If mitigation is required to reduce the impacts below significant the FONSI shall identify the mitigation and describe applicable monitoring and enforcement measures intended to ensure the implementation of the mitigation measures.

    (d) Prepare an EIS. The Commission shall require that the proposal be evaluated in an EIS, prepared in accordance with subpart D to this part, if the EA indicates significant environmental impacts that cannot be mitigated below a specified level of significance.

    (e) Rejected. The Commission may always elect to reject a proposal.

    § 900.305 Findings of no significant impact.

    (a) Definition. Finding of no significant impact (FONSI) means a document by the Commission briefly presenting the reasons why an action, not otherwise excluded as provided in § 900.204, will not have a significant impact on the human environment and for which an EIS will not be prepared.

    (b) Applicant responsibility. The applicant shall assist the Commission with preparing the EA. The Commission remains responsible for compiling the public hearing summary or minutes, where applicable; and copies of any written comments received and responses thereto.

    (c) Content. A FONSI shall include the EA or a summary of it and shall note any other environmental documents related to it (40 CFR 1501.7(a)(5)). If the assessment is included, the finding need not repeat any of the discussion in the assessment but may incorporate it by reference.

    (d) Publication. The Commission shall make the final FONSI available to the public on the Commission Web site.

    (e) Special circumstances. The FONSI notice of availability will be made available for public review (including State and areawide clearinghouses) for 30 days before the Commission makes its final determination whether to prepare an environmental impact statement and before the action may begin (40 CFR 1501.4(e)(2)) where:

    (1) The proposed action is, or is closely similar to, one which normally requires the preparation of an environmental impact statement under § 900.405; or

    (2) The nature of the proposed action is one without precedent.

    § 900.306 Proposals normally requiring an EA.

    Proposals that normally require preparation of an EA include the following:

    (a) Initial field demonstration of a new technology; and

    (b) Field trials of a new product or new uses of an existing technology.

    Subpart D—Environmental Impact Statements
    § 900.401 Notice of intent and scoping.

    (a) The Commission shall publish a NOI, as described in 40 CFR 1508.22, in the Federal Register as soon as practicable after a decision is made to prepare an EIS, in accordance with 40 CFR 1501.7. If there will be a lengthy period of time between the Commission's decision to prepare an EIS and its actual preparation, the Commission may defer publication of the NOI until a reasonable time before preparing the EIS, provided that the Commission allows a reasonable opportunity for interested parties to participate in the EIS process. Consistent with § 900.201(b), the Commission and the applicant will coordinate during the time period prior to the publication of the NOI to identify: the scope of the action, potential modifications to the proposal, potential alternatives, environmental constraints, potential timeframes for the environmental review, and federal, state, or tribal entities that could be interested in the project, including those with the potential to become cooperating agencies. Through the NOI, the Commission shall invite comments and suggestions on the scope of the EIS.

    (b) Publication of the NOI in the Federal Register shall begin the public scoping process. The public scoping process for a Commission EIS shall allow a minimum of 30 days for the receipt of public comments.

    § 900.402 Preparation and filing of draft and final EISs.

    (a) General. Except for proposals for legislation as provided for in 40 CFR 1506.8, EISs shall be prepared in two stages and may be supplemented.

    (b) Format. The EIS format recommended by 40 CFR 1502.10 shall be used unless a determination is made on a particular project that there is a compelling reason to do otherwise. In such a case, the EIS format must meet the minimum requirements prescribed in 40 CFR 1502.10, as further described in 40 CFR 1502.11 through 1502.18.

    (c) Applicant role. The draft or final EIS shall be prepared by the Commission with assistance from the applicant under appropriate guidance and direction from the Approving Official.

    (d) Third-party consultants. A third-party consultant selected by the Commission or in cooperation with a cooperating agency may prepare the draft or final EIS.

    (e) Commission responsibility. The Commission shall provide a schedule with time limits, guidance, participate in the preparation, independently evaluate, and take responsibility for the content of the draft and final EIS.

    (f) Filing. After a draft or final EIS has been prepared, the Commission shall file the EIS with the Environmental Protection Agency (EPA). The EPA will publish a notice of availability in accordance with 40 CFR 1506.9 and 1506.10.

    (g) Draft to final EIS. When a final EIS does not require substantial changes from the draft EIS, the Commission may document required changes in errata sheets, insertion pages, and revised sections. The Commission will then circulate such changes together with comments on the draft EIS, responses to comments, and other appropriate information as its final EIS. The Commission will not circulate the draft EIS again; however, the Commission will post the EIS on its Web site and provide the draft EIS if requested.

    (h) Record of decision. A record of decision (ROD) will be prepared in accordance with 40 CFR 1505.2.

    § 900.403 Supplemental EIS.

    (a) Supplements to either draft or final EISs shall be prepared, as prescribed in 40 CFR 1502.9, when the Commission finds that there are substantial changes are proposed in a project that are relevant to environmental concerns; or when there are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.

    (b) Where Commission action remains to be taken and the EIS is more than three years old, the Commission will review the EIS to determine whether it is adequate or requires supplementation.

    (c) The Commission shall prepare, circulate and file a supplement to an EIS in the same fashion (exclusive of scoping) as a draft and final EIS. In addition, the supplement and accompanying administrative record shall be included in the administrative record for the proposal. When an applicant is involved, the applicant shall, under the direction of the approving official, provide assistance.

    (d) An NOI to prepare a supplement to a final EIS will be published in those cases where a ROD has already been issued.

    § 900.404 Adoption.

    (a) The Commission may adopt a draft or final EIS or portion thereof (see 40 CFR 1506.3), including a programmatic EIS, prepared by another agency.

    (b) If the actions covered by the original EIS and the proposal are substantially the same, the Commission shall recirculate it as a final statement. Otherwise, the Commission shall treat the statement as a draft and recirculate it except as provided in paragraph (c) of this section.

    (c) Where the Commission is a cooperating agency, it may adopt the EIS of the lead agency without recirculating it when, after an independent review of the EIS, the Commission concludes that its comments and suggestions have been satisfied.

    (d) When the Commission adopts an EIS which is not final within the agency that prepared it, or when the action it assesses is the subject of a referral under 40 CFR part 1504, or when the EIS's adequacy is the subject of a judicial action which is not final, the Commission shall so specify.

    § 900.405 Proposals normally requiring an EIS.

    An EIS will normally be required for:

    (a) Large scale infrastructure construction efforts such as the relocation of an entire community;

    (b) A project that requires a formal consultation under Section 7 of the Endangered Species Act; or

    (c) Where implementation of the proposal may directly cause or induce changes that significantly:

    (1) Displace population;

    (2) Alter the character of existing residential areas; or

    (3) Adversely affect a floodplain.

    Appendix A to Part 900—Categorical Exclusions A. General Categorical Exclusions

    Actions consistent with any of the following categories are, in the absence of extraordinary circumstances, categorically excluded from further analysis in an EA or EIS:

    A1. Routine administrative and management activities including, but not limited to, those activities related to budgeting, finance, personnel actions, procurement activities, compliance with applicable executive orders and procedures for sustainable or “greened” procurement, retaining legal counsel, public affairs activities (e.g., issuing press releases, newsletters and notices of funding availability), internal and external program evaluation and monitoring (e.g., site visits), database development and maintenance, and computer systems administration.

    A2. Routine activities that the Commission does to support its program partners and stakeholders, such as serving on task forces, ad hoc committees or representing Commission interests in other forums.

    A3. Approving and issuing grants for administrative overhead support.

    A4. Approving and issuing grants for social services, education and training programs, including but not limited to support for Head Start, senior citizen programs, drug treatment programs, and funding internships, except for projects involving construction, renovation, or changes in land use.

    A5. Approving and issuing grants for facility planning and design.

    A6. Nondestructive data collection, inventory, study, research, and monitoring activities (e.g., field, aerial and satellite surveying and mapping).

    A7. Research, planning grants and technical assistance projects that are not reasonably expected to commit the federal government to a course of action, to result in legislative proposals, or to result in direct development.

    A8. Acquisition and installation of equipment including, but not limited to, EMS, emergency and non-expendable medical equipment (e.g., digital imaging devices and dental equipment), and communications equipment (e.g., computer upgrades).

    B. Program Categorical Exclusions

    Actions consistent with any of the following categories are, in the absence of extraordinary circumstances, categorically excluded from further analysis and documentation in an EA or EIS upon completion of the Denali Commission CATEX checklist:

    B1. Upgrade, repair, maintenance, replacement, or minor renovations and additions to buildings, roads, harbors and other maritime facilities, grounds, equipment, and other facilities, including but not limited to, roof replacement, foundation repair, ADA access ramp and door improvements, weatherization and energy efficiency related improvements, HVAC renovations, painting, floor system replacement, repaving parking lots and ground maintenance, that do not result in a change in the functional use of the real property.

    B2. Engineering studies and investigations that do not permanently change the environment.

    B3. Construction or lease of new infrastructure including, but not limited to, health care facilities, community buildings, housing, and bulk fuel storage and power generation plants, where such lease or construction:

    (a) Is at the site of existing infrastructure and capacity is not substantially increased; or

    (b) Is for infrastructure of less than 12,000 square feet of useable space when less than two aces of surface land area are involved at a new site.

    B4. Construction or modification of electric power stations or interconnection facilities (including, but not limited to, switching stations and support facilities).

    B5. Construction of electric powerlines approximately ten miles in length or less, or approximately 20 miles in length or less within previously disturbed or developed powerline or pipeline rights-of-way.

    B6. Upgrading or rebuilding approximately twenty miles in length or less of existing electric powerlines, which may involve minor relocations of small segments or the powerlines.

    B7. Demolition, disposal, or improvements involving buildings or structures when done in accordance with applicable regulations, including those regulations applying to removal of asbestos, polychlorinated biphenyls (PCBs), and other hazardous materials.

    PARTS 901-999 [RESERVED] Dated: July 6, 2016. Joel Neimeyer, Federal Co-Chair.
    [FR Doc. 2016-18176 Filed 8-10-16; 8:45 am] BILLING CODE P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 11 [PS Docket No. 15-94; FCC 16-80] Amendment of the Emergency Alert System AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Federal Communications Commission (FCC or Commission) revises its rules governing the Emergency Alert System (EAS) to add three new EAS event codes, covering extreme wind and storm surges, as well as revise the territorial boundaries of the geographic location codes for two offshore marine areas.

    DATES:

    Effective September 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Fowlkes, Deputy Bureau Chief, Public Safety and Homeland Security Bureau, at (202) 418-7452, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Order (Order) in PS Docket No. 15-94, FCC 16-80, adopted on July 6, 2016, and released on July 11, 2016. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov.

    Synopsis of the Order

    1. The Order revises the Part 11 EAS rules to add three new EAS event codes, covering extreme wind and storm surges, as well as revise the territorial boundaries of the geographic location codes for two offshore marine areas. The Commission initiated this proceeding in response to a request from the National Weather Service (NWS) of the National Oceanic and Atmospheric Administration (NOAA) that the Commission adopt these revisions to harmonize the EAS with the NWS's weather radio system. Virtually all commenters addressing these revisions supported their adoption.

    I. Background

    2. The EAS is a national public warning system through which broadcasters, cable systems, and other EAS Participants deliver alerts to the public to warn them of impending emergencies and dangers to life and property. The primary purpose of the EAS is to provide the President with “the capability to provide immediate communications and information to the general public at the national, state and local levels during periods of national emergency.” The EAS also is used by state and local governments, as well as the NWS, to distribute alerts. According to NWS, about 90 percent of all EAS activations are generated by NWS and relate to short-term weather events. The Commission, the Federal Emergency Management Agency (FEMA), and NWS implement the EAS at the federal level. The EAS is a broadcast-based, hierarchical alert message distribution system through which an alert message originator at the local, state or national level encodes (or arranges to have encoded) a message in the EAS Protocol, which provides basic information about the emergency involved. The message is then broadcast by one or more EAS Participants and subsequently relayed from one station to another until all affected EAS Participants have received the alert and delivered it to the public. This process of EAS alert distribution among EAS Participants is often referred to as the “daisy chain” distribution architecture.

    3. The EAS Protocol utilizes fixed codes to identify various aspects of the alert. Of particular relevance to the Order, the EAS Protocol utilizes a three-character “event code” to describe the nature of the alert (e.g., “TOR” signifies tornado). The EAS Protocol identifies “National” event codes, such as the EAN and National Periodic Test (NPT), which EAS Participants use as part of required Presidential alerts and tests, and which EAS Participants are required to disseminate, and “State and Local” event codes, such as Amber alerts and weather-related alerts issued by the NWS, which EAS Participants disseminate on a voluntary basis. In addition, the EAS Protocol utilizes six-digit numerical location codes to identify the geographic area(s) to which the alert applies. Unlike the state and territory geographic location codes, which are based on an American National Standards Institute (ANSI) standard, the codes assigned to the offshore marine areas were created by the NWS and adopted by the Commission in 2002 at NWS's request, following notice and opportunity for public comment.

    II. Discussion A. Proposed EAS Event Codes

    4. NWS requested that the Commission add a new “Extreme Wind Warning” (EWW) event code to provide the public with advance notice of the onset of extreme sustained surface winds (greater than or equal to 115 miles per hour) associated with a major land-falling hurricane (Category 3 or higher). NWS also requested that the Commission add two new event codes covering storm surges: “Storm Surge Watch” (SSA) and “Storm Surge Warning” (SSW). NWS indicated that the “Storm Surge Watch/Warning will be issued when there is a significant risk of life-threatening inundation from rising water moving inland from the ocean.”

    5. Decision. We grant NWS's request and revise Section 11.31 of the EAS rules to add the EWW, SSA and SSW event codes to the EAS Protocol. As we observed in the Notice of Proposed Rulemaking (NWS NPRM) in PS Docket No. 15-94, 80 FR 47886 (Aug. 10, 2015), there is considerable data attesting to the dangers posed to life and property by both high winds and, in particular, storm surges, associated with hurricanes. While the EAS Protocol currently contains event codes covering hurricanes, these codes only generally warn of an impending hurricane—they do not specifically cover extreme high winds associated with a Category 3 or higher hurricane or storm surges associated with a hurricane. The record demonstrates that existing event codes contained in the EAS Protocol are not adequate substitutes for the adoption of the EWW, SSA and SSW event codes. As NWS has observed, for example, use of the TOR event code during prior hurricanes led to confusion among the public and the dissemination of incorrect risk-avoidance advice. Monroe County Florida Emergency Management observes that “[c]oastal residents may know or have an anticipated expectation regarding the impact of flood warnings which may be due in part to wind, tide, or heavy rain[, and] that anticipation can be confused unless the wording used is completely different as proposed.” We do not find that the public interest would be served by relying on inadequate warnings that might provide incorrect or even opposite remedial advice to the public. Based on the record before us and the subject matter expertise of the NWS, we conclude that adoption of the event codes proposed by the NWS will improve the function of the EAS, enhance safety of life and property, and therefore is in the public interest.

    6. We do not find EAS equipment manufacturer, TFT, Inc.'s (TFT), arguments against adoption of the new event codes persuasive. The dangers posed by hurricane-induced extreme high winds and storm surges are well established, and the record in this proceeding establishes a need and desire for adoption of these codes to better address such dangers. The National Association of Broadcasters, for example, states that “[e]xplicit codes for storm surges and warnings would better reflect their rapid development and movement than the existing codes for a flood watch or warning, or other water-related situations.” Radio Hatteras states that “[t]he addition of EWW, SSA and SSW codes would significantly enhance public safety in coastal regions” TFT's objection that the public will not appreciate the nuances between the specific dangers posed by extreme winds and storm surges caused by a hurricane and the dangers posed generally by the hurricane itself has no support in the record. Monroe County Florida Emergency Management, for example, contends that “[s]tudies show, the public is more likely to follow protective action recommendation, such as evacuations or shelter in place, or limit travel, if the directives are clearly and concisely communicated to them.” Moreover, the NWS indicates that having the new codes become effective in the summer of 2016 will provide the NWS sufficient time to conduct outreach and education on the meaning of these new codes before the NWS begins to issue alerts using these codes for the 2017 hurricane season. The outreach and education that NWS intends to conduct will include a public education campaign, including “public service announcements over NWR; NWS News Releases; official NWS Service Change Notifications; advertising on NWS Web sites; updates to official preparedness brochures and pamphlets; briefings to emergency managers; presentations at federal, state and local hurricane conferences; concurrent outreach and partnering efforts with FEMA; and extensive community outreach efforts by the NWS Warning Coordination Meteorologist in every Weather Forecast Office impacted by tropical cyclones.”

    B. Proposed Geographic Location Code Revisions

    7. NWS also requested that the Commission revise the areas defined in the geographic location codes identified in Section 11.31(f) of the EAS rules as location codes 75 and 77, which cover offshore marine areas. Specifically, NWS indicated that it has changed the end point it uses for generating weather alerts for both of these areas from Bonita Beach, Florida, to Ocean Reef, Florida, and, accordingly, requested that the area covered by location code 75 be changed to “Western North Atlantic Ocean, and along U.S. East Coast, south of Currituck Beach Light, NC, following the coastline to Ocean Reef, FL, including the Caribbean,” and that the area covered by location code 77 be changed to “Gulf of Mexico, and along the U.S. Gulf Coast from the Mexican border to Ocean Reef, FL.” NWS stated that harmonizing the definitions for these areas in the EAS rules to match those used by the NWS would alleviate potential confusion among broadcasters, the emergency management community and the maritime commerce community that issue and monitor alerts for these areas. NWS again noted that it had checked with several EAS encoder/decoder manufacturers, and was informed that the cost and time to make the requested change would be nominal.

    8. Decision. We grant NWS's request and change the defined areas identified in Section 11.31(f) of the EAS rules for location codes 75 and 77 to “Western North Atlantic Ocean, and along U.S. East Coast, south of Currituck Beach Light, NC, following the coastline to Ocean Reef, FL, including the Caribbean,” and “Gulf of Mexico, and along the U.S. Gulf Coast from the Mexican border to Ocean Reef, FL,” respectively. These definitional changes amount to minor modifications to location definitions created and used by the NWS. Further, harmonizing the Part 11 definitions for these locations with those used by the NWS is necessary to ensure that the SMW and other marine-specific alerts reach their intended audiences. Such action also should eliminate any potential for confusion that might otherwise exist among EAS Participants, the emergency management community and the maritime commerce community in the event that the EAS rules and NWS used different location definitions. We also observe that EAS equipment manufacturers have confirmed that these changes can be implemented by EAS Participants via software downloads with minimal effort.

    9. We do not find TFT's arguments against adoption of the new location codes persuasive. Whether these codes are widely used or not, we do not see what public interest would be served by allowing continued disharmony between the EAS definitions and those used by the NWS, particularly as these could lead to marine alerts not reaching their intended audiences as well as confusion among the maritime users operating in these geographic areas, potentially placing the safety of vessels and their crews at risk. Further, EAS Participants may install and utilize the revised codes as they deem fit, and we find that the EAS Participants that actually use these codes are best situated to determine whether use of the revised location codes is necessary and meaningful to the areas they serve.

    10. Finally, we also revise footnote 1 of Section 11.31 to delete the reference to the past deadline and to clarify that the numbers assigned to the offshore marine areas listed in the table of geographic areas in Section 11.31(f), while consistent with the ANSI standard, are not a product of that standard, but rather were assigned by the NWS. No party commented on that proposed change, which in any event, is largely administrative in nature. We conclude that harmonizing the definitions in the EAS with those used by the NWS will eliminate the potential for needless confusion among EAS Participants, the emergency management community and the maritime commerce community as to the geographic application of these codes, and maintain the efficiency of marine operations and safety of vessels and their crews.

    C. Cost Benefit Analysis

    11. The Commission observes that EAS equipment manufacturers have indicated in the record that the new codes and code revisions can be implemented by EAS Participants via minimally burdensome and low-cost software downloads. Further, use of these codes is not mandatory for EAS Participants; EAS Participants are free to implement them if and when they see fit, thus reducing the overall costs to EAS Participants even further.

    12. We observe that although EAS equipment manufacturers must make the new event and locations codes available to all EAS Participants, these manufacturers have indicated in the record that the codes can be implemented by EAS Participants via minimally burdensome and low cost software downloads. Further, use of these codes is not mandatory for EAS Participants; EAS Participants are free to implement them if and when they see fit, thus reducing the overall costs to EAS Participants even further. While some currently deployed legacy EAS device models may not be capable of being updated to accommodate these codes, we observe that any such equipment already is required to be replaced to accommodate the recently adopted NPT event code and “000000” geographic code for national testing no later than July 30, 2016, thus, no EAS Participant will be faced with the cost of obtaining new EAS equipment simply to use the new event codes and geographic locations code revisions adopted in this item.

    13. Based on the record, we anticipate that the only cost to EAS Participants who elect to install these new event codes and geographic location code revisions will be whatever labor cost is involved in downloading the software patches into their devices and associated clerical work. We further anticipate that such installation would not on average take more than one hour. However, even using a worst case cost figure of $125.00 per device—which figure represents the labor cost estimate approved by the Office of Management and Budget for an EAS Participant to fill out the Commission's online reporting form for EAS National Tests at a total time expenditure of five hours—the cost of implementing these codes are far exceeded by the benefits they provide. At a per-unit cost of $125.00, even if all EAS Participants elected to implement these codes (an unlikely event in areas not prone to hurricanes), the aggregate cost of adopting these new codes would be approximately $3.5 million.

    14. With respect to benefits, we have proposed that the benchmark for measuring these types of expected benefits should be the value of a statistical life (VSL), currently estimated at $9.1 million. Accordingly, the value of this risk reduction to the public, measured in terms of expected lives saved, is at least $9.1 million, which far exceeds the one-time, highly conservative $3.5 million aggregated cost estimate if each and every EAS Participant across the U.S. elected to implement these new codes and code revisions. Furthermore, this expected benefit is a conservative valuation because the EAS is likely to save more than just one life in the event of a storm surge or extreme high winds caused by a Category 3 or higher hurricane, will accrue annually, and does not include the benefits associated with reducing injuries and associated medical costs, mitigating property damage, and minimizing the disruption of our national economy. Accordingly, we conclude that the minor burdens associated with adopting these codes will be more than offset by the benefits to public safety that will accrue from the introduction of these new codes into the EAS alerting framework.

    D. Implementation Schedule

    15. Decision. We believe that the prompt deployment of alerts using these new codes is consistent with the safety of the public in affected areas. Accordingly, we require EAS equipment manufacturers to integrate these codes into equipment yet to be manufactured or sold, and make necessary software upgrades available to EAS Participants no later than six months from the effective date of the rule amendments adopted in this Order. We observe that EAS equipment manufacturers already have confirmed that these code changes can be implemented fairly easily in the field, and no manufacturer has indicated that implementing such changes on the production line would present any difficulties or require any more time than six months. We also allow EAS Participants to upgrade their existing EAS equipment to include the new event and location code revisions on a voluntary basis until their equipment is replaced. We observe that this approach is the same approach taken by the Commission the only other time that it adopted new event and location codes, and the record does not indicate that any problems arose as a result of that approach.

    16. We will not mandate installation of these codes. First, the event codes and location code revisions adopted in this item are germane to only a relatively small subset of EAS Participants located in areas affected by hurricane high winds and storm surges. We believe EAS Participants in these areas already are highly motivated to install and use these codes, as demonstrated by NWS's surveys. Second, as indicated, this approach is consistent with the approach taken by the Commission the only other time it adopted event and location codes, and that time the Commission adopted codes that were germane to all EAS Participants. Third, the use by EAS Participants of these codes, like all State and local event codes, is and has always been voluntary, and no commenter has presented any arguments as to why that should not continue to be the case.

    17. Although we are not mandating that EAS Participants upgrade their existing EAS equipment to incorporate the new event codes and location code revisions, we will require EAS Participants who replace their EAS equipment after one year from the effective date of this Order to install EAS equipment that is capable of receiving and transmitting the new event codes and revised location codes. Thus, after this deadline, EAS Participants may not replace their existing EAS equipment with used equipment or older models of equipment that has not been upgraded to incorporate the new codes. This will ensure that all EAS Participants have the capability to receive and transmit the new codes when their EAS equipment is replaced. We observe that this approach is consistent with that taken by the Commission in the Report and Order in EB Docket No. 01-66, 67 FR 18502 (April 16, 2002), and allows for a transition of deployed equipment that mirrors ordinary equipment replacement cycles for those EAS Participants that do not have an immediate need to install the new codes.

    18. With respect to transitioning to the new codes, NWS has indicated that it will not initiate alerts using any of the proposed codes until the 2017 Atlantic Hurricane season. The NWS states that focusing on the 2017 Atlantic Hurricane season will allow the NWS to deploy the codes in a uniform manner, and will allow for an extensive public outreach program. The 2017 Atlantic Hurricane season falls well outside of the six month deadline we adopt today for equipment yet to be manufactured or sold and the one year deadline we require for EAS Participants who replace their EAS equipment. Thus, EAS Participants will have sufficient time to install the codes or purchase compliant equipment in time for the NWS actual adoption of the codes. Because the NWS implementation dates for the proposed codes fall outside of our deadlines, and because the NWS will only deploy the codes after an extensive education and outreach program, we believe that the NWS will be able to deliver the appropriate alerts to all recipients without the need for any transition period where it issues alerts using both codes. We also believe that the deadlines we adopt today are consistent with the NWS schedule, as any extra time between our deadline and the NWS's actual use of the codes in an alert will allow EAS equipment manufacturers and EAS Participants time to resolve any technical issues that may arise.

    III. Procedural Matters A. Accessible Formats

    19. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    B. Regulatory Flexibility Analysis

    20. As required by the Regulatory Flexibility Act of 1980, see 5 U.S.C. 603, the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) of the possible significant economic impact on small entities of the policies and rules addressed in this document.

    C. Paperwork Reduction Act Analysis

    21. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    D. Congressional Review Act

    22. The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act (“CRA”), see 5 U.S.C. 801(a)(1)(A).

    E. Final Regulatory Flexibility Analysis

    23. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was included in the NWS NPRM. The Commission sought comments on the IRFA. Because the Order amends the Commission's rules, this Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

    1. Need for, and Objectives of, the Order

    24. This Order adopts changes to the Commission's Part 11 rules governing the Emergency Alert System (EAS). Specifically, the Order adds three new EAS Event Codes, covering extreme wind (“Extreme Wind Warning”) and storm surges (“Storm Surge Watch” and “Storm Surge Warning”), and revises the territorial boundaries of geographic location codes 75 and 77 used by the EAS. These rule revisions improve the capacity of the EAS to warn the public of impending threats to life and property, and ensure that the geographic definitions of location codes 75 and 77 utilized by the EAS are harmonized with those employed by the National Weather Service (NWS).

    2. Summary of Significant Issues Raised by Public Comments in Response to the IRFA

    25. The Small Business Administration (SBA) filed no comments in this proceeding, and there were no other comments specifically addressed to the IRFA.

    3. Description and Estimate of the Number of Small Entities to Which Rules Will Apply

    26. The RFA directs agencies to provide a description of and, where feasible, an estimate of, the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. The following are categories of small entities that may be affected by the rules adopted in the Order: Small Businesses, Small Organizations, and Small Governmental Jurisdictions; Television Broadcasting (including commercial television stations; licensed noncommercial educational stations; licensed Class A stations; licensed low power television stations; and licensed TV translators); Radio Stations (including low power FM stations); Wired Telecommunications Carriers; Incumbent Local Exchange Carriers (Incumbent LECs); Competitive Local Exchange Carriers (Competitive LECs), Competitive Access Providers (CAPs), Shared-Tenant Service Providers, and Other Local Service Providers; Satellite Telecommunications; Direct Broadcast Satellite (“DBS”) Service; and “All Other Telecommunications” (comprised of establishments primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation).

    4. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

    27. None.

    5. Steps Taken To Minimize the Significant Economic Impact on Small Entities and Significant Alternatives Considered

    28. The RFA requires an agency to describe any significant, specifically small business alternatives that it has considered in reaching its conclusions, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.”

    29. The rule changes adopted in this Order implement certain EAS warning codes and location code definitional changes that are unique, and implemented by small entity and larger-sized regulated entities on a voluntary basis. Thus, the Order does not mandate burdens on regulated entities of any size. Moreover, the record in this proceeding indicates that the costs associated with voluntarily implementing the codes contained in the Order should be de minimis or non-existent.

    30. Report to Congress: The Commission will send a copy of the Order, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. A copy of the Order and FRFA (or summaries thereof) will also be published in the Federal Register.

    IV. Ordering Clauses

    31. Accordingly, IT IS ORDERED that pursuant to Sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), 706, and 715 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(o), 301, 303(r), 303(v), 307, 309, 335, 403, 544(g), 606, and 615, this Order IS ADOPTED.

    List of Subjects in 47 CFR Part 11

    Radio, Television.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer. Final Rules

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 11 as follows:

    PART 11—EMERGENCY ALERT SYSTEM (EAS) 1. The authority citation for part 11 continues to read as follows: Authority:

    47 U.S.C. 151, 154 (i) and (o), 303(r), 544(g) and 606.

    2. Section 11.31 is amended by revising paragraphs (e) and (f) to read as follows:
    § 11.31 EAS protocol.

    (e) The following Event (EEE) codes are presently authorized:

    Nature of activation Event codes National Codes (Required): Emergency Action Notification (National only) EAN. National Information Center NIC National Periodic Test NPT. Required Monthly Test RMT. Required Weekly Test RWT. State and Local Codes (Optional): Administrative Message ADR. Avalanche Warning AVW. Avalanche Watch AVA. Blizzard Warning BZW. Child Abduction Emergency CAE. Civil Danger Warning CDW. Civil Emergency Message CEM. Coastal Flood Warning CFW. Coastal Flood Watch CFA. Dust Storm Warning DSW. Earthquake Warning EQW. Evacuation Immediate EVI. Extreme Wind Warning EWW. Fire Warning FRW. Flash Flood Warning FFW. Flash Flood Watch FFA. Flash Flood Statement FFS. Flood Warning FLW. Flood Watch FLA. Flood Statement FLS. Hazardous Materials Warning HMW. High Wind Warning HWW. High Wind Watch HWA. Hurricane Warning HUW. Hurricane Watch HUA. Hurricane Statement HLS. Law Enforcement Warning LEW. Local Area Emergency LAE. Network Message Notification NMN. 911 Telephone Outage Emergency TOE. Nuclear Power Plant Warning NUW. Practice/Demo Warning DMO. Radiological Hazard Warning RHW. Severe Thunderstorm Warning SVR. Severe Thunderstorm Watch SVA. Severe Weather Statement SVS. Shelter in Place Warning SPW Special Marine Warning SMW. Special Weather Statement SPS. Storm Surge Watch SSA. Storm Surge Warning SSW. Tornado Warning TOR. Tornado Watch TOA. Tropical Storm Warning TRW. Tropical Storm Watch TRA. Tsunami Warning TSW. Tsunami Watch TSA. Volcano Warning VOW. Winter Storm Warning WSW. Winter Storm Watch WSA.

    (f) The All U.S. State, Territory and Offshore (Marine Area) ANSI number codes (SS) are as follows. County ANSI numbers (CCC) are contained in the State EAS Mapbook.

    (f) The All U.S., State, Territory and Offshore (Marine Area) ANSI number codes (SS) are as follows. County ANSI numbers (CCC) are contained in the State EAS Mapbook.

    ANSI No. All U.S 00 State: AL 01 AK 02 AZ 04 AR 05 CA 06 CO 08 CT 09 DE 10 DC 11 FL 12 GA 13 HI 15 ID 16 IL 17 IN 18 IA 19 KS 20 KY 21 LA 22 ME 23 MD 24 MA 25 MI 26 MN 27 MS 28 MO 29 MT 30 NE 31 NV 32 NH 33 NJ 34 NM 35 NY 36 NC 37 ND 38 OH 39 OK 40 OR 41 PA 42 RI 44 SC 45 SD 46 TN 47 TX 48 UT 49 VT 50 VA 51 WA 53 WV 54 WI 55 WY 56 Terr.: AS 60 FM 64 GU 66 MH 68 PR 72 PW 70 UM 74 VI 78 Offshore (Marine Areas) 1 Eastern North Pacific Ocean, and along U.S. West Coast from Canadian border to Mexican border 57 North Pacific Ocean near Alaska, and along Alaska coastline, including the Bering Sea and the Gulf of Alaska 58 Central Pacific Ocean, including Hawaiian waters 59 South Central Pacific Ocean, including American Samoa waters 61 Western Pacific Ocean, including Mariana Island waters 65 Western North Atlantic Ocean, and along U.S. East Coast, from Canadian border south to Currituck Beach Light, N.C 73 Western North Atlantic Ocean, and along U.S. East Coast, south of Currituck Beach Light, NC, following the coastline to Ocean Reef, FL, including the Caribbean 75 Gulf of Mexico, and along the U.S. Gulf Coast from the Mexican border to Ocean Reef, FL 77 Lake Superior 91 Lake Michigan 92 Lake Huron 93 Lake St. Clair 94 Lake Erie 96 Lake Ontario 97 St. Lawrence River above St. Regis 98 1 The numbers assigned to the offshore marine areas listed in this table are not described under the ANSI standard, but rather are numeric codes that were assigned by the National Weather Service.
    [FR Doc. 2016-18962 Filed 8-10-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 213 and 218 [Docket DARS-2016-0023] Defense Federal Acquisition Regulation Supplement; Technical Amendment AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Final rule.

    SUMMARY:

    DoD is making a technical amendment to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.

    DATES:

    Effective August 11, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Jennifer L. Hawes, Defense Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 571-372-6115; facsimile 571-372-6094.

    SUPPLEMENTARY INFORMATION:

    This final rule amends DFARS 213.201(g) to add a reference to guidance available in DFARS Procedures, Guidance, and Information on the use of the higher micro-purchase thresholds prescribed in FAR 13.201(g) to support a declared contingency operation or to facilitate defense against or recovery from nuclear, biological, chemical, or radiological attack. A reference to DFARS 213.201 is also added at DFARS 218.201.

    List of Subjects in 48 CFR Parts 213 and 218

    Government procurement.

    Jennifer L. Hawes, Editor, Defense Acquisition Regulations System.

    Therefore, 48 CFR parts 213 and 218 are amended as follows:

    PART 213—SIMPLIFIED ACQUISITION PROCEDURES 1. The authority citation for 48 CFR part 213 continues to read as follows: Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    2. Add section 213.201 to read as follows:
    213.201 General.

    (g) See PGI 213.201(g) for guidance on use of the higher micro-purchase thresholds prescribed in FAR 13.201(g) to support a declared contingency operation or to facilitate defense against or recovery from nuclear, biological, chemical, or radiological attack.

    PART 218—EMERGENCY ACQUISITIONS 3. The authority citation for 48 CFR part 218 is revised to read as follows: Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    218.201 [Amended]
    4. Amend section 218.201 by, in paragraph (3), removing “See 213.270(c)(3)” and adding “See 213.201(g) and 213.270(c)(3)” in its place.
    [FR Doc. 2016-18705 Filed 8-10-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF TRANSPORTATION Federal Transit Administration 49 CFR Part 670 [Docket No. FTA-2015-0009] RIN 2132-AB22 Public Transportation Safety Program AGENCY:

    Federal Transit Administration (FTA), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    The Federal Transit Administration is issuing a final rule to establish substantive and procedural rules for FTA's administration of a comprehensive safety program to improve the safety of the Nation's public transportation systems. This final rule provides the framework for FTA to monitor, oversee and enforce transit safety, based on the methods and principles of Safety Management Systems.

    DATES:

    The effective date of this rule is September 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    For program matters, contact Brian Alberts, Office of Transit Safety and Oversight, (202) 366-1783 or [email protected] For legal matters, contact Candace Key, Office of Chief Counsel, (202) 366-1936 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Statutory Authority C. Summary of Major Provisions D. Costs and Benefits II. Rulemaking Background III. Summary of NPRM Comments and FTA's Responses A. General Comments B. Section-by-Section Comments IV. Regulatory Analyses and Notices I. Executive Summary A. Purpose of Regulatory Action

    This final rule establishes substantive and procedural rules to support the Federal Transit Administrator in carrying out the Public Transportation Safety Program (Safety Program), first authorized in the Moving Ahead for Progress in the 21st Century Act (MAP-21) (Pub. L. 112-141 (2012)), and codified at 49 U.S.C. 5329. On December 4, 2015, the President signed into law the Fixing America's Surface Transportation (FAST) Act (Pub. L. 114-94 (2015)). The FAST Act made two amendments to the Safety Program that affect today's rulemaking and are discussed further, below.

    B. Statutory Authority

    Under 49 U.S.C. 5329 (Section 5329), FTA, through the authority delegated by the Secretary of the Department of Transportation, must create a comprehensive Public Transportation Safety Program. Most notably, Section 5329 provides FTA with the following explicit authorities to administer the Safety Program and to take enforcement actions:

    • 49 U.S.C. 5329(f), provides FTA with the authority to inspect and audit a public transportation system; make reports and issue directives with respect to the safety of a public transportation system or the public transportation industry generally; issue subpoenas and take depositions; require the production of documents; prescribe recordkeeping and reporting requirements; investigate public transportation accidents and incidents; enter into and inspect the equipment, rolling stock, operations and relevant records of a public transportation system; and issue regulations.

    • 49 U.S.C. 5329(g) authorizes FTA to take enforcement actions against a recipient of Federal financial assistance under 49 U.S.C. chapter 53 that is noncompliant with Federal transit safety law, through issuing directives, requiring more frequent oversight, imposing more frequent reporting requirements, requiring that chapter 53 funds be spent to correct safety deficiencies before those funds are spent on other projects, and withholding funds from a recipient.

    • 49 U.S.C. 5329(h) authorizes FTA to impose restrictions and prohibitions on a recipient's operations, where FTA determines that an unsafe practice or condition creates a substantial risk of death or personal injury.

    C. Summary of Major Provisions

    In the Notice of Proposed Rulemaking (NPRM), 80 FR 48794, (August 14, 2015), FTA proposed (1) to add a new part 670, “Public Transportation Safety Program,” to title 49 of the Code of Federal Regulations (CFR); (2) to formally adopt a Safety Management Systems (SMS) approach as the foundation of the Safety Program; (3) to establish substantive and procedural rules for FTA's administration of the Safety Program; and (4) to describe the contents of a National Public Transportation Safety Plan (National Safety Plan or Plan).

    This final rule will add a new part 670, “Public Transportation Safety Program,” to title 49 of the CFR. In response to public comments, FTA has made a number of nonsubstantive, clarifying edits. In addition, FTA has made the following substantive changes:

    1. Amended section 670.23(b) to state that FTA may withhold not more than 25 percent of a recipient's Urbanized Area Formula funds.

    2. Amended section 670.27 to provide that the Deputy Administrator may issue special directives, with petitions for reconsideration going to the Administrator.

    3. Amended section 670.29 to remove language stating that FTA would consider whether a recipient has complied with an advisory when taking enforcement actions.

    D. Costs and Benefits

    This final rule establishes substantive and procedural rules for FTA's authority to inspect, investigate, audit, examine and test transit agencies' facilities, equipment, and records; direct or withhold Federal transit funds; and issue directives and advisories. The final rule does not impose additional costs on entities other than FTA. The costs to recipients associated with FTA's enforcement authorities are captured in the rulemakings for Public Transportation Agency Safety Plans, State Safety Oversight, and the Public Transportation Safety Certification Training Program. FTA received a number of comments on the cost assumptions in the NPRM, which are summarized in section III, below.

    II. Rulemaking Background

    On October 3, 2013, FTA introduced the transit industry to fundamental changes to the Federal transit safety program authorized by MAP-21 with a consolidated advance notice of proposed rulemaking (ANPRM). 78 FR 61251. FTA issued the ANPRM to provide the public with a better understanding of FTA's proposed approach to implementing the requirements for transit asset management and safety, and to obtain stakeholder input. Throughout the ANPRM, FTA expressed its intention to adopt a comprehensive approach to transit asset management and safety that would be scalable and flexible. In addition, the ANPRM highlighted the inherent linkages between asset condition (state of good repair) and safety performance through the explanation of FTA's anticipated proposal to adopt the principles and methods of SMS as the foundation for the development, implementation, oversight and enforcement of the Safety Program.

    In the August 2015 NPRM, FTA proposed a series of specific substantive and procedural rules for FTA's administration of the Safety Program. FTA took the public comments on both the ANPRM and NPRM into consideration in developing today's final rule.

    III. Summary of NPRM Comments and FTA's Responses

    FTA received comments from 118 entities, including transit agencies, trade associations, state and local governments, and private citizens. Some comments were outside the scope of this rulemaking, and some pertained to other safety rulemakings. For example, many commenters expressed support for MAP-21's safety objectives, but indicated that FTA appeared to be using language to implement SMS principles that would be more appropriate for the rail transit industry or that do not translate easily to the bus industry. To the extent these comments concerned the applicability of FTA's authority to specific types of transit agencies, please see the below discussion on “Purpose and Applicability.” To the extent these comments concerned the scalability of SMS, we believe they are more appropriately handled in the final rule concerning the Public Transportation Agency Safety Plans, which FTA plans to issue in the coming months. In general, this document does not respond to those comments that were not related to the substance of today's rulemaking; however, to assist with understanding the intent of today's rule, FTA does address some comments that are related to other safety rulemakings. Following are summaries of the comments received and FTA's responses.

    A. General Comments Comments: Costs and Benefits

    A number of commenters stated that the rule would have moderate to significant direct cost implications and economic impacts, due to its detailed implementation requirements, including nationwide SMS implementation. Some commenters were concerned that the proposed rule would impose costs and administrative burdens on States and transit agencies. Some commenters suggested that the NPRM would be an “unfunded mandate” because FTA did not identify any specially designated funding that could be used by recipients towards complying with the rule. Some commenters stated that FTA had not properly accounted for the costs to recipients, including State Safety Oversight Agencies (SSOAs), to implement the other rulemakings required under 49 U.S.C. 5329. Some commenters indicated that it is difficult to evaluate and quantify the costs of implementing each component of the Safety Program rule until FTA issues all of the final rules on safety.

    Several commenters requested that FTA cite the research study that provided the data and analysis supporting its assumption that the rule would not have a financial impact on the economy, States, and transit agencies. Some commenters noted that recipients would incur additional costs such as requiring more staff to implement SMS and comply with FTA's safety rulemakings. Other commenters suggested that recipients would incur costs when responding to FTA enforcement actions.

    FTA Response: Costs and Benefits

    FTA has considered the comments and continues to find that this rule does not impose specific costs to recipients. Rather, this final rule establishes substantive and procedural rules to support FTA's own administration of the Safety Program. The final rule does not require recipients to take any specific action. Specific requirements for recipients, such as implementing SMS, have been outlined by FTA in the proposed and final rulemakings (as applicable) for Public Transportation Agency Safety Plans, the State Safety Oversight Program, and the Public Transportation Safety Certification Training Program. The cost projections, underlying assumptions, and research for each requirement are included in the cost benefit analysis section for each of those rulemakings.

    Comments: Funding

    A few commenters stated that adequate funding should be set aside, authorized, and appropriated by Congress prior to implementation of this rulemaking. Further, a few commenters indicated that funding to implement the Safety Program (including reporting requirements) should not come from existing operating and capital improvement grant funds, but rather from new and additional grant funds set aside by FTA. One commenter suggested that FTA create a special category of funding that local agencies could use to pay for the costs to mitigate risks associated with safety inspection findings. One commenter suggested that FTA designate special funding for hazard mitigation.

    Some commenters noted that FTA should be aware of existing and increasing funding shortfalls already faced by many recipients, including forced service cuts, fare increases and layoffs. Commenters noted that the expected cost implications would create significant issues with their prioritization of funding.

    Several commenters recommended that FTA work to secure the necessary funding at the Federal, State, and local level and that each State be allowed to distribute the funds. One commenter stated that FTA should examine the process by which other U.S. Department of Transportation agencies secure funding for their safety programs.

    FTA Response: Funding

    The Safety Program is a requirement of 49 U.S.C. 5329. Congress determines the level of funding for the Federal transit program. FTA recognizes the need for increased investments in transit at all levels of government, and recommends funding levels for the Federal transit programs through the annual congressional appropriations process.

    Comments: Tribal Consultation

    FTA received one comment related to Tribal consultation. The commenter indicated that the worthy goal of this rulemaking can only properly be realized in Indian Country following meaningful consultation with Tribal governments and technical discussions and collaboration with the Tribal Transportation Program Coordinating Committee. The commenter noted that most Tribal transit systems operate on a very small scale, and with severe financial and administrative limitations. The commenter stated that for these practical reasons, FTA has an obligation as a prudent policy maker to engage in a meaningful consultation with Tribal nations prior to developing regulations that will apply to Tribally-operated transit systems. The commenter stated that the represented Tribes do not agree with FTA's view that Tribal consultation requirements do not apply to this rule. The commenter recommended that FTA either clarify the scope of the rule so that it does not apply to Tribes or engage in formal Tribal consultation before issuing a final rule.

    FTA Response: Tribal Consultation

    FTA appreciates the comments from Tribal representatives. However, FTA disagrees that this rule will have “substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.” Executive Order 13175, November 6, 2000. This rule establishes substantive and procedural rules for FTA's administration of the Safety Program. As noted above, this regulation outlines FTA's authorities to conduct reviews, audits, investigations, examinations, inspections and testing, and to issue findings and directives which would require corrective actions by recipients. The rule does not impose specific requirements on Tribes or any other recipients. Therefore, FTA finds that the final rule does not impose substantial direct effects on one or more Indian Tribes and does not impose substantial direct compliance costs on Tribal governments.

    Although not required to under Executive Order 13175, FTA has engaged in active consultation with Tribes in the development of this final rule. In advance of publishing an NPRM, FTA sought comment from the transit industry on a wide range of topics pertaining to the new Public Transportation Safety Program provisions authorized by MAP-21 through an ANPRM. FTA asked specific questions about how FTA should apply the new safety requirements to recipients of the section 5311 Tribal Transit Formula Program and Tribal Transit Discretionary Program. Additionally, FTA continued to engage with the industry following the publication of the NPRM through subsequent outreach efforts, including a webinar for small, rural and Tribal transit providers, which was held on October 27, 2015. FTA also held a listening session at the National Rural Transit Assistance Program Annual Meeting, which historically has been well attended by Tribal representatives.

    Comments: Other

    One commenter suggested that the proposed rule would create federalism issues and asked FTA to explain why it did not believe that the rule would create federalism issues.

    FTA Response: Other

    Pursuant to Executive Order 13132, to the extent practicable and permitted by law, a Federal agency cannot promulgate two types of rules unless it meets certain conditions. The two types of rules are:

    1. Rules with Federalism Implications, substantial direct compliance costs on state and local governments, and not required by statute, and

    2. Rules with Federalism Implications and that preempt state or local law.

    Federalism Implications are defined as having substantial direct effects on States or local governments (individually or collectively), on the relationship between the National government and the States, or on the distribution of power and responsibilities among the various levels of government. FTA does not believe that this rule has substantial direct effects on States or local governments or the distribution of power and responsibilities among the various levels of government. Further, this rule does not preempt State or local law. This rule merely restates FTA's statutory authority to administer the Safety Program and provides processes to support FTA's administration of the Safety Program.

    B. Section by Section Comments Subpart A General Provisions 670.1 Purpose and Applicability

    This section proposed that the purpose of the regulations would be to establish a Public Transportation Safety Program, and that the part would apply to all recipients of Federal transit funds.

    Comments: Purpose and Applicability

    Several commenters requested clarification regarding the applicability of the proposed rule. One commenter asked for clarification regarding the statutory authority that was referenced in the proposed purpose and applicability section.

    One commenter stated that the proposed rule could be read to apply to Tribes that are direct recipients and to Tribes that are subrecipients of a State. Some commenters suggested that the rule should not apply to commuter rail operators that are subject to Federal Railroad Administration (FRA) regulations and recommended that FTA amend subpart D to clearly exclude commuter railroads. A few commenters queried whether the proposed rule would apply to bus operations. Two commenters asked if SSOAs would be considered recipients within the scope of this rule. One commenter suggested that FTA clarify whether the proposed rule would apply to third party contractors.

    Some commenters indicated that the rule should allow flexibility for a State recipient to determine whether the rules should apply to subrecipients. One commenter asserted that Section 5329 allows FTA to adopt a different approach for the Enhanced Mobility of Seniors and Individuals with Disabilities Formula Program authorized at 49 U.S.C. 5310 (Section 5310) because Section 5329 specifically references the Rural Area Formula Program, 49 U.S.C. 5311, and the Urbanized Area Formula Program, 49 U.S.C. 5307, but makes no reference to Section 5310 grantees. The commenter recommended that FTA add language under section 670.1 to state that the part would not apply to public transportation systems that only receive Section 5310 funds. The commenter also recommended that FTA allow direct recipients under the Section 5310 program to lay out their approach to safety for their subrecipients in the State or Program Management Plan required under the Section 5310 program circular (C 9070 1G).

    FTA Response: Purpose and Applicability

    With the enactment of MAP-21, Congress directed FTA to develop a Public Transportation Safety Program for all recipients of Federal financial assistance under 49 U.S.C. chapter 53. Section 5329(a) of Title 49 of the United States Code specifically defines recipient as a “State or local governmental authority, or any other operator of a public transportation system.” Accordingly, this final rule applies to recipients of Federal financial assistance under 49 U.S.C. chapter 53, regardless of mode, including recipients of funding under 49 U.S.C. 5310 that provide public transportation, States, SSOAs, and Tribes. The rule applies to contractors who function in the capacity of the defined recipients; however, a recipient ultimately is responsible for ensuring its contractors are in compliance with the Safety Program.

    FTA recognizes that some recipients, such as commuter rail operators, are subject to the safety regulatory requirements of other Federal agencies. Accordingly, a chapter 53 recipient that operates commuter rail, light rail, and a bus system will continue to have its commuter rail operations governed by the FRA, but its light rail and bus operations will be governed by 49 U.S.C. 5329 and FTA's safety regulations.

    FTA has amended this section in the final rule to align with the definition of “recipient” at 49 U.S.C. 5329(a) and to clarify that the rule establishes substantive and procedural rules for FTA's administration of the Safety Program.

    670.3 Policy

    This section proposed the formal adoption of Safety Management Systems (SMS) as the basis for enhancing the safety of public transportation in the United States.

    Comments: Policy: Safety Management Systems

    A number of commenters indicated support for FTA's adoption of SMS principles and methods as the basis for the Safety Program. Other commenters were critical of SMS being FTA's sole approach to implementing the Safety Program. Some commenters stated that FTA's approach is focused on urban rail transit systems. These commenters noted that FTA should provide alternative methods for implementing the Safety Program that are consistent with SMS concepts, but are more applicable to smaller bus systems.

    Several commenters suggested that FTA adopt an approach that is simple to understand and easy to implement. One commenter expressed confidence that an SMS approach would result in improved and uniform safety standards across the country, but suggested that without further clarification from FTA, the proposed rule could unduly burden smaller public transportation systems by subjecting them to currently unknown facets of SMS that are only necessary or, in practice, applicable to the largest public transportation systems.

    FTA RESPONSE: Policy: Safety Management System

    FTA understands those commenters that expressed concern over FTA's proposed adoption of SMS as the basis for the Safety Program. To clarify, the NPRM did not propose, nor does this final rule require a recipient to adopt SMS. On February 5, 2016, FTA issued a proposed rule for Public Transportation Agency Safety Plans that would require each recipient to develop an agency safety plan based on SMS (See 81 FR 6344-71). The preamble to that rule describes SMS as a scalable and flexible approach that can apply across the transit industry. The comment period for the Public Transportation Agency Safety Plan closed on April 5, 2016. FTA is reviewing the public comments and anticipates publishing a final rule this calendar year.

    FTA disagrees with those commenters who suggest that SMS is not a practical approach for the Nation's diverse transit industry. FTA is taking a risk-based, proactive approach to implementation of the Public Transportation Safety Program. Specifically, the SMS pillars of safety risk management and safety assurance are designed to assist in identifying in advance where potential safety risks reside, and developing and implementing mitigations (rules, directives, guidance, best practices) that would prevent the likelihood and minimize the severity of the risk. FTA is committed to developing, implementing, and consistently improving strategies and processes to ensure that transit achieves the highest practicable level of safety. SMS is FTA's approach to achieving this goal by building a 21st-century safety regime that is flexible, scalable, and responsive to emerging safety issues.

    FTA has revised this section in the final rule to clarify that the policy statement specifically applies to actions undertaken by FTA.

    670.5 Definitions

    This section included proposed definitions for terms used in the NPRM.

    Comments: Definitions

    Commenters generally were concerned that any words or language intended to describe an event or circumstance that would trigger an enforcement action under the proposed rule must be defined clearly and concisely so that all affected recipients are treated equally. Some commenters felt that if the terms were left to the discretion and interpretation of the investigator or FTA representative handling the issue, there would be the potential for an uneven application of the regulation across recipients and subrecipients. In light of this concern, a number of commenters suggested that FTA clarify some of the proposed definitions, including, specifically, Accountable Executive; pattern or practice; audit; examination; inspection; investigation; corrective action plan; advisory; National Public Transportation Safety Plan; recipient; and testing.

    In general, FTA appreciates the concerns regarding some of the proposed definitions, and the requests for additional definitions. As appropriate, FTA has incorporated into this rulemaking definitions that appear in other Section 5329 rulemakings, including the definition of hazard. FTA made changes to the following definitions to clarify their meaning: Advisory; audit; corrective action plan; directive; examination; inspection; pattern or practice; and State Safety Oversight Agency.

    “Accountable Executive”

    Several commenters asked whether an “Accountable Executive” would be an agency CEO or general manager. Some commenters also asked for clarification on the qualifications required to fulfill this role, stating that incumbents with this responsibility should possess comparable levels of competence, experience and authority to ensure consistency across the industry. One commenter requested that FTA revised the definition to state that a State Department of Transportation (State DOT), by virtue of providing funds, advice, or administrative planning or support to a subrecipient agency, is not an Accountable Executive with respect to that agency. Finally, one commenter asked FTA to define “Transit Asset Management Plan,” which appears without elaboration in the definition of Accountable Executive.

    FTA RESPONSE: FTA has aligned the definition of “Accountable Executive” with the definition established in the final State Safety Oversight rule, now codified at 49 CFR part 674. FTA believes the definition is both broad and specific enough to allow the intended local safety oversight responsibility to function effectively while also allowing for flexibility to scale to the needs of various recipients and their systems. Notably, a State DOT would not be an Accountable Executive; however, there may be situations in which an employee of a State DOT is an Accountable Executive, as when the State DOT provides public transportation service. FTA declines to establish minimum qualifications for Accountable Executives, as the level of experience and authority required may vary from agency to agency. The term “Transit Asset Management Plan” which appears within the definition of “Accountable Executive” is not defined in this rule because it is defined in FTA's recently issued Transit Asset Management rule. (See 81 FR 48890, July 26, 2016.) FTA believes the definition for “National Public Transportation Safety Plan” is sufficient given the additional description of the Plan in section 670.31.

    “Pattern or practice” and “Finding”

    A number of commenters were concerned that the definition of “pattern or practice” is unclear, and does not explicitly define what constitutes a “finding.” In particular, commenters were concerned with the lack of specificity on what minimal and maximal time span between findings would constitute a pattern; whether findings would be limited to only violations found during one investigation or over multiple investigations; and whether findings must be related or be of some specific but undefined level of severity. Commenters suggested that “finding” should be included as a defined term, to clarify how the results of inspections, investigations, audits, examinations and testing relate to “findings” and whether the conclusions from inspections, investigations, audits, examinations and testing constitute “findings” or if a “finding” is something pursuant to a more specific process or particular procedure. Some commenters suggested that pattern or practice should be more explicitly defined as two or more events within a 12-month period. Finally, a few commenters stated that a pattern or practice should only apply to multiple findings with the same operator and not across multiple operators in an overall public transit system.

    FTA RESPONSE: FTA has chosen not to make substantive changes to the proposed definition of “pattern or practice.” A narrow definition of this term would limit FTA's ability to administer its safety oversight responsibilities. Moreover, a pattern or practice triggering an enforcement action will differ from one recipient to the next, and will depend, in part, on a recipient's mode of operation, the size and complexity of the recipient's operations, and the recipient's unique operating environment. This same rationale applies to many other definitions FTA is leaving unchanged. Finally, terms such as “finding” that are not defined by statute or regulation will be interpreted in accordance with the definition set forth in dictionaries of common usage.

    “Examination,” “Inspection,” “Audit” and “Investigation”

    Several commenters stated the differences between the definitions of “examination,” “inspection,” “audit” and “investigation” were minor and not well-defined, particularly the differences between examination and inspection. Some questioned why an inspection might lead to a finding of a pattern or practice of safety violations, but examinations and audits would not. One commenter suggested deleting “examination” since it was very similar to “inspection.”

    FTA RESPONSE: In response to concerns over the lack of obvious distinctions between the definitions of examinations, inspections, audits and investigations, FTA has revised the definition of “inspection” in the final rule to elaborate on the activities and distinguishing characteristics of an inspection versus an “examination.” Specifically, the final rule clarifies that an inspection is a physical act of observation whereas an examination is a process. Each of these functions—investigations, inspections, audits, and examinations—are authorized by 49 U.S.C. 5329(g), and each is a separate but integral part of the overall mechanism and process for collecting relevant information for purposes of safety oversight. FTA has chosen not to define the phrase “reasonable time and manner” as it applies to this information collection process, as a narrow definition of this term would impede FTA's ability to effectively carry out its congressionally mandated safety oversight role.

    “Unsafe Condition or Practice” and “Safety Violation”

    With respect to the definition of “pattern or practice” and in general response to the proposed rule's sections on enforcement actions, several commenters asked FTA to define “unsafe condition or practice” and “safety violation.” Some also suggested adding the term “serious” or “serious safety violation” as a definition to clarify what constituted “serious” safety violations, and what the relative and actionable difference was between a “serious” safety violation and a safety violation that was not “serious.”

    FTA RESPONSE: FTA does not believe that it is appropriate to define “serious safety violation” through regulation. As previously mentioned, FTA's approach to the administration of the safety program is both scalable and flexible. A narrow definition of “serious safety violation” would impede FTA's ability to provide flexible oversight of the Safety Program. For example, a serious safety violation could include a violation of Federal transit safety law that leads to death or serious injury of a passenger or transit employee. A serious safety violation also could include a violation of Federal transit safety law that could lead to death or serious injury of a passenger or transit employee. Further, a serious safety violation could include a rail transit agency's failure to comply with a corrective action plan or a small bus operator's failure to develop and implement a transit agency safety plan, once the rule requiring such plans becomes final. FTA does not believe that the aforementioned examples, however, encompass the full scope of what FTA could consider a serious safety violation, and therefore does not agree that it should define the term in this rule.

    “Recipient”

    Some commenters stated that although the definition of “recipient” implies inclusion of SSOAs as recipients of Chapter 53 funding, the description of actual affected entities throughout the NPRM suggested that it applied to public transit agencies and not SSOAs. Those commenters asked for clarification on whether SSOAs were implicitly included in the definition. Those commenters further stated that if FTA intended to include SSOAs, there would be a disincentive for SSOAs to participate in the formula grant program, and recommended that FTA explicitly exclude SSOAs from the definition of “recipient.”

    FTA RESPONSE: In response to comments, FTA has revised the definition of “recipient” to align with the statutory definition of that term at 49 U.S.C. 5329(a). We have also clarified that the term “recipient” includes State Safety Oversight Agencies.

    “More Frequent Oversight”

    A few commenters asked FTA to define what it meant by “more frequent oversight” as part of the suite of enforcement actions that FTA could initiate under section 670.21.

    FTA RESPONSE: FTA does not agree that it should provide a definition for the term “more frequent oversight.” The frequency of enhanced oversight of a recipient by FTA will vary on a case-by-case basis.

    “Reportable Incident” and “Occurrence”

    One commenter asked if the definitions from FTA's SSO rule, codified at 49 CFR 674, of “reportable incident” and “occurrence” would be incorporated into the current proposed rule.

    FTA RESPONSE: Definitions for “reportable incident” and “occurrence” were not included in the NPRM, and therefore, will not be included in this final rule.

    “Corrective Action Plan”

    A few commenters asked FTA to enhance the existing “corrective action plan” definition to capture the broader processes or mechanisms associated with the ongoing management of corrective action plans by recipients and oversight agencies.

    FTA RESPONSE: FTA has revised the definition of “corrective action plan” to align with the definition of that term in the final rule for State Safety Oversight at 49 CFR part 674.

    Other Terms

    One commenter asked for definitions of the following individual terms: “hazard”; “assessment”; “evaluation”; “light rail” and “heavy rail”; “enforcement”; “employee accident and injury”; and “near miss”. Commenters also suggested that FTA define the following additional terms: analysis; safety deficiency; noncompliance; public transportation system; and state of good repair.

    FTA RESPONSE: FTA is not including definitions for the following terms that were not included in the NPRM proposals: “light rail,” “heavy rail,” “employee accident and injury,” and “near miss.” The following terms are not defined in this rule, statute or regulation and will be interpreted in accordance with the definition set forth in dictionaries of common usage: “assessment”; “evaluation”;” analysis”; and “noncompliance.”

    FTA does not agree that it needs to define the term “public transportation system.” FTA believes that it is clear that the term means a transit system operated by a recipient of funds under 49 U.S.C. chapter 53 and “recipient” is a defined term under the rule.

    FTA does not agree that it should define the term “safety deficiency.” What amounts to a “safety deficiency” will vary on a case-by-case basis.

    As required by 49 U.S.C. 5326(b)(1), FTA has defined the term “state of good repair” in the Transit Asset Management final rule, which was published on July 26, 2016. (81 FR 48889).

    Subpart B—Compliance Assessments

    In this final rule, FTA has changed the heading of this subpart from “Compliance Assessments” to “Inspections, Investigations, Audits, Examinations and Testing” to better describe the subject matter of this subpart.

    670.11 General

    In this final rule, FTA has changed the title of this section from “Inspections, Investigations, Audits, Examinations and Testing” to “General.” In the NPRM, this section set forth FTA's statutory authority to conduct inspections, investigations, audits, examinations and testing. In the NPRM, FTA asked how it should define “reasonable time and manner” for entering into and inspecting a recipient's equipment, facilities, rolling stock, operations, and relevant records.

    Comments: General

    With respect to “reasonable time,” commenters suggested: (1) At least forty-eight hours; (2) twenty-four hours; (3) a few days (4); five days; (5) thirty days; and (6) sixty days. A few commenters also recommended that FTA adopt the investigation processes currently used by other Federal agencies. A few commenters indicated the need for more clarity and requested that FTA propose specific language to define the terms “reasonable time” and “reasonable manner.” One commenter requested clarity regarding “written notice” as it is used in section 670.11(b). Another commenter asked what would trigger an inspection: passage of time; a particular incident; or an industry-wide issue. The commenter stated that uncertainties would lead to confusion about what is expected as transit agencies seek to accommodate FTA's efforts and requirements. Another commenter requested that FTA define the SSOA's role and responsibilities when FTA takes enforcement actions.

    One commenter stated that FTA should clarify whether it has the authority to enter a transit property even without the consent of the recipient. The commenter noted that even with written notification, a recipient may object to external auditors entering its property for various reasons, including insufficient training (such as roadway worker protection) and administrative issues, such as schedule conflicts. Other commenters requested that FTA clarify the following: (1) Whether its representatives must be escorted by authorized transit agency representatives while on the property for the purposes of conducting an audit or inspection; and (2) whether FTA representatives must receive agency-required safety training (such as roadway worker protection) in order to enter a rail right-of-way. Several commenters noted that FTA should require its representatives to follow all of a recipient's applicable safety rules and procedures during the course of conducting an audit or inspection.

    Regarding the process for providing notice, some commenters stated that FTA should provide advance written notice to a recipient stating the purpose for the inspection. Several commenters noted that the written notice should reference the specific information that FTA would be seeking. A few commenters recommended that FTA also provide notice to an SSOA prior to inspecting a rail transit agency. Many commenters suggested that the written notice should be directed to a recipient's general manager, chief executive officer, or other Accountable Executive, with a copy provided to the SSOA. A few commenters stated that notification should include an official letter emailed to the Accountable Executive or their designated point of contact and a phone call. Several commenters suggested that FTA require some form of delivery/read receipt to confirm a recipient's receipt of the notification.

    One commenter recommended that FTA work cooperatively and collaboratively with a recipient to establish an agenda for the site visit. Other commenters acknowledged that emergency situations would eliminate the need for notification. Two commenters noted that there should be limits on the number of times FTA can audit a transit agency unless there are significant safety findings during an audit or investigation. One commenter indicated support for unannounced FTA inspections, testing, and records reviews, but noted that the Federal process should not prevent the transit agency from providing its routine transit service safely, nor put any of the FTA, SSOA, transit agency personnel, or members of the public at risk during the process.

    Some commenters recommended that Federal personnel should receive the recipient's approved track safety training prior to conducting activities within a recipient's transit system. One commenter stated that Federal personnel should provide a recipient with details of their safety training and certification.

    One commenter stated that a final rule explicitly should allow host agencies to determine reasonable and safe options for granting an FTA request to inspect or test equipment, or to enter restricted or otherwise potentially hazardous areas. Additionally, the commenter suggested that a final rule should allow the host agency's lead representative to call an emergency “stop” to activities, at his or her discretion, for fire-life-safety reasons, if unsafe behavior is observed that could potentially place a person in danger, or if required personal protective equipment is not worn or not used appropriately.

    Commenters requested additional details regarding how, why and when FTA would enter a public transportation system to conduct a safety inspection. Commenters also requested that FTA define its role, responsibilities and authority in the testing and inspection of a public transportation system's equipment, facilities, rolling stock and operations.

    A number of commenters questioned how FTA and SSOAs would coordinate activities with a rail transit agency when FTA exercises its authority under the section. Some commenters recommended that FTA develop program standards for conducting activities under the section and submit them for public comment. Several commenters also noted that the proposed regulatory text did not include notification to the State when FTA would notify a recipient of its intent to exercise authority under the section. A few other commenters recommended that FTA focus its oversight on rail safety, asserting that bus-only systems are already safe.

    One commenter asked how FTA's inspections, oversight, safety standards, or directives would complement, supplement, or possibly conflict with those of SSOAs. The commenter recommended that FTA clarify the nature of coordination, if any, between FTA and an SSOA. The commenter also suggested that FTA's authority to conduct random safety inspections at any time without notice or coordination with a rail transit agency could consequently divert critical staff resources away from operations or maintenance activities or interfere with the smooth functioning of daily transit operations.

    Commenters also asked whether FTA would delegate its authority to carry out this section to an SSOA. Similarly, a commenter stated that since SSOAs and FTA are safety oversight partners, there should be a mechanism for FTA to work with an SSOA and factor SSOA findings into any FTA enforcement action. The commenter recommended that there should be a detailed process for monitoring corrective actions between FTA and SSOAs.

    FTA also received comments regarding how this section aligned with FTA's available online SMS Awareness training. One commenter noted, and asked for an explanation of, an apparent discrepancy between FTA's SMS Awareness training, which specifically says that investigations are not a function of SMS, and the NPRM, which indicates that the inspections, investigations, audits, examinations and testing are directly a part of an SMS approach.

    Several commenters noted that the SMS reviews and audits should be part of the triennial or state management reviews, unless there has been an accident that the National Transportation Safety Board (NTSB) is investigating. These commenters recommended that FTA define the specific types of incidents or complaints that could result in an FTA audit or investigation. Another commenter suggested that FTA state the frequency it proposes to inspect, audit or perform a “compliance assessment” of each property. This commenter also recommended that for efficiency purposes, FTA's inspection cycle should correspond with the SSOA triennial reviews of local rail transit operators. Commenters stated that if a property is undertaking a robust SMS, then the FTA assessment cycle should be longer. For clarity, commenters recommended that FTA include language which describes the new compliance assessments contemplated by this rulemaking, and describes how they will correspond with existing oversight programs and grant management procedures.

    With regard to proposed section 670.11(b), commenters queried whether the prescription of “recordkeeping and reporting requirements” was meant to apply solely to the production of documents for the purposes of the inspection or audit at hand, or if FTA would be able to direct agency-wide recordkeeping and reporting practices at any time.

    FTA Response: General

    FTA appreciates those commenters who responded to our request for comment on how “reasonable time” and “reasonable manner” should be defined for the purpose of FTA entering into and inspecting equipment, facilities, rolling stock, operations and relevant records. Upon consideration of the comments, FTA has decided not to define “reasonable time” or “reasonable manner” in regulatory text. FTA does not believe that narrowly defining “reasonable time and manner” would enable FTA to sufficiently oversee the safety of our Nation's transit systems. For instance, there are a number of scenarios that may require FTA to enter into and inspect a recipient's property with minimal notification.

    Accordingly, under the final rule, the Administrator has discretion in determining what amounts to a reasonable time and manner, on a case-by-case basis. FTA believes it should have flexibility with regard to how it will notify a recipient. Thus, the medium utilized to convey notice should not be limited by regulatory text. FTA will use reasonable means of communication to include telephonic and electronic media. FTA will work with transit systems and appropriate State entities to ensure that adequate notice is provided so that Federal personnel do not unduly impede operations.

    FTA does not agree with those commenters who indicated that a host agency should be able to place limitations on FTA's exercise of its statutory authority when conducting compliance activities associated with this rule. Further, FTA does not agree with commenters who suggested that it should prescribe through regulation how and when it would conduct safety inspections, investigations, audits, examinations and testing. FTA's actions will be based on consideration of particular sets of facts. FTA does not believe that limiting the scope of the actions it has the authority to take via rulemaking contributes to improving public transportation safety. Relatedly, FTA does not believe it is appropriate to define through regulation its role, responsibilities, and authority in the inspecting, investigating, auditing, examining, and testing of a public transportation system's equipment, facilities, rolling stock and operation, as each activity may require flexibility on behalf of FTA and the recipient.

    FTA agrees with those commenters who suggested that FTA and its designees comply with a recipient's safety and training protocols and requirements. FTA will coordinate with recipients to ensure its activities are carried out in a safe manner. In addition, when FTA conducts safety activities at a rail transit agency, FTA will coordinate with the relevant SSOA as necessary and to the extent practicable. However, it may not always be feasible for an FTA representative to undergo agency-specific training or verify his or her training to a recipient before conducting safety activities on behalf of FTA under this rule.

    In general, FTA disagrees with those commenters who suggested that FTA provide more prescriptive processes. FTA believes that a certain level of flexibility is necessary in order for the agency to effectively administer the Safety Program. For example, FTA does not believe that it should be limited to only engaging in activities under this section upon the consent of a recipient. To do so would be unreasonable, considering there will likely be occasions when inspections and investigations are required when FTA becomes aware of an accident. In addition, FTA does not agree with commenters who suggested that FTA formally establish a schedule for conducting activities under this section or that FTA align its activities under this section with existing audit processes. FTA may establish a formal schedule for conducting activities under this section in the future, but a schedule is not appropriate for this rule.

    In exercising its enhanced statutory authority for safety oversight, FTA recognizes the critical role of State and local safety oversight partners. To that end, FTA will work with SSOA and transit system personnel to accommodate operational and staffing challenges that may occur as it exercises its authority. However, FTA does not agree that it should delegate its authority to the SSOAs. In response to the comment regarding SMS Awareness training, FTA notes that implementation of SMS principles in no way contradicts or conflicts with its authority to engage in inspections, investigations, or other regulatory compliance processes.

    One commenter asked whether the proposed provision to impose more frequent reporting requirements applied to documents requested for purposes of an audit or inspection, or if FTA would be able to direct agency-wide recordkeeping and reporting practices at any time. As proposed, FTA could impose more frequent reporting requirements that would not necessarily be tied to an audit or inspection. FTA maintained this provision in the final rule without substantive change.

    FTA made a few nonsubstantive, clarifying edits to this section in the final rule. In addition, FTA eliminated the 30-day response timeframe for document requests because there may be instances where FTA needs requested information more quickly. Also, as stated above, FTA refined the notice provision in this section to provide that the Administrator will decide on a case-by-case basis what “reasonable time and manner” would be for FTA to enter into and inspect or test equipment, facilities, rolling stock, operations, and relevant records.

    670.13 Request for Confidential Treatment of Records

    This section proposed procedures for a recipient to request confidential treatment of any record filed with or otherwise provided to FTA in connection with its administration of the Safety Program.

    Comments: Request for Confidential Treatment of Records

    Many commenters questioned the authority by which FTA would be able to protect information it received from recipients from public disclosure. Commenters asked how FTA would ensure the integrity of confidential information during all phases of the reporting and information retention process. A few commenters stated that the proposed regulatory text was insufficient to provide automatic blanket protection for any information pertaining to public safety or that is safety-critical or safety-sensitive. Several commenters stated that FTA's proposed confidentiality clause would add nothing to existing law, and only narrow the exemption window through overly technical requirements which would allow automatic full disclosure of potentially security sensitive information if a transit agency accidentally neglects to submit the correct format.

    A few commenters suggested that FTA clarify that the Freedom of Information Act (FOIA) exemptions apply to all recipients, whether or not they are subject to FOIA. One commenter further noted FTA should explicitly recognize confidentiality provisions under other FOIA-like policies that are adopted by transit agencies. However, a number of commenters asserted that State law could overrule Federal confidentiality protection, and that the language of the proposed rule was not sufficient to prevent documents from being discovered in a civil action or being disclosed in response to a public records request at the State level. Commenters suggested that FTA should recognize that States are unable to afford transit agencies this protection, even if FTA determines a record is confidential. The commenters recommended that FTA provide protection for any sensitive or confidential information, and ensure that Federal confidentiality supersedes any State disclosure requirements.

    Another commenter asked that FTA describe the objective process FTA would use to determine if records are subject to public disclosure. One commenter was concerned that a recipient may use the provision to report directly to FTA and bypass and withhold information from its SSOA, which is obligated (as a State/local agency) under State law to disclose any investigative reports or safety information.

    A few commenters expressed concern that FTA proposed to reserve the right to make its own final determination of whether a confidentiality request would be granted. Commenters asked for clarification on the circumstances under which FTA would not keep records confidential, as requested. The commenters also stated such authority to make final determinations would overrule existing State laws and authorities, as well as Sensitive Security Information (SSI) guidelines.

    One large transit agency commented that 18 U.S.C. 1905 applies only to Federal employees or Federal agencies, and not to transit agencies since they are not Federal entities. The commenter suggested that this section should therefore include clarification that the disclosure provisions of 18 U.S.C. 1905 will apply to transit agencies that submit records pursuant to a request for confidentiality, even though they are not Federal entities. Another commenter stated that since an agency is required to submit any record for which it is seeking confidential status, the act of that submittal destroys or constitutes a waiver of a transit agency's right to confidentiality of records for which it claims attorney-client or work product privilege. The commenter suggested that a transit agency could instead provide pertinent information regarding date, time, location and a brief explanation of the basis for asserting attorney-client or work product privilege.

    Several commenters suggested that FTA allow a transit agency 30 working days to evaluate and respond to a decision by the Administrator to deny a confidentiality request. Commenters recommended that a final rule provide a reasonable appeal mechanism for transit agencies that disagree with the Administrator's decision to release records. Other commenters recommended that the minimum amount of time given to an agency to respond to an FTA denial of confidential treatment should be changed to at least 10 days, due to the harm that such release could cause.

    FTA Response: Request for Confidential Treatment of Records

    To clarify, the proposed confidentiality provision was not intended to protect information from public disclosure. The provision was intended to provide recipients with the opportunity to alert FTA of the alleged confidentiality of a requested record. Unlike other Federal safety regulatory agencies, FTA does not have statutory authority to protect safety-related information. However, under the State Safety Oversight (SSO) rules at 49 CFR 674.27(a)(7), an SSOA's program standard must include procedures for protecting the confidentiality of investigation reports.

    Documents submitted to FTA are subject to FOIA and are generally releasable to the public upon request. FTA may maintain the confidentiality of accident investigations, incident reports, and other safety-related information to the maximum extent permitted under Federal law, including the nine exemptions under FOIA. FTA will evaluate whether or not a document may be withheld from public disclosure under the Department of Transportation's FOIA rules at 49 CFR part 7.

    FTA agrees that its confidential treatment of information would not preempt State law; therefore, recipients should exercise their use of this provision accordingly.

    FTA made nonsubstantive, clarifying edits to this section in the final rule.

    Subpart C Enforcement 670.21 General

    This section of the NPRM set forth the Administrator's enforcement authorities under 49 U.S.C. 5329.

    In general, FTA's responses to comments received on this section are addressed in other sections throughout the preamble. For example, comments related to reporting requirements are addressed in the response to comments under section 670.11, above. Responses to comments related to withholding of funds immediately follow this section, below.

    FTA has made two changes to this section as a result of FAST Act amendments made to 49 U.S.C. 5329. First, FTA revised section 670.21(e) to limit withholding of a recipient's 49 U.S.C. 5307 funds to no more than twenty-five (25) percent. Second, FTA added a new section 670.21(g) to explicitly incorporate into this rule FTA's authority to issue restrictions and prohibitions on a recipient's operations, if through testing, inspection, investigation, audit or research the Administrator determines that an unsafe condition or practice, or a combination of unsafe conditions and practices, exist such that there is a substantial risk of death or personal injury. The language in the rule is identical to the language in the statute. Further, the proposed rule included the authority for FTA to issue special directives in the event an unsafe practice or condition caused an emergency situation involving a hazard of death, personal injury, damage to property or equipment, or significant harm to the environment. The authority under new section 670.21(g) may be considered a specific type of special directive, applicable in certain circumstances, and thus is materially related to FTA's proposal to issue special directives. Moreover, FTA finds good cause to include reference to its authority to issue restrictions and prohibitions in the final rule. In the NPRM, section 670.21(a)-(f) included a list of the authorities provided to FTA by Congress in MAP-21 to carry out the Safety Program. In this final rule, FTA has added a new subsection 670.21(g) which merely adds to the list of authorities provided to FTA under MAP-21, to reflect the authority to issue restrictions and prohibitions that was added under the FAST Act. Accordingly, FTA has “good cause” under the Administrative Procedure Act (5 U.S.C. 553(b)) to finalize these provisions at this time because additional public comment is “unnecessary” as the rule merely restates the statutory provision.

    670.23 Use or Withholding of Funds

    This section proposed procedures for FTA to direct the use of Chapter 53 funds where safety deficiencies are identified by the Administrator or an SSOA. This section also proposed procedures for withholding of Chapter 53 funds from a recipient or State for non-compliance, where the Administrator determines that there has been a pattern or practice of serious violations of the Safety Program or any regulation or directive issued under those laws for which the Administrator exercises enforcement authority for safety.

    Comments: Use or Withholding of Funds

    Many commenters expressed concern about the potential loss of Federal funding as a result of safety violations, as many safety violations may be due to preexisting and chronic underinvestment, with any loss of funding resulting in a worsening of transit agencies' financial situations and greater safety deficiencies. In addition, several commenters stated that the connection between States, SSOAs and transit agencies was unclear, and that the NPRM did not explain how a State would be held responsible for a safety deficiency at a transit agency. These commenters asked that the rule clarify what is meant by a State, and to clearly differentiate how the notification, appeal, and withholding actions and procedures would affect the various entities.

    One commenter stated that SSOAs should not be subject to this section because, although the definition of “recipient” in section 670.5 implies inclusion of SSOAs, the description of actual affected entities throughout the NPRM instead suggests only public transit agencies. The commenter suggested that SSOA funding be excluded from the definition of “recipient” under section 670.5.

    Several commenters expressed concern that funding could be withheld from the entire State or SSOA, due to the action (or inaction) of a single subrecipient, thus penalizing all the subrecipients in the State. The commenters asked that FTA add language to section 670.23 to either explain the rationale and process for holding a State liable for the deficiencies of a particular transit agency, or add language which would limit enforcement actions to the particular subrecipient instead of the entire State. Similarly, one commenter stated that there should be a process to ensure that a rail transit agency in one State does not cause FTA to withhold chapter 53 funds from an SSOA or rail transit agency in another State.

    Several commenters stated that section 670.23(b)(3) only allows, but does not compel, FTA to consider a recipient's response to a notice of violation. Commenters suggested that FTA should have to consider a recipient's response to a notice of violation. These commenters also stated that this section did not adequately provide an opportunity for notice and comment. In addition, commenters stated that this section did not provide a sufficient process for a transit agency to appeal an erroneous notice of violation, which could result in a significant loss of funding. One commenter further stated that withholding of funds should be considered only after consultation with the SSOA and after a rail transit agency has been given ample opportunity to address the safety concern and respond to FTA. One commenter suggested that FTA should not withhold funding from a recipient who corrects an identified deficiency by implementing FTA's required remedial action and mitigates the deficiency within the 90 days following the initial notice of violation.

    Some commenters stated that because of the similarities between this section and section 670.27, special directives should be invoked as a remedy for program deficiencies before withholding funds, and that this sequence should be clearly required in the rule. Another commenter requested that section 670.23 be incorporated into section 670.27, due to its more developed appeal process, so that transit agencies would have more recourse in the case of an FTA decision to withhold funding.

    Several commenters asked what would happen if FTA failed to adhere to the established 30-day decision timeline under section 670.23(b)(3) and queried whether the violation would be automatically dismissed if the deadline passed or whether FTA would be subject to consequences for missing the deadlines. One commenter stated that an FTA decision to redirect or withhold funds amounts to an unfunded mandate.

    FTA Response: Use or Withholding of Funds

    FTA understands that many transit operators, especially smaller transit operators, have limited financial resources. However, FTA believes that the decision to withhold funds should be at the discretion of the FTA Administrator, in consideration of the nature and severity of the safety violation at issue. FTA may consult with an SSOA before withholding any funding or issuing a violation to a rail transit agency. However, FTA does not believe that it needs to prescribe such a process in regulatory text.

    FTA will not hold an SSOA directly accountable for a safety deficiency at a rail transit agency. However, FTA may hold an SSOA accountable for failing to adequately oversee a rail transit system. Accordingly, FTA does not believe that SSOAs should be excluded from this rule. FTA agrees that all subrecipients in a State should not be held accountable for one subrecipient's actions, and we have removed the word “State” from 670.23(c)(ii). FTA will not withhold funds from a rail transit agency because of a safety issue related to another rail transit agency.

    In the NPRM, FTA proposed a process for a recipient to respond to a notice of violation. FTA proposed to issue a response to the recipient within 30 days of its receipt of the recipient's response. FTA has changed “may” to “shall” to indicate the Administrator will consider a recipient's response. FTA intends to make a decision within 30 days of receiving a response from a recipient, but FTA will not automatically dismiss violations if it misses the deadline.

    FTA's enforcement tools under the Safety Program include directing the use of funds, withholding funds, and issuing directives. Intentionally, FTA did not define specific circumstances that would trigger FTA to take one action over another or prescribe specific timeframes that a recipient would need to comply with a special directive. An enforcement action that may be appropriate to address one recipient's safety issue may not be appropriate to address the same issue at another recipient's transit system. FTA's recipients range in diversity of mode, operating environment, sophistication, expertise and resources. FTA believes it is important to establish and implement the Safety Program in a manner that is both scalable and flexible. FTA does not agree that requiring that funding be redirected or withheld is an unfunded mandate.

    In the final rule, FTA has reorganized this section for clarity. In addition, FTA has revised this section to limit the amount that may be withheld to not more than 25% of section 5307 funds in accordance with 49 U.S.C. 5329(g).

    670.25 General Directives and 670.27 Special Directives

    In section 670.25, FTA proposed procedures for the issuance of a general directive by the Administrator. In section 670.27, FTA proposed procedures for the issuance of a special directive to one or more named recipients.

    Comments: General Directives and Special Directives

    FTA received a number of comments related to the proposed rule for general and special directives. Some commenters asked for clarifications on the proposed procedures for both types of directives. Some comments requested that FTA specify which directives require general manager and Board response, stipulate timelines for response due dates, and clarify the notice and appeal processes. One commenter stated that there was no process identified for FTA to notify a recipient in a timely way that its response to a directive is satisfactory, which could delay a recipient's implementation of a corrective action and put the transit system in a position of increased liability or undermine public confidence. One commenter noted that State and local agencies would need time to implement a general or special directive and recommended that FTA provide a time period for implementation.

    Several commenters noted that the processes for responding to or appealing the FTA Administrator's decisions under part 670 are inconsistent depending on whether it is a general directive, a special directive, or a withholding of funds. One commenter suggested that FTA devote one section solely to responding to or appealing the Administrator's decisions.

    A number of commenters noted that the rule did not define emergency situations that might give rise to the issuance of a general directive. Commenters suggested that FTA define “emergency situation.”

    Some commenters stated that FTA did not have the authority to take enforcement action because of a “significant harm to the environment.”

    One commenter requested that FTA provide specific details about the enforcement action that could be taken under each section. A commenter asked how FTA would identify the need for a general or special directive and how FTA would ensure that qualified persons were involved in the development of a directive.

    One commenter noted that under proposed section 670.27(d), a recipient would be required to “observe” a special directive during FTA's review of a petition for reconsideration. The commenter also noted that proposed section 670.27(f)(4) did not provide a timeframe from when FTA would make a decision to when a recipient would be notified of FTA's decision, during which time a recipient would still be required to “observe” the special directive. The commenter asked what “observe” meant and how FTA would enforce the provision if a recipient could not meet the requirements of a special directive.

    One commenter suggested that petitions for reconsideration should, at a minimum, be handled by the original authority, a peer, or a superior authority, instead of the FTA Chief Counsel, asserting that the Chief Counsel should not be placed in the position of appellate authority over his or her Administrator.

    FTA Response: General Directives and Special Directives

    Intentionally, FTA did not define specific circumstances that would trigger FTA to take one action over another or prescribe specific timeframes that a recipient would need to comply with either a general or special directive. As stated above, an enforcement action that may be appropriate to address one recipient's safety issue may not be appropriate to address the same issue at another recipient's transit system. FTA's recipients range in diversity of mode, operating environment, sophistication, expertise and resources. FTA believes that it is important to establish and implement the Safety Program in a manner that is both scalable and flexible.

    In section 670.25, FTA proposed to issue general directives that could apply to all recipients or a subset of recipients and that would be effective upon notice provided by the Administrator in the Federal Register. A general directive would be subject to a public comment period. Following the public notice and comment period, FTA would publish a response to the comments in the Federal Register. The Federal Register notice also would include a final iteration of the general directive.

    Upon further consideration, FTA has determined that general directives and the Federal Register process are not appropriate means with which to address an emergency situation. However, FTA believes that providing notice and an opportunity for comment through the Federal Register is an appropriate method of addressing safety issues that require mitigation, but need not be addressed immediately upon notice. Accordingly, under the final rule, FTA would not use a general directive to address an emergency situation.

    Special directives are the more appropriate tool to address emergency situations. In the NPRM, FTA proposed to issue a special directive to one or more named recipients to address a safety issue specific to the recipient's transit systems. A special directive would become effective upon direct notice from FTA to a recipient. FTA has retained the NPRM provisions related to when FTA would issue a special directive.

    FTA agrees with the commenter who suggested that FTA's Chief Counsel should not be placed in the position of appellate authority over the Administrator. Under this rule, the Deputy Administrator will issue special directives, and the Administrator will serve as the final appellate authority for special directives. Within 90 days of the receipt of a petition for reconsideration, the Administrator would either grant or deny a petition, in whole or in part, and provide notice to a recipient of his or her decision.

    Because FTA will issue special directives when it FTA finds a substantial risk of death or personal injury, or damage to property or equipment, a recipient will be required to “observe” the actions required under a special directive while its petition was being reviewed by the Administrator. Within this context, “observe” means that the recipient must implement the requirements under the special directive during the review period. FTA will provide guidance to a recipient on what specific steps need be taken to implement the requirements of the special directive during the review period.

    FTA agrees with commenters who suggested that FTA not take action under this rule to address a “significant harm to the environment.” FTA's primary goal under the Safety Program is to ensure the safety of passengers and transit workers. Readers should note, however, that FTA does have the authority to address environmental issues related to a public transportation system that have an impact on passenger or worker safety. FTA has revised the final rule to remove the language related to harm to the environment.

    670.29 Advisories

    This section described how the Administrator would issue advisories, which would recommend corrective actions to resolve or mitigate an unsafe condition.

    Comments: Advisories

    Several commenters noted that, as proposed, compliance by a recipient with an advisory would be discretionary. Commenters also noted that advisories issued by other Federal agencies are not discretionary and include required actions. Accordingly, a commenter suggested that FTA use “bulletin” instead of “advisory.”

    Commenters asked why FTA did not propose to submit an advisory to a public notice and comment process similar to what was proposed for a general directive. One commenter recommended that FTA establish a formal process for issuing advisories. Several commenters requested clarification on how an advisory would be issued and whether a recipient would have an opportunity to respond.

    There were a number of comments related to proposed section 670.29(b). In that section, FTA proposed that the Administrator could take a recipient's noncompliance with an advisory into consideration when deciding to take an enforcement action. One commenter noted that this section was inconsistent with SMS. The commenter noted that each agency would determine whether or not the hazard or risk referenced in the advisory was relevant, and if so, determine an appropriate strategy to reduce risk to an acceptable level, which could include an alternative mitigation than what was recommended in the advisory.

    Some commenters asked whether the subject matter of an advisory could lead to the issuance of a special directive. One commenter asked whether FTA planned to issue civil penalties against a recipient which did not comply with an advisory, and noted that other U.S. DOT administrations do not assess civil penalties under such circumstances.

    Several commenters sought clarification on the difference between an advisory and a directive. One commenter suggested that FTA strike the section on advisories because FTA should address unsafe conditions with a general directive.

    FTA Response: Advisories

    In the NPRM, FTA proposed that advisories would include recommended actions. Directives require a recipient to take mandatory action to mitigate a specific safety risk. FTA believes it is important to establish several tools that may be used to address different levels of safety risks, from low to high. An advisory would be used to address lower level safety risks or in situations where FTA lacks sufficient data to accurately assess the risk.

    Commenters were accurate in their assertions that “compliance” with an advisory would be at a recipient's discretion. FTA agrees that each agency should determine whether or not the hazard or risk addressed in an advisory is relevant to its system and determine appropriate mitigations. Due to the nature of an advisory, a recipient need not “comply” with an advisory, but instead would decide whether or not to adopt the recommended actions. Accordingly, FTA has revised this section in the final rule to remove the language stating that the Administrator would take a recipient's noncompliance with an advisory into consideration when taking enforcement actions. FTA is aware that other Federal agencies use advisories to impose mandatory requirements on their regulated communities. FTA has elected to impose mandatory requirements through the use of directives, and recommendations through the use of advisories.

    FTA does not have the authority to issue civil penalties. However, FTA could issue a directive subsequent to an advisory if FTA finds that the hazard or risk identified in the advisory requires further mitigation.

    FTA does not agree that it should submit mere recommendations through the public notice and comment process or establish another formal process for issuing an advisory. FTA will notify recipients of an advisory by publishing a notice in the Federal Register. FTA will continue to post advisories to its public Web site and incorporate them into the National Safety Plan.

    670.31 Purpose and Content of the National Public Transportation Safety Plan

    This section described the statutory mandates and proposed components of a National Public Transportation Safety Plan (National Safety Plan).

    Comments: National Safety Plan

    Several commenters supported FTA's proposals for a National Safety Plan. Some commenters requested additional information and clarification about the contents of a National Safety Plan in order to be able to comply with the Plan's requirements. One commenter asked how FTA would update a National Safety Plan and whether each update would be subject to notice and comment.

    One commenter stated that a National Safety Plan must be implemented via rulemaking if SSOAs would be expected to ensure that rail transit agencies are complying with the Plan. The commenter stated that a National Safety Plan should not be updated periodically because any changes may require an SSOA to establish new rules, which would be cumbersome, time consuming and expensive. Further, the commenter noted that many small transit providers adopt rules, policies and safety plans through Board actions. Therefore, if a National Safety Plan is changed periodically, transit agencies would need several months to comply with any changes, and to allow an opportunity for comment.

    One commenter requested that FTA coordinate the development of safety criteria and standards with the other U.S. DOT modal administrations, such as the FRA, to avoid conflicting standards. One commenter encouraged FTA to coordinate with transit agencies in the development of standards and criteria. The commenter suggested that a National Safety Plan include a description of safety outcomes and goals, and methods for identifying risks and targeting priorities to achieve safety goals.

    Several commenters noted that it was difficult to comment on a National Safety Plan because FTA had not published final rules for other components of the Public Transportation Safety Program. Some commenters requested additional information from FTA on the nexus between state of good repair and safety.

    One commenter suggested that FTA adopt the framework for a National Safety Plan that was recommended by the Transit Advisory Committee for Safety (TRACS). The commenter noted that the proposed rule included a few of the TRACS recommendations, but would benefit from a more detailed description of the necessary elements that contribute to a more robust framework.

    Several commenters suggested other issues that FTA should address in a National Safety Plan, including employee issues such as driver assaults, restroom breaks, and blind spots. To ensure the safety of transit operators, a commenter recommended that a National Safety Plan require that buses be equipped with clear plastic partitions, a driver side door or window, and an emergency alarm. A commenter also recommended that a National Safety Plan require increased use of wayside fare collection, which the commenter suggested is a safer means to collect payment. Another commenter stated that a National Safety Plan must address blind spots, which make safe operation of transit buses difficult. Other commenters suggested that a National Safety Plan address pedestrian and bicycle safety.

    FTA Response: National Safety Plan

    FTA intends for the National Safety Plan to serve as both the primary tool for FTA to communicate with the transit industry about its safety performance, and as a repository of guidance, best practices, technical assistance, tools and other information. FTA believes that a flexible approach to implementing a National Safety Plan would be the most effective way to disseminate information. Therefore, FTA intends to publish proposed substantive updates to the National Safety Plan, such as new performance criteria, for public notice and comment, but does not believe that the National Safety Plan needs to be a rule. FTA will incorporate guidance, technical assistance, and other tools into the Plan as they become available.

    In the NPRM, FTA proposed the initial contents of a National Safety Plan. The list of proposed contents was not exhaustive. On February 5, 2016, FTA published its first proposed National Safety Plan for public notice and comment. See 81 FR 6372. The proposed Plan includes four safety performance criteria, an SMS implementation guide, and other guidance. The proposed Plan also includes proposed voluntary standards. FTA will coordinate with relevant U.S. DOT modal administrations and the transit industry in the adoption of any mandatory standards. In addition, the proposed Plan discusses safety outcomes and goals, the nexus between state of good repair and safety, pedestrian and bicycle safety, and the role of TRACS. The comment period for the proposed Plan closed on April 5, 2016, and FTA expects to publish its first National Safety Plan in the near future.

    FTA revised this section in the final rule to reflect changes to 49 U.S.C. 5329(b) as amended by the FAST Act, which require a National Safety Plan to include standards to ensure the safe operation of transit systems.

    IV. Regulatory Analyses and Notices Executive Order 12866 and 13563; USDOT Regulatory Policies and Procedures

    Executive Orders 12866 and 13563 direct Federal 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. Also, Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. As stated above, FTA does not believe that this rule imposes direct costs on entities other than FTA.

    FTA has determined this rulemaking is a nonsignificant regulatory action within the meaning of Executive Order 12866 and is nonsignificant within the meaning of the U.S. Department of Transportation's regulatory policies and procedures. FTA has determined that this rulemaking is not economically significant. The rule will not result in an effect on the economy of $100 million or more. The rule will not adversely affect the economy, interfere with actions taken or planned by other agencies, or generally alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

    Regulatory Flexibility Act

    In compliance with the Regulatory Flexibility Act (Pub. L. 96-354; 5 U.S.C. 601-612), FTA has evaluated the likely effects of the rule on small entities, and has determined that they will not have a significant economic impact on a substantial number of small entities.

    Unfunded Mandates Reform Act of 1995

    This rule will not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; 109 Stat. 48).

    Executive Order 13132 (Federalism)

    FTA has analyzed this rule in accordance with the principles and criteria established by Executive Order 13132, and determined that this rule will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. FTA has also determined that this rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions. Moreover, consistent with Executive Order 13132, FTA has determined that the rule does not impose direct compliance costs on State and local governments.

    Executive Order 12372 (Intergovernmental Review)

    The regulations effectuating Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this rulemaking.

    Paperwork Reduction Act

    This rulemaking will not impose additional collection requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., or the OMB regulation at 5 CFR 1320.8(d). To the extent that there are any costs and burdens associated with any collections under this rule, the information collection will be incorporated into the rulemakings for Public Transportation Agency Safety Plans, State Safety Oversight, and the Safety Certification Training Program.

    National Environmental Policy Act

    The National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq., requires Federal agencies to analyze the potential environmental effects of their proposed actions in the form of a categorical exclusion, environmental assessment, or environmental impact statement. This rule is categorically excluded under FTA's environmental impact procedure at 23 CFR 771.118(c)(4), pertaining to planning and administrative activities that do not involve or lead directly to construction, such as the promulgation of rules, regulations, and directives. FTA has determined that no unusual circumstances exist in this instance, and that a categorical exclusion is appropriate for this rulemaking.

    Executive Order 12630 (Taking of Private Property)

    This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (March 15, 1998), Governmental Actions and Interference with Constitutionally Protected Property Rights.

    Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations)

    Executive Order 12898 (February 8, 1994) directs every Federal agency to make environmental justice part of its mission by identifying and addressing the effects of all programs, policies, and activities on minority populations and low-income populations. The USDOT environmental justice initiatives accomplish this goal by involving the potentially affected public in developing transportation projects that fit harmoniously within their communities without compromising safety or mobility. Additionally, FTA has issued a program circular addressing environmental justice in public transportation, C 4703.1, “Environmental Justice Policy Guidance for Federal Transit Administration Recipients.” This circular provides a framework for FTA grantees as they integrate principles of environmental justice into their transit decision-making processes. The Circular includes recommendations for State Departments of Transportation, Metropolitan Planning Organizations, and public transportation systems on how to: (1) Fully engage environmental justice populations in the transportation decision-making process; (2) determine whether environmental justice populations would be subjected to disproportionately high and adverse human health or environmental effects of a public transportation project, policy, or activity; and (3) avoid, minimize, or mitigate these effects.

    Executive Order 12988 (Civil Justice Reform)

    This action meets the applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (February 5, 1996), Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    Executive Order 13045 (Protection of Children)

    FTA has analyzed this rule under Executive Order 13045 (April 21, 1997), Protection of Children from Environmental Health Risks and Safety Risks. FTA certifies that this rule will not cause an environmental risk to health or safety that may disproportionately affect children.

    Executive Order 13175 (Tribal Consultation)

    FTA has analyzed this action under Executive Order 13175 (November 6, 2000), and believes that it will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. Therefore, a tribal summary impact statement is not required.

    Executive Order 13211 (Energy Effects)

    FTA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). FTA has determined that this action is not a significant energy action under the Executive Order, given that the action is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.

    Privacy Act

    Anyone is able to search the electronic form of all comments received into any of FTA's dockets by the name of the individual submitting the comment or signing the comment if submitted on behalf of an association, business, labor union, or any other entity. You may review USDOT's complete Privacy Act Statement published in the Federal Register on April 11, 2000, at 65 FR 19477-8.

    Statutory/Legal Authority for This Rulemaking

    This rulemaking is issued under the authority of 49 U.S.C. 5329(f)(7), which authorizes the Secretary to issue rules to carry out the mandate for a Public Transportation Safety Program at 49 U.S.C. 5329.

    Regulation Identification Number

    A Regulation Identification Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN set forth in the heading of this document can be used to cross-reference this action with the Unified Agenda.

    List of Subjects in 49 CFR Part 670

    Public Transportation, Safety.

    Issued in Washington, DC, under authority delegated in 49 CFR 1.91. Carolyn Flowers, Acting Administrator.

    For the reasons set forth in the preamble, and under the authority of 49 U.S.C. 5329(f)(7), and the delegations of authority at 49 CFR 1.91, FTA hereby amends Chapter VI of Title 49, Code of Federal Regulations, by adding part 670 as set forth below:

    PART 670—PUBLIC TRANSPORTATION SAFETY PROGRAM Subpart A—General Provisions Sec. 670.1 Purpose and applicability. 670.3 Policy. 670.5 Definitions. Subpart B—Inspections, Investigations, Audits, Examinations, and Testing 670.11 General. 670.13 Request for confidential treatment of records. Subpart C—Enforcement 670.21 General. 670.23 Use or withholding of funds. 670.25 General directives. 670.27 Special directives. 670.29 Advisories. Subpart D—National Public Transportation Safety Plan 670.31 Purpose and contents of the National Public Transportation Safety Plan. Authority:

    49 U.S.C. 5329, 49 CFR 1.91.

    Subpart A—General Provisions
    § 670.1 Purpose and applicability.

    This part carries out the mandate of 49 U.S.C. 5329 to improve the safety of public transportation systems. This part establishes substantive and procedural rules for FTA's administration of the Public Transportation Safety Program. This part applies to recipients of Federal financial assistance under 49 U.S.C. chapter 53.

    § 670.3 Policy.

    The Federal Transit Administration (FTA) has adopted the principles and methods of Safety Management Systems (SMS) as the basis for enhancing the safety of public transportation in the United States. FTA will follow the principles and methods of SMS in its development of rules, regulations, policies, guidance, best practices and technical assistance administered under the authority of 49 U.S.C. 5329.

    § 670.5 Definitions.

    As used in this part:

    Accountable Executive means a single, identifiable individual who has ultimate responsibility for carrying out the Public Transportation Agency Safety Plan of a public transportation agency; responsibility for carrying out the agency's Transit Asset Management Plan; and control or direction over the human and capital resources needed to develop and maintain both the agency's Public Transportation Agency Safety Plan in accordance with 49 U.S.C. 5329(d), and the agency's Transit Asset Management Plan in accordance with 49 U.S.C. 5326.

    Administrator means the Federal Transit Administrator or his or her designee.

    Advisory means a notice that informs or warns a recipient of hazards or risks to the recipient's public transportation system. An advisory may include recommendations for avoiding or mitigating the hazards or risks.

    Audit means a review or analysis of records and related materials, including, but not limited to, those related to financial accounts.

    Corrective action plan means a plan developed by a recipient that describes the actions the recipient will take to minimize, control, correct or eliminate risks and hazards, and the schedule for taking those actions. Either a State Safety Oversight Agency of FTA may require a recipient to develop and carry out a corrective action plan.

    Deputy Administrator means the Federal Transit Deputy Administrator or his or her designee.

    Directive means a written communication from FTA to a recipient that requires the recipient to take one or more specific actions to ensure the safety of the recipient's public transportation system.

    Examination means a process for gathering or analyzing facts or information related to the safety of a public transportation system.

    FTA means the Federal Transit Administration.

    Hazard means any real or potential condition that can cause injury, illness, or death; damage to or loss of the facilities, equipment, rolling stock, or infrastructure of a recipient's public transportation system; or damage to the environment.

    Inspection means a physical observation of equipment, facilities, rolling stock, operations, or records for the purpose of gathering or analyzing facts or information.

    Investigation means the process of determining the causal and contributing factors of an accident, incident or hazard for the purpose of preventing recurrence and mitigating risk.

    National Public Transportation Safety Plan means the plan to improve the safety of all public transportation systems that receive Federal financial assistance under 49 U.S.C. Chapter 53.

    Pattern or practice means two or more findings by FTA of a recipient's violation of the requirements of 49 U.S.C. 5329 or the regulations thereunder.

    Recipient means a State or local governmental authority, or any other operator of public transportation that receives financial assistance under 49 U.S.C. Chapter 53. The term “recipient” includes State Safety Oversight Agencies.

    Record means any writing, drawing, map, recording, diskette, DVD, CD-ROM, tape, film, photograph, or other documentary material by which information is preserved. The term “record” also includes any such documentary material stored electronically.

    Risk means the composite of predicted severity and likelihood of the potential effect of a hazard.

    Safety Management System (SMS) means a formal, top-down, organization-wide data-driven approach to managing safety risk and assuring the effectiveness of a recipient's safety risk mitigations. SMS includes systematic procedures, practices and policies for managing risks and hazards.

    State means a State of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, American Samoa, and the Virgin Islands.

    State Safety Oversight Agency means an agency established by a State that meets the requirements and performs the functions specified by 49 U.S.C. 5329(e) and the regulations set forth in 49 CFR part 659 or 49 CFR part 674.

    Testing means an assessment of equipment, facilities, rolling stock or operations of a recipient's public transportation system.

    Subpart B—Inspections, Investigations, Audits, Examinations and Testing
    § 670.11 General.

    (a) The Administrator may conduct investigations, inspections, audits and examinations, and test the equipment, facilities, rolling stock and operations of a recipient's public transportation system.

    (b) To the extent practicable, the Administrator will provide notice to a recipient prior to initiating any activities carried out under the authorities listed in paragraph (a) of this section.

    (c) The Administrator will conduct activities carried out under this section at reasonable times and in a reasonable manner, as determined by the Administrator.

    (d) In carrying out this section, the Administrator may require the production of relevant documents and records, take evidence, issue subpoenas and depositions, and prescribe recordkeeping and reporting requirements.

    § 670.13 Request for confidential treatment of records.

    (a) The Administrator may grant a recipient's request for confidential treatment of records produced under § 670.11, on the basis that the records are—

    (1) Exempt from the mandatory disclosure requirements of the Freedom of Information Act (5 U.S.C. 552);

    (2) Required to be held in confidence by 18 U.S.C. 1905; or

    (3) Otherwise exempt from public disclosure under Federal or State laws.

    (b) A recipient must submit the record that contains the alleged confidential information with the request for confidential treatment.

    (c) A recipient's request for confidential treatment must include a statement justifying nondisclosure and provide the specific legal basis upon which the request for nondisclosure should be granted.

    (d) A recipient's justification statement must indicate whether the recipient is requesting confidentiality for the entire record, or whether non-confidential information in the record can be reasonably segregated from the confidential information. If a recipient is requesting confidentiality for only a portion of the record, the request must include a copy of the entire record and a second copy of the record where the purportedly confidential information has been redacted. The Administrator may assume there is no objection to public disclosure of the record in its entirety if the requestor does not submit a second copy of the record with the confidential information redacted at the time that the request is submitted.

    (e) A recipient must mark any record containing any information for which confidential treatment is requested as follows—“CONFIDENTIAL” or “CONTAINS CONFIDENTIAL INFORMATION” in bold letters.

    (f) The Administrator will provide notice to a recipient of his or her decision to approve or deny a request, in whole or in part, no less than five (5) days prior to the public disclosure of a record by FTA. The Administrator will provide an opportunity for a recipient to respond to his or her decision prior to the public disclosure of a record.

    Subpart C—Authorities
    § 670. 21 General.

    In addition to actions described in §§ 670.23 through 670.29, in exercising his or her authority under this part, the Administrator may—

    (a) Require more frequent oversight of a recipient by a State Safety Oversight Agency that has jurisdiction over the recipient;

    (b) Impose requirements for more frequent reporting by a recipient;

    (c) Order a recipient to develop and carry out a corrective action plan; and

    (d) Issue restrictions and prohibitions, if through testing, inspection, investigation, audit or research carried out under Chapter 53, the Administrator determines that an unsafe condition or practice, or a combination of unsafe conditions and practices, exist such that there is a substantial risk of death or personal injury.

    § 670.23 Use or withholding of funds.

    (a) Directing the use of funds. The Administrator may require a recipient to use Chapter 53 funds to correct safety violations identified by the Administrator or a State Safety Oversight Agency before such funds are used for any other purpose.

    (b) Withholding of funds. Except as provided under 49 CFR part 674, the Administrator may withhold not more than twenty-five (25) percent of funds apportioned under 49 U.S.C. 5307 from a recipient when the Administrator has evidence that the recipient has engaged in a pattern or practice of serious safety violations, or has otherwise refused to comply with the Public Transportation Safety Program, as codified at 49 U.S.C. 5329, or any regulation or directive issued under those laws for which the Administrator exercises enforcement authority for safety.

    (c) Notice. The Administrator will issue a notice of violation that includes the amount the Administrator proposes to redirect or withhold at least ninety (90) days prior to the date from when the funds will be redirected or withheld. The notice will contain—

    (1) A statement of the legal authority for its issuance;

    (2) A statement of the regulatory provisions or directives FTA believes the recipient has violated;

    (3) A statement of the remedial action sought to correct the violation; and

    (4) A statement of facts supporting the proposed remedial action.

    (d) Reply. Within thirty (30) days of service of a notice of violation, a recipient may file a written reply with the Administrator. Upon receipt of a written request, the Administrator may extend the time for filing for good cause shown. The reply must be in writing, and signed by the recipient's Accountable Executive or equivalent entity. A written reply may include an explanation for the alleged violation, provide relevant information or materials in response to the alleged violation or in mitigation thereof, or recommend alternative means of compliance for consideration by the Administrator.

    (e) Decision. The Administrator will issue a written decision within thirty (30) days of his or her receipt of a recipient's reply. The Administrator shall consider a recipient's response in determining whether to dismiss the notice of violation in whole or in part. If a notice of violation is not dismissed, the Administrator may undertake any other enforcement action he or she deems appropriate.

    § 670.25 General directives.

    (a) General. The Administrator may issue a general directive under this part that is applicable to all recipients or a subset of recipients for the following reasons—

    (1) The Administrator determines that an unsafe condition or practice, or a combination of unsafe conditions and practices, exists such that there is a risk of death or personal injury, or damage to property or equipment; or

    (2) For any other purpose where the Administrator determines that the public interest requires the avoidance or mitigation of a hazard or risk.

    (b) Effective date. A general directive is effective upon final notice provided by the Administrator under paragraph (e) of this section.

    (c) Notice. The Administrator will provide notice of a general directive to recipients in the Federal Register. The notice will include at minimum—

    (1) A reference to the authority under which the directive is being issued;

    (2) A statement of the purpose of the issuance of the directive, including a description of the subjects or issues involved and a statement of the remedial actions sought; and

    (3) A statement of the time within which written comments must be received by FTA.

    (d) Consideration of comments received. The Administrator will consider all timely comments received. Late filed comments will be considered to the extent practicable.

    (e) Final notice. After consideration of timely comments received, the Administrator will publish a notice in the Federal Register that includes both a response to comments and a final general directive or a statement rescinding, revising, revoking or suspending the directive.

    § 670.27 Special directives.

    (a) General. The Deputy Administrator may issue a special directive under this part to one or more named recipients for the following reasons—

    (1) The Deputy Administrator has reason to believe that a recipient is engaging in conduct, or there is evidence of a pattern or practice of a recipient's conduct, in violation of the Public Transportation Safety Program or any regulation or directive issued under those laws for which the Administrator exercises enforcement authority for safety;

    (2) The Deputy Administrator determines that an unsafe condition or practice, or a combination of unsafe conditions and practices exists such that there is a substantial risk of death or personal injury, or damage to property or equipment; or

    (3) For any other purpose where the Deputy Administrator determines that the public interest requires the avoidance or mitigation of a hazard or risk through immediate compliance.

    (b) Effective date. A special directive is effective upon notice provided by the Deputy Administrator under paragraph (c) of this section.

    (c) Notice. The Deputy Administrator will provide notice to a recipient that is subject to a special directive. The Deputy Administrator may initially provide notice through telephonic or electronic communication; however, written notice will be served by personal service or by U.S. mail following telephonic or electronic communication. Notice will include the following information, at minimum—

    (1) The name of the recipient or recipients to which the directive applies;

    (2) A reference to the authority under which the directive is being issued; and

    (3) A statement of the purpose of the issuance of the directive, including a description of the subjects or issues involved, a statement of facts upon which the notice is being issued, a statement of the remedial actions being sought, and the date by which such remedial actions must be taken.

    (d) Petition for reconsideration. Within thirty (30) days of service of a notice issued under paragraph (c) of this section, a recipient may file a petition for reconsideration with the Administrator. Unless explicitly stayed or modified by the Administrator, a special directive will remain in effect and must be observed pending review of a petition for reconsideration. Any such petition:

    (1) Must be in writing and signed by a recipient's Accountable Executive or equivalent entity;

    (2) Must include a brief explanation of why the recipient believes the special directive should not apply to it or why compliance with the special directive is not possible, is not practicable, is unreasonable, or is not in the public interest; and

    (3) May include relevant information regarding the factual basis upon which the special directive was issued, information in response to any alleged violation or in mitigation thereof, recommend alternative means of compliance for consideration, and any other information deemed appropriate by the recipient.

    (e) Request for extension. Upon written request, the Administrator may extend the time for filing a request for reconsideration for good cause shown.

    (f) Filing a petition for reconsideration. A petition must be submitted to the Office of the Administrator, Federal Transit Administration, using one of the following methods—

    (1) Email to FTA, sent to an email address provided in the notice of special directive;

    (2) Facsimile to FTA at 202-366-9854; or

    (3) Mail to FTA at: FTA, Office of the Administrator, 1200 New Jersey Ave. SE., Washington, DC 20590.

    (g) Processing of petitions for reconsideration—(1) General. Each petition received under this section will be reviewed and disposed of by the Administrator no later than ninety days (90) after receipt of the petition. No hearing, argument or other proceeding will be held directly on a petition before its disposition under this section.

    (2) Grants. If the Administrator determines the petition contains adequate justification, he or she may grant the petition, in whole or in part.

    (3) Denials. If the Administrator determines the petition does not justify modifying, rescinding or revoking the directive, in whole or in part, he or she may deny the petition.

    (4) Notification. The Administrator will issue notification to a recipient of his or her decision.

    (h) Judicial review. A recipient may seek judicial review in an appropriate United States District Court after a final action of FTA under this section, as provided in 5 U.S.C. 701-706.

    § 670.29 Advisories.

    In any instance in which the Administrator determines there are hazards or risks to public transportation, the Administrator may issue an advisory which recommends corrective actions, inspections, conditions, limitations or other actions to avoid or mitigate any hazards or risks. The Administrator will issue notice to recipients of an advisory in the Federal Register.

    Subpart D—National Public Transportation Safety Plan
    § 670.31 Purpose and contents of the National Public Transportation Safety Plan.

    Periodically, FTA will issue a National Public Transportation Safety Plan to improve the safety of all public transportation systems that receive funding under 49 U.S.C. Chapter 53. The National Public Transportation Safety Plan will include the following—

    (a) Safety performance criteria for all modes of public transportation, established through public notice and comment;

    (b) The definition of state of good repair;

    (c) Minimum safety performance standards for vehicles in revenue operations, established through public notice and comment;

    (d) Minimum performance standards for public transportation operations established through public notice and comment;

    (e) The Public Transportation Safety Certification Training Program;

    (f) Safety advisories, directives and reports;

    (g) Best practices, technical assistance, templates and other tools;

    (h) Research, reports, data and information on hazard identification and risk management in public transportation, and guidance regarding the prevention of accidents and incidents in public transportation; and

    (i) Any other content as determined by FTA.

    [FR Doc. 2016-18920 Filed 8-10-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 219 [Docket No. 150413360-6558-04] RIN 0648-BF02 Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Northeast Fisheries Science Center Fisheries Research AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS' Office of Protected Resources (hereinafter “OPR” or “we” or “our”), upon request of NMFS' Northeast Fisheries Science Center (NEFSC), hereby issues a regulation to govern the unintentional taking of marine mammals incidental to fisheries research conducted in a specified geographical region, over the course of five years. This regulation, which allows for the issuance of a Letter of Authorization for the incidental take of marine mammals during the described activities and specified timeframes, prescribes the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, as well as requirements pertaining to the monitoring and reporting of such taking.

    DATES:

    Effective from September 12, 2016 through September 9, 2021.

    ADDRESSES:

    A copy of the NEFSC's application, application addendum, and supporting documents, as well as a list of the references cited in this document, are available on the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm. In case of problems accessing these documents, please call the contact listed below this section (see FOR FURTHER INFORMATION CONTACT).

    FOR FURTHER INFORMATION CONTACT:

    Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Executive Summary

    This regulation, under the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.), establishes a framework for authorizing the take of marine mammals incidental to the NEFSC's fisheries research activities in a specified geographical region (the Atlantic coast region which includes the Northeast U.S. Continental Shelf Large Marine Ecosystem (Northeast LME) and a portion of the Southeast U.S. Continental Shelf Large Marine Ecosystem (Southeast LME)).

    The NEFSC collects a wide array of information necessary to evaluate the status of exploited fishery resources and the marine environment. Depending on the research, the NEFSC's conducts the following types of research: (1) Fishery-independent research directed by NEFSC scientists and conducted onboard NOAA-owned and operated vessels or NOAA-chartered vessels; (2) fishery-independent research directed by cooperating scientists (other agencies, academic institutions, and independent researchers) conducted onboard non-NOAA vessels; and (3) fishery-dependent research conducted onboard commercial fishing vessels, with or without NOAA scientists onboard.

    Purpose and Need for This Regulatory Action

    OPR received an application from the NEFSC requesting five-year regulations and authorization to take multiple species of marine mammals. We anticipate take to occur in the Atlantic coast region by the following means: Level B harassment incidental to the use of active acoustic devices, visual disturbance of pinnipeds, and Level A harassment, serious injury, or mortality incidental to the use of fisheries research gear. This regulation is valid for five years from the date of issuance. Please see “Background” later in this document for definitions of harassment.

    Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361 et seq.) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if, after notice and public comment, the agency makes certain findings and issues regulations. This regulation contains mitigation, monitoring, and reporting requirements.

    Legal Authority for the Regulatory Action

    Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing the five-year regulations and any subsequent Letters of Authorization.

    Summary of Major Provisions Within the Final Regulation

    The following provides a summary of some of the major provisions within this regulation for the NEFSC's fisheries research activities in the Atlantic coast region. We have determined that the NEFSC's adherence to the mitigation, monitoring, and reporting measures listed later in this regulation would achieve the least practicable adverse impact on the affected marine mammals. They include:

    • Required monitoring of the sampling areas to detect the presence of marine mammals before deployment of pelagic trawl nets, bottom-contact trawl gear, pelagic or demersal longline gear, gillnets, fyke nets, pots, traps, and other gears;

    • Required implementation of standard tow durations of not more than 30 minutes to reduce the likelihood of incidental take of marine mammals;

    • Required implementation of the mitigation strategy known as the “move-on rule,” which incorporates best professional judgment, when necessary during trawl and longline operations;

    • Required compliance with applicable vessel speed restrictions; and

    • Required compliance with applicable and relevant take reduction plans for marine mammals.

    Cost and Benefits

    This final rule, specific only to the NEFSC's fishery research activities, is not significant under Executive Order 12866, Regulatory Planning and Review.

    Availability of Supporting Information

    We provided SUPPLEMENTARY INFORMATION in the NPRM for this activity in the Federal Register on July 9, 2015 (80 FR 39542), and two corrections to the proposed rulemaking in the Federal Register on August 6, 2015 (80 FR 46939), and August 17, 2015 (80 FR 49196). We did not reprint all of that information here in its entirety. Instead, we represent sections from the proposed rule in this document and provide either a summary of the material presented in the proposed rule or a note referencing the page(s) in the proposed rule where the public can find the information. We address any information that has changed since the proposed rule in this document. Additionally, this final rule contains a section that responds to the public comments submitted during the 30-day public comment period and the two extensions of the public comment period.

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if OPR finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. OPR has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Summary of Request

    On December 17, 2014, OPR received an adequate and complete request from the NEFSC for authorization to take marine mammals incidental to fisheries research activities. We received an initial draft of the request on February 12, 2014, followed by revised drafts on September 19 and October 1, 2014. On December 29, 2014 (79 FR 78065), we published a notice of receipt of the NEFSC's application in the Federal Register, requesting comments and information related to the NEFSC request for thirty days. All comments received were considered in development of the proposed rulemaking and are available on the Internet at: www.nmfs.noaa.gov/pr/permits/incidental/research.htm.

    The NEFSC proposes to conduct fisheries research using the following types of gear: Pelagic trawl gear used at various levels in the water column, bottom-contact trawl gear, pelagic and demersal longlines with multiple hooks, gillnets, fyke nets, dredges, pots, traps, and other gear. If a marine mammal interacts with gear deployed by the NEFSC, the outcome could potentially be Level A harassment, serious injury (i.e., any injury that will likely result in mortality), or mortality. However, there is not sufficient information upon which to base a prediction of what the outcome could be for any particular interaction. Therefore, the NEFSC has pooled the estimated number of incidents of take expected to result from gear interactions, and we have assessed the potential impacts accordingly. The NEFSC also uses various active acoustic devices in the conduct of fisheries research, and use of these devices has the potential to result in Level B harassment of marine mammals. Level B harassment of pinnipeds hauled out on the shoreline may also occur, in some locations within the Atlantic coast region, as a result of visual disturbance from vessels conducting NEFSC research. This regulation is valid for five years from the date of issuance.

    The NEFSC conducts fisheries research surveys in the Atlantic coast region which spans the United States-Canadian border to Florida. This specified geographic region includes the following subareas: The Gulf of Maine, Georges Bank, Southern New England waters, the Mid-Atlantic Bight, and the coastal waters of northeast Florida. The NEFSC requested authorization to take individuals of 10 species by Level A harassment, serious injury, or mortality (hereafter referred to as M/SI + Level A) and of 19 species by Level B harassment.

    Description of the Specified Activity Overview

    The NEFSC collects a wide array of information necessary to evaluate the status of exploited fishery resources and the marine environment. NEFSC scientists conduct fishery-independent research onboard NOAA-owned and operated vessels or on chartered vessels. For other types of surveys, cooperating scientists may conduct fishery-independent research onboard non-NOAA vessels. Finally, the NEFSC sponsors some fishery-dependent research conducted onboard commercial fishing vessels, with or without NEFSC scientists onboard.

    The NEFSC plans to administer and conduct approximately 48 survey programs over the five-year period. The gear types used fall into several categories: Pelagic trawl gear used at various levels in the water column; bottom-contact trawl gear; pelagic and demersal longlines; gillnets; fyke nets; pots; traps; and other gear. The use of pelagic and bottom trawl nets, gillnets, fyke nets, and pelagic longline gears are likely to result in interactions with marine mammals. The majority of these surveys also use active acoustic devices.

    The federal government has a responsibility to conserve and protect living marine resources in U.S. waters and has also entered into a number of international agreements and treaties related to the management of living marine resources in international waters outside the United States. NOAA has the primary responsibility for managing marine fin and shellfish species and their habitats, with that responsibility delegated within NOAA to NMFS.

    In order to direct and coordinate the collection of scientific information needed to make informed fishery management decisions, Congress created six Regional Fisheries Science Centers, each a distinct organizational entity and the scientific focal point within NMFS for region-based federal fisheries-related research. This research aims at monitoring fish stock recruitment, abundance, survival and biological rates, geographic distribution of species and stocks, ecosystem process changes, and marine ecological research. The NEFSC is the research arm of NMFS in the greater Atlantic Ocean region of the United States. The NEFSC conducts research and provides scientific advice to manage fisheries and conserve protected species in Northeast and Southeast LMEs and provides scientific information to support the New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the Atlantic States Marine Fisheries Commission, and numerous other domestic and international fisheries management organizations.

    Dates and Duration

    The specified activity may occur at any time during the five-year period of validity of the issued regulation. Dates and duration of individual surveys are inherently uncertain, based on congressional funding levels for the NEFSC, weather conditions, or ship contingencies. In addition, the NEFSC designs the cooperative research program to provide flexibility on a yearly basis in order to address issues as they arise. Some cooperative research projects last multiple years or may continue with modifications. Other projects only last one year and are not continued. Most cooperative research projects undergo an annual competitive selection process to determine funding for projects based on proposals developed by many independent researchers and fishing industry participants. NEFSC survey activity occurs during most months of the year; however, most trawl surveys occur during the spring, summer, and fall. Longline surveys occur either biannually in the spring or annually in the summer and a small number of gillnet surveys occur annually in the summer.

    Specified Geographical Region

    The NEFSC operates within the Atlantic coast region, which was described in detail in the notice of proposed rulemaking for this activity in the Federal Register on July 9, 2015 (80 FR 39544-39546). We refer the public to that document for further information.

    Detailed Description of Activities

    We provided a detailed description of the NEFSC's planned research activities, gear types and active acoustic sound sources used in the notice of proposed rulemaking (80 FR 39546-39560; July 9, 2015) and do not repeat that information here. There are no changes to the specified activities, gear types, or active acoustic sound sources described in that document.

    Comments and Responses

    We published a notice of proposed rulemaking in the Federal Register on July 9, 2015 (80 FR 39542) and requested comments and information from the public. We also published two corrections and extensions of the public comment period for the proposed rulemaking in the Federal Register on August 6, 2015 (80 FR 46939), and August 17, 2015 (80 FR 49196). During the 70-day public comment period, we received letters from the Marine Mammal Commission (Commission), a joint letter from the Humane Society of the United States and Whale and Dolphin Conservation (HSUS/WDC), and comments from two private citizens which were not germane to the proposed action. We provide the comments and our responses here, and we have posted those comments on the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm and on the federal e-Rulemaking Portal at www.regulations.gov (enter 0648-BF02 in the “Search” box and scroll down to the Comments section). Please see the comment letters for the full rationale behind our response to the recommendations.

    Comment 1: The Commission recommends that OPR develop criteria and guidance for determining when prospective applicants should request taking by Level B harassment incidental to the use of sub-bottom profilers, echosounders, and other sonars, stating that we should follow a consistent approach in assessing the potential for taking by Level B harassment from active acoustic systems.

    Response: OPR agrees with the Commission's recommendation. Generally speaking, there has been a lack of information and scientific consensus regarding the potential effects of electromechanical sources (including scientific sonars) on marine mammals, which may differ depending on the acoustic system and species in question as well as the environment in which an applicant operates the system. We are currently working to ensure that our consideration on the use of these types of active acoustic sources is consistent and look forward to the Commission's advice as we develop guidance as recommended.

    Comment 2: The Commission recommends that the OPR require the NEFSC to estimate the numbers of marine mammals taken by Level B harassment incidental to use of active acoustic sources (e.g., echosounders) based on the 120-decibel (dB) rather than the 160-dB root mean square (rms) threshold. Please see the notice of proposed rulemaking (80 FR 39542; July 9, 2015) for a discussion related to acoustic terminology and thresholds. In addition, the Commission recommends that the OPR formulate a strategy for updating behavioral thresholds for all types of sound sources (i.e., impulsive and non-impulsive) incorporating new data regarding behavioral thresholds and finalize the thresholds within the next year or two.

    Response: Continuous sounds are those whose sound pressure level remains above that of the ambient sound, with negligibly small fluctuations in sound levels (NIOSH, 1998; ANSI, 2005), while intermittent sounds are defined as sounds with interrupted levels of low or no sound (NIOSH, 1998). Thus, echosounder signals are not continuous sounds but rather intermittent sounds. One can further define intermittent sounds as either impulsive or non-impulsive. Impulsive sounds have been defined as sounds which are typically transient, brief (less than one second), broadband, and consist of a high peak pressure with rapid rise time and rapid decay (ANSI, 1986; NIOSH, 1998). Echosounder signals also have durations that are typically very brief (less than one second), with temporal characteristics that more closely resemble those of impulsive sounds than non-impulsive sounds, which typically have more gradual rise times and longer decays (ANSI, 1995; NIOSH, 1998). With regard to behavioral thresholds, we consider the temporal and spectral characteristics of echosounder signals to more closely resemble those of an impulse sound than a continuous sound.

    The Commission suggests that, for certain sources considered here, the interval between pulses would not be discernible to the animal, rendering them effectively continuous. However, echosounders emit pulses in a similar fashion as odontocete echolocation click trains. Research indicates that marine mammals, in general, have extremely fine auditory temporal resolution and can detect each signal separately (e.g., Au et al., 1988; Dolphin et al., 1995; Supin and Popov, 1995; Mooney et al., 2009), especially for species with echolocation capabilities. Therefore, it is highly unlikely that marine mammals would perceive echosounder signals as being continuous. The Commission provides numerous references purporting to demonstrate behavioral responses by marine mammals to received levels of sound below 160 dB rms from sources with characteristics similar to those used by the NEFSC. However, the vast majority of these references concern acoustic deterrent devices, which we do not believe are similar to the NEFSC's acoustic sources.

    In conclusion, echosounder signals are intermittent rather than continuous signals, and the fine temporal resolution of the marine mammal auditory system allows them to perceive these sounds as such. Further, the physical characteristics of these signals indicate a greater similarity to the way that intermittent, impulsive sounds are received. Therefore, the 160-dB threshold (typically associated with impulsive sources) is more appropriate than the 120-dB threshold (typically associated with continuous sources) for estimating takes by behavioral harassment incidental to use of such sources. This response represents the consensus opinion of acoustics experts from NMFS' OPR and Office of Science and Technology.

    Finally, we agree with the Commission's recommendation to revise existing acoustic criteria and thresholds as necessary to specify threshold levels that would be more appropriate for a wider range of sound sources and are currently in the process of producing such revisions (see 80 FR 45642, July 31, 2015). NOAA recognizes, as new science becomes available, that our current categorizations (i.e., impulse versus continuous) may not fully encompass the complexity associated with behavioral responses (e.g., context) and are working toward addressing these issues in future acoustic guidance. With respect to updating behavioral thresholds for different types of sound sources as soon as possible, OPR agrees with the Commission's recommendation. Due to the complexity and variability of marine mammal behavioral responses, NOAA will continue to work on developing guidance regarding the effects of anthropogenic sound on marine mammal behavior.

    Comment 3: The Commission notes that we have delineated two categories of acoustic sources, largely based on frequency, with those sources operating at frequencies greater than the known hearing ranges of any marine mammal (i.e., greater than 180 kHz) lacking the potential to cause disruption of behavioral patterns. The Commission recommends that we review the recent scientific literature on acoustic sources with frequencies above 180 kHz (i.e., Deng et al., 2014; Hastie et al., 2014) and incorporate those findings into our criteria and guidance for determining when prospective applicants should request authorization for taking by Level B harassment from the use of echosounders, sonars, and sub-bottom profilers.

    Response: We are aware of the referenced literature and considered that information in our notice of proposed rulemaking (80 FR 39558, July 9, 2015). In general, the referenced work indicates that “sub-harmonics” could be “detectable” by certain species at distances up to several hundred meters. However, this detectability is in reference to ambient noise, not to OPR's established 160-dB threshold for assessing the potential for incidental take for these sources (see also our response to Comment 2). Source levels of the secondary peaks considered in these studies—those within the hearing range of some marine mammals—range from 135-166 dB, meaning that these sub-harmonics either would be below the threshold for behavioral harassment or would attenuate to such a level within a few meters. Beyond these important study details, these high-frequency (i.e., Category 1) sources and any energy they may produce below the primary frequency that could be audible to marine mammals would be dominated by a few primary sources (e.g., EK60) that are operated near-continuously—much like other Category 2 sources considered in our assessment of potential incidental take from the NEFSC's use of active acoustic sources—and the potential range above threshold would be so small as to essentially discount them.

    Comment 4: HSUS/WDC provided comments on OPR's process for evaluating and adopting the NEFSC's Draft Programmatic Environmental Assessment (PEA) as described in the notice of proposed rulemaking. The commenters state that “. . . [NMFS] has `evaluated the Draft EA and [we] are proposing to adopt it,' which would seem to indicate that no or only insubstantial changes were made, despite substantial critique of the Draft PEA. Moreover, NMFS appears to have finalized the Draft PEA as it states that [HSUS/WDC's] comments were `considered' in finalizing the PEA.”

    Response: OPR would like to clarify the process for evaluating the NEFSC's Draft PEA. First, we clearly state in our notice of proposed rulemaking (80 FR 39600, July 9, 2015) that the NEFSC, not NMFS' OPR, prepared the Draft PEA in accordance with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and the Council on Environmental Quality (CEQ) regulations (40 CFR 1500-1508). The NEFSC released the Draft PEA for public review and comment in the Federal Register on December 29, 2014 (79 FR 78061); considered public comments in the interim; and finalized their PEA in November 2015. The NEFSC addresses public comments on the Draft PEA—including those submitted by HSUS/WDC in Section 1.5 of the Final PEA which is available on the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm.

    Second, for the purposes of determining whether the issuance of regulations and a subsequent Letter of Authorization (LOA) would have a significant effect on the human environment, OPR stated that we would independently evaluate the NEFSC's Draft PEA, propose to adopt it (i.e., the final PEA that addresses public comments received on the NEFSC's Draft PEA and our notice of proposed rulemaking); or prepare a separate NEPA analysis and incorporate relevant portions of NEFSC's Draft PEA by reference (80 FR 39600, July 9, 2015). Thus, the commenters' statement that “. . . NMFS appears to have finalized the Draft PEA as it states that our comments were “considered” in finalizing the PEA,” is inaccurate, as the NEFSC had not finalized the Draft PEA at the time of publishing the proposed rulemaking in July 2015.

    Comment 5: HSUS/WDC commented that “it would be important for commenters at this stage to understand whether the agency was simply adopting status quo mitigation measures discussed in the preferred alternative of the DPEA or including additional conservation measures for this permit. It would also be helpful to compare the data used in assessing status of, and impacts to, marine mammals discussed in the Draft PEA and which we critiqued in our comments. Yet there is no means of comparing what was proposed in the draft to what NMFS says it will adopt in a final form to allow understanding of whether changes were made in response to comments.”

    Response: See our Response to Comment 4. The NEFSC adhered to the procedural requirements of NEPA; the CEQ regulations for implementing NEPA, and NOAA Administrative Order 216-6 in developing the Final PEA. The connected federal action covered under the NEFSC's Final PEA is the issuance of regulations and subsequent Letter of Authorization (LOA) for the incidental taking of marine mammals under the MMPA. Under section 101(a)(5)(A) of the MMPA, OPR must consider a reasonable range of mitigation measures that may reduce the impact on marine mammals among other factors. However, some of the additional measures considered in the NEFSC's Alternative 3 could prevent them from maintaining the scientific integrity of its research programs. The NEFSC would normally exclude these measures from consideration in the Chapter 1 of the Final PEA as they would not meet the NEFSC's purpose and need under NEPA. Again, the NEFSC provides information on how they considered and addressed public comments in the Final PEA in Sections 1.5 of that document. Also, Sections 4.4 and 4.6 describe the NEFSC's consideration of Alternative 3 which includes a suite of mitigation measures that the NEFSC did not propose to implement as a part of its Preferred Action under Alternative 2.

    Comment 6: HSUS/WDC commented on a discrepancy between Table 3 and Table 20 in the notice of proposed rulemaking for the potential biological removal (PBR) level for short-beaked common dolphins.

    Response: We thank the commenters for their review and have corrected the PBR value for short-beaked common dolphins to show 1,125 in Table 9 of this document instead of 170, which is the average annual human caused mortality estimate. The information provided in Table 3 in the notice of proposed rulemaking for short-beaked common dolphins is correct and has not changed.

    Comment 7: HSUS/WDC commented that NMFS should re-examine impacts to bottlenose dolphin stocks since the NEFSC's research plans have not changed from what the NEFSC presented in the original application for an LOA and the Draft PEA. The commenters note that NMFS reduced the number of impacted bottlenose dolphin stocks to three: Western North Atlantic (WNA) Offshore, WNA Northern Migratory Coastal and WNA Southern Migratory Coastal rather than expand the list to consideration of all coastal bottlenose dolphin stocks as HSUS/WDC suggested in their 2014 comments on the original application for an LOA and the Draft PEA.

    Response: The NEFSC considered HSUS/WDC's public comments on the likelihood of their research activities affecting certain stocks of bottlenose dolphins and reanalyzed the locations of their research activities relative to the ranges of estuarine and coastal bottlenose dolphin stocks in the Southeast LME within the Atlantic coast region. Based on that reanalysis and consideration of public comments, the NEFSC determined that the impact of their coastal research activities, namely the Apex Predators Bottom Longline Coastal Shark and the Cooperative Atlantic States Shark Pupping and Nursery Ground (COASTSPAN) Surveys, within the Southeast LME was smaller than the information presented in the original 2014 application for an LOA and the Draft PEA.

    The NEFSC's revised analysis revealed that the Apex Predators Bottom Longline Coastal Shark Survey intersects with the estimated ranges of three stocks of bottlenose dolphins: The WNA Offshore; the WNA Northern Migratory Coastal; and the WNA Southern Migratory Coastal stocks. This survey generally samples in water depths greater than 20 m (66 ft) (i.e., outside the typical range of estuarine dolphin stocks) and does not intersect with the remaining three coastal stocks in question: The WNA South Carolina-Georgia Coastal; the WNA Northern Florida Coastal; and the WNA Central Florida Coastal. The NEFSC determined that a take request was not warranted based on the following factors including: (1) The efficacy of the planned mitigation and monitoring measures in reducing the effects of the specified activity to the level of least practicable adverse impact; (2) the survey's location (offshore in water depths greater than 20 m [66 ft] depth) which has limited overlap with the primary habitat of the coastal morphotype of bottlenose dolphins; (3) the total survey effort (less than 50 days annually); (4) seasonality (spring); and (5) survey frequency (conducted every two to three years).

    In assessing the impacts of the COASTSPAN survey, the NEFSC did not request take from the estuarine stocks of bottlenose dolphins in North Carolina, South Carolina, Georgia, and Florida, due to limited survey effort in estuarine waters. As discussed in the notice of proposed rulemaking (80 FR 39587, July 9, 2015), in the future, if there is a bottlenose dolphin take from one of the estuarine stocks (to be determined by genetic sampling), the NEFSC will consult with OPR and the Atlantic Bottlenose Dolphin Take Reduction Team under the Adaptive Management provisions of the final rule to discuss appropriate modifications to COASTSPAN survey protocols.

    NMFS provided a revised accounting of those coastal bottlenose dolphin stocks potentially impacted by the NEFSC's research activities within the 2015 Addendum to the NEFSC's 2014 LOA Application, available at: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm which NMFS announced in the “Availability” section of the Federal Register notice of proposed rulemaking, 80 FR 39542, July 9, 2015. Table 20 in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) shows the total estimated take by mortality, serious injury, and Level A harassment for the three stocks. The NEFSC take request for bottlenose dolphins includes two in trawl gear, five in gillnet gear, one in longline gear, and three for the potential take of one unidentified delphinid by trawl, gillnet, and/or longline for the WNA Offshore, the WNA Northern Migratory Coastal, and the WNA Southern Migratory Coastal stocks during the five-year authorization period.

    The NEFSC notes in their final PEA that the Southeast Fisheries Science Center's (SEFSC) research activities could also potentially interact with the some of the same offshore and coastal stocks in the Atlantic coast region. The SEFSC is currently developing a Draft PEA and LOA application concerning fisheries research under its responsibility within the Atlantic coast region. The SEFSC's Draft PEA will also include consideration of coastal and estuarine bottlenose dolphin stocks within their future LOA application. This will include consideration of the NEFSC's research activities that occur in the Atlantic coast region. Thus, NMFS will be able to consider the combined impacts of incidental take related to NEFSC and SEFSC research activities on all bottlenose dolphin stocks within the Atlantic coast region.

    Comment 8: HSUS/WDC commented that the NEFSC's LOA application did not consider the impact of an unusual mortality event (UME) in the northwest Atlantic Ocean on the overall abundance (and PBR for each stock) of the WNA Northern and Southern Migratory Coastal stocks and the resident populations of the South Carolina/Georgia Coastal, North Florida Coastal and Central Florida Coastal stocks. They suggested that NMFS should reconsider the impacts of additional research-related takes on those stocks.

    Response: NMFS considered UMEs within the notice of proposed rulemaking for this activity in the Federal Register on July 9, 2015 (80 FR 39569). See our Response to Comment 7 with respect to the lack of anticipated impacts related to NEFSC research activities on the WNA South Carolina-Georgia Coastal, the WNA Northern Florida Coastal, and the WNA Central Florida Coastal stocks of bottlenose dolphins.

    The dolphin stocks that may potentially occur within the vicinity of NEFSC coastal research activities include: The WNA Offshore, the WNA Northern Migratory Coastal, the Southern Migratory Coastal, and the WNA Southern Migratory Coastal stocks. However, specific information is lacking on which particular population or populations are affected by the UME (NMFS, 2015).

    As discussed in the notice of proposed rulemaking and in the analyses in other referenced documents, NMFS has evaluated the potential effects of the NEFSC's research activities on a number of marine mammal species, including impacts to bottlenose dolphins stocks subject to the current UME and concludes that NEFSC's activities will have a negligible impact on those stocks.

    Comment 9: HSUS/WDC expressed concern that we may not be appropriately accounting for behavioral impacts incidental to the NEFSC's use of active acoustic sources and noted that such impacts could occur at greater distances than considered in our analysis. The commenters discuss the results from Risch et al. (2012) and suggest that it is likely that disturbance from some of the NEFSC's active acoustic sources would be more widespread than projected thus underestimating the occurrence of Level B harassment.

    Response: See our Response to Comment 2. Beyond consideration of a different threshold for assessing potential behavioral impacts, it is not clear what additional or different approaches to impact assessment HSUS et al. might recommend. Absent a specific recommendation to consider, we believe that our approach to assessing the potential for behavioral harassment incidental to the NEFSC's use of active acoustics is appropriate. NMFS' assessment of acoustic impacts and the associated take estimates represent the consensus opinion of acoustics experts from NMFS' Office of Protected Resources and Office of Science and Technology.

    The Risch et al. (2012) study documented reductions in humpback whale vocalizations in the Stellwagen Bank National Marine Sanctuary concurrent with transmissions of the Ocean Acoustic Waveguide Remote Sensing (OAWRS) low-frequency fish sensor system at distances of 200 km from the source. The recorded OAWRS produced a series of frequency modulated pulses (between 0.4 and 1 kHZ, much lower in frequency, longer in duration, with the potential to mask mysticete vocalizations at longer distances than the predominant frequencies produced by the NEFSC's active acoustic sources which attenuate at shorter distances from the source) and the signal received levels ranged from 88 to 110 dB re: 1 μPa (Risch et al., 2012). The authors hypothesized that individuals did not leave the area but instead ceased singing and noted that the duration and frequency range of the OAWRS signals (a novel sound to the whales) were similar to those of natural humpback whale song components used during mating (Risch et al., 2012). However, Gong et al. (2014), disputes these findings, suggesting that (Risch et al., 2012) mistook natural variations in humpback whale song occurrence for changes caused by OAWRS activity approximately 200 km away. Risch et al. (2014) responded to Gong et al. (2014) and highlighted the context-dependent nature of behavioral responses to acoustic stressors.

    Furthermore, the three predominant acoustic sources used by the NEFSC produce frequencies above the known functional hearing ranges for mysticetes. Mysticetes, including the humpback whale, are not likely to perceive most signals produced through the NEFSC's use of active acoustic sources and are therefore unlikely to behaviorally respond in a manner considered take. The NEFSC's initial estimates of Level B harassment due to acoustic sources did not consider functional hearing ranges and are therefore overestimates for mysticetes. For the final rule, NMFS has considered functional hearing and has revised the expected take for mysticetes accordingly.

    Comment 10: HSUS/WDC commented on NMFS corrections to the proposed rule that increased the projected mortality estimates for gray and harbor seals and sought clarification on the proposed increase in take for both species.

    Response: The NEFSC reported an interaction with one gray seal during a Spring Bottom Trawl Survey in April 2015, after releasing their LOA application and Draft PEA for public comment. In order to account for the potential for future gear interaction indicated by this event, NMFS included this information within the notice of proposed rulemaking (80 FR 39582, July 9, 2015; see Table 4, footnote 2). NMFS then used this information to adjust the estimated take by mortality for gray seals and harbor seals (a species with potential similar gear vulnerability as the gray seal) accordingly in the Federal Register notice of correction (80 FR 46939, August 6, 2015).

    Mitigation

    In order to issue an incidental take authorization under section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for subsistence uses.” NMFS provided a full description of the planned mitigation measures, including background discussion related to certain elements of the mitigation plan, in the notice of proposed rulemaking (80 FR 39595, July 9, 2015). Please see that document for more detail.

    General Measures

    Coordination and communication—We require that the NEFSC take all necessary measures to coordinate and communicate in advance of each specific survey with NOAA's Office of Marine and Aviation Operations (OMAO), or other relevant parties, to ensure that all mitigation measures and monitoring requirements described herein, as well as the specific manner of implementation and relevant event-contingent decision-making processes, are clearly understood and agreed-upon. This may involve describing all required measures when submitting cruise instructions to OMAO or when completing contracts with external entities. The NEFSC will coordinate and conduct briefings at the outset of each survey and as necessary between ship's crew (commanding officer/master or designee(s), as appropriate) and scientific party in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures. The chief scientist (CS) will be responsible for coordination with the Officer on Deck (OOD; or equivalent on non-NOAA platforms) to ensure that requirements, procedures, and decision-making processes are understood and properly implemented.

    For all NEFSC-affiliated research projects and vessels, the vessel coordinator and center director reviews cruise instructions and protocols for avoiding adverse interactions with protected species. If the research is conducted on a NOAA vessel, the Commanding Officer finalizes these instructions. If any inconsistencies or deficiencies are found, the written instructions will be made fully consistent with the Northeast Fisheries Observer Program (NEFOP) training materials and any guidance on decision-making that arises out of the training opportunities described earlier. In addition, the NEFSC will review informational placards and reporting procedures and update them as necessary for consistency and accuracy. Many research cruises already include pre-sail review of protected species protocols. The NEFSC will require pre-sail briefings before all research cruises, including those conducted by cooperating partners, as part of its continuing research program.

    Protected species training—In an effort to help standardize and further emphasize the importance of protected species information, the NEFSC will implement a formalized protected species training program for all crew members as part of its continuing research program that will be required for all NEFSC-affiliated research projects, including cooperative research partners. The NEFSC will conduct training programs on a regular basis which will include topics such as monitoring and sighting protocols, species identification, decision-making factors for avoiding take, procedures for handling and documenting protected species caught in research gear, and reporting requirements. Required training will occur through participation in protected species training programs developed by the regional commercial Fisheries Observer Program, which will typically be the NEFOP.

    All NEFSC research crew members that may be assigned to monitor for the presence of marine mammals during future surveys will be required to attend an initial training course and refresher courses annually or as necessary. The implementation of this new training program will formalize and standardize the information provided to all crew that might experience protected species interactions during research activities.

    Vessel speed—Vessel speed during active sampling rarely exceeds 5 kt, with typical speeds being 2 to 4 kt. Transit speeds vary from 6 to 14 kt but average 10 kt. These low vessel speeds minimize the potential for ship strike (see “Potential Effects of the Specified Activity on Marine Mammals and Their Habitat” for an in-depth discussion of ship strike). At any time during a survey or in transit, if a crew member standing watch or dedicated marine mammal observer sights marine mammals that may intersect with the vessel course, that individual will immediately communicate the presence of marine mammals to the bridge for appropriate course alteration or speed reduction, as possible, to avoid incidental collisions.

    Other gears—The NEFSC deploys a wide variety of gear to sample the marine environment during all of their research cruises. Many of these types of gear (e.g., plankton nets, video camera and ROV deployments) are not considered to pose any risk to marine mammals and are therefore not subject to specific mitigation measures. In addition, specific aspects of gear design, survey protocols (e.g., number of hooks), and limited frequency of use indicate that certain types of gears that may otherwise be expected to have the potential to result in take of marine mammals do not pose significant risk to certain species of marine mammals (e.g., large whales interactions with NEFSC longline gears) and are not subject to specific mitigation measures due to the low level of survey effort and small survey footprint relative to that of commercial fisheries. However, at all times when the NEFSC is conducting survey operations at sea, the OOD and/or CS and crew will monitor for any unusual circumstances that may arise at a sampling site and use best professional judgment to avoid any potential risks to marine mammals during use of all research equipment.

    Handling procedures—The NEFSC will implement a number of handling protocols to minimize potential harm to marine mammals that are incidentally taken during the course of fisheries research activities. In general, protocols have already been prepared for use on commercial fishing vessels. Because incidental take of marine mammals in fishing gear is similar for commercial fisheries and research surveys, NEFSC proposes to adopt these protocols, which are expected to increase post-release survival. In general, following a “common sense” approach to handling captured or entangled marine mammals will present the best chance of minimizing injury to the animal and of decreasing risks to scientists and vessel crew. Handling or disentangling marine mammals carries inherent safety risks, and using best professional judgment and ensuring human safety is paramount. The NEFSC protected species training programs will include procedures for handling and documenting protected species caught in research gear, and reporting requirements. The CS and appropriate members of the research crews will also be trained using the same monitoring, data collection, and reporting protocols for protected species as is required by the NEFOP.

    Trawl Survey Visual Monitoring and Operational Protocols

    The mitigation requirements described here are applicable to all beam, mid-water, and bottom trawl operations conducted by the NEFSC.

    Visual monitoring—The OOD, CS (or other designated member of the Scientific Party), and crew standing watch on the bridge visually scan for marine mammals (and other protected species) during all daytime operations. Marine mammal watches will be conducted by scanning the surrounding waters with bridge binoculars to survey the area upon arrival at the station, during visual and sonar reconnaissance of the trawl line to look for potential hazards (e.g., commercial fishing gear, unsuitable bottom for trawling, etc.), and while the gear is deployed. During nighttime operations, visual observation will be conducted using the naked eye, to the extent allowed by available vessel lighting.

    Operational procedures—The primary purpose of conducting visual monitoring period is to implement the “move-on rule.” If marine mammals are sighted around the vessel before setting the gear, the OOD may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. During daytime trawl operations, research trawl gear is not deployed if marine mammals have been sighted near the ship unless those animals do not appear to be in danger of interactions with the trawl, as determined by the judgment of the OOD and CS. The efficacy of the move-on rule is limited during night time trawl operations or other periods of limited visibility. However, operational lighting from the vessel illuminates the water in the immediate vicinity of the vessel during gear setting and retrieval.

    After moving on, if marine mammals are still visible from the vessel and appear to be at risk, the OOD may decide to move the vessel again or skip the sampling station. The OOD will consult with the CS or other designated scientist (identified prior to the voyage and noted on the cruise plan) and other experienced crew as necessary to determine the best strategy to avoid potential takes of these species. Strategies are based on the species encountered, their numbers and behavior, their position and vector relative to the vessel, and other factors. For instance, a whale transiting through the area and heading away from the vessel may not require any move, or may require only a short move from the initial sampling site, while a pod of dolphins gathered around the vessel may require a longer move from the initial sampling site or possibly cancellation of the station if the dolphins follow the vessel. If trawling operations have been delayed because of the presence of marine mammals, then the vessel resumes trawl operations (when practical) only when the animals have not been sighted near the vessel or otherwise determined to no longer be at risk. This decision is at the discretion of the OOD and is situationally dependent.

    In general, trawl operations will be conducted immediately upon arrival on station in order to minimize the time during which marine mammals may become attracted to the vessel. However, in some cases it will be necessary to conduct small net tows (e.g., bongo net) prior to deploying trawl gear in order to avoid trawling through extremely high densities of gelatinous zooplankton that can damage trawl gear.

    Once the trawl net is in the water, the OOD, CS, and/or crew standing watch will continue to visually monitor the surrounding waters and will maintain a lookout for marine mammal presence as far away as environmental conditions allow.

    If marine mammals are sighted before the gear is fully retrieved, the most appropriate response to avoid marine mammal interaction will be determined by the professional judgment of the CS, watch leader, OOD and other experienced crew as necessary. This judgment will be based on past experience operating trawl gears around marine mammals (i.e., best professional judgment) and on NEFSC training sessions that will facilitate dissemination of expertise operating in these situations (e.g., factors that contribute to marine mammal gear interactions and those that aid in successfully avoiding such events). Best professional judgment takes into consideration the species, numbers, and behavior of the animals, the status of the trawl net operation (e.g., net opening, depth, and distance from the stern), the time it would take to retrieve the net, and safety considerations for changing speed or course. We recognize that it is not possible to dictate in advance the exact course of action that the OOD or CS should take in any given event involving the presence of marine mammals in proximity to an ongoing trawl tow, given the sheer number of potential variables, combinations of variables that may determine the appropriate course of action, and the need to consider human safety in the operation of fishing gear at sea. Nevertheless, we require a full accounting of factors that shape both successful and unsuccessful decisions and these details will be fed back into NEFSC training efforts and ultimately help to refine the best professional judgment that determines the course of action taken in any given scenario (see further discussion in “Monitoring and Reporting”).

    Speed and course alterations, Tow duration and direction—The vessel's speed during active sampling with trawl nets will not exceed 5 kt. Typical towing speeds are 2-4 kt. Transit speed between active sampling stations will range from 10-12 kt, except in areas where vessel speeds are regulated to lower speeds. When operating in North Atlantic right whale Seasonal Management Areas, Dynamic Management Areas, or in the vicinity of right whales or surface active groups of large baleen whales the vessel's speed will not exceed 10 kt. Further, vessels will reduce speed and change course in the vicinity of resting groups of large whales.

    As noted earlier, if marine mammals are sighted prior to deployment of the trawl net, the vessel may be moved away from the animals to a new station at the discretion of the OOD. Also, at any time during a survey or in transit, any crew member that sights marine mammals that may intersect with the vessel course will immediately communicate their presence to the bridge for appropriate course alteration or speed reduction as possible to avoid incidental collisions.

    Standard survey protocols that are expected to lessen the likelihood of marine mammal interactions include standardized tow durations and distances. Standard tow durations of not more than 30 minutes at the target depth will be implemented, excluding deployment and retrieval time (which may require an additional 30 minutes, depending on target depth), to reduce the likelihood of attracting and incidentally taking marine mammals. Short tow durations decrease the opportunity for marine mammals to find the vessel and investigate. The exceptions to the 30-minute tow duration are the Atlantic Herring Acoustic Pelagic Trawl Survey and the Deep-Water Biodiversity Survey where the total time in the water (deployment, fishing, and haul-back) are 40 to 60 minutes and 180 minutes, respectively.

    Trawl tow distances will be less than 3 nm—typically 1-2 nm, depending on the specific survey and trawl speed—which NMFS expects to reduce the likelihood of attracting and incidentally taking marine mammals.

    Gear maintenance—The crew will be careful when emptying the trawl to avoid damage to marine mammals that may be caught in the gear but are not visible upon retrieval. The gear will be emptied as quickly as possible after retrieval in order to determine whether or not marine mammals are present. The vessel's crew will clean trawl nets prior to deployment to remove prey items that might attract marine mammals. Catch volumes are typically small with every attempt made to collect all organisms caught in the trawl.

    Dredge Survey Visual Monitoring and Operational Protocols

    The mitigation requirements described here are applicable to all hydraulic, New Bedford-type, commercial, and Naturalist dredge operations conducted by the NEFSC.

    Visual monitoring—Visual monitoring requirements for all dredge gears are the same as those described above for trawl surveys. Please see that section for full details of the visual monitoring and “move-on” protocols. However, care will be taken when emptying the dredge to avoid damage to protected species that may be caught in the gear but are not visible upon retrieval. The gear will be emptied as quickly as possible after retrieval in order to determine whether or not protected species are present.

    Tow duration and direction—Standard dredge durations are 15 minutes or less, excluding deployment and retrieval time, to reduce the likelihood of attracting and incidentally taking protected species.

    Longline Gear Visual Monitoring and Operational Protocols

    Visual monitoring—Visual monitoring requirements for pelagic or demersal longline surveys are the same as those described above for trawl surveys. Please see that section for full details.

    Operational procedures—Prior to setting the gear, the OOD, CS, and crew visually scan the waters surrounding the vessel for protected species at least 30 minutes before deploying the longline gear. This typically occurs during transit through the setting area and then returning back to the starting point. Longline sets may be delayed if marine mammals have been detected near the vessel in the 30 minutes prior to setting the gear.

    For the Apex Predators Bottom Longline Coastal Shark Survey, which has a separate survey protocol from the COASTSPAN and NEFOP Observer Bottom Longline Training surveys conducted by NEFSC, the OOD, CS, and crew use a one nautical mile radius around the vessel to guide the decision on whether marine mammals are at risk of interactions before deploying the gear. The vessel may be moved to a new location if marine mammals are present and the OOD uses professional judgment to minimize the risk to marine mammals from potential gear interactions.

    The OOD, CS, and crew standing watch will continually monitor the gear to look for hooked or entangled marine mammals and other protected species and will release the animal following standard handling and release protocols for marine mammals.

    The NEFSC has established standard soak times of three hours for bottom longline and two to five hours for pelagic longline surveys. The CS will ensure that soak times do not exceed five hours, except in cases where weather or mechanical difficulty delay gear retrieval.

    NEFSC longline protocols specifically prohibit chumming (releasing additional bait to attract target species to the gear). Bait is removed from hooks during retrieval and retained on the vessel until all gear is removed from the area. The crew will not discard offal or spent bait while longline gear is in the water to reduce the risk of marine mammals detecting the vessel or being attracted to the area.

    If marine mammals are detected while longline gear is in the water, the OOD exercises similar judgment and discretion to avoid incidental take of marine mammals as described for trawl gear. The species, number, and behavior of the marine mammals are considered along with the status of the ship and gear, weather and sea conditions, and crew safety factors.

    If marine mammals are present during setting operations, immediate retrieval or halting the setting operations may be warranted. If setting operations have been halted due to the presence of marine mammals, resumption of setting will not begin until no marine mammals have been observed for at least 15 minutes. When visibility allows, the OOD, CS, and crew standing watch will conduct set checks every 15 minutes to look for hooked, or entangled marine mammals.

    If marine mammals are present during retrieval operations, haul-back will be postponed until the OOD determines that it is safe to proceed. If haul-back operations have been halted due to the presence of marine mammals, resumption of haul-back would begin when no marine mammals have been observed for at least 15 minutes. When visibility allows, the OOD, CS, and crew standing watch will conduct set checks every 15 minutes to look for hooked, trapped, or entangled marine mammals.

    Gillnet Visual Monitoring and Operational Protocols

    Visual monitoring—The monitoring procedures for gillnets are similar to those described for trawl gear. The NEFSC does not propose to use pelagic gillnets in any survey.

    Operational procedures—Gillnets are not deployed if marine mammals have been sighted on arrival at the sample site. The exception is for animals that, because of their behavior, travel vector or other factors, do not appear to be at risk of interaction with the gillnet gear. If no marine mammals are present, the gear is set and monitored during the soak. If a marine mammal is sighted during the soak and appears to be at risk of interaction with the gear, then the gear is pulled immediately.

    For the COASTSPAN surveys, which are performed in areas where estuarine dolphins may occur, the NEFSC will actively monitor for potential bottlenose dolphin entanglements by hand checking the gillnet gear every 20 minutes by lifting the foot net. Also, in the unexpected case of a bottlenose dolphin entanglement, the NEFSC would request and arrange for expedited genetic sampling in order to determine the stock and would photograph the dorsal fin and submit to the Southeast Stranding Coordinator for identification/matching to bottlenose dolphins in the Mid-Atlantic Bottlenose Dolphin Photo-identification Catalog.

    On the NEFOP Observer Gillnet Training cruises, which occur in areas covered by the HPTRP, acoustic pingers and weak links are used on all gillnets consistent with the Harbor Porpoise Take Reduction Plan regulations at (50 CFR 229.33) for commercial fisheries to reduce marine mammal bycatch. Under the HPTRP, gillnet gear used in specific areas during specific times are required to be equipped with pingers. We discuss the use of pingers and their acoustic characteristics later within the subsection titled “Cooperative Research Visual Monitoring and Operational Protocols.”

    All NEFOP protocols concerning monitoring and reporting protected species interactions are followed as per the current NEFOP Observer Manual (available on the internet at http://www.nefsc.noaa.gov/fsb/manuals/2013/NEFSC_Observer_Program_Manual.pdf). The soak duration time is 12 to 24 hours. Communication with the NEFOP Training Lead and the vessel captain occurs within 24 to 48 hours prior to setting of gear. During these communications, the NEFOP Training Lead and Captain decide when to set the gear, specifically taking into account any possible weather delays to avoid a long soak period. They do not deploy the gear if a significant weather delay is expected that would increase the preferred soak duration to greater than 24 hours. In those situations, the gear set times will be delayed.

    Fyke Net Visual Monitoring and Operational Protocols

    Visual monitoring—Fyke nets are normally set inshore by small boat crews, who will visually survey areas prior to deploying the nets. Monitoring is done prior to setting and during net retrieval which is conducted every 12 to 24-hours. If marine mammals are in close proximity (approximately 100 m) of the setting location, the field team will make a determination if the set location needs to be moved. If marine mammals are observed to interact with the gear during the setting, the crew will lift and remove the gear from the water.

    Operational procedures—A 2-m fyke net will be deployed with a marine mammal excluder device that reduces the effective mouth opening to less than 15 cm. The 1-m fyke net does not require an excluder device as the opening is 12 cm. These small openings will prevent marine mammals from entering the nets.

    Beach Seine Visual Monitoring and Operational Protocols

    Visual monitoring—Prior to setting the seine nets, researchers will visually survey the area for marine mammals. They will also observe for marine mammals continuously during sampling.

    Operational procedures—Seines are deployed with one end held on shore by a crew member and the net slowly deployed by boat in an arc and then retrieved by pulling both ends onto shore. Typical seine hauls are less than 15 minutes with the resulting catch sampled and released. Scientists will look as far as field of view permits from the beach in the general sampling area before the net is fished and will not deploy if marine mammals are present. If marine mammals are observed to be interacting with the gear, it will be lifted and removed from the water.

    Rotary Screw Trap Visual Monitoring and Operational Protocols

    Visual monitoring—Sites are visually surveyed for marine mammals prior to submerging the gear in the water channel. The traps remain in the water for an extended period of time and sampling crews tend the traps on a daily basis. The researchers will modify, delay, or conclude the sampling period depending on the numbers of marine mammals nearby and their potential for interacting with the gear as determined by the professional judgment of the researchers.

    Operational procedures—Under most conditions the live car (i.e., catch holding pen) is about 75 percent full of water, which would allow any trapped mammals to breath until release from the trap. Rotary screw trap tending schedules are adjusted according to conditions of the river/estuary and threats to protected species (i.e., presence of ESA-listed fish or marine mammals in the area). If capture occurs, the animal is temporarily retained in a live tank and released as soon as possible.

    Cooperative Research Visual Monitoring and Operational Protocols

    The mitigation requirements described earlier are applicable to commercial fishing vessels engaged in NEFSC cooperative research using trawls, dredges, longline, hook and line, lobster pots/traps, and gillnet gears.

    These commercial fishing vessels are significantly smaller than the NOAA vessels, and depending on their size and configuration, marine mammal sighting may be difficult to make during all aspects of fishing operations. Further, scientific personnel are normally restricted from the deck during gear setting and haul-back operations. For all vessel size classes, it is unlikely that the individual(s) searching for marine mammals will have unrestricted 360 degree visibility around the vessel. However, observations during approach to a fishing station and during gear setting and haul-back may be feasible and practicable from the wheelhouse.

    These projects will also comply with the TRP mitigation measures and gear requirements specified for their respective fisheries and areas (e.g., pingers, sinking groundlines, and weak links on gillnet gear).

    The NEFSC will review all NEFSC-affiliated research instructions and protocols for avoiding adverse interactions with protected species. If those instructions/protocols are not fully consistent with NEFOP training materials and guidance on decision-making that arises from NEFSC protected species training, the NEFSC will incorporate specific language into its contracts and agreements with NEFSC-affiliated research partners requiring adherence to all required training requirements, operating procedures, and reporting requirements for protected species.

    Operational procedures—For the Apex Predators Bottom Longline Coastal Shark and COASTSPAN longline and gillnet surveys, NEFSC partners would implement the Move-on-Rule. During the soak, the line is run and if any marine mammals are sighted the line is pulled immediately. On COASTSPAN gillnet surveys, gillnets are continuously monitored during the 3-hour soak time by under-running it, pulling it across the boat while leaving the net ends anchored. All animals, algae and other objects are removed with each pass as the net is reset into the water to minimize bycatch mortality.

    Acoustic deterrent devices—NEFSC-affiliated cooperative research projects involving commercial vessels and gear, as well as the NEFOP Observer Training Gillnet Surveys currently deploy acoustic pingers on anchored sinking gillnets in areas where they are required by commercial fisheries to comply with requirements in the HPTRP (50 CFR 229.33). We considered the use of pingers in our notice of proposed rulemaking (80 FR 39558, July 9, 2015) and we do not discuss the potential taking of marine mammals resulting from NEFSC's use of pingers further in this document.

    Pot/Trap Visual Monitoring and Operational Protocols

    Several NEFSC and cooperative research surveys use fish or lobster pots to selectively capture species for research, tagging studies, and sample collection. Fish pots select for particular species by configuring the entrances, mesh, and escape tunnels (or “vents”) to allow retention of the target species, while excluding larger animals, and allowing smaller animals to escape from the pot before retrieval.

    Visual monitoring—The NEFSC and/or cooperating institutions shall initiate marine mammal watches (visual observation) no less than 30 minutes prior to both deployment and retrieval of the pot and trap gear. Marine mammal watches shall be conducted by scanning the surrounding waters with the naked eye and binoculars (or monocular). During nighttime operations, visual observation shall be conducted using the naked eye and available vessel lighting.

    Operational Procedures—The NEFSC and/or cooperating institutions shall deploy pot gear as soon as is practicable upon arrival at the sampling station. The primary purpose of conducting a visual monitoring period is to implement the “move-on rule.” The NEFSC and/or cooperating institutions shall implement the move-on rule. If marine mammals are sighted near the vessel before setting the gear, the NEFSC, as appropriate may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, the NEFSC may decide to move again or to skip the station. The NEFSC may use best professional judgment in making this decision but may not elect to conduct the pot and trap activity when animals remain near the vessel.

    If marine mammals are sighted near the vessel during the soak and are determined to be at risk of interacting with the gear, then the NEFSC and/or cooperating institutions shall carefully retrieve the gear as quickly as possible. The NEFSC and/or cooperating institutions may use best professional judgment in making this decision.

    The NEFSC and/or cooperating institutions shall ensure that surveys deploy gear fulfilling all pot/trap universal commercial gear configurations such as weak link requirements and marking requirements as specified by applicable take reduction plans as required for commercial pot/trap fisheries.

    The NEFSC shall ensure that cooperating institutions conducting pot and trap surveys adhere to monitoring and mitigation requirements and shall include required protocols in all survey instructions, contracts, and agreements.

    Acoustic Telemetry Gear Visual Monitoring and Operational Protocols

    The NEFSC deploys passive acoustic telemetry receivers in many of Maine's rivers, estuaries, bays and into the Gulf of Maine. These receivers monitor tagged Atlantic salmon, as well as other tagged animals of collaborators along the east coast.

    Visual monitoring—The receivers are set by small boat crews that visually survey the area for marine mammals prior to setting. Interactions with the gear or boats are not expected.

    Operational Procedures—Receivers are anchored using a 24-pound mushroom anchor or a 79-pound cement mooring and attached to a surface float by an 11/16 inch sinking pot warp with a weight rating of 1,200 pounds. Units in the estuary and bay are equipped with whale-safe weak links with a weight rating of 600 pounds. Other receivers are deployed on coastal commercial lobstermen's fishing gears which comply with fishing regulations for nearshore operations. The receivers are recovered twice annually, but the traps are tended according to required fishing schedules of the fishery.

    We have carefully evaluated the NEFSC's planned mitigation measures and considered a range of other measures in the context of ensuring that we prescribed the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.

    Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed here:

    (1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    (2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

    (3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

    (4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only).

    (5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.

    (6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the NEFSC's planned measures, as well as other measures considered, NMFS has determined that these mitigation measures provide the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Description of Marine Mammals in the Area of the Specified Activity

    NMFS previously reviewed the NEFSC species descriptions—which summarize available information regarding status and trends, distribution and habitat preferences, behavior and life history, and auditory capabilities of the potentially affected species—for accuracy and completeness and refer the reader to Sections 3 and 4 of the NEFSC's application, as well as to NMFS' Stock Assessment Reports (SARs; www.nmfs.noaa.gov/pr/sars/). We also provided information related to all species with expected potential for occurrence in the specified geographical region where the NEFSC plans to conduct the specified activities, summarizing information related to the population or stock, including PBR. Please see Table 3 in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) for that information. We do not repeat that information here.

    Potential Effects of the Specified Activity on Marine Mammals and Their Habitat

    NMFS provided a summary and discussion of the ways that components of the specified activity (e.g., gear deployment, use of active acoustic sources, and visual disturbance) may impact marine mammals and their habitat in the notice of proposed rulemaking (80 FR 39595, July 9, 2015). Specifically, we considered potential effects to marine mammals from ship strike, physical interaction with various gear types, use of active acoustic sources, and visual disturbance of pinnipeds, as well as effects to prey species and to acoustic habitat. We do not repeat that information here.

    Estimated Take by Incidental Harassment, Serious Injury, or Mortality

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].” Serious injury means any injury that will likely result in mortality (50 CFR 216.3).

    Take of marine mammals incidental to the NEFSC's research activities could occur as a result of: (1) Injury or mortality due to gear interaction; (2) behavioral disturbance resulting from the use of active acoustic sources (Level B harassment only); or (3) behavioral disturbance of pinnipeds hauled out on the shoreline resulting from close proximity of research vessels (Level B harassment only).

    Estimated Take Due to Gear Interaction

    Historical Interactions—In order to estimate the number of potential incidents of take that could occur by M/SI + Level A through gear interaction, we first considered the NEFSC's past record of such incidents, and then also considered other species that may have similar vulnerabilities to the NEFSC's trawl, gillnet, and fyke net gear for which we have historical interaction records. We describe historical interactions with NEFSC research gear in Tables 1, 2, and 3 in this rule. Available records are for the years 2004 through the present. Please see the NEFSC's Final PEA for specific locations of these incidents.

    Table 1—Historical Interactions With Trawl Gear Gear Survey Date Species Number killed Number released alive Total Gourock high speed midwater rope trawl Atlantic Herring Survey 10/8/2004 Short-beaked common dolphin (Western NA stock) 2 0 2 Bottom trawl (4-seam, 3 bridle) NEFSC Standard Bottom Trawl Survey 11/11/2007 Short-beaked common dolphin (Western NA stock) 1 0 1 Gourock high speed midwater rope trawl Atlantic Herring Survey 10/11/2009 Minke whale 0 1 1 1 Bottom trawl (4-seam, 3 bridle) Spring Bottom Trawl Survey 4/4/2015 Gray seal 1 2 0 1 Total individuals captured (total number of interactions given in parentheses) Short-beaked common dolphin (3)
  • Minke whale (1)
  • 3
  • 0
  • 0
  • 1
  • 3
  • 1
  • Gray seal (1) 1 0 1 1 According to the incident report, “The net's cod end and whale were brought aboard just enough to undo the cod end and free the whale. It was on deck for about five minutes. While on deck, it was vocalizing and moving its tail up and down. The whale swam away upon release and appeared to be fine. Estimated length was 19 feet.″ The NEFSC later classified this incidental take as a serious injury using NMFS criteria for such determinations published in January 2012 (Cole and Henry, 2013). 2 The NEFSC filed an incident report for this incidental take on April 4, 2015.
    Table 2—Historical Interactions with Gillnet Gear Gear Survey Date Species Number killed Number released alive Total Gillnet COASTSPAN 11/29/2008 Common Bottlenose dolphin (Northern South Carolina Estuarine System stock) 1 1 0 1 Gillnet NEFOP Observer Gillnet Training Trips 5/4/2009 Gray seal 1 0 1 Gillnet NEFOP Observer Gillnet Training Trips 5/4/2009 Harbor porpoise 1 0 1 Total individuals captured (total number of interactions given in parentheses) Bottlenose dolphin (1)
  • Gray seal (1)
  • 1
  • 1
  • 0
  • 0
  • 1
  • 1
  • Harbor porpoise (1) 1 0 1 1 In 2008, the COASTSPAN gillnet survey caught and killed one common bottlenose dolphin while a cooperating institution was conducting the survey in South Carolina. This was the only occurrence of incidental take in these surveys. Although no genetic information is available from this dolphin, based on the location of the event, NMFS retrospectively assigned this mortality to the Northern South Carolina Estuarine System stock in 2015 from the previous classification as the western North Atlantic stock (Waring et al., 2014).
    Table 3—Historical Interactions With Fyke Net Gear Gear Survey Date Species Number killed Number released alive Total Fyke Net Maine Estuaries Diadromous Survey 10/25/2010 Harbor seal 1 0 1 Total 0 1 0 1

    The NEFSC has no recorded interactions with any gear other than midwater and bottom trawl, gillnet, and fyke net gears. As noted in the notice of proposed rulemaking (80 FR 39595, July 9, 2015), we anticipate future interactions with the same gear types.

    In order to use these historical interaction records in a precautionary manner as the basis for the take estimation process, and because we have no specific information to indicate whether any given future interaction might result in M/SI versus Level A harassment, we conservatively assume that all interactions equate to mortality.

    During trawl surveys, the NEFSC has recorded interactions with short-beaked common dolphins (Western North Atlantic stock; two total interactions with three individual animals); minke whale (one total interaction with one animal); and gray seal (one total interaction with one animal). Common dolphins are the species most likely to interact with NEFSC trawl gear with an average of 1.5 dolphins captured per interaction.

    During gillnet surveys, the NEFSC has recorded interactions with short-beaked common dolphins (Northern South Carolina Estuarine System stock; one total interaction with one animal); gray seal (one total interaction with one animal); and harbor porpoise (one total interaction with one animal).

    During one fyke net survey in 2010, the NEFSC recorded one interaction with one harbor seal. Since this recorded interaction, the NEFSC now requires the use of marine mammal excluder devices as a mitigation measure for this gear type.

    In order to produce the most precautionary take estimates possible, we use here the entirety of the data available to us (i.e., 2004-15).

    In order to estimate the potential number of incidents of M/SI + Level A that could occur incidental to the NEFSC's use of midwater and bottom trawl, gillnet, fyke net, and longline gear in the Atlantic coast region over the five-year period from 2015-20, we first look at the six species described that have been taken historically and then evaluate the potential vulnerability of additional species to these gears.

    Table 4 in this document shows the 11-year annual average captures of these six species and the projected five-year totals for this final rule, for trawl, gillnet, and fyke net gear. In order to produce precautionary estimates, we calculate the annual average for the 11-year period (2004-2015) and round up the annual to the nearest whole number. Because the NEFSC requests take for a five-year period, we multiply the annual average by five and assume that this number may be taken within the effective five-year period of the proposed authorization.

    To date, infrequent interactions of trawl nets, gillnets, and fyke net gears with marine mammals have occurred in the Atlantic coast region during NEFSC research activities. The NEFSC interaction rates have exhibited some inter-annual variation in numbers, possibly due to changing marine mammal densities and distributions and dynamic oceanographic conditions. This approach is precautionary. Estimating takes of species captured historically will produce an estimate higher than the historic average take for each species taken incidentally during past NEFSC research. We use this methodology to ensure accounting for the maximum amount of potential take in the future, as well as accounting for the fluctuations in inter-annual variability observed during the 11-year time period. Moreover, these estimates are based on the assumption that annual effort over the proposed five-year authorization period will not exceed the annual effort during the period 2004-2015.

    Table 4—Annual Average Captures (2004-15) and Projected Five-Year Total for Historically-Captured Species Gear Species 2004 05 06 07 08 09 10 11 12 13 14 15 Avg. per year Projected
  • 5-year
  • total 1
  • Trawl Short-beaked common dolphin 2 0 0 1 0 0 0 0 0 0 0 0 0.27 5 Minke whale 0 0 0 0 0 1 0 0 0 0 0 0 0.09 5 Gray seal 0 0 0 0 0 0 0 0 0 0 0 1 0.09 5 Gillnet Common bottlenose dolphin 0 0 0 0 1 0 0 0 0 0 0 0 0.09 2 5 Harbor porpoise 0 0 0 0 0 1 0 0 0 0 0 0 0.09 5 Gray seal 0 0 0 0 0 1 0 0 0 0 0 0 0.09 5 Fyke net Harbor seal 0 0 0 0 0 0 1 0 0 0 0 0 0.09 5 1 The estimated total is the product of the 2004-2015 annual average rounded up to the nearest whole number and multiplied by the five-year timespan of the proposed rule. 2 The projected 5-year total includes an estimate of 5 each for the Western North Atlantic offshore, the Western North Atlantic Northern Migratory Coastal, and the Western North Atlantic Southern Migratory Coastal stocks of common bottlenose dolphins. The NEFSC is not requesting take for the estuarine stocks of bottlenose dolphins for the COASTPAN surveys.

    As background to the process of determining which species not historically taken may have sufficient vulnerability to capture in NEFSC gear to justify inclusion in the take authorization request, we note that the NEFSC is NMFS' research arm in the Greater Atlantic region which we consider as a leading source of expert knowledge regarding marine mammals (e.g., behavior, abundance, density) in the areas where the NEFSC operates. The NEFSC formulated the take requests for species selected by NEFSC subject matter experts who based their selections on the best available information. We have concurred with these decisions.

    In order to evaluate the potential vulnerability of additional species to trawl gears, gillnets, and fyke nets, we first consulted NMFS' List of Fisheries (LOF), which classifies U.S. commercial fisheries into one of three categories according to the level of incidental marine mammal M/SI that is known to occur on an annual basis over the most recent five-year period (generally) for which data has been analyzed. Despite no historical records of take in the NEFSC's pelagic and bottom longline surveys, there is a substantial record of marine mammal take in commercial fisheries using similar gears. Therefore, we consider potential takes through use of longline gear through analogy to commercial fisheries. NMFS provided this information, as presented in the 2015 LOF (79 FR 77919; January 28, 2015), in Tables 8, 9, and 10 in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) and do not reproduce it here.

    Information related to incidental M/SI in relevant commercial fisheries is not, however, the sole determinant of whether it may be appropriate to authorize M/SI + Level A incidental to NEFSC survey operations. A number of factors (e.g., species-specific knowledge regarding animal behavior, overall abundance in the geographic region, density relative to NEFSC survey effort, feeding ecology, propensity to travel in groups commonly associated with other species historically taken) were taken into account by the NEFSC to determine whether a species may have a similar vulnerability to certain types of gear as historically taken species. In some cases, we have determined that species without documented M/SI may nevertheless be vulnerable to capture in NEFSC research gear. We have also determined that some species groups with documented M/SI are not likely to be vulnerable to capture in NEFSC gear. In these instances, we provide further explanation later in this document. Those species with no records of historical interaction with NEFSC research gear and no documented M/SI in relevant commercial fisheries, and for which the NEFSC has not requested the authorization of incidental take, are not considered further in this section. The NEFSC believes generally that any sex or age class of those species for which take authorization is requested could be captured.

    Non-historical interactions—In addition to those species the NEFSC has directly interacted with research fishing gear over the 11-year period (2004-2015), the NEFSC believes it is appropriate to include estimates for future incidental takes of a number of species that have not been taken historically but inhabit the same areas and show similar types of behaviors and vulnerabilities to such gear as the “reference” species taken in the past. The NEFSC believes the potential for take of these other “analogous” species would be low and would occur rarely, if at all, based on lack of takes over the past 11 years.

    We note that prior takes in the cooperative research fishery are assigned to the respective fishery; therefore the NEFSC did not consider those types of take in formulating the requested authorization. The NEFSC only estimated takes for NEFSC gear that: (1) Had a prior take in the historical record or (2) had analogous takes with commercial fishing gear.

    Vulnerability of analogous species to different gear types is informed by the record of interactions by the analogous and reference species with commercial fisheries using gear types similar to those used in research. Furthermore, when determining the amount of take requested, we make a distinction between analogous species thought to have the same vulnerability for incidental take as the reference species and those analogous species that may have a similar vulnerability. In those cases thought to have the same vulnerability, the request is for the same number per year as the reference species. In those cases thought to have similar vulnerability, the request is less than the reference species. For example, the NEFSC believes the vulnerability of harbor seals to be taken in trawl gear and gillnets is the same as for gray seals (one per year) and thus requests one harbor seal per year (total of five over the authorization period) for trawl gear and gillnets.

    Alternatively, the potential for take of Atlantic white-sided dolphins in gillnets is expected to be similar but less than that associated with harbor porpoises (one per year) and the reduced request relative to this reference species is one Atlantic white sided dolphin over the entire five-year authorization period.

    The approach outlined here reflects: (1) Concern that some species with which we have not had historical interactions may interact with these gears, (2) acknowledgment of variation between sets, and (3) understanding that many marine mammals are not solitary so if a set results in take, the take could be greater than one animal. In these particular instances, the NEFSC estimates the take of these species to be equal to the maximum interactions per any given set of a reference species historically taken during 2004-2015.

    Trawls—To estimate the requested taking of analogous species, the NEFSC identified several species in the western North Atlantic Ocean which may have similar vulnerability to research-based trawls as the short-beaked common dolphin. The maximum take of short-beaked common dolphin was two individuals in one trawl set in 2004. Therefore, on the basis of similar vulnerability, the NEFSC estimates two potential takes over the five year authorization period for each of the following species in trawls: Risso's dolphin; common bottlenose dolphin (offshore and both northern and southern coastal migratory stocks); Atlantic-white-sided dolphin; white-beaked dolphin; Atlantic spotted dolphin; and harbor porpoise. For these species, we propose to authorize a total taking by M/SI + Level A of two individuals over the five-year timespan (see Table 5).

    Other dolphin species may have similar vulnerabilities as those listed above but because of the timing and location of NEFSC research activities, the NEFSC concluded that the likelihood for take of these species was low (see Tables 8, 9, and 10 in the notice of proposed rulemaking [80 FR 39595, July 9, 2015]). Those species include: Pantropical spotted dolphin; striped dolphin; Fraser's dolphin; rough-toothed dolphin; Clymene dolphin; and spinner dolphin.

    Two pinniped species may be taken in commercial fisheries analogous to NEFSC research trawl activities. Therefore, NEFSC requests one potential take each of gray and harbor seals annually in trawls over the LOA authorization period. For these pinniped species, we propose to authorize a total taking by M/SI + Level A of five individuals over the five-year timespan (see Table 5).

    Gillnets—To estimate the requested take of analogous species for gillnets, the NEFSC identified several species in the western North Atlantic Ocean which may have similar vulnerability to research-based gillnet surveys as the bottlenose dolphin due to similar behaviors and distributions in the survey areas.

    Gillnet surveys typically occur nearshore in bays and estuaries. The NEFSC caught one gray seal and one harbor porpoise during Northeast Fisheries Observer Program training gillnet surveys. The NEFSC believes that harbor seals have the same vulnerability to be taken in gillnets as gray seals and therefore estimates five takes of harbor seals in gillnets over the five-year authorization period. For this species, we propose to authorize a total taking by M/SI + Level A of five individuals over the five-year timespan (see Table 5).

    Likewise, the NEFSC believes that Atlantic white-sided dolphins and short-beaked common dolphins have a similar vulnerability to be taken in gillnets as harbor porpoise and bottlenose dolphins and estimates one take each of Atlantic white-sided dolphin and short-beaked common dolphin in gillnet gear over the five-year authorization period. For this species, we propose to authorize a total taking by M/SI + Level A of one individual over the five-year timespan (see Table 5).

    In 2008, the COASTSPAN gillnet survey caught and killed one common bottlenose dolphin while a cooperating institution was conducting the survey in South Carolina. This was the only occurrence of incidental take in these surveys. The NEFSC is not requesting any bottlenose dolphin takes from the Northern South Carolina Estuarine System stock, because of limited survey effort in estuarine waters. The NEFSC considers there to be a remote chance of incidentally taking a bottlenose dolphin from the estuarine stocks. Thus, the NEFSC is not requesting take for the estuarine stocks of bottlenose dolphins for the COASTPAN longline and gillnet surveys. However, in the future, if there is a bottlenose dolphin take from the estuarine stocks as confirmed by genetic sampling, the NEFSC will reconsider its take request in consultation and coordination with the NMFS Office of Protected Resources and the Atlantic Bottlenose Dolphin Take Reduction Team.

    Fyke nets—For fyke nets, the NEFSC believes that gray seals have a similar vulnerability for incidental take as harbor seals which interacted once in a single fyke net set during the past 11 years. For the period of this authorization, the NEFSC estimates one take annually by fyke net for gray and harbor seals over the five-year authorization period. Thus, for gray and harbor seals, we propose to authorize a total taking by M/SI + Level A of five individuals of harbor and gray seals over the five-year timespan (see Table 5).

    Longlines—While the NEFSC has not historically interacted with large whales or other cetaceans in its longline gear, it is well documented that some of these species are taken in commercial longline fisheries. The 2015 LOF classifies commercial fisheries based on prior interactions with marine mammals. Although the NEFSC used this information to help make an informed decision on the probability of specific cetacean and large whale interactions with longline gear, many other factors were also taken into account (e.g., relative survey effort, survey location, similarity in gear type, animal behavior, prior history of NEFSC interactions with longline gear, etc.). Therefore, there are several species that have been shown to interact with commercial longline fisheries but for which the NEFSC is not requesting take. For example, the NEFSC is not requesting take of large whales, long-finned pilot whales, and short-finned pilot whales in longline gear. Although these species could become entangled in longline gear, the probability of interaction with NEFSC longline gear is extremely low considering a low level of survey effort relative to that of commercial fisheries, the short length of the mainline, and low numbers of hooks used. Based on the amount of fish caught by commercial fisheries versus NEFSC fisheries research, the “footprint” of research effort compared to commercial fisheries is very small. The NEFSC considered previously caught species (as outlined in the 2015 List of Fisheries, see Tables 8, 9, and 10 in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) in analogous commercial fisheries to have a higher probability of take; however, all were not included for potential take by the NEFSC. Historically, marine mammals have never been caught or entangled in NEFSC longline gear. However, such gear could be considered analogous to potential commercial longline surveys that may be conducted elsewhere (e.g., Garrison, 2007; Roche et al., 2007; Straley et al., 2014). Given the potential for interactions, NEFSC estimates one take over the five-year authorization period of the following cetaceans in longline gear: Risso's dolphin; common bottlenose dolphin (offshore and both northern and southern coastal migratory stocks); and short-beaked common dolphins. For these species, we propose to authorize a total taking by M/SI + Level A of one individual over the five-year timespan (see Table 5).

    It is also possible that researchers may not be able to identify a captured animal to the species level with certainty. Certain pinnipeds and small cetaceans are difficult to differentiate at sea, especially in low-light situations or when a quick release is necessary. For example, a captured delphinid that is struggling in the net may escape or be freed before positive identification is made. Therefore, the NEFSC has requested the authorization of incidental M/SI + Level A for an unidentified delphinid by trawl (1 individual), gillnet (1 individual), and longline (1 individual) gears over the course of the five-year period of the proposed authorization. Similarly, the NEFSC has requested the authorization of incidental M/SI + Level A for an unidentified pinniped by trawl (1 individual), fyke net (1 individual), gillnet (1 individual), and longline (1 individual) gears.

    Table 5 summarizes total estimated take due to gear interactions in the Atlantic coast region; these estimates reflects revisions from those provided in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) and the correction to the proposed rulemaking in the Federal Register on August 6, 2015 (80 FR 46939).

    Table 5—Total Estimated M/SI + Level A Due to Gear Interaction in the Atlantic Coast Region, 2015-2020 Species Est. 5-year total, trawl 1 Est. 5-year total, gillnet 1 Est. 5-year total, longline 1 Est. 5-year total, fyke net 1 Total, all gears Minke whale 5 0 0 0 5 Risso's dolphin 2 0 1 0 3 Atlantic white-sided dolphin 2 1 0 0 3 White-beaked dolphin 2 0 0 0 2 Short-beaked common dolphin 5 1 1 0 7 Atlantic spotted dolphin 2 0 0 0 2 Common bottlenose dolphin
  • (WNA offshore stock) 2
  • 2 5 1 0 8
    Common bottlenose dolphin
  • (WNA N. Migratory stock) 2
  • 2 5 1 0 8
    Common bottlenose dolphin
  • (WNA S. Migratory stock) 2
  • 2 5 1 0 8
    Harbor porpoise 2 5 0 0 7 Unidentified delphinid 1 1 1 0 3 Harbor seal 5 5 0 5 15 Gray seal 5 5 0 5 15 Unidentified pinniped 1 1 1 1 4 1 Please see preceding text for derivation of take estimates. 2 The NEFSC is not requesting takes for the estuarine stocks of bottlenose dolphins for the COASTPAN surveys.
    Estimated Take Due to Acoustic Harassment

    As described in the notice of proposed rulemaking (80 FR 39595, July 9, 2015), we believe that NEFSC's use of active acoustic sources has, at most, the potential to cause Level B harassment of marine mammals. In order to attempt to quantify the potential for Level B harassment to occur, NMFS (including the NEFSC and acoustics experts from other parts of NMFS) developed an analytical framework considering characteristics of the active acoustic systems described in the notice of proposed rulemaking (80 FR 39595, July 9, 2015) under Description of Active Acoustic Sound Sources, their expected patterns of use in the Atlantic coast region, and characteristics of the marine mammal species that may interact with them. We believe that this quantitative assessment benefits from its simplicity and consistency with current NMFS acoustic guidance regarding Level B harassment but caution that, based on a number of deliberately precautionary assumptions, the resulting take estimates should be seen as a likely overestimate of the potential for behavioral harassment to occur as a result of the operation of these systems.

    The assessment paradigm for active acoustic sources used in NEFSC fisheries research is relatively straightforward and has a number of key simplifying assumptions. NMFS' current acoustic guidance requires in most cases that we assume Level B harassment occurs when a marine mammal receives an acoustic signal at or above a simple step-function threshold. For use of these active acoustic systems, the current threshold is 160 dB re 1 μPa (rms) for Level B harassment. Estimating the number of exposures at the 160-dB received level requires several determinations, each of which is described sequentially here:

    (1) A detailed characterization of the acoustic characteristics of the effective sound source or sources in operation;

    (2) The operational areas exposed to levels at or above those associated with Level B harassment when these sources are in operation;

    (3) A method for quantifying the resulting sound fields around these sources; and

    (4) An estimate of the average density for marine mammal species in each area of operation.

    Quantifying the spatial and temporal dimension of the sound exposure footprint (or “swath width”) of the active acoustic devices in operation on moving vessels and their relationship to the average density of marine mammals enables a quantitative estimate of the number of individuals for which sound levels exceed the relevant threshold for each area. The number of potential incidents of Level B harassment is ultimately estimated as the product of the volume of water ensonified at 160 dB rms or higher and the volumetric density of animals determined from simple assumptions about their vertical stratification in the water column. Specifically, reasonable assumptions based on what is known about diving behavior across different marine mammal species were made to segregate those that predominately remain in the upper 200 m of the water column versus those that regularly dive deeper during foraging and transit. We described the approach used (including methods for estimating each of the calculations described above) and the assumptions made that result in conservative estimates in significant detail in our notice of proposed rulemaking (80 FR 39595, July 9, 2015), and do not repeat the discussion here.

    As a result of discussion with NMFS subject matter experts in drafting the final rule, we have determined it appropriate to account for marine mammal functional hearing, although our consideration of functional hearing is fairly simplistic. We now consider functional hearing cut-offs (i.e., ranges of the functional hearing groups described in the notice of proposed rulemaking [80 FR 39595, July 9, 2015] and in Southall et al. [2007]) in a straightforward manner in these calculations (i.e., sources are considered unlikely to lead to any Level B harassment if they are above or below functional hearing cut-offs). The result of this consideration is recognition that mysticetes are unlikely to perceive these signals; therefore, receipt of the signal would be highly unlikely to result in any reaction considered to be harassment.

    However, the known differences in hearing sensitivities between different marine mammal species, and within a functional hearing range (e.g., as reflected in auditory weighting functions), are not considered in estimates of Level B harassment by acoustic sources. All species are assumed to be equally sensitive to acoustic systems operating within their functional hearing range; therefore, the quantitative results presented here remain conservative with respect to functional hearing. We provide a summary of the results in Table 6.

    Table 6—Densities and Estimated Source-, Stratum-, and Species-Specific Annual Estimates of Level B Harassment in the Atlantic Coast Region and Adjacent Offshore Waters Species Volumetric density (#/km3) Estimated Level B harassment (#s of animals) in 0-200m depth stratum EK60 ME70 DSM300 Estimated Level B harassment in >200m depth stratum EK60 Total Atlantic Coast Region Cetaceans North Atlantic right whale n/a 0 0 0 NA 1 0 Humpback whale n/a 0 0 0 NA 1 0 Fin whale n/a 0 0 0 NA 1 0 Sei whale n/a 0 0 0 NA 1 0 Minke whale n/a 0 0 0 NA 1 0 Blue whale n/a 0 0 0 NA 1 0 Sperm whale 0.00005 0 0 0 NA 2 0 Dwarf sperm whale 0.0001 0 0 0 NA 2 0 Pygmy sperm whale 0.0001 0 0 0 NA 2 0 Killer Whale 0.00 0 0 0 NA 2 0 Pygmy killer whale 0.00 0 0 0 NA 2 0 Northern bottlenose whale 0.00 0 0 0 NA 2 0 Cuvier's beaked whale 0.0105 3 8 2 NA 13 Mesoplodon beaked whales 0.0105 3 8 2 NA 13 Melon-headed whale 0.00 0 0 0 NA 2 0 Risso's dolphin 0.011 3 8 2 NA 13 Long-finned pilot whale 0.1725 41 127 35 NA 203 Short-finned pilot whale 0.1725 41 127 35 NA 203 Atlantic white-sided dolphin 0.122 29 90 25 NA 144 White-beaked dolphin 0.0405 10 30 8 NA 48 Short-beaked common dolphin 1.0575 254 780 213 NA 1,247 Atlantic spotted dolphin 0.00 0 0 0 NA 2 0 Pantropical spotted dolphin 0.00 0 0 0 NA 2 0 Striped dolphin 0.00 0 0 0 NA 2 0 Fraser's dolphin 0.00 0 0 0 NA 2 0 Rough toothed dolphin 0.00 0 0 0 NA 2 0 Clymene dolphin 0.00 0 0 0 NA 2 0 Spinner dolphin 0.00 0 0 0 NA 2 0 Common bottlenose dolphin (offshore) 0.0300 7 22 6 NA 35 Common bottlenose dolphin (coastal) 0.5165 124 381 104 NA 609 Harbor Porpoise 0.0965 23 71 19 NA 113 Atlantic Coast Region Pinnipeds Harbor Seal 1.422 342 1,049 287 NA 1,678 Gray Seal 0.00 0 0 0 NA 2 0 Harp Seal 0.00 0 0 0 NA 2 0 Hooded Seal 0.00 0 0 0 NA 2 0 Offshore Area Cetaceans North Atlantic right whale n/a 0 0 0 0 2 0 Humpback whale n/a 0 0 0 0 2 0 Fin whale n/a 0 0 0 0 2 0 Sei whale n/a 0 0 0 0 2 0 Minke whale n/a 0 0 0 0 2 0 Blue whale n/a 1 1 0 0 1 0 Sperm whale 0.0304 12 3 0 15 15 Dwarf sperm whale 0.004 0 0 0 2 2 Pygmy sperm whale 0.004 0 0 0 2 2 Killer Whale 0.00 0 0 0 0 2 0 Pygmy killer whale 0.00 0 0 0 0 2 0 Northern bottlenose whale 0.0034 0 0 0 2 2 Cuvier's beaked whale 0.0312 2 3 15 20 Mesoplodon beaked whales 0.0312 2 3 0 15 20 Melon-headed whale 0.00 0 0 0 0 2 0 Risso's dolphin 0.422 22 44 0 0 66 Long-finned pilot whale 0.0512 3 5 0 24 32 Short-finned pilot whale 0.0512 3 5 0 24 32 Atlantic white-sided dolphin 0.00 0 0 0 0 2 0 White-beaked dolphin 0.00 0 0 0 0 2 0 Short-beaked common dolphin 0.9375 49 97 0 0 146 Atlantic spotted dolphin 0.104 5 11 0 0 16 Pantropical spotted dolphin 0.00 0 0 0 0 2 0 Striped dolphin 1.514 79 157 0 0 236 Fraser's dolphin 0.00 0 0 0 0 2 0 Rough toothed dolphin 0.008 0 1 0 0 1 Clymene dolphin 0.00 0 0 0 0 2 0 Spinner dolphin 0.00 0 0 0 0 2 0 Common bottlenose dolphin (offshore) 0.2630 14 27 0 0 41 n/a: not applicable 1 For mysticetes unlikely to be impacted by the predominant active acoustic sources used by the NEFSC, NMFS adjusted the take estimates from ten to zero based on functional hearing group sensitivity for mysticetes. 2 For species with unknown or very low volumetric densities, NMFS adjusted the take estimates from ten to zero because of the low probability of sighting or interaction with these species during most research cruises with the active acoustic instruments used in NEFSC research. Estimated Take Due to Physical Disturbance

    Estimated take due to physical disturbance could potentially occur in the Penobscot River Estuary as a result of the unintentional approach of NEFSC vessels to pinnipeds hauled out on ledges.

    The NEFSC uses four gear types (fyke nets, beach seine, rotary screw traps, and Mamou shrimp trawl) to monitor fish communities in the Penobscot River Estuary. The NEFSC conducts the annual surveys over specific sampling periods which could use any gear type: Mamou trawling is conducted year-round; fyke net and beach seine surveys are conducted April-November; and rotary screw trap surveys from April-June.

    We anticipate that trawl, fyke net, and beach seine surveys may disturb harbor seals and gray seals hauled out on tidal ledges through physical presence of researchers. The NEFSC conducts these surveys in upper Penobscot Bay above Fort Point Ledge where there is only one minor seal ledge (Odum Ledge) used by approximately 50 harbor seals (i.e., based on a June 2001 survey). Although one cannot assume that the number of seals using this region is stable over the April-November survey period; it is likely lower in spring and autumn.

    There were no observations of gray seals in the 2001 survey, but recent anecdotal information suggests that a few gray seals may share the haulout site. These fisheries research activities do not entail intentional approaches to seals on ledges (i.e., boats avoid close approach to tidal ledges and no gear is deployed near the tidal ledges); only behavioral disturbance incidental to small boat activities is anticipated. It is likely that some pinnipeds on the ledges would move or flush from the haul-out into the water in response to the presence or sound of NEFSC survey vessels. Behavioral responses may be considered according to the scale shown in Table 7. We consider responses corresponding to Levels 2-3 to constitute Level B harassment.

    Table 7—Seal Response to Disturbance Level Type of response Definition 1 Alert Seal head orientation or brief movement in response to disturbance, which may include turning head towards the disturbance, craning head and neck while holding the body rigid in a u-shaped position, changing from a lying to a sitting position, or brief movement of less than twice the animal's body length. 2 Movement Movements in response to the source of disturbance, ranging from short withdrawals at least twice the animal's body length to longer retreats over the beach, or if already moving a change of direction of greater than 90 degrees. 3 Flush All retreats (flushes) to the water.

    The NEFSC estimated potential incidents of Level B harassment due to physical disturbance (Table 8) using the following assumptions: (1) All hauled out seals may be disturbed by passing research skiffs, although researchers have estimated that only about 10 percent (5 animals in a group of 50) have been visibly disturbed in the past; and (2) approximately 50 harbor seals and 20 gray seals may be disturbed by the passage of researchers for each survey effort (100 fyke net sets, 100 beach seine sets, and 200 Mamou shrimp trawls per year).

    The estimated total number of instances of harassment is approximately 20,000 for harbor seals and 8,000 for gray seals annually.

    Table 8—Estimated Annual Level B Harassment Take of Pinnipeds Associated With Surveys in the Lower Estuary of the Penobscot River Species Estimated seals on ledge haulout Survey gear Number of sets Survey season Estimated
  • instances of harassment
  • Harbor seal
  • Gray seal
  • 50
  • 20
  • Fyke net 100 April-November 5,000
  • 2,000
  • Harbor seal
  • Gray seal
  • 50
  • 20
  • Beach seine 100 April-November 5,000
  • 2,000
  • Harbor seal
  • Gray seal
  • 50
  • 20
  • Mamou shrimp trawl 200 Year-round 10,000
  • 4,000
  • Summary of Estimated Incidental Take

    Here we provide summary tables detailing the total proposed incidental take authorization on an annual basis for the NEFSC in the Atlantic coast region, as well as other information relevant to the negligible impact analyses.

    Table 9—Summary Information Related to Proposed Annual Take Authorization in the Atlantic Coast Region, 2016-2021 Species 1 Proposed total
  • annual Level B
  • harassment
  • authorization
  • Percent of
  • estimated
  • population
  • Proposed total M/SI + Level A authorization, 2015-2020 Estimated
  • maximum
  • annual M/SI + Level A 2
  • PBR 3 % PBR 4 Stock trend 5
    North Atlantic Right whale 0 0 0 0 n/a Humpback whale 0 0 0 0 n/a Minke whale 0 0 5 1 162 0.62 ? Sei whale 0 0 0 0 n/a ? Fin whale 0 0 0 0 n/a ? Blue whale 0 0 0 0 n/a ? Sperm whale 15 0.65 0 0 n/a ? Kogia spp. 4 0.10 0 0 n/a ? Cuvier's beaked whale 33 0.51 0 0 n/a ? Northern bottlenose whale 2 undet 0 0 n/a ? Mesoplodont beaked whales 33 0.47 0 0 n/a Bottlenose dolphin (WNA Offshore)  6 76 0.10 6 11 2.2 561 0.39 ? Bottlenose dolphin (WNA, Northern Migratory Coastal) 6 609 5.27 6 11 2.2 86 2.56 ? Bottlenose dolphin (WNA, Southern Migratory Coastal)  6 609 6.64 6 11 2.2 63 3.49 ? Pantropical spotted dolphin 0 0 0 0 n/a ? Atlantic spotted dolphin 16 0.06 3 0.6 316 0.19 ? Spinner dolphin 0 undet. 0 0 n/a ? Striped dolphin 236 0.45 0 0 n/a ? Short-beaked common dolphin 1,393 0.80 10 2 1,152 1.18 ? White-beaked dolphin 48 2.90 3 0.6 10 6.00 ? Atlantic white-sided-dolphin 144 0.32 5 1 304 0.33 ? Risso's dolphin 79 0.43 5 1 126 0.79 ? Fraser's dolphin 0 undet 0 0 n/a ? Rough-toothed dolphin 1 0.37 0 0 n/a ? Clymene dolphin 0 0 0 0 n/a ? Melon-headed whale 0 undet 0 0 n/a ? Pygmy killer whale 0 undet 0 0 n/a ? Northern bottlenose whale 12 undet 0 0 n/a ? Long-finned pilot whale 235 0.89 0 0 n/a ? Short-finned pilot whale 235 1.09 0 0 n/a ? Harbor porpoise 113 0.14 7 1.4 706 0.20 ? Gray seal 7 0; 8,000 2.42 15 3.6 1,469 0.25 Harp seal 0 0 0 0 n/a →↑ Harbor seal 7 1,678; 20,000 2.48 15 3.6 1,662 0.22 ? Unidentified delphinid n/a n/a n/a Unidentified pinniped n/a n/a n/a Please see preceding text for details. 1 For species with multiple stocks in the Atlantic coast regions or for species groups (Kogia spp. and Mesoplodont beaked whales), indicated level of take could occur to individuals from any stock or species (not including coastal and estuarine stocks of bottlenose dolphins). 2 This column represents the total number of incidents of M/SI + Level A that could potentially accrue to the specified species or stock and is the number carried forward for evaluation in the negligible impact analysis (later in this document). To reach this total, we add one to the total for each pinniped or delphinid that may be captured in longline or gillnet gear, one to the total for each delphinid that may be captured in trawl gear, and one pinniped that may be captured in fyke net gear. This represents the potential that the take of an unidentified pinniped or delphinid could accrue to any given stock captured in that gear. The proposed take authorization is formulated as a five-year total; the annual average is used only for purposes of negligible impact analysis. We recognize that portions of an animal may not be taken in a given year. 3 See Table 3 in the proposed notice of rulemaking and following discussion for more detail regarding PBR. 4 Estimated maximum annual M/SI + Level A expressed as a percentage of PBR. 5 See relevant SARs for more information regarding stock status and trends. Interannual increases may not be interpreted as evidence of a trend. 6 For these stocks of bottlenose dolphins, the estimated annual maximum numbers of M/SI + Level A reflect the stock-specific trawl estimate (2), plus five for gillnet take, plus one for longline take, plus three for the potential take of one unidentified delphinid by trawl, gillnet, and longline. 7 The first number represents estimated annual Level B take by acoustic sources. The second number represents estimated annual Level B take by the physical disturbance during surveys in Penobscot Bay.
    Analyses and Determinations

    Here we provide negligible impact analyses and small numbers analyses for the Atlantic coast region. Unless otherwise specified, the discussion below is intended to apply to all of the species for which take is authorized, i.e., those discussed previously and indicated in Table 9 given that the anticipated effects of these activities are expected to be similar in nature, and there is no information about the size, status, or structure of any species or stock that would lead to a different analysis. In some cases we add species-specific factors.

    Negligible Impact Analyses

    NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” by mortality, serious injury, and Level A or Level B harassment, we consider other factors, such as the likely nature of any behavioral responses (e.g., intensity, duration), the context of any such responses (e.g., critical reproductive time or location, migration), as well as effects on habitat. We also evaluate the number, intensity, and context of estimated takes by evaluating this information relative to population status. The impacts from other past and ongoing anthropogenic activities are incorporated into these analyses via their impacts on the environmental baseline (e.g., as reflected in the density/distribution and status of the species, population size and growth rate).

    In 1988, Congress amended the MMPA, with provisions for the incidental take of marine mammals in commercial fishing operations. Congress directed NMFS to develop and recommend a new long-term regime to govern such incidental taking (see MMC, 1994). The need to set allowable take levels incidental to commercial fishing operations led NMFS to suggest a new and simpler conceptual means for assuring that incidental take does not cause any marine mammal species or stock to be reduced or to be maintained below the lower limit of its Optimum Sustainable Population (OSP) level. That concept (PBR) was incorporated in the 1994 amendments to the MMPA, wherein Congress enacted MMPA sections 117 and 118, establishing a new regime governing the incidental taking of marine mammals in commercial fishing operations and stock assessments.

    PBR, which is defined by the MMPA (16 U.S.C. 1362(20)) as “the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population,” is one tool that can be used to help evaluate the effects of M/SI on a marine mammal stock. OSP is defined by the MMPA (16 U.S.C. 1362(9)) as “the number of animals which will result in the maximum productivity of the population or the species, keeping in mind the carrying capacity of the habitat and the health of the ecosystem of which they form a constituent element.” A primary goal of the MMPA is to ensure that each stock of marine mammal either does not have a level of human-caused M/SI that is likely to cause the stock to be reduced below its OSP level or, if the stock is depleted (i.e., below its OSP level), does not have a level of human-caused mortality and serious injury that is likely to delay restoration of the stock to OSP level by more than ten percent in comparison with recovery time in the absence of human-caused M/SI.

    PBR appears within the MMPA only in section 117 (relating to periodic stock assessments) and in portions of section 118 describing requirements for take reduction plans for reducing marine mammal bycatch in commercial fisheries. PBR was not designed as an absolute threshold limiting human activities, but as a means to evaluate the relative impacts of those activities on marine mammal stocks. Specifically, assessing M/SI relative to a stock's PBR may signal to NMFS the need to establish take reduction teams in commercial fisheries and may assist NMFS and existing take reduction teams in the identification of measures to reduce and/or minimize the taking of marine mammals by commercial fisheries to a level below a stock's PBR. That is, where the total annual human-caused M/SI exceeds PBR, NMFS is not required to halt fishing activities contributing to total M/SI but rather may prioritize working with a take reduction team to further mitigate the effects of fishery activities via additional bycatch reduction measures.

    Since the introduction of PBR, NMFS has used the concept almost entirely within the context of implementing sections 117 and 118 and other commercial fisheries management-related provisions of the MMPA, including those within section 101(a)(5)(E) related to the taking of ESA-listed marine mammals incidental to commercial fisheries (64 FR 28800; May 27, 1999). The MMPA requires that PBR be estimated in stock assessment reports and that it be used in applications related to the management of take incidental to commercial fisheries (i.e., the take reduction planning process described in section 118 of the MMPA. Although NMFS has not historically applied PBR outside the context of sections 117 and 118, NMFS recognizes that as a quantitative tool, PBR may be useful in certain instances for evaluating the impacts of other human-caused activities on marine mammal stocks. In this analysis, we consider incidental M/SI relative to PBR for each affected stock, in addition to considering the interaction of those removals with incidental taking of that stock by harassment, within our evaluation of the likely impacts of the proposed activities on marine mammal stocks and in determining whether those impacts are likely to be negligible. Our use of PBR in this case does not make up the entirety of our impact assessment, but rather is utilized as a known, quantitative metric for evaluating whether the proposed activities are likely to have a population-level effect on the affected marine mammal stocks. For the purposes of analyzing this specified activity, NMFS acknowledges that some of the fisheries research activities use similar gear and may have similar effects, but on a smaller scale, as marine mammal take by commercial fisheries.

    Species/Group Specific Analysis—To avoid repetition, the majority of our determinations apply to all the species listed in Table 9, given that the anticipated effects of the NEFSC research activities are expected to be relatively similar in nature. Where there are meaningful differences between species or stocks, or groups of species, in anticipated individual responses to activities, impact of expected take on the population due to differences in population status, or impacts on habitat, we describe them within the section or within a separate sub-section. See the Brief Background on Sound section earlier in the notice of proposed rulemaking (80 FR 39542, July 9, 2015) for a description of marine mammal functional hearing groups as originally designated by Southall et al. (2007).

    Acoustic Effects—Please refer to Table 9 for information relating to this analysis. As described in greater depth previously (see Acoustic Effects, in the notice of proposed rulemaking (80 FR 39542, July 9, 2015)), we do not believe that the NEFSC's use of active acoustic sources has the likely potential to cause any effect exceeding Level B harassment of marine mammals. In addition, for the majority of species, the proposed annual take by Level B harassment is very low in relation to the population abundance estimate (less than 7.5 percent) for each stock.

    We have produced what we believe to be conservative estimates of potential incidents of Level B harassment. The procedure for producing these estimates, described in detail in the notice of proposed rulemaking (80 FR 39542, July 9, 2015) and summarized earlier in the Estimated Take Due to Acoustic Harassment section, represents NMFS' best effort towards balancing the need to quantify the potential for occurrence of Level B harassment due to production of underwater sound with a general lack of information related to the specific way that these acoustic signals, which are generally highly directional and transient, interact with the physical environment and to a meaningful understanding of marine mammal perception of these signals and occurrence in the areas where the NEFSC operates. The sources considered here have moderate to high output frequencies (10 to 200 kHz), generally short ping durations, and are typically focused (highly directional) to serve their intended purpose of mapping specific objects, depths, or environmental features. In addition, some of these sources can be operated in different output modes (e.g., energy can be distributed among multiple output beams) that may lessen the likelihood of perception by and potential impacts on marine mammals in comparison with the quantitative estimates that guide our take authorization.

    In particular, low-frequency hearing specialists (i.e., mysticetes) are less likely to perceive or, given perception, to react to these signals. These groups have reduced functional hearing at the higher frequencies produced by active acoustic sources considered here (e.g., primary operating frequencies of 38-200 kHz) and, based purely on their auditory capabilities, the potential impacts are likely much less (or non-existent). However, for purposes of this analysis, we assume that the take levels proposed for authorization would not occur for mysticetes. As described previously, there is some minimal potential for temporary effects to hearing for certain marine mammals (i.e., odontocete cetaceans), but most effects would likely be limited to temporary behavioral disturbance. Effects on individuals that are taken by Level B harassment will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring), reactions that are considered to be of low severity (e.g., Southall et al., 2007). There is the potential for behavioral reactions of greater severity, including displacement, but because of the directional nature of the sources considered here and because the source is itself moving, these outcomes are unlikely and would be of short duration if they did occur. Although there is no information on which to base any distinction between incidents of harassment and individuals harassed, the same factors, in conjunction with the fact that NEFSC survey effort is widely dispersed in space and time, indicate that repeated exposures of the same individuals would be very unlikely.

    Take by M/SI + Level A—We now consider the level of taking by M/SI + Level A proposed for authorization. First, it is likely that required injury determinations will show some undetermined number of gear interactions to result in Level A harassment rather than serious injury; therefore, our authorized take numbers are overestimates with regard solely to M/SI. In addition, we note that these take levels are likely precautionary overall when considering that: (1) Estimates for historically taken species were developed assuming that the annual average number of takes from 2004-2015, would occur in each year from 2015-20; and that (2) the majority of species for which take authorization is proposed have never been taken in NEFSC surveys.

    However, assuming that all of the takes proposed for authorization actually occur, we assess these quantitatively by comparing to the calculated PBR for each stock. Estimated M/SI + Level A for all stocks is significantly less than PBR (less than six percent for each stock).

    Large whales (North Atlantic right, blue, fin, sei, humpback, and sperm whales)Due to their very low numbers within the NEFSC research area and a tendency to occur primarily in waters outside of the NEFSC research area, blue, sperm, and sei whales rarely coincide with NEFSC fisheries research vessels. Thus, we anticipate that any potential gear interactions are unlikely. There have been no entanglements or takes of blue, sperm, or sei whales or any ESA-listed marine mammals in NEFSC fisheries research. Thus, there are no requested take by M/SI + Level A of these species during the next five years. Given the mitigation measures in place and the lack of historical takes, the NEFSC does not expect to have any adverse gear interactions with ESA-listed cetaceans in research surveys.

    Long- and short-finned pilot whales—Due to the low levels of survey effort in hotspot areas for pilot whales, adherence to gear requirements for longline surveys, low numbers of hooks and sets used in longline surveys, and short soak times with continuous monitoring during gillnet surveys, we anticipate that any potential gear interactions are unlikely. There have been no entanglements or takes of long- or short-finned pilot whales in NEFSC fisheries research. Thus, there are no requested take by M/SI + Level A of these species during the next five years.

    Take by Physical Disturbance—We note that the NEFSC conducts one set of research activities where the physical presence of researchers may result in Level B incidental harassment of pinnipeds on haulouts. This level of periodic incidental harassment would have temporary effects and would not be expected to alter the continued use of the tidal ledges by seals. Anecdotal reports from previous monitoring show that the pinnipeds returned to the various sites and did not permanently abandon haul-out sites after the NEFSC conducted their research activities. Based on the following factors, the NEFSC's research activities are not likely to cause permanent abandonment of the haulout areas, injury, serious injury, or mortality because: (1) The effects of the research activities would be limited to short-term startle responses and localized behavioral changes due to the short and sporadic duration of the research activities; (2) minor and brief responses, such as short-duration startle or alert reactions, are not likely to constitute disruption of behavioral patterns, such as migration, nursing, breeding, feeding, or sheltering; and (3) the availability of alternate areas for pinnipeds to avoid the resultant visual disturbances from the research operations.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the planned mitigation measures, we find that the total marine mammal take from NEFSC fisheries research activities will have a negligible impact on the affected marine mammal species or stocks in the Atlantic coast region. In summary, this finding of negligible impact is founded on the following factors: (1) The possibility of injury, serious injury, or mortality from the use of active acoustic devices may reasonably be considered discountable; (2) the anticipated incidents of Level B harassment from the use of active acoustic devices consist of, at worst, temporary and relatively minor modifications in behavior; (3) the predicted number of incidents of combined Level A harassment, serious injury, and mortality are at insignificant levels relative to all affected stocks; and (4) the presumed efficacy of the planned mitigation measures in reducing the effects of the specified activity to the level of least practicable adverse impact. In addition, no M/SI is proposed for authorization for any species or stock that is listed under the ESA. In combination, we believe that these factors demonstrate that the specified activity will have only short-term effects on individuals (resulting from Level B harassment) and that the total level of taking will not impact rates of recruitment or survival sufficiently to result in population-level impacts.

    Small Numbers Analyses

    Please see Table 9 for information relating to this small numbers analysis. The total amount of taking proposed for authorization is less than 6.0 percent for all stocks.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed mitigation measures, we find that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks in the Atlantic coast region.

    Monitoring and Reporting

    In order to issue an incidental take authorization for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

    Any monitoring requirement we prescribe should improve our understanding of one or more of the following:

    • Occurrence of marine mammal species in action area (e.g., presence, abundance, distribution, density).

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving, or feeding areas).

    • Individual responses to acute stressors, or impacts of chronic exposures (behavioral or physiological).

    • How anticipated responses to stressors impact either: (1) long-term fitness and survival of an individual; or (2) population, species, or stock.

    • Effects on marine mammal habitat and resultant impacts to marine mammals.

    • Mitigation and monitoring effectiveness.

    The NEFSC plans to make more systematic its training, operations, data collection, animal handling and sampling protocols, etc. in order to improve its ability to understand how mitigation measures influence interaction rates and ensure its research operations are conducted in an informed manner and consistent with lessons learned from those with experience operating these gears in close proximity to marine mammals. It is in this spirit that NMFS and the NEFSC crafted the monitoring requirements described here.

    Visual Monitoring

    Marine mammal watches are a standard part of conducting fisheries research activities, and are implemented as described previously in Mitigation. Marine mammal watches and monitoring occur prior to deployment of gear, and they continue until gear is brought back on board. Office of Marine Aviation and Operations personnel operating NOAA vessels are required to monitor interactions with protected species (and report interactions to the NEFSC Director). Similarly, there is a condition of grant and contract awards for monitoring of protected species takes.

    In the Penobscot Bay only, the NEFSC will monitor any potential disturbance of pinnipeds on ledges, paying particular attention to the distance at which different species of pinniped are disturbed. Disturbance will be recorded according to the three-point scale, representing increasing seal response to disturbance, shown in Table 7.

    Training

    The NEFSC anticipates that additional information on practices to avoid marine mammal interactions can be gleaned from training sessions and more systematic data collection standards. The NEFSC will conduct annual trainings for all chief scientists and other personnel who may be responsible for conducting dedicated marine mammal visual observations to explain mitigation measures and monitoring and reporting requirements, mitigation and monitoring protocols, marine mammal identification, recording of count and disturbance observations (relevant to Penobscot Bay surveys), completion of datasheets, and use of equipment. Some of these topics may be familiar to NEFSC staff, who may be professional biologists; the NEFSC shall determine the agenda for these trainings and ensure that all relevant staff have necessary familiarity with these topics.

    The NEFSC will also dedicate a portion of training to discussion of best professional judgment (which is recognized as an integral component of mitigation implementation; see “Mitigation”), including use in any incidents of marine mammal interaction and instructive examples where use of best professional judgment was determined to be successful or unsuccessful. We recognize that many factors come into play regarding decision-making at sea and that it is not practicable to simplify what are inherently variable and complex situational decisions into rules that may be defined on paper. However, it is our intent that use of best professional judgment be an iterative process from year to year, in which any at-sea decision-maker (i.e., responsible for decisions regarding the avoidance of marine mammal interactions with survey gear through the application of best professional judgment) learns from the prior experience of all relevant NEFSC personnel (rather than from solely their own experience). The outcome should be increased transparency in decision-making processes where best professional judgment is appropriate and, to the extent possible, some degree of standardization across common situations, with an ultimate goal of reducing marine mammal interactions. It is the responsibility of the NEFSC to facilitate such exchange.

    Handling Procedures and Data Collection

    Improved standardization of handling procedures were discussed previously in Mitigation. In addition to the benefits implementing these protocols are believed to have on the animals through increased post-release survival, NEFSC believes adopting these protocols for data collection will also increase the information on which “serious injury” determinations (NMFS, 2012a, b) are based and improve scientific knowledge about marine mammals that interact with fisheries research gears and the factors that contribute to these interactions. NEFSC personnel will be provided standard guidance and training regarding handling of marine mammals, including how to identify different species, bring an individual aboard a vessel, assess the level of consciousness, remove fishing gear, return an individual to water and log activities pertaining to the interaction.

    NEFSC will record interaction information on either existing data forms created by other NMFS programs or will develop their own standardized forms. To aid in serious injury determinations and comply with the current NMFS Serious Injury Guidelines (NMFS, 2012a, b), researchers will also answer a series of supplemental questions on the details of marine mammal interactions.

    Reporting

    As is normally the case, NEFSC will coordinate with the relevant stranding coordinators for any unusual marine mammal behavior and any stranding, beached live/dead, or floating marine mammals that are encountered during field research activities. The NEFSC will follow a phased approach with regard to the cessation of its activities and/or reporting of such events, as described in the proposed regulatory texts following this preamble. In addition, Chief Scientists (or cruise leader, CS) will provide reports to NEFSC leadership and to the Office of Protected Resources (OPR) by event, survey leg, and cruise. As a result, when marine mammals interact with survey gear, whether killed or released alive, a report provided by the CS will fully describe any observations of the animals, the context (vessel and conditions), decisions made and rationale for decisions made in vessel and gear handling. The circumstances of these events are critical in enabling the NEFSC and OPR to better evaluate the conditions under which takes are most likely occur. We believe in the long term this will allow the avoidance of these types of events in the future.

    The NEFSC will submit annual summary reports to OPR including: (1) Annual line-kilometers surveyed during which the EK60, ME70, DSM900 (or equivalent sources) were predominant; (2) summary information regarding use of all NEFSC-specific gears, including: longline (including bottom and vertical lines), gillnet, fyke net, and trawl (including bottom trawl) gear, including number of sets, hook hours, tows, etc., specific to each gear; (3) accounts of all incidents of marine mammal interactions, including circumstances of the event and descriptions of any mitigation procedures implemented or not implemented and why; (4) summary information related to any disturbance of pinnipeds during the Penobscot Bay surveys, including event-specific total counts of animals present, counts of reactions according to the three-point scale shown in Table 7, and distance of closest approach; and (5) a written evaluation of the effectiveness of NEFSC mitigation strategies in reducing the number of marine mammal interactions with survey gear, including best professional judgment and suggestions for changes to the mitigation strategies, if any. The period of reporting will be a one year period beginning at the date of issuance of the LOA. The NEFSC must submit the report not less than ninety days following the end of the reporting period. Submission of this information is in service of an adaptive management framework allowing NMFS to make appropriate modifications to mitigation and/or monitoring strategies, as necessary, during the five-year period of validity for these regulations.

    NMFS has established a formal incidental take reporting system, the Protected Species Incidental Take (PSIT) database, requiring that incidental takes of protected species be reported within 48 hours of the occurrence. The PSIT generates automated messages to NMFS staff, alerting them to the event and to the fact that updated information describing the circumstances of the event has been entered into the database. The PSIT and CS reports represent not only valuable real-time reporting and information dissemination tools but also serve as an archive of information that may be mined in the future to study why takes occur by species, gear, region, etc.

    The NEFSC will also collect and report all necessary data, to the extent practicable given the primacy of human safety and the well-being of captured or entangled marine mammals, to facilitate serious injury (SI) determinations for marine mammals that are released alive. NEFSC will require that the CS complete data forms (already developed and used by commercial fisheries observer programs) and address supplemental questions, both of which have been developed to aid in SI determinations. NEFSC understands the critical need to provide as much relevant information as possible about marine mammal interactions to inform decisions regarding SI determinations. In addition, the NEFSC will perform all necessary reporting to ensure that any incidental M/SI is incorporated as appropriate into relevant SARs.

    Adaptive Management

    The final regulation governing the take of marine mammals incidental to NEFSC fisheries research survey operations in the specified geographical region contains an adaptive management component. The inclusion of an adaptive management component is both valuable and necessary within the context of five-year regulation for activities that have been associated with marine mammal mortality.

    The reporting requirements associated with this final rule are designed to provide OPR with monitoring data from the previous year to allow consideration of whether any changes are appropriate. NMFS OPR and the NEFSC will meet annually to discuss the monitoring reports and current science and whether mitigation or monitoring modifications are appropriate. The use of adaptive management allows NMFS OPR to consider new information from different sources to determine (with input from the NEFSC regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.

    The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by this regulation or subsequent LOA.

    Changes to the Proposed Regulations

    As a result of clarifying discussions with NEFSC, we made certain changes to the proposed regulations as described here. These changes are considered minor and do not affect any of our preliminary determinations.

    Mitigation Measures for Pot/Trap Gear

    As described in the notice of proposed rulemaking (80 FR 39546-39560; July 9, 2015), NEFSC engages in cooperative research activities and observer training that may use different gear types and vary from year to year, while remaining within the overall scope of activity described and analyzed for NEFSC. Within the scope of the proposed rule, NEFSC plans to conduct or fund observer training using pot/trap gear within the period of validity for these regulations; therefore, it is appropriate to specify mitigation measures specific to this gear type. Inclusion of mitigation measures specific to pot/trap gear does not affect any of our determinations, and does not reflect an increase in the total amount or type of activity anticipated or change in the extent or type of taking anticipated.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no relevant subsistence uses of marine mammals implicated by these actions, in the specified geographical region for which we are issuing this regulation. Therefore, we have determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    There are multiple marine mammal species listed under the ESA with confirmed or possible occurrence in the specified geographical region. In the Northeast Region, research surveys occur in two areas that have been designated as critical habitat for the North Atlantic right whale (NOAA, 1994). These are the Cape Cod Bay (CCB) Critical Habitat Area and the Great South Channel (GSC) Critical Habitat Area. NMFS OPR initiated consultation with NMFS' Greater Atlantic Regional Office (GARFO) under section 7 of the ESA on the promulgation of a five-year regulation and the subsequent issuance of an LOA to the NEFSC under section 7 of the ESA. In June 2016, the GARFO issued a biological opinion to OPR and the NEFSC (concerning conduct of the specified activities) which concluded that the issuance of the authorization is not likely to jeopardize the continued existence of any listed marine mammal species is not likely to adversely affect any listed marine mammal species. The opinion also concluded that the issuance of the authorization would not affect any designated critical habitat.

    National Environmental Policy Act (NEPA)

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), as implemented by the regulations published by the CEQ (40 CFR parts 1500-1508), the NEFSC prepared a PEA to consider the direct, indirect and cumulative effects to the human environment resulting from the described research activities. OPR made NEFSC's draft PEA available to the public for review and comment, in relation to its suitability for adoption by OPR in order to assess the impacts to the human environment of issuance of a regulation and subsequent Letter of Authorization to the NEFSC. Also in compliance with NEPA and the CEQ regulations, as well as NOAA Administrative Order 216-6, OPR has reviewed NEFSC's PEA, determined it to be sufficient, and adopted that PEA and signed a Finding of No Significant Impact (FONSI) on August 2, 2016. The NEFSC's EA and OPR's FONSI for this action may be found on the Internet at www.nmfs.noaa.gov/pr/permits/incidental/research.htm.

    Classification

    Per the procedures established to implement Executive Order 12866, the Office of Management and Budget has determined that this rule is not significant.

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities. The factual basis for this certification was published with the proposed rule and is not repeated here. No comments were received regarding the economic impact of this final rule. As a result, a final regulatory flexibility analysis is not required and one was not prepared.

    This rule does not contain a collection-of-information requirement subject to the provisions of the Paperwork Reduction Act (PRA) because the applicant is a federal agency. Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.

    List of Subjects in 50 CFR Part 219

    Exports, Fish, Imports, Indians, Labeling, Marine mammals, Penalties, Reporting and recordkeeping requirements, Seafood, Transportation.

    Dated: August 2, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For reasons set forth in the preamble, the NMFS amends 50 CFR part 219 as follows:

    PART 219—REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS 1. The authority citation for part 219 continues to read as follows: Authority:

    16 U.S.C. 1361 et seq.

    2. Add subpart D to part 219 to read as follows: Subpart D—Taking Marine Mammals Incidental to Northeast Fisheries Science Center Fisheries Research in the Atlantic Coast Region Sec. 219.31 Specified activity and specified geographical region. 219.32 Effective dates. 219.33 Permissible methods of taking. 219.34 Prohibitions. 219.35 Mitigation requirements. 219.36 Requirements for monitoring and reporting. 219.37 Letters of Authorization. 219.38 Renewals and modifications of Letters of Authorization. 219.39—219.40 [Reserved] Authority:

    16 U.S.C. 1361 et seq.

    Subpart D—Taking Marine Mammals Incidental to Northeast Fisheries Science Center Fisheries Research in the Atlantic Coast Region
    § 219.31 Specified activity and specified geographical region.

    (a) Regulations in this subpart apply only to the National Marine Fisheries Service's (NMFS) Northeast Fisheries Science Center (NEFSC) and those persons it authorizes or funds to conduct activities on its behalf for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to research survey program operations.

    (b) The taking of marine mammals by NEFSC may be authorized in a Letter of Authorization (LOA) only if it occurs within the Atlantic coast region.

    § 219.32 Effective dates.

    Regulations in this subpart are effective September 12, 2016 through September 9, 2021.

    § 219.33 Permissible methods of taking.

    (a) Under LOAs issued pursuant to § 216.106 of this chapter and § 219.7, the Holder of the LOA (hereinafter “NEFSC”) may incidentally, but not intentionally, take marine mammals within the area described in § 219.31(b) by Level B harassment associated with use of active acoustic systems and physical or visual disturbance of hauled-out pinnipeds and by Level A harassment, serious injury, or mortality associated with use of trawl, dredge, bottom and pelagic longline, gillnet, pot and trap, fyke net, beach seine, and rotary screw trap gears, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the appropriate LOA, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the appropriate LOA.

    § 219.34 Prohibitions.

    Notwithstanding takings contemplated in § 219.31 and authorized by a LOA issued under § 216.106 of this chapter and § 219.7, no person may, in connection with the activities described in § 219.31:

    (a) Take any marine mammal not specified in § 219.33(b);

    (b) Take any marine mammal specified in § 219.33(b) in any manner other than as specified;

    (c) Take a marine mammal specified in § 219.33(b) if NMFS determines such taking results in more than a negligible impact on the species or stocks of such marine mammal;

    (d) Take a marine mammal specified in § 219.33(b) if NMFS determines such taking results in an unmitigable adverse impact on the species or stock of such marine mammal for taking for subsistence uses; or

    (e) Violate, or fail to comply with, the terms, conditions, and requirements of this subpart or a LOA issued under § 216.106 of this chapter and § 219.37.

    § 219.35 Mitigation requirements.

    When conducting the activities identified in § 219.31(a), the mitigation measures contained in any LOA issued under § 216.106 of this chapter and § 219.37 must be implemented. These mitigation measures shall include but are not limited to:

    (a) General conditions:

    (1) NEFSC shall take all necessary measures to coordinate and communicate in advance of each specific survey with the National Oceanic and Atmospheric Administration's (NOAA) Office of Marine and Aviation Operations (OMAO) or other relevant parties on non-NOAA platforms to ensure that all mitigation measures and monitoring requirements described herein, as well as the specific manner of implementation and relevant event-contingent decision-making processes, are clearly understood and agreed upon.

    (2) NEFSC shall coordinate and conduct briefings at the outset of each survey and as necessary between the ship's crew (Commanding Officer/master or designee(s), contracted vessel owners, as appropriate) and scientific party or in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    (3) NEFSC shall coordinate as necessary on a daily basis during survey cruises with OMAO personnel or other relevant personnel on non-NOAA platforms to ensure that requirements, procedures, and decision-making processes are understood and properly implemented.

    (4) When deploying any type of sampling gear at sea, NEFSC shall at all times monitor for any unusual circumstances that may arise at a sampling site and use best professional judgment to avoid any potential risks to marine mammals during use of all research equipment.

    (5) All vessels must comply with applicable and relevant take reduction plans, including any required use of acoustic deterrent devices.

    (6) All vessels must comply with applicable speed restrictions.

    (7) NEFSC shall implement handling and/or disentanglement protocols as specified in the guidance provided to NEFSC survey personnel.

    (b) Trawl survey protocols:

    (1) NEFSC shall conduct trawl operations as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall initiate marine mammal watches (visual observation) prior to sampling. Marine mammal watches shall be conducted by scanning the surrounding waters with the naked eye and binoculars (or monocular). During nighttime operations, visual observation shall be conducted using the naked eye and available vessel lighting.

    (3) NEFSC shall implement the “move-on rule.” If a marine mammal is sighted around the vessel before setting the gear, NEFSC may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, NEFSC may decide to move again or to skip the station. NEFSC may use best professional judgment in making this decision.

    (4) NEFSC shall maintain visual monitoring effort during the entire period of time that trawl gear is in the water (i.e., throughout gear deployment, fishing, and retrieval). If marine mammals are sighted before the gear is fully removed from the water, NEFSC shall take the most appropriate action to avoid marine mammal interaction. NEFSC may use best professional judgment in making this decision.

    (5) If trawling operations have been suspended because of the presence of marine mammals, NEFSC may resume trawl operations when practicable only when the animals are believed to have departed the area. NEFSC may use best professional judgment in making this determination.

    (6) NEFSC shall implement standard survey protocols to minimize potential for marine mammal interaction, including maximum tow durations at target depth and maximum tow distance, and shall carefully empty the trawl as quickly as possible upon retrieval. Trawl nets must be cleaned prior to deployment.

    (c) Dredge survey protocols:

    (1) NEFSC shall deploy dredge gear as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall initiate marine mammal watches (visual observation) prior to sampling. Marine mammal watches shall be conducted by scanning the surrounding waters with the naked eye and binoculars (or monocular). During nighttime operations, visual observation shall be conducted using the naked eye and available vessel lighting.

    (3) NEFSC shall implement the “move-on rule.” If marine mammals are sighted around the vessel before setting the gear, the NEFSC may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, NEFSC may decide to move again or to skip the station. NEFSC may use best professional judgment in making this decision but may not elect to conduct dredge survey activity when animals remain near the vessel.

    (4) NEFSC shall maintain visual monitoring effort during the entire period of time that dredge gear is in the water (i.e., throughout gear deployment, fishing, and retrieval). If marine mammals are sighted before the gear is fully removed from the water, NEFSC shall take the most appropriate action to avoid marine mammal interaction. NEFSC may use best professional judgment in making this decision.

    (5) If dredging operations have been suspended because of the presence of marine mammals, NEFSC may resume operations when practicable only when the animals are believed to have departed the area. NEFSC may use best professional judgment in making this determination.

    (6) NEFSC shall carefully empty the dredge gear as quickly as possible upon retrieval to determine if marine mammals are present in the gear.

    (d) Bottom and pelagic longline survey protocols:

    (1) NEFSC shall deploy longline gear as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall initiate marine mammal watches (visual observation) no less than thirty minutes prior to both deployment and retrieval of the longline gear. Marine mammal watches shall be conducted by scanning the surrounding waters with the naked eye and binoculars (or monocular). During nighttime operations, visual observation shall be conducted using the naked eye and available vessel lighting.

    (3) NEFSC shall implement the “move-on rule.” If marine mammals are sighted near the vessel 30 minutes before setting the gear, the NEFSC may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, NEFSC may decide to move again or to skip the station. NEFSC may use best professional judgment in making this decision but may not elect to conduct longline survey activity when animals remain near the vessel.

    (4) For the Apex Predators Bottom Longline Coastal Shark Survey, if one or more marine mammals are observed within 1 nautical mile (nmi) of the planned location in the 30 minutes before gear deployment, NEFSC shall transit to a different section of the sampling area to maintain a minimum set distance of 1 nmi from the observed marine mammals. If, after moving on, marine mammals remain within 1 nmi, NEFSC may decide to move again or to skip the station. NEFSC may use best professional judgment in making this decision but may not elect to conduct pelagic longline survey activity when animals remain within the 1-nmi zone.

    (5) NEFSC shall maintain visual monitoring effort during the entire period of gear deployment or retrieval. If marine mammals are sighted before the gear is fully deployed or retrieved, NEFSC shall take the most appropriate action to avoid marine mammal interaction. NEFSC may use best professional judgment in making this decision.

    (6) If deployment or retrieval operations have been suspended because of the presence of marine mammals, NEFSC may resume such operations after there are no sightings of marine mammals for at least 15 minutes within the area or within the 1-nmi area for the Apex Predators Bottom Longline Coastal Shark Survey. NEFSC may use best professional judgment in making this decision.

    (7) NEFSC shall implement standard survey protocols, including maximum soak durations and a prohibition on chumming.

    (e) Gillnet survey protocols:

    (1) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall deploy gillnet gear as soon as is practicable upon arrival at the sampling station.

    (2) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall initiate marine mammal watches (visual observation) prior to both deployment and retrieval of the gillnet gear. When the vessel is on station during the soak, marine mammal watches shall be conducted during the soak by scanning the surrounding waters with the naked eye and binoculars (or monocular).

    (3) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall implement the “move-on rule.” If marine mammals are sighted near the vessel before setting the gear, the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains, may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains may decide to move again or to skip the station. The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains may use best professional judgment in making this decision but may not elect to conduct the gillnet survey activity when animals remain near the vessel.

    (4) If marine mammals are sighted near the vessel during the soak and are determined to be at risk of interacting with the gear, then the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall carefully retrieve the gear as quickly as possible. The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains may use best professional judgment in making this decision.

    (5) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall implement standard survey protocols, including continuously monitoring the gillnet gear during soak time and removing debris with each pass as the net is reset into the water to minimize bycatch.

    (6) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall ensure that surveys deploy acoustic pingers on gillnets in areas where required for commercial fisheries. NEFSC must ensure that the devices are operating properly before deploying the net.

    (7) NEFSC shall ensure that cooperating institutions, contracted vessels, or commercially-hired captains conducting gillnet surveys adhere to monitoring and mitigation requirements and shall include required protocols in all survey instructions, contracts, and agreements.

    (8) For the COASTSPAN gillnet surveys, the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains will actively monitor for potential bottlenose dolphin entanglements by hand-checking the gillnet every 20 minutes. In the unexpected case of a bottlenose dolphin entanglement, the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall request and arrange for expedited genetic sampling for stock determination. The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall also photograph the dorsal fin and submit the image to the NMFS Southeast Stranding Coordinator for identification/matching to bottlenose dolphins in the Mid-Atlantic Bottlenose Dolphin Photo-identification Catalog.

    (f) Pot and trap survey protocols:

    (1) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall deploy pot gear as soon as is practicable upon arrival at the sampling station.

    (2) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall initiate marine mammal watches (visual observation) no less than 30 minutes prior to both deployment and retrieval of the pot and trap gear. Marine mammal watches shall be conducted by scanning the surrounding waters with the naked eye and binoculars (or monocular). During nighttime operations, visual observation shall be conducted using the naked eye and available vessel lighting.

    (3) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall implement the move-on rule. If marine mammals are sighted near the vessel before setting the gear, the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains, as appropriate, may decide to move the vessel away from the marine mammal to a different section of the sampling area if the animal appears to be at risk of interaction with the gear. If, after moving on, marine mammals are still visible from the vessel, the NEFSC, and/or its cooperating institutions, contracted vessels, or commercially-hired captains may decide to move again or to skip the station. The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains may use best professional judgment in making this decision but may not elect to conduct the pot and trap activity when animals remain near the vessel.

    (4) If marine mammals are sighted near the vessel during the soak and are determined to be at risk of interacting with the gear, then the NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall carefully retrieve the gear as quickly as possible. The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains may use best professional judgment in making this decision.

    (5) The NEFSC and/or its cooperating institutions, contracted vessels, or commercially-hired captains shall ensure that surveys deploy gear fulfilling all Pot/Trap universal commercial gear configurations such as weak link requirements and marking requirements as specified by applicable take reduction plans as required for commercial pot/trap fisheries.

    (6) The NEFSC shall ensure that its cooperating institutions, contracted vessels, or commercially-hired captains conducting pot and trap surveys adhere to monitoring and mitigation requirements and shall include required protocols in all survey instructions, contracts, and agreements.

    (g) Fyke net gear protocols:

    (1) NEFSC shall conduct fyke net gear deployment as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall visually survey the area prior to both deployment and retrieval of the fyke net gear. NEFSC shall conduct monitoring and retrieval of the gear every 12- to 24-hour soak period.

    (3) If marine mammals are in close proximity (approximately 328 feet [100 meters]) of the setting location, NEFSC shall determine if the set location should be moved. NEFSC may use best professional judgment in making this decision.

    (4) If marine mammals are observed to interact with the gear during the setting, NEFSC shall lift and remove the gear from the water.

    (5) NEFSC must install and use a marine mammal excluder device at all times when the 2-meter fyke net is used.

    (h) Beach seine gear protocols:

    (1) NEFSC shall conduct beach seine deployment as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall visually survey the area prior to both deployment and retrieval of the seine net gear.

    (3) If marine mammals are in close proximity of the seining location, NEFSC shall lift the net and remove it from the water. NEFSC may use best professional judgment in making this decision.

    (i) Rotary screw trap gear protocols:

    (1) NEFSC shall conduct rotary screw trap deployment as soon as is practicable upon arrival at the sampling station.

    (2) NEFSC shall visually survey the area prior to both setting and retrieval of the rotary screw trap gear. If marine mammals are observed in the sampling area, NEFSC shall suspend or delay the sampling. NEFSC may use best professional judgment in making this decision.

    (3) NEFSC shall tend to the trap on a daily basis to monitor for marine mammal interactions with the gear.

    (4) If the rotary screw trap captures a marine mammal, NEFSC shall carefully release the animal as soon as possible.

    § 219.36 Requirements for monitoring and reporting.

    (a) Visual monitoring program:

    (1) Marine mammal visual monitoring shall occur: prior to deployment of beam, mid-water, and bottom trawl, bottom and pelagic longline, gillnet, fyke net, beach seine, pot, trap, and rotary screw trap gear; throughout deployment of gear and active fishing of all research gears; and throughout retrieval of all research gear.

    (2) Marine mammal watches shall be conducted by watch-standers (those navigating the vessel and/or other crew) at all times when the vessel is being operated.

    (3) NEFSC shall monitor any potential disturbance of pinnipeds on ledges, paying particular attention to the distance at which different species of pinniped are disturbed. Disturbance shall be recorded according to a three-point scale of response (i.e., 1 = alert; 2 = movement; 3 = flight) to disturbance.

    (b) The NEFSC shall continue to conduct a local census of pinniped haulout areas prior to conducting any fisheries research in the Penobscot River estuary to better understand the local abundance of animals. The NEFSC's census reports will now include an accounting of disturbance based on the three-point scale of response severity metrics.

    (c) Training:

    (1) NEFSC must conduct annual training for all chief scientists and other personnel (including its cooperating institutions, contracted vessels, or commercially-hired captains) who may be responsible for conducting dedicated marine mammal visual observations to explain mitigation measures and monitoring and reporting requirements, mitigation and monitoring protocols, marine mammal identification, completion of datasheets, and use of equipment. NEFSC may determine the agenda for these trainings.

    (2) NEFSC shall also dedicate a portion of training to discussion of best professional judgment, including use in any incidents of marine mammal interaction and instructive examples where use of best professional judgment was determined to be successful or unsuccessful.

    (3) NEFSC shall coordinate with NMFS' Southeast Fisheries Science Center (SEFSC) regarding surveys conducted in the southern portion of the Atlantic coast region, such that training and guidance related to handling procedures and data collection is consistent.

    (d) Handling procedures and data collection:

    (1) NEFSC must develop and implement standardized marine mammal handling, disentanglement, and data collection procedures. These standard procedures will be subject to approval by NMFS Office of Protected Resources (OPR).

    (2) When practicable, for any marine mammal interaction involving the release of a live animal, NEFSC shall collect necessary data to facilitate a serious injury determination.

    (3) NEFSC shall provide its relevant personnel with standard guidance and training regarding handling of marine mammals, including how to identify different species, bring/or not bring an individual aboard a vessel, assess the level of consciousness, remove fishing gear, return an individual to water, and log activities pertaining to the interaction.

    (4) NEFSC shall record such data on standardized forms, which will be subject to approval by OPR. The data shall be collected at a sufficient level of detail (e.g., circumstances leading to the interaction, extent of injury, condition upon release) to facilitate serious injury determinations under the MMPA.

    (e) Reporting:

    (1) NEFSC shall report all incidents of marine mammal interaction to NMFS' Protected Species Incidental Take database within 48 hours of occurrence.

    (2) NEFSC shall provide written reports to OPR upon request following any marine mammal interaction (animal captured or entangled in research gear). In the event of a marine mammal interaction, these reports shall include details of survey effort, full descriptions of any observations of the animals, the context (vessel and conditions), decisions made and rationale for decisions made in vessel and gear handling.

    (3) Annual reporting:

    (i) The period of reporting will be one year beginning at the date of issuance of the LOA. NEFSC shall submit an annual summary report to OPR not later than ninety days following the end of the reporting period.

    (ii) These reports shall contain, at minimum, the following:

    (A) Annual line-kilometers surveyed during which the EK60, ME70, DSM300 (or equivalent sources) were predominant and associated pro-rated estimates of actual take;

    (B) Summary information regarding use of the following: All trawl gear, all longline gear, all gillnet gear, all dredge gear, fyke net gear, beach seine net gear, and rotary screw trap gear (including number of sets, hook hours, tows, and tending frequency specific to each gear type);

    (C) Accounts of all incidents of marine mammal interactions, including circumstances of the event and descriptions of any mitigation procedures implemented or not implemented and why;

    (D) Summary information from the pinniped haulout censuses in the and summary information related to any disturbance of pinnipeds, including event-specific total counts of animals present, counts of reactions according to a three-point scale of response severity (1 = alert; 2 = movement; 3 = flight), and distance of closest approach;

    (E) A written evaluation of the effectiveness of NEFSC mitigation strategies in reducing the number of marine mammal interactions with survey gear, including best professional judgment and suggestions for changes to the mitigation strategies, if any;

    (F) Final outcome of serious injury determinations for all incidents of marine mammal interactions where the animal(s) were released alive; and

    (G) A summary of all relevant training provided by the NEFSC and any coordination with the Southeast Fishery Science Center, the Greater Atlantic Regional Office, and the Southeast Regional Office, NMFS.

    (f) Reporting of injured or dead marine mammals:

    (1) In the unanticipated event that the specified activity clearly causes the take of a large whale (i.e., entanglement or ship strike) or if the NEFSC and/or its cooperating institutions observe a carcass entangled in gear or struck by any vessel, the NEFSC and/or its cooperating institutions must immediately report the incident to 866-755-6622 in the Northeast region (VA-ME) and 877-WHALE-HELP in the Southeast region (FL-NC). If personnel are unable to call these numbers, personnel must contact the United States Coast Guard (USCG). For active entanglements, NEFSC personnel and/or its cooperating institutions are not allowed to remove any gear until they receive a temporary authorization from NMFS.

    (2) In the unanticipated event that the activity defined in § 219.31(a) clearly causes the take of a marine mammal in a prohibited manner, NEFSC and/or its cooperating institution personnel engaged in the research activity shall immediately cease such activity until such time as an appropriate decision regarding activity continuation can be made by the NEFSC Director (or designee). For large whales, the NEFSC and/or its cooperating institutions must first contact the hotline numbers or the USCG as outlined in paragraph (f)(1) of this section. The NEFSC must also report the incident immediately to OPR, the Greater Atlantic Regional Stranding Coordinator, and the Southeast Regional Stranding Coordinator, NMFS. OPR will review the circumstances of the prohibited take and work with NEFSC to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The report must include the following information:

    (i) Time, date, and location (latitude/longitude) of the incident;

    (ii) Description of the incident;

    (iii) Environmental conditions (including wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    (iv) Description of all marine mammal observations in the 24 hours preceding the incident;

    (v) Species identification or description of the animal(s) involved;

    (vi) Status of all sound source use in the 24 hours preceding the incident;

    (vii) Water depth;

    (viii) Fate of the animal(s); and

    (ix) Photographs or video footage of the animal(s).

    (3) In the event that NEFSC and/or its cooperating institutions discover an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (e.g., in less than a moderate state of decomposition), NEFSC shall immediately report the incident to OPR, the Greater Atlantic Regional Stranding Coordinator, and the Southeast Regional Stranding Coordinator, NMFS. For large whales, the NEFSC and/or its cooperating institutions must first contact the hotline numbers or the USCG as outlined in paragraph (f)(1) of this section. The report must include the same information identified in paragraph (f)(2) of this section. Activities may continue while OPR reviews the circumstances of the incident. OPR will work with NEFSC to determine whether additional mitigation measures or modifications to the activities are appropriate.

    (4) In the event that NEFSC and/or its cooperating institutions discover an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities defined in § 219.31(a) (e.g., previously wounded animal, carcass with moderate to advanced decomposition, scavenger damage), NEFSC shall report the incident to OPR, the Greater Atlantic Regional Stranding Coordinator, and the Southeast Regional Stranding Coordinator, NMFS within 24 hours of the discovery. For large whales, the NEFSC and/or its cooperating institutions must first contact the hotline numbers or the USCG as outlined in paragraph (f)(1) of this section. NEFSC shall provide photographs or video footage or other documentation of the stranded animal sighting to OPR, the Greater Atlantic Regional Stranding Coordinator, and the Southeast Regional Stranding Coordinator, NMFS.

    § 219.37 Letters of Authorization.

    (a) To incidentally take marine mammals pursuant to these regulations, NEFSC must apply for and obtain an LOA.

    (b) An LOA, unless suspended or revoked, may be effective for a period of time not to exceed the expiration date of these regulations.

    (c) If an LOA expires prior to the expiration date of these regulations, NEFSC may apply for and obtain a renewal of the LOA.

    (d) In the event of projected changes to the activity or to mitigation and monitoring measures required by an LOA, NEFSC must apply for and obtain a modification of the LOA as described in § 219.38.

    (e) The LOA shall set forth:

    (1) Permissible methods of incidental taking;

    (2) Means of effecting the least practicable adverse impact (i.e., mitigation) on the species, its habitat, and on the availability of the species for subsistence uses; and

    (3) Requirements for monitoring and reporting.

    (f) Issuance of the LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations.

    (g) Notice of issuance or denial of an LOA shall be published in the Federal Register within thirty days of a determination.

    § 219.38 Renewals and modifications of Letters of Authorization.

    (a) An LOA issued under § 216.106 of this chapter and § 219.37 for the activity identified in § 219.31(a) shall be renewed or modified upon request by the applicant, provided that:

    (1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section), and

    (2) OPR determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were implemented.

    (b) For an LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting (excluding changes made pursuant to the adaptive management provision in in paragraph (c)(1) of this section) that do not change the findings made for the regulations or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), OPR may publish a notice of proposed LOA in the Federal Register, including the associated analysis of the change, and solicit public comment before issuing the LOA.

    (c) An LOA issued under § 216.106 of this chapter and § 219.37 for the activity identified in § 219.31(a) may be modified by OPR under the following circumstances:

    (1) Adaptive Management—OPR may modify (including augment) the existing mitigation, monitoring, or reporting measures (after consulting with NEFSC regarding the practicability of the modifications) if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the preamble for these regulations.

    (i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, or reporting measures in an LOA:

    (A) Results from NEFSC's monitoring from the previous year(s).

    (B) Results from other marine mammal and/or sound research or studies.

    (C) Any information that reveals marine mammals may have been taken in a manner, extent or number not authorized by these regulations or subsequent LOAs.

    (ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, OPR will publish a notice of proposed LOA in the Federal Register and solicit public comment.

    (2) Emergencies—If OPR determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in § 219.32(b), an LOA may be modified without prior notice or opportunity for public comment. Notice would be published in the Federal Register within thirty days of the action.

    §§ 219.39—219.40 [Reserved]
    [FR Doc. 2016-18739 Filed 8-10-16; 8:45 am] BILLING CODE 3510-22-P
    81 155 Thursday, August 11, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-8503; Airspace Docket No. 16-ASW-11] Proposed Amendment of Class D and E Airspace for the Following Texas Towns; Houston Sugar Land, TX; Alice, TX; Bay City, TX; Brenham, TX; Burnet, TX; Falfurrias, TX; Graford, TX; and Hamilton, TX, and Proposed Revocation of Class E Airspace; Austin Horseshoe Bay Resort Airport, TX AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class D and Class E surface area airspace at Sugar Land Regional Airport, Houston Sugar Land, TX. The FAA also proposes to modify Class E airspace extending upward from 700 feet above the surface at Kingsville Kleberg County Airport, Alice, TX; Bay City Municipal Airport, Bay City, TX; Brenham Municipal Airport, Brenham, TX; Burnet Municipal Airport-Kate Craddock Field, Burnet, TX; Brooks County Airport, Falfurrias, TX; Possum Kingdom Airport, Graford, TX; and Hamilton Municipal Airport, Hamilton, TX. Decommissioning of non-directional radio beacons (NDBs), cancellation of NDB approaches, and implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at these airports. This action also proposes to remove Class E airspace at Horseshoe Bay Resort Airport, Austin, TX, as controlled airspace is no longer needed. Additionally, the geographic coordinates at Bay City Municipal Airport, Brenham Municipal Airport, and Brooks County Airport, as well as the name of Sugar Land Regional Airport (formerly Sugar Land Municipal/Hull Field) would be adjusted to coincide with the FAA's aeronautical database.

    DATES:

    Comments must be received on or before September 26, 2016.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, 20590; telephone (202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No. FAA-2016-8503; Airspace Docket No. 16-ASW-11, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX, 76177; telephone (817) 222-5711.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class D airspace and Class E surface area airspace at Sugar Land Regional Airport, Houston Sugar Land, TX; amend Class E airspace extending upward from 700 feet above the surface at Kingsville Kleberg County Airport, Alice, TX; Bay City Municipal Airport, Bay City, TX; Brenham Municipal Airport, Brenham, TX; Burnet Municipal Airport-Kate Craddock Field, Burnet, TX; Brooks County Airport, Falfurrias, TX; Possum Kingdom Airport, Graford, TX; and Hamilton Municipal Airport, Hamilton, TX; and remove Class E at Horseshoe Bay Resort Airport, Austin, TX.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8503/Airspace Docket No. 16-ASW-11.” The postcard will be date/time stamped and returned to the commenter.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX, 76177.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying:

    Class D airspace and Class E surface area airspace within a 5.8-mile radius of Sugar Land Regional Airport, Houston Sugar Land, TX, and updating the name of airport to coincide with the FAA's aeronautical database;

    Class E airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Kingsville, Kleberg County Airport, Alice, TX, with an extension northwest of the airport from the 6.6-mile radius to 10.3 miles;

    Within a 6.5-mile radius of Bay City Municipal Airport, Bay City, TX, and updating the geographic coordinates of the airport to coincide with the FAAs aeronautical database;

    Within a 6.5-mile radius of Brenham Municipal Airport, Brenham TX, and updating the geographic coordinates of the airport to coincide with the FAAs aeronautical database;

    Within a 6.6-mile radius of the Burnet Municipal Airport-Kate Craddock Field, Burnet, TX;

    Within a 6.6-mile radius of Brooks County Airport, Falfurrias, TX, and updating the geographic coordinates of the airport to coincide with the FAAs aeronautical databases;

    Within a 7.0-mile radius of Possum Kingdom Airport, Graford, TX, with extensions to the northeast of the airport from the 7.0-mile radius to 10.9 miles, and to the southwest of the airport from the 7.0-mile radius to 10.9 miles;

    And within a 6.5-mile radius of Hamilton Municipal Airport, Hamilton, TX, with extensions to the north of the airport from the 6.5-mile radius to 9.4 miles, and to the south of the airport from the 6.5-mile radius to 10.3 miles;

    The Class E airspace area extending upward from 700 feet above the surface within a 6.5-mile radius of Horseshoe Bay Resort Airport, Austin Horseshoe Bay Resort Airport, TX, would be removed as the SIAPs have been cancelled and controlled airspace is no longer needed.

    Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures at the above airports. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

    Class D and E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 5000 Class D Airspace. ASW TX D Houston Sugar Land, TX [Amended] Sugar Land, Sugar Land Regional Airport, TX (Lat. 29°37′20″ N., long. 95°39′24″ W.)

    That airspace extending upward from the surface to and including 2,600 feet MSL within a 5.8-mile radius of Sugar Land Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. ASW TX E2 Houston Sugar Land, TX [Amended] Sugar Land, Sugar Land Regional Airport, TX (Lat. 29°37′20″ N., long. 95°39′24″ W.)

    Within a 5.8-mile radius of Sugar Land Regional Airport. This Class E airspace is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASW TX E5 Alice, TX [Amended] Alice International Airport, TX (Lat. 27°44′27″ N., long. 98°01′37″ W.) Orange Grove NALF, TX (Lat. 27°53′49″ N., long. 98°02′37″ W.) Navy Orange Grove TACAN (Lat. 27°53′43″ N., long. 98°02′33″ W.) Kingsville, Kleberg County Airport, TX (Lat. 27°33′03″ N., long. 98°01′51″ W.)

    That airspace extending upward from 700 feet above the surface within a 7.5-mile radius of Alice International Airport, and within 2 miles each side of the 135° bearing from Alice International Airport extending from the 7.5-mile radius to 9.8 miles southeast of the airport, and within a 7.2-mile radius of the Orange Grove NALF, and within 1.6 miles each side of the 129° radial of the Navy Orange Grove TACAN extending from the 7.2-mile radius of the Orange Grove NALF to 11 miles southeast of the Orange Grove NALF, and within 1.5 miles each side of the 320° radial of the Navy Orange Grove TACAN extending from the 7.2-mile radius of the Orange Grove NALF to 9.7 miles northwest of the Orange Grove NALF, and within a 6.6-mile radius of Kleberg County Airport, and within 4.0 miles each side of the 320° bearing from the Kleberg County Airport from the 6.6-mile radius to 10.3 miles northwest of the airport, excluding that airspace within the Corpus Christi, TX, Class E airspace area.

    ASW TX E5 Austin, Horseshoe Bay Resort Airport, TX [Removed] ASW TX E5 Bay City, TX [Amended] Bay City Municipal Airport, TX (Lat. 28°58′24″ N., long. 95°51′48″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Bay City Municipal Airport.

    ASW TX E5 Brenham, TX [Amended] Brenham Municipal Airport, TX (Lat. 30°13′11″ N., long. 96°22′28″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Brenham Municipal Airport.

    ASW TX E5 Burnet, TX [Amended] Burnet Municipal Airport-Kate Craddock Field, TX (Lat. 30°44′20″ N., long. 98°14′19″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Burnet Municipal Airport-Kate Craddock Field.

    ASW TX E5 Falfurrias, TX [Amended] Brooks County Airport, TX (Lat. 27°12′22″ N., long. 98°07′16″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Brooks County Airport.

    ASW TX E5 Graford, TX [Amended] Possum Kingdom Airport, TX (Lat. 32°55′24″ N., long. 98°26′13″ W.)

    That airspace extending upward from 700 feet above the surface within a 7.0-mile radius of Possum Kingdom Airport and within 4 miles each side of the 031° bearing from the airport extending from the 7.0-mile radius to 10.9 miles northeast of the airport, and within 4 miles each side of the 210° bearing from the airport extending from the 7.0-mile radius to 10.9 miles southwest of the airport.

    ASW TX E5 Hamilton, TX [Amended] Hamilton Municipal Airport, TX (Lat. 31°39′57″ N., long. 98°08′55″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Hamilton Municipal Airport, and within 2 miles each side of the 009° bearing from the airport extending from the 6.5-mile radius to 9.4 miles north of the airport, and within 2 miles each side of the 189° bearing from the airport extending from the 6.5-mile radius to 10.3 miles south of the airport.

    Issued in Fort Worth, Texas, on August 1, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2016-18769 Filed 8-10-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-8557; Airspace Docket No. 16-AGL-17] Proposed Amendment of Class E Airspace for the Following Wisconsin Towns; Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI; Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI, and Proposed Revocation of Class E Airspace; Wausau, WI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Langlade County Airport, Antigo, WI; John F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown Airport, Wausau, WI. Decommissioning of non-directional radio beacon (NDB), cancellation of NDB approaches, and implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at the above airports. This action also proposes to remove Class E surface area airspace at Wausau Municipal Airport (Wausau Downtown Airport), Wausau, WI, as a review has determined that the airport no longer meets the requirements for this airspace. Additionally, the geographic coordinates at Langlade County Airport, John F. Kennedy Memorial Airport, Cumberland Municipal Airport, Eagle River Union Airport, and Wausau Downtown Airport (formerly Wausau Municipal Airport) would be adjusted to coincide with the FAAs aeronautical database.

    DATES:

    Comments must be received on or before September 26, 2016.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No. FAA-2016-8557; Airspace Docket No. 16-AGL-17, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX, 76177; telephone (817) 222-5711.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace extending upward from 700 feet above the surface at Langlade County Airport, Antigo, WI; John F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown Airport, Wausau, WI; and remove Class E surface area airspace at Wausau Downtown Airport (formerly Wausau Municipal Airport), Wausau, WI.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8557/Airspace Docket No. 16-AGL-17.” The postcard will be date/time stamped and returned to the commenter.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX, 76177.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface:

    Within a 6.5-mile radius of Langlade County Airport, Antigo, WI, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 7.0-mile radius of John F. Kennedy Memorial Airport, Ashland, WI, with an extension southwest of the airport from the 7.0-mile radius to 8.2 miles, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 7.1-mile radius of Black River Falls Area Airport, Black River Falls, WI, with an extension southwest of the airport from the 7.1-mile radius to 11.7 miles, with an extension northeast of the airport from the 7.1-mile radius to 11.4 miles;

    Within a 6.9-mile radius of Cable Union Airport, Cable Union, WI;

    Within a 6.4-mile radius of Cumberland Municipal Airport, Cumberland, WI, with extensions from the 6.4-mile radius to 10.2 miles west and east; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 6.5-mile radius of Eagle River Union Airport, Eagle River, WI, with an extension southwest of the airport from the 6.5-mile radius to 9.2 miles, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 6.6-mile radius of Sawyer County Airport, Hayward, WI, with an extension northeast of the airport from the 6.6-mile radius to 8.5 miles;

    And within a 6.8-mile radius of Wausau Downtown Airport, Wausau, WI, and updating the name and geographic coordinates of the airport to coincide with the FAA's aeronautical database.

    The Class E airspace designated as a surface area at Wausau Municipal Airport, Wausau, WI, would be removed as the airport no longer meets the requirements for this airspace.

    Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures at the above airports. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

    Class E airspace designations are published in paragraphs 6002 and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 6002 Class E Airspace Designated as Surface Areas. AGL WI E2 Wausau, WI [Removed] Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL WI E5 Antigo, WI [Amended] Langlade County Airport, WI (Lat. 45°09′14″ N., long. 89°06′38″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Langlade County Airport.

    AGL WI E5 Ashland, WI [Amended] John F. Kennedy Memorial Airport, WI (Lat. 46°32′55″ N., long. 90°55′08″ W.)

    That airspace extending upward from 700 feet above the surface within a 7.0-mile radius of John F. Kennedy Memorial Airport, and within 2.9 miles each side of the 201° bearing from the airport extending from the 7.0-mile radius to 8.2 miles southwest of the airport.

    AGL WI E5 Black River Falls, WI [Amended] Black River Falls Area Airport (Lat. 44°15′03″ N., long. 90°51′19″ W.)

    That airspace extending upward from 700 feet above the surface within a 7.1-mile radius of Black River Falls Area Airport, and within 2 miles each side of the 081° bearing from the airport extending from the 7.1-mile radius to 11.4 miles east of the airport, and within 2 miles each side of the 260° bearing from the airport extending from the 7.1-mile radius to 11.7 miles west of the airport.

    AGL WI E5 Cable Union, WI [Amended] Cable Union Airport, WI (Lat. 46°11′42″ N., long. 91°14′54″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.9-mile radius of Cable Union Airport.

    AGL WI E5 Cumberland, WI [Amended] Cumberland Municipal Airport, WI (Lat. 45°30′22″ N., long. 91°58′51″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Cumberland Municipal Airport, and within 2 miles each side of the 091° bearing from the airport extending from the 6.4-mile radius to 10.2 miles east of the airport, and within 2 miles each side of the 270° bearing from the airport extending from the 6.4-mile radius to 10.2 miles west of the airport.

    AGL WI E5 Eagle River, WI [Amended] Eagle River Union Airport, WI (Lat. 45°55′56″ N., long. 89°16′06″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Eagle River Union Airport, and within 2 miles each side of the 225° bearing from the airport extending from the 6.5-mile radius to 9.2 miles southwest of the airport.

    AGL WI E5 Hayward, WI [Amended] Sawyer County Airport, WI (Lat. 46°01′31″ N., long. 91°26′39″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Sawyer County Airport, and within 2 miles each side of the 025° bearing from the airport extending from the 6.6-mile radius to 8.5 miles northeast of the airport.

    AGL WI E5 Wausau, WI [Amended] Wausau Downtown Airport, WI (Lat. 44°55′35″ N., long. 89°37′37″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Wausau Downtown Airport.

    Issued in Fort Worth, Texas, on July 29, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2016-18773 Filed 8-10-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 30 and 206 [Docket No. FR-5353-N-02] RIN 2502-AI79 Federal Housing Administration (FHA): Strengthening the Home Equity Conversion Mortgage Program AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Supplemental notice of proposed rulemaking.

    SUMMARY:

    On May 19, 2016, HUD published in the Federal Register, a proposed rule that would codify several significant changes to FHA's Home Equity Conversion Mortgage program that were previously issued under the authority granted to HUD in the Housing and Economic Recovery Act of 2008 and the Reverse Mortgage Stabilization Act of 2013, and to make additional regulatory changes. The Home Equity Conversion Mortgage program is FHA's reverse mortgage program that enables seniors who have equity in their homes to withdraw a portion of the accumulated equity. The intent of the Home Equity Conversion Mortgage program is to ease the financial burden on elderly homeowners facing increased health, housing, and subsistence costs at a time of reduced income. This document opens the public comment period solely for the provision addressed in this document to address a suggested change offered during the public comment period for the proposed rule regarding the lender's option to file a claim when the loan balance reaches 98 percent of the maximum claim amount.

    DATES:

    Comment Due Date: September 12, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this notice to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.

    1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0001.

    2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    Note:

    To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the document. No Facsimile Comments. Facsimile (FAX) comments are not acceptable.

    Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339. Copies of all comments submitted are available for inspection and downloading at www.regulations.gov.

    FOR FURTHER INFORMATION, CONTACT:

    Karin Hill, Senior Policy Advisor, Office of Single Family Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 9282, Washington, DC 20410; telephone number 202-402-3084 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the toll- free Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION: I. Background A. The HECM Program

    On May 19, 2016, at 81 FR 31769, HUD published a document that proposed to amend its regulations, at 24 CFR parts 30 and 206, that govern HUD's reverse mortgage program, called the Home Equity Conversion Mortgage (HECM) program. The HECM program allows eligible borrowers, 62 years of age or older, to convert the equity in their homes into liquid assets. The withdrawal of equity may take a variety of forms, as authorized by the National Housing Act (NHA) and selected by the borrower. The home, which serves as security for the FHA-insured mortgage, must be, and must continue to be, the borrower's principal residence during the life of the borrower. For adjustable interest rate HECMs, equity payments to the borrower may be in the form of monthly disbursements for life or a fixed term of years, disbursements from a line of credit advance or a combination of monthly disbursements and a line of credit. For fixed interest rate HECMs, equity payments to the borrower must be in the form of a single lump sum disbursement at closing.

    The maximum amount of equity in the home that is available to a borrower under a HECM loan is the “principal limit” that is calculated for that loan. The borrower retains ownership of the property and may sell the home at any time keeping any residual sale proceeds in excess of the outstanding loan balance. Until the mortgage is repaid, and regardless of whether or not additional disbursements under the mortgage are permissible, interest on the mortgage, mortgage insurance premiums, and servicing charges, where applicable, continue to accrue.

    The subject of this document regards the mortgagee's election of the assignment option as provided in § 206.107(a). This section gives the mortgagee an option, before the mortgage is submitted for insurance endorsement, to select either: (1) The assignment option, which allows the mortgagee to assign the HECM to the Secretary if the mortgage balance is equal to or greater than 98 percent of the maximum claim amount; or (2) the shared premium option, which allows the mortgagee to retain a portion of the monthly mortgage insurance premiums (MIP) but does not allow the mortgagee to assign the mortgage unless the mortgagee fails to make payments and the Secretary demands assignment. Under the assignment option, the mortgagee may only assign the mortgage to the Secretary if the following are also true: (1) The mortgagee is current in making the required payments to the mortgagor; (2) the mortgagee is current in making the required MIP payments to the Secretary; (3) the mortgage is not due and payable; and (4) the mortgage is a first lien of record and title to the property securing the mortgage is good and marketable.

    B. The Proposed Rule and the Public Comment

    The May 19, 2016, proposed rule proposed to codify a number of changes that had been implemented through mortgagee letters under the authority of the Housing and Economic Recovery Act of 2008 (Pub. L. 110-289, approved July 30, 2008) (HERA) and the Reverse Mortgage Stabilization Act of 2013 (Pub. L. 113-29, approved August 9, 2013) (RMSA).

    The public comment period on the proposed rule closed on July 18, 2016. All public comments submitted to date can be found at https://www.regulations.gov/document?D=HUD-2016-0052-0001, and each public comment is assigned a number that begins with HUD-2016-0052. On June 23, 2016, a public commenter (HUD-2016-0052-0010) brought to HUD's attention a suggested change to the HECM program's policy that grants the mortgagee the option to assign a HECM loan to FHA if the outstanding loan balance is equal to or greater than 98 percent of the maximum claim amount. The commenter stated that, in some cases, a mortgagee may decline to file a claim in this scenario if the property value has risen rapidly and the loan has an above-market rate. The commentator concluded that lenders in this way have a “put option” and “can choose to keep the best loans and make claims for the worst ones”. In order to address this issue, the commenter suggested that HUD require that an assignment claim be made when the loans reach 98 percent of the maximum claim amount. HUD seeks public comment on the feasibility of this proposal as HUD is considering whether to adopt it.

    II. Proposed Approach To Require Claims Be Made at 98 Percent of Maximum Claim Amount

    Through this document, HUD solicits public comment solely on the issue of requiring mortgagees to file a claim when the HECM loan reaches 98 percent of the maximum claim amount. If HUD were to implement this proposal, HUD would amend § 206.107(a) to require the mortgagee to assign the mortgage to the Commissioner if the mortgage balance is equal to or greater than 98 percent of the maximum claim amount, or the mortgagor has requested a payment which exceeds the difference between the maximum claim amount and the mortgage balance.

    By proposing the change to the assignment option suggested by the public commenter, HUD would not alter the other proposed changes to § 206.107(a). The criteria for assigning a HECM loan to the Commissioner in § 206.107(a) would remain, thereby still precluding the mortgagee from assigning the HECM loan if the loan or the mortgagee's servicing of the loan does not meet the criteria. Therefore, the proposal would require the mortgagee to assign the mortgage to the Commissioner at the given threshold unless the loan or the mortgagee's servicing of the loan does not meet the assignment criteria.

    HUD is soliciting public comment solely on this proposal for a period of 30 days.

    Dated: August 9, 2016. Genger Charles, General Deputy Assistant Secretary for Housing.
    [FR Doc. 2016-19255 Filed 8-10-16; 8:45 am] BILLING CODE 4210-67-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 50 [EPA-HQ-OAR-2016-0408; FRL-9950-46-OAR] RIN 2060-AS89 Technical Correction to the National Ambient Air Quality Standards for Particulate Matter AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing revisions to correct an equation in an appendix in the National Ambient Air Quality Standards (NAAQS) for Particle Pollution. In the “Rules and Regulations” section of the Federal Register, we are approving the correction as a direct final rule without a prior proposed rule. If we receive no adverse comment, we will not take further action on this proposed rule. Equation 2 describes an intermediate step in the calculation of the design value for the annual PM2.5 (particles with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers) NAAQS. This proposed action would correct a scrivener's error in one of the equations used to calculate an annual mean PM2.5 concentration, to properly account for cases where a site does not have four complete quarters of data and passes one of two substitution tests. This change accurately reflects the intended calculation of the annual mean PM2.5 design value and is consistent with the text elsewhere in the appendix.

    DATES:

    Written comments must be received by September 12, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0408, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (e.g., on the Web, Cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Brett Gantt, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Air Quality Analysis Group (Mail Code: C304-04), Research Triangle Park, NC 27711; telephone number: (919) 541-5274; fax number: (919) 541-3613; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. Why is the EPA issuing this proposed rule?

    This document proposes a revision in appendix N to correct a scrivener's error in an intermediate equation in the calculation of the annual PM2.5 design value to properly account for cases where a site does not have four complete quarters of data in a specific year and passes the minimum quarterly value substitution test. We have published a direct final rule approving the revisions to appendix N in the “Rules and Regulations” section of this Federal Register because we view this as a non-controversial action and anticipate no adverse comment. We have explained our reasons for this action in the preamble of the direct final rule.

    If we receive no adverse comment, we will not take further action on this proposed rule. If we receive adverse comment, we will withdraw the direct final rule, and it will not take effect. We would address all public comments in any subsequent final rule based on this proposed rule.

    We do not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the information provided in the ADDRESSES section of this document.

    II. Does this action apply to me?

    This action applies to you if you are calculating the annual PM2.5 design value for a site which does not have four complete quarters of data for a specific year and passes the minimum quarterly value substitution test.

    III. Environmental Justice

    The EPA has determined that this proposed 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 rule does not relax the calculation of the annual PM2.5 NAAQS design values and, therefore, will not cause decreases in the design values used to designate and classify nonattainment areas and assess progress towards meeting the NAAQS.

    IV. Statutory and Executive Order Reviews

    For a complete discussion of the administrative requirements applicable to this action, see the direct final rule in the “Rules and Regulations” section of this Federal Register.

    List of Subjects in 40 CFR Part 50

    Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.

    Dated: August 3, 2016. Gina McCarthy, Administrator.

    For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend title 40, chapter I of the Code of Federal Regulations as follows:

    PART 50—NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS 1. The authority citation for Part 50 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    2. In appendix N to part 50, in section 4.4, Equation 2 is revised to read as follows: Appendix N to Part 50—Interpretation of the National Ambient Air Quality Standards for PM2.5 4.4 Equations for the Annual PM2.5 NAAQS

    (b) * * *

    EP11AU16.003 Where: X y = the annual mean concentration for year y (y = 1, 2, or 3); n Q,y = the number of complete quarters Q in year y; and X q,y = the mean for quarter q of year y (result of equation 1).
    [FR Doc. 2016-19033 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2012-0263; FRL-9950-35-Region 6] Approval and Promulgation of Implementation Plans; Oklahoma; Disapproval of Prevention of Significant Deterioration for Particulate Matter Less Than 2.5 Micrometers—Significant Impact Levels and Significant Monitoring Concentration AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to disapprove severable portions of the February 6, 2012, Oklahoma State Implementation Plan (SIP) submittal that establish certain de minimis thresholds for particulate matter less than 2.5 micrometers in diameter (PM2.5) in the Prevention of Significant Deterioration (PSD) permitting requirements. Specifically, we are proposing to disapprove provisions that adopt and implement the PM2.5 significant impact levels (SILs) and significant monitoring concentration (SMC); both of which were vacated by a federal court and subsequently removed from federal PSD regulations. We are proposing to disapprove the submitted provisions as inconsistent with federal laws and regulations for the permitting of PM2.5. The EPA is proposing this disapproval under section 110 and part C of the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before September 12, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2012-0263, at http://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact Ms. Adina Wiley, (214) 665-2115, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Adina Wiley, (214) 665-2115, [email protected] To inspect the hard copy materials, please schedule an appointment with Ms. Adina Wiley or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

    Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

    I. Background A. CAA and SIPs

    Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). These ambient standards currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA approved SIP regulations and control strategies are federally enforceable.

    B. Prior Federal Action

    Under Section 165(a) of the CAA, a major source may not commence construction unless the source has been issued a permit and has satisfied certain requirements. Among those requirements, the permit applicant must demonstrate that emissions from construction or operation of the facility will not cause, or contribute to, air pollution in excess of any increment, NAAQS, or any other applicable emission standard of performance. This statutory requirement has been incorporated into federal regulations at 40 CFR 51.166(k)(1). Moreover, to support this analysis, PSD permit applications must contain air quality monitoring data representing air quality in the area affected by the proposed source for the 1-year period preceding receipt of the application. This statutory requirement has been incorporated into federal regulations at 40 CFR 51.166(m)(ii)-(iv).

    In 2010, the EPA promulgated regulations for SIPs concerning PSD permitting for PM2.5 which included two voluntary screening tools: SILs and SMCs. 75 FR 64864 (Oct. 20, 2010). The SILs are screening tools that states with PSD SIPs apply in the issuance of a PSD permit to demonstrate that the proposed source's allowable emissions will not cause or contribute to a violation of the NAAQS or increment. The SMC has been used to exempt sources from the requirement in the CAA to collect preconstruction monitoring data for up to 1 year before submitting a permit application in order to help determine existing ambient air quality. 78 FR 73699 (Dec. 9, 2013).

    Sierra Club filed a petition for review of the PSD regulations containing the PM2.5 SILs and SMC with the United States Court of Appeals for the District of Columbia Circuit (the Court). On January 22, 2013, the Court issued an opinion granting a request from the EPA to vacate and remand to the EPA portions of the October 20, 2010, PSD regulations establishing the PM2.5 SIL and further vacating the portions of the PSD regulations establishing a PM2.5 SMC. See, Sierra Club v. EPA, 706 F.3d 428 (D.C. Cir. 2013).

    In response to the Court's decision, the EPA amended its regulations to remove the affected PM2.5 SIL regulations from the federal regulations and to replace the existing PM2.5 SMC value with a “zero” threshold. 78 FR 73698 (Dec. 9, 2013). In that rulemaking, the EPA removed the regulatory text related to the affected PM2.5 SILs at sections 51.166(k)(2) and 52.21(k)(2). Although the Court vacated the PM2.5 SMC provisions in 40 CFR 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c), the EPA did not remove the affected regulatory text, but instead revised the concentration for the PM2.5 SMC listed in sections 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c) to zero micrograms per cubic meter (0 μg/m3). Because 40 CFR 51.166(i)(5)(iii) and 40 CFR 52.21(i)(5)(iii) establish an exemption from air monitoring requirements for any pollutant “not listed in paragraph (i)(5)(i),” the EPA explained that it would not be appropriate to remove the reference to PM2.5 in paragraph (i)(5)(i). Were the EPA to completely remove PM2.5 from the list of pollutants in sections 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c) of the PSD regulations, PM2.5 would no longer be a listed pollutant and the paragraph (iii) provision could be interpreted as giving reviewing authorities the discretion to exempt permit applicants from the requirement to conduct monitoring for PM2.5, in contravention of the Court's decision and the CAA. Instead, the EPA revised the concentration listed in sections 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c) to “0” micrograms per cubic meter (μg/m3). This means that there is no air quality impact level below which a reviewing authority has the discretion to exempt a source from the PM2.5 monitoring requirements at 40 CFR 52.21(m).

    C. Oklahoma's Submittal

    On February 6, 2012, Oklahoma submitted revisions to its PSD SIP at OAC 252:100-8-33(c)(1)(C) that adopted provisions substantively identical to the EPA PSD SIP's requirement for PM2.5 PSD SMC. 40 CFR 51.166(i)(5)(i). The February 6, 2012, submittal also included revisions to OAC 252:100-8-35(a)(2) that adopted provisions substantively identical to the EPA PSD SIP's requirements for PM2.5 PSD SILs. 40 CFR 51.166(k)(2). The February 6, 2012, submittal included other revisions to the Oklahoma SIP that are severable from the voluntary PSD exemptions. Our Technical Support Document (TSD), available in the rulemaking docket, identifies the separate EPA actions addressing the remainder of the February 6, 2012 submittal.

    II. The EPA's Evaluation

    Our analysis, available in our TSD, finds that the State of Oklahoma adopted and submitted on February 6, 2012, revisions to the Oklahoma SIP that were substantively consistent with the voluntary exemptions from PSD monitoring at 40 CFR 51.166(i)(5)(i) and the requirements for a source impact analysis at 40 CFR 51.166(k)(2) promulgated on October 20, 2010. Subsequent to the submittal of these provisions, the Court vacated and remanded these provisions to the EPA. On December 9, 2013, we promulgated revisions to the PSD SIP rules that removed the vacated PM2.5 SILs provision and replaced the existing PM2.5 SMC value with a “zero” threshold level at 40 CFR 51.166. Because the PM2.5 SILs and SMC are no longer valid exemptions from the requirements of a PSD SIP, we propose to disapprove these revisions submitted to be included in the Oklahoma PSD SIP as they are inconsistent with the federal statutory and regulatory permitting requirements for PM2.5.

    Disapproval of the submitted PM2.5 SILs at OAC 252:100-8-35(a)(2) ensures that the provisions at OAC 252:100-8-35(a)(1) 1 in the existing SIP continue to apply to PM2.5. Namely, that the owner or operator of the proposed source or modification shall demonstrate that, as of the source's start-up date, allowable emissions increases from that source or modification, in conjunction with all other applicable emissions increases or reductions (including secondary emissions) would not cause or contribute to any increase in ambient concentrations that would exceed any NAAQS in any air quality control region; or the remaining available PSD increment for the specified air contaminants in any area, as determined by the Director of the Oklahoma Department of Environmental Quality.

    1 The EPA proposed approval of OAC 252:100-8-35(a)(1) on June 30, 2016, as consistent with federal PSD requirements. See 81 FR 42587.

    Disapproval of the submitted PM2.5 SMC at OAC 252:100-8-33(c)(1) means that PM2.5 will not be a listed pollutant in the state's requirement for ambient monitoring data, and would appear to allow PSD permit applicants to avoid submitting PM2.5 monitoring data as part of their permit application. To address this concern, the Oklahoma Department of Environmental Quality submitted a letter on February 25, 2016, that demonstrated the State retains authority to require pre- and post-construction PSD monitoring for PM2.5 under the Oklahoma PSD SIP in the event that the EPA disapproves OAC 252:100-8-33(c)(1). Specifically, the SIP, under OAC 252:100-8-35.1(b)(3),2 grants the ODEQ Director the authority to request information regarding the air quality impact of the source or modification. The ODEQ interprets this SIP provision to grant the Director the authority to request monitoring data for PM2.5 as required under 40 CFR 51.166(m). Further, as noted in our December 9, 2013, final rule, any State regulations or approved SIP provisions adopting the PM2.5 SIL and SMC are unlawful and may not be applied even prior to their removal from the applicable State regulations or SIP. See 78 FR 73698, 73700. Because reliance on the PM2.5 SIL and SMC has been deemed unlawful, and because the State has provided a letter demonstrating underlying authority in the Oklahoma SIP at OAC 252:100-8-35.1(b)(3) to require pre- and post-construction monitoring for PM2.5, we have determined it is appropriate to disapprove the submitted PM2.5 SMC provisions at OAC 252:100-8-33(c)(1).

    2 The EPA proposed approval of OAC 252:100-8-35.1(b)(3) on June 30, 2016, as consistent with federal PSD requirements. See 81 FR 42587.

    The EPA has an obligation under section 110 of the CAA to act on submitted SIP revisions unless these revisions are withdrawn by the State. Therefore, the EPA has a duty to act on the submitted Oklahoma provisions pertaining to the PM2.5 SILs and SMC, because these provisions were submitted for EPA's review on February 6, 2012, and the state has not withdrawn the portion of the SIP submission containing these provisions. Our proposed action today will disapprove this portion of the February 6, 2012 SIP submission because these provisions are inconsistent with the federal statutory and regulatory SIP permitting requirements for PM2.5.

    III. Proposed Action

    We are proposing to disapprove severable portions of the February 6, 2012, Oklahoma SIP submittal establishing the voluntary PM2.5 SILs provision and SMC. The EPA has made the preliminary determination that these submitted revisions to the Oklahoma SIP are disapprovable because they establish permitting SIP requirements that are inconsistent with the federal statutory and regulatory permitting requirements for PM2.5. Therefore, under section 110 and part C of the CAA, and for the reasons presented above, the EPA is proposing to disapprove the following revisions:

    • Substantive revisions to the Oklahoma SIP at OAC 252:100-8-33(c)(1)(C) establishing the PM2.5 SMC as submitted on February 6, 2012; and

    • Substantive revisions to the Oklahoma PSD program in OAC 252:100-8-35(a)(2) establishing the PM2.5 PSD SILs provision as submitted on February 6, 2012.

    The EPA is proposing to disapprove the revisions listed because the submitted provisions are inconsistent with the federal statutory and regulatory permitting requirements for PM2.5. Upon finalization of this disapproval owners or operators of a proposed source or modification will continue to satisfy the source impact analysis provisions for PM2.5 as required under the Oklahoma SIP at OAC 252:100-8-35(a)(1). Additionally, the State of Oklahoma would continue to have the necessary authority to require monitoring of PM2.5 under the Oklahoma SIP at OAC 252:100-8-35.1(b)(3) consistent with the provisions of 40 CFR 52.21(m). Finalization of this proposed disapproval will not require the EPA to promulgate a Federal Implementation Plan, because the Oklahoma PSD program will continue to satisfy the Federal PSD SIP requirements for PM2.5 monitoring and source impact analysis. We are proposing this disapproval under section 110 and part C of the Act; as such, the EPA will not impose sanctions as a result of a final disapproval.

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

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA. There is no burden imposed under the PRA because this action proposes to disapprove submitted revisions that are no longer consistent with federal laws and regulations for the regulation and permitting of PM2.5.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action proposes to disapprove submitted revisions that are no longer consistent with federal laws and regulations for the regulation and permitting of PM2.5, and therefore will have no impact on small entities.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. This action proposes to disapprove submitted revisions that are no longer consistent with federal laws and regulations for the regulation and permitting of PM2.5, and therefore will have no impact on small governments.

    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.

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

    This action does not have tribal implications as specified in Executive Order 13175. This action proposes to disapprove provisions of state law that are no longer consistent with federal law for the regulation and permitting of PM2.5; there are no requirements or responsibilities added or removed from Indian Tribal Governments. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it disapproves state permitting provisions that are inconsistent with federal laws and regulations for the regulation and permitting of PM2.5.

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

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

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This action is not subject to Executive Order 12898 because it disapproves state permitting provisions that are inconsistent with federal laws and regulations for the regulation and permitting of PM2.5.

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: July 29, 2016. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2016-18895 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R06-RCRA-2016-0176; FRL-9950-12-Region 6] Arkansas: Final Authorization of State Hazardous Waste Management Program Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The State of Arkansas has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant Final authorization to the State of Arkansas. In the “Rules and Regulations” section of this Federal Register, EPA is authorizing the changes by direct final rule. EPA did not make a proposal prior to the direct final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the direct final rule. Unless we get written comments which oppose this authorization during the comment period, the direct final rule will become effective 60 days after publication and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the direct final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time.

    DATES:

    Send your written comments by September 12, 2016.

    ADDRESSES:

    Submit any comments identified by Docket ID No. EPA-R06-RCRA-2016-0176, by one of the following methods:

    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    2. Email: [email protected]

    3. Mail: Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.

    4. Hand Delivery or Courier. Deliver your comments to Alima Patterson, Region 6, Regional Authorization Coordinator, Permit Section (RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.

    Instructions: Do not submit information that you consider to be CBI or otherwise protected through regulations.gov, or email. Direct your comment to Docket No. EPA-R06-RCRA-2016-0176. The Federal regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. You can view and copy Arkansas's application and associated publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following locations: Arkansas Department of Environmental Quality, 8101 Interstate 30, Little Rock, Arkansas 72219-8913, (501) 682-0876. Interested persons wanting to examine these documents should make an appointment with the office at least two weeks in advance.

    FOR FURTHER INFORMATION CONTACT:

    Alima Patterson, Region 6, Regional Authorization Coordinator, RCRA Permits Section (RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, (214) 665-8533 and Email address [email protected]

    SUPPLEMENTARY INFORMATION:

    For additional information, please see the direct final published in the “Rules and Regulations” section of today's Federal Register.

    Dated: July 14, 2016. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2016-18432 Filed 8-10-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 202, 212, 215, 234, 239, and 252 [Docket DARS-2016-0028] RIN 0750-AJ01 Defense Federal Acquisition Regulation Supplement: Procurement of Commercial Items (DFARS Case 2016-D006) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Acts for Fiscal Years 2013 and 2016 relating to commercial item acquisitions.

    DATES:

    Comments on the proposed rule should be submitted in writing to the address shown below on or before October 11, 2016, to be considered in the formation of a final rule.

    ADDRESSES:

    Submit comments identified by DFARS Case 2016-D006, using any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “DFARS Case 2016-D006” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DFARS Case 2016-D006.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “DFARS Case 2016-D006” on your attached document.

    Email: [email protected] Include DFARS Case 2016-D006 in the subject line of the message.

    Fax: 571-372-6094.

    Mail: Defense Acquisition Regulations System, Attn: Mr. Mark Gomersall, OUSD(AT&L)DPAP/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060.

    Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mark Gomersall, telephone 571-372-6099.

    SUPPLEMENTARY INFORMATION: I. Background

    DoD is proposing to amend the DFARS to implement the requirements of sections 851 through 853 and 855 through 857 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92, enacted November 25, 2015), as well as the requirements of section 831 of the NDAA for FY 2013 (Pub. L. 112-239, enacted January 2, 2013). This rule also provides guidance to contracting officers to promote consistency and uniformity in the acquisition process.

    On August 3, 2015, DoD published proposed DFARS rule 2013-D034 to implement the requirements of section 831 (80 FR 45918). Based on the comments received in response to that proposed rule, and in order to implement the requirements in sections 851 through 853 and 855 through 857 of the NDAA for FY 2016, DFARS rule 2013-D034 was closed into this proposed DFARS rule.

    II. Discussion and Analysis A. Proposed DFARS Revisions

    This rule proposes to amend the DFARS as follows:

    1. Definitions of “market prices,” “market research,” “nontraditional defense contractor,” “relevant sales data,” and “uncertified cost data” are added.

    2. DFARS 212.102, Applicability, is amended to instruct contracting officers on the treatment of prior commercial item determinations and nontraditional defense contractors.

    3. DFARS 212.209, Determination of price reasonableness, is added to provide a hierarchy of data for contracting officers to consider when making determinations of price reasonableness.

    4. DFARS subpart 212.72, Limitation on conversion of procurement from commercial acquisition procedures, is added.

    5. DFARS 215.402, Pricing policy, is amended to provide information regarding the contracting officer's responsibility for determining if the information provided by the offeror is sufficient to determine price reasonableness.

    6. DFARS 215.403-1, Prohibition on obtaining certified cost or pricing data (10 U.S.C. 2306a and 41 U.S.C. chapter 35), is amended to provide a reference to 212.102 regarding prior commercial item determinations.

    7. DFARS 215.404-1, Proposal analysis techn