Federal Register Vol. 82, No.247,

Federal Register Volume 82, Issue 247 (December 27, 2017)

Page Range61129-61442
FR Document

82_FR_247
Current View
Page and SubjectPDF
82 FR 61431 - Adjustments of Certain Rates of PayPDF
82 FR 61413 - To Take Certain Actions Under the African Growth and Opportunity Act and for Other PurposesPDF
82 FR 61338 - Sunshine Act Meeting; National Science BoardPDF
82 FR 61304 - Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; AvailabilityPDF
82 FR 61129 - Blended Retirement System; CorrectionPDF
82 FR 61334 - Division of Coal Mine Workers' Compensation; Proposed Extension of Existing Collection; Comment RequestPDF
82 FR 61145 - Agency Reorganization; CorrectionPDF
82 FR 61306 - National Vaccine Injury Compensation Program; List of Petitions ReceivedPDF
82 FR 61320 - Allocations, Common Application, Waivers, and Alternative Requirements for Community Development Block Grant Disaster Recovery Grantees; State of Texas AllocationPDF
82 FR 61340 - Comment Request for Review of a Revised Information Collection: Customer Satisfaction SurveysPDF
82 FR 61338 - Comment Request for Review of a Revised Information Collection: Organizational Assessment SurveysPDF
82 FR 61339 - Comment Request for Review of a Revised Information Collection: Leadership Assessment SurveysPDF
82 FR 61338 - Submission for Review: It's Time To Sign Up for Direct Deposit or Direct Express, RI 38-128PDF
82 FR 61230 - Endangered and Threatened Wildlife and Plants; Listing the Yangtze Sturgeon as an Endangered SpeciesPDF
82 FR 61341 - Submission for Review: Alternative Annuity Election, RI 20-80PDF
82 FR 61276 - Intent To Prepare a Draft Integrated Environmental Impact Statement (EIS) for the New Jersey Back Bays (NJBB) Coastal Storm Risk Management (CSRM) Feasibility StudyPDF
82 FR 61293 - Human Studies Review Board; Notification of Public MeetingsPDF
82 FR 61203 - Approval of California Air Plan Revisions, Northern Sierra Air Quality Management DistrictPDF
82 FR 61184 - Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; CorrectionPDF
82 FR 61293 - Notice of Final National Pollutant Discharge Elimination System (NPDES) General Permit for the Eastern Portion of the Outer Continental Shelf (OCS) of the Gulf of Mexico (GEG460000); Availability of Finding of No Significant ImpactPDF
82 FR 61205 - Proposed Rule; Renewable Fuel Standard Program; Grain Sorghum Oil PathwayPDF
82 FR 61172 - Minimum Technical Standards for Class II Gaming Systems and EquipmentPDF
82 FR 61294 - Proposed Agency Information Collection Activities; Comment RequestPDF
82 FR 61251 - Notice of Public Meeting of the Montana Advisory CommitteePDF
82 FR 61251 - Agenda and Notice of Public Meetings of the South Dakota Advisory CommitteePDF
82 FR 61309 - National Cancer Institute; Notice of Closed MeetingsPDF
82 FR 61310 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
82 FR 61308 - National Institute on Aging Notice of Closed MeetingPDF
82 FR 61243 - Fisheries of the Exclusive Economic Zone Off Alaska; Nontrawl Lead Level 2 ObserversPDF
82 FR 61241 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Vermilion Snapper Management Measures; Amendment 47PDF
82 FR 61200 - Statutory Cable, Satellite, and DART License Reporting PracticesPDF
82 FR 61364 - Fifty Fourth RTCA SC-224 Standards for Airport Security Access Control Systems PlenaryPDF
82 FR 61362 - New Orleans Public Belt Railroad Corporation-Acquisition and Operation Exemption-Public Belt Railroad Commission of the City of New OrleansPDF
82 FR 61266 - Submission for OMB Review; Comment RequestPDF
82 FR 61268 - Submission for OMB Review; Comment RequestPDF
82 FR 61365 - Proposed Collection of Information: Subscription for Purchase and Issue of U.S. Treasury Securities, State and Local Government SeriesPDF
82 FR 61300 - Alimentation Couche-Tard Inc. and CrossAmerica Partners LP; Analysis To Aid Public CommentPDF
82 FR 61178 - Drawbridge Operation Regulation; Columbia River, Vancouver, WAPDF
82 FR 61326 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Records and Supporting Data: Importation, Receipt, Storage, and Disposition by Explosives Importers, Manufacturers, Dealers, and UsersPDF
82 FR 61361 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Jasper Johns: `Something Resembling Truth' ” ExhibitionPDF
82 FR 61284 - Steel Reef Pipelines US LLC; Notice of Application for Section 3 Authorization and Presidential PermitPDF
82 FR 61282 - Merchant Hydro Developers, LLC; Notice of Surrender of Preliminary PermitPDF
82 FR 61283 - Goodyear Lake Hydro, LLC; Notice Soliciting Scoping CommentsPDF
82 FR 61286 - Swan Lake North Hydro LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and PrescriptionsPDF
82 FR 61280 - Jason and Carol Victoria Presley; Notice of Intent To File Subsequent License Application, Filing of Pre-Application Document, Request to use the Traditional Licensing Process, and Request To Waive Pre-Filing RequirementsPDF
82 FR 61290 - PacifiCorp; Notice of Draft License Application (DLA) and Draft Preliminary Draft Environmental Assessment (PDEA) and Request for Preliminary Terms a nd ConditionsPDF
82 FR 61282 - Brookfield Energy Marketing LP v. Green Mountain Power Corporation; Notice of ComplaintPDF
82 FR 61292 - Notice of Application; Texas Eastern Transmission, LPPDF
82 FR 61292 - City of Colton, California; Notice of FilingPDF
82 FR 61283 - City of Riverside, California; Notice of FilingPDF
82 FR 61289 - Notice of Filing; City of Azusa, CaliforniaPDF
82 FR 61283 - Notice of Filing; City of Pasadena, CaliforniaPDF
82 FR 61281 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; States Edge Wind I Holding LLCPDF
82 FR 61288 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; States Edge Wind I LLCPDF
82 FR 61282 - Notice of Filing; City of Banning, CaliforniaPDF
82 FR 61282 - Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company StatusPDF
82 FR 61288 - Notice of Filing; Western Area Power AdministrationPDF
82 FR 61281 - Notice of Filing; Western Area Power AdministrationPDF
82 FR 61291 - Notice of Application; Algonquin Gas Transmission, LLCPDF
82 FR 61285 - Combined Notice of Filings #1PDF
82 FR 61147 - Truth in Lending Act (Regulation Z) Adjustment to Asset-Size Exemption ThresholdPDF
82 FR 61335 - Applied Sciences Advisory Committee; Meeting.PDF
82 FR 61129 - Common Crop Insurance Regulations; California Avocado Crop Insurance ProvisionsPDF
82 FR 61134 - Common Crop Insurance Regulations; Cultivated Clam Crop Insurance ProvisionsPDF
82 FR 61258 - National Cybersecurity Center of Excellence (NCCoE) Transport Layer Security (TLS) Server Certificate Management Building BlockPDF
82 FR 61265 - NIST Special Publication 2000-02: Conformity Assessment Considerations for Federal AgenciesPDF
82 FR 61265 - NIST Special Publication 2000-01: ABC's of Conformity AssessmentPDF
82 FR 61261 - National Conference on Weights and Measures Interim MeetingPDF
82 FR 61260 - Notice of Localization and Tracking System Testing ConsortiumPDF
82 FR 61310 - Commercial Fishing Safety Advisory CommitteePDF
82 FR 61327 - Notice of Request for Certification of Texas Capital Counsel MechanismPDF
82 FR 61252 - Approval of Subzone Status; R.W. Smith & Co/TriMark USA, LLC; Lewisville, TexasPDF
82 FR 61252 - Foreign-Trade Zone (FTZ) 122-Corpus Christi, Texas; Authorization of Production Activity, Voestalpine Texas, LLC, Subzone 122T (Hot Briquetted Iron and By-Products) Portland, TexasPDF
82 FR 61252 - Approval of Subzone Status; North American Hoganas Company Johnstown, Hollsopple and St. Mary's, PennsylvaniaPDF
82 FR 61279 - Notice of 229 Boundary for the Fort Saint Vrain Independent Spent Fuel Storage InstallationPDF
82 FR 61145 - Home Mortgage Disclosure (Regulation C) Adjustment to Asset-Size Exemption ThresholdPDF
82 FR 61278 - Agency Information Collection Extension/RevisionPDF
82 FR 61279 - Office of Science, Office of High Energy Physics; Request for Information: Impacts From and to Quantum Information Science in High Energy PhysicsPDF
82 FR 61252 - 100- to 150-Seat Large Civil Aircraft From Canada: Final Affirmative Countervailing Duty DeterminationPDF
82 FR 61255 - 100- to 150-Seat Large Civil Aircraft From Canada: Final Affirmative Determination of Sales at Less Than Fair ValuePDF
82 FR 61190 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management AreaPDF
82 FR 61269 - Agency Information Collection Activities: Comment RequestPDF
82 FR 61368 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Fiscal Service Information Collection RequestsPDF
82 FR 61263 - National Cybersecurity Center of Excellence (NCCoE) Mitigating Internet of Things (IoT) Based Distributed Denial of Service (DDoS) Building BlockPDF
82 FR 61257 - National Cybersecurity Center of Excellence (NCCoE) Privileged Account Management for the Financial Services SectorPDF
82 FR 61302 - Agency Information Collection Activities; Submission for OMB Review; Comment RequestPDF
82 FR 61329 - Notice of Request for Certification of Arizona Capital Counsel Mechanism OLP Docket No. 166PDF
82 FR 61255 - Advisory Committee on Supply Chain Competitiveness: Notice of Public MeetingsPDF
82 FR 61199 - Exclusion of Foreign Currency Gain or Loss Related to Business Needs From Foreign Personal Holding Company Income; Mark-to-Market Method of Accounting for Section 988 Transactions; CorrectionPDF
82 FR 61335 - Notice of Solicitation of Proposals for Calendar Year 2018 Basic Field Grant AwardsPDF
82 FR 61177 - Treatment of Transactions in Which Federal Financial Assistance Is Provided; CorrectionPDF
82 FR 61276 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; DC School Choice Incentive ProgramPDF
82 FR 61277 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; State Educational Agency and Local Educational Agency-School Data Collection and Reporting Under ESEA, Title I, Part APDF
82 FR 61311 - Merchant Marine Personnel Advisory Committee; VacanciesPDF
82 FR 61308 - Agency Information Collection Request. 30-Day Public Comment RequestPDF
82 FR 61170 - Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate ImmobilizationPDF
82 FR 61163 - Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic NeoplasmsPDF
82 FR 61168 - Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for HeadachePDF
82 FR 61162 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test SystemsPDF
82 FR 61330 - Information Collection Activities; Comment RequestPDF
82 FR 61332 - Petitions for Modification of Application of Existing Mandatory Safety StandardsPDF
82 FR 61326 - Meeting of the Advisory Committee; MeetingPDF
82 FR 61360 - Privacy Act of 1974; Matching ProgramPDF
82 FR 61325 - Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; Submission of Questionnaire for OMB ReviewPDF
82 FR 61365 - Bank Secrecy Act Advisory Group; Solicitation of Application for MembershipPDF
82 FR 61325 - Hardwood Plywood From ChinaPDF
82 FR 61166 - Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric DisordersPDF
82 FR 61274 - Government-Industry Advisory Panel; Notice of Federal Advisory Committee MeetingPDF
82 FR 61271 - Arms Sales NotificationPDF
82 FR 61192 - Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment PeriodPDF
82 FR 61274 - Submission for OMB Review; Comment RequestPDF
82 FR 61273 - Proposed Collection; Comment RequestPDF
82 FR 61271 - Submission for OMB Review; Comment RequestPDF
82 FR 61289 - Combined Notice of FilingsPDF
82 FR 61287 - Combined Notice of Filings #2PDF
82 FR 61289 - Combined Notice of Filings #1PDF
82 FR 61354 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Proposed Changes to The Options Clearing Corporation's Margin MethodologyPDF
82 FR 61351 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Penny Pilot ProgramPDF
82 FR 61337 - Federal Council on the Arts and the Humanities; Arts and Artifacts Indemnity Panel Advisory CommitteePDF
82 FR 61323 - Invasive Species Advisory Committee; Request for NominationsPDF
82 FR 61368 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection RequestsPDF
82 FR 61199 - Withdrawal of Proposed Rule for Dog Management at the Golden Gate National Recreation Area, CaliforniaPDF
82 FR 61324 - Termination Notice for the Dog Management Plan and Environmental Impact Statement, Golden Gate National Recreation Area, CaliforniaPDF
82 FR 61341 - TCG BDC, Inc., et al.PDF
82 FR 61317 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 61318 - Agency Information Collection Activities; Revision of a Currently Approved Collection: Application for Premium Processing ServicePDF
82 FR 61269 - Pacific Fishery Management Council; Public MeetingPDF
82 FR 61267 - Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
82 FR 61268 - Pacific Fishery Management Council; Public Meetings and HearingsPDF
82 FR 61366 - Notice of OFAC Sanctions ActionsPDF
82 FR 61178 - Approval of California Air Plan Revisions; Anti-Idling RegulationsPDF
82 FR 61328 - Notice of Lodging of Proposed Consent Decree Under The Comprehensive Environmental Response, Compensation and Liability ActPDF
82 FR 61328 - Notice of Lodging of Proposed Consent Decree Under the Clean Water ActPDF
82 FR 61143 - Community Reinvestment Act RegulationsPDF
82 FR 61319 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Collection of Qualitative Feedback through Focus GroupsPDF
82 FR 61140 - Civil Monetary Penalties Annual Inflation AdjustmentsPDF
82 FR 61353 - The Hartford Mutual Funds, Inc., et al.PDF
82 FR 61336 - Records Schedules; Availability and Request for CommentsPDF
82 FR 61304 - Patient Safety Organizations: Voluntary Relinquishment From the Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO)PDF
82 FR 61180 - Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle RefrigerantPDF
82 FR 61363 - Request for Comments and Notice of a Public Hearing Regarding the 2018 Special 301 ReviewPDF
82 FR 61151 - Airworthiness Directives; Rolls-Royce Corporation Turbofan EnginesPDF
82 FR 61329 - Large Residential Washers (LRWs)PDF
82 FR 61193 - Indian Electric Power UtilitiesPDF
82 FR 61213 - Water Quality Standards for the State of Missouri's Lakes and ReservoirsPDF
82 FR 61153 - Revisions, Clarifications, and Technical Corrections to the Export Administration RegulationsPDF
82 FR 61270 - US Air Force Scientific Advisory Board Notice of MeetingPDF
82 FR 61372 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Testing and Training Activities Conducted in the Eglin Gulf Test and Training Range in the Gulf of MexicoPDF
82 FR 61200 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Regulatory Definition of Volatile Organic CompoundPDF
82 FR 61312 - Chemical Facility Anti-Terrorism Standards Personnel Surety ProgramPDF
82 FR 61229 - Solicitation of New Safe Harbors and Special Fraud AlertsPDF

Issue

82 247 Wednesday, December 27, 2017 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Patient Safety Organizations; Delistings: Regenstrief Center for Healthcare Engineering at Purdue University, 61304 2017-27803 Agriculture Agriculture Department See

Federal Crop Insurance Corporation

AIRFORCE Air Force Department NOTICES Meetings: Air Force Scientific Advisory Board, 61270-61271 2017-27598 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61326-61327 2017-27922 Consumer Financial Protection Bureau of Consumer Financial Protection RULES Home Mortgage Disclosure (Regulation C) Adjustment to Asset-Size Exemption Threshold, 61145-61147 2017-27879 Truth in Lending Act (Regulation Z) Adjustment to Asset-Size Exemption Threshold: Official Interpretation, 61147-61151 2017-27897 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61269-61270 2017-27872 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction, 61184-61190 2017-27949 Civil Rights Civil Rights Commission NOTICES Meetings: Montana Advisory Committee, 61251 2017-27941 South Dakota Advisory Committee, 61251-61252 2017-27940 Coast Guard Coast Guard RULES Drawbridge Operations: Columbia River, Vancouver, WA, 61178 2017-27923 NOTICES Requests for Nominations: Commercial Fishing Safety Advisory Committee, 61310-61311 2017-27886 Merchant Marine Personnel Advisory Committee, 61311-61312 2017-27858 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency RULES Community Reinvestment Act Regulations, 61143-61145 2017-27813 Copyright Office Copyright Office, Library of Congress PROPOSED RULES Statutory Cable, Satellite, and DART License Reporting Practices, 61200 2017-27933 Defense Department Defense Department See

Air Force Department

See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61271, 61273-61274 2017-27837 2017-27838 2017-27839 Arms Sales, 61271-61273 2017-27841 Meetings: Government-Industry Advisory Panel, 61274-61275 2017-27842
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: DC School Choice Incentive Program, 61276-61277 2017-27861 State Educational Agency and Local Educational Agency—School Data Collection and Reporting under ESEA, Title I, Part A, 61277-61278 2017-27860 Employment and Training Employment and Training Administration NOTICES Investigations: Large Residential Washers, 61329-61330 2017-27670 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61278 2017-27878 Boundary for Fort Saint Vrain Independent Spent Fuel Storage Installation, 61279 2017-27880 Requests for Information: Impacts from and to Quantum Information Science in High Energy Physics, 61279-61280 2017-27877
Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: New Jersey Back Bays Coastal Storm Risk Management Feasibility Study, 61276 2017-27952 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Anti-Idling Regulations, 61178-61180 2017-27818 Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant, 61180-61184 2017-27800 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Northern Sierra Air Quality Management District, 61203-61205 2017-27950 Virginia; Revisions to Regulatory Definition of Volatile Organic Compound, 61200-61203 2017-27522 Renewable Fuel Standard Program: Grain Sorghum Oil Pathway, 61205-61213 2017-27946 Water Quality Standards for State of Missouri's Lakes and Reservoirs, 61213-61229 2017-27621 NOTICES Meetings: Human Studies Review Board, 61293-61294 2017-27951 National Pollutant Discharge Elimination System General Permits: Eastern Portion of Outer Continental Shelf of Gulf of Mexico, 61293 2017-27947 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Rolls-Royce Corporation Turbofan Engines, 61151-61153 2017-27778 NOTICES Meetings: Fifty Fourth RTCA SC-224 Standards for Airport Security Access Control Systems Plenary, 61364-61365 2017-27932 Federal Crop Federal Crop Insurance Corporation RULES Common Crop Insurance Regulations: California Avocado Crop Insurance Provisions, 61129-61133 2017-27895 Cultivated Clam Crop Insurance Provisions, 61134-61140 2017-27894 Federal Deposit Federal Deposit Insurance Corporation RULES Community Reinvestment Act Regulations, 61143-61145 2017-27813 Federal Election Federal Election Commission RULES Civil Monetary Penalties Annual Inflation Adjustments, 61140-61143 2017-27808 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Algonquin Gas Transmission, LLC, 61291-61292 2017-27901 Texas Eastern Transmission, LP, 61292 2017-27912 Combined Filings, 61285-61290 2017-27834 2017-27835 2017-27836 2017-27900 Complaints: Brookfield Energy Marketing LP v. Green Mountain Power Corp., 61282 2017-27913 Effectiveness of Exempt Wholesale Generator Status: CA Flats Solar 150, LLC, et al., 61282-61283 2017-27904 Environmental Assessments; Availability, etc.: PacifiCorp, 61290-61291 2017-27914 Filings: City of Banning, CA, 61282 2017-27905 City of Azusa, CA, 61289 2017-27909 City of Colton, CA, 61292-61293 2017-27911 City of Pasadena, CA, 61283 2017-27908 City of Riverside, CA, 61283 2017-27910 Western Area Power Administration, 61281, 61288 2017-27902 2017-27903 Hydroelectric Applications: Swan Lake North Hydro, LLC, 61286-61287 2017-27916 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: States Edge Wind I Holding, LLC, 61281 2017-27907 States Edge Wind I, LLC, 61288-61289 2017-27906 License Applications: Goodyear Lake Hydro, LLC, 61283-61284 2017-27917 Jason and Carol Victoria Presley, 61280-61281 2017-27915 Preliminary Permits; Surrenders: Merchant Hydro Developers, LLC, 61282 2017-27918 Presidential Permits; Applications: Steel Reef Pipelines US, LLC, 61284-61285 2017-27919 Federal Reserve Federal Reserve System RULES Community Reinvestment Act Regulations, 61143-61145 2017-27813 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61294-61300 2017-27942 Federal Retirement Federal Retirement Thrift Investment Board RULES Blended Retirement System; Correction, 61129 2017-27964 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61302-61304 2017-27868 Proposed Consent Agreements: Alimentation Couche-Tard, Inc. and CrossAmerica Partners, LP, 61300-61302 2017-27924 Financial Crimes Financial Crimes Enforcement Network NOTICES Requests for Nominations: Bank Secrecy Act Advisory Group, 61365 2017-27846 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Subscription For Purchase and Issue of U.S. Treasury Securities, State and Local Government Series, 61365-61366 2017-27926 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Species: Listing Yangtze Sturgeon as Endangered Species, 61230-61241 2017-27954 Food and Drug Food and Drug Administration RULES Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of Reagents for Molecular Diagnostic Instrument Test Systems, 61162-61163 2017-27853 Hematology and Pathology Devices; Classification of Flow Cytometric Test System for Hematopoietic Neoplasms, 61163-61166 2017-27855 Neurological Devices; Classification of Computerized Behavioral Therapy Device for Psychiatric Disorders, 61166-61168 2017-27843 Neurological Devices; Classification of External Vagal Nerve Stimulator for Headache, 61168-61169 2017-27854 Radiology Devices; Classification of Rectal Balloon for Prostate Immobilization, 61170-61171 2017-27856 PROPOSED RULES Food Additive Petitions (Animal Use): Akzo Nobel Surface Chemistry AB, 61192-61193 2017-27840 NOTICES Guidance: Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers, 61304-61306 2017-28043 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 61366-61368 2017-27819 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Voestalpine Texas, LLC; Foreign-Trade Zone 122; Corpus Christi, TX, 61252 2017-27882 Subzone Approvals: North American Hoganas Co.; Johnstown, Hollsopple and St. Mary's, PA, 61252 2017-27881 R.W. Smith and Co/TriMark USA, LLC; Lewisville, TX, 61252 2017-27883 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

Inspector General Office, Health and Human Services Department

See

National Institutes of Health

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61308 2017-27857
Health Resources Health Resources and Services Administration NOTICES Lists of Petitions Received: National Vaccine Injury Compensation Program, 61306-61308 2017-27961 Homeland Homeland Security Department See

Coast Guard

See

U.S. Citizenship and Immigration Services

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Chemical Facility Anti-Terrorism Standards Personnel Surety Program, 61312-61317 2017-27519
Housing Housing and Urban Development Department NOTICES Community Development Block Grant Disaster Recovery Grantees: Allocations, Common Application, Waivers, and Alternative Requirements; State of Texas Allocation, 61320-61323 2017-27960 Indian Affairs Indian Affairs Bureau PROPOSED RULES Indian Electric Power Utilities, 61193-61199 2017-27668 Industry Industry and Security Bureau RULES Revisions, Clarifications, and Technical Corrections to Export Administration Regulations, 61153-61162 2017-27616 Inspector General Health Inspector General Office, Health and Human Services Department PROPOSED RULES Solicitation of New Safe Harbors and Special Fraud Alerts, 61229-61230 2017-27117 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

National Indian Gaming Commission

See

National Park Service

NOTICES Requests for Nominations: Invasive Species Advisory Committee, 61323-61324 2017-27829
Internal Revenue Internal Revenue Service RULES Treatment of Transactions in Which Federal Financial Assistance Is Provided; Correction, 61177-61178 2017-27862 2017-27863 PROPOSED RULES Exclusion of Foreign Currency Gain or Loss Related to Business Needs from Foreign Personal Holding Company Income: Mark-to-Market Method of Accounting for Transactions; Correction, 61199 2017-27865 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: 100- to 150-Seat Large Civil Aircraft from Canada, 61252-61254 2017-27875 Determinations of Sales at Less Than Fair Value: 100- to 150-Seat Large Civil Aircraft from Canada, 61255-61257 2017-27874 Meetings: Advisory Committee on Supply Chain Competitiveness, 61255 2017-27866 International Trade Com International Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Global Digital Trade 2: Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness, 61325-61326 2017-27847 Investigations; Determinations, Modifications, and Rulings, etc.: Hardwood Plywood from China, 61325 2017-27845 Joint Joint Board for Enrollment of Actuaries NOTICES Meetings: Advisory Committee, 61326 2017-27849 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

NOTICES Proposed Consent Decrees: CERCLA, 61328-61329 2017-27817 Clean Water Act, 61328 2017-27816 Requests for Certifications: Arizona Capital Counsel Mechanism, 61329 2017-27867 Texas Capital Counsel Mechanism, 61327-61328 2017-27885
Labor Department Labor Department See

Employment and Training Administration

See

Labor Statistics Bureau

See

Mine Safety and Health Administration

See

Workers Compensation Programs Office

Labor Statistics Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61330-61332 2017-27852 Legal Legal Services Corporation NOTICES Solicitations of Proposals: Calendar Year 2018 Basic Field Grant Awards, 61335 2017-27864 Library Library of Congress See

Copyright Office, Library of Congress

Mine Mine Safety and Health Administration NOTICES Petitions for Modifications: Application of Existing Mandatory Safety Standards, 61332-61334 2017-27850 NASA National Aeronautics and Space Administration NOTICES Meetings: Applied Sciences Advisory Committee, 61335-61336 2017-27896 National Archives National Archives and Records Administration NOTICES Records Schedules, 61336-61337 2017-27804 National Credit National Credit Union Administration RULES Agency Reorganization; Correction, 61145 2017-27962 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Federal Council on Arts and Humanities, Arts and Artifacts Indemnity Panel Advisory Committee, 61337-61338 2017-27830 National Indian National Indian Gaming Commission RULES Minimum Technical Standards for Class II Gaming Systems and Equipment, 61172-61177 2017-27945 National Institute National Institute of Standards and Technology NOTICES ABC's of Conformity Assessment, 61265-61266 2017-27891 Conformity Assessment Considerations for Federal Agencies, 61265 2017-27892 Localization and Tracking System Testing Consortium, 61260-61261 2017-27889 Meetings: National Conference on Weights and Measures, 61261-61263 2017-27890 National Cybersecurity Center of Excellence Mitigating Internet of Things Based Distributed Denial of Service Building Block, 61263-61264 2017-27870 National Cybersecurity Center of Excellence Privileged Account Management for Financial Services Sector, 61257-61258 2017-27869 National Cybersecurity Center of Excellence: Transport Layer Security Server Certificate Management Building Block, 61258-61260 2017-27893 National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 61309-61310 2017-27939 National Institute of Allergy and Infectious Diseases, 61310 2017-27938 National Institute on Aging, 61308-61309 2017-27937 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 61190-61191 2017-27873 PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of Gulf of Mexico; Vermilion Snapper Management Measures; Amendment 47, 61241-61243 2017-27934 Fisheries of the Exclusive Economic Zone Off Alaska: Nontrawl Lead Level 2 Observers, 61243-61250 2017-27935 Taking and Importing Marine Mammals Incidental to Specified Activities: Testing and Training Activities Conducted in Eglin Gulf Test and Training Range in Gulf of Mexico, 61372-61409 2017-27580 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61266-61269 2017-27927 2017-27928 2017-27929 Meetings: Fisheries of Gulf of Mexico; Southeast Data, Assessment, and Review, 61267-61268 2017-27821 Pacific Fishery Management Council, 61268-61269 2017-27820 2017-27822 National Park National Park Service PROPOSED RULES Dog Management; Golden Gate National Recreation Area, CA; Withdrawal, 61199 2017-27827 NOTICES Environmental Impact Statements; Availability, etc.: Dog Management Plan; Golden Gate National Recreation Area, CA; Termination, 61324-61325 2017-27826 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 61338 2017-28115 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alternative Annuity Election, 61341 2017-27953 Customer Satisfaction Surveys, 61340-61341 2017-27959 It's Time to Sign Up for Direct Deposit or Direct Express, 61338 2017-27955 Leadership Assessment Surveys, 61339-61340 2017-27957 Organizational Assessment Surveys, 61338-61339 2017-27958 Presidential Documents Presidential Documents PROCLAMATIONS Trade: African Growth and Opportunity Act; Beneficiary Country Designations (Proc. 9687), 61411-61430 2017-28144 EXECUTIVE ORDERS Government Agencies and Employees: Rates of Pay; Adjustments (EO 13819), 61431-61442 2017-28160 Securities Securities and Exchange Commission NOTICES Applications: Hartford Mutual Funds, Inc., et al., 61353-61354 2017-27807 TCG BDC, Inc., et al., 61341-61351 2017-27825 Self-Regulatory Organizations; Proposed Rule Changes: Nasdaq PHLX, LLC, 61351-61353 2017-27831 Options Clearing Corp., 61354-61360 2017-27832 Social Social Security Administration NOTICES Privacy Act; Matching Program, 61360-61361 2017-27848 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Jasper Johns: Something Resembling Truth, 61361-61362 2017-27921 Surface Transportation Surface Transportation Board NOTICES Acquisitions and Operation Exemptions: New Orleans Public Belt Railroad Corp.; Public Belt Railroad Commission of City of New Orleans, 61362-61363 2017-27931 Trade Representative Trade Representative, Office of United States NOTICES Public Hearings: 2018 Special 301 Review; Request for Comments, 61363-61364 2017-27798 Transportation Department Transportation Department See

Federal Aviation Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Financial Crimes Enforcement Network

See

Fiscal Service

See

Foreign Assets Control Office

See

Internal Revenue Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61368-61370 2017-27828 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Multiple Fiscal Service Information Collection Requests, 61368 2017-27871
U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Premium Processing Service, 61318-61319 2017-27823 Collection of Qualitative Feedback through Focus Groups, 61319-61320 2017-27809 Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 61317-61318 2017-27824 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 61334-61335 2017-27963 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 61372-61409 2017-27580 Part III Presidential Documents, 61411-61442 2017-28144 2017-28160 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 electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

82 247 Wednesday, December 27, 2017 Rules and Regulations FEDERAL RETIREMENT THRIFT INVESTMENT BOARD 5 CFR Part 1600 Blended Retirement System; Correction AGENCY:

Federal Retirement Thrift Investment Board.

ACTION:

Final rule; correction.

SUMMARY:

The Federal Retirement Thrift Investment Board (“FRTIB”) is correcting a final rule that appeared in the Federal Register on December 19, 2017. The document issued final regulations implementing the new Blended Retirement System. The correction is a technical amendment to a cross-reference.

DATES:

This rule is effective January 1, 2018.

FOR FURTHER INFORMATION CONTACT:

Brandon Ford, Attorney-Advisor, Federal Retirement Thrift Investment Board, Office of General Counsel, 77 K Street NE, Suite 1000, Washington, DC 20002, 202-864-8734, [email protected]

SUPPLEMENTARY INFORMATION:

In FR Doc. 17-27304 appearing on page 60102 in the Federal Register of Tuesday, December 19, 2017, the following corrections are made:

§ 1600.19 [Corrected]
1. On page 60102, in the second column, in § 1600.19, in paragraph (a), in the first sentence, “paragraph (d)” is corrected to read “paragraph (c)”. 2. On page 60102, in the second column, in § 1600.19, in the introductory text of paragraph (b)(1), “paragraph (d)” is corrected to read “paragraph (c)”. Dated: December 21, 2017. Megan Grumbine, General Counsel and Liaison Officer.
[FR Doc. 2017-27964 Filed 12-26-17; 8:45 am] BILLING CODE 6760-01-P
DEPARTMENT OF AGRICULTURE Federal Crop Insurance Corporation 7 CFR Part 457 [Docket No. FCIC-17-0002] RIN 0563-AC58 Common Crop Insurance Regulations; California Avocado Crop Insurance Provisions AGENCY:

Federal Crop Insurance Corporation, USDA.

ACTION:

Final rule with request for comments.

SUMMARY:

The Federal Crop Insurance Corporation (FCIC) amends the Common Crop Insurance Regulations to provide California Avocado insurance. The provisions will be used in conjunction with the Common Crop Insurance Policy Basic Provisions (Basic Provisions), which contain standard terms and conditions common to most crop programs. The intended effect of this action is to convert the California Avocado pilot crop insurance program to a regulatory insurance program for the 2020 and succeeding crop years.

DATES:

Effective date: This final rule is effective December 27, 2017.

Applicability date: The changes are applicable for the 2020 and succeeding crop years. California avocado is a two-year policy and the 2020 crop year encompasses all policies earning premium when insurance attaches after the Contract Change Date of August 31, 2018.

Comment due date: FCIC will accept written comments on this final rule until close of business January 26, 2018. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.

ADDRESSES:

FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket ID No. FCIC-17-0002, by any of the following methods:

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

Mail: Director, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, P.O. Box 419205, Kansas City, MO 64141-6205.

FCIC will post all comments received, including those received by mail, without change to http://www.regulations.gov, including any personal information provided. Once these comments are posted to this website, the public can access all comments at its convenience from this website. All comments must include the agency name and docket number or Regulatory Information Number (RIN) for this rule. For detailed instructions on submitting comments and additional information, see http://www.regulations.gov. If interested persons are submitting comments electronically through the Federal eRulemaking Portal and want to attach a document, FCIC requests that the document attachment be in a text-based format. If interested persons want to attach a document that is a scanned Adobe PDF file, it must be scanned as text and not as an image, thus allowing FCIC to search and copy certain portions of the submissions. For questions regarding attaching a document that is a scanned Adobe PDF file, please contact the Risk Management Agency (RMA) Web Content Team at (816) 823-4694 or by email at [email protected]

Privacy Act: Anyone is able to search the electronic form of all comments received for any dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/#!privacyNotice.

FOR FURTHER INFORMATION CONTACT:

Ron Lundine, Director, Product Management, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-3854.

SUPPLEMENTARY INFORMATION:

Background

FCIC offered an actual production history pilot crop insurance program for California grown avocados beginning with the 2010 crop year. The pilot program is offered in six California counties. In 2013, the FCIC's Board of Directors approved continuation and expansion until such time the program could be made permanent. For the 2016 crop year, 1,041 policies were sold and 35,072 acres of avocado orchards were insured in California. This rule will add the California avocado program to the Code of Federal Regulations.

The FCIC is issuing this final rule without opportunity for prior notice and comment. The Administrative Procedure Act (APA) exempts rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” from the statutory requirement for prior notice and opportunity for public comment (5 U.S.C. 553(a)(2)). A Federal crop insurance policy is a contract and is thus exempt from APA notice-and-comment procedures.

Previously, changes made to the Federal crop insurance policies codified in the Code of Federal Regulations were required to be implemented through the notice-and-comment rulemaking process. Such action was not required by the APA, which exempts contracts. Rather, the requirement originated with a notice USDA published in the Federal Register on July 24, 1971 (36 FR 13804) stating that the Department of Agriculture would, to the maximum extent practicable, use the notice-and-comment rulemaking process when making program changes, including those involving contracts. FCIC complied with this notice over the subsequent years. On October 28, 2013, USDA published a notice in the Federal Register (78 FR 64194) rescinding the prior notice, thereby making contracts again exempt from the notice-and-comment rulemaking process. This exemption applies to the 30-day notice prior to implementation of a rule. Therefore, the policy changes made by this final rule are effective upon publication in the Federal Register.

However, FCIC is providing a 30-day comment period and invites interested persons to participate in this rulemaking by submitting written comments. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.

Executive Orders 12866, 13563, 13771 and 13777

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” established a federal policy to alleviate unnecessary regulatory burdens on the American people. The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has not reviewed this rule. The rule is not subject to Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.”

Paperwork Reduction Act of 1995

Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, subchapter I), the collections of information in this rule have been approved by OMB under control number 0563-0053.

E-Government Act Compliance

FCIC is committed to complying with the E-Government Act of 2002, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

Executive Order 13132

It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Federal Crop Insurance Corporation has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Federal Crop Insurance Corporation will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

Regulatory Flexibility Act

FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, and all producers are required to submit a notice of loss and production information to determine the indemnity amount for an insured cause of crop loss. Whether a producer has 10 acres or 1,000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act (FCIA) authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have a significant impact on a substantial number of small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).

Federal Assistance Program

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

Executive Order 12372

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See 2 CFR part 415, subpart C.

Executive Order 12988

This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or action by FCIC directing the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.

Environmental Evaluation

This action is not expected to have a significant impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

List of Subjects in 7 CFR Part 457

Crop insurance, California avocado, Reporting and recordkeeping requirements.

Final Rule.

Accordingly, as set forth in the preamble, the Federal Crop Insurance Corporation amends 7 CFR part 457 applicable for the 2020 and succeeding crop years as follows:

PART 457—COMMON CROP INSURANCE REGULATIONS 1. The authority citation for part 457 continues to read as follows: Authority:

7 U.S.C. 1506(l), 1506(o).

2. Section 457.175 is added to read as follows:
§ 457.175 California avocado crop insurance provisions.

The California avocado crop provisions for the 2020 and succeeding crop years are as follows:

FCIC policies:

United States Department of Agriculture Federal Crop Insurance Corporation California Avocado Crop Provisions 1. Definitions

CDFA. The California Department of Food and Agriculture.

Commercial sale. Any transaction in which avocados have been inspected under the rules of the CDFA and to which a marketing assessment payment applies under the Hass Avocado Promotion, Research, and Information Act of 2000.

Crop year. The period of time that begins on December 1 immediately prior to the time the avocado trees normally bloom and that ends on October 31 of the calendar year following such bloom. Crop year is designated by the calendar year following the year in which the avocado trees normally bloom.

Direct marketing. The sale of the insured crop directly to consumers without the intervention of an intermediary such as a wholesaler, retailer, packer, processor, shipper, or buyer. Examples of direct marketing include selling through an on-farm or roadside stand, farmer's market, and permitting the general public to enter the fields for the purpose of picking all or a portion of the crop.

Harvest. Picking of marketable avocado fruit from the trees or from the ground when permitted as described in section 11(c).

Initially apply. Your application for crop insurance under these Crop Provisions for the first time and following each time you have cancelled the insurance or the insurance has terminated by action of the policy.

Interplanted. Acreage in which two or more crops are planted in any form of an alternating or mixed pattern.

Marketable. An avocado fruit that meets the standards published by the CDFA with respect to maturity, defects, size, and weight.

No. 2 avocado. An avocado fruit that is marketable but that is diverted into processing uses due to visual defects resulting from an insured cause of loss.

Pound. A unit of weight equal to sixteen ounces avoirdupois.

Rootstock. The root and stem portion of a tree to which a scion can be grafted.

Scion. Twig or portion of a twig of one plant that is grafted onto a rootstock.

Set out. Transplanting a tree into the orchard or grafting a scion onto rootstock.

Stumping. A practice whereby the lateral branches of an avocado tree are removed. A portion of the bole also may be removed. The resulting stump is approximately 4 feet or greater in height.

Type. A term used to designate different varieties of avocados, as more fully described in the Special Provisions.

2. Unit Division

(a) Unless limited by the Special Provisions, a basic unit as defined in section 1 of the Basic Provisions may be divided into optional units if, for each optional unit, you meet the following:

(1) All optional units you select for the crop year are identified on the acreage report for that crop year (Units will be determined when the acreage is reported but may be adjusted or combined to reflect the actual unit structure when adjusting a loss. No further unit division may be made after the acreage reporting date for any reason);

(2) You have records that are acceptable to us for at least the most recently completed crop year for all optional units that you will report in the current crop year (You may be required to produce the records for all optional units for the most recently completed crop year);

(3) You have records of marketed or stored production from each optional unit maintained in such a manner that permits us to verify the production from each optional unit, or the production from each optional unit is kept separate until loss adjustment is completed by us.

(b) Each optional unit must meet one or more of the following conditions, unless otherwise specified in the Special Provisions:

(1) Be of a different type; or

(2) Consist of acreage located on non-contiguous land.

(c) Subsections (a) and (c) of section 34 of the Basic Provisions do not apply to these Crop Provisions.

3. Insurance Guarantees, Coverage Levels, and Prices for Determining Indemnities

In addition to the requirements of section 3 of the Basic Provisions:

(a) You may select only one coverage level for all the avocados in the county insured under this policy.

(b) You must report, on or before the production reporting date designated in section 3 of the Basic Provisions, by unit:

(1) Any damage, stumping (including the year or years that the stumping was performed), or removal of trees; change in orchard practices; or any other circumstance that may reduce the expected yield per acre to less than the approved yield and the number of affected acres and trees;

(2) The number of trees on insurable and uninsurable acreage;

(3) The age of the trees;

(4) Any acreage excluded under section 6 of these Crop Provisions; and

(5) For acreage interplanted with another crop:

(i) The age of the interplanted crop, and type if applicable;

(ii) The planting pattern; and

(iii) Any other information we request to establish your approved yield per acre.

(c) We will reduce the approved yield whenever we determine any one or more of the factors specified in this section are likely to have a negative impact upon that average yield. If you fail to provide complete and accurate information required by this section, and pursuant to the definition of approved yield, we will reduce that yield as necessary at any time we become aware of any such omission.

(d) In the event the avocado trees are damaged to the extent that we determine the APH history you certified no longer is representative of the potential production of the unit, we will reduce your approved yield to a level consistent with that reduced potential. Such reduction will not occur for a crop year for which insurance already has attached if the damage is due to a cause of loss that is insurable for the avocado fruit.

(e) In lieu of that specific provision in section 3(f) of the Basic Provisions, you are required to report the production for the crop year that ended on the October 31 immediately preceding the cancellation date. For example, you must report your production for the 2008 crop year by the production reporting date for the 2010 crop year. All other provisions of section 3(f) apply.

(f) When you initially apply for insurance:

(1) You must certify your production records for at least the most recently completed crop year;

(2) If you do not certify your production records for any one or more of the three crop years immediately prior to the most recently completed crop year, you will be assigned a percentage of the transitional yield included in the actuarial documents for that crop year. The percentages will be those described in 7 CFR part 400 subpart G. All other provisions of 7 CFR part 400 subpart G apply.

4. Contract Changes

In accordance with section 4 of the Basic Provisions, the contract change date is the August 31 that precedes the cancellation date.

5. Cancellation and Termination Dates

In accordance with section 2 of the Basic Provisions, the cancellation and termination dates are the November 30 immediately prior to the first day of the crop year.

6. Insured Crop

(a) In accordance with section 8 of the Basic Provisions, the crop insured will be all the avocados in the county grown on insurable acreage, and for which premium rates are provided:

(1) In which you have a share;

(2) That is grown for harvest as avocado fruit for commercial sale;

(3) That is a type identified in the actuarial documents;

(4) That is irrigated; and

(5) That is grown on trees that, if inspected, are considered acceptable to us.

(b) In addition to the provisions of section 8 of the Basic Provisions that identify an uninsurable crop, we do not insure any avocados produced on trees that have not reached the sixth growing season after set out unless the unit has produced an average of at least 2,000 pounds of avocados per acre in one of the most recent three crop years or as otherwise specified in the Special Provisions.

(c) Avocado trees that have been stumped are not insurable for three calendar years after the year stumping was performed. The calendar year stumping occurred will be considered to be the actual calendar year if performed between January 1 and June 30 of that year. It will be considered to be the following calendar year if performed between July 1 and December 31.

7. Insurable Acreage

(a) In lieu of that part of section 9 of the Basic Provisions that prohibits insurance attaching to a crop planted with another crop, avocados interplanted with another perennial crop are insurable unless we inspect the acreage and determine it does not meet the requirements of insurability contained in these Crop Provisions.

(b) In addition to the acreage designated as not insurable in section 9 of the Basic Provisions, we will not insure avocados produced on any acreage infected with Phytophthora root rot unless you follow good orchard management practices as recommended by agricultural experts.

8. Insurance Period

(a) In accordance with the provisions of section 11 of the Basic Provisions:

(1) Coverage begins on December 1st of the crop year.

(2) The calendar date for the end of the insurance period is the second October 31st of the crop year.

(b) In addition to the provisions of section 11 of the Basic Provisions:

(1) If you acquire an insurable share in any insurable acreage on or before the acreage reporting date of any crop year, and if we inspect and consider the acreage acceptable, insurance will be considered to have attached to such acreage on the calendar date for the beginning of the insurance period.

(2) If you relinquish your insurable interest on any acreage of avocados on or before the acreage reporting date of any crop year, insurance will not be considered to have attached to such acreage for that crop year unless:

(i) A transfer of right to an indemnity or a similar form approved by us is completed by all affected parties;

(ii) We are notified by you or the transferee in writing of such transfer on or before the acreage reporting date; and

(iii) The transferee is eligible for crop insurance.

No premium will be due or indemnity paid unless a properly executed transfer of right to an indemnity has been filed with us.

9. Causes of Loss

(a) In accordance with section 12 of the Basic Provisions, insurance is provided against unavoidable loss of production due to the following causes of loss occurring within the insurance period:

(1) Adverse weather conditions;

(2) Fire, unless weeds and other forms of undergrowth have not been controlled or pruning debris has not been removed from the orchard;

(3) Insects and disease, but not damage due to insufficient or improper application of control measures;

(4) Wildlife;

(5) Earthquake;

(6) Volcanic eruption; or

(7) Failure of the irrigation water supply due to an insured cause of loss specified in sections 9(a)(1) through (6).

(b) In addition to the causes of loss excluded in section 12 of the Basic Provisions, we will not insure against damage or loss of production due to:

(1) Theft;

(2) Phytophthora root rot, if you do not maintain cultural practices to minimize the potential for damage due to this pathogen; or

(3) Inability to market the avocados for any reason other than actual physical damage from an insurable cause specified in this section. For example, we will not pay you an indemnity if you are unable to market any avocado fruit due to quarantine, boycott, or refusal of any person to accept such fruit.

10. Duties in the Event of Damage or Loss

In addition to the requirements of section 14 of the Basic Provisions:

(a) You must notify us at least 15 days before any production from any unit will be sold by direct marketing. We will conduct an inspection and appraisal, if needed, that will be used to determine your production to count for such production. If damage occurs after this inspection, we will conduct one or more additional inspections as needed. These inspections, and any acceptable records provided by you, will be used to determine your production to count. Failure to give timely notice as required will result in production to count determined as described in section 11(c) if we are not able to determine the amount of such production;

(b) If you intend to claim an indemnity on any unit, you must notify us immediately so we may inspect the unit. You must not sell or otherwise dispose of any damaged production until we have given you written consent to do so, or 15 days, whichever is earlier. If you fail to meet the requirements of this subsection all such production will be considered undamaged and included as production to count;

(c) We will not perform any appraisals of potential production earlier than the July that follows the bloom for the crop year; and

(d) You must notify us immediately if you intend to stump 10 percent or more of the trees on a unit after insurance has attached for the crop year.

11. Settlement of Claim

(a) We will determine your loss separately for each unit you defined on your acreage report or that we find to exist in accordance with section 2 of these Crop Provisions. If you do not or cannot provide acceptable records of production for the crop year for:

(1) Any optional unit, we will combine all optional units for which such records were not provided; or

(2) Any basic unit, we will allocate commingled production to each basic unit in proportion to our liability on the harvested acreage for each unit.

(b) In the event of loss or damage covered by this policy, we will settle your claim by:

(1) Multiplying the insured acreage by the production guarantee;

(2) Subtracting from the result of section 11(b)(1) the total production to count (see section 11(c);

(3) Multiplying the result in section 11(b)(2) by the price election, by the price election factor, and by your share.

(c) The total production to count from all insurable acreage on the unit will include the value of all appraised and harvested production, as follows:

(1) Appraised production to be counted will include:

(i) Not less than the production guarantee per acre for acreage:

(A) That is abandoned;

(B) That is sold or otherwise disposed by direct marketing if you failed to provide the notice required by section 10 and we were not able to determine the amount of such production;

(C) That is damaged solely by uninsured causes; or

(D) For which you fail to provide production records that are acceptable to us;

(ii) Potential production lost due to uninsured causes;

(iii) Unharvested marketable production (the quantity of such production may be reduced as described in section 11(d));

(iv) Potential production on insured acreage you intend to put to another use or abandon, if you agree to our appraisal of such production. Upon such agreement, the insurance period for that acreage will end when you put the acreage to another use or abandon the crop. If agreement on the appraised production is not reached:

(A) If you do not elect to continue to care for the crop, we may give you consent to put the acreage to another use if you agree to leave intact, and provide sufficient care for, representative samples of the crop in locations acceptable to us. The production to count for such acreage will be based on the greater of the harvested production or our appraisal in accordance with Section 15(b) of the Basic Provisions from the samples at the time harvest should have occurred. If you do not leave the required samples intact, or fail to provide sufficient care for the samples, our appraisal made prior to giving you consent to put the acreage to another use will be used to determine the production to count; or

(B) If you elect to continue to care for the crop, the production to count for the acreage will be based on the greater of harvested production or our reappraisal in accordance with section 15(b) of the Basic Provisions if additional damage occurs and the crop is not harvested; and

(2) All marketable harvested production (the quantity of such production may be reduced as described in section 11(d)). Any production that is not marketable due to an insured cause of loss will not be included in the production to count.

(d) The quantity of appraised and harvested marketable production may be reduced if the production is considered to be a No. 2 avocado and the price of such marketable production is less than 75 percent of the maximum price election. The quantity of such production will be multiplied by an adjustment factor equal to the lesser of 1.00 or the price of the damaged avocados divided by the maximum price election.

12. Late and Prevented Planting

Sections 16 and 17 of the Basic Provisions do not apply to these Crop Provisions.

13. Written Agreements

Section 18 of the Basic Provisions does not apply to these Crop Provisions.

14. Example of Your Insurance Protection

You certify production records that support the yields per acre shown below:

Year Yield/acre 1 4,559 2 2,978 3 10,112 4 2,014 5 2,420

AVERAGE (APPROVED) Yield = 4,417 lbs.

Assume you selected the 65 percent coverage level. The unit contains 10 acres. The production guarantee per acre is:

4,417 × 65% = 2,871 lbs. per acre

The production guarantee for the unit is:

2,871 × 10 acres = 28,710 lbs.

Assume further that the price election is $0.90 per lb. The liability (amount of insurance) for the unit is equal to:

28,710 lbs. × $0.90 = $25,839

Assume the unit produced 15,000 lbs. Your share is 100 percent.

The indemnity is calculated as follows:

2,871 × 10 acres = 28,710 lbs. 28,710 lbs. −15,000 lbs. = 13,710 lbs. 13,710 lbs. × $0.90 × 1.000 = $12,339.
Signed in Washington, DC, on December 19, 2017. Heather Manzano, Acting Manager, Federal Crop Insurance Corporation.
[FR Doc. 2017-27895 Filed 12-26-17; 8:45 am] BILLING CODE 3410-08-P
DEPARTMENT OF AGRICULTURE Federal Crop Insurance Corporation 7 CFR Part 457 [Docket No. FCIC-17-0003] RIN 0563-AC59 Common Crop Insurance Regulations; Cultivated Clam Crop Insurance Provisions AGENCY:

Federal Crop Insurance Corporation, USDA.

ACTION:

Final rule with request for comments.

SUMMARY:

The Federal Crop Insurance Corporation (FCIC) amends the Common Crop Insurance Regulations to provide Cultivated Clam insurance. The provisions will be used in conjunction with the Common Crop Insurance Policy Basic Provisions (Basic Provisions), which contain standard terms and conditions common to most crop programs. The intended effect of this action is to convert the Cultivated Clam pilot crop insurance program to a regulatory insurance program for the 2019 and succeeding crop years.

DATES:

Effective date: This final rule is effective December 27, 2017.

Applicability date: The changes are applicable for the 2019 and succeeding crop years.

Comment due date: FCIC will accept written comments on this final rule until close of business January 26, 2018. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.

ADDRESSES:

FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket

ID No. FCIC-17-0003, by any of the following methods:

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

Mail: Director, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, P.O. Box 419205, Kansas City, MO 64141-6205.

FCIC will post all comments received, including those received by mail, without change to http://www.regulations.gov, including any personal information provided. Once these comments are posted to this website, the public can access all comments at its convenience from this website. All comments must include the agency name and docket number or Regulatory Information Number (RIN) for this rule. For detailed instructions on submitting comments and additional information, see http://www.regulations.gov. If interested persons are submitting comments electronically through the Federal eRulemaking Portal and want to attach a document, FCIC requests that the document attachment be in a text-based format. If interested persons want to attach a document that is a scanned Adobe PDF file, it must be scanned as text and not as an image, thus allowing FCIC to search and copy certain portions of the submissions. For questions regarding attaching a document that is a scanned Adobe PDF file, please contact the Risk Management Agency (RMA) Web Content Team at (816) 823-4694 or by email at [email protected]

Privacy Act: Anyone is able to search the electronic form of all comments received for any dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/#!privacyNotice.

FOR FURTHER INFORMATION CONTACT:

Ron Lundine, Director, Product Management, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-3854.

SUPPLEMENTARY INFORMATION: Background

FCIC offered a pilot crop insurance program for cultivated clams beginning with the 1999 crop year. The program is offered in nine counties in Massachusetts, South Carolina, and Virginia. After a program evaluation, in 2014 the FCIC's Board of Directors authorized the Cultivated Clam Pilot Crop Insurance Program to be converted from a pilot to a permanent program in Massachusetts, South Carolina, and Virginia. For the 2016 crop year, 42 policies were sold and 352,563,049 clams were insured in Massachusetts, South Carolina, and Virginia. This rule will add the Cultivated Clam Program to the Code of Federal Regulations.

The FCIC is issuing this final rule without opportunity for prior notice and comment. The Administrative Procedure Act (APA) exempts rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” from the statutory requirement for prior notice and opportunity for public comment (5 U.S.C. 553(a)(2)). A Federal crop insurance policy is a contract and is thus exempt from APA notice-and-comment procedures. Previously, changes made to the Federal crop insurance policies codified in the Code of Federal Regulations were required to be implemented through the notice-and-comment rulemaking process. Such action was not required by the APA, which exempts contracts. Rather, the requirement originated with a notice USDA published in the Federal Register on July 24, 1971 (36 FR 13804), stating that the Department of Agriculture would, to the maximum extent practicable, use the notice-and-comment rulemaking process when making program changes, including those involving contracts. FCIC complied with this notice over the subsequent years. On October 28, 2013, USDA published a notice in the Federal Register (78 FR 64194) rescinding the prior notice, thereby making contracts again exempt from the notice-and-comment rulemaking process. This exemption applies to the 30-day notice prior to implementation of a rule. Therefore, the policy changes made by this final rule are effective upon publication in the Federal Register.

However, FCIC is providing a 30-day comment period and invites interested persons to participate in this rulemaking by submitting written comments. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.

Executive Orders 12866, 13563, 13771 and 13777

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” established a federal policy to alleviate unnecessary regulatory burdens on the American people. The Office of Management and Budget (OMB) designated this rule as not significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has not reviewed this rule. The rule is not subject to Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.”

Paperwork Reduction Act of 1995

Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, subchapter I), the collections of information in this rule have been approved by OMB under control number 0563-0053.

E-Government Act Compliance

FCIC is committed to complying with the E-Government Act of 2002, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

Executive Order 13132

It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Federal Crop Insurance Corporation has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Federal Crop Insurance Corporation will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

Regulatory Flexibility Act

FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, and all producers are required to submit a notice of loss and production information to determine the indemnity amount for an insured cause of crop loss. Whether a producer has 10 acres or 1000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act (FCIA) authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have a significant impact on a substantial number of small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).

Federal Assistance Program

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

Executive Order 12372

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See 2 CFR part 415, subpart C.

Executive Order 12988

This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or action by FCIC directing the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.

Environmental Evaluation

This action is not expected to have a significant impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

List of Subjects in 7 CFR Part 457

Crop insurance, Cultivated clam, Reporting and recordkeeping requirements.

Final Rule

Accordingly, as set forth in the preamble, the Federal Crop Insurance Corporation amends 7 CFR part 457, applicable for the 2019 and succeeding crop years, as follows:

PART 457—COMMON CROP INSURANCE REGULATIONS 1. The authority citation for 7 CFR part 457 continues to read as follows: Authority:

7 U.S.C. 1506(l), 1506(o).

2. Section 457.176 is added to read as follows:
§ 457.176 Cultivated clam crop insurance provisions.

The cultivated clam crop provisions for the 2019 and succeeding crop years are as follows:

FCIC policies:

United States Department of Agriculture Federal Crop Insurance Corporation Cultivated Clam Crop Provisions 1. Definitions.

Amount of insurance. For each basic unit, your inventory value multiplied by the coverage level percentage you elect, and multiplied by your share. However, for catastrophic risk protection policies, amount of insurance is your inventory value multiplied by the coverage level percentage you elect (for CAT coverage the level is limited to 50 percent), multiplied by your share, and multiplied by 55 percent. Your accumulated paid indemnities during the crop year for each basic or optional unit may not exceed your amount of insurance.

Basic unit value before loss. The stage value of all undamaged insurable clams, in the basic unit or, if elected, all optional units combined, immediately prior to the occurrence of any loss as determined by our appraisal. This allows the amount of insurance under the policy to be prorated among the individual units based on the actual value of the clams in the unit at the time of loss. It is also the basis for determining whether or not an indemnity is due. This value is used to ensure that you have not under-reported your clam inventory value.

Clam. A cultivated Mercenaria mercenaria (quahog).

Crop year. The twelve-month period beginning December 1 and extending through November 30 of the next calendar year, designated by the calendar year in which insurance ends.

Crop year deductible. The deductible percentage multiplied by the sum of the inventory values within each basic unit. The crop year deductible will be increased for any increases in the inventory value on the inventory value report. The crop year deductible will be reduced by any previously incurred deductible if you timely report each loss to us.

Deductible percentage. An amount equal to 100 percent minus the percent of coverage you select. The percentage is 50 percent for catastrophic risk protection coverage.

Disease. Any pathogen or group of pathogens, parasitic infestation or plague verified by an aquaculture pathologist and shown to be a primary cause to the death of the insured clams.

Freeze. The formation of ice in the cells of the animal caused by low air temperatures.

Global Positioning System (GPS). A space based radio position, navigation, and time transfer system involving satellites and computers to determine the latitude and longitude of a receiver on Earth by computing the time difference for signals from different satellites to reach the receiver and referenced in the Special Provisions.

Growing location. A lease parcel, permit or licensed area, whose boundaries are readily discernable above the water, and identified on a map that shows enough detail to distinguish seeded areas within the site.

Growout bag. A mesh bag used throughout the growing season to contain clams when placed in the appropriate growing medium and as further defined by the Special Provisions.

Harvest. Removal of marketable clams from the unit. Clams that are removed from the growing location but not of sufficient size to be marketable are not considered harvested if returned to the growing location.

Ice floe. Floating ice formed in sheets on the sea surface.

Inventory value. The total of the stage values from the inventory value report.

Inventory value report. Your report that declares the stage values of insurable clams in accordance with section 6. See the Cultivated Clam Insurance Standards Handbook, Exhibit 5 for the inventory value report completion instructions and form.

Land. The land under a body of water suitable for planting clams and the column of water above the land if designated and controlled by state law.

Lease. A contract that grants use of land in or assigned to a county for a specified term and for a specified payment and provides the lessee with the exclusive use of the land to plant clams.

Lease parcel. A legally identifiable tract or plot of land covered by a lease, permit, or license.

License. Official or legal permission that grants use of land in or assigned to a county for a specified term and provides the licensee with the exclusive use of the land to plant clams.

Non-contiguous. In lieu of the definition in the Basic Provisions, separately-named, high-density aquaculture lease sites or shellfish sites are considered non-contiguous, unless limited by the Special Provisions. Individual land parcels within such sites are not considered non-contiguous.

Occurrence deductible.

(a) This deductible allows a smaller deductible than the crop year deductible to be used when:

(1) Inventory values are less than the reported basic unit value; or

(2) You have elected optional units, if applicable.

(b) The occurrence deductible is the lesser of:

(1) The deductible percentage multiplied by the unit value before loss multiplied by the under-report factor; or

(2) The crop year deductible.

Permit. A document giving official or legal permission to use land in or assigned to a county for a specified term and provides the permittee with the exclusive use of the land to plant clams.

Planting. The placing of seed clams into the appropriate growing medium for the practice specified.

Pollution. The presence in the water of a substance that directly causes death of the clams. The substance shall not be parasitical, bacterial, fungal or viral, or any substance used by you for medicinal purposes. Pollution will also include any increase or decrease in the content of any normal soluble or insoluble constituent of water including mud and silt, feed residues, solid or liquid fish wastes, dissolved gases and any other substance normally present in the water of the lease parcel.

Practical to replant. In lieu of the definition of “Practical to replant” contained in section 1 of the Basic Provisions, unless limited by the Special Provisions, practical to replant is defined as our determination, after loss or damage to the insured crop, based on factors including, but not limited to the causes of loss listed in section 10 of these provisions, that replanting the insured crop will allow the crop to develop normally during the remainder of the crop year. Unavailability of seed clams will not be considered a valid reason for failure to replant.

Practice. The cultural methods of producing clams such as trays, mesh bags, round pens, lantern nets or bottom planting.

Replant. Unless limited by the Special Provisions, performing the cultural practices necessary to prepare for replacement of insurable clams that were destroyed by an insurable cause of loss and then placing living insurable clams into mesh bags or pens, or seeding them into prepared growout beds, bottom culture, bottom trays, or floating trays on insurable acreage.

Salinity. The dissolved solids (typically salts such as chloride, sodium, and potassium) in ocean water expressed as parts per thousand.

Seed clam.

(a) For clams placed in a field nursery or a nursery bag—a clam that is a minimum of 5 millimeters, measured at the longest shell distance that is parallel to the hinge.

(b) For all others—a clam which is a minimum of 10 millimeters, measured at the longest shell distance that is parallel to the hinge.

Separately named high-density aquaculture lease site. The submerged subdivided land under a body of water suitable for the cultivation of clams and identified and named separately by the Division of Marine Resources or similar regulatory agency.

Shellfish harvest ban. A State or Federal order that prohibits harvesting clams for human food in areas where monitoring program data indicates that fecal material, pathogenic microorganisms, poisonous or deleterious substances, marine toxins, or radio nuclides have reached excessive concentrations.

Stage. Clams that have attained the size or age specified for stage 1, 2, 3, or 4 as defined in the Special Provisions.

Stage value. The dollar value of the inventory of all insurable clams at each stage based on the survival factors and the prices shown in the actuarial documents for such stages, in each unit on your inventory value report, including any revision that increases the value of your insurable inventory.

Storm surge. A significant increase or decrease in water depth relative to normal tides that is caused by a strong, continuous and prolonged strong flow of onshore or offshore winds.

Survival factor. A factor shown on the actuarial documents that represents the expected percentage of clams that will normally survive. If you provide production records for three consecutive years, your records will be used in lieu of the factor contained in the actuarial document to determine the survival factor. The survival factor is applied at the time of inventory and is not applied a second time to the same inventory when a loss occurs. Clams that are seeded subsequent to the annual inventory value report must be adjusted by the survival factor.

Tidal wave. A large water wave, wave train, or a series of waves, generated in a body of water by an impulsive disturbance that vertically displaces the water column or a destructive type of wave motion in seas and oceans, associated with either strong winds or underwater earthquakes.

Under-report factor. The factor that adjusts your indemnity for under-reporting of inventory values. The factor is always used in determining any indemnities. The under-report factor is the lesser of: (a) 1.000; or (b) the sum of all stage values reported on all the inventory value reports, minus the total of all previous losses, as adjusted by any previous under-reporting factors, divided by the basic unit value before loss.

Unit value after loss. The value of the remaining insurable clams in each basic or optional unit based on the percentage of the reference maximum dollar amount contained in the actuarial documents, immediately following the occurrence of a loss as determined by our appraisal, plus any reduction in value due to uninsured causes. This is used to determine the loss of value for each individual unit so that losses can be paid on an individual unit basis, optional or basic, as applicable.

Unit value before loss. The stage value of undamaged insurable clams in the basic or optional unit, as applicable, immediately prior to the loss occurrence. The determined value will include the number of seeded and harvested clams and stages that existed on the date of the inventory value report, adjusted for changes in accordance with subparagraph 22A(2) of the Insurance Standards Handbook, including but not limited to; the reference maximum dollar amount contained in the actuarial documents; and the applicable survival factors. This allows the amount of insurance under the policy to be divided among the individual units in accordance with the value of the clams in the unit at the time of loss for determining whether you are entitled to an indemnity for insured losses in the unit, optional or basic, as applicable. Clams that are seeded subsequent to the annual inventory value report being submitted must be adjusted by the survival factor before they are added to the beginning inventory during the process of establishing the “Unit value before loss.”

2. Unit Division

(a) In addition to the definition of basic unit contained in section 1 of the Basic

Provisions, a basic unit may be divided into optional units in accordance with section 2(b). Note that even if you elect optional unit coverage, amount of insurance, crop year deductible, under-report factor, premium, and the total amount of indemnity payable under this policy will be controlled by the basic unit value before loss.

(b) If you elect the additional level of coverage, for an additional premium, inventory that would otherwise be a basic unit may, unless limited by the Special Provisions, be divided into optional units by non-contiguous lease parcels. Additional optional units may also be authorized in the Special Provisions. If you elect optional units, you must provide separate inventory reports for each unit and keep all records of seeding, harvest, and uninsured losses separately by unit.

(c) Failure to keep or report separate records will result in all optional unit inventories under a basic unit being combined in a basic unit at loss time.

(d) If you elect optional units, your amount of insurance will be divided among optional units in relation to unit value before loss of clams in each optional unit. If, at the time of loss, the aggregate value of the clams in your optional units exceeds your basic unit inventory value, you will be subject to the under-report factor provisions.

3. Amount of Insurance

(a) In addition to the requirements of section 3 of the Basic Provisions, you may only select one coverage level percentage for all clams, regardless of their stage, insured under this policy.

(b) Your amount of insurance will be reduced by the amount of any indemnity paid under this policy.

(c) For an additional premium, you may increase your amount of insurance in accordance with section 6(d).

(d) The production reporting requirements contained in section 3 of the Basic Provisions are not applicable.

(e) For seeded clams, the amount of insurance is the product of the reference maximum dollar amount of insurance and the fraction of the maximum value associated with the applicable stage multiplied by the coverage level selected multiplied by your share.

4. Contract Changes

In accordance with section 4 of the Basic Provisions, the contract change date is August 31 of each year, or as specified in the actuarial documents.

5. Cancellation and Termination Dates

In accordance with section 2 of the Basic Provisions, the cancellation and termination dates are November 30, or as specified in the actuarial documents.

6. Clam Inventory Value Report

In lieu of section 6 of the Basic Provisions:

(a) For insurance to attach for the crop year, you must submit an inventory value report to us with your application and for each subsequent crop year, not later than November 30 preceding the crop year, or by the date specified in the Special Provisions.

(b) The inventory value report must be submitted yearly and include, for each basic or optional unit all growing locations, the stages of the clams and the stage values, and your share by growing location.

(1) The inventory value must also reflect the stages as shown in the Special Provisions.

(2) At our option and at any time, you may be required to provide documentation in support of any of your reports, including, but not limited to, a detailed listing of growing locations, unit values, the numbers and the sizes of clams seeded or placed for grow-out; your share, sales of clams and purchases of seed clams for the 3 previous crop years, and of your ability to properly obtain and maintain clams.

(3) For catastrophic level policies only, you must report your clam sales for the previous crop year on the clam inventory value report. You may be required to provide documentation to support such sales.

(c) Your inventory value report, including any revised report, will be used to determine your premium and amount of insurance.

(d) If allowed for in the Special Provisions you may revise your inventory value report to increase the reported inventory value. We may inspect the inventory. Your revised inventory value report, if allowed by the Special Provisions, will be considered accepted by us and coverage will begin on any proposed increase in inventory value at the later of December 1, the date shown in the Special Provisions, or 30 days after your written request is received by us, unless we reject the proposed increase in your inventory value in writing. We will reject any requested increase if a loss occurs before the later of December 1, the date shown in the Special Provisions, or within 30 days of the date the request is made.

(e) Failure to report the full value of your stage value will result in the reduction of any claim in accordance with section 14(d).

(f) For catastrophic insurance coverage only: Your inventory value report for all clams cannot exceed the lesser of the value from section 6(b) or the percent shown on the actuarial documents of your previous year's sales of clams unless you provide acceptable records to prove your actual inventory value.

(g) Your inventory value report must reflect your insurable clam inventory according to the prices contained in the actuarial documents. In no instance will we be liable for values greater than those contained in the actuarial documents.

(h) You must report all clams on the unit including any clams owned or subleased by other individuals or entities.

(i) No application or inventory value reports, except revisions, will be accepted after November 30, unless otherwise provided in the Special Provisions.

7. Premium

(a) In lieu of section 7(c) of the Basic Provisions, we will determine your premium by multiplying the amount of insurance by the appropriate premium rate and by the premium adjustment factors listed on the actuarial documents.

(b) Additional premium from an increase in the inventory value report is due and payable when we accept the revised inventory value report.

(c) In addition to the provisions in section 7 of the Basic Provisions, the premium will be adjusted for partial crop years for the year of seeding and for clam leases you acquire. Premium will be charged for the entire month, as shown in the actuarial documents, for any month during which any amount of coverage is provided.

8. Insured Crop

In lieu of the provisions of section 8 and section 9 of the Basic Provisions, the insured crop is all the clams in the county that:

(a) Meet all the requirements for insurability and for which prices are provided in the actuarial documents;

(b) Are acceptable to us;

(c) Are grown by a person, who in at least three of the five previous crop years:

(1) Grew clams for commercial sale; and

(2) Participated in the management of a clam farming operation by at least exercising decision-making authority over all operational aspects of the farm.

(d) Are grown in a county for which a premium rate is provided in the actuarial documents;

(e) Are in a growing location acceptable to us and for which you provided GPS coordinates with your clam inventory value report in accordance with the Special Provisions; and

(f) Use a practice that fixes the insurable clams to the land within the growing location.

9. Insurance Period

(a) In accordance with section 11 of the Basic Provisions, coverage begins the later of:

(1) The date the pre-acceptance inspection, if applicable, is complete unless we notify you that your inventory is not insurable; or

(2) If your inventory is insurable:

(i) On December 1 for new applications, when the application and the inventory value report are submitted by October 30;

(ii) On the 31st day following the date of submission for new applications, when the application and the inventory value report are submitted between November 1 and 30;

(iii) On December 1 for policies continued from the prior year if the inventory value report is submitted by October 30;

(iv) On the 31st day following the date of submission of the inventory value report for policies continued from the prior year when the inventory value report is submitted between November 1 and 30; and

(v) However, you acquire a financial interest in any insurable clams after coverage begins, but after December 1 of the crop year, and our inspection determines that the clams are acceptable, insurance will be considered to have attached to such clams 30 days after a revised inventory report is accepted by us indicating the stage value of the acquired clams; or

(vi) On the date contained in the Special Provisions.

(b) Insurance ends at the earliest of:

(1) The date of final adjustment of a loss when the total indemnities due equal the amount of insurance;

(2) November 30; or

(3) A date specified in the Special Provisions. (c) Insurance ceases immediately on any clams removed from the unit.

10. Causes of Loss

(a) In accordance with the provisions of section 12 of the Basic Provisions, insurance is provided for the death of clams caused only by the following causes of loss that occur within the insurance period unless otherwise limited by the Special Provisions:

(1) Oxygen depletion due to vegetation, microbial activity, harmful algae bloom, or high water temperature unless otherwise limited by the Special Provisions;

(2) Disease, if medication does not exist for control of the disease;

(3) Freeze;

(4) Hurricane;

(5) Decrease in salinity associated with a weather event verified by National Oceanic & Atmospheric Administration (NOAA) or United States Geologic Survey (USGS) or as otherwise defined in the Special Provisions;

(6) Tidal wave;

(7) Storm surge that is associated with a local weather event and verified by NOAA or USGS; or

(8) Ice floe.

(b) In addition to the causes of loss excluded in section 12 of the Basic Provisions, we do not insure against any loss caused by:

(1) Your inability to market clams as a direct result of quarantine, shellfish harvest ban, boycott, or refusal of a buyer to accept production;

(2) Collapse or failure of buildings or structures;

(3) Loss of market value;

(4) Vandalism;

(5) Theft;

(6) Pollution;

(7) Predation (unless allowed by the Special Provisions);

(8) Dredging;

(9) Any cause of loss that occurred prior to or after the insurance period;

(10) Any unexplained shortages or disappearance of inventory; or

(11) Failure of the clam to grow to a marketable size.

11. Replanting Payments

Unless otherwise stated in the Special Provisions:

(a) In accordance with the provisions contained in section 13 of the Basic Provisions, a replanting payment is allowed for insurable clams if death of the clams was due to an insurable cause of loss.

(b) The maximum amount of the replanting payment will be the lesser of your actual cost of replanting or the result obtained by multiplying the replanting payment amount contained in the Special Provisions by your insured share.

(c) Notwithstanding the provisions of section 13 of the Basic Provisions, only one replanting payment will be made per lease parcel planted within the crop year.

(d) You may not collect a replant payment and an indemnity for the same loss.

12. Duties in the Event of Damage or Loss

In addition to your duties contained in section 14 of the Basic Provisions,

(a) You must obtain our written consent prior to changing or discontinuing your normal practices with respect to care and maintenance of the insured clams. Failure to obtain our written consent will result in the denial of your claim.

(b) If you are claiming disease as the cause of loss, you must prove at your own expense that the death of the clams was due to disease by isolating a sample of the clams and identifying the disease following histological or pathological examination conducted by a veterinarian who is a certified fish pathologist or a person approved by us.

13. Access to Insured Crop and Records, and Records Retention

In addition to the requirements of section 21 of the Basic Provisions, you must permit us to inspect the insurable clams at any time and take samples of damaged and undamaged clams for inspection, testing, and analysis, and examine and make copies of your records.

14. Settlement of Claim

We will determine indemnities for any unit as follows:

(a) Determine the under-report factor for the basic unit;

(b) Determine the occurrence deductible;

(c) Subtract unit value after loss from unit value before loss;

(d) Multiply the result of 14(c) by the under-report factor;

(e) Subtract the occurrence deductible from the result in section 14(d); and

(f) If the result of section 14(e) is greater than zero, and subject to the limit of section 14(g);

(1) For other than catastrophic risk protection coverage, your indemnity equals the result of section 14(e), multiplied by your share.

(2) For catastrophic risk protection coverage, your indemnity equals the result of section 14(e) multiplied by 55 percent, multiplied by your share.

(g) The total of all indemnities for the crop year will not exceed the amount of insurance.

15. Written Agreements

The written agreement provisions in the Basic Provisions do not apply.

16. Late Planting

Provisions of section 16 of the Basic Provisions do not apply.

17. Prevented Planting

Provisions of section 17 of the Basic Provisions do not apply.

18. Loss Examples Single Unit Loss Example

Assume you have a 100 percent share, the inventory value reported by you is $100,000, and your coverage level is 75 percent. Your amount of insurance is $75,000 ($100,000 × .75). At the time of loss, unit value before loss is $95,000, unit value after loss is $30,000 and basic unit value before loss is $100,000. The deductible percentage is 25 percent (100−75), the crop year deductible is $25,000 (.25 × $100,000). Your indemnity would be calculated as follows:

Step (1) Determine the under-report factor; $100,000 ÷ $95,000 = 1.000;

Step (2) Determine the occurrence deductible; .25 × $95,000 × 1.000 = $23,750;

Step (3) Calculate the difference between unit value before loss and unit value after loss; $95,000−$30,000 = $65,000;

Step (4) Result of step 3 multiplied by the underreport factor (step 1); $65,000 × 1.000 = $65,000;

Step (5) Result of step 4 minus the occurrence deductible; $65,000−$23,750 = $41,250;

Step (6) Result of step 5 multiplied by your share; $41,250 × 1.000 = $41,250 indemnity payment.

Multiple Unit Multiple Loss Example

Assume you have a 100 percent share, the inventory value reported by you is $100,000, and your coverage level is 75 percent. You have two optional units, unit 1 and unit 2. Your amount of insurance is $75,000 ($100,000 × .75). You have a loss on unit 1 and no loss on unit 2. At the time of loss, unit value before loss on unit 1 is $60,000, unit value after loss on unit 1 is $18,000 and basic unit value before loss is $125,000. The deductible percentage is 25 percent (100−75), the crop year deductible is $25,000 (.25 × $100,000). Your indemnity would be calculated as follows:

Step (1) Determine the under-report factor; $100,000 ÷ $125,000 = .80;

Step (2) Determine the occurrence deductible; .25 × $60,000 × .80 = $12,000;

Step (3) Calculate the difference between unit value before loss and unit value after loss; $60,000−$18,000 = $42,000;

Step (4) Result of step 3 multiplied by the underreport factor (step 1); $42,000 × .80 = $33,600;

Step (5) Result of step 4 minus the occurrence deductible; $33,600−$12,000 = $21,600;

Step (6) Result of step 5 multiplied by your share; $21,600 × 1.000 = $21,600 indemnity payment.

Your crop year deductible is reduced to $13,000 ($25,000−$12,000). Your amount of insurance is reduced to $53,400 ($75,000−$21,600). You do not restock unit 1 after the first loss. Values on unit 2 do not change from those measured at the time of the loss on unit 1. Assume you have a loss later in the crop year on unit 2. Unit value before loss on unit 2 is $65,000, unit value after loss on unit 2 is $0.00 and basic unit value before loss on the basic unit is $83,000. Your loss would be determined as follows:

Step (1) Determine the remaining amount of insurance; $100,000−$33,600 = $66,400;

Step (2) Determine the under-report factor; $66,400 ÷ $83,000 = .800;

Step (3) Determine the occurrence deductible; $25,000−$12,000 = $13,000;

Step (4) Calculate the difference between unit value before loss and unit value after loss; $65,000−$0.00 = $65,000;

Step (5) Result of step 4 multiplied by the underreport factor (step 2); $65,000 × .800 = $52,000;

Step (6) Result of step 5 minus the occurrence deductible; $52,000−$13,000 = $39,000;

Step (7) Result of step 6 multiplied by your share; $39,000 × 1.000 = $39,000 indemnity payment.

Signed in Washington, DC, on December 19, 2017. Heather Manzano, Acting Manager, Federal Crop Insurance Corporation.
[FR Doc. 2017-27894 Filed 12-26-17; 8:45 am] BILLING CODE 3410-08-P
FEDERAL ELECTION COMMISSION 11 CFR Part 111 [Notice 2017-18] Civil Monetary Penalties Annual Inflation Adjustments AGENCY:

Federal Election Commission.

ACTION:

Final rule.

SUMMARY:

As required by the Federal Civil Penalties Inflation Adjustment Act of 1990, the Federal Election Commission is adjusting for inflation the civil monetary penalties established under the Federal Election Campaign Act, the Presidential Election Campaign Fund Act, and the Presidential Primary Matching Payment Account Act. The civil monetary penalties being adjusted are those negotiated by the Commission or imposed by a court for certain statutory violations, and those imposed by the Commission for late filing of or failure to file certain reports required by the Federal Election Campaign Act. The adjusted civil monetary penalties are calculated according to a statutory formula and the adjusted amounts will apply to penalties assessed after the effective date of these rules.

DATES:

This final rule is effective on December 27, 2017.

FOR FURTHER INFORMATION CONTACT:

Mr. Neven F. Stipanovic, Acting Assistant General Counsel, or Mr. Eugene J. Lynch, Paralegal, Office of General Counsel, (202) 694-1650 or (800) 424-9530.

SUPPLEMENTARY INFORMATION:

The Federal Civil Penalties Inflation Adjustment Act of 1990 (the “Inflation Adjustment Act”),1 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the “2015 Act”),2 requires federal agencies, including the Commission, to adjust for inflation the civil monetary penalties within their jurisdiction according to prescribed formulas. A civil monetary penalty is “any penalty, fine, or other sanction” that (1) “is for a specific monetary amount” or “has a maximum amount” under federal law; and (2) that a federal agency assesses or enforces “pursuant to an administrative proceeding or a civil action” in federal court.3 Under the Federal Election Campaign Act, 52 U.S.C. 30101-46 (“FECA”), the Commission may seek and assess civil monetary penalties for violations of FECA, the Presidential Election Campaign Fund Act, 26 U.S.C. 9001-13, and the Presidential Primary Matching Payment Account Act, 26 U.S.C. 9031-42.

1 Public Law 101-410, 104 Stat. 890 (codified at 28 U.S.C. 2461 note), amended by Debt Collection Improvement Act of 1996, Public Law 104-134, sec. 31001(s)(1), 110 Stat. 1321, 1321-373; Federal Reports Elimination Act of 1998, Public Law 105-362, sec. 1301, 112 Stat. 3280.

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

3 Inflation Adjustment Act § 3(2).

The Inflation Adjustment Act requires federal agencies to adjust their civil penalties annually, and the adjustments must take effect no later than January 15 of every year.4 Pursuant to guidance issued by the Office of Management and Budget,5 the Commission is now adjusting its civil monetary penalties for 2018.6

4 Inflation Adjustment Act § 4(a).

5See Inflation Adjustment Act § 7(a) (requiring OMB to “issue guidance to agencies on implementing the inflation adjustments required under this Act”); see also Memorandum from Mick Mulvaney, Director, Office of Management and Budget, to Heads of Executive Departments and Agencies, M-18-03 (Dec. 15, 2017), https://www.whitehouse.gov/wp-content/uploads/2017/11/M-18-03.pdf (“OMB Memorandum”).

6 Inflation Adjustment Act § 5.

The Commission must adjust for inflation its civil monetary penalties “notwithstanding Section 553” of the Administrative Procedures Act (“APA”).7 Thus, the APA's notice-and-comment and delayed effective date requirements in 5 U.S.C. 553(b)-(d) do not apply because Congress has specifically exempted agencies from these requirements.8

7 Inflation Adjustment Act § 4(b)(2).

8See, e.g., Asiana Airlines v. FAA, 134 F.3d 393, 396-99 (D.C. Cir. 1998) (finding APA “notice and comment” requirement not applicable where Congress clearly expressed intent to depart from normal APA procedures).

Furthermore, because the inflation adjustments made through these final rules are required by Congress and involve no Commission discretion or policy judgments, these rules do not need to be submitted to the Speaker of the House of Representatives or the President of the Senate under the Congressional Review Act, 5 U.S.C. 801 et seq. Moreover, because the APA's notice-and-comment procedures do not apply to these final rules, the Commission is not required to conduct a regulatory flexibility analysis under 5 U.S.C. 603 or 604. See 5 U.S.C. 601(2), 604(a). Nor is the Commission required to submit these revisions for congressional review under FECA. See 5 U.S.C. 30111(d)(1), (4) (providing for congressional review when Commission “prescribe[s]” a “rule of law”).

The new penalty amounts will apply to civil monetary penalties that are assessed after the date the increase takes effect, even if the associated violation predated the increase.9

9 Inflation Adjustment Act § 6.

Explanation and Justification

The Inflation Adjustment Act requires the Commission to annually adjust its civil monetary penalties for inflation by applying a cost-of-living-adjustment (“COLA”) ratio.10 The COLA ratio is the percentage that the Consumer Price Index (“CPI”) 11 “for the month of October preceding the date of the adjustment” exceeds the CPI for October of the previous year.12 To calculate the adjusted penalty, the Commission must increase the most recent civil monetary penalty amount by the COLA ratio.13 According to the Office of Management and Budget, the COLA ratio for 2018 is 0.02041, or 2.041%; thus, to calculate the new penalties, the Commission must multiply the most recent civil monetary penalties in force by 1.02041.14

10 The COLA ratio must be applied to the most recent civil monetary penalties. Inflation Adjustment Act, § 4(a); see also OMB Memorandum at 2.

11 The Inflation Adjustment Act, sec. 3, uses the CPI “for all-urban consumers published by the Department of Labor.”

12 Inflation Adjustment Act, § 5(b)(1).

13 Inflation Adjustment Act, § 5(a), (b)(1).

14 OMB Memorandum at 1.

The Commission assesses two types of civil monetary penalties that must be adjusted for inflation. First are penalties that are either negotiated by the Commission or imposed by a court for violations of FECA, the Presidential Election Campaign Fund Act, or the Presidential Primary Matching Payment Account Act. These civil monetary penalties are set forth at 11 CFR 111.24. Second are the civil monetary penalties assessed through the Commission's Administrative Fines Program for late filing or non-filing of certain reports required by FECA. See 52 U.S.C. 30109(a)(4)(C) (authorizing Administrative Fines Program), 30104(a) (requiring political committee treasurers to report receipts and disbursements within certain time periods). The penalty schedules for these civil monetary penalties are set out at 11 CFR 111.43 and 111.44.

1. 11 CFR 111.24—Civil Penalties

FECA establishes the civil monetary penalties for violations of FECA and the other statutes within the Commission's jurisdiction. See 52 U.S.C. 30109(a)(5), (6), (12). Commission regulations in 11 CFR 111.24 provide the current inflation-adjusted amount for each such civil monetary penalty. To calculate the adjusted civil monetary penalty, the Commission multiplies the most recent penalty amount by the COLA ratio and rounds that figure to the nearest dollar.

The actual adjustment to each civil monetary penalty is shown in the chart below.

Section Most recent civil
  • penalty
  • COLA New civil
  • penalty
  • 11 CFR 111.24(a)(1) $19,057 1.02041 $19,446 11 CFR 111.24(a)(2)(i) 40,654 1.02041 41,484 11 CFR 111.24(a)(2)(ii) 66,666 1.02041 68,027 11 CFR 111.24(b) 5,701 1.02041 5,817 11 CFR 111.24(b) 14,252 1.02041 14,543
    2. 11 CFR 111.43, 111.44—Administrative Fines

    FECA authorizes the Commission to assess civil monetary penalties for violations of the reporting requirements of 52 U.S.C. 30104(a) according to the penalty schedules “established and published by the Commission.” 52 U.S.C. 30109(a)(4)(C)(i). The Commission has established two such schedules: The schedule in 11 CFR 111.43(a) applies to reports that are not election sensitive, and the schedule in 11 CFR 111.43(b) applies to reports that are election sensitive.15 Each schedule contains two columns of penalties, one for late-filed reports and one for non-filed reports, with penalties based on the level of financial activity in the report and, if late-filed, its lateness.16 In addition, 11 CFR 111.43(c) establishes a civil monetary penalty for situations in which a committee fails to file a report and the Commission cannot calculate the relevant level of activity. Finally, 11 CFR 111.44 establishes a civil monetary penalty for failure to file timely reports of contributions received less than 20 days, but more than 48 hours, before an election. See 52 U.S.C. 30104(a)(6).

    15 Election sensitive reports are certain reports due shortly before an election. See 11 CFR 111.43(d)(1).

    16 A report is considered to be “not filed” if it is never filed or is filed more than a certain number of days after its due date. See 11 CFR 111.43(e).

    To determine the adjusted civil monetary penalty amount for each level of activity, the Commission multiplies the most recent penalty amount by the COLA ratio and rounds that figure to the nearest dollar. The new civil monetary penalties are shown in the schedules in the rule text, below.

    List of Subjects in 11 CFR Part 111

    Administrative practice and procedures, Elections, Law enforcement, Penalties.

    For the reasons set out in the preamble, the Federal Election Commission amends subchapter A of chapter I of title 11 of the Code of Federal Regulations as follows:

    PART 111—COMPLIANCE PROCEDURE (52 U.S.C. 30109, 30107(a)) 1. The authority citation for part 111 continues to read as follows: Authority:

    52 U.S.C. 30102(i), 30109, 30107(a), 30111(a)(8); 28 U.S.C. 2461 nt.

    § 111.24 [Amended]
    2. Section 111.24 is amended as follows:

    In the table below, for each section indicated in the left column, remove the number indicated in the middle column, and add in its place the number indicated in the right column.

    Section Remove Add 111.24(a)(1) $19,057 $19,446 111.24(a)(2)(i) 40,654 41,484 111.24(a)(2)(ii) 66,666 68,027 111.24(b) 5,701 5,817 111.24(b) 14,252 14,543
    3. Section 111.43 is amended by revising paragraphs (a), (b), and (c) to read as follows:
    § 111.43 What are the schedules of penalties?

    (a) The civil money penalty for all reports that are filed late or not filed, except election sensitive reports and pre-election reports under 11 CFR 104.5, shall be calculated in accordance with the following schedule of penalties:

    If the level of activity in the report was: And the report was filed late, the civil money penalty is: Or the report was not filed, the civil money penalty is: $1-4,999.99 a [$34 + ($6 × Number of days late)] × [1 + (.25 × Number of previous violations)] $333 × [1 + (.25 × Number of previous violations)]. $5,000-9,999.99 [$66 + ($6 × Number of days late)] × [1 + (.25 × Number of previous violations)] $400 × [1 + (.25 × Number of previous violations)]. $10,000-24,999.99 [$142 + ($6 × Number of days late)] × [1 + (.25 × Number of previous violations)] $667 × [1 + (.25 × Number of previous violations)]. $25,000-49,999.99 [$283 + ($27 × Number of days late)] × [1 + (.25 × Number of previous violations)] $1200 × [1 + (.25 × Number of previous violations)]. $50,000-74,999.99 [$426 + ($107 × Number of days late)] × [1 + (.25 × Number of previous violations)] $3828 × [1 + (.25 × Number of previous violations)]. $75,000-99,999.99 [$567 + ($142 × Number of days late)] × [1 + (.25 × Number of previous violations)] $4961 × [1 + (.25 × Number of previous violations)]. $100,000-149,999.99 [$850 + ($178 × Number of days late)] × [1 + (.25 × Number of previous violations)] $6380 × [1 + (.25 × Number of previous violations)]. $150,000-199,999.99 [$1135 + ($212 × Number of days late)] × [1 + (.25 × Number of previous violations)] $7797 × [1 + (.25 × Number of previous violations)]. $200,000-249,999.99 [$1417 + ($248 × Number of days late)] × [1 + (.25 × Number of previous violations)] $9214 × [1 + (.25 × Number of previous violations)]. $250,000-349,999.99 [$2127 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $11,341 × [1 + (.25 × Number of previous violations)]. $350,000-449,999.99 [$2836 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $12,758 × [1 + (.25 × Number of previous violations)]. $450,000-549,999.99 [$3544 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $13,466 × [1 + (.25 × Number of previous violations)]. $550,000-649,999.99 [$4253 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $14,177 × [1 + (.25 × Number of previous violations)]. $650,000-749,999.99 [$4961 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $14,885 × [1 + (.25 × Number of previous violations)]. $750,000-849,999.99 [$5670 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $15,594 × [1 + (.25 × Number of previous violations)]. $850,000-949,999.99 [$6380 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $16,302 × [1 + (.25 × Number of previous violations)]. $950,000 or over [$7088 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $17,011 × [1 + (.25 × Number of previous violations)]. a The civil money penalty for a respondent who does not have any previous violations will not exceed the level of activity in the report.

    (b) The civil money penalty for election sensitive reports that are filed late or not filed shall be calculated in accordance with the following schedule of penalties:

    If the level of activity in the report was: And the report was filed late, the civil money penalty is: Or the report was not filed, the civil money penalty is: $1-$4,999.99 a [$66 + ($13 × Number of days late)] × [1 + (.25 × Number of previous violations)] $667 × [1 + (.25 × Number of previous violations)]. $5,000-$9,999.99 [$134 + ($13 × Number of days late)] × [1 + (.25 × Number of previous violations)] $800 × [1 + (.25 × Number of previous violations)]. $10,000-24,999.99 [$200 + ($13 × Number of days late)] × [1 + (.25 × Number of previous violations)] $1200 × [1 + (.25 × Number of previous violations)]. $25,000-49,999.99 [$426 + ($34 × Number of days late)] × [1 + (.25 × Number of previous violations)] $1866 × [1 + (.25 × Number of previous violations)]. $50,000-74,999.99 [$638 + ($107 × Number of days late)] × [1 + (.25 × Number of previous violations)] $4253 × [1 + (.25 × Number of previous violations)]. $75,000-99,999.99 [$850 + ($142 × Number of days late)] × [1 + (.25 × Number of previous violations)] $5670 × [1 + (.25 × Number of previous violations)]. $100,000-149,999.99 [$1276 + ($178 × Number of days late)] × [1 + (.25 × Number of previous violations)] $7088 × [1 + (.25 × Number of previous violations)]. $150,000-199,999.99 [$1701 + ($212 × Number of days late)] × [1 + (.25 × Number of previous violations)] $8505 × [1 + (.25 × Number of previous violations)]. $200,000-249,999.99 [$2127 + ($248 × Number of days late)] × [1 + (.25 × Number of previous violations)] $10,633 × [1 + (.25 × Number of previous violations)]. $250,000-349,999.99 [$3190 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $12,758 × [1 + (.25 × Number of previous violations)]. $350,000-449,999.99 [$4253 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $14,177 × [1 + (.25 × Number of previous violations)]. $450,000-549,999.99 [$5316 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $15,594 × [1 + (.25 × Number of previous violations)]. $550,000-649,999.99 [$6380 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $17,011 × [1 + (.25 × Number of previous violations)]. $650,000-749,999.99 [$7442 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $18,430 × [1 + (.25 × Number of previous violations)]. $750,000-849,999.99 [$8505 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $19,846 × [1 + (.25 × Number of previous violations)]. $850,000-949,999.99 [$9569 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $21,263 × [1 + (.25 × Number of previous violations)]. $950,000 or over [$10,633 + ($283 × Number of days late)] × [1 + (.25 × Number of previous violations)] $22,682 × [1 + (.25 × Number of previous violations)]. a The civil money penalty for a respondent who does not have any previous violations will not exceed the level of activity in the report.

    (c) If the respondent fails to file a required report and the Commission cannot calculate the level of activity under paragraph (d) of this section, then the civil money penalty shall be $7,797.

    § 111.44 [Amended]
    4. In § 111.44, amend paragraph (a)(1) by removing “$139” and adding in its place “$142”. Dated: December 19, 2017.

    On behalf of the Commission.

    Steven T. Walther, Chairman, Federal Election Commission.
    [FR Doc. 2017-27808 Filed 12-26-17; 8:45 am] BILLING CODE 6715-01-P
    DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Parts 25 and 195 [Docket ID OCC-2017-0025] RIN 1557-AE30 FEDERAL RESERVE SYSTEM 12 CFR Part 228 [Regulation BB; Docket No. R-1574] RIN 7100-AE84 FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 345 RIN 3064-AE58 Community Reinvestment Act Regulations AGENCY:

    Office of the Comptroller of the Currency, Treasury (OCC); Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Joint final rule; technical amendment.

    SUMMARY:

    The OCC, the Board, and the FDIC (collectively, the Agencies) are amending their Community Reinvestment Act (CRA) regulations to adjust the asset-size thresholds used to define “small bank” or “small savings association” and “intermediate small bank” or “intermediate small savings association.” As required by the CRA regulations, the adjustment to the threshold amount is based on the annual percentage change in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). The FDIC is also amending its definition of “consumer loan” to correct a typographical error included in a CRA final rule issued on November 24, 2017.

    DATES:

    Effective Date: January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    OCC: Emily Boyes, Attorney, Community and Consumer Law Division, (202) 649-6350; Christopher Rafferty, Law Clerk, Legislative and Regulatory Activities Division, (202) 649-5490; for persons who are deaf or hearing impaired, TTY, (202) 649-5597; or Vonda Eanes, Director, Compliance Risk Policy Division, (202) 649-5470, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.

    Board: Amal S. Patel, Senior Supervisory Consumer Financial Services Analyst, (202) 912-7879; or Cathy Gates, Senior Project Manager, (202) 452-2099, Division of Consumer and Community Affairs, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    FDIC: Patience R. Singleton, Senior Policy Analyst, Supervisory Policy Branch, Division of Depositor and Consumer Protection, (202) 898-6859; or Richard M. Schwartz, Counsel, Legal Division, (202) 898-7424, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    SUPPLEMENTARY INFORMATION: Background and Description of the Joint Final Rule

    The Agencies' CRA regulations establish CRA performance standards for small and intermediate small banks and savings associations. The CRA regulations define small and intermediate small banks and savings associations by reference to asset-size criteria expressed in dollar amounts, and they further require the Agencies to publish annual adjustments to these dollar figures based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each 12-month period ending in November, with rounding to the nearest million. 12 CFR 25.12(u)(2), 195.12(u)(2), 228.12(u)(2), and 345.12(u)(2). This adjustment formula was first adopted for CRA purposes by the OCC, the Board, and the FDIC on August 2, 2005, effective September 1, 2005. 70 FR 44256 (Aug. 2, 2005). The Agencies noted that the CPI-W is also used in connection with other federal laws, such as the Home Mortgage Disclosure Act. See 12 U.S.C. 2808; 12 CFR 1003.2. On March 22, 2007, and effective July 1, 2007, the former Office of Thrift Supervision (OTS), the agency then responsible for regulating savings associations, adopted an annual adjustment formula consistent with that of the other federal banking agencies in its CRA rule previously set forth at 12 CFR part 563e. 72 FR 13429 (Mar. 22, 2007).

    Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),1 effective July 21, 2011, CRA rulemaking authority for federal and state savings associations was transferred from the OTS to the OCC, and the OCC subsequently republished, at 12 CFR part 195, the CRA regulations applicable to those institutions.2 In addition, the Dodd-Frank Act transferred responsibility for supervision of savings and loan holding companies and their non-depository subsidiaries from the OTS to the Board, and the Board subsequently amended its CRA regulation to reflect this transfer of supervisory authority.3

    1 Public Law 111-203, 124 Stat. 1376 (2010).

    2See OCC interim final rule, 76 FR 48950 (Aug. 9, 2011).

    3See Board interim final rule, 76 FR 56508 (Sept. 13, 2011).

    The threshold for small banks and small savings associations was revised most recently in December 2016 and became effective January 18, 2017. 82 FR 5354 (Jan. 18, 2017). The current CRA regulations provide that banks and savings associations that, as of December 31 of either of the prior two calendar years, had assets of less than $1.226 billion are small banks or small savings associations. Small banks and small savings associations with assets of at least $307 million as of December 31 of both of the prior two calendar years and less than $1.226 billion as of December 31 of either of the prior two calendar years are intermediate small banks or intermediate small savings associations. 12 CFR 25.12(u)(1), 195.12(u)(1), 228.12(u)(1), and 345.12(u)(1). This joint final rule revises these thresholds.

    During the 12-month period ending November 2017, the CPI-W increased by 2.11 percent. As a result, the Agencies are revising 12 CFR 25.12(u)(1), 195.12(u)(1), 228.12(u)(1), and 345.12(u)(1) to make this annual adjustment. Beginning January 1, 2018, banks and savings associations that, as of December 31 of either of the prior two calendar years, had assets of less than $1.252 billion are small banks or small savings associations. Small banks and small savings associations with assets of at least $313 million as of December 31 of both of the prior two calendar years and less than $1.252 billion as of December 31 of either of the prior two calendar years are intermediate small banks or intermediate small savings associations. The Agencies also publish current and historical asset-size thresholds on the website of the Federal Financial Institutions Examination Council at http://www.ffiec.gov/cra/.

    Additionally, on November 24, 2017, the Agencies amended their collective CRA regulations (82 FR 55734) to be consistent with prior amendments to Regulation C by the Consumer Financial Protection Bureau. Section 345.12(j) of the FDIC's CRA regulation, which provides for the definition of “consumer loan,” contained a typographical error in the Federal Register publication: § 345.12(j)(4) was reserved in error. To correct this error, § 345.12(j)(5) is redesignated as § 345.12(j)(4) and § 345.12(j)(5) is removed.

    Administrative Procedure Act and Effective Date

    Under 5 U.S.C. 553(b)(B) of the Administrative Procedure Act (APA), an agency may, for good cause, find (and incorporate the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.

    The amendments to the regulations to adjust the asset-size thresholds for small and intermediate small banks and savings associations result from the application of a formula established by a provision in the respective CRA regulations that the Agencies previously published for comment. See 70 FR 12148 (Mar. 11, 2005), 70 FR 44256 (Aug. 2, 2005), 71 FR 67826 (Nov. 24, 2006), and 72 FR 13429 (Mar. 22, 2007). As a result, §§ 25.12(u)(1), 195.12(u)(1), 228.12(u)(1), and 345.12(u)(1) of the Agencies' respective CRA regulations are amended by adjusting the asset-size thresholds as provided for in §§ 25.12(u)(2), 195.12(u)(2), 228.12(u)(2), and 345.12(u)(2).

    Accordingly, the Agencies' rules provide no discretion as to the computation or timing of the revisions to the asset-size criteria. Furthermore, amending the FDIC's definition of “consumer loan” to correct a typographical error is a technical and non-substantive revision. For these reasons, the Agencies have determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary.

    The effective date of this joint final rule is January 1, 2018. Under 5 U.S.C. 553(d)(3) of the APA, the required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except, among other things, as provided by the agency for good cause found and published with the rule. Because this rule adjusts asset-size thresholds consistent with the procedural requirements of the CRA rules, the Agencies conclude that it is not substantive within the meaning of the APA's delayed effective date provision. Moreover, the Agencies find that there is good cause for dispensing with the delayed effective date requirement, even if it applied, because their current rules already provide notice that the small and intermediate small asset-size thresholds will be adjusted as of December 31 based on 12-month data as of the end of November each year.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) does not apply to a rulemaking when a general notice of proposed rulemaking is not required. 5 U.S.C. 603 and 604. As noted previously, the Agencies have determined that it is unnecessary to publish a general notice of proposed rulemaking for this joint final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

    Paperwork Reduction Act of 1995

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) states that no agency may conduct or sponsor, nor is the respondent required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Agencies have determined that this final rule does not create any new, or revise any existing, collections of information pursuant to the Paperwork Reduction Act. Consequently, no information collection request will be submitted to the OMB for review.

    Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act), 2 U.S.C. 1532, requires the OCC to prepare a budgetary impact statement before promulgating any final rule for which a general notice of proposed rulemaking was published. As discussed above, the OCC has determined that the publication of a general notice of proposed rulemaking is unnecessary. Accordingly, this joint final rule is not subject to section 202 of the Unfunded Mandates Act.

    List of Subjects 12 CFR Part 25

    Community development, Credit, Investments, National banks, Reporting and recordkeeping requirements.

    12 CFR Part 195

    Community development, Credit, Investments, Reporting and recordkeeping requirements, Savings associations.

    12 CFR Part 228

    Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.

    12 CFR Part 345

    Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.

    DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Chapter I

    For the reasons discussed in the SUPPLEMENTARY INFORMATION section, 12 CFR parts 25 and 195 are amended as follows:

    PART 25—COMMUNITY REINVESTMENT ACT AND INTERSTATE DEPOSIT PRODUCTION REGULATIONS 1. The authority citation for part 25 continues to read as follows: Authority:

    12 U.S.C. 21, 22, 26, 27, 30, 36, 93a, 161, 215, 215a, 481, 1814, 1816, 1828(c), 1835a, 2901 through 2908, and 3101 through 3111.

    2. Section 25.12 is amended by revising paragraph (u)(1) to read as follows:
    § 25.12 Definitions.

    (u) Small bank—(1) Definition. Small bank means a bank that, as of December 31 of either of the prior two calendar years, had assets of less than $1.252 billion. Intermediate small bank means a small bank with assets of at least $313 million as of December 31 of both of the prior two calendar years and less than $1.252 billion as of December 31 of either of the prior two calendar years.

    PART 195—COMMUNITY REINVESTMENT 3. The authority citation for part 195 continues to read as follows: Authority:

    12 U.S.C. 1462a, 1463, 1464, 1814, 1816, 1828(c), 2901 through 2908, and 5412(b)(2)(B).

    4. Section 195.12 is amended by revising paragraph (u)(1) to read as follows:
    § 195.12 Definitions.

    (u) Small savings association—(1) Definition. Small savings association means a savings association that, as of December 31 of either of the prior two calendar years, had assets of less than $1.252 billion. Intermediate small savings association means a small savings association with assets of at least $313 million as of December 31 of both of the prior two calendar years and less than $1.252 billion as of December 31 of either of the prior two calendar years.

    FEDERAL RESERVE SYSTEM 12 CFR Chapter II

    For the reasons set forth in the SUPPLEMENTARY INFORMATION section, the Board of Governors of the Federal Reserve System amends part 228 of chapter II of title 12 of the Code of Federal Regulations as follows:

    PART 228—COMMUNITY REINVESTMENT (REGULATION BB) 5. The authority citation for part 228 is revised to read as follows: Authority:

    12 U.S.C. 321, 325, 1828(c), 1842, 1843, 1844, and 2901 et seq.

    6. Section 228.12 is amended by revising paragraph (u)(1) to read as follows:
    § 228.12 Definitions.

    (u) Small bank—(1) Definition. Small bank means a bank that, as of December 31 of either of the prior two calendar years, had assets of less than $1.252 billion. Intermediate small bank means a small bank with assets of at least $313 million as of December 31 of both of the prior two calendar years and less than $1.252 billion as of December 31 of either of the prior two calendar years.

    FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Chapter III Authority and Issuance

    For the reasons set forth in the SUPPLEMENTARY INFORMATION section, the Board of Directors of the Federal Deposit Insurance Corporation amends part 345 of chapter III of title 12 of the Code of Federal Regulations to read as follows:

    PART 345—COMMUNITY REINVESTMENT 7. The authority citation for part 345 continues to read as follows: Authority:

    12 U.S.C. 1814-1817, 1819-1820, 1828, 1831u and 2901-2908, 3103-3104, and 3108(a).

    8. Section 345.12 is amended by redesignating paragraph (j)(5) as paragraph (j)(4) and revising paragraph (u)(1) to read as follows:
    § 345.12 Definitions.

    (u) Small bank—(1) Definition. Small bank means a bank that, as of December 31 of either of the prior two calendar years, had assets of less than $1.252 billion. Intermediate small bank means a small bank with assets of at least $313 million as of December 31 of both of the prior two calendar years and less than $1.252 billion as of December 31 of either of the prior two calendar years.

    Dated: December 19, 2017. Karen Solomon, Acting Senior Deputy Comptroller and Chief Counsel<E T="03">.</E>

    By order of the Board of Governors of the Federal Reserve System, acting through the Secretary of the Board under delegated authority.

    Ann E. Misback, Secretary of the Board.

    By order of the Board of Directors.

    Dated at Washington, DC, this 14th day of December 2017. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2017-27813 Filed 12-26-17; 8:45 am] BILLING CODE 4810-33-P; 6210-01-P; 6714-01-P
    NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 790 RIN 3133-AE81 Agency Reorganization; Correction AGENCY:

    National Credit Union Administration (NCUA).

    ACTION:

    Final rule; correction.

    SUMMARY:

    The NCUA is correcting a final rule that appeared in the Federal Register on December 20, 2017. The document implemented certain features of the NCUA reorganization that the NCUA Board announced earlier this year. This correction amends one reference within the document.

    DATES:

    This correction is effective January 6, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Wirick, Senior Staff Attorney, Office of General Counsel, 1775 Duke Street, Alexandria, VA 22314 or telephone (703) 518-6540.

    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2017-27411, appearing on page 60290 in the Federal Register of Wednesday, December 20, 2017, the following corrections are made:

    § 790.2 [Corrected]
    On page 60292, in the second column, in part 790, in amendment 10, the instruction “In § 790.2, revise the second sentence of paragraph (b)(6), paragraph (b)(12), the third sentence of paragraph (b)(13), and paragraph (b)(15) to read as follows:” is corrected to read “In § 790.2, revise the second sentence of paragraph (b)(6), paragraph (b)(12), the fourth sentence of paragraph (b)(13), and paragraph (b)(15) to read as follows:” By the National Credit Union Administration Board on December 21, 2017. Gerard Poliquin, Secretary of the Board
    [FR Doc. 2017-27962 Filed 12-26-17; 8:45 am] BILLING CODE 7535-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1003 Home Mortgage Disclosure (Regulation C) Adjustment to Asset-Size Exemption Threshold AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Final rule; official commentary.

    SUMMARY:

    The Bureau of Consumer Financial Protection (Bureau) is issuing a final rule amending the official commentary that interprets the requirements of the Bureau's Regulation C (Home Mortgage Disclosure) to reflect the asset-size exemption threshold for banks, savings associations, and credit unions based on the annual percentage change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the 2.1 percent increase in the average of the CPI-W for the 12-month period ending in November 2017, the exemption threshold is adjusted to increase to $45 million from $44 million. Therefore, banks, savings associations, and credit unions with assets of $45 million or less as of December 31, 2017, are exempt from collecting data in 2018.

    DATES:

    This final rule is effective January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Monique Chenault, Paralegal Specialist, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552, at (202) 435-7700.

    SUPPLEMENTARY INFORMATION: I. Background

    The Home Mortgage Disclosure Act of 1975 (HMDA) (12 U.S.C. 2801-2810) requires most mortgage lenders located in metropolitan areas to collect data about their housing related lending activity. Annually, lenders must report their data to the appropriate Federal agencies and make the data available to the public. The Bureau's Regulation C (12 CFR part 1003) implements HMDA.

    Prior to 1997, HMDA exempted certain depository institutions as defined in HMDA (i.e., banks, savings associations, and credit unions) with assets totaling $10 million or less as of the preceding year-end. In 1996, HMDA was amended to expand the asset-size exemption for these depository institutions. 12 U.S.C. 2808(b). The amendment increased the dollar amount of the asset-size exemption threshold by requiring a one-time adjustment of the $10 million figure based on the percentage by which the CPI-W for 1996 exceeded the CPI-W for 1975, and it provided for annual adjustments thereafter based on the annual percentage increase in the CPI-W, rounded to the nearest multiple of $1 million.

    The definition of “financial institution” in § 1003.2(g) provides that the Bureau will adjust the asset threshold based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each 12-month period ending in November, rounded to the nearest $1 million. For 2017, the threshold was $44 million. During the 12-month period ending in November 2017, the average of the CPI-W increased by 2.1 percent. As a result, the exemption threshold is increased to $45 million. Thus, banks, savings associations, and credit unions with assets of $45 million or less as of December 31, 2017, are exempt from collecting data in 2018. An institution's exemption from collecting data in 2018 does not affect its responsibility to report data it was required to collect in 2017.

    II. Procedural Requirements A. Administrative Procedure Act

    Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). Pursuant to this final rule, comment 2(g)-2 in Regulation C, supplement I, is amended to update the exemption threshold. The amendment in this final rule is technical and non-discretionary, and it merely applies the formula established by Regulation C for determining any adjustments to the exemption threshold. For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

    Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule. 5 U.S.C. 553(d). At a minimum, the Bureau believes the amendments fall under the third exception to section 553(d). The Bureau finds that there is good cause to make the amendments effective on January 1, 2018. The amendment in this final rule is technical and non-discretionary, and it applies the method previously established in the agency's regulations for determining adjustments to the threshold.

    B. Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a).

    C. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR part 1320), the agency reviewed this final rule. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.

    D. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), CFPB 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 the rule taking effect. The Office of Information and Regulatory Affairs (OIRA) has designated this rule as not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 12 CFR Part 1003

    Banking, Banks, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations.

    Authority and Issuance

    For the reasons set forth above, the Bureau amends Regulation C, 12 CFR part 1003, as set forth below:

    PART 1003—HOME MORTGAGE DISCLOSURE (REGULATION C) 1. The authority citation for part 1003 continues to read as follows: Authority:

    12 U.S.C. 2803, 2804, 2805, 5512, 5581.

    2. In Supplement I to Part 1003, under Section 1003.2—Definitions, 2(g) Financial Institution is revised to read as follows: Supplement I to Part 1003—Official Interpretations Section 1003.2—Definitions 2(g) Financial Institution

    1. Preceding calendar year and preceding December 31. The definition of financial institution refers both to the preceding calendar year and the preceding December 31. These terms refer to the calendar year and the December 31 preceding the current calendar year. For example, in 2019, the preceding calendar year is 2018 and the preceding December 31 is December 31, 2018. Accordingly, in 2019, Financial Institution A satisfies the asset-size threshold described in § 1003.2(g)(1)(i) if its assets exceeded the threshold specified in comment 2(g)-2 on December 31, 2018. Likewise, in 2020, Financial Institution A does not meet the loan-volume test described in § 1003.2(g)(1)(v)(A) if it originated fewer than 25 closed-end mortgage loans during either 2018 or 2019.

    2. Adjustment of exemption threshold for banks, savings associations, and credit unions. For data collection in 2018, the asset-size exemption threshold is $45 million. Banks, savings associations, and credit unions with assets at or below $45 million as of December 31, 2017, are exempt from collecting data for 2018.

    3. Merger or acquisition—coverage of surviving or newly formed institution. After a merger or acquisition, the surviving or newly formed institution is a financial institution under § 1003.2(g) if it, considering the combined assets, location, and lending activity of the surviving or newly formed institution and the merged or acquired institutions or acquired branches, satisfies the criteria included in § 1003.2(g). For example, A and B merge. The surviving or newly formed institution meets the loan threshold described in § 1003.2(g)(1)(v)(B) if the surviving or newly formed institution, A, and B originated a combined total of at least 500 open-end lines of credit in each of the two preceding calendar years. Likewise, the surviving or newly formed institution meets the asset-size threshold in § 1003.2(g)(1)(i) if its assets and the combined assets of A and B on December 31 of the preceding calendar year exceeded the threshold described in § 1003.2(g)(1)(i). Comment 2(g)-4 discusses a financial institution's responsibilities during the calendar year of a merger.

    4. Merger or acquisition—coverage for calendar year of merger or acquisition. The scenarios described below illustrate a financial institution's responsibilities for the calendar year of a merger or acquisition. For purposes of these illustrations, a “covered institution” means a financial institution, as defined in § 1003.2(g), that is not exempt from reporting under § 1003.3(a), and “an institution that is not covered” means either an institution that is not a financial institution, as defined in § 1003.2(g), or an institution that is exempt from reporting under § 1003.3(a).

    i. Two institutions that are not covered merge. The surviving or newly formed institution meets all of the requirements necessary to be a covered institution. No data collection is required for the calendar year of the merger (even though the merger creates an institution that meets all of the requirements necessary to be a covered institution). When a branch office of an institution that is not covered is acquired by another institution that is not covered, and the acquisition results in a covered institution, no data collection is required for the calendar year of the acquisition.

    ii. A covered institution and an institution that is not covered merge. The covered institution is the surviving institution, or a new covered institution is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in the offices of the merged institution that was previously covered and is optional for covered loans and applications handled in offices of the merged institution that was previously not covered. When a covered institution acquires a branch office of an institution that is not covered, data collection is optional for covered loans and applications handled by the acquired branch office for the calendar year of the acquisition.

    iii. A covered institution and an institution that is not covered merge. The institution that is not covered is the surviving institution, or a new institution that is not covered is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in offices of the previously covered institution that took place prior to the merger. After the merger date, data collection is optional for covered loans and applications handled in the offices of the institution that was previously covered. When an institution remains not covered after acquiring a branch office of a covered institution, data collection is required for transactions of the acquired branch office that take place prior to the acquisition. Data collection by the acquired branch office is optional for transactions taking place in the remainder of the calendar year after the acquisition.

    iv. Two covered institutions merge. The surviving or newly formed institution is a covered institution. Data collection is required for the entire calendar year of the merger. The surviving or newly formed institution files either a consolidated submission or separate submissions for that calendar year. When a covered institution acquires a branch office of a covered institution, data collection is required for the entire calendar year of the merger. Data for the acquired branch office may be submitted by either institution.

    5. Originations. Whether an institution is a financial institution depends in part on whether the institution originated at least 25 closed-end mortgage loans in each of the two preceding calendar years or at least 500 open-end lines of credit in each of the two preceding calendar years. Comments 4(a)-2 through -4 discuss whether activities with respect to a particular closed-end mortgage loan or open-end line of credit constitute an origination for purposes of § 1003.2(g).

    6. Branches of foreign banks—treated as banks. A Federal branch or a State-licensed or insured branch of a foreign bank that meets the definition of a “bank” under section 3(a)(1) of the Federal Deposit Insurance Act (12 U.S.C. 1813(a)) is a bank for the purposes of § 1003.2(g).

    7. Branches and offices of foreign banks and other entities—treated as nondepository financial institutions. A Federal agency, State-licensed agency, State-licensed uninsured branch of a foreign bank, commercial lending company owned or controlled by a foreign bank, or entity operating under section 25 or 25A of the Federal Reserve Act, 12 U.S.C. 601 and 611 (Edge Act and agreement corporations) may not meet the definition of “bank” under the Federal Deposit Insurance Act and may thereby fail to satisfy the definition of a depository financial institution under § 1003.2(g)(1). An entity is nonetheless a financial institution if it meets the definition of nondepository financial institution under § 1003.2(g)(2).

    Dated: December 14, 2017. Mick Mulvaney, Acting Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-27879 Filed 12-21-17; 4:15 pm] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1026 Truth in Lending Act (Regulation Z) Adjustment to Asset-Size Exemption Threshold AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Final rule; official interpretation.

    SUMMARY:

    The Bureau is amending the official commentary that interprets the requirements of the Bureau's Regulation Z (Truth in Lending) to reflect a change in the asset-size threshold for certain creditors to qualify for an exemption to the requirement to establish an escrow account for a higher-priced mortgage loan based on the annual percentage change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W) for the 12-month period ending in November. The exemption threshold is adjusted to increase to $2.112 billion from $2.069 billion. The adjustment is based on the 2.1 percent increase in the average of the CPI-W for the 12-month period ending in November 2017. Therefore, creditors with assets of less than $2.112 billion (including assets of certain affiliates) as of December 31, 2017, are exempt, if other requirements of Regulation Z also are met, from establishing escrow accounts for higher-priced mortgage loans in 2018. This asset limit will also apply during a grace period, in certain circumstances, with respect to transactions with applications received before April 1 of 2019. The adjustment to the escrows asset-size exemption threshold will also increase a similar threshold for small-creditor portfolio and balloon-payment qualified mortgages. Balloon-payment qualified mortgages that satisfy all applicable criteria, including being made by creditors that have (together with certain affiliates) total assets below the threshold, are also excepted from the prohibition on balloon payments for high-cost mortgages.

    DATES:

    This final rule is effective January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Monique Chenault, Paralegal Specialist, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552, at (202) 435-7700.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA to add section 129D(a), which contains a general requirement that an escrow account be established by a creditor to pay for property taxes and insurance premiums for certain first-lien higher-priced mortgage loan transactions. TILA section 129D also generally permits an exemption from the higher-priced mortgage loan escrow requirement for a creditor that meets certain requirements, including any asset-size threshold the Bureau may establish.

    In the 2013 Escrows Final Rule,1 the Bureau established such an asset-size threshold of $2 billion, which would adjust automatically each year, based on the year-to-year change in the average of the CPI-W for each 12-month period ending in November, with rounding to the nearest million dollars.2 In 2015, the Bureau revised the criteria for small creditors, and rural and underserved areas, for purposes of certain special provisions and exemptions from various requirements provided to certain small creditors under the Bureau's mortgage rules.3 As part of this revision the Bureau made certain changes that affect how the asset-size threshold applies. The Bureau revised § 1026.35(b)(2)(iii)(C) and its accompanying commentary to include in the calculation of the asset-size threshold the assets of the creditor's affiliates that regularly extended covered transactions secured by first liens during the applicable period. The Bureau also added a grace period from calendar year to calendar year to allow an otherwise eligible creditor that exceeded the asset limit in the preceding calendar year (but not in the calendar year before the preceding year) to continue to operate as a small creditor with respect to transactions with applications received before April 1 of the current calendar year.4 5 For 2017, the threshold was $2.069 billion.

    1 78 FR 4726 (Jan. 22, 2013).

    2See 12 CFR 1026.35(b)(2)(iii)(C).

    3See 80 FR 59944 (Oct. 2, 2015).

    4See 80 FR 59943, 59951 (Oct. 2, 2015).

    5 The Bureau also issued an interim final rule in March 2016 to revise certain provisions in Regulation Z to effectuate the Helping Expand Lending Practices in Rural Communities Act's amendments to TILA (Pub. L. 114-94, section 89003, 129 Stat. 1312, 1800-01 (2015)). The rule broadened the cohort of creditors that may be eligible under TILA for the special provisions allowing origination of balloon-payment qualified mortgages and balloon-payment high-cost mortgages, as well as for the escrow exemption. See 81 FR 16074 (Mar. 25, 2016).

    During the 12-month period ending in November 2017, the average of the CPI-W increased by 2.1 percent. As a result, the exemption threshold is increased to $2.112 billion for 2018. Thus, if the creditor's assets together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2017 are less than $2.112 billion on December 31, 2017, and it meets the other requirements of § 1026.35(b)(2)(iii), it will be exempt in 2018 from the escrow-accounts requirement for higher-priced mortgage loans and will also be exempt from the escrow-accounts requirement for higher-priced mortgage loans for purposes of any loan consummated in 2019 for which the application was received before April 1, 2019. The adjustment to the escrows asset-size exemption threshold will also increase the threshold for small-creditor portfolio and balloon-payment qualified mortgages under Regulation Z. The requirements for small-creditor portfolio qualified mortgages at § 1026.43(e)(5)(i)(D) reference the asset threshold in § 1026.35(b)(2)(iii)(C). Likewise, the requirements for balloon-payment qualified mortgages at § 1026.43(f)(1)(vi) reference the asset threshold in § 1026.35(b)(2)(iii)(C). Under § 1026.32(d)(1)(ii)(C), balloon-payment qualified mortgages that satisfy all applicable criteria in § 1026.43(f)(1)(i) through (vi) and (f)(2), including being made by creditors that have (together with certain affiliates) total assets below the threshold in § 1026.35(b)(2)(iii)(C), are also excepted from the prohibition on balloon payments for high-cost mortgages.

    II. Procedural Requirements A. Administrative Procedure Act

    Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). Pursuant to this final rule, comment 35(b)(2)(iii)-1 in Regulation Z is amended to update the exemption threshold. The amendment in this final rule is technical and merely applies the formula previously established in Regulation Z for determining any adjustments to the exemption threshold. For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

    Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule. 5 U.S.C. 553(d). At a minimum, the Bureau believes the amendments fall under the third exception to section 553(d). The Bureau finds that there is good cause to make the amendments effective on January 1, 2018. The amendment in this document is technical and applies the method previously established in the agency's regulations for automatic adjustments to the threshold.

    B. Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a).

    C. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR part 1320), the agency reviewed this final rule. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.

    D. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), CFPB 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 the rule taking effect. The Office of Information and Regulatory Affairs (OIRA) has designated this rule as not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 10 CFR Part 1026

    Advertising, Appraisal, Appraiser, Banking, Banks, Consumer protection, Credit, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth in lending.

    Authority and Issuance

    For the reasons set forth above, the Bureau amends Regulation Z, 12 CFR part 1026, as set forth below:

    PART 1026—TRUTH IN LENDING (REGULATION Z) 1. The authority citation for part 1026 continues to read as follows: Authority:

    12 U.S.C. 2601, 2603-2605, 2607, 2609, 2617, 3353, 5511, 5512, 5532, 5581; 15 U.S.C. 1601 et seq.

    2. In Supplement I to Part 1026—Official Interpretations, under Section 1026.35—Requirements for Higher-Priced Mortgage Loans, 35(b)(2) Exemptions, Paragraph 35(b)(2)(iii) is revised to read as follows: Supplement I to Part 1026—Official Interpretations Section 1026.35—Requirements for Higher-Priced Mortgage Loans 35(b)(2) Exemptions. Paragraph 35(b)(2)(iii).

    1. Requirements for exemption. Under § 1026.35(b)(2)(iii), except as provided in § 1026.35(b)(2)(v), a creditor need not establish an escrow account for taxes and insurance for a higher-priced mortgage loan, provided the following four conditions are satisfied when the higher-priced mortgage loan is consummated:

    i. During the preceding calendar year, or during either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year, a creditor extended a first-lien covered transaction, as defined in § 1026.43(b)(1), secured by a property located in an area that is either “rural” or “underserved,” as set forth in § 1026.35(b)(2)(iv).

    A. In general, whether the rural-or-underserved test is satisfied depends on the creditor's activity during the preceding calendar year. However, if the application for the loan in question was received before April 1 of the current calendar year, the creditor may instead meet the rural-or-underserved test based on its activity during the next-to-last calendar year. This provides creditors with a grace period if their activity meets the rural-or-underserved test (in § 1026.35(b)(2)(iii)(A)) in one calendar year but fails to meet it in the next calendar year.

    B. A creditor meets the rural-or-underserved test for any higher-priced mortgage loan consummated during a calendar year if it extended a first-lien covered transaction in the preceding calendar year secured by a property located in a rural-or-underserved area. If the creditor does not meet the rural-or-underserved test in the preceding calendar year, the creditor meets this condition for a higher-priced mortgage loan consummated during the current calendar year only if the application for the loan was received before April 1 of the current calendar year and the creditor extended a first-lien covered transaction during the next-to-last calendar year that is secured by a property located in a rural or underserved area. The following examples are illustrative:

    1. Assume that a creditor extended during 2016 a first-lien covered transaction that is secured by a property located in a rural or underserved area. Because the creditor extended a first-lien covered transaction during 2016 that is secured by a property located in a rural or underserved area, the creditor can meet this condition for exemption for any higher-priced mortgage loan consummated during 2017.

    2. Assume that a creditor did not extend during 2016 a first-lien covered transaction secured by a property that is located in a rural or underserved area. Assume further that the same creditor extended during 2015 a first-lien covered transaction that is located in a rural or underserved area. Assume further that the creditor consummates a higher-priced mortgage loan in 2017 for which the application was received in November 2017. Because the creditor did not extend during 2016 a first-lien covered transaction secured by a property that is located in a rural or underserved area, and the application was received on or after April 1, 2017, the creditor does not meet this condition for exemption. However, assume instead that the creditor consummates a higher-priced mortgage loan in 2017 based on an application received in February 2017. The creditor meets this condition for exemption for this loan because the application was received before April 1, 2017, and the creditor extended during 2015 a first-lien covered transaction that is located in a rural or underserved area.

    ii. The creditor and its affiliates together extended no more than 2,000 covered transactions, as defined in § 1026.43(b)(1), secured by first liens, that were sold, assigned, or otherwise transferred by the creditor or its affiliates to another person, or that were subject at the time of consummation to a commitment to be acquired by another person, during the preceding calendar year or during either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year. For purposes of § 1026.35(b)(2)(iii)(B), a transfer of a first-lien covered transaction to “another person” includes a transfer by a creditor to its affiliate.

    A. In general, whether this condition is satisfied depends on the creditor's activity during the preceding calendar year. However, if the application for the loan in question is received before April 1 of the current calendar year, the creditor may instead meet this condition based on activity during the next-to-last calendar year. This provides creditors with a grace period if their activity falls at or below the threshold in one calendar year but exceeds it in the next calendar year.

    B. For example, assume that in 2015 a creditor and its affiliates together extended 1,500 loans that were sold, assigned, or otherwise transferred by the creditor or its affiliates to another person, or that were subject at the time of consummation to a commitment to be acquired by another person, and 2,500 such loans in 2016. Because the 2016 transaction activity exceeds the threshold but the 2015 transaction activity does not, the creditor satisfies this condition for exemption for a higher-priced mortgage loan consummated during 2017 if the creditor received the application for the loan before April 1, 2017, but does not satisfy this condition for a higher-priced mortgage loan consummated during 2017 if the application for the loan was received on or after April 1, 2017.

    C. For purposes of § 1026.35(b)(2)(iii)(B), extensions of first-lien covered transactions, during the applicable time period, by all of a creditor's affiliates, as “affiliate” is defined in § 1026.32(b)(5), are counted toward the threshold in this section. “Affiliate” is defined in § 1026.32(b)(5) as “any company that controls, is controlled by, or is under common control with another company, as set forth in the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.).” Under the Bank Holding Company Act, a company has control over a bank or another company if it “directly or indirectly or acting through one or more persons owns, controls, or has power to vote 25 per centum or more of any class of voting securities of the bank or company”; it “controls in any manner the election of a majority of the directors or trustees of the bank or company”; or the Federal Reserve Board “determines, after notice and opportunity for hearing, that the company directly or indirectly exercises a controlling influence over the management or policies of the bank or company.” 12 U.S.C. 1841(a)(2).

    iii. As of the end of the preceding calendar year, or as of the end of either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year, the creditor and its affiliates that regularly extended covered transactions secured by first liens, together, had total assets that are less than the applicable annual asset threshold.

    A. For purposes of § 1026.35(b)(2)(iii)(C), in addition to the creditor's assets, only the assets of a creditor's “affiliate” (as defined by § 1026.32(b)(5)) that regularly extended covered transactions (as defined by § 1026.43(b)(1)) secured by first liens, are counted toward the applicable annual asset threshold. See comment 35(b)(2)(iii)-1.ii.C for discussion of definition of “affiliate.”

    B. Only the assets of a creditor's affiliate that regularly extended first-lien covered transactions during the applicable period are included in calculating the creditor's assets. The meaning of “regularly extended” is based on the number of times a person extends consumer credit for purposes of the definition of “creditor” in § 1026.2(a)(17). Because covered transactions are “transactions secured by a dwelling,” consistent with § 1026.2(a)(17)(v), an affiliate regularly extended covered transactions if it extended more than five covered transactions in a calendar year. Also consistent with § 1026.2(a)(17)(v), because a covered transaction may be a high-cost mortgage subject to § 1026.32, an affiliate regularly extends covered transactions if, in any 12-month period, it extends more than one covered transaction that is subject to the requirements of § 1026.32 or one or more such transactions through a mortgage broker. Thus, if a creditor's affiliate regularly extended first-lien covered transactions during the preceding calendar year, the creditor's assets as of the end of the preceding calendar year, for purposes of the asset limit, take into account the assets of that affiliate. If the creditor, together with its affiliates that regularly extended first-lien covered transactions, exceeded the asset limit in the preceding calendar year—to be eligible to operate as a small creditor for transactions with applications received before April 1 of the current calendar year—the assets of the creditor's affiliates that regularly extended covered transactions in the year before the preceding calendar year are included in calculating the creditor's assets.

    C. If multiple creditors share ownership of a company that regularly extended first-lien covered transactions, the assets of the company count toward the asset limit for a co-owner creditor if the company is an “affiliate,” as defined in § 1026.32(b)(5), of the co-owner creditor. Assuming the company is not an affiliate of the co-owner creditor by virtue of any other aspect of the definition (such as by the company and co-owner creditor being under common control), the company's assets are included toward the asset limit of the co-owner creditor only if the company is controlled by the co-owner creditor, “as set forth in the Bank Holding Company Act.” If the co-owner creditor and the company are affiliates (by virtue of any aspect of the definition), the co-owner creditor counts all of the company's assets toward the asset limit, regardless of the co-owner creditor's ownership share. Further, because the co-owner and the company are mutual affiliates the company also would count all of the co-owner's assets towards its own asset limit. See comment 35(b)(2)(iii)-1.ii.C for discussion of the definition of “affiliate.”

    D. A creditor satisfies the criterion in § 1026.35(b)(2)(iii)(C) for purposes of any higher-priced mortgage loan consummated during 2016, for example, if the creditor (together with its affiliates that regularly extended first-lien covered transactions) had total assets of less than the applicable asset threshold on December 31, 2015. A creditor that (together with its affiliates that regularly extended first-lien covered transactions) did not meet the applicable asset threshold on December 31, 2015 satisfies this criterion for a higher-priced mortgage loan consummated during 2016 if the application for the loan was received before April 1, 2016 and the creditor (together with its affiliates that regularly extended first-lien covered transactions) had total assets of less than the applicable asset threshold on December 31, 2014.

    E. Under § 1026.35(b)(2)(iii)(C), the $2,000,000,000 asset threshold adjusts automatically each year based on the year-to-year change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers, not seasonally adjusted, for each 12-month period ending in November, with rounding to the nearest million dollars. The Bureau will publish notice of the asset threshold each year by amending this comment. For calendar year 2018, the asset threshold is $2,112,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2017 has total assets of less than $2,112,000,000 on December 31, 2017, satisfies this criterion for purposes of any loan consummated in 2018 and for purposes of any loan consummated in 2019 for which the application was received before April 1, 2019. For historical purposes:

    1. For calendar year 2013, the asset threshold was $2,000,000,000. Creditors that had total assets of less than $2,000,000,000 on December 31, 2012, satisfied this criterion for purposes of the exemption during 2013.

    2. For calendar year 2014, the asset threshold was $2,028,000,000. Creditors that had total assets of less than $2,028,000,000 on December 31, 2013, satisfied this criterion for purposes of the exemption during 2014.

    3. For calendar year 2015, the asset threshold was $2,060,000,000. Creditors that had total assets of less than $2,060,000,000 on December 31, 2014, satisfied this criterion for purposes of any loan consummated in 2015 and, if the creditor's assets together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2014 were less than that amount, for purposes of any loan consummated in 2016 for which the application was received before April 1, 2016.

    4. For calendar year 2016, the asset threshold was $2,052,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2015 had total assets of less than $2,052,000,000 on December 31, 2015, satisfied this criterion for purposes of any loan consummated in 2016 and for purposes of any loan consummated in 2017 for which the application was received before April 1, 2017.

    5. For calendar year 2017, the asset threshold was $2,069,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2016 had total assets of less than $2,069,000,000 on December 31, 2016, satisfied this criterion for purposes of any loan consummated in 2017 and for purposes of any loan consummated in 2018 for which the application was received before April 1, 2018.

    iv. The creditor and its affiliates do not maintain an escrow account for any mortgage transaction being serviced by the creditor or its affiliate at the time the transaction is consummated, except as provided in § 1026.35(b)(2)(iii)(D)(1) and (2). Thus, the exemption applies, provided the other conditions of § 1026.35(b)(2)(iii) are satisfied, even if the creditor previously maintained escrow accounts for mortgage loans, provided it no longer maintains any such accounts except as provided in § 1026.35(b)(2)(iii)(D)(1) and (2). Once a creditor or its affiliate begins escrowing for loans currently serviced other than those addressed in § 1026.35(b)(2)(iii)(D)(1) and (2), however, the creditor and its affiliate become ineligible for the exemption in § 1026.35(b)(2)(iii) on higher-priced mortgage loans they make while such escrowing continues. Thus, as long as a creditor (or its affiliate) services and maintains escrow accounts for any mortgage loans, other than as provided in § 1026.35(b)(2)(iii)(D)(1) and (2), the creditor will not be eligible for the exemption for any higher-priced mortgage loan it may make. For purposes of § 1026.35(b)(2)(iii), a creditor or its affiliate “maintains” an escrow account only if it services a mortgage loan for which an escrow account has been established at least through the due date of the second periodic payment under the terms of the legal obligation.

    Dated: December 14, 2017. Mick Mulvaney, Acting Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-27897 Filed 12-21-17; 4:15 pm] BILLING CODE 4810-AM-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0750; Product Identifier 2017-NE-24-AD; Amendment 39-19137; AD 2017-26-06] RIN 2120-AA64 Airworthiness Directives; Rolls-Royce Corporation Turbofan Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Rolls-Royce Corporation (RRC) AE 3007A and AE 3007C model turbofan engines. This AD was prompted by an updated analysis that lowered the life limit of fan wheels installed on the affected engines. This AD requires removal of the affected fan wheel at new, lower life limits. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2018.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 31, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-02-05, Indianapolis, IN 46225; phone: 317-230-3774; email: [email protected]; internet: www.rolls-royce.com. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

    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-2017-0750; 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 final rule, 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:

    Kyri Zaroyiannis, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847-294-7836; fax: 847-294-7834; email: [email protected]

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain RRC AE 3007A and AE 3007C model turbofan engines. The NPRM published in the Federal Register on September 22, 2017 (82 FR 44357). The NPRM was prompted by an updated stress analysis that showed higher stress than previously calculated in the aft retainer flange scallop of the fan wheel, part number (P/N) 23061670. As a result, RRC reduced the published life of the affected fan wheel. The NPRM proposed to require removal of the affected fan wheel at new, lower life limits. We are issuing this AD to correct the unsafe condition on these products.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. The Air Line Pilots Association supported the NPRM.

    Conclusion

    We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed except for minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    We reviewed RRC Alert Service Bulletin (ASB) AE 3007A-A-72-424/ASB AE 3007C-A-72-327 (one document), Revision 1, dated April 20, 2017. The ASB provides updated life limits for the affected fan wheels. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 341 engines installed on airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on
  • U.S. operators
  • Replace fan wheel (P/N 23061670) at reduced life 0 work-hours x $85 per hour = $0 $12,357 (pro-rated cost of part) $12,357 $4,213,737
    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    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, and

    (4) Will not 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): 2017-26-06 Roll-Royce Corporation (Type Certificate previously held by Allison Engine Company): Amendment 39-19137; Docket No. FAA-2017-0750; Product Identifier 2017-NE-24-AD. (a) Effective Date

    This AD is effective January 30, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Rolls-Royce Corporation (RRC) AE 3007A, AE 3007A1, AE 3007A1/1, AE 3007A1/2, AE 3007A1/3, AE 3007A1P, AE 3007A1E, AE 3007A3, AE 3007C and 3007C1 turbofan engines with a fan wheel, part number (P/N) 23061670, installed.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine/turboprop Engine, Turbine Section.

    (e) Unsafe Condition

    This AD was prompted by an updated analysis that lowered the life limit of fan wheels installed on the affected engines. We are issuing this AD to prevent failure of the fan wheel. The unsafe condition, if not corrected, could result in failure of the fan wheel, uncontained release of the fan wheel, damage to the engine, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    (1) For all AE 3007A, AE 3007A1, AE 3007A1/1, AE 3007A1/2, AE 3007A1/3, AE 3007A1P, AE 3007A1E, AE 3007A3, AE 3007C and 3007C1 engines with an installed fan wheel, P/N 23061670, after the effective date of this AD, remove the affected fan wheel before exceeding the new life limits identified in Planning Information, paragraph 1.F., of RRC Alert Service Bulletin (ASB) AE 3007A-A-72-424/ASB AE 3007C-A-72-327 (one document), Revision 1, dated April 20, 2017.

    (2) After the effective date of this AD, do not return to service any engine with a fan wheel, P/N 23061670, with a fan wheel life that exceeds the new life limits identified in Planning Information, paragraph 1.C., of RRC ASB AE 3007A-A-72-424/ASB AE 3007C-A-72-327 (one document), Revision 1, dated April 20, 2017.

    (h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the Chicago ACO Branch, send it to the attention of the person identified in paragraph (i) of this AD.

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (i) Related Information

    For more information about this AD, contact Kyri Zaroyiannis, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E. Devon Ave. Des Plaines, IL 60018; phone: 847-294-7836; fax: 847-294-7834; email: [email protected]

    (j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

    (i) Rolls-Royce Corporation (RRC) Alert Service Bulletin AE 3007A-A-72-424/ASB AE 3007C-A-72-327 (one document), Revision 1, dated April 20, 2017.

    (ii) Reserved.

    (3) For RRC service information identified in this AD, contact Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-02-05, Indianapolis, IN 46225; phone: 317-230-3774; email: [email protected]; internet: www.rolls-royce.com.

    (4) You may view this service information at FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7125.

    (5) You may view this service information that is incorporated by reference 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/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on December 18, 2017. Robert J. Ganley, Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2017-27778 Filed 12-26-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 732, 734, 738, 740, 746, and 774 [170207157-7157-01] RIN 0694-AH31 Revisions, Clarifications, and Technical Corrections to the Export Administration Regulations AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Final rule; correcting amendments.

    SUMMARY:

    In this final rule, the Bureau of Industry and Security corrects certain provisions in the Export Administration Regulations (EAR) to provide accurate references and fix typographical errors, and amend several Export Control Classification Numbers (ECCNs) to enhance consistency with the other ECCNs on the Commerce Control List (CCL). The corrections are editorial in nature and do not affect license requirements.

    DATES:

    This rule is effective December 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ivan Mogensen, Office of Exporter Services, Bureau of Industry and Security, by telephone: (202) 482-2440 or email: [email protected]

    SUPPLEMENTARY INFORMATION: Overview

    This final rule updates six parts of the EAR to correct typographical errors, clarify inaccurate or unclear internal references, and correct inconsistencies in certain entries on the Commerce Control List (CCL).

    Part 732

    Section 732.4(b) discusses steps to be taken when reviewing license exceptions for exports and reexports. In § 732.4(b)(7)(ii), there is a reference to § 740.20(g) listing ECCNs that may be eligible for subsequent export or reexport under license exception STA, following submission of a license application. However, only ECCN 9A610.a is listed in § 732.4(b)(7)(ii), while ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, “spacecraft” in ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4, 9A515.g, and 9E515.b, .d, .e, and .f (which also now appear in § 740.20(g)), are inadvertently omitted. This correction adds the omitted items listed in § 740.20(g) to § 732.4(b)(7)(ii). Additionally, because these items include both commodities and technology, the term “aircraft” in the reference to 9A610.a is replaced with “item.”

    This rule also clarifies and corrects the Export Control Decision Tree diagram in supplement No. 1 to part 732 that was last revised in a final rule published February 6, 2004 (69 FR 5686 (Feb. 6, 2004)). Several of the decision “blocks” in the flowchart contain references that are unclear or incorrect. This rule provides clarity by changing references to the general prohibitions to citations of specific sections of the EAR, and correcting improper citations to ensure that the citations contained in all decision blocks coincide with the appropriate sections of the EAR. Specifically, the changes are as follows: In the block which begins “Is your item classified under an ECCN on the CCL,” a direct citation to § 736.2(b)(1) through (3) replaces a reference to General Prohibitions 1 through 3, which did not inform the reader where the prohibitions could be found in the EAR; in the block which begins “Is there an `X' in the box,” the EAR citations now directly follow references to the Commerce Country Chart and the CCL, respectively; and, in the block which begins “Use License Exception,” the citation to § 740.1, which is an introduction, is replaced with a reference to the whole of part 740. Additionally, several grammatical errors are addressed, and the section symbol (“§ ”) is added wherever a section of the EAR is referenced in the decision blocks for clarity. Finally, this final rule changes the supplement's name from “Decision Tree” to “Export Control Decision Tree” to match the title of the diagram, and the duplicative parenthetical in the graphic title reading “(Supp. No. 1 to Part 732)” is deleted.

    Part 734

    Section 734.18 was created in the rule Revisions to Definitions in the Export Administration Regulations (81 FR 35586 (June 3, 2016)) and discusses activities that are not exports, reexports, or transfers. The note following the end of § 734.18(a)(5)(iv) discusses data in transit via the internet, but the note is incorrectly described as the note to paragraph (a)(4)(iv). This rule changes the note to refer to § 734.18(a)(5)(iv).

    Part 738

    In § 738.2(d)(1), Composition of an entry, there is a description of the meaning attached to each alphanumeric character making up an Export Control Classification Number. This paragraph currently explains that the second “digit” in an ECCN indicates the “Reason for Control.” However, in paragraph (d)(1)(i) of this section, the paragraph refers to the Reason for Control as the third “digit.” This final rule amends § 738.2(d)(1)(i) to replace the word “digit” with “alphanumeric character” in order to maintain consistency and prevent confusion.

    Additionally, in § 738.2, this final rule makes a correction in § 738.2(d)(2)(iv)(C)(2). The text of this paragraph uses ECCN 2B992 as an example when providing an overview of how to read an ECCN heading on the Commerce Control List (CCL). However, in the latter part of the section, the text erroneously references ECCN 2B999 instead of 2B992. This rule replaces the reference to ECCN 2B999 with 2B992 in this section to correct the ECCN reference.

    Part 740

    Section 740.20(g)(1) lists 9x515 and “600 series” ECCNs that are eligible for license exception Strategic Trade Authorization. This includes ECCNs 9A515.a.1, .a.2, .a.3, .a.4, and .g, 9A610.a, and technology ECCNs 9E515.b, .d, .e, and .f. In the final rule Revisions to the Export Administration Regulations (EAR): Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control under the United States Munitions List (USML) (82 FR 2875 (Jan. 10, 2017)), the phrase “that provide space-based logistics, assembly or servicing of any spacecraft (e.g., refueling)” following the list of ECCN 9A515 items paragraphs was intended to be removed since it is only applicable to 9A515.a.4 and not to the other ECCNs. Since the phrase was not removed, this rule removes the phrase to prevent confusion by users.

    Part 746

    This rule amends § 746.9(a) by removing an outdated reference to § 734.2(b) for the definitions of “deemed export” and “deemed reexport,” as that section is currently reserved, and replacing it with references to §§ 734.13(b) and 734.14(b), because the relevant definitions for deemed “export” and deemed “reexport” has been found in those two sections of the EAR since the publication of the final rule Revisions to Definitions in the Export Administration Regulations (81 FR 35586). Additionally, consistent with the guidance in § 774.1(d), the double quotes around deemed export and deemed reexport in § 746.9 are removed as these terms do not appear in § 772.1.

    Part 774

    This rule makes corrections to six ECCNs in supplement No. 1 to part 774, “Commerce Control List,” by correcting misspellings and creating conforming changes. The corrections are as follows:

    ECCNs 0A606, 8A609, and 9A610: This final rule amends these ECCNs to correct the title of § 740.20(g) that is referenced in paragraph (1) in the Special Conditions for STA section of the ECCN entries. Currently, these sections refer to § 740.20(g) as License Exception STA eligibility requests for “600 series” end items, when the current title for this section is License Exception STA eligibility requests for 9x515 and “600 series” items. The title of § 740.20(g) was changed in the rule Revisions to the Export Administration Regulations (EAR): Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML); (79 FR 27417 (May 13, 2014)), but the change was not made to the corresponding ECCNs. This rule amends the title reference in these ECCNs to match the current title of § 740.20(g).

    ECCNs 0D606.a and 0E606.a: This final rule amends ECCN subparagraphs 0D606.a and 0E606.a to include references to ECCNs 0B606 and 0C606. The headings of both 0D606 and 0E606 refer to 0B606 and 0C606 but these references do not appear in Items paragraph .a of the List of Items Controlled section. This inconsistency has generated confusion as to whether 0D606.a software “specially designed” for the “development,” “production,” operation or maintenance of the items controlled under ECCNs 0B606 and 0C606 or 0E606.a technology required for the “development,” “production,” operation or maintenance of the items controlled under ECCNs 0B606 and 0C606 is controlled or not. This edit removes this confusion by clarifying that such software is controlled under ECCN 0D606.a and such technology is controlled under ECCN 0E606.a.

    ECCN 2B352: This final rule corrects ECCN 2B352 by revising, in the List of Items Controlled section, Items paragraphs g.1, i.1, i.2 and i.3 and the Technical Notes at the end of the Items paragraphs. The corrections are as follows: The word “dependant” is replaced with the American spelling of the word “dependent” in Items paragraph g.1; double quotes are added around the term “aircraft” in Items paragraphs i.1 and i.2, and in Technical Notes 1 and 3 because “aircraft” is a defined term in the EAR; double quotes are added around the term “laser” in Technical Notes 3.a and .b for the same reason; double quotes are replaced with single quotes around the term `VMD' in Items paragraphs i.1 and i.2 and the term is clarified in Technical Note 3; single quotes are added to the term `aerosol generating units' in Items paragraphs i.2 and i.3 and Technical Note 1.

    ECCN 8A609: This final rule revises Related Control paragraph (3) under the List of Items Controlled section in ECCN 8A609 to add a reference to Category VI of the International Traffic in Arms Regulations (ITAR). This is done to indicate that certain diesel engines and electric motors for both EAR surface vessels of war and ITAR surface vessels of war are controlled under ECCN 8A992.g. Additionally, double quotes are added around the term “subject to the EAR” because it is a defined term in the EAR.

    Export Administration Act

    Since August 21, 2001, the Export Administration Act of 1979, as amended, has been in lapse. However, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 15, 2017, 82 FR 39005 (August 16, 2017) has continued the EAR in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

    Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been designated not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

    2. This final rule does not contain information collections subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA). Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number.

    3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

    4. The Department of Commerce finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act otherwise requiring prior notice and the opportunity for public comment because they are unnecessary. The revisions made by this rule are administrative in nature and do not affect the privileges and obligations of the public. Additionally, it is important that the edits and clarifications are added as soon as possible to prevent improper interpretation of the EAR. The Department also finds that there is good cause under 5 U.S.C. 553(b)(A) to waive the provisions of the Administrative Procedure Act requiring notice and comment because these changes are limited to providing guidance on existing interpretations of current EAR provisions. Because these revisions are not substantive changes to the EAR, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable. No other law requires that a notice of proposed rulemaking and opportunity for public comment be given for this rule. The analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable because no general notice of proposed rulemaking was required for this rule by 5 U.S.C. 553, or by any other law. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

    List of Subjects 15 CFR Part 732

    Administrative practice and procedure, Exports, Reporting and recordkeeping requirements

    15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology

    15 CFR Part 738

    Exports

    15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.

    15 CFR Parts 746 and 774

    Exports, Reporting and recordkeeping requirements.

    Accordingly, parts 732, 734, 738, 740, 746, and 774 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows:

    PART 732—[AMENDED] 1. The authority citation for 15 CFR part 732 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

    2. Section 732.4 is amended by revising paragraph (b)(7)(ii) to read as follows:
    § 732.4 Steps regarding License Exceptions.

    (b) * * *

    (7) * * *

    (ii) If you are going to file a license application with BIS for the export, reexport, or in-country transfer for aircraft or military vessels controlled under ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, certain “spacecraft” controlled under ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4 or 9A515.g, ECCN 9A610.a, or technology under ECCNs 9E515.b, .d, .e, or .f, § 740.20(g) permits you to request in the application that subsequent exports of the type of aircraft, spacecraft, military vessels, or technology at issue be eligible for export under License Exception STA. The types of “items” controlled under ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, certain spacecraft controlled under ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4 or 9A515.g, ECCN 9A610.a, and technology ECCNs 9E515.b, .d, .e, or .f, that have been determined to be eligible for License Exception STA pursuant to § 740.20(g) are identified in the License Exceptions paragraphs of ECCNs 0A606, 8A609, 8A620, 9A610, 9A515, and 9E515. Supplement No. 2 to part 748, paragraph (w) (License Exception STA eligibility requests), contains the instructions for such applications.

    Note 1 to paragraph (b)(7)(ii):

    If you intend to use License Exception STA, return to paragraphs (a) and then (b) of this section to review the Steps regarding the use of license exceptions.

    3. Supplement No. 1 to part 732 is revised to read as follows: BILLING CODE 3510-33-P ER27DE17.004 BILLING CODE 3510-33-C PART 734—[AMENDED] 4. The authority citation for 15 CFR part 734 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

    § 734.18 [Amended]
    5. Section 734.18 is amended by redesignating the note to paragraph (a)(4)(iv) as note 1 to paragraph (a)(5)(iv). PART 738—[AMENDED] 6. The authority citation for 15 CFR part 738 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

    7. Section 738.2 is amended by revising paragraphs (d)(1)(i) and (d)(2)(iv)(C)(2) to read as follows:
    § 738.2 Commerce Control List (CCL) structure.

    (d) * * *

    (1) * * *

    (i) Since Reasons for Control are not mutually exclusive, numbers are assigned in order of precedence. As an example, if an item is controlled for both National Security and Missile Technology reasons, the entry's third alphanumeric character will be a “0”. If the item is controlled only for Missile Technology the third alphanumeric character will be “1”.

    (2) * * *

    (iv) * * *

    (C) * * *

    (2) “(See List of Items Controlled)” is in the middle of the ECCN heading. If the phrase “(see List of Items Controlled)” appears in the middle of the ECCN heading, then all portions of the heading that follow the phrase “(see List of Items Controlled)” will list items controlled in addition to the list in the “items” paragraph. An example of such a heading is ECCN 2B992 Non-“numerically controlled” machine tools for generating optical quality surfaces, (see List of Items Controlled) and “specially designed” “parts” and “components” therefor. Under the ECCN 2B992 example, the “items” paragraph must be reviewed to determine whether your item is contained within the first part of the heading (“non-`numerically controlled' machine tools for generating optical quality surfaces”) and classified under 2B992. The second part of the ECCN 2B992 heading (“and `specially designed' `parts' and `components' therefor”) contains the exclusive list described in the heading. ECCNs 1A006, 3B992, 4A001, 6A006 and 7A001 are other examples where the phrase “(see List of Items Controlled)” appears in the middle of the ECCN heading.

    PART 740—[AMENDED] 8. The authority citation for 15 CFR part 740 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

    9. Section 740.20 is amended by revising paragraph (g)(1) to read as follows:
    § 740.20 License Exception Strategic Trade Authorization (STA).

    (g) * * *

    (1) Applicability. Any person may request License Exception STA eligibility for end items described in ECCN 0A606.a, ECCN 8A609.a, ECCNs 8A620.a or .b, “spacecraft” in ECCNs 9A515.a.1, .a.2, .a.3, .a.4, or .g, 9A610.a, or technology ECCNs 9E515.b, .d, .e, or .f.

    PART 746—[AMENDED] 10. The authority citation for 15 CFR part 746 is revised to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017); Notice of May 9, 2017, 82 FR 21909 (May 10, 2017).

    9. Section 746.9 is amended by revising paragraph (a) to read as follows:
    § 746.9 Syria.

    (a) License requirements. A license is required for the export or reexport to Syria of all items subject to the EAR, except food and medicine classified as EAR99 (food and medicine are defined in part 772 of the EAR). A license is required for the deemed export and deemed reexport, as described in §§ 734.13(b) and 734.14(b) of the EAR, respectively, of any technology or source code on the Commerce Control List (CCL) to a Syrian foreign national. Deemed exports and deemed reexports to Syrian foreign nationals involving technology or source code subject to the EAR but not listed on the CCL do not require a license.

    PART 774—[AMENDED] 11. The authority citation for 15 CFR part 774 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017).

    12. In supplement No. 1 to part 774, Category 0, ECCN 0A606 is revised to read as follows: Supplement No. 1 to Part 774—The Commerce Control List 0A606 Ground vehicles and related commodities, as follows (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Control(s) Country Chart (See Supp. No. 1 to part 738) NS applies to entire entry, except 0A606.b and .y NS Column 1 NS applies to 0A606.b NS Column 2 RS applies to entire entry, except 0A606.b and .y RS Column 1 RS applies to 0A606.b RS Column 2 AT applies to entire entry AT Column 1 UN applies to entire entry, except 0A606.y See § 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions for STA STA: (1) Paragraph (c)(1) of License Exception STA (§ 740.20(c)(1) of the EAR) may not be used for any item in 0A606.a, unless determined by BIS to be eligible for License Exception STA in accordance with § 740.20(g) (License Exception STA eligibility requests for 9x515 and “600 series” items). (2) Paragraph (c)(2) of License Exception STA (§ 740.20(c)(2) of the EAR) may not be used for any item in 0A606. List of Items Controlled Related Controls: (1) The ground vehicles, other articles, technical data (including software) and services described in 22 CFR part 121, Category VII are subject to the jurisdiction of the International Traffic in Arms Regulations. (2) See ECCN 0A919 for foreign-made “military commodities” that incorporate more than a de minimis amount of U.S.-origin “600 series” controlled content. Related Definitions: N/A Items: a. Ground vehicles, whether manned or unmanned, “specially designed” for a military use and not enumerated or otherwise described in USML Category VII. Note 1 to paragraph .a:

    For purposes of paragraph .a, “ground vehicles” include (i) tanks and armored vehicles manufactured prior to 1956 that have not been modified since 1955 and that do not contain a functional weapon or a weapon capable of becoming functional through repair; (ii) military railway trains except those that are armed or are “specially designed” to launch missiles; (iii) unarmored military recovery and other support vehicles; (iv) unarmored, unarmed vehicles with mounts or hard points for firearms of .50 caliber or less; and (v) trailers “specially designed” for use with other ground vehicles enumerated in USML Category VII or ECCN 0A606.a, and not separately enumerated or otherwise described in USML Category VII. For purposes of this note, the term “modified” does not include incorporation of safety features required by law, cosmetic changes (e.g., different paint or repositioning of bolt holes) or addition of “parts” or “components” available prior to 1956.

    Note 2 to paragraph .a:

    A ground vehicle's being “specially designed” for military use for purposes of determining controls under paragraph .a. entails a structural, electrical or mechanical feature involving one or more “components” that are “specially designed” for military use. Such “components” include:

    a. Pneumatic tire casings of a kind “specially designed” to be bullet-proof;

    b. Armored protection of vital “parts” (e.g., fuel tanks or vehicle cabs);

    c. Special reinforcements or mountings for weapons;

    d. Black-out lighting.

    b. Other ground vehicles, “parts” and “components,” as follows:

    b.1. Unarmed vehicles that are derived from civilian vehicles and that have all of the following:

    b.1.a. Manufactured or fitted with materials or “components” other than reactive or electromagnetic armor to provide ballistic protection to level III (National Institute of Justice standard 0108.01, September 1985) or better;

    b.1.b. A transmission to provide drive to both front and rear wheels simultaneously, including those vehicles having additional wheels for load bearing purposes whether driven or not;

    b.1.c. Gross vehicle weight rating (GVWR) greater than 4,500 kg; and

    b.1.d. Designed or modified for off-road use.

    b.2. “Parts” and “components” having all of the following:

    b.2.a. “Specially designed” for vehicles specified in paragraph .b.1 of this entry; and

    b.2.b. Providing ballistic protection to level III (National Institute of Justice standard 0108.01, September 1985) or better.

    Note 1 to paragraph b:

    Ground vehicles otherwise controlled by 0A606.b.1 that contain reactive or electromagnetic armor are subject to the controls of USML Category VII.

    Note 2 to paragraph b:

    ECCN 0A606.b.1 does not control civilian vehicles “specially designed” for transporting money or valuables.

    Note 3 to paragraph b:

    “Unarmed” means not having installed weapons, installed mountings for weapons, or special reinforcements for mounts for weapons.

    c. Air-cooled diesel engines and engine blocks for armored vehicles that weigh more than 40 tons.

    d. Fully automatic continuously variable transmissions for tracked combat vehicles.

    e. Deep water fording kits “specially designed” for ground vehicles controlled by ECCN 0A606.a or USML Category VII.

    f. Self-launching bridge “components” not enumerated in USML Category VII(g) “specially designed” for deployment by ground vehicles enumerated in USML Category VII or this ECCN.

    g. through w. [RESERVED]

    x. “Parts,” “components,” “accessories,” and “attachments” that are “specially designed” for a commodity enumerated or otherwise described in ECCN 0A606 (other than 0A606.b or 0A606.y) or a defense article enumerated in USML Category VII and not elsewhere specified on the USML or in 0A606.y.

    Note 1:

    Forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacture where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by ECCN 0A606.x are controlled by ECCN 0A606.x.

    Note 2:

    “Parts,” “components,” “accessories” and “attachments” enumerated in USML paragraph VII(g) are subject to the controls of that paragraph. “Parts,” “components,” “accessories” and “attachments” described in ECCN 0A606.y are subject to the controls of that paragraph.

    y. Specific “parts,” “components,” “accessories,” and “attachments” “specially designed” for a commodity enumerated or otherwise described in this ECCN (other than ECCN 0A606.b) or for a defense article in USML Category VII and not elsewhere specified on the USML or the CCL, as follows, and “parts,” “components,” “accessories,” and “attachments” “specially designed” therefor:

    y.1. Brake discs, rotors, drums, calipers, cylinders, pads, shoes, lines, hoses, vacuum boosters, and parts therefor;

    y.2. Alternators and generators;

    y.3. Axles;

    y.4. Batteries;

    y.5. Bearings (e.g., ball, roller, wheel);

    y.6. Cables, cable assembles, and connectors;

    y.7. Cooling system hoses;

    y.8. Hydraulic, fuel, oil, and air filters, other than those controlled by ECCN 1A004;

    y.9. Gaskets and o-rings;

    y.10. Hydraulic system hoses, fittings, couplings, adapters, and valves;

    y.11. Latches and hinges;

    y.12. Lighting systems, fuses, and “components;”

    y.13. Pneumatic hoses, fittings, adapters, couplings, and valves;

    y.14. Seats, seat assemblies, seat supports, and harnesses;

    y.15. Tires, except run flat; and

    y.16. Windows, except those for armored vehicles.

    13. In supplement No. 1 to part 774, Category 0, ECCN 0D606 is revised to read as follows: 0D606 “Software” “specially designed” for the “development,” “production,” operation, or maintenance of ground vehicles and related commodities controlled by 0A606, 0B606, or 0C606 (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Control(s) Country Chart (See Supp. No. 1 to part 738) NS applies to entire entry NS Column 1 RS applies to entire entry RS Column 1 AT applies to entire entry AT Column 1 UN applies to entire entry See § 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) CIV: N/A TSR: N/A Special Conditions for STA STA: Paragraph (c)(2) of License Exception STA (§ 740.20(c)(2) of the EAR) may not be used for any “software” in 0D614. List of Items Controlled Related Controls: (1) “Software” directly related to articles enumerated in USML Category IX is subject to the control of USML paragraph IX(e). (2) See ECCN 0A919 for foreign made “military commodities” that incorporate more than a de minimis amount of US-origin “600 series” items. Related Definitions: N/A Items:

    a. “Software” “specially designed” for the “development,” “production,” operation, or maintenance of commodities controlled by ECCNs 0A606 (except for ECCNs 0A606.b or 0A606.y), 0B606, or 0C606.

    b. [RESERVED]

    14. In supplement No. 1 to part 774, Category 0, ECCN 0E606 is revised to read as follows: 0E606 “Technology” “required” for the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of ground vehicles and related commodities in 0A606, 0B606, 0C606, or software in 0D606 (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Control(s) Country Chart (See Supp. No. 1 to part 738) NS applies to entire entry NS Column 1 RS applies to entire entry RS Column 1 AT applies to entire entry AT Column 1 UN applies to entire entry See § 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) CIV: N/A TSR: N/A Special Conditions for STA STA: Paragraph (c)(2) of License Exception STA (§ 740.20(c)(2) of the EAR) may not be used for any technology in 0E614. List of Items Controlled Related Controls: “Technical data” directly related to articles enumerated in USML Category IX is subject to the control of USML paragraph IX(e). Related Definitions: N/A Items:

    a. “Technology” “required” for the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of commodities enumerated or otherwise described in ECCN 0A606 (except for ECCNs 0A606.b or 0A606.y), 0B606, or 0C606.

    b. [RESERVED]

    15. In supplement No. 1 to part 774, Category 2, ECCN 2B352 is revised to read as follows: 2B352 Equipment capable of use in handling biological materials, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT Control(s) Country Chart (See Supp. No. 1 to part 738). CB applies to entire entry CB Column 2 AT applies to entire entry AT Column 1 List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: N/A GBS: N/A CIV: N/A List of Items Controlled Related Controls: See ECCNs 1A004 and 1A995 for protective equipment that is not covered by this entry. Also see ECCN 9A120 for controls on certain “UAV” systems designed or modified to dispense an aerosol and capable of carrying elements of a payload in the form of a particulate or liquid, other than fuel “parts” or “components” of such vehicles, of a volume greater than 20 liters. Related Definitions: (1) “Lighter than air vehicles”—balloons and airships that rely on hot air or on lighter-than-air gases, such as helium or hydrogen, for their lift. (2) “UAVs”—Unmanned Aerial Vehicles. (3) “VMD”—Volume Median Diameter. Items:

    a. Containment facilities and related equipment, as follows:

    a.1. Complete containment facilities at P3 or P4 containment level.

    Technical Note:

    P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004).

    a.2. Equipment designed for fixed installation in containment facilities specified in paragraph a.1 of this ECCN, as follows:

    a.2.a. Double-door pass-through decontamination autoclaves;

    a.2.b. Breathing air suit decontamination showers;

    a.2.c. Mechanical-seal or inflatable-seal walkthrough doors.

    b. Fermenters and components as follows:

    b.1. Fermenters capable of cultivation of micro-organisms or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a capacity of 20 liters or greater.

    b.2. Components designed for such fermenters, as follows:

    b.2.a. Cultivation chambers designed to be sterilized or disinfected in situ;

    b.2.b. Cultivation chamber holding devices; or

    b.2.c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control).

    Technical Note:

    Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous-flow systems.

    c. Centrifugal separators capable of the continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all of the following characteristics:

    c.1. One or more sealing joints within the steam containment area;

    c.2. A flow rate greater than 100 liters per hour;

    c.3. “Parts” or “components” of polished stainless steel or titanium; and

    c.4. Capable of in-situ steam sterilization in a closed state.

    Technical Note: Centrifugal separators include decanters.

    d. Cross (tangential) flow filtration equipment and “accessories,” as follows:

    d.1. Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all of the following characteristics:

    d.1.a. A total filtration area equal to or greater than 1 square meter (1 m2); and

    d.1.b. Having any of the following characteristics:

    d.1.b.1. Capable of being sterilized or disinfected in-situ; or

    d.1.b.2. Using disposable or single-use filtration “parts” or “components”.

    N.B.: 2B352.d.1 does not control reverse osmosis and hemodialysis equipment, as specified by the manufacturer.

    d.2. Cross (tangential) flow filtration “parts” or “components” (e.g., modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square meters (0.2 m2) for each component and designed for use in cross (tangential) flow filtration equipment controlled by 2B352.d.1.

    TECHNICAL NOTE:

    In this ECCN, “sterilized” denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g., steam) or chemical agents. “Disinfected” denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. “Disinfection” and “sterilization” are distinct from “sanitization”, the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability.

    e. Steam, gas or vapor sterilizable freeze-drying equipment with a condenser capacity of 10 kg of ice or greater in 24 hours (10 liters of water or greater in 24 hours) and less than 1000 kg of ice in 24 hours (less than 1,000 liters of water in 24 hours).

    f. Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics:

    f.1. A water evaporation capacity of ≥ 0.4 kg/h and ≤ 400 kg/h;

    f.2. The ability to generate a typical mean product particle size of ≤ 10 micrometers with existing fittings or by minimal modification of the spray-dryer with atomization nozzles enabling generation of the required particle size; and

    f.3. Capable of being sterilized or disinfected in situ.

    g. Protective and containment equipment, as follows:

    g.1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure;

    Technical Note: This entry does not control suits designed to be worn with self-contained breathing apparatus.

    g.2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:

    g.2.a. Fully enclosed workspace where the operator is separated from the work by a physical barrier;

    g.2.b. Able to operate at negative pressure;

    g.2.c. Means to safely manipulate items in the workspace; and

    g.2.d. Supply and exhaust air to and from the workspace is high-efficiency particulate air (HEPA) filtered.

    Note 1 to 2B352.g.2:

    2B352.g.2 controls class III biosafety cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004) or constructed in accordance with national standards, regulations or guidance.

    Note 2 to 2B352.g.2:

    2B352.g.2 does not control isolators “specially designed” for barrier nursing or transportation of infected patients.

    h. Aerosol inhalation equipment designed for aerosol challenge testing with microorganisms, viruses or toxins, as follows:

    h.1. Whole-body exposure chambers having a capacity of 1 cubic meter or greater.

    h.2. Nose-only exposure apparatus utilizing directed aerosol flow and having a capacity for the exposure of 12 or more rodents, or two or more animals other than rodents, and closed animal restraint tubes designed for use with such apparatus.

    i. Spraying or fogging systems and “parts” and “components” therefor, as follows:

    i.1. Complete spraying or fogging systems, “specially designed” or modified for fitting to “aircraft,” “lighter than air vehicles,” or “UAVs,” capable of delivering, from a liquid suspension, an initial droplet `VMD' of less than 50 microns at a flow rate of greater than 2 liters per minute;

    i.2. Spray booms or arrays of `aerosol generating units', “specially designed” or modified for fitting to “aircraft,” “lighter than air vehicles,” or “UAVs,” capable of delivering, from a liquid suspension, an initial droplet `VMD' of less than 50 microns at a flow rate of greater than 2 liters per minute;

    i.3. `Aerosol generating units' “specially designed” for fitting to the systems specified in paragraphs i.1 or i.2 of this ECCN.

    Technical Notes:

    1. `Aerosol generating units' are devices “specially designed” or modified for fitting to “aircraft” and include nozzles, rotary drum atomizers and similar devices.

    2. This ECCN does not control spraying or fogging systems, “parts” and “components,” as specified in 2B352.i, that are demonstrated not to be capable of delivering biological agents in the form of infectious aerosols.

    3. Volume Median Diameter `VMD' for droplets produced by spray equipment or nozzles “specially designed” for use on “aircraft” or “UAVs” should be measured using either of the following methods (pending the adoption of internationally accepted standards):

    a. Doppler “laser” method,

    b. Forward “laser” diffraction method.

    16. In supplement No. 1 to part 774, Category 8, ECCN 8A609 is revised to read as follows: 8A609 Surface vessels of war and related commodities (see List of Items Controlled) License Requirements Reason for Control: NS, RS, AT, UN Control(s) Country Chart (See Supp. No. 1 to part 738) NS applies to entire entry, except 8A609.y NS Column 1 RS applies to entire entry, except 8A609.y RS Column 1 AT applies to entire entry AT Column 1 UN applies to entire entry, except 8A609.y See § 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions for STA STA: (1) Paragraph (c)(1) of License Exception STA (§ 740.20(c)(1) of the EAR) may not be used for any item in 8A609.a, unless determined by BIS to be eligible for License Exception STA in accordance with § 740.20(g) (License Exception STA eligibility requests for 9x515 and “600 series” items). List of Items Controlled Related Controls: (1) Surface vessels of war and special naval equipment, and technical data (including software), and services directly related thereto, described in 22 CFR part 121, Category VI, Surface Vessels of War and Special Naval Equipment, are subject to the jurisdiction of the International Traffic in Arms Regulations. (2) See ECCN 0A919 for foreign-made “military commodities” that incorporate more than a de minimis amount of U.S.-origin “600 series” controlled content. (3) For controls on diesel engines and electric motors that are “subject to the EAR” for surface vessels of war “subject to the EAR” or “subject to the ITAR,” see ECCN 8A992.g. For diesel engines and electric motors for surface vessels of war “subject to the ITAR,” see 22 CFR part 121, Category VI(c) for parts, components, accessories, and attachments, “specially designed” for developmental vessels funded by the Department of Defense via contract or other funding authorization. (4) For controls on military gas turbine engines and related items for vessels of war, see ECCN 9A619.

    Related Definitions: N/A

    Items:

    a. Surface vessels of war “specially designed” for a military use and not enumerated or otherwise described in the USML.

    Note 1:

    8A609.a includes: (i) Underway replenishment ships; (ii) surface vessel and submarine tender and repair ships, except vessels that are “specially designed” to support naval nuclear propulsion plants; (iii) non-submersible submarine rescue ships; (iv) other auxiliaries (e.g., AGDS, AGF, AGM, AGOR, AGOS, AH, AP, ARL, AVB, AVM, and AVT); (v) amphibious warfare craft, except those that are armed; and (vi) unarmored and unarmed coastal, patrol, roadstead, and Coast Guard and other patrol craft with mounts or hard points for firearms of .50 caliber or less.

    Note 2:

    For purposes of paragraph .a, surface vessels of war includes vessels “specially designed” for military use that are not identified in paragraph (a) of ITAR § 121.15, including any demilitarized vessels, regardless of origin or designation, manufactured prior to 1950 and that have not been modified since 1949. For purposes of this note, the term modified does not include incorporation of safety features required by law, cosmetic changes (e.g., different paint), or the addition of “parts” or “components” available prior to 1950.

    b. Non-magnetic diesel engines with a power output of 50 hp or more and either of the following:

    b.1. Non-magnetic content exceeding 25% of total weight; or

    b.2. Non-magnetic parts other than crankcase, block, head, pistons, covers, end plates, valve facings, gaskets, and fuel, lubrication and other supply lines.

    c. through w. [RESERVED]

    x. “Parts,” “components,” “accessories” and “attachments” that are “specially designed” for a commodity enumerated or otherwise described in ECCN 8A609 (except for 8A609.y) or a defense article enumerated or otherwise described in USML Category VI and not specified elsewhere on the USML, in 8A609.y or 3A611.y.

    Note 1:

    Forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacturing where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by ECCN 8A609.x are controlled by ECCN 8A609.x.

    Note 2:

    “Parts,” “components,” “accessories” and “attachments” specified in USML subcategory VI(f) are subject to the controls of that paragraph. “Parts,” “components,” “accessories,” and “attachments” specified in ECCN 8A609.y are subject to the controls of that paragraph.

    y. Specific “parts,” “components,” “accessories” and “attachments” “specially designed” for a commodity subject to control in this ECCN or for a defense article in USML Category VI and not elsewhere specified in the USML, as follows, and “parts,” “components,” “accessories,” and “attachments” “specially designed” therefor:

    y.1. Public address (PA) systems;

    y.2. Filters and filter assemblies, hoses, lines, fittings, couplings, and brackets for pneumatic, hydraulic, oil and fuel systems;

    y.3. Galleys;

    y.4. Lavatories;

    y.5. Magnetic compass, magnetic azimuth detector;

    y.6. Medical facilities;

    y.7. Potable water tanks, filters, valves, hoses, lines, fittings, couplings, and brackets;

    y.8. Panel knobs, indicators, switches, buttons, and dials whether unfiltered or filtered for use with night vision imaging systems;

    y.9. Emergency lighting;

    y.10. Gauges and indicators;

    y.11. Audio selector panels.

    17. In supplement No. 1 to part 774, Category 9, ECCN 9A610 is revised to read as follows. 9A610 Military aircraft and related commodities, other than those enumerated in 9A991.a (see List of Items Controlled) License Requirements Reason for Control: NS, RS, MT, AT, UN Control(s) Country Chart (See Supp. No. 1 to part 738) NS applies to entire entry except:
  • 9A610.b; parts and components controlled in 9A610.x if being exported or reexported for use in an aircraft controlled in 9A610.b; and 9A610.y
  • NS Column 1
    RS applies to entire entry except:
  • 9A610.b; parts and components controlled in 9A610.x if being exported or reexported for use in an aircraft controlled in 9A610.b; and 9A610.y
  • RS Column 1
    MT applies to 9A610.t, .u, .v, and .w MT Column 1 AT applies to entire entry AT Column 1 UN applies to entire entry except 9A610.y See § 746.1(b) for UN controls
    List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions For STA STA: (1) Paragraph (c)(1) of License Exception STA (§ 740.20(c)(1) of the EAR) may not be used for any item in 9A610.a (i.e., “end item” military aircraft), unless determined by BIS to be eligible for License Exception STA in accordance with § 740.20(g) (License Exception STA eligibility requests for 9x515 and “600 series” items). (2) Paragraph (c)(2) of License Exception STA (§ 740.20(c)(2) of the EAR) may not be used for any item in 9A610. List of Items Controlled Related Controls: (1) Military aircraft and related articles that are enumerated in USML Category VIII, and technical data (including software) directly related thereto, are subject to the ITAR. (2) See ECCN 0A919 for controls on foreign-made “military commodities” that incorporate more than a de minimis amount of U.S.-origin “600 series” controlled content. (3) See USML Category XIX and ECCN 9A619 for controls on military aircraft gas turbine engines and related items. Related Definitions: In paragraph .y of this entry, the term `fluid' includes liquids and gases. Items:

    a. `Military Aircraft' “specially designed” for a military use that are not enumerated in USML paragraph VIII(a).

    Note 1:

    For purposes of paragraph .a the term `military aircraft' means the LM-100J aircraft and any aircraft “specially designed” for a military use that are not enumerated in USML paragraph VIII(a). The term includes: Trainer aircraft; cargo aircraft; utility fixed wing aircraft; military helicopters; observation aircraft; military non-expansive balloons and other lighter than air aircraft; and unarmed military aircraft, regardless of origin or designation. Aircraft with modifications made to incorporate safety of flight features or other FAA or NTSB modifications such as transponders and air data recorders are “unmodified” for the purposes of this paragraph .a.

    Note 2:

    9A610.a does not control `military aircraft' that:

    a. Were first manufactured before 1946;

    b. Do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and

    c. Do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation.

    b. L-100 aircraft manufactured prior to 2013.

    c.-d. [Reserved]

    e. Mobile aircraft arresting and engagement runway systems for aircraft controlled by either USML Category VIII(a) or ECCN 9A610.a.

    f. Pressure refueling equipment and equipment that facilitates operations in confined areas, “specially designed” for aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a.

    g. Aircrew life support equipment, aircrew safety equipment and other devices for emergency escape from aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a.

    h. Parachutes, paragliders, complete parachute canopies, harnesses, platforms, electronic release mechanisms, “specially designed” for use with aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and “equipment” “specially designed” for military high altitude parachutists, such as suits, special helmets, breathing systems, and navigation equipment.

    i. Controlled opening equipment or automatic piloting systems, designed for parachuted loads.

    j. Ground effect machines (GEMS), including surface effect machines and air cushion vehicles, “specially designed” for use by a military.

    k. through s. [Reserved]

    t. Composite structures, laminates, and manufactures thereof “specially designed” for unmanned aerial vehicles controlled under USML Category VIII(a) with a range equal to or greater than 300 km.

    Note to paragraph .t:

    Composite structures, laminates, and manufactures thereof “specially designed” for unmanned aerial vehicles controlled under USML Category VIII(a) with a maximum range less than 300 km are controlled in paragraph .x of this entry.

    u. Apparatus and devices “specially designed” for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and capable of a range equal to or greater than 300 km.

    Note to paragraph .u:

    Apparatus and devices “specially designed” for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a with a maximum range less than 300 km are controlled in paragraph .x of this entry.

    v. Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.

    Note to paragraph .v:

    Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a. that are not capable of delivering at least 500 kilograms payload to a range of at least 300 km are controlled in paragraph .x of this entry.

    w. Pneumatic hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.

    Note to paragraph .w:

    Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., not capable of delivering at least 500 kilograms payload to a range of at least 300 km are controlled in paragraph .x of this entry.

    x. “Parts,” “components,” “accessories,” and “attachments” that are “specially designed” for a commodity enumerated or otherwise described in ECCN 9A610 (except for 9A610.y) or a defense article enumerated or otherwise described in USML Category VIII and not elsewhere specified on the USML or in 9A610.y, 9A619.y, or 3A611.y.

    y. Specific “parts,” “components,” “accessories,” and “attachments” “specially designed” for a commodity subject to control in this entry, ECCN 9A619, or for a defense article in USML Categories VIII or XIX and not elsewhere specified in the USML or the CCL, and other aircraft commodities “specially designed” for a military use, as follows, and “parts,” “components,” “accessories,” and “attachments” “specially designed” therefor:

    y.1. Aircraft tires;

    y.2. Analog gauges and indicators;

    y.3. Audio selector panels;

    y.4. Check valves for hydraulic and pneumatic systems;

    y.5. Crew rest equipment;

    y.6. Ejection seat mounted survival aids;

    y.7. Energy dissipating pads for cargo (for pads made from paper or cardboard);

    y.8. Fluid filters and filter assemblies;

    y.9. Galleys;

    y.10. Fluid hoses, straight and unbent lines (for a commodity subject to control in this entry or defense article in USML Category VIII), and fittings, couplings, clamps (for a commodity subject to control in this entry or defense article in USML Category VIII) and brackets therefor;

    y.11. Lavatories;

    y.12. Life rafts;

    y.13. Magnetic compass, magnetic azimuth detector;

    y.14. Medical litter provisions;

    y.15. Cockpit or cabin mirrors;

    y.16. Passenger seats including palletized seats;

    y.17. Potable water storage systems;

    y.18. Public address (PA) systems;

    y.19. Steel brake wear pads (does not include sintered mix or carbon/carbon materials);

    y.20. Underwater locator beacons;

    y.21. Urine collection bags/pads/cups/pumps;

    y.22. Windshield washer and wiper systems;

    y.23. Filtered and unfiltered panel knobs, indicators, switches, buttons, and dials;

    y.24. Lead-acid and Nickel-Cadmium batteries;

    y.25. Propellers, propeller systems, and propeller blades used with reciprocating engines;

    y.26. Fire extinguishers;

    y.27. Flame and smoke/CO2 detectors;

    y.28. Map cases;

    y.29. `Military Aircraft' that were first manufactured from 1946 to 1955 that do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation;

    y.30. “Parts,” “components,” “accessories,” and “attachments,” other than electronic items or navigation equipment, for use in or with a commodity controlled by ECCN 9A610.h;

    y.31. Identification plates and nameplates; and

    y.32. Fluid manifolds.

    Dated: December 18, 2017. Richard E. Ashooh, Assistant Secretary for Export Administration.
    [FR Doc. 2017-27616 Filed 12-26-17; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-6593] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective December 27, 2017. The classification was applicable on November 19, 2013.

    FOR FURTHER INFORMATION CONTACT:

    Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Upon request, FDA has classified the reagents for molecular diagnostic instrument test systems as class I (general controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On October 4, 2013, Illumina, Inc., submitted a request for De Novo classification of the MiSeqDx Universal Kit 1.0. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class I if general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review of the information submitted in the request, we determined that the device can be classified into class I. FDA has determined that general controls will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on November 19, 2013, FDA issued an order to the requestor classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 862.3800. We have named the generic type of device reagents for molecular diagnostic instrument test systems, and it is identified as reagents other than analyte specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together, and labeled nucleic acid molecules.

    FDA has identified the following risks to health associated specifically with this type of device in table 1.

    Table 1—Reagents for Molecular Diagnostic Instrument Test Systems Risks and Mitigation Measures Identified risks Mitigation measures Inaccurate test results due to inconsistently manufactured test system reagents General controls, including current good manufacturing practices.

    Section 510(l)(1) of the FD&C Act provides that a device within a type that has been classified into class I under section 513 of the FD&C Act is exempt from premarket notification under section 510(k), unless the device is of substantial importance in preventing impairment of human health or presents a potentially unreasonable risk of illness or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt from the premarket notification requirements under section 510(k), subject to the limitations of exemptions in 21 CFR 862.9.

    III. Analysis of Environmental Impact

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

    IV. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 820, regarding current good manufacturing practices, have been approved under OMB control number 0910-0073.

    List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

    PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 continues to read as follows: Authority:

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

    2. Add § 862.3800 to subpart D to read as follows:
    § 862.3800 Reagents for molecular diagnostic instrument test systems.

    (a) Identification. Reagents for molecular diagnostic test systems are reagents other than analyte specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together, and labeled nucleic acid molecules.

    (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedure in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27853 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. FDA-2017-N-6643] Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective December 27, 2017. The classification was applicable on June 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Upon request, FDA has classified the flow cytometric test system for hematopoietic neoplasms as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On October 3, 2016, Beckman Coulter submitted a request for De Novo classification of the ClearLLab Reagents (T1, T2, B1, B2, M). FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on June 29, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 864.7010. We have named the generic type of device flow cytometric test system for hematopoietic neoplasms, and it is identified as a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

    Table 1—Flow Cytometric Test for Hematopoietic Neoplasms Risks and Mitigation Measures Identified risks Mitigation measures/21 CFR section Incorrect test results (false negatives or false positives) General Controls and Special Controls (1) and (2) (21 CFR 864.7010(b)(1) and (2)). Incorrect interpretation of device results by the end user General Controls and Special Controls (1), (2), and (3) (21 CFR 864.7010(b)(1), (2), and (3)). Patient harm from specimen(s) collection General Controls and Special Control (1) (21 CFR 864.7010(b)(1)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    III. Analysis of Environmental Impact

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

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows:

    PART 864—HEMATOLOGY AND PATHOLOGY DEVICES 1. The authority citation for part 864 is revised to read as follows: Authority:

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

    2. Add § 864.7010 to subpart H to read as follows:
    § 864.7010 Flow cytometric test system for hematopoietic neoplasms.

    (a) Identification. A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

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

    (1) Premarket notification submissions must include the following information:

    (i) The indications for use must indicate the clinical hematopoietic neoplasms for which the assay was designed and validated, for example, chronic leukemia or lymphoma.

    (ii) A detailed device description including the following:

    (A) A detailed description of all test components, all required reagents, and all instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods.

    (B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software.

    (C) A detailed description of methodology and assay procedure.

    (D) A description of appropriate internal and external quality control materials that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure, if applicable.

    (E) Detailed specifications for sample collection, processing, and storage.

    (F) Detailed specification of the criteria for test results interpretation and reporting including pre-established templates.

    (G) If applicable, based on the output of the results, a description of the specific number of events to collect, result outputs, and analytical sensitivity of the assay that will be reported.

    (iii) Information that demonstrates the performance characteristics of the test, including:

    (A) Device performance data from either a method comparison study comparing the specific lymphocyte cell markers to a predicate device or data collected through a clinical study demonstrating clinical validity using well-characterized clinical specimens. Samples must be representative of the intended use population of the device including hematologic neoplasms and the specific sample types for which the test is indicated for use.

    (B) If applicable, device performance data from a clinical study demonstrating clinical validity for parameters not established in a predicate device of this generic type using well-characterized prospectively obtained clinical specimens including all hematologic neoplasms and the specific sample types for which the device is indicated for use.

    (C) Device precision data using clinical samples to evaluate the within-lot, between-lot, within-run, between run, site-to-site and total variation using a minimum of three sites, of which at least two sites must be external sites. Results shall be reported as the standard deviation and percentage coefficient of variation for each level tested.

    (D) Reproducibility data generated using a minimum of three lots of reagents to evaluate mean fluorescence intensity and variability of the recovery of the different markers and/or cell populations.

    (E) Data from specimen and reagent carryover testing performed using well-established methods (e.g., CLSI H26-A2).

    (F) Specimen and prepared sample stability data established for each specimen matrix in the anticoagulant combinations and storage/use conditions that will be indicated.

    (G) A study testing anticoagulant equivalency in all claimed specimen type/anticoagulant combinations using clinical specimens that are representative of the intended use population of the device.

    (H) Analytic sensitivity data using a dilution panel created from clinical samples.

    (I) Analytical specificity data, including interference and cross-contamination.

    (J) Device stability data, including real-time stability of reagents under various storage times and temperatures.

    (K) For devices that include polyclonal antibodies, Fluorescence Minus One (FMO) studies to evaluate non-specific binding for all polyclonal antibodies. Each FMO tube is compared to reagent reference to demonstrate that no additional population appears when one marker is absent. Pre-specified acceptance criteria must be provided and followed.

    (L) For devices indicated for use as a semi-quantitative test, linearity data using a dilution panel created from clinical samples.

    (M) For devices indicated for use as a semi-quantitative test, clinically relevant analytical sensitivity data, including limit of blank, limit of detection, and limit of quantification.

    (iv) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing the device.

    (2) The 21 CFR 809.10 compliant labeling must include the following:

    (i) The intended use statement in the 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include a statement that the results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. The intended use statement must also include information on what the device detects and measures, whether the device is qualitative, semi-quantitative, and/or quantitative, the clinical indications for which the device is to be used, and the specific population(s) for which the device is intended.

    (ii) A detailed description of the performance studies conducted to comply with paragraph (b)(1)(iii) of this section and a summary of the results.

    (3) As part of the risk management activities performed under 21 CFR 820.30 design controls, product labeling and instruction manuals must include clear examples of all expected phenotypic patterns and gating strategies using well-defined clinical samples representative of both abnormal and normal cellular populations. These samples must be selected based upon the indications described in paragraph (b)(1)(i) of this section.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27855 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-6642] Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for psychiatric disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective December 27, 2017. The classification was applicable on September 14, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Antkowiak, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2663, Silver Spring, MD 20993-0002, 240-402-3705, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the computerized behavioral therapy device for psychiatric disorders as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On May 16, 2016, Pear Therapeutics, Inc., submitted a request for De Novo classification of the reSET. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on September 14, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5801. We have named the generic type of device computerized behavioral therapy device for psychiatric disorders, and it is identified as a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

    Table 1—Computerized Behavioral Therapy Device for Psychiatric Disorders Risks and Mitigation Measures Identified risks Mitigation measures Device provides ineffective treatment, leading to worsening condition Clinical data; Software verification, validation, and hazard analysis; and labeling. Device software failure, leading to delayed access Software verification, validation, and hazard analysis; and Labeling. Use error/improper device use Labeling.

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    At the time of classification, computerized behavioral therapy devices for psychiatric disorders are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

    III. Analysis of Environmental Impact

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

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

    PART 882—NEUROLOGICAL DEVICES 1. The authority citation for part 882 continues to read as follows: Authority:

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

    2. Add § 882.5801 to subpart F to read as follows:
    § 882.5801 Computerized behavioral therapy device for psychiatric disorders.

    (a) Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.

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

    (1) Clinical data must be provided to fulfill the following:

    (i) Describe a validated model of behavioral therapy for the psychiatric disorder; and

    (ii) Validate the model of behavioral therapy as implemented by the device.

    (2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.

    (3) The following labeling must be provided:

    (i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.

    (ii) Patient and physician labeling must list compatible devices.

    (iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.

    (iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.

    (v) Physician labeling must include a summary of the clinical testing with the device.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27843 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-6531] Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective December 27, 2017. The classification was applicable on April 14, 2017.

    FOR FURTHER INFORMATION CONTACT:

    William Heetderks, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2682, Silver Spring, MD 20993-0002, 240-402-5360, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Upon request, FDA has classified the external vagal nerve stimulator for headache as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On October 16, 2015, electroCore, LLC, submitted a request for De Novo classification of the gammaCore Non-invasive Vagus Nerve Stimulator. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on April 14, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5892. We have named the generic type of device external vagal nerve stimulator for headache, and it is identified as a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

    Table 1—External Vagal Nerve Stimulator for Headache Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction resulting from patient contacting components Biocompatibility evaluation and Labeling. Electrical shock injury from device failure Electrical safety, thermal, and mechanical testing; Software verification, validation, and hazard analysis; and Labeling. Incorrect stimulation resulting from interference from other electrical devices Electromagnetic compatibility testing. Stimulation side effects such as the following Labeling. • Seizure • Cardiac side effects • Worsening of headache. Ineffective therapeutic response due to device failure Non-clinical performance testing; Software verification, validation, and hazard analysis; and Labeling. User error Labeling.

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    At the time of classification, external vagal nerve stimulators for headache are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

    III. Analysis of Environmental Impact

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

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

    PART 882—NEUROLOGICAL DEVICES 1. The authority citation for part 882 continues to read as follows: Authority:

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

    2. Add § 882.5892 to subpart F to read as follows:
    § 882.5892 External vagal nerve stimulator for headache.

    (a) Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

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

    (1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (μC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.

    (2) Software verification, validation, and hazard analysis shall be performed.

    (3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.

    (4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).

    (5) The labeling must include:

    (i) Instructions for proper use of the device, including placement of the device on the patient; and

    (ii) Instructions on care and cleaning of the device.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27854 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2017-N-6855] Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective December 27, 2017. The classification was applicable on January 28, 2014.

    FOR FURTHER INFORMATION CONTACT:

    Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the rectal balloon for prostate immobilization as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s. As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On July 15, 2013, RadiaDyne, LLC submitted a request for De Novo classification of the prostate immobilizer rectal balloon. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on January 28, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 892.5720. We have named the generic type of device rectal balloon for prostate immobilization, and it is identified as a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

    Table 1—Rectal Balloon for Prostate Immobilization Risks and Mitigation Measures Identified risks Mitigation measures/21 CFR section Anorectal Toxicity Special controls (1)(i) (21 CFR 892.5720(b)(1)(i)), (1)(ii) (21 CFR 892.5720(b)(1)(ii)), (1)(iii) (21 CFR 892.5720(b)(1)(iii)), (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Tissue Damage Special controls (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (1)(v) (21 CFR 892.5720(b)(1)(v)), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Perforation of the Rectum Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B)), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Irradiation of Healthy Tissue Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B)), (2)(i)(B) (21 CFR 892.5720(b)(2)(i)(B)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Patient Intolerance Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A)), (2)(i)(C) (21 CFR 892.5720(b)(2)(i)(C)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

    III. Analysis of Environmental Impact

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

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows:

    PART 892—RADIOLOGY DEVICES 1. The authority citation for part 892 is revised to read as follows: Authority:

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

    2. Add § 892.5720 to subpart F to read as follows:
    § 892.5720 Rectal balloon for prostate immobilization.

    (a) Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

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

    (1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:

    (i) Biocompatibility testing of the final finished device;

    (ii) If provided sterile, sterilization validation;

    (iii) If not provided sterile, bioburden testing of the final finished device;

    (iv) Shelf life and expiration date validation; and

    (v) Performance testing including but not limited to:

    (A) Venting mechanism (if device has a vent mechanism);

    (B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and

    (C) Structural integrity testing (e.g., tensile strength, balloon leakage and burst strength).

    (2) Labeling that includes:

    (i) Appropriate warnings and contraindications, including, but not limited to the following statements:

    (A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”;

    (B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”;

    (C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and

    (D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.”

    (ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;

    (iii) Whether the device is sterile or non-sterile; and

    (iv) An expiration date.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27856 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    NATIONAL INDIAN GAMING COMMISSION 25 CFR Part 547 RIN 3141-AA64 Minimum Technical Standards for Class II Gaming Systems and Equipment AGENCY:

    National Indian Gaming Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The National Indian Gaming Commission is amending its minimum technical standards for Class II gaming systems and equipment. The rule amends the regulations that describe how tribal governments, tribal gaming regulatory authorities, and tribal gaming operations comply with the minimum technical standards.

    DATES:

    Effective Date: January 26, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Austin Badger, National Indian Gaming Commission; 1849 C Street NW, MS 1621, Washington, DC 20240. Telephone: 202-632-7003.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The Act establishes the National Indian Gaming Commission (NIGC or Commission) and sets out a comprehensive framework for the regulation of gaming on Indian lands. On October 10, 2008, the NIGC published a final rule in the Federal Register establishing minimum technical standards for Class II gaming systems and equipment. 73 FR 60508. The minimum technical standards are designed to assist tribal gaming regulatory authorities (TGRAs) and operators with ensuring the integrity and security of Class II gaming, the accountability of Class II gaming revenue, and provide guidance to equipment manufacturers and distributors of Class II gaming systems. The minimum technical standards do not classify which games are Class II and which games are Class III.

    When implemented in 2008, the part 547 minimum technical standards introduced several new requirements for Class II gaming systems designed to protect the security and integrity of Class II gaming systems and tribal operations. The Commission understood, however, that some existing Class II gaming systems might not meet all of the requirements of the minimum technical standards. Therefore, to avoid any potentially significant economic and practical consequences of requiring immediate compliance, the Commission implemented a five-year sunset provision which allowed eligible gaming systems manufactured before November 10, 2008 (2008 Systems) to remain on the gaming floor. The Commission believed that a five-year period was sufficient for market forces to move systems toward compliance with the standards applicable to systems manufactured on or after November 10, 2008.

    On September 21, 2012, the NIGC published a final rule in the Federal Register which included an amendment delaying the sunset provision by an additional five years. 77 FR 58473. The Commission recognized that its prior analysis regarding the continued economic viability of 2008 Systems had proven to be mistaken. The NIGC had established the initial five-year period during a much stronger economy. Many tribal gaming operations set new priorities during the following economic downturn that required keeping a 2008 System on the gaming floor for a longer period. Balancing the economic needs of the industry against a risk that potentially increases as technology advances and 2008 Systems remain static, the Commission determined that 2008 Systems could continue to be offered for play until November 10, 2018.

    Now, with the November 10, 2018, sunset for 2008 Systems approaching, the Commission has determined that it is in the best interest of Indian gaming to amend the regulations that describe how tribal governments, tribal gaming regulatory authorities, and tribal gaming operations comply with the minimum technical standards. The amendments include removal of the sunset provision, providing for additional annual review of 2008 Systems by TGRAs, and requiring all modifications of Class II gaming systems to be subject to a uniform independent laboratory testing and TGRA approval process. The Commission has determined that the amended rule continues to fulfill the rule's ultimate goal of assisting tribes in ensuring the security and integrity of Class II games played with technologic aids, the auditability of the gaming revenue that those games earn, and accounting and allowing for evolving and new technology.

    II. Development of the Rule

    The development of the rule formally began with the Commission's notice to tribal leaders by letter dated November 22, 2016, of the topic's inclusion in the Commission's 2017 tribal consultation series. Thereafter, on March 23, 2017, in Tulsa, OK, and April 12, 2017, in San Diego, CA, the NIGC consulted on the 2008 Systems and associated sunset provision of the minimum technical standards. The Commission also solicited written comments through May 31, 2017. In addition, NIGC staff attended meetings with the National Indian Gaming Association Class II Subcommittee, as well as other representatives from the gaming industry. The consultations and meetings, combined with the written comments, proved invaluable in the development of a discussion draft issued on June 14, 2017, which, among other proposed amendments, proposed removing the November 10, 2018, sunset for 2008 Systems. Additional written comments responsive to the discussion draft were solicited through July 15, 2017.

    The Commission subsequently published a proposed rule in the Federal Register on September 28, 2017. 82 FR 45228. The proposed rule included several amendments to the discussion draft prompted by the Commission's careful consideration of the substantive comments received through consultation and written submissions. The proposed rule included the Commission's responses to comments received and invited interested parties to continue to participate in the rulemaking process by submitting comments and any supporting data responsive to the proposed rule to the Commission by November 13, 2017. The comments received throughout this process have proven invaluable to the Commission in developing this rule amending the minimum technical standards for Class II gaming systems and equipment.

    III. Review of Public Comments

    In response to the proposed rule the Commission received the following comments.

    Removal of the Sunset Provision

    Comment: Commenters overwhelmingly supported removal of the sunset provision. One commenter, however, suggested that the sunset provision should not be removed.

    Response: The following responses seek to address each of the substantive arguments raised by the commenter that suggested the sunset provision should not be removed.

    Comment: A commenter suggested that the public and tribes would be best served if all Class II gaming systems adhered to a uniform minimum standard.

    Response: The Commission acknowledges that the rule permits the continued existence of two sets of minimum standards for Class II gaming systems—one for 2008 Systems and one for systems manufactured after November 10, 2008. The Commission disagrees, however, that a uniform minimum standard is necessary to best serve the needs of the public and tribes.

    First and foremost, the Commission's minimum technical standards are just that—minimums. The standards implemented by tribes applicable to gaming operations within their lands are not required nor intended to be uniform. Each tribe is empowered and encouraged to implement additional or more stringent tribal standards applicable to Class II gaming systems operating within their lands. IGRA and the Commission recognize that tribes have the primary responsibility for regulating Class II gaming within their lands. A stated purpose of IGRA is to promote tribal economic development, self-sufficiency, and self-government. 25 U.S.C. 2702(1). The minimum technical standards are therefore designed to give TGRAs the primary role in approving Class II gaming systems and modifications.

    The Commission's minimum technical standards represent the standards that, in the Commission's judgment, are best able to assist TGRAs with ensuring the integrity and security of Class II gaming, ensuring the accountability of Class II gaming revenue, and providing guidance to equipment manufacturers and distributors of Class II gaming systems. Importantly, the minimum technical standards are one component of a regulatory framework that includes the Commission's minimum internal control standards (MICS). 25 CFR part 543. The Commission endeavored to place all minimum requirements for the design, construction, and implementation of Class II gaming systems into the minimum technical standards and all minimum requirements for the operation of such systems, and the authorization, recognition, and recordation of gaming and gaming-related transactions into the MICS. The MICS apply uniformly to the operation of all Class II gaming, irrespective of Class II gaming system manufacture date.

    The Commission's minimum technical standards and MICS make meaningful the Commission's monitoring, inspection, and examination authority. 25 U.S.C. 2706(b). Without such minimums, the Commission would be required to independently evaluate, at significant expense, the technical standards and internal controls implemented by each tribe to determine whether each tribe's technical standards and internal controls adequately protected the security and integrity of Indian gaming. With such minimums, the Commission can efficiently evaluate a tribal gaming operation by verifying that the operation adheres to standards and controls that meet or exceed Commission minimums. Thus, the Commission has long maintained that it has a regulatory interest in a uniform set of minimum standards—an interest that includes the efficient administration of its monitoring, inspection, and examination authority.

    In 2008, 2012, and now, the Commission has sought to balance its interest in a uniform set of minimum standards against the economic impact of applying those standards to systems manufactured before the standards were in place. The Commission recognizes that despite being initially certified to a subset of the standards applicable to newer systems, 2008 Systems have continued to operate within the overall regulatory framework in a manner that protects the security and integrity of Indian gaming. The Commission credits tribes, TGRAs and manufacturers for, as the Commission acknowledged in 2012, the relatively few problems to the patron or the gaming operations attributable to 2008 Systems. In balance, the Commission has determined that the continued operation of 2008 Systems is in the best interest of Indian gaming provided that such systems are subject to additional annual review by TGRAs. The Commission is fully prepared, however, to revisit the minimum technical standards, including those applicable to 2008 Systems, if necessary to address any threat to the integrity of Class II gaming systems and equipment.

    Finally, the Commission acknowledges that it has previously expressed concern regarding risks that potentially increase as technology advances and 2008 Systems remain static. The Commission now recognizes, however, that 2008 Systems have generally not remained static, but instead have been modified over time in compliance with existing regulations. Repair and replacement of individual components of Class II gaming systems have been and continue to be permitted. Modification of components of 2008 Systems also continue to be permitted provided the TGRA determines that the modification either maintains compliance with the requirements for 2008 Systems or increases compliance with the requirements for newer systems. The rule seeks to continue to facilitate the on-going modification of 2008 Systems as needed to respond to developments in technology with the goal of increased compliance with the requirements for newer systems.

    Comment: A commenter suggests that the economic needs of tribes considered by the Commission in 2008 and 2012 are no longer applicable.

    Response: The Commission has determined that, while the significance of the economic factors considered by the Commission in 2008 and 2012 has decreased over time, economic factors remain applicable. As noted previously, 2008 Systems have generally been modified over time towards increased compliance with the standards for newer systems. Thus, the economic impact of the sunset provision, if left in place, is the cost of the remaining modifications needed to bring the system into compliance with the standards for newer systems. The Commission notes that tribes, as the customers of Class II gaming systems and equipment, will ultimately incur those costs.

    The Commission also recognizes that the economic health of the Indian gaming industry as a whole, which includes both Class II and Class III gaming, is not representative of the economic health of individual Indian gaming operations that may be affected by the sunset provision. Indian gaming operations vary in size and measures of economic success. The Commission and staff engaged extensively with the tribal gaming industry on the continued use of 2008 Systems and heard the costs of complying with the sunset provision would fall primarily on the tribes least able to afford it. Additionally, the Commission received many comments asserting that failing to remove the sunset provision would cause significant economic harm to tribes.

    Comment: A commenter suggests that removal of the sunset provision would have anti-competitive effects. The commenter suggests that manufacturers that maintain obsolete 2008 Systems are economically rewarded while new market entrants are punished.

    Response: The Commission notes that IGRA, as informed by consultation with tribes, forms the basis for all Commission regulations. Nevertheless, the Commission does not agree that removal of the sunset provision has a significant anti-competitive effect. Importantly, the rule brings parity to the independent testing laboratory requirements for 2008 Systems and newer systems. All modifications to a Class II gaming systems are now required to be tested against the standards for newer systems. And, while TGRAs retain the authority to approve a modification to a 2008 System that maintains compliance with 2008 System standards, 2008 Systems are also subject to an additional annual review which is not applicable to newer systems.

    In addition, the minimum technical standards are not intended to render any particular Class II gaming system technology “obsolete.” The minimum technical standards require the implementation of certain features which may be implemented by a wide array of technology. The minimum technical standards are intended to provide all manufacturers with the flexibility to implement technologies unforeseen and undeveloped when the rule was first promulgated. Importantly, the minimum technical standards allow Class II gaming systems to be modified over time as manufacturers innovate new implementations of the required features. Tribes and tribal gaming regulatory authorities may also add additional or more stringent requirements for manufacturers to implement. Finally, to the extent that a specific technical standard potentially impedes innovation, TGRAs and gaming operations are able to submit to the NIGC Chairman for approval an alternate minimum standard that accomplishes the same purpose.

    Comment: A commenter suggests that removal of the sunset provision transforms the rule into a major rule having an effect on the economy of $100 million or more because the 2008 System provisions were initially implemented to avoid up to $3.7 billion in lost revenue in the industry.

    Response: The Commission has determined that the commenter's assumptions are mistaken. The Commission found that the annual cost to the Indian gaming industry of the technical standards, considered alone, was $3.1 million in 2008. 73 FR 60508, 60512. The figure cited by the commenter appears to have been inferred from a February 1, 2008 economic impact study which considered not only the potential economic impact of minimum technical standards (part 547) but also of the MICS (part 543) and game classification standards (proposed but not adopted). The Commission has determined that there is no plausible basis for finding that the removal of the sunset provision from the minimum technical standards approximately ten years after the standards were first promulgated could have an effect on the economy of $100 million or more.

    Comment: A commenter suggests that the 2008 System standards should meet the standards required for an alternate minimum standard for a newer system.

    Response: The Commission's alternate minimum standard provisions recognize that there may be alternatives to the Commission's minimum standards that will “achieve a level of security and integrity sufficient to accomplish the purpose of the standard it is to replace.” 25 CFR 547.17(a)(1). The 2008 System provisions are specific to systems manufactured before November 10, 2008. The alternate minimum standard provisions are equally applicable to 2008 Systems and to newer systems. In other words, the 2008 Systems standards are the standards against which an alternate minimum standard for a 2008 System would be evaluated against.

    2008 Systems Annual Review

    Comment: Commenters suggest that the NIGC has provided no compelling reason to change the existing reporting requirements. Commenters suggest that it would be redundant to require annual re-review of testing laboratory reports which amounts to a restatement of certification opinions that have already been submitted to the NIGC.

    Response: The Commission does not believe that the annual review requirement is unnecessary. First, the Commission believes that removal of the sunset provision warrants annual review specific to 2008 Systems. The annual review requirement will ensure that 2008 Systems are adequately monitored and that 2008 Systems that meet the standards applicable to newer systems are identified by the TGRA and gaming operation. In addition, the annual review requirement requires the TGRA to identify the components of the 2008 System that prevent the system from being approved as a newer system. The Commission believes this information will be useful to the Commission, TGRAs, and gaming operations in considering whether the applicable technical standards, in conjunction with applicable internal controls, continue to adequately protect the integrity and security of Class II gaming and accountability of Class II gaming revenue.

    Second, the Commission does not believe that the annual review requirement is redundant. Existing 2008 System requirements require TGRAs to maintain records of all modifications so long as the Class II gaming system that is the subject of the modification remains available to the public for play. The rule adds as an additional requirement that TGRAs review the existing modification records annually to determine whether the 2008 Systems, as currently modified, may be approved pursuant to the provisions for newer systems. The required finding by the TGRA is based on its review of existing documentation and does not require TGRAs to obtain new testing laboratory reports. Components for which existing laboratory reports show that the component does not meet the standards for newer systems, as well as components for which laboratory reports have not been maintained, would be included in the required finding as components preventing approval of the system under the standards for newer systems. To further assist TGRAs in conducting the required review and developing the findings, the Commission intends to issue guidance specific to the annual review requirement for 2008 Systems.

    Testing Standards for All Modifications

    Comment: Commenters suggest the new requirement that modifications to 2008 Systems be tested to the standards for newer systems is unnecessary and will only result in additional costs with no practical benefit. Commenters suggest that TGRAs should be able to determine whether to test a modification to the standards for newer systems or to 2008 System standards.

    Response: The Commission believes the new requirement appropriately balances laboratory testing requirements with TGRA approval requirements without imposing unreasonable costs. The rule requires the testing laboratory to test all modifications to the technical standards for newer systems. The rule recognizes the primary regulator status of the TGRA by providing that the TGRA is required to determine, among other requirements, whether the modification will maintain the system's compliance or advance the system's compliance with the standards for newer systems. Testing all modifications to the standards for newer systems therefore ensures that TGRAs are provided with the information needed to make such a determination.

    Records

    Comment: Commenters expressed reluctance to expose sensitive testing and compliance records to possible public disclosure. Commenters suggest that records only be available for review on site by NIGC staff or on a government-to-government basis. Commenters request that the second and third sentence of paragraph (g) be removed.

    Response: The Commission believes that paragraph (g) appropriately describes the Commission's obligations with regards to the inspection and release of records as set forth by IGRA, the Freedom of Information Act, 5 U.S.C. 552, and the Privacy Act of 1974, 5 U.S.C. 552a. The second sentence of paragraph (g), as limited by the third sentence, describes the Commission's intended internal use of such information.

    Regulatory Matters Tribal Consultation

    The National Indian Gaming Commission is committed to fulfilling its tribal consultation obligations—whether directed by statute or administrative action such as Executive Order (EO) 13175 (Consultation and Coordination with Indian Tribal Governments)—by adhering to the consultation framework described in its Consultation Policy published July 15, 2013. The NIGC's consultation policy specifies that it will consult with tribes on Commission Action with Tribal Implications, which is defined as: Any Commission regulation, rulemaking, policy, guidance, legislative proposal, or operational activity that may have a substantial direct effect on an Indian tribe on matters including, but not limited to the ability of an Indian tribe to regulate its Indian gaming; an Indian Tribe's formal relationship with the Commission; or the consideration of the Commission's trust responsibilities to Indian tribes. As discussed above, the NIGC engaged in extensive consultation on this topic and received and considered comments in developing this rule.

    Regulatory Flexibility Act

    The rule will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Moreover, Indian Tribes are not considered to be small entities for the purposes of the Regulatory Flexibility Act.

    Small Business Regulatory Enforcement Fairness Act

    The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rule does not have an effect on the economy of $100 million or more. The rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions. Nor will the rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.

    Unfunded Mandates Reform Act

    The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

    Takings

    In accordance with Executive Order 12630, the Commission has determined that the rule does not have significant takings implications. A takings implication assessment is not required.

    Civil Justice Reform

    In accordance with Executive Order 12988, the Commission has determined that the rule does not unduly burden the judicial system and meets the requirements of section 3(a) and 3(b)(2) of the Order.

    National Environmental Policy Act

    The Commission has determined that the rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.

    Paperwork Reduction Act

    The information collection requirements contained in this rule were previously approved by the Office of Management and Budget (OMB) as required by 44 U.S.C. 3501 et seq. and assigned OMB Control Number 3141- 0007, which expired in August of 2011. The NIGC is in the process of reinstating that Control Number.

    List of Subjects in 25 CFR Part 547

    Gambling, Indian—lands, Indian—tribal government, Reporting and recordkeeping requirements.

    Therefore, for reasons stated in the preamble, 25 CFR part 547 is amended as follows:

    PART 547—MINIMUM TECHNICAL STANDARDS FOR CLASS II GAMING SYSTEMS AND EQUIPMENT 1. The authority citation for part 547 continues to read as follows: Authority:

    25 U.S.C. 2706(b).

    2. Revise § 547.5 to read as follows:
    § 547.5 How does a tribal government, TGRA, or tribal gaming operation comply with this part?

    (a) Gaming systems manufactured before November 10, 2008. (1) Any Class II gaming system manufactured before November 10, 2008, that is not compliant with paragraph (b) of this section may be made available for use at any tribal gaming operation if:

    (i) The Class II gaming system software that affects the play of the Class II game, together with the signature verification required by § 547.8(f) was submitted to a testing laboratory within 120 days after November 10, 2008, or October 22, 2012;

    (ii) The testing laboratory tested the submission to the standards established by § 547.8(b), § 547.8(f), and § 547.14;

    (iii) The testing laboratory provided the TGRA with a formal written report setting forth and certifying to the findings and conclusions of the test;

    (iv) The TGRA made a finding, in the form of a certificate provided to the supplier or manufacturer of the Class II gaming system, that the Class II gaming system is compliant with § 547.8(b), § 547.8(f), and § 547.14;

    (v) The Class II gaming system is only used as approved by the TGRA and the TGRA transmitted its notice of that approval, identifying the Class II gaming system and its components, to the Commission;

    (vi) Remote communications with the Class II gaming system are only allowed if authorized by the TGRA; and

    (vii) Player interfaces of the Class II gaming system exhibit information consistent with § 547.7(d) and any other information required by the TGRA.

    (2) For so long as a Class II gaming system is made available for use at any tribal gaming operation pursuant to this paragraph (a) the TGRA shall:

    (i) Retain copies of the testing laboratory's report, the TGRA's compliance certificate, and the TGRA's approval of the use of the Class II gaming system;

    (ii) Maintain records identifying the Class II gaming system and its current components; and

    (iii) Annually review the testing laboratory reports associated with the Class II gaming system and its current components to determine whether the Class II gaming system may be approved pursuant to paragraph (b)(1)(v) of this section. The TGRA shall make a finding identifying the Class II gaming systems reviewed, the Class II gaming systems subsequently approved pursuant to paragraph (b)(1)(v), and, for Class II gaming systems that cannot be approved pursuant to paragraph (b)(1)(v), the components of the Class II gaming system preventing such approval.

    (3) If the Class II gaming system is subsequently approved by the TGRA pursuant to paragraph (b)(1)(v) as compliant with paragraph (b) of this section, this paragraph (a) no longer applies.

    (b) Gaming system submission, testing, and approval—generally. (1) Except as provided in paragraph (a) of this section, a TGRA may not permit the use of any Class II gaming system in a tribal gaming operation unless:

    (i) The Class II gaming system has been submitted to a testing laboratory;

    (ii) The testing laboratory tests the submission to the standards established by:

    (A) This part;

    (B) Any applicable provisions of part 543 of this chapter that are testable by the testing laboratory; and

    (C) The TGRA;

    (iii) The testing laboratory provides a formal written report to the party making the submission, setting forth and certifying its findings and conclusions, and noting compliance with any standard established by the TGRA pursuant to paragraph (b)(1)(ii)(C) of this section;

    (iv) The testing laboratory's written report confirms that the operation of a player interface prototype has been certified that it will not be compromised or affected by electrostatic discharge, liquid spills, electromagnetic interference, or any other tests required by the TGRA;

    (v) Following receipt of the testing laboratory's report, the TGRA makes a finding that the Class II gaming system conforms to the standards established by:

    (A) This part;

    (B) Any applicable provisions of part 543 of this chapter that are testable by the testing laboratory; and

    (C) The TGRA.

    (2) For so long as a Class II gaming system is made available for use at any tribal gaming operation pursuant to this paragraph (b) the TGRA shall:

    (i) Retain a copy of the testing laboratory's report; and

    (ii) Maintain records identifying the Class II gaming system and its current components.

    (c) Class II gaming system component repair, replacement, or modification. (1) As permitted by the TGRA, individual hardware or software components of a Class II gaming system may be repaired or replaced to ensure proper functioning, security, or integrity of the Class II gaming system.

    (2) A TGRA may not permit the modification of any Class II gaming system in a tribal gaming operation unless:

    (i) The Class II gaming system modification has been submitted to a testing laboratory;

    (ii) The testing laboratory tests the submission to the standards established by:

    (A) This part;

    (B) Any applicable provisions of part 543 of this chapter that are testable by the testing laboratory; and

    (C) The TGRA;

    (iii) The testing laboratory provides a formal written report to the party making the submission, setting forth and certifying its findings and conclusions, and noting compliance with any standard established by the TGRA pursuant to paragraph (c)(2)(ii)(C) of this section;

    (iv) Following receipt of the testing laboratory's report, the TGRA makes a finding that the:

    (A) The modification will maintain or advance the Class II gaming system's compliance with this part and any applicable provisions of part 543 of this chapter; and

    (B) The modification will not detract from, compromise or prejudice the proper functioning, security, or integrity of the Class II gaming system;

    (3) If a TGRA authorizes a component modification under this paragraph, it must maintain a record of the modification and a copy of the testing laboratory report so long as the Class II gaming system that is the subject of the modification remains available to the public for play.

    (d) Emergency Class II gaming system component modifications. (1) A TGRA, in its discretion, may permit the modification of previously approved components to be made available for play without prior laboratory testing or review if the modified hardware or software is:

    (i) Necessary to correct a problem affecting the fairness, security, or integrity of a game or accounting system or any cashless system, or voucher system; or

    (ii) Unrelated to game play, an accounting system, a cashless system, or a voucher system.

    (2) If a TGRA authorizes modified components to be made available for play or use without prior testing laboratory review, the TGRA must thereafter require the hardware or software manufacturer to:

    (i) Immediately advise other users of the same components of the importance and availability of the update;

    (ii) Immediately submit the new or modified components to a testing laboratory for testing and verification of compliance with this part and any applicable provisions of part 543 of this chapter that are testable by the testing laboratory; and

    (iii) Immediately provide the TGRA with a software signature verification tool meeting the requirements of § 547.8(f) for any new or modified software component.

    (3) If a TGRA authorizes a component modification under this paragraph, it must maintain a record of the modification and a copy of the testing laboratory report so long as the Class II gaming system that is the subject of the modification remains available to the public for play.

    (e) Compliance by charitable gaming operations. This part does not apply to charitable gaming operations, provided that:

    (1) The tribal government determines that the organization sponsoring the gaming operation is a charitable organization;

    (2) All proceeds of the charitable gaming operation are for the benefit of the charitable organization;

    (3) The TGRA permits the charitable organization to be exempt from this part;

    (4) The charitable gaming operation is operated wholly by the charitable organization's employees or volunteers; and

    (5) The annual gross gaming revenue of the charitable gaming operation does not exceed $3,000,000.

    (f) Testing laboratories. (1) A testing laboratory may provide the examination, testing, evaluating and reporting functions required by this section provided that:

    (i) It demonstrates its integrity, independence and financial stability to the TGRA.

    (ii) It demonstrates its technical skill and capability to the TGRA.

    (iii) If the testing laboratory is owned or operated by, or affiliated with, a tribe, it must be independent from the manufacturer and gaming operator for whom it is providing the testing, evaluating, and reporting functions required by this section.

    (iv) The TGRA:

    (A) Makes a suitability determination of the testing laboratory based upon standards no less stringent than those set out in § 533.6(b)(1)(ii) through (v) of this chapter and based upon no less information than that required by § 537.1 of this chapter, or

    (B) Accepts, in its discretion, a determination of suitability for the testing laboratory made by any other gaming regulatory authority in the United States.

    (v) After reviewing the suitability determination and the information provided by the testing laboratory, the TGRA determines that the testing laboratory is qualified to test and evaluate Class II gaming systems.

    (2) The TGRA must:

    (i) Maintain a record of all determinations made pursuant to paragraphs (f)(1)(iii) and (f)(1)(iv) of this section for a minimum of three years.

    (ii) Place the testing laboratory under a continuing obligation to notify it of any adverse regulatory action in any jurisdiction where the testing laboratory conducts business.

    (iii) Require the testing laboratory to provide notice of any material changes to the information provided to the TGRA.

    (g) Records. Records required to be maintained under this section must be made available to the Commission upon request. The Commission may use the information derived therefrom for any lawful purpose including, without limitation, to monitor the use of Class II gaming systems, to assess the effectiveness of the standards required by this part, and to inform future amendments to this part. The Commission will only make available for public review records or portions of records subject to release under the Freedom of Information Act, 5 U.S.C. 552; the Privacy Act of 1974, 5 U.S.C. 552a; or the Indian Gaming Regulatory Act, 25 U.S.C. 2716(a).

    Dated: December 19, 2017. Jonodev O. Chaudhuri, Chairman. Kathryn Isom-Clause, Vice Chair. E. Sequoyah Simermeyer, Associate Commissioner.
    [FR Doc. 2017-27945 Filed 12-26-17; 8:45 am] BILLING CODE 7565-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9825] RIN 1545-BJ08 Treatment of Transactions in Which Federal Financial Assistance Is Provided; Correction AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final regulations; correction.

    SUMMARY:

    This document contains corrections to final regulations (TD 9825) that were published in the Federal Register on Thursday, October 19, 2017. The final regulations are under section 597 of the Internal Revenue Code. These final regulations amend existing regulations that address the federal income tax treatment of transactions in which federal financial assistance is provided to banks and domestic building and loan associations, and they clarify the federal income tax consequences of those transactions to banks, domestic building and loan associations, and related parties.

    DATES:

    This correction is effective on December 27, 2017 and applicable on or after October 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Russell G. Jones at (202) 317-5357, or Ken Cohen at (202) 317-5367 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION:

    Background

    The final regulations (TD 9825) that are the subject of this correction are issued under section 597 of the Internal Revenue Code.

    Need for Correction

    As published, the final regulation (TD 9825) contains errors that may prove to be misleading and are in need of clarification.

    Correction of Publication

    Accordingly, the final regulations (TD 9825) that are the subject of FR Doc. 2017-21129 appearing on page 48618 in the Federal Register of Thursday, October 19, 2017, are corrected as follows:

    On page 48619, in the second column, in the preamble, under the caption “Special Analyses”, in the fifth line, the language “Executive Order 13653. Therefore, a” is corrected to read “Executive Order 13563. Therefore, a”.

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration).
    [FR Doc. 2017-27863 Filed 12-26-17; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9825] RIN 1545-BJ08 Treatment of Transactions in Which Federal Financial Assistance Is Provided; Correction AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Correcting amendment.

    SUMMARY:

    This document contains corrections to final regulations (TD 9825) that were published in the Federal Register on Thursday, October 19, 2017. The final regulations are under section 597 of the Internal Revenue Code. These final regulations amend existing regulations that address the federal income tax treatment of transactions in which federal financial assistance is provided to banks and domestic building and loan associations, and they clarify the federal income tax consequences of those transactions to banks, domestic building and loan associations, and related parties.

    DATES:

    This correction is effective on December 27, 2017 and is applicable on or after October 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Russell G. Jones at (202) 317-5357, or Ken Cohen at (202) 317-5367 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION:

    Background

    The final regulations (TD 9825) that are the subject of this correction are issued under section 597 of the Internal Revenue Code.

    Need for Correction

    As published, the final regulations (TD 9825) contain errors that may prove to be misleading and are in need of clarification.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Correction of Publication

    Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

    PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 1.597-5 is amended by revising the seventh and eighth sentences of paragraph (f), Example 4, and by revising the first and second sentences of paragraph (f), Example 5 (ii), to read as follows:
    § 1.597-5 Taxable Transfers.

    (f) * * *

    Example 4.

    * * * The fair market value of the loans is their Expected Value, $800,000 (the sum of the $500,000 Third-Party Price and the $300,000 that the Agency would pay if N sold the loans for $500,000). The fair market value of each foreclosed property is its Expected Value, $80,000 (the sum of the $50,000 Third-Party Price and the $30,000 that the Agency would pay if N sold the foreclosed property for $50,000) under paragraph (b) of § 1.597-1. * * *

    Example 5.

    * * *

    (ii) At the end of 2018, the Third-Party Price for the loans drops to $400,000, and the Third-Party Price for each of the foreclosed properties remains at $50,000. The fair market value of the loans at the end of Year 2 is their Expected Value, $600,000 ($400,000 Third-Party Price + $200,000 (the amount of the loss if the loans were disposed of for the Third-Party Price × 33.33%) (the Average Reimbursement Rate does not change)). * * *

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration).
    [FR Doc. 2017-27862 Filed 12-26-17; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-1109] Drawbridge Operation Regulation; Columbia River, Vancouver, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulations.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burlington Northern Santa Fe (BNSF) Railway Bridge across the Columbia River, mile 105.6, at Vancouver, WA. The deviation is necessary to accommodate replacement gears, shafts and bearings. This deviation allows the bridge to remain in the closed-to-navigation position during maintenance activities.

    DATES:

    This deviation is effective from 8 a.m. to 3 p.m. on December 27, 2017.

    ADDRESSES:

    The docket for this deviation, USCG-2017-1109 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

    SUPPLEMENTARY INFORMATION:

    BNSF requested that the BNSF Swing Bridge across the Columbia River, mile 105.6, remain closed to marine vessel traffic to install new swing gears, shafts and bearings. During this installation period, the swing span of the bridge will be in the closed-to-navigation position. The BNSF Swing Bridge, mile 105.6, provides 39 feet of vertical clearance above Columbia River Datum 0.0 while in the closed position.

    The subject bridge operates in accordance with 33 CFR 117.5. This deviation allows the swing span of the BNSF Railway Bridge across the Columbia River, mile 105.6, to remain in the closed-to-navigation position, and need not open for maritime traffic from 8 a.m. to 3 p.m. on December 27, 2017. The bridge shall operate in accordance to 33 CFR 117.5 at all other times. Waterway usage on this part of the Columbia River includes vessels ranging from large ships to commercial tug and tow vessels to recreational pleasure craft including cabin cruisers and sailing vessels. Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will not be able to open for emergencies during this closure period, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: December 21, 2017. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2017-27923 Filed 12-26-17; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2017-0383; FRL-9972-49-Region 9] Approval of California Air Plan Revisions; Anti-Idling Regulations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a revision to the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs), oxides of nitrogen (NOX) and particulate matter (PM) from the idling of diesel-powered trucks. We are approving portions of a state rule submitted by the California Air Resources Board (CARB) to regulate these emission sources under the Clean Air Act (CAA or the Act).

    DATES:

    This rule will be effective on January 26, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2017-0383. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., 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 http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Buss, EPA Region IX, (415) 947-4152, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Proposed Action

    On September 29, 2017, the EPA proposed to approve subsections (c)(1)(A) and (c)(1)(B) of Title 13 California Code of Regulations (CCR) Section 2485, “Airborne Toxic Control Measure to Limit Diesel-Fueled Commercial Motor Vehicle Idling” (collectively, “Idling Restrictions”). The California Air Resources Board (CARB) adopted Section 2485 on September 1, 2006, and submitted the Idling Restrictions and other portions of Section 2485 to the EPA on December 9, 2011.1

    1 As described in the proposal, the EPA previously approved other portions of section 2485 into the SIP on June 16, 2016. 81 FR 39423, 39443.

    We proposed to approve these provisions because we determined that they comply with relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

    II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period. During this period, we received 10 comments. All comments received were either supportive of or not specific to this action and thus are not addressed here.

    III. EPA Action

    No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.

    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 the portions of 13 CCR 2485 described in the amendments to 40 CFR part 52 set forth below. Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.2 The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    2 62 FR 27968 (May 22, 1997)

    V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve 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);

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

    • 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 Clean Air Act; and

    • Does not provide the 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, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    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 action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 26, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: December 12, 2017. Alexis Strauss, Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations 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 F—California 2. Section 52.220a is amended by adding in paragraph (c) in table 1 an entry for “2485, subsections (c)(1)(A), (c)(1)(B) only” after the entry for “2485, excluding (c)(1)(A), (c)(1)(B), (c)(3)(B)” to read as follows:
    § 52.220a Identification of plan—in part.

    (c) * * *

    Table 1—EPA-Approved Statutes and State Regulations 1 State citation Title/subject State effective date EPA approval date Additional explanation *         *         *         *         *         *         * 2485, subsections (c)(1)(A), (c)(1)(B) only Airborne Toxic Control Measure to Limit Diesel-Fueled Commercial Motor Vehicle Idling November 15, 2006 [Insert Federal Register citation], December 27, 2017 Submitted December 9, 2011. Limits diesel vehicle idling to 5 minutes. *         *         *         *         *         *         * 1 Table 1 lists EPA-approved California statutes and regulations incorporated by reference in the applicable SIP. Table 2 of paragraph (c) lists approved California test procedures, test methods and specifications that are cited in certain regulations listed in Table 1. Approved California statutes that are nonregulatory or quasi-regulatory are listed in paragraph (e).
    [FR Doc. 2017-27818 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [EPA-HQ-OAR-2017-0213; FRL-9972-48-OAR] RIN 2060-AT43 Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    On September 28, 2017, the Environmental Protection Agency (EPA) published a direct final rule and an accompanying notice of proposed rulemaking entitled “Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant.” Because EPA received adverse comment, EPA is withdrawing the direct final rule through a separate notice. In this action, EPA is finalizing its proposal to correct the editing oversight that led to a potential conflict in a prior rulemaking as to whether or not containers holding two pounds or less of non-exempt substitute refrigerants for use in motor vehicle air conditioning that are not equipped with a self-sealing valve can be sold to persons that are not certified technicians, provided those small cans were manufactured or imported prior to January 1, 2018. This action clarifies that those small cans manufactured or imported prior to January 1, 2018 may continue to be sold to persons that are not certified as technicians under sections 608 or 609 of the Clean Air Act.

    DATES:

    This final rule is effective December 27, 2017.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0213. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information may not be publicly available, e.g., 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 electronically through http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Sara Kemme by regular mail: U.S. Environmental Protection Agency, Stratospheric Protection Division (6205T), 1200 Pennsylvania Avenue NW, Washington, DC 20460; by telephone: (202) 566-0511; or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. What action is the Agency taking?

    On September 28, 2017, EPA published a Direct Final Rule (82 FR 45202) to make a minor change to resolve a potential conflict in regulatory text at 40 CFR 82.154(c)(1)(x) to ensure that it conforms to the EPA's intention. We stated in that direct final rule that if we received adverse comment by October 30, 2017, we would publish a timely withdrawal in the Federal Register so that the direct final rule would not take effect. EPA received adverse comment on that direct final rule by October 30, 2017 and is publishing a separate notice withdrawing that direct final rule.

    To accompany the direct final rule, EPA also published a Notice of Proposed Rulemaking on September 28, 2017 entitled “Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant” (82 FR 45253). That notice proposed to make the same change in the regulatory text as in the direct final rule. This action addresses the relevant comments received and finalizes the revisions in the proposal.

    B. Does this action apply to me?

    Categories and entities potentially affected by this action include entities that distribute or sell small cans of refrigerant for use in motor vehicle air conditioning (MVAC) systems. Regulated entities include, but are not limited to, importers, manufacturers, and distributors of small cans of refrigerant (NAICS codes 325120, 441310, 447110) such as automotive parts and accessories stores and industrial gas manufacturers. This list is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility, company, business, or organization could be regulated by this action, you should carefully examine the regulations at 40 CFR part 82, subpart F. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

    C. Judicial Review

    Under CAA section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by February 26, 2018. This final action is a nationally applicable regulation and has nationwide scope and effect because it makes revisions to the EPA's regulations for the National Recycling and Emission Reduction Program found at 40 CFR part 82, subpart F, which are nationally applicable regulations that have nationwide scope and effect. Under CAA section 307(d)(7)(B), only an objection to this final action that was raised with reasonable specificity during the period for public comment can be raised during judicial review. This section also provides a mechanism for EPA to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to [EPA] that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of this rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, Environmental Protection Agency, Room 3000, William Jefferson Clinton Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy to the person listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344-A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

    D. Effective Date

    Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. 553(d), generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register. EPA is issuing this final rule under section 307(d) of the Clean Air Act (CAA), which states: “The provisions of section 553 through 557 . . . of Title 5 shall not, except as expressly provided in this section, apply to actions to which this subsection applies.” CAA section 307(d)(1). Thus, section 553(d) of the APA does not apply to this rule. EPA is nevertheless acting consistently with the policies underlying APA section 553(d) in making this rule effective immediately upon publication in the Federal Register. APA section 553(d) provides an exception for any action that grants or recognizes an exemption or relieves a restriction. This final rule relieves a restriction on the sale of certain small cans of MVAC refrigerant that were manufactured or imported prior to January 1, 2018.

    II. Background

    Section 608 of the CAA bears the title “National Recycling and Emission Reduction Program.” Under the structure of section 608, this program has three main components. First, section 608(a) requires EPA to establish standards and requirements regarding use and disposal of class I and II substances,1 including a comprehensive refrigerant management program to limit emissions of ozone-depleting refrigerants. The CAA directs EPA to include regulations that reduce the use and emissions of class I and II substances to the lowest achievable level and that maximize the recapture and recycling of such substances. The second component, section 608(b), requires that the regulations issued pursuant to subsection (a) contain requirements for the safe disposal of class I and class II substances. The third component, section 608(c), prohibits the knowing venting, release, or disposal of ozone-depleting refrigerants and their substitutes during the maintenance, service, repair, or disposal of air-conditioning and refrigeration appliances or industrial process refrigeration.

    1 A class I or class II substance refers to an ozone-depleting substance listed 40 CFR part 82 subpart A, appendix A or appendix B, respectively.

    EPA first issued regulations under section 608 of the CAA on May 14, 1993 (58 FR 28660), to establish the national refrigerant management program for ozone-depleting refrigerants recovered during the maintenance, service, repair, and disposal of air-conditioning and refrigeration appliances. These regulations were intended to substantially reduce the use and emissions of ozone-depleting refrigerants. EPA revised these regulations through subsequent rulemakings published on August 19, 1994 (59 FR 42950), November 9, 1994 (59 FR 55912), August 8, 1995 (60 FR 40420), July 24, 2003 (68 FR 43786), March 12, 2004 (69 FR 11946), January 11, 2005 (70 FR 1972), May 23, 2014 (79 FR 29682), and April 10, 2015 (80 FR 19453). For a more detailed summary of the history of EPA's Refrigerant Management Program see the discussion in the most recent update to these regulations at 81 FR 82272, 82275 (Nov. 18, 2016).

    On November 9, 2015, EPA proposed updates to the refrigerant management regulations under section 608 of the CAA (80 FR 69458). Among other things, EPA proposed to extend the sales restriction to non-exempt substitute refrigerants with an exception for small cans of refrigerant for use in MVAC. That is, the proposed revisions would have restricted the sale of non-exempt substitute refrigerants to certified technicians, with an exception for small cans (two pounds or less) of non-exempt substitute refrigerant for the servicing of MVACs 2 if the cans had a self-sealing valve. EPA requested comments on several aspects of that proposal including a scenario that would have included a sell-through provision for all small cans manufactured or imported prior to that effective date. (80 FR 69481). The proposal further stated that:

    2 In this context, containers that meet these criteria are referred to interchangeably as “small cans of MVAC refrigerant,” “small cans of refrigerant for MVAC servicing,” or simply “small cans.”

    For manufacture and import of small cans of refrigerant for MVAC servicing, EPA is proposing a compliance date of one year from publication of the final rule. EPA is also proposing to allow small cans manufactured and placed into initial inventory or imported before that date to be sold for one additional year. For example, if the rule is published on July 1, 2016, small can manufacturers would have until July 1, 2017, to transition their manufacturing lines to add self-sealing valves. Manufacturers, distributors, and auto parts stores would be able to sell all small cans manufactured and placed into initial inventory or imported prior to July 1, 2017, until July 1, 2018. EPA seeks comments on this proposed implementation timeline. [80 FR 69509]

    On November 18, 2016, EPA published a rule finalizing the proposed restriction that non-exempt substitute refrigerants may only be sold to technicians certified under sections 608 or 609 of the CAA. (81 FR 82280). In the case of refrigerant for use in MVAC, EPA finalized the exemption for the sale of certain small cans of non-ozone-depleting substitutes with a self-sealing valve to allow the do-it-yourself community to continue servicing their personal vehicles. Id. However, the agency intended to allow the continued sale of small cans manufactured or imported prior to the January 1, 2018 compliance date. The preamble to the final rule stated that, “EPA is requiring that small cans of non-exempt substitute refrigerant be outfitted with self-sealing valves by January 1, 2018. Based on comments, EPA is not finalizing the proposal to prohibit the sale of small cans that do not contain self-sealing valves that were manufactured or imported prior to that requirement taking effect.” Id. The preamble further stated:

    With regards to small cans of MVAC refrigerant, manufacturers, distributors and retailers of automotive refrigerant supported the proposed “manufacture-by” date of one year from publication of the final rule, but commented that they oppose a sell-through date for small cans that do not have self-sealing valves. They commented that such a requirement would be inefficient, burdensome, costly, and environmentally problematic. It would require all retailers to know of the requirement and establish processes for returning unsold cans back to the manufacturer for destruction. More likely, the cans may be improperly disposed of, which would negate the environmental benefit of the new provisions. One commenter stated that a “manufacture-by” date would shift EPA's burden in ensuring compliance from a few manufacturers to thousands of retailers. Furthermore, commenters cited EPA's July 2015 SNAP rule (80 FR 42901; July 20, 2015) which listed HFC-134a as unacceptable for use as an aerosol as of a “manufacture-by” date, rather than a “sell-by” date. [81 FR 82342]

    EPA described its intention to allow the continued sale of small cans without self-sealing valves that were manufactured or imported before the January 1, 2018, compliance date as follows:

    In response to the comments received on EPA's proposal to allow small cans manufactured and placed into initial inventory or imported before that date to be sold for one additional year, EPA is not finalizing the sell-through requirement and is finalizing only a date by which small cans must be manufactured or imported with a self-sealing valve. EPA agrees that this is the least-burdensome option and that it avoids the potential for any unintended consequences of a “sell-by” date. [81 FR 82342]

    These intentions were also expressed in the regulatory text at 40 CFR 82.154(c)(2), which was revised in the November 2016 rule. However, because of an editing error, another provision, 40 CFR 82.154(c)(1)(ix), contains text that could be construed as contradicting the Agency's clearly expressed intent to allow non-technicians to purchase, and retailers to sell, small cans of refrigerant for use in MVAC that were manufactured or imported before the January 1, 2018, compliance date irrespective of whether they have a self-sealing valve.

    The Automotive Refrigeration Products Institute and the Auto Care Association inquired about whether the language in 40 CFR 82.154(c)(1)(ix) effectively negates the provision in 40 CFR 82.154(c)(2) and the preamble discussion showing EPA's intention to allow small cans of refrigerant for use in MVAC manufactured or imported before January 1, 2018, to continue to be sold without self-sealing valves. EPA published a direct final rule and an accompanying notice of proposed rulemaking to revise the regulatory text, so that persons in possession of small cans of refrigerant for use in MVAC without self-sealing valves that were manufactured or imported before January 1, 2018, can be assured that they will be able to sell off their existing inventories without disruption.

    The public comment period for the notice of proposed rulemaking that accompanied the direct final rule closed on October 30, 2017. EPA received adverse comment on the direct final rule and accordingly is publishing a notice withdrawing the direct final rule. EPA is now finalizing the regulatory revisions based on the accompanying proposal, “Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant” (82 FR 45253). The regulatory text being finalized in this action is the same as the revised text in the direct final rule.

    In the direct final rule, which is being withdrawn, EPA explained that the action would eliminate burden associated with regulatory uncertainty in this area. The Automotive Refrigeration Products Institute and the Auto Care Association informed EPA that the lack of clarity surrounding the status of small cans of refrigerant for use in MVAC without self-sealing valves that were manufactured or imported before the compliance date created confusion for their members. Unless resolved, this lack of clarity could unnecessarily influence sales of automotive refrigerant during 2017. This is because retailers may not want to stock large numbers of these small cans of refrigerant for use in MVAC unless they are given some assurance that they will be able to sell off any remaining inventory after January 1, 2018. There is also the concern that if clarity is not provided by January 1, 2018, retailers may feel compelled to manually pull cans without self-sealing valves from their shelves and return the cans to their supplier(s). This rule eliminates the cost of that stranded inventory and also eliminates other non-quantified burdens associated with the removal of such cans from the market, such as the labor involved in segregating small cans with self-sealing valves from those without self-sealing valves and physically pulling those from shelves.

    III. Response to Comments

    EPA received several comments on the direct final rule, some of which were adverse at least in part. EPA is addressing those comments, as relevant, in this final rule. Consistent with the statements in the direct final rule and the parallel proposed rule, EPA did not initiate a second comment period on this action.

    One commenter asked why it is that the sell through provision proposed in 2015 was not finalized, if the intent was to protect ozone.3 The commenter stated that finalizing a sell through provision that does not permit the sales of refrigerant without a self-sealing valve would have a greater benefit for the general welfare, stating that it would reduce harmful gases being released and bolster the argument for allowing do-it-yourselfers to be allowed to purchase the product, regardless of the impending compliance date. Conversely, another commenter wrote that the selling of these cans will present very little damage to the ozone 4 and does not break any regulations, acts, or executive orders that have been previously passed. However, the commenter further said that the extended use of such cans of refrigerant that leak could pose a small threat to our ozone in the future and that for this reason, they should not be able to be imported or manufactured after the date of January 1, 2018.

    3 EPA believes the commenter is referring to stratospheric ozone.

    4 EPA believes the commenter is referring to stratospheric ozone.

    EPA responds that it disagrees that the first commenter's suggestion would have a greater benefit for the general welfare, for reasons explained in its response to comments on the 2016 final rule.5 More specifically, in the 2016 final rule EPA noted that comments from distributors and retailers of automotive refrigerant supported the proposed “manufacture-by” date of one year from publication of the final rule, but commented that they oppose a sell-through date for small cans that do not have self-sealing valves. (81 FR 82342). They commented that such a requirement would be inefficient, burdensome, costly, and environmentally problematic, and that it would require all retailers to know of the requirement and establish processes for returning unsold cans back to the manufacturer for destruction. Id. EPA further noted in the 2016 rule the comment that the cans may be improperly disposed of, which would negate the environmental benefit of the new provisions added in that rule. Id. EPA additionally noted the point made by one commenter who stated that a “manufacture-by” date would shift EPA's burden in ensuring compliance from a few manufacturers to thousands of retailers. Id. EPA responded in the 2016 final rule that to allow all entities in the distribution chain time to plan for and communicate changes to the sales restriction on non-exempt substitute refrigerants, as well as the requirement for self-sealing valves on small cans, EPA was finalizing a sales restriction date and “manufacture-by” or “import-by” date of January 1, 2018. Id. EPA also noted this was consistent with past practice in a Significant New Alternatives Policy (SNAP) Program rule (id., citing 80 FR 42901; July 20, 2015). For all of these reasons, EPA continues to support the approach articulated in the 2016 final rule and is finalizing the revisions in the September 28, 2017 proposal, so that EPA's intent in the 2016 final rule to have a sales restriction date be based on a “manufacture-by” or “import-by” date of January 1, 2018 is effectuated.

    5 EPA additionally notes that to the extent that the comments are based on a premise that the provision applies to containers that hold ozone-depleting refrigerants, that premise is mistaken, as explained in a later comment response.

    EPA received one comment that EPA should require self-sealing valves for all refrigerants in order to prevent inadvertent release of ozone-depleting substances (ODS). This comment is outside of the scope of this rulemaking, which clarifies the status of small cans of non-exempt substitute refrigerant for use in MVACs that were manufactured or imported prior to January 1, 2018. The exemption at issue in this rule does not apply to any container that contains ODS. Further, there are no ODS that are allowed to be sold in small cans for MVAC use. All ODS refrigerants are subject to a sales restriction that places restrictions on the sale of such substances to people who are certified technicians (40 CFR 82.154(c)). Given there are no ODS MVAC refrigerants currently sold in small cans and given that all ODS refrigerants are subject to the sales restriction, EPA did not propose to require self-sealing valves on small cans of ODS MVAC refrigerant and is not finalizing such a requirement.

    EPA received one comment that the agency should not allow the sale of small cans of MVAC refrigerants because instead of taking corrective measures and replacing leaking refrigeration system components, business owners are purchasing these small cans at automotive stores and recharging commercial equipment themselves. This comment is likewise outside the scope of this action. EPA did not propose to eliminate or revise the aspects of the provision at 40 CFR 82.154(c)(1)(ix) that allows the continued sale of small cans of MVAC refrigerants to people who are not certified technicians subject to certain conditions (for example, that they have a self-sealing valve) and is not finalizing such a provision.

    One comment asked whether self-sealing valves are required for small containers of R-134a, a non-exempt substitute refrigerant used in MVACs, if they are sold only to certified technicians. EPA responds that the self-sealing valve specifications at 40 CFR 82.154(c)(2) establish eligibility for the exception from the sales restriction at 40 CFR 82.154(c)(1)(ix). If the buyer is a certified technician, then adherence to 40 CFR 82.154(c)(2) would not be required, but the seller would be responsible for the recordkeeping at 40 CFR 82.154(c)(3).

    EPA also received a comment suggesting that EPA consider a future regulatory action to require that small cans of MVAC refrigerant be labeled with the date of manufacture. EPA appreciates the suggestion. As noted by the commenter, however, this comment is outside the scope of this current rulemaking. In the direct final rule EPA specifically noted that “EPA is not making, and is not seeking comment on, any changes to the regulations at 40 CFR part 82, subpart F other than the revision discussed in this notice.” (82 FR 45202). EPA did not propose to require labeling of small cans of MVAC refrigerant. In addition, while EPA recognizes labels may bring increased transparency, the costs and benefits associated with this suggested revision have not been assessed. Thus, EPA is not finalizing the commenter's suggested changes at this time.

    After considering all of the comments received, EPA concludes that it is appropriate to finalize the revisions as proposed and is doing so in this final action.

    IV. Statutes and Executive Orders Review 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. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

    This action is expected to be an Executive Order 13771 deregulatory action. EPA described the potential cost savings of this action in the direct final rule. (82 FR 45202).

    C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden under the PRA. The regulatory revisions finalized in this action do not contain any information collection activities

    D. 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. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This rule does not impose any new regulatory requirements. It is deregulatory in that it clarifies that small cans of refrigerant for use in MVAC may be sold to persons who are not certified technicians even if they are not equipped with a self-sealing valve, so long as those small cans are manufactured or imported prior to January 1, 2018. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

    E. Unfunded Mandates Reform Act

    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.

    F. 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.

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

    This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. This rule does not impose any new regulatory requirements. It is deregulatory in that it corrects a potential conflict in the refrigerant management regulations as to whether or not small cans of refrigerant for use in MVAC could be sold to non-technicians if they were manufactured or imported prior to January 1, 2018, and do not have a self-sealing valve. Thus, Executive Order 13175 does not apply to this action.

    H. 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.

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

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

    J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

    This action does not affect the level of protection provided to human health or the environment. This action corrects a potential conflict in the refrigerant management regulations as to whether or not small cans of refrigerant for use in MVAC could be sold to non-technicians if the cans were manufactured or imported prior to January 1, 2018, and do not have a self-sealing valve. This action clarifies that those small cans of refrigerant for use in MVAC may be sold to persons who are not certified technicians.

    L. Congressional Review Act (CRA)

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

    List of Subjects in 40 CFR Part 82

    Environmental protection, Air pollution control, Chemicals, Reporting and recordkeeping requirements.

    Dated: December 15, 2017. E. Scott Pruitt, Administrator.

    For the reasons set forth in the preamble, the Environmental Protection Agency amends 40 CFR part 82 as follows:

    PART 82—PROTECTION OF STRATOSPHERIC OZONE 1. The authority citation for part 82 continues to read as follows: Authority:

    42 U.S.C. 7414, 7601, 7671-7671q.

    2. In § 82.154, revise paragraph (c)(1)(ix) to read as follows:
    § 82.154 Prohibitions.

    (c) * * *

    (1) * * *

    (ix) The non-exempt substitute refrigerant is intended for use in an MVAC and is sold in a container designed to hold two pounds or less of refrigerant, has a unique fitting, and, if manufactured or imported on or after January 1, 2018, has a self-sealing valve that complies with the requirements of paragraph (c)(2) of this section.

    [FR Doc. 2017-27800 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 414, 416, and 419 [CMS-1678-CN] RIN 0938-AT03 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Final rule; correction.

    SUMMARY:

    This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled “Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.”

    DATES:

    Effective Date: January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Lela Strong (410) 786-3213.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In FR Doc. R1-2017-23932 of December 14, 2017 (82 FR 59216), titled “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” (hereinafter referred to as the CY 2018 OPPS/ASC final rule), there were a number of technical errors that are identified and corrected in the Correction of Errors section below. The provisions in this correction document are effective as if they had been included in the document published December 14, 2017. Accordingly, the corrections are effective January 1, 2018.

    We note that the CY 2018 OPPS/ASC final rule was originally published on pages 52356 through 52637 in the issue of Monday, November 13, 2017. In that publication, a section of the document was omitted due to a printing error. Therefore, on December 14, 2017, the CY 2018 OPPS/ASC final rule was republished in its entirety. Accordingly, any corrections made in this document are made to the December 14, 2017 republished version.

    II. Summary of Errors A. Errors in the Preamble 1. Hospital Outpatient Prospective Payment System (OPPS) Corrections

    On page 59256, we are correcting the OPPS weight scalar based on the conforming policy correction to the Ambulatory Payment Classification (APC) assignment of Healthcare Common Procedure Coding System (HCPCS) code 93880 in APC 5522 (Level 2 Imaging without Contrast) to APC 5523 (Level 3 Imaging without Contrast).

    On page 59262, we are correcting language related to hospital-specific Cost-to-Charge Ratios (CCRs) and their application on payments for pass-through devices.

    On pages 59269 through 59271, we use the payment rates available in Addenda A and B to display calculation of adjusted payment and copayment. Due to the correction of OPPS payment rates as a result of the corrected OPPS weight scalar, we are also correcting the payment and copayment numbers used in the example.

    On page 59277, due to the corrected OPPS APC geometric mean cost as a result of the conforming policy correction to the imaging without contrast APCs, we are correcting the list of APCs excepted from the 2 times rule for calendar year (CY) 2018. Specifically, we are revising Table 14 to include APC 5523 (Level 3 Imaging without Contrast) to this list, for a total of 12 APCs.

    On page 59295, we inadvertently excluded a summary of a comment and our response to that comment. We are revising the discussion to include the comment and response.

    On page 59311, due to the correction in OPPS APC geometric mean cost as a result of the conforming policy correction to the imaging without contrast APCs in Addendum A and Addendum B, we are also correcting the CY 2018 APC geometric mean cost for APC 5522 (Level 2 Imaging without Contrast) and APC 5523 (Level 3 Imaging without Contrast) in Table 54 as well as in the OPPS Addenda A and B.

    On page 59323, we incorrectly listed the HCPCS code that describes Lung biopsy plug with delivery system as C2623 instead of C2613.

    On page 59369, we inadvertently omitted vaccines assigned to OPPS status indicator “F” from the 340B payment adjustment exclusion. Specifically, we stated in the preamble that “We remind readers that our 340B payment policy applies to only OPPS separately payable drugs (status indicator “K”) and does not apply to vaccines (status indicator “L” or “M”), or drugs with transitional pass-through payment status (status indicator “G”).” We are correcting this statement to read “We remind readers that our 340B payment policy applies to only OPPS separately payable drugs (status indicator “K”) and does not apply to vaccines (status indicator “F”, “L” or “M”), or drugs with transitional pass-through payment status (status indicator “G”).” In addition, we are also correcting the statement on page 59369 that reads “Part B drugs or biologicals excluded from the 340B payment adjustment include vaccines (assigned status indicator “L” or “M”) and drugs with OPPS transitional pass-through payment status (assigned status indicator “G”)” to correctly state our final policy that “Part B drugs or biologicals excluded from the 340B payment adjustment include vaccines (assigned status indicator “F”, “L” or “M”) and drugs with OPPS transitional pass-through payment status (assigned status indicator “G”).”

    On pages 59412 through 59413, we are correcting a typographical error in the title of Table 87.

    On pages 59482 through 59483, we are correcting the count of excepted Rural Sole Community Hospitals as well as the count of other providers that were listed in regards to the 340B Program.

    On pages 59486 through 59488, we provided and described Table 88—Estimated Impact of the CY 2018 Changes for the Hospital Outpatient Prospective Payment System, based on rates which applied an incorrect scalar. We have updated Table 88 and the description of the table to reflect the corrections to the scalar as a result of the corrections to geometric mean costs in APCs 5522 and 5523.

    2. Ambulatory Surgical Center (ASC) Payment System Corrections

    On page 59413, the discussion of ASC Payment for Covered Ancillary Services for CY 2018 was inadvertently omitted. We are including that discussion in this correcting document.

    On page 59422, we inadvertently published an incorrect ASC conversion factor of $44.663 for ASCs that do not meet the quality reporting requirements. With the correct application of our established policy, the corrected 2018 ASC conversion factor for ASCs that do not meet the quality reporting requirements is $44.674.

    3. Partial Hospitalization Program Corrections

    On page 59375, the text states: “We proposed to apply our established methodologies in developing the CY 2018 geometric mean per diem costs and payment rates, including the application of a ±2 standard deviation trim on costs per day for CMHCs and a CCR≤5 hospital service day trim for hospital-based PHP providers.” The less than or equal to sign that appears in this sentence is incorrect and misstates our trim policy. Therefore, we are correcting “CCR≤5” to read “CCR>5.”

    B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted on the CMS Website 1. OPPS Addenda Posted on the CMS Website

    The payment and copayment rates in Addendum A (Final OPPS APCs for CY 2018), Addendum B (Final OPPS Payment by HCPCS Code for CY 2018), Addendum C (Final HCPCS Codes Payable Under the 2018 OPPS by APC), and the payment rates in the 2018 OPPS APC Offset File and the 2018 OPPS HCPCS Device Offset File that were published on the CMS website in conjunction with the CY 2018 OPPS/ASC final rule are corrected to reflect the corrected assignment of HCPCS code 93880 to APC 5522 (Level 2 Imaging without Contrast) and APC 5523 (Level 3 Imaging without Contrast).

    In addition, in Addendum B, 17 HCPCS codes were incorrectly assigned to OPPS status indicator “Q4” when they should have been assigned to status indicator “A.” We are correcting the mistake by assigning status indicator “A” to these codes as shown in the chart that follows.

    HCPCS code Short descriptor CI SI 81105 Hpa-1 genotyping NC A 81106 Hpa-2 genotyping NC A 81107 Hpa-3 genotyping NC A 81108 Hpa-4 genotyping NC A 81109 Hpa-5 genotyping NC A 81110 Hpa-6 genotyping NC A 81111 Hpa-9 genotyping NC A 81112 Hpa-15 genotyping NC A 81120 Idh1 common variants NC A 81121 Idh2 common variants NC A 81175 Asxl1 full gene sequence NC A 81176 Asxl1 gene target seq alys NC A 81448 Hrdtry perph neurphy panel NC A 81520 Onc breast mrna 58 genes NC A 81521 Onc breast mrna 70 genes NC A 81541 Onc prostate mrna 46 genes NC A 81551 Onc prostate 3 genes NC A

    In Addendum M, we inadvertently excluded Current Procedural Terminology (CPT) codes 71045 (Radiologic examination, chest; single view) and 71046 (Radiologic examination, chest; 2 views). The revised Addendum M includes these codes. CPT codes 71045 and 71046 replaced CPT codes 71010 (Radiologic examination, chest; single view, frontal) and 71020 (Radiologic examination, chest, 2 views, frontal and lateral; with apical lordotic procedure) effective January 1, 2018. Since the predecessor codes were assigned to composite APC 5041 (Critical Care) and APC 5045 (Trauma Response with Critical Care) before January 1, 2018, the replacement codes are assigned to the same composite APCs effective January 1, 2018.

    In Addendum P, we inadvertently excluded the following 7 CPT codes:

    • 0409T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; pulse generator only);

    • 0410T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; atrial electrode only);

    • 0411T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; ventricular electrode only);

    • 0414T (Removal and replacement of permanent cardiac contractility modulation system pulse generator only);

    • 0446T (Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training);

    • 0449T (Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; initial device); and

    • 28291 (Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant).

    CPT codes 0409T, 0410T, 0411T, 0414T, 0446T, 0449T represent procedures requiring the implantation of medical devices that do not have yet have associated claims data and therefore have been granted device-intensive status with a default device offset percentage of 41 percent, per our current policy outlined in the CY 2017 OPPS/ASC final rule with comment (81 FR 79658). CPT code 28291 replaced CPT code 28293 (Correction, hallux valgus (bunion), with or without sesamoidectomy; resection of joint with implant) which previously held the device-intensive designation with a device offset percentage of 43.78 percent. Since the predecessor code was device-intensive, CPT code 28291 is also device-intensive status and a device offset percentage of 43.78 percent based on the offset from the predecessor code.

    To view the corrected CY 2018 OPPS status indicator, payment and copayment rates, that result from these technical corrections as well as CPT codes that were inadvertently excluded, we refer readers to the Addenda and supporting files that are posted on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Select “CMS-1678-CN” from the list of regulations. All corrected Addenda for this correcting document are contained in the zipped folder titled “2018 OPPS Final Rule Addenda” at the bottom of the page for CMS-1678-CN.

    2. ASC Payment System Addenda Posted on the CMS Website

    As a result of the technical corrections described in Section II.A. and II.B.1. of this correction notice, we have updated Addenda AA and BB to reflect the final corrected payment rates and indicators for CY 2018 for ASC covered surgical procedures and covered ancillary services. In addition, in addendum BB, we inadvertently included HCPCS code Q2040 (Tisagenlecleucel, up to 250 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per infusion) as a separately payable drug when furnished in the ASC setting. Because the complement of services required to furnish the drug described by HCPCS code Q2040 are not all covered ASC surgical procedures, we are correcting the error by removing HCPCS code Q2040 from Addendum BB.

    To view the corrected final CY 2018 ASC payment rates and indicators that result from these technical corrections, we refer readers to the Addenda and supporting files on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.html. Select “CMS-1678-CN” from the list of regulations. All corrected ASC addenda for this correcting document are contained in the zipped folder entitled “Addendum AA, BB, DD1, DD2, and EE” at the bottom of the page for CMS-1678-CN.

    In addition, we inadvertently excluded the below nine codes from the file labeled “CY 2018 ASC Procedures to which the No Cost/Full Credit and Partial Credit Device Adjustment Policy Applies”. These nine codes were included as ASC device-intensive procedures to which the no cost/full credit and partial credit device adjustment policy applies in the CY 2017 final rule, and we did not intend any changes to them for CY 2018.

    • 0409T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; pulse generator only);

    • 0410T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; atrial electrode only);

    • 0411T (Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; ventricular electrode only);

    • 0414T (Removal and replacement of permanent cardiac contractility modulation system pulse generator only);

    • 0446T (Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training);

    • 0449T (Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; initial device);

    • 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level);

    • 22869 (Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level); and

    • 28291 (Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant).

    To view the revised version of the “CY 2018 ASC Procedures to which the No Cost/Full Credit and Partial Credit Device Adjustment Policy Applies,” we refer readers to the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Policy-Files.html.

    III. Waiver of Proposed Rulemaking

    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. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date of the APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

    We believe that this correcting document does not constitute a rulemaking that would be subject to these requirements. This correcting document corrects technical and typographic errors in the preamble, addenda, payment rates, tables, and appendices included or referenced in the CY 2018 OPPS/ASC final rule but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, the corrections made through this correcting document are intended to ensure that the information in the CY 2018 OPPS/ASC final rule accurately reflects the policies adopted in that rule.

    In addition, even if this were a rulemaking to which the notice and comment procedures 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 final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2018 OPPS/ASC final rule accurately reflects our policies as of the date they take effect and are applicable.

    Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply correctly implementing the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2018 OPPS/ASC final rule accurately reflects these payment methodologies and policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements.

    IV. Correction of Errors

    In FR Doc. R1-2017-23932 of December 14, 2017 (82 FR 59216), make the following corrections:

    1. On page 59256, third column, first paragraph, in line 11, correct “1.4457” to read “1.4458”.

    2. On page 59262, second column, second full paragraph, in line 7, add the parenthetical phrase “(in cases where we are unable to use the implantable device CCR)” after the words “pass-through devices”.

    3. On page 59269,

    a. Third column, last full paragraph,

    (1) In line 17, correct “$572.81” to read “$575.85.”

    (2) In line 21, correct “$561.35” to read “$561.39.”

    b. Third column, last partial paragraph,

    (1) In lines 5 and 6, correct “$442.53 (.60 * $572.81 * 1.2876).” to read “$442.56 (.60 * $575.85 * 1.2876).”

    (2) In line 9, correct “$443.68 (.60 * $561.35 * 1.2876).” to read “$443.70 (.60 * $561.39 * 1.2876).”

    (3) In line 12, correct “$229.12 (.40 * $572.81).” to read “$229.14 (.40 * $575.85).”

    4. On page 59270, first column, first partial paragraph,

    a. In line 2, correct “$224.54 (.40 * $561.35).” to read “$224.56 (.40 * $561.39).”

    b. In lines 6 and 7, correct “$671.65 ($442.53 + $229.12).” to read “$671.70 ($442.56 + $229.14).”

    c. In lines 9 and 10, correct “$658.22 ($433.68 + $224.54).” to read “$658.26 ($443.70 + $224.56).”

    5. On page 59271, first column, second full paragraph, under “Step 1,” in line 8, correct “$572.81” to read “$575.85.”

    6. On page 59277, Table 14—APC Exceptions to the 2 Times Rule for CY 2018, is corrected to read as follows:

    Table 14—APC Exceptions to the 2 Times Rule for CY 2018 APC CY 2018 APC title 5112 Level 2 Musculoskeletal Procedures 5521 Level 1 Imaging without Contrast 5522 Level 2 Imaging without Contrast 5523 Level 3 Imaging without Contrast 5524 Level 4 Imaging without Contrast 5571 Level 1 Imaging with Contrast 5691 Level 1 Drug Administration 5721 Level 1 Diagnostic Tests and Related Services 5731 Level 1 Minor Procedures 5732 Level 2 Minor Procedures 5771 Cardiac Rehabilitation 5823 Level 3 Health and Behavior Services

    7. On page 59295, third column,

    a. After the first partial paragraph, add the following comment and response:

    Comment: We received a comment to the CY 2018 OPPS/ASC proposed rule requesting the reassignment of the procedures assigned to APCs 5361 (Level 1 Laparoscopy and Related Services) and 5362 (Level 2 Laparoscopy and Related Services) to ensure a more logical distribution of procedure costs between these two APCs.

    Response: We appreciate the suggestion and will consider for future rulemaking. We note that in the CY 2018 OPPS/ASC proposed rule, there was no violation of the 2 times rule for either APC 5361 or APC 5362.

    b. First full paragraph, in line 2, correct “comment” to read “comments”.

    8. On page 59311, Table 54—Comparison of CY 2017 and CY 2018 Geometric Mean Costs For The Imaging APCs, is corrected to read as follows:

    Table 54-Comparison of CY 2017 and CY 2018 Geometric Mean Costs for the Imaging APCs APC APC group title CY 2017 APC
  • geometric mean cost
  • CY 2018 APC
  • geometric mean cost
  • 5521 Level 1 Imaging without Contrast $61.53 $62.08 5522 Level 2 Imaging without Contrast 115.88 114.39 5523 Level 3 Imaging without Contrast 232.21 232.17 5524 Level 4 Imaging without Contrast 462.23 486.38 5571 Level 1 Imaging with Contrast 272.40 252.58 5572 Level 2 Imaging with Contrast 438.42 456.08 5573 Level 3 Imaging with Contrast 675.23 681.45

    9. On page 59323, second column, second full paragraph, in line 4, correct “C2623” to read “C2613”.

    10. On page 59369,

    a. Second column, second full paragraph, in line 5, correct “status indicator “L” or “M”” to read “status indicator “F”, “L”, or “M””.

    b. Third column, first full paragraph, in line 19, correct “status indicator “L” or “M”” to read “status indicator “F”, “L”, or “M””.

    11. On page 59375, second column, third full paragraph, in line 7, correct “CCR ≤5” to read “CCR>5”.

    12. On pages 59412 and 59413, in the title for Table 87, correct “ASDC” to read “ASC”.

    13. On page 59413, second column, after the second full paragraph, add the following paragraphs before the section titled, “D. ASC Payment for Covered Surgical Procedures and Covered Ancillary Services”:

    “2. Covered Ancillary Services

    Consistent with the established ASC payment system policy, in the CY 2018 OPPS/ASC proposed rule (82 FR 33662) we proposed to update the ASC list of covered ancillary services to reflect the payment status for the services under the CY 2018 OPPS. We noted that maintaining consistency with the OPPS may result in proposed changes to ASC payment indicators for some covered ancillary services because of changes that are being finalized under the OPPS for CY 2018. For example, a covered ancillary service that was separately paid under the ASC payment system in CY 2017 may be proposed for packaged status under the CY 2018 OPPS and, therefore, also under the ASC payment system for CY 2018.

    To maintain consistency with the OPPS, we proposed to continue this reconciliation of packaged status for the ASC payment system for CY 2018. Comment indicator “CH,” discussed in section XII.F. of the proposed rule, was used in Addendum BB to the proposed rule (which is available via the internet on the CMS website) to indicate covered ancillary services for which we proposed a change in the ASC payment indicator to reflect a proposed change in the OPPS treatment of the service for CY 2018.

    We included all ASC covered ancillary services and their proposed payment indicators for CY 2018 in Addendum BB to the proposed rule. We invited public comments on this proposal.

    We did not receive any public comments on these proposals. Therefore, we are finalizing, without modification, our proposal to update the ASC list of covered ancillary services to reflect the payment status for the services under the OPPS. All CY 2018 ASC covered ancillary services and their final payment indicators are included in Addendum BB to this final rule (which is available via the internet on the CMS website).”

    14. On page 59422, first column, first partial paragraph, in line 1, correct “44.663” to read “44.674”.

    15. On page 59482, third column, second partial paragraph, in line 43, correct “270” to read “247”.

    16. On page 59483, first column, third partial paragraph, in line 29, correct “$199” to read “$169”.

    17. On page 59486,

    a. First column, first full paragraph, in line 16, correct “0.5” to read “0.6”.

    b. Third column, first full paragraph, in line 6, correct “1.2” to read “1.3”.

    18. On page 59487 through 59488, Table 88—Estimated Impact of the CY 2018 Changes for the Hospital Outpatient Prospective Payment System, is corrected to read as follows:

    Table 88—Estimated Impact of the CY 2018 Changes for the Hospital Outpatient Prospective Payment System Number of
  • hospitals
  • APC
  • recalibration
  • (all changes)
  • New wage
  • index and
  • provider
  • adjustments
  • 340B
  • adjustment
  • All budget
  • neutral
  • changes
  • (combined cols 2-4)
  • with market
  • basket update
  • All changes
    (1) (2) (3) (4) (5) (6) ALL PROVIDERS * 3,878 0.0 0.0 0.0 1.3 1.4 ALL HOSPITALS (excludes hospitals held harmless and CMHCs) 3,765 0.0 0.1 −0.1 1.4 1.5 URBAN HOSPITALS 2,951 0.1 0.1 −0.3 1.3 1.3 LARGE URBAN (GT 1 MILL.) 1,589 0.1 0.0 −0.2 1.2 1.3 OTHER URBAN (LE 1 MILL.) 1,362 0.0 0.2 −0.3 1.3 1.4 RURAL HOSPITALS 814 −0.3 0.0 1.4 2.5 2.7 SOLE COMMUNITY 372 −0.2 0.1 2.6 3.9 4.0 OTHER RURAL 442 −0.4 −0.2 0.0 0.8 0.9 BEDS (URBAN): 0-99 BEDS 1,021 0.0 0.0 1.9 3.3 3.4 100-199 BEDS 850 0.0 0.2 1.2 2.8 2.9 200-299 BEDS 468 0.1 0.1 0.5 2.0 2.1 300-499 BEDS 399 0.1 0.0 −0.4 1.1 1.2 500 + BEDS 213 0.0 0.1 −2.2 −0.7 −0.6 BEDS (RURAL): 0-49 BEDS 333 −0.6 −0.2 2.1 2.7 2.9 50-100 BEDS 297 −0.2 −0.2 1.9 2.8 3.0 101-149 BEDS 97 −0.3 0.1 1.1 2.3 2.4 150-199 BEDS 49 −0.2 0.1 0.7 2.0 2.1 200 + BEDS 38 −0.3 0.4 0.8 2.4 2.5 REGION (URBAN): NEW ENGLAND 144 0.2 0.4 −0.2 1.7 1.8 MIDDLE ATLANTIC 348 0.1 −0.2 −0.1 1.2 1.3 SOUTH ATLANTIC 463 0.0 0.3 −0.4 1.3 1.4 EAST NORTH CENT 471 0.0 0.1 −0.2 1.3 1.4 EAST SOUTH CENT 178 −0.1 −0.1 −1.6 −0.4 −0.3 WEST NORTH CENT 191 0.1 0.5 −0.6 1.4 1.5 WEST SOUTH CENT 513 0.0 0.3 0.9 2.5 2.6 MOUNTAIN 211 0.3 −0.9 −0.2 0.5 0.7 PACIFIC 383 0.1 0.0 −0.6 0.8 0.9 PUERTO RICO 49 −0.4 0.2 2.9 4.1 4.2 REGION (RURAL): NEW ENGLAND 21 0.1 1.5 1.2 4.2 4.2 MIDDLE ATLANTIC 53 −0.1 −0.5 1.8 2.5 2.7 SOUTH ATLANTIC 124 −0.4 −0.6 0.7 1.1 1.2 EAST NORTH CENT 122 −0.2 0.0 1.5 2.7 2.8 EAST SOUTH CENT 155 −0.6 −0.1 0.0 0.7 0.8 WEST NORTH CENT 98 −0.1 0.2 2.4 3.9 4.1 WEST SOUTH CENT 161 −0.7 0.3 2.6 3.6 3.7 MOUNTAIN 56 0.0 −0.3 1.9 2.9 3.3 PACIFIC 24 −0.2 0.1 1.7 3.0 3.0 TEACHING STATUS: NON-TEACHING 2,655 −0.1 0.1 1.3 2.8 2.9 MINOR 761 0.1 0.1 0.1 1.6 1.7 MAJOR 349 0.1 0.0 −2.4 −1.0 −0.9 DSH PATIENT PERCENT: 0 10 0.0 0.2 3.2 4.8 4.9 GT 0-0.10 272 0.2 −0.1 2.8 4.4 4.5 0.10-0.16 263 0.2 0.0 2.7 4.3 4.4 0.16-0.23 572 0.1 0.3 2.6 4.4 4.5 0.23-0.35 1132 0.0 0.1 −0.4 1.0 1.2 GE 0.35 935 0.0 0.0 −2.2 −0.9 −0.8 DSH NOT AVAILABLE ** 581 −2.0 0.1 2.0 1.4 1.6 URBAN TEACHING/DSH: TEACHING & DSH 1,002 0.1 0.0 −1.1 0.3 0.4 NO TEACHING/DSH 1,386 0.1 0.2 1.3 2.9 3.0 NO TEACHING/NO DSH 10 0.0 0.2 3.2 4.8 4.9 DSH NOT AVAILABLE2 553 −1.9 0.1 1.9 1.4 1.6 TYPE OF OWNERSHIP: VOLUNTARY 1,979 0.0 0.0 −0.3 1.2 1.3 PROPRIETARY 1,293 0.1 0.1 2.7 4.3 4.5 GOVERNMENT 493 −0.1 0.2 −1.6 −0.1 0.0 CMHCs 49 12.5 0.2 3.2 17.8 17.9 Column (1) shows total hospitals and/or CMHCs. Column (2) includes all final CY 2018 OPPS policies and compares those to the CY 2017 OPPS. Column (3) shows the budget neutral impact of updating the wage index by applying the FY 2018 hospital inpatient wage index, including all hold harmless policies and transitional wages. The rural adjustment continues our current policy of 7.1 percent so the budget neutrality factor is 1. The budget neutrality adjustment for the cancer hospital adjustment is 1.0008 because the target payment-to-cost ratio changes from 0.91 in CY 2017 to 0.89 in CY 2018 and is further reduced by 1 percentage point to 0.88 in accordance with the 21st Century Cures Act. However, this reduction does not affect the budget neutrality adjustment consistent with statute. Column (4) shows the impact of the 340B drug payment reductions and the corresponding increase in non-drug payments. Column (5) shows the impact of all budget neutrality adjustments and the addition of the 1.35 percent OPD fee schedule update factor (2.7 percent reduced by 0.6 percentage points for the productivity adjustment and further reduced by 0.75 percentage point as required by law). Column (6) shows the additional adjustments to the conversion factor resulting from the frontier adjustment, a change in the pass-through estimate, and adding estimated outlier payments. These 3,878 providers include children and cancer hospitals, which are held harmless to pre-BBA amounts, and CMHCs. ** Complete DSH numbers are not available for providers that are not paid under IPPS, including rehabilitation, psychiatric, and long-term care hospitals.

    19. On page 59488, bottom third of the page,

    a. Second column, first partial paragraph, in line 6, correct “17.2” to read “17.9”.

    b. Third column, first partial paragraph, in line 10, correct “17.2” to read “17.9”.

    Dated: December 20, 2017. Ann C. Agnew, Executive Secretary to the Department, Department of Health and Human Services.
    [FR Doc. 2017-27949 Filed 12-22-17; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 161020985-7181-02] RIN 0648-XF908 Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is reallocating the projected unused amount of Pacific cod from catcher vessels equal to or greater than 60 feet (18.3 meters) length overall (LOA) using pot gear to catcher/processors (C/Ps) using pot gear, catcher vessels less than 60 feet (18.3 meters) LOA using hook-and-line or pot gear, and C/Ps using hook-and-line gear in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2017 total allowable catch of Pacific cod to be harvested.

    DATES:

    Effective December 21, 2017, through 2400 hours, Alaska local time (A.l.t.), December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2017 Pacific cod total allowable catch (TAC) specified for catcher vessels greater than or equal to 60 feet LOA using pot gear in the BSAI is 15,389 metric tons (mt) as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and reallocation (82 FR 47162, October 11, 2017).

    The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that catcher vessels greater than or equal to 60 feet LOA using pot gear will not be able to harvest 1,500 mt of the remaining 2017 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(5). Therefore, in accordance with § 679.20(a)(7)(iii), taking into account the capabilities of the sectors to harvest reallocated amounts of Pacific cod, and following the hierarchies set forth in § 679.20(a)(7)(iii)(A) and § 679.20(a)(7)(iii)(B), NMFS reallocates 155 mt of Pacific cod to C/Ps using pot gear, 200 mt to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear, and 1,145 mt to C/Ps using hook-and-line gear.

    The harvest specifications for Pacific cod included in the final 2017 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and reallocations (FR 57162, December 4, 2017; 82 FR 43503, September 18, 2017; 82 FR 41899, September 5, 2017; and 82 FR 8905, February 1, 2017; 82) are revised as follows: 13,889 mt for catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear, 4,999 mt for C/Ps using pot gear, 9,271 mt for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear, and 107,589 mt for C/Ps using hook-and-line gear.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from catcher vessels greater than or equal to 60 feet (18.3 m) LOA using pot gear to C/Ps using pot gear, catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear, and catcher/processors using hook-and-line gear in the BSAI management area. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 6, 2017.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 21, 2017. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-27873 Filed 12-21-17; 4:15 pm] BILLING CODE 3510-22-P
    82 247 Wednesday, December 27, 2017 Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2017-N-5476] Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; petition for rulemaking; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 21, 2017, proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.

    DATES:

    FDA is reopening the comment period on the notice of petition published in the Federal Register of September 21, 2017 (82 FR 44128). Submit either electronic or written comments by January 26, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-N-5476 for “Food Additives Permitted in Feed and Drinking Water of Animals; glyceryl polyethylene glycol (15) ricinoleate.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Chelsea Trull, Center for Veterinary Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of September 21, 2017 (82 FR 44128), FDA gave notice that Akzo Nobel Surface Chemistry AB had filed a petition to amend Title 21 of the Code of Federal Regulations in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture.

    Interested persons were originally given until October 23, 2017, to comment on the petitioner's environmental assessment.

    The environmental assessment was not placed on public display until October 13, 2017. On our own initiative, we are reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent environmental issues. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on this important issue.

    Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-27840 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 175 [167A2100DD/AAKC001030/A0A501010.999900 253G] RIN 1076-AF31 Indian Electric Power Utilities AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule revises regulations addressing electric power utilities of the Colorado River, Flathead, and San Carlos Indian irrigation projects to use plain language, update definitions, lengthen a regulatory deadline, and make other minor changes.

    DATES:

    Comments must be received on or before February 26, 2018.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal eRulemaking Portal: www.regulations.gov. Search for Docket No. BIA-2016-0002 and follow the instructions for submitting comments.

    Mail, Hand Delivery, or Courier: Elizabeth Appel, Director, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, Attn: 1076-AF31, U.S. Dept. of the Interior, 1849 C Street NW, Mail Stop 3642, Washington, DC 20240.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Appel, Director, Office of Regulatory Affairs and Collaborative Action, Office of the Assistant Secretary—Indian Affairs; telephone (202) 273-4680, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background II. Description of Changes III. Procedural Requirements A. Regulatory Planning and Review (E.O.s 12866 and 13563) and Reducing Regulation and Controlling Regulatory Costs (E.O. 13771) B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act D. Unfunded Mandates Reform Act E. Takings (E.O. 12630) F. Federalism (E.O. 13132) G. Civil Justice Reform (E.O. 12988) H. Consultation With Indian Tribes (E.O. 13175) I. Paperwork Reduction Act J. National Environmental Policy Act K. Effects on the Energy Supply (E.O. 13211) L. Clarity of This Regulation I. Background

    Various statutes provide the Bureau of Indian Affairs (BIA) with authority to issue this regulation and for administering electric power utilities for the Colorado River, Flathead (Mission Valley Power), and San Carlos Indian irrigation projects. For example, see 5 U.S.C. 301; 25 U.S.C. 13; 25 U.S.C. 385c; 43 Stat. 475-76; 45 Stat. 210-13; 49 Stat. 1039-40; 49 Stat. 1822-23; 54 Stat. 422; 62 Stat. 269-73; 65 Stat. 254; 99 Stat. 319-20. Each of these power projects provides energy, transmission, and distribution of electrical services to customers in their respective service areas. BIA (or the contracting/compacting Indian Tribe) provides oversight and limited technical assistance for power projects and conducts operations and maintenance of the distribution systems.

    The regulations addressing BIA's administration of the power utilities are at 25 CFR part 175, Indian Electric Power Utilities. These regulations were last updated in 1991.

    II. Description of Changes

    The revisions being proposed today are intended to make the regulations more user-friendly through plain language. The proposed rule would also update definitions, lengthen the time by which BIA must issue a decision on an appeal from 30 days to 60 days (by referring to 25 CFR 2.19(a)), and require publication of rate adjustments in the Federal Register. The following tables summarize the proposed changes:

    Current 25 CFR
  • section
  • Proposed 25 CFR section Summary of proposed changes
    175.1 Definitions 175.100 What terms should I know for this part? Deletes the definitions of “appellant” and “officer-in-charge.”
  • Adds definitions for “bill,” “CFR,” “day(s),” “delinquent,” “due date,” “electric energy,” “energy,” “fee,” “I, me, my, you, and your,” “must,” “past due bill,” “power,” “public notice,” “purchased power,” “taxpayer identification number,” “utility(ies),” and “we, us, and our.”
  • Replaces definition of “Area Director” with a definition of “BIA.”
  • Revises the definition of “customer,” “electric power utility,” “electric service,” “operations manual,” “service,” “service fee.”
  • Revises the definition of “power rate” and replaces it with the terms “rate” and “electric power rate.”
  • Revises the definition of “service agreement” and replaces it with the term “agreement.”
  • Revises the definition of “special contract” and replaces it with the term “special agreement.”
  • 175.2 Purpose 175.105 What is the purpose of this part? Revises for plain language. 175.3 Compliance 175.110 Does this part apply to me? Revises for plain language. 175.4 Authority of area director N/A Deletes provisions containing delegations of authority to eliminate possible conflicts with the Departmental Delegations of Authority. 175.5 Operations manual 175.115 How does BIA administer its electric power utilities?
  • 175.120 What are Operations Manuals?
  • Revises for plain language, deletes specific means by which public notice of changes will be provided, and incorporates instead the definition of “public notice,” which provides for publishing information consistent with the operations manual.
    175.6 Information collection 175.600 How does the Paperwork Reduction Act affect this part? Revises for plain language. 175.10 Revenues collected from power operations 175.200 Why does BIA collect revenue from you and the other customers it serves, and how is that revenue used?
  • 175.205 When are BIA rates and fees reviewed?
  • Revises for plain language and deletes amortization as an example for what BIA may use revenue.
    175.11 Procedures for setting service fees 175.210 What is BIA's procedure for setting service fees? Deletes provisions containing delegations of authority to eliminate possible conflicts with Departmental Delegations of Authority. 175.12 Procedures for adjusting electric power rates except for adjustments due to changes in the cost of purchased power or energy 175.215 What is BIA's procedure for adjusting electric power rates?
  • 175.220 How long do rate and fee adjustments stay in effect?
  • Adds a requirement for BIA to publish a proposed rate adjustment in the Federal Register.
    175.13 Procedures for adjusting electric power rates to reflect changes in the cost of purchased power or energy 175.235 How does BIA include changes in purchased power costs to our electric power rates? Revises for plain language. 175.20 Gratuities N/A This section is deleted because it is already addressed by other laws. 175.21 Discontinuance of service 175.315 What will happen if I do not pay my bill? Revises for plain language. 175.22 Requirements for receiving electrical service 175.125 How do I request and receive service? Revises for plain language. 175.23 Customer responsibilities N/A Deleted because this provision is for a project-specific authority addressed at the local BIA level. 175.24 Utility responsibilities N/A Incorporates the substance into proposed sections 175.115 and 175.120, which refer to operations manual instead of setting out responsibilities. 175.30 Billing 175.300 How does BIA calculate my electric bill? Revises for plain language. 175.31 Methods and terms of payment 175.310 How do I pay my bill? Replaces provision stating that the utility may refuse, for cause, to accept personal checks with a general statement that the electric utility that serves you may provide additional requirements. 175.32 Collections 175.315 What will happen if I do not pay my bill?
  • 175.320 What will happen if my service is disconnected and my account remains delinquent?
  • Revises for plain language.
    175.40 Financing of extensions and upgrades 175.400 Will the utility extend or upgrade its electric system to serve new or increased loads? Revises to direct customers to contact the electric power utility for more information. 175.50 Obtaining rights-of-way 175.500 How does BIA manage rights-of-way? Revises to direct customers to contact the electric power utility for more information. 175.51 Ownership. 175.60 Appeals to the area director 175.145 Can I appeal a BIA decision? Combines current sections 175.60 and 175.61 into a paragraph that refers to 25 CFR part 2 rather than explicitly stating appeal procedures. Increases the time by which BIA must issue a decision on an appeal from 30 days to 60 days (see 25 CFR 2.19(a)).
  • Adds a new paragraph (b) to clarify that a customer must pay the bill to continue to receive service.
  • Incorporates section 175.62 into new paragraphs (c) through (e).
  • 175.61 Appeals to the Interior Board of Indian Appeals. 175.62 Utility actions pending the appeal process.
    New Provisions Current 25 CFR
  • section
  • Proposed 25 CFR section Summary of proposed changes
    N/A 175.130 What information must I provide when I request service? New section. N/A 175.135 Why is BIA collecting this information? New section. N/A 175.140 What is BIA's authority to collect my taxpayer identification number? New section. N/A 175.225 What is the Federal Register, and where can I get it? New section. N/A 175.230 Why are changes to purchased power costs not included in the procedure for adjusting electric power rates? New section. N/A 175.320 What will happen if my service is disconnected and my account remains delinquent? New section. N/A 175.305 When is my bill due? New section.
    III. Procedural Requirements A. Regulatory Planning and Review (E.O.s 12866 and 13563) and Reducing Regulation and Controlling Regulatory Costs (E.O. 13771)

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

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

    This proposed rule is not expected to be an E.O. 13771 regulatory action because this proposed rule is not significant under E.O. 12866.

    B. Regulatory Flexibility Act

    This document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rule does not make any changes to electric power rates or service fees.

    C. Small Business Regulatory Enforcement Fairness Act

    This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

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

    (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions;

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

    D. Unfunded Mandates Reform Act

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

    E. Takings (E.O. 12630)

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

    F. Federalism (E.O. 13132)

    Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. A Federalism summary impact statement is not required.

    G. Civil Justice Reform (E.O. 12988)

    This rule complies with the requirements of E.O. 12988. Specifically, this rule:

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

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

    H. Consultation With Indian Tribes (E.O. 13175 and Departmental Policy)

    The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consult with Indian Tribes and recognize their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in E.O. 13175 for substantial direct effects on federally recognized Indian Tribes and have consulted with those Tribes served by the electric power utilities subject to this rule. We hosted two in-person Tribal consultation sessions in the vicinity of Tribes served by the electric power utilities: one on April 14, 2016, in Pablo, Montana, and one on April 19, 2016, in Phoenix, Arizona. One Tribe submitted comments on the draft regulation, to which we have responded by letter because the comments are primarily unique to the local utility. If any Tribe would like additional consultation opportunities on these regulatory changes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice, preferably within the first 30 days of the comment period.

    I. Paperwork Reduction Act

    The information collection requirements contained in 25 CFR part 175 are authorized by OMB Control Number 1076-0021, with an expiration date of June 30, 2019. A submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) is not required because this proposed rule would not affect the information collection requirements contained in 25 CFR part 175. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    J. National Environmental Policy Act

    This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of an administrative nature. (For further information, see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

    K. Effects on the Energy Supply (E.O. 13211)

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

    L. Clarity of This Regulation

    We are required by Executive Orders 12866 (section 1(b)(12)), 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use common, everyday words and clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you think lists or tables would be useful, etc.

    List of Subjects in 25 CFR Part 175

    Administrative practice and procedure, Electric power, Indians-lands, Reporting and recordkeeping requirements.

    For the reasons given in the preamble, the Bureau of Indian Affairs, Department of the Interior proposes to amend chapter 1 of title 25 Code of Federal Regulations by revising part 175 to read as follows:

    PART 175—INDIAN ELECTRIC POWER UTILITIES Subpart A—General Provisions Sec. 175.100 What terms should I know for this part? 175.105 What is the purpose of this part? 175.110 Does this part apply to me? 175.115 How does BIA administer its electric power utilities? 175.120 What are Operations Manuals? 175.125 How do I request and receive service? 175.130 What information must I provide when I request service? 175.135 Why is BIA collecting this information? 175.140 What is BIA's authority to collect my taxpayer identification number? 175.145 Can I appeal a BIA decision? Subpart B—Service Fees, Electric Power Rates and Revenues 175.200 Why does BIA collect revenue from you and the other customers it serves, and how is that revenue used? 175.205 When are BIA rates and fees reviewed? 175.210 What is BIA's procedure for adjusting service fees? 175.215 What is BIA's procedure for adjusting electric power rates? 175.220 How long do rate and fee adjustments stay in effect? 175.225 What is the Federal Register, and where can I get it? 175.230 Why are changes to purchased power costs not included in the procedure for adjusting electric power rates? 175.235 How does BIA include changes in purchased power costs to our electric power rates? Subpart C—Billing, Payments, and Collections 175.300 How does BIA calculate my electric power bill? 175.305 When is my bill due? 175.310 How do I pay my bill? 175.315 What will happen if I do not pay my bill? 175.320 What will happen if my service is disconnected and my account remains delinquent? Subpart D—System Extensions and Upgrades, Rights-of-Way, and Paperwork Reduction Act 175.400 Will the utility extend or upgrade its electric system to serve new or increased loads? 175.500 How does BIA manage rights-of-way? 175.600 How does the Paperwork Reduction Act affect this part? Authority:

    5 U.S.C. 301; 25 U.S.C. 13; 25 U.S.C. 385c; 43 Stat. 475-76; 45 Stat. 210-13; 49 Stat. 1039-40; 49 Stat. 1822-23; 54 Stat. 422; 62 Stat. 269-73; 65 Stat. 254; 99 Stat. 319-20.

    Subpart A—General Provisions
    § 175.100 What terms should I know for this part?

    Agreement means the executed written form between you and the utility providing your service, except for service provided under a Special Agreement.

    BIA means the Bureau of Indian Affairs within the United States Department of the Interior or the BIA's authorized representative.

    Bill means our written statement notifying you of the charges and/or fees you owe the United States for the administration, operation, maintenance, rehabilitation, and/or construction of the electric power utility servicing you.

    CFR means Code of Federal Regulations.

    Customer means any person or entity to whom we provide service.

    Customer service is the assistance or service provided to customers, except for the actual delivery of electric power or energy. Customer service may include: Line extension, system upgrade, meter testing, connections or disconnection, special meter reading, or other assistance or service as provided in the Operations Manual.

    Day(s) means calendar day(s).

    Delinquent means an account that has not been paid and settled by the due date.

    Due date means the date by which you must pay your bill. The due date is printed on your bill.

    Electric energy (see Electric power).

    Electric power means the energy we deliver to meet customers' electrical needs.

    Electric power rate means the charges we establish for delivery of energy to our customers, which includes administration costs and operation and maintenance costs in addition to the cost of purchased power.

    Electric power utility means all structures, equipment, components, and human resources necessary for the delivery of electric service.

    Electric service means the delivery of electric power by our utility to our customers.

    Energy means electric power.

    Fee (see Service fee).

    I, me, my, you, and your means all interested parties, especially persons or entities to which we provide service and receive use of our electric power service.

    Must means an imperative or mandatory act or requirement.

    Operations manual means the written policies, practices, procedures and requirements of the utility providing your service. The Operations Manual supplements this Part and includes our responsibilities to our customers and our customers' responsibilities to the utility.

    Past due bill means a bill that has not been paid by the due date.

    Power (see Energy).

    Public notice is the notice provided by publishing information consistent with the utility's Operations Manual.

    Purchased power means the power we must purchase from power marketing providers for resale to our customers to meet changing power demands. Each of our utilities establishes its own power purchasing agreement based on its power demands and firm power availability.

    Rate (see Electric power rate).

    Reserve funds means funds held in reserve for maintenance, repairs, or unexpected expenses.

    Revenue means the monies we collect from our customers through service fees and electric power rates.

    Service (see Electric service).

    Service fee means our charge for providing or performing a specific administrative or customer service.

    Special agreement means a written agreement between you and us for special conditions or circumstances including unmetered services.

    Taxpayer identification number means either your Social Security Number or your Employer Identification Number.

    Utility(ies) (see Electric power utility).

    Utility office(s) means our facility used for conducting business with our customers and the general public.

    We, us, and our means the United States Government, the Secretary of the Interior, the BIA, and all who are authorized to represent us in matters covered under this Part.

    § 175.105 What is the purpose of this part?

    The purpose of this part is to establish the regulations for administering BIA electric power utilities.

    § 175.110 Does this part apply to me?

    This part applies to you if we provide you service or if you request service from us.

    § 175.115 How does BIA administer its electric power utilities?

    We promote efficient administration, operation, maintenance, and construction of our utilities by following and enforcing:

    (a) Applicable statutes, regulations, Executive Orders, Indian Affairs manuals, Operations Manuals;

    (b) Applicable written policies, procedures, directives, safety codes; and

    (c) Utility industry standards.

    § 175.120 What are Operations Manuals?

    (a) We maintain an Operations Manual for each of our utilities. Each utility's Operations Manual is available at the utility.

    (b) The Operations Manual sets forth the requirements for the administration, management, policies, and responsibilities of that utility and its customers.

    (c) We update our Operations Manual for each utility to reflect changing requirements to administer, operate, or maintain that utility.

    (d) When we determine it necessary to revise an Operations Manual, we will:

    (1) Provide public notice of the proposed revision;

    (2) State the effective date of the proposed revision;

    (3) State how and when to submit your comments on our proposed revision;

    (4) Provide 30 days from the date of the notice to submit your comments; and

    (5) Consider your comments and provide notice of our final decision.

    § 175.125 How do I request and receive service?

    (a) If you need electrical service in an area where we provide service, you must contact our utility in that service area.

    (b) To receive service, you must enter into an Agreement with that utility after it has determined that you have met its requirements.

    § 175.130 What information must I provide when I request service?

    At a minimum, you must provide the utility with the following information when you request service:

    (a) Your full legal name or the legal name of the entity needing service;

    (b) Your taxpayer identification number;

    (c) Your billing address;

    (d) Your service address; and

    (e) Any additional information required by the utility.

    § 175.135 Why is BIA collecting this information?

    We are collecting this information so we can:

    (a) Provide you with service;

    (b) Bill you for the service we provide; and

    (c) Account for monies you pay us, including any deposits as outlined in the Operations Manual.

    § 175.140 What is BIA's authority to collect my taxpayer identification number?

    We are required to collect your taxpayer identification number under the authority of, and as prescribed in, the Debt Collection Improvement Act of 1996, Public Law 104-134 (110 Stat. 1321-364).

    § 175.145 Can I appeal a BIA decision?

    (a) You may appeal a decision in accordance with the procedures set out in 25 CFR part 2, unless otherwise prohibited by law.

    (b) If the appeal involves the discontinuation of service, the utility is not required to resume the service during the appeal process unless the customer meets the utility's requirements.

    (c) If you appeal your bill, you must pay your bill in accordance with this part to continue to receive service from us.

    (1) If the appeal involves the amount of your bill, the bill will be considered paid under protest until the final decision has been rendered on appeal.

    (2) If you appeal your bill but do not pay the bill in full, you may not continue to receive service from us. If the final decision rendered in the appeal requires payment of the bill, the bill will be handled as a delinquent account and the amount of the bill may be subject to interest, penalties, and administrative costs pursuant to 31 U.S.C. 3717 and 31 CFR 901.9.

    (3) If the appeal involves an electric power rate, the rate will be applied and remain in effect subject to the final decision on the appeal.

    Subpart B—Service Fees, Electric Power Rates and Revenues
    § 175.200 Why does BIA collect revenue from you and the other customers it serves, and how is that revenue used?

    (a) The revenue we collect from you and the other customers is authorized by 25 U.S.C. 385c (60 Stat. 895, as amended by 65 Stat. 254).

    (b) The revenue we collect may be used to:

    (1) Pay for operation and maintenance of the utility; and

    (2) Maintain Reserve Funds to:

    (i) Make repairs and replacements to the utility;

    (ii) Defray emergency expenses;

    (iii) Ensure the continuous operation of the power system; and

    (iv) Pay other allowable expenses and obligations to the extent required or permitted by law.

    § 175.205 When are BIA rates and fees reviewed?

    We review our rates and fees at least annually to:

    (a) Determine if our financial requirements are being met to ensure the reliable operation of the utility serving you; and

    (b) Determine if revenues are sufficient to meet the statutory requirements.

    § 175.210 What is BIA's procedure for adjusting service fees?

    If, based on our annual review, we determine our service fees need to be adjusted:

    (a) We will notify you at least 30 days prior to the effective date of the adjustment; and

    (b) We will publish a schedule of the adjusted service fees in a local newspaper(s) and post them in the local utility office serving you.

    § 175.215 What is BIA's procedure for adjusting electric power rates?

    Except for purchased power costs, if we determine electric power rates need to be adjusted, we will:

    (a) Hold public meetings and notify you of their respective time, date, and location by newspaper notice and a notice posted in the utility office serving you;

    (b) Provide you notice at least 15 days prior to the meeting;

    (c) Provide you a description of the proposed rate adjustment;

    (d) Provide you information on how, where, and when to submit comments on our proposed rate adjustment;

    (e) Make a final determination on the proposed rate adjustment after all comments have been received, reviewed, and evaluated; and

    (f) Publish the proposed rate adjustment and the final rate in the Federal Register if we determine the rate adjustment is necessary.

    § 175.220 How long do rate and fee adjustments stay in effect?

    These adjustments remain in effect until we conduct a review and determine adjustments are necessary.

    § 175.225 What is the Federal Register, and where can I get it?

    The Federal Register is the official daily publication for rules, proposed rules, and notices of official actions by Federal agencies and organizations, as well as Executive Orders and other Presidential Documents and is produced by the Government Publishing Office (GPO). You can get Federal Register publications by:

    (a) Visiting www.federalregister.gov or www.thefederalregister.org/fdsys;

    (b) Writing to the GPO at Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954; or

    (c) Calling the GPO at (202) 512-1800.

    § 175.230 Why are changes to purchased power costs not included in the procedure for adjusting electric power rates?

    Changes to purchased power costs are not included in the procedure for adjusting electric power rates because unforeseen increases in the cost of purchased power are:

    (a) Not under our control;

    (b) Determined by current market rates; and

    (c) Subject to market fluctuations that can occur at an undetermined time and frequency.

    § 175.235 How does BIA include changes in purchased power costs in electric power rates?

    When our cost of purchased power changes:

    (a) We determine the effect of the change;

    (b) We adjust the purchased power component of your bill accordingly;

    (c) We add the purchased power adjustment to the existing electric power rate and put it into effect immediately;

    (d) The purchased power adjustment remains in effect until we determine future adjustments are necessary;

    (e) We must publish in the local newspaper and post at our office a notice of the purchase power adjustment and the basis for the adjustment; and

    (f) Our decision to make a purchased power adjustment must be final.

    Subpart C—Billing, Payments, and Collections
    § 175.300 How does BIA calculate my electric power bill?

    (a) We calculate your electric power bill based on the:

    (1) Current rate schedule for your type service; and

    (2) Applicable service fees for your type service.

    (b) If you have a metered service we must:

    (1) Read your meter monthly;

    (2) Calculate your bill based on your metered energy consumption; and

    (3) Issue your bill monthly, unless otherwise provided in a Special Agreement.

    (c) If we are unable to calculate your metered energy consumption, we must make a reasonable estimate based on one of the following reasons:

    (1) Your meter has failed;

    (2) Your meter has been tampered with; or

    (3) Our utility personnel are unable to read your meter.

    (d) If you have an unmetered service, we calculate your bill in accordance with your Special Agreement.

    § 175.305 When is my bill due?

    The due date is provided on your bill.

    § 175.310 How do I pay my bill?

    You may pay your bill by any of the following methods:

    (a) In person at our utility office;

    (b) Mail your payment to the address stated on your bill; or

    (c) As further provided by the electric utility that serves you.

    § 175.315 What will happen if I do not pay my bill?

    (a) If you do not pay your bill prior to the close of business on the due date, your bill will be past due.

    (b) If your bill is past due we may:

    (1) Disconnect your service; and

    (2) Not reconnect your service until your bill, including any applicable fees, is paid in full.

    (c) Specific regulations regarding non-payment can be found in 25 CFR 143.5(c).

    § 175.320 What will happen if my service is disconnected and my account remains delinquent?

    (a) If your service has been disconnected and you still have an outstanding balance, we will assess you interest, penalties, and administrative costs in accordance with 31 CFR 901.9.

    (b) We must forward your delinquent balance to the United States Treasury if it is not paid within 180 days after the original due date in accordance with 31 CFR 901.1.

    Subpart D—System Extensions and Upgrades, Rights-of-Way, and Paperwork Reduction Act
    § 175.400 Will the utility extend or upgrade its electric system to serve new or increased loads?

    The utility may extend or upgrade its electric system to serve new or increased loads. Contact your electric power utility providing service in your area for further information on new or increased loads.

    § 175.500 How does BIA manage rights-of-way?

    Contact your electric power utility providing service in your area for further information on rights-of-way.

    § 175.600 How does the Paperwork Reduction Act affect this part?

    The collection of information contained in this part have been approved by the Office of Management and Budget under 44 U.S.C. 3501 et seq. and assigned OMB Control Number 1076-0021. Response is required to obtain a benefit. A Federal agency may not conduct or sponsor, and you are not required to respond to, a collection of information unless the form or regulation requesting the information displays a currently valid OMB Control Number. Send comments regarding this collection of information, including suggestions for reducing the burden, to the Information Collection Clearance Officer—Indian Affairs, 1849 C Street NW, Washington, DC 20240.

    Dated: October 19, 2017. John Tahsuda, Principal Deputy Assistant Secretary—Indian Affairs, Exercising the Authority of the Assistant Secretary—Indian Affairs.
    [FR Doc. 2017-27668 Filed 12-26-17; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-119514-15] RIN 1545-BM80 Exclusion of Foreign Currency Gain or Loss Related to Business Needs From Foreign Personal Holding Company Income; Mark-to-Market Method of Accounting for Section 988 Transactions; Correction AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of proposed rulemaking; correction.

    SUMMARY:

    This document contains corrections to the proposed regulations (REG-119514-15) that were published in the Federal Register on Tuesday, December 19, 2017. The proposed regulations provide guidance on the treatment of foreign currency gain or loss of a controlled foreign corporation (CFC) under the business needs exclusion from foreign personal holding company income (FPHCI). The proposed regulations also provide an election for a taxpayer to use a mark-to-market method of accounting for foreign currency gain or loss attributable to section 988 transactions. In addition, the proposed regulations permit the controlling United States shareholders of a CFC to automatically revoke certain elections concerning the treatment of foreign currency gain or loss.

    DATES:

    Written or electronic comments and requests for a public hearing, for the notice of proposed rulemaking at 82 FR 60135, December 19, 2017, are still being accepted and must be received by March 19, 2018.

    ADDRESSES:

    Send submissions to CC:PA:LPD:PR (REG-119514-15), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-119514-15), Courier's desk, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224, or sent electronically, via the Federal eRulemaking Portal at www.regulations.gov (IRS REG-119514-15).

    FOR FURTHER INFORMATION CONTACT:

    Jeffery G. Mitchell, (202) 317-6934 (not a toll-free number).

    SUPPLEMENTARY INFORMATION: Background

    The proposed regulations that are the subject of this correction are under sections 446, 954 and 988 of the Internal Revenue Code.

    Need for Correction

    As published, the proposed regulations contain errors which may prove to be misleading and need to be clarified.

    Correction of Publication

    Accordingly, the proposed regulations (REG-119514-15) that are the subject of FR Doc. 2017-27320 are corrected as follows:

    On page 60138, in the preamble, first column, the first full paragraph is corrected to read:

    “Although the borrowing and lending in the same nonfunctional currency are economically offsetting, section 475 creates the potential for a mismatch of gains and losses for a treasury center CFC. If the treasury center CFC qualifies as a dealer under section 475, for example because it regularly purchases debt from related CFCs in the ordinary course of a trade or business, the treasury center CFC generally must use a mark-to-market method of accounting for its securities. See section 475 and § 1.475(c)-1(a)(3)(i). However, § 1.475(c)-2(a)(2) provides that a dealer's own issued debt liabilities are not securities for purposes of section 475. Consequently, a treasury center CFC that marks to market its assets but not its liabilities may recognize any offsetting foreign currency gains and losses in different taxable years. To avoid this mismatch, taxpayers have taken positions that match a treasury center CFC's foreign currency gains and losses under a variety of theories. No inference is intended in these proposed regulations as to whether these positions are permissible in the years prior to the application of these proposed regulations.”

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, Procedure and Administration.
    [FR Doc. 2017-27865 Filed 12-26-17; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 7 [NPS-PWR-GOGA-24579; PPPWGOGAPO, PPMPSPD1Z.YM0000] Withdrawal of Proposed Rule for Dog Management at the Golden Gate National Recreation Area, California AGENCY:

    National Park Service, Interior.

    ACTION:

    Withdrawal of proposed rule.

    SUMMARY:

    The National Park Service (NPS) no longer intends to prepare a final rule or issue a Golden Gate National Recreation Area dog management plan. The NPS has terminated the rulemaking process.

    DATES:

    The proposed rule is withdrawn as of December 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dana Polk, Public Affairs Office, Park Headquarters, Fort Mason, Building 201, San Francisco, CA 94123; phone 415-561-4728.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the National Environmental Policy Act (NEPA) and the regulations implementing NEPA (40 CFR parts 1500-1508 and 43 CFR part 46), the NPS published a proposed rule for dog management on February 24, 2016 (81 FR 9139). The NPS has now cancelled that planning process and terminated the associated NEPA and rulemaking processes. No final rule will be issued.

    Dated: December 19, 2017. Martha J. Lee, Acting Regional Director, Pacific West Region.
    [FR Doc. 2017-27827 Filed 12-26-17; 8:45 am] BILLING CODE 4312-52-P
    LIBRARY OF CONGRESS Copyright Office 37 CFR Part 201 [Docket No. 2005-6] Statutory Cable, Satellite, and DART License Reporting Practices AGENCY:

    U.S. Copyright Office, Library of Congress.

    ACTION:

    Notice of proposed rulemaking; extension of comment period.

    SUMMARY:

    The United States Copyright Office is extending the deadlines for the submission of written comments in response to its December 1, 2017 notice of proposed rulemaking concerning the royalty reporting practices of cable operators under section 111 and proposed revisions to the Statement of Account forms, and on proposed amendments to the Statement of Account filing requirements.

    DATES:

    The comment period for the notice of proposed rulemaking, published on December 1, 2017 (82 FR 56926), is extended. Initial written comments must be received no later than 11:59 p.m. Eastern Time on March 16, 2018. Written reply comments must be received no later than 11:59 p.m. Eastern Time on April 6, 2018.

    ADDRESSES:

    For reasons of government efficiency, the Copyright Office is using the regulations.gov system for the submission and posting of public comments in this proceeding. All comments are therefore to be submitted electronically through regulations.gov. Specific instructions for submitting comments are available on the Copyright Office website at https://copyright.gov/rulemaking/section111. If electronic submission of comments is not feasible due to lack of access to a computer and/or the internet, please contact the Office using the contact information below for special instructions.

    FOR FURTHER INFORMATION CONTACT:

    Sarang V. Damle, General Counsel and Associate Register of Copyrights, by email at [email protected], Regan A. Smith, Deputy General Counsel, by email at [email protected], or Anna Chauvet, Assistant General Counsel, by email at [email protected], or any of them by telephone at 202-707-8350.

    SUPPLEMENTARY INFORMATION:

    On December 1, 2017, the Office issued a notice of proposed rulemaking (“NPRM”) on proposed rules governing the royalty reporting practices of cable operators under section 111 and proposed revisions to the Statement of Account forms, and on proposed amendments to the Statement of Account filing requirements.1 After determining that meetings with interested parties might be beneficial and that reply comments would be appropriate for this rulemaking, on December 11, 2017, the Office issued a notice of ex-parte communication and request for reply comments.2

    1 82 FR 56926 (Dec. 1, 2017).

    2 82 FR 58153 (Dec. 11, 2017).

    On December 13, 2017, NCTA—The Internet & Television Association submitted a motion seeking to extend the initial comment period until March 16, 2018, with written comments due by April 2, 2018.3

    3 COLC-2017-0013-0003.

    To ensure that commenters have sufficient time to respond to the NPRM, the Office is extending the deadline for the submission of initial written comments to 11:59 p.m. Eastern Time on March 16, 2018. Written reply comments must be received no later than 11:59 p.m. Eastern Time on April 6, 2018.

    Dated: December 19, 2017. Karyn Temple Claggett, Acting Register of Copyrights and Director of the U.S. Copyright Office.
    [FR Doc. 2017-27933 Filed 12-26-17; 8:45 am] BILLING CODE 1410-30-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0544; FRL-9972-40-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Regulatory Definition of Volatile Organic Compound AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve two state implementation plan (SIP) revisions (Revision C16 and Revision I16) formally submitted by the Commonwealth of Virginia. These revisions pertain to amendments made to the definition of “volatile organic compound” (VOC) in the Virginia Administrative Code to conform with EPA's regulatory definition of VOC. Specifically, these amendments remove the record keeping and reporting requirements for t-butyl acetate (also known as tertiary butyl acetate or TBAC; Chemical Abstracts Service [CAS] number: 540-88-5) and add 1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane (also known as HFE-347pcf2; CAS number: 406-78-0) as a compound excluded from the regulatory definition of VOC, which match actions EPA has taken. EPA is approving these revisions to update the definition of VOC in the Virginia SIP under the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before January 26, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0544 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, 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. 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 the person identified in the For Further Information Contact section. 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.

    FOR FURTHER INFORMATION CONTACT:

    Sara Calcinore, (215) 814-2043, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 31, 2017, the Commonwealth of Virginia, through the Virginia Department of Environmental Quality (VADEQ), submitted two SIP revisions (Revisions C16 and Revision I16). Revision C16 requested that the definition of VOC be updated in the Virginia SIP to conform with EPA's February 25, 2016 (81 FR 9339) final rulemaking updating EPA's regulatory definition of VOC in 40 CFR 51.100(s) to remove the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC. Revision I16 requests that the definition of VOC be updated in the Virginia SIP to conform with EPA's August 1, 2016 (81 FR 50330) final rulemaking updating EPA's regulatory definition of VOC in 40 CFR 51.100(s) to add 1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of compounds excluded from EPA's regulatory definition of VOC.

    I. Background

    VOCs are organic compounds of carbon that, in the presence of sunlight, react with sources of oxygen molecules, such as nitrogen oxides (NOX) and carbon monoxide (CO), in the atmosphere to produce tropospheric ozone, commonly known as smog. Common sources that may emit VOCs include paints, coatings, housekeeping and maintenance products, and building and furnishing materials. Outdoor emissions of VOCs are regulated by EPA primarily to prevent the formation of ozone.

    VOCs have different levels of volatility, depending on the compound, and react at different rates to produce varying amounts of ozone. VOCs that are non-reactive or of negligible reactivity to form ozone react slowly and/or form less ozone; therefore, reducing their emissions has limited effects on local or regional ozone pollution. Section 302(s) of the CAA specifies that EPA has the authority to define the meaning of VOC and what compounds shall be treated as VOCs for regulatory purposes. It is EPA's policy that organic compounds with a negligible level of reactivity should be excluded from the regulatory definition of VOC in order to focus control efforts on compounds that significantly affect ozone concentrations. EPA uses the reactivity of ethane as the threshold for determining whether a compound has negligible reactivity.

    Compounds that are less reactive than, or equally reactive to, ethane under certain assumed conditions may be deemed negligibly reactive and, therefore, suitable for exemption by EPA from the regulatory definition of VOC. The policy of excluding negligibly reactive compounds from the regulatory definition of VOC was first laid out in the “Recommended Policy on Control of Volatile Organic Compounds” (42 FR 35314, July 8, 1977) and was supplemented subsequently with the “Interim Guidance on Control of Volatile Organic Compounds in Ozone State Implementation Plans” (70 FR 54046, September 13, 2005). The regulatory definition of VOC as well as a list of compounds that are designated by EPA as negligibly reactive can be found at 40 CFR 51.100(s).

    On September 30, 1999, EPA proposed to revise the regulatory definition of VOC in 40 CFR 51.100(s) to exclude TBAC as a VOC (64 FR 52731). In most cases, when a negligibly reactive VOC is exempted from the definition of VOC, emissions of that compound are no longer recorded, collected, or reported to states or the EPA as part of VOC emissions. However, EPA's final rule excluded TBAC from the definition of VOC for purposes of VOC emissions limitations or VOC content requirements, but continued to define TBAC as a VOC for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements that apply to VOC (69 FR 69298, November 29, 2004) (2004 Final Rule). This was primarily due to EPA's conclusion in the 2004 Final Rule that “negligibly reactive” compounds may contribute significantly to ozone formation if present in sufficient quantities and that emissions of these compounds need to be represented accurately in photochemical modeling analyses. Per EPA's 2004 Final Rule, Virginia partially excluded TBAC from the regulatory definition of VOC, which was approved into Virginia's SIP on August 18, 2006 (71 FR 47742).

    When EPA exempted TBAC from the VOC definition for purposes of control requirements in the 2004 Final Rule, EPA created a new category of compounds and a new reporting requirement that required that emissions of TBAC be reported separately by states and, in turn, by industry. However, EPA did not issue any guidance on how TBAC emissions should be tracked and reported. Therefore, the data that was reported as a result of these requirements was incomplete and inconsistent. Also, in the 2004 Final Rule, EPA stated that the primary objective of the recordkeeping and reporting requirements for TBAC was to address the cumulative impacts of “negligibly reactive” compounds and suggested that future exempt compounds may also be subject to such requirements. However, such requirements were not included in any other proposed or final VOC exemptions.

    Because having high quality data on TBAC emissions alone was unlikely to be useful in assessing the cumulative impacts of “negligibly reactive” compounds on ozone formation, EPA subsequently concluded that the recordkeeping and reporting requirements for TBAC were not achieving their primary objective of informing more accurate photochemical modeling in support of SIP submissions. Also, there was no evidence that TBAC was being used at levels that would cause concern for ozone formation and that the requirements were not providing sufficient information to evaluate the cumulative impacts of exempted compounds. Therefore, because the requirements were not addressing EPA's concerns as they were intended, EPA revised the regulatory definition of VOC under 40 CFR 51.100(s) to remove the recordkeeping and reporting requirements for TBAC (February 25, 2016, 81 FR 9341). EPA's rationale for this action is explained in more detail in the final rule for that action. See 81 FR 50330 (August 1, 2016).

    On August 1, 2016, EPA promulgated a final rule revising the regulatory definition of VOC in 40 CFR 51.100(s) to add HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC (81 FR 50330). This action was based on EPA's consideration of the compound's negligible reactivity and low contribution to ozone as well as the low likelihood of risk to human health or the environment. EPA's rationale for this action is explained in more detail in the final rule for this action. See 81 FR 50330 (August 1, 2016).

    II. Summary of SIP Revision and EPA Analysis

    In order to conform with EPA's current regulatory definition of VOC in 40 CFR 51.100(s), the Virginia State Air Pollution Control Board amended the definition of VOC in 9 VAC 5-10-20. These amendments removed the recordkeeping and reporting requirements for TBAC (Revision C16) and added HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC (Revision I16). Revision C16 was adopted by the State Air Pollution Control Board on June 17, 2016 and was effective as of December 15, 2016. Revision I16 was adopted by the State Air Pollution Control Board on December 5, 2014 and was effective as of July 30, 2015. VADEQ formally submitted Revision C16 and Revision I16 as two separate SIP revisions on July 31, 2017.

    Virginia's amendments to the definition of VOC in 9 VAC 5-10-20 are in accordance with EPA's regulatory changes to the definition of VOC in 40 CFR 51.100(s) and are therefore approvable for the Virginia SIP in accordance with CAA section 110. Also, because EPA has made the determination that TBAC and HFE-347pcf2 are of negligible reactivity and therefore have low contributions to ozone as well as low likelihood of risk to human health or the environment, removing these chemicals from the definition of VOC in the Virginia SIP as well as the recordkeeping and reporting requirements for these chemicals will not interfere with attainment of any NAAQS, reasonable further progress, or any other requirement of the CAA. Thus, the removal of the recordkeeping and reporting requirements for TBAC and the addition of HFR-347pcf2 to the list of compounds excluded from the regulatory definition of VOC is in accordance with CAA section 110(l).

    III. Proposed Action

    EPA is proposing to approve both Revision C16 and Revision I16, submitted on July 31, 2017, as revisions to the Virginia SIP, as the submissions meet the requirements of CAA section 110. Revision C16 updates the regulatory definition of VOC in the Virginia SIP and removes the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC. Revision I16 updates the regulatory definition of VOC in the Virginia SIP to add HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

    IV. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

    On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.”

    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”

    Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

    V. Incorporation by Reference

    In this proposed rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the updated definition of VOC in 9 VAC 5-10-20 of the Virginia Administrative Code that removed the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC and added HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC. EPA has made, and will continue to make, these materials generally available through http://www.regulations.gov and at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

    VI. Statutory and Executive Order Reviews

    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 proposed 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);

    • is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

    • 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).

    This action amending the definition of VOC in the Virginia SIP to conform with the regulatory definition of VOC in 40 CFR 51.100(s) is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: December 12, 2017. Cosmo Servidio, Regional Administrator, Region III.
    [FR Doc. 2017-27522 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2017-0737; FRL-9972-57-Region 9] Approval of California Air Plan Revisions, Northern Sierra Air Quality Management District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a revision to the Northern Sierra Air Quality Management District (NSAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of particulate matter (PM) from wood burning devices. We are proposing to approve a local measure to reduce emissions from these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by January 26, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0737 at http://www.regulations.gov, or via email to Doris Lo, at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, 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 the person identified in the FOR FURTHER INFORMATION CONTACT section. 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.

    FOR FURTHER INFORMATION CONTACT:

    Rynda Kay, EPA Region IX, (415) 947-4118, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. The State's Submittal A. What measure did the State submit? B. Are there other versions of this measure? C. What is the purpose of the submitted measure? II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the measure? B. Does the measure meet the evaluation criteria? C. Public Comment and Proposed Action III. Incorporation by Reference IV. Statutory and Executive Order Reviews I. The State's Submittal A. What measure did the State submit?

    Table 1 lists the measure addressed by this proposal with the dates that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

    Table 1—Submitted Measure Local agency Resolution No. Measure title Adopted Submitted NSAQMD 2017-01 Northern Sierra Air Quality Management District Resolution #2017-01 01/23/17 02/28/17

    On August 28, 2017, the submittal for the NSAQMD measure was deemed by operation of law to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

    B. Are there other versions of this measure?

    There are no previous versions of the NSAQMD measure in the SIP.

    C. What is the purpose of the submitted measure?

    Particulate matter, including PM with diameters that are generally 2.5 microns or smaller (PM2.5) and PM with diameters that are generally 10 microns or smaller (PM10), contributes to effects that are harmful to human health and the environment, including premature mortality, aggravation of respiratory and cardiovascular disease, decreased lung function, visibility impairment, and damage to vegetation and ecosystems. Section 110(a) of the CAA requires states to submit regulations that control PM emissions.

    On January 15, 2013, the EPA revised the National Ambient Air Quality Standards (NAAQS) for PM2.5 to provide increased protection of public health by lowering the level of the annual standards from 15 to 12 micrograms per cubic meter (µg/m3) (40 CFR 50.18). Effective April 15, 2015, the EPA designated and classified the Plumas County nonattainment area (NAA) as moderate nonattainment for the 2012 PM2.5 NAAQS (40 CFR 81.305; 80 FR 2206, 2218). CARB submitted the NSAQMD measure on February 28, 2017, as part of an attainment plan to address nonattainment area SIP requirements for the 2012 PM2.5 NAAQS in the Plumas County NAA.

    The submitted measure is an enforceable commitment by the NSAQMD to implement a woodstove change-out incentive program during the 2016-2022 timeframe in accordance with specific program requirements that are designed to achieve quantifiable, surplus, enforceable, and permanent PM2.5 emission reductions in the Plumas County NAA. The program requirements ensure, among other things, that older, dirtier wood stoves currently in operation in the Plumas County NAA will be replaced with EPA-certified wood stoves or other less-polluting devices. The woodstove change-out program is funded by the EPA's 2015 Targeted Air Shed Grant Program, the NSAQMD, and other agencies and is the primary control strategy in California's attainment plan for the 2012 PM2.5 NAAQS in the Plumas County NAA.

    The enforceable commitment obligates the NSAQMD to achieve specific amounts of PM2.5 emission reductions through implementation of the woodstove change-out program by specific years, to submit annual reports to the EPA detailing its implementation of the program and the projected emission reductions, and to adopt and submit substitute measures by specific dates if the EPA determines that the woodstove change-out program will not achieve the necessary emission reductions. The EPA's technical support document (TSD) has more information about this measure.

    We intend to evaluate California's PM2.5 attainment plan for the Plumas County NAA as a whole through a subsequent notice-and-comment rulemaking action.

    II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the measure?

    Generally, SIP control measures must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).

    The CAA explicitly provides for the use of economic incentive programs (EIPs) as one tool for states to use to achieve attainment of the NAAQS (see, e.g., CAA sections 110(a)(2)(A), 172(c)(6), and 183(e)(4)). EIPs use market-based strategies to encourage the reduction of emissions from stationary, area, and mobile sources in an efficient manner. EPA has promulgated regulations for statutory EIPs required under section 182(g) of the Act and has issued guidance for discretionary EIPs (see 59 FR 16690 (April 7, 1994), codified at 40 CFR part 51, subpart U and U.S. EPA, “Improving Air Quality with Economic Incentive Programs,” January 2001 (“2001 EIP Guidance”)).1

    1 A “discretionary economic incentive program” is “any EIP submitted to the EPA as an implementation plan revision for purposes other than to comply with the statutory requirements of sections 182(g)(3), 182(g)(5), 187(d)(3), or 187(g) of the Act.” 40 CFR 51.491.

    EPA's guidance documents addressing EIPs and other nontraditional programs provide for some flexibility in meeting established SIP requirements for enforceability and quantification of emission reductions, provided the State takes clear responsibility for ensuring that the emission reductions necessary to meet applicable CAA requirements are achieved. Accordingly, EPA has consistently stated that nontraditional emission reduction measures submitted to satisfy SIP requirements under the Act must be accompanied by appropriate “enforceable commitments” from the State to monitor emission reductions achieved and to rectify shortfalls in a timely manner (see, e.g., U.S. EPA, “Incorporating Emerging and Voluntary Measures in a State Implementation Plan (SIP),” September 2004 (“2004 Emerging and Voluntary Measures Guidance”) at pages 8-12 and U.S. EPA, “Guidance for Quantifying and Using Emission Reductions from Voluntary Woodstove Changeout Programs in State Implementation Plans,” January 2006 (“2006 Woodstove Guidance”) at page 7). The EPA has also consistently stated that, where a State intends to rely on a nontraditional program to satisfy CAA requirements, the State must demonstrate that the program achieves emission reductions that are quantifiable, surplus, enforceable, and permanent (see, e.g., 2001 EIP Guidance at Section 4.1 and 2006 Woodstove Guidance at 3-4).

    Guidance documents that we use to evaluate discretionary EIPs and other nontraditional emission reduction programs include the following:

    • “Improving Air Quality with Economic Incentive Programs” January 2001 (EPA-452/R-01-001) (“2001 EIP Guidance”).

    • “Incorporating Emerging and Voluntary Measure in a State Implementation Plan (SIP),” Stephen D. Page, OAQPS, October 4, 2004 (“2004 Emerging and Voluntary Measures Guidance”).

    • “Guidance on Incorporating Bundled Measures in a State Implementation Plan,” Stephen D. Page, OAQPS, and Margo Oge, OTAQ, August 16, 2005 (“2005 Bundled Measures Guidance”).

    • “Guidance for Quantifying and Using Emission Reductions from Voluntary Woodstove Changeout Programs in State Implementation Plans,” January 2006 (EPA-456/B-06-001) (“2006 Woodstove Guidance”).

    B. Does the measure meet the evaluation criteria?

    The submitted commitment contains clear, nondiscretionary and mandatory obligations that are enforceable against the NSAQMD and ensure that information about the emission reductions achieved through the woodstove change-out program will be readily available to the public through the NSAQMD's submission of annual reports to the EPA. Our approval of this commitment would make these obligations enforceable by the EPA and by citizens under the CAA. The commitment obligates the District to implement a new program that achieves quantifiable, surplus, permanent, and enforceable PM2.5 emission reductions and does not alter any existing SIP requirements. Our approval of the commitment into the SIP would strengthen the SIP and would not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements, consistent with the requirements of CAA section 110(l). Section 193 of the CAA does not apply to this action because this measure does not modify any SIP control requirement that was in effect before November 15, 1990.

    We are proposing to find that the submitted measure satisfies CAA requirements for enforceability, SIP revisions, and nontraditional emission reduction programs as interpreted in EPA guidance documents. The TSD contains more information on our evaluation of this measure.

    C. Public Comment and Proposed Action

    The EPA proposes to fully approve the submitted measure under CAA section 110(k)(3) based on a conclusion that the measure satisfies all applicable requirements. We will accept comments from the public on this proposal until January 26, 2018. If we take final action to approve the submitted measure, our final action will incorporate this measure into the federally enforceable SIP.

    III. Incorporation by Reference

    In this action, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the NSAQMD measure described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    IV. Statutory and Executive Order Reviews

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

    • 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 Clean Air Act; and

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). 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: December 14, 2017. Deborah Jordan, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-27950 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 80 [EPA-HQ-OAR-2017-0655; FRL-9972-59-OAR] RIN 2060-AT82 Proposed Rule; Renewable Fuel Standard Program; Grain Sorghum Oil Pathway AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    In this proposed rule, the Environmental Protection Agency (EPA) is providing an opportunity to comment on an analysis of the lifecycle greenhouse gas (GHG) emissions associated with certain biofuels that are produced from grain sorghum oil extracted at dry mill ethanol plants at any point downstream from sorghum grinding, also known as distiller sorghum oil. EPA seeks comment on its proposed assessment that using distillers sorghum oil as feedstock results in no significant agricultural sector GHG emissions; and that biodiesel and heating oil produced from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from distillers sorghum oil via a hydrotreating process, would meet the lifecycle GHG emissions reduction threshold of 50 percent required for advanced biofuels, and biomass-based diesel under the Renewable Fuel Standard program. Based on these analyses, EPA is proposing to amend the RFS program regulations to define the term “distillers sorghum oil”. We also propose to add to the regulations approved pathways from the production of biodiesel and heating oil from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from distillers sorghum oil via a hydrotreating process.

    DATES:

    Comments must be received on or before January 26, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2017-0655, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn 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, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Diana Galperin, Office of Air and Radiation, Office of Transportation and Air Quality, Mail Code: 6401A, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 202-564-5687; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Outline of This Preamble I. General Information II. Public Participation III. Introduction IV. Analysis of GHG Emissions Associated With Production of Biofuels From Distillers Sorghum Oil A. Overview of Distillers Sorghum Oil B. Analysis of Lifecycle GHG Emissions 1. Livestock Sector Impacts 2. Feedstock Production 3. Feedstock Transport 4. Feedstock Pretreatment 5. Fuel Production 6. Fuel Distribution 7. Fuel Use 8. Results of GHG Lifecycle Analysis V. Consideration of Lifecycle Analysis Results VI. Summary VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs C. Paperwork Reduction Act D. Regulatory Flexibility Act (RFA) E. Unfunded Mandates Reform Act (UMRA) F. Executive Order 13132: Federalism G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use J. National Technology Transfer Advancement Act (NTTAA) K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information A. Does this action apply to me?

    Entities potentially affected by this proposed rule are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel or renewable fuels such as ethanol, biodiesel, heating oil, renewable diesel, naphtha and liquefied petroleum gas. Potentially regulated categories include:

    Examples of potentially affected entities NAICS 1 codes Sorghum Farming 11119, 111191, 111199 Petroleum refineries (including importers). 324110 Ethyl alcohol manufacturing. 325193 Other basic organic chemical manufacturing. 325199 Chemical and allied products merchant wholesalers. 424690 Petroleum Bulk Stations and Terminals; Petroleum 424710, 424720 Other fuel dealers. 454310

    This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that the EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria in the referenced regulations. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

    1 North American Industry Classification System.

    B. What action is the Agency taking?

    EPA is proposing to amend the RFS program regulations to define the term “distillers sorghum oil” as oil from grain sorghum that is extracted at a dry mill ethanol plant at any location downstream of grinding the grain sorghum kernel, provided that the grain sorghum is converted to ethanol, the oil is rendered unfit for food uses without further refining, and the distillers grains resulting from the dry mill and oil extraction processes are marketable as animal feed. We also propose to add to Table 1 to 80.1426(f), approved pathways from the production of biodiesel and heating oil from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from distillers sorghum oil via a hydrotreating process. Alternatively, or in addition, EPA may consider the comments it receives in response to this document in evaluating facility-specific pathway petitions submitted pursuant to 40 CFR 80.1416 that propose using distillers sorghum oil to make biofuel.

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

    Statutory authority for this action comes from Clean Air Act sections 114, 208, 211, and 301.

    II. Public Participation

    EPA will not hold a public hearing on this matter unless a request is received by the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble by January 11, 2018. If EPA receives such a request, we will publish information related to the timing and location of the hearing and a new deadline for public comment.

    III. Introduction

    Section 211(o) of the Clean Air Act (CAA) establishes the Renewable Fuel Standard (RFS) program, under which EPA sets annual percentage standards specifying the amount of renewable fuel, as well as three subcategories of renewable fuel, that must be used to reduce or replace fossil fuel present in transportation fuel, heating oil, or jet fuel. Non-exempt 2 renewable fuels must achieve at least a 20 percent reduction in lifecycle GHG emissions as compared to a 2005 petroleum baseline. Advanced biofuel and biomass-based diesel must achieve at least a 50 percent reduction, and cellulosic biofuel must achieve at least a 60 percent reduction.

    2 A baseline volume of renewable fuel produced from facilities that commenced construction on or before December 19, 2007, and which completed construction by December 19, 2010 without an 18-month hiatus in construction, is exempt from the minimum 20 percent GHG reduction requirement that otherwise applies to renewable fuel. In addition, a baseline volume of ethanol from facilities that commenced construction after December 19, 2007, and on or before December 31, 2009, qualifies for the same exemption if construction was completed within 36 months without an 18-month hiatus in construction; the facility was fired with natural gas, biomass, or any combination thereof, at all times the facility operated between December 19, 2007 and December 31, 2009; and the baseline volume continues to be produced through processes fired with natural gas, biomass, or any combination thereof.

    In addition to the lifecycle GHG reduction requirements, renewable identification numbers (RINs) may only be generated if the fuel meets the other definitional criteria for renewable fuel (e.g., produced from renewable biomass as defined in the regulations, and used to reduce or replace the quantity of fossil fuel present in transportation fuel, heating oil, or jet fuel) in CAA section 211(o) and the RFS regulations at 40 CFR part 80 subpart M.

    Since the formation of the RFS program, EPA has periodically promulgated rules to add new pathways to the regulations.3 In addition, EPA has approved facility-specific pathways through the petition process in 40 CFR 80.1416. There are three critical components of approved fuel pathways under the RFS program: (1) Fuel type; (2) feedstock; and (3) production process. Each pathway is associated with a specific “D code” depending on whether the fuel meets the requirements for renewable fuel, advanced fuel, cellulosic fuel, or biomass-based diesel.

    3 Please see information on Pathways I and Pathways II in 40 CFR part 80 subpart M, and in the Federal Register at 78 FR 14190 (March 5, 2013) and 79 FR 42128 (July 18, 2014). More information on these can be found at: https://www.epa.gov/renewable-fuel-standard-program/final-rule-identify-additional-fuel-pathways-under-renewable-fuel and https://www.epa.gov/renewable-fuel-standard-program/renewable-fuel-pathways-ii-final-rule-identify-additional-fuel.

    EPA's lifecycle analyses are used to assess the overall GHG emissions of a fuel throughout each stage of its production and use. The results of these analyses, considering uncertainty and the weight of available evidence, are used to determine whether a fuel meets the necessary GHG reductions required under the CAA. Lifecycle analysis includes an assessment of emissions related to the full fuel lifecycle, including feedstock production, feedstock transportation, fuel production, fuel transportation and distribution, and tailpipe emissions. Per the CAA definition of lifecycle GHG emissions, EPA's lifecycle analyses also include an assessment of significant indirect emissions, such as those from land use changes and agricultural sector impacts.

    EPA received a petition from the National Sorghum Producers (NSP), submitted under partial claims of confidential business information (CBI), requesting that EPA evaluate the GHG emissions associated with biofuels produced using grain sorghum oil derived from dry mill ethanol production as a feedstock, and that EPA provide a determination of the renewable fuel categories, if any, for which such biofuels may be eligible. In this action, EPA is proposing to amend the RFS program regulations to define the term “distillers sorghum oil” as oil from grain sorghum that is extracted at a dry mill ethanol plant at any location downstream of grinding the grain sorghum kernel, provided that the grain sorghum is converted to ethanol, the oil is rendered unfit for food uses without further refining, and the distillers grains resulting from the dry mill and oil extraction processes are marketable as animal feed. We also propose to add to Table 1 to 40 CFR 80.1426(f), approved pathways from the production of biodiesel and heating oil from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel, heating oil, naphtha, and LPG produced from distillers sorghum oil via a hydrotreating process. Alternatively, or in addition, EPA may consider the comments it receives in response to this document in evaluating facility-specific pathway petitions submitted pursuant to 40 CFR 80.1416 that propose using distillers sorghum oil to make biofuel.

    This preamble describes EPA's analysis of the GHG emissions associated with distillers sorghum oil when used to produce specified biofuels. The analysis considers a scenario where distillers sorghum oil is extracted from distillers grains with solubles (DGS) at dry mill plants that produce ethanol from grain sorghum and where the remaining reduced-oil DGS co-product is used as animal feed. The distillers sorghum oil is then used as a feedstock for conversion into certain biofuels. As described in Section IV of this preamble, we estimate that the lifecycle GHG emissions associated with the production of biodiesel and heating oil produced from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel, naphtha, and LPG, produced from distillers sorghum oil via a hydrotreating process, are approximately 80 percent less than the lifecycle GHG emissions associated with the baseline petroleum fuels they would replace. Based on these results, we propose to find that these biofuels would meet the 50 percent GHG reduction threshold required for advanced biofuel and biomass-based diesel. We also anticipate that heating oil produced through transesterification or hydrotreating from distillers sorghum oil would meet the 50 percent GHG emission reduction threshold required for advanced biofuel and biomass-based diesel.4 EPA is seeking public comment on its analyses of the lifecycle GHG emissions related to biofuels produced from distillers sorghum oil.

    4 As defined in the RFS regulations at 40 CFR 80.1401, biomass-based diesel excludes renewable fuel that is co-processed with petroleum. Such fuel may qualify as advanced biofuel if it meets the 50 percent GHG reduction threshold.

    IV. Analysis of GHG Emissions Associated With Production of Biofuels From Distillers Sorghum Oil A. Overview of Distillers Sorghum Oil

    Dry mill ethanol plants grind and ferment grain sorghum, produce ethanol from the fermented grain sorghum starch, and also produce a DGS co-product (made of non-fermentable solids, solubles syrup, and sorghum oil) that is sold as a type of livestock feed. A portion of the oil that would otherwise reside in the DGS can be extracted at the ethanol plant, typically through gravimetric methods. At dry mill ethanol plants, sorghum oil is recovered through methods nearly identical to that of corn oil extracted from DGS, and corn and sorghum oil extraction can occur at the same facilities.

    EPA has approved pathways for the production of ethanol from grain sorghum made through a dry mill process as qualifying for renewable fuel (D code 6) RINs, and in some cases advanced biofuel (D code 5) RINs, depending on process energy sources used during production.5 However, the regulations do not currently include pathways for the production of other biofuels from grain sorghum. According to the U.S. Department of Agriculture (USDA), the largest regions for grain sorghum production in the United States are located in Texas, Oklahoma, and Kansas.6 Currently about 30 percent of grain sorghum grown, or 120 million bushels a year, goes towards ethanol production.7 For comparison, in recent years over 5,200 million bushels of corn have been used for ethanol production annually.8 Distillers sorghum oil is still a relatively niche product, and the NSP petition anticipates a potential of 12 to 21 million ethanol-equivalent gallons of fuel to be produced from the oil per year.

    5 Table 1 to 40 CFR 80.1426, Rows R and S.

    6 USDA, NASS, “Sorghum for Grain 2016 Harvested Acres by County for Selected States,” https://www.nass.usda.gov/Charts_and_Maps/graphics/AS-HA-RGBChor.pdf.

    7 Sorghum Checkoff, “Renewables,” http://www.sorghumcheckoff.com/market-opportunities/renewables, accessed 09-05-2017.

    8 USDA, ERS, “Table 5— Corn supply, disappearance, and share of total corn used for ethanol,” U.S. Bioenergy Statistics, https://www.ers.usda.gov/data-products/us-bioenergy-statistics/us-bioenergy-statistics/#Feedstocks, accessed 09-05-2017.

    We propose to define distillers sorghum oil to mean oil recovered at a point downstream of where a dry mill grain sorghum ethanol plant grinds the grain sorghum, provided that the grain sorghum is converted to ethanol, the oil is rendered unfit for food uses without further refining, and the distillers grains resulting from the dry mill and oil extraction processes are marketable as animal feed. So long as these criteria are met, a variety of recovery methods could be implemented. For example, this would include recovery of sorghum oil before fermentation from the slurry or from liquefaction tanks. It would also include recovery of sorghum oil after fermentation from the thin stillage and/or DGS. Further, it would also include recovery of sorghum oil by a third-party from DGS produced by a dry mill sorghum ethanol plant.

    B. Analysis of Lifecycle GHG Emissions

    EPA evaluated the GHG emissions associated with using distillers sorghum oil as a biofuel feedstock based on information provided by the petitioner and other available data sources. GHG emissions include emissions from production and transport of distillers sorghum oil; the processing of the oil into biofuel; transport of the biofuel from the production facility to the fuel-blender; and, ultimately the use of the biofuel by the end consumer. The methodology EPA used for this analysis is generally the same approach used for the March 2010 RFS rule for lifecycle analyses of several other biofuel feedstocks, such as distillers corn oil and yellow grease.9 We believe that applying the same methodology for these feedstocks is appropriate given similarities in how these feedstocks are produced, transported and processed into biofuel. These similarities are explained further in this section.

    9 The March 2010 RFS rule preamble (75 FR 14670, March 26, 2010) and Regulatory Impact Analysis (RIA) (EPA-420-R-10-006) provide further discussion of our approach. These documents are available online at https://www.epa.gov/renewable-fuel-standard-program/renewable-fuel-standard-rfs2-final-rule-additional-resources.

    EPA's lifecycle analyses include upstream emissions, which include the significant direct and indirect GHG emissions (including such emissions from land use changes) associated with producing a feedstock and transporting it to the processing facility. All of the upstream emissions were calculated and taken into account in EPA's evaluation of the lifecycle GHG emissions associated with grain sorghum ethanol.10 Based on our analysis, producing distillers sorghum oil at a dry mill ethanol plant converting grain sorghum to ethanol, and using the extracted sorghum oil as a biofuel feedstock does not result in additional upstream emissions, compared to the upstream emissions that have already been calculated and attributed to grain sorghum ethanol. Further, based on our analysis, the production of distillers sorghum oil does not significantly impact the upstream emissions associated with grain sorghum ethanol. While producing distillers sorghum oil may impact livestock markets, through the effects of de-oiling DGS, we discuss in the next section why, based on the data we have reviewed, we do not anticipate this to cause any significant indirect impacts. We welcome comments on this data and analysis.

    10 See the December 2012 grain sorghum ethanol rule (77 FR 74592).

    1. Livestock Sector Impacts

    During a typical dry mill ethanol production process, DGS are produced. These DGS are then used as animal feed, thereby displacing feed crops and the GHG emissions associated with growing and transporting those feed crops. When distillers sorghum oil is produced, DGS continue to be created with reduced oil content. A significant portion of this analysis focuses on reviewing how reduced-oil DGS compare to full-oil DGS in terms of feed values and displacement of other feeds.

    Chemically, full-oil and reduced-oil sorghum DGS share similar compositions, primarily made up of crude protein, fat, and natural and acid detergent fibers. Where the two products differ most significantly is in their acid detergent fiber and fat concentrations. Table IV.1 shows the key nutrients that make up dried full-oil and reduced-oil DGS.

    11 The chart lists the most prominent nutrients in distillers grains. Data provided by the National Sorghum Producers. Data for full-oil Sorghum DDGS is sourced from Nutrient Requirements of Swine, 2012 National Academies Press, Washington DC, pg 329. Data for reduced-oil Sorghum DDGS was calculated by National Sorghum Producers using the ratio of (1) corn DDGS, between 6 to 9 percent Oil; and (2) corn DDGS, less than 4 percent oil from Nutrient Requirements of Swine, 2012 National Academies Press, Washington, DC, pp. 266 and 267.

    Table IV.1—Key Nutrient Make-Up of Full-Oil and Reduced-Oil Dried Distillers Grains With Solubles (DDGS) 11 Nutrient Full-oil
  • sorghum
  • DDGS
  • Reduced-oil
  • sorghum
  • DDGS
  • Crude Protein, % 30.80 31.36 Crude Fat, % (aka Ether Extract) 9.75 3.91 Neutral Detergent Fiber (NDF), % 33.60 37.23 Acid Detergent Fiber (ADF), % 22.68 31.91 Ash, % 6.62 7.60 Calcium, % 0.12 0.08 Phosphorus, % 0.76 0.96 Lysine, % 0.82 0.62 Methionine, % 0.54 0.47 Cystine, % 0.53 0.61 Tryptophan, % 0.25 0.23

    The difference in fat values is important as crude fat concentrations impact net energy uptake by the livestock. A memorandum to the docket shows the total net energy profiles by livestock of full-oil and reduced-oil sorghum DGS.12 Should fat content not be at sufficient levels, livestock producers might need to add nutrients or other types of feed to meet appropriate nutritional targets. This is reflected in the “displacement rate” of a DGS, which indicates how much weight a pound of distillers grain can replace of another feed. A lower displacement rate for a reduced-oil distillers grain as compared to a full-oil distillers grain could result in additional GHG emissions as it suggests that additional feed is required. In the case of reduced-oil sorghum DGS, we believe that it is unlikely that additional feed will be needed to backfill for the extracted oil.

    12 “Summary of Net Energy Impacts of Reduced-Oil Sorghum Dried Distillers Grains with Solubles (DDGS) on Livestock,” Air Docket EPA-HQ-OAR-2017-0655.

    Research suggests that for poultry and swine, “increased concentrations of free fatty acids have a negative impact on lipid digestion and energy content.” 13 Free fatty acids are a class of acids that form part of a lipid molecule. Full-oil DGS typically contain higher levels of free fatty acids and thus may have a negative impact on the fat digestion of poultry and swine. This supports the conclusion that while the fat content may be lower for reduced-oil DGS, feeding values of this product should not be worse than full-oil DGS for poultry and swine.

    13 Kerr, B.J., W.A. Dozier, and G.C. Shurson. (2016). “Lipid digestibility and energy content of distillers' corn oil in swine and poultry,” Journal of Animal Science. 94:2900-2908. doi:10.2527/jas.2016-0440, pp. 2905.

    For dairy, there are also benefits from feeding reduced-oil DGS as compared to full-oil DGS. Research on dairy cows shows that reduced-oil DGS produce a lessened likelihood of the onset of milk fat depression.14 Milk fat depression occurs when milk fat is reduced by 0.2 percent or more.15 If milk fat depression occurs over the long term, a decline in overall milk production may occur as well as worsened health conditions of the herd. High fat diets have been linked with this condition and have been shown to worsen the rumen environment of dairy cattle.16 Therefore, dairy producers seek to avoid high fat diets. Given the benefits of reduced-oil DGS over full-oil DGS for milk fat production, it is expected that reduced-oil DGS will be preferred over full-oil DGS by dairy producers and that displacement rates will be no worse than those of full-oil DGS.

    14 H.A. Ramirez-Ramirez, E. Castillo Lopez, C.J.R. Jenkins, N.D. Aluthge, C. Anderson, S.C. Fernando, K.J. Harvatine, P.J. Kononoff, (2016). “Reduced-fat dried distillers grains with solubles reduces the risk for milk fat depression and supports milk production and ruminal fermentation in dairy cows,” Journal of Dairy Science, Volume 99, Issue 3 Pages 1912-1928, ISSN 0022-0302, http://dx.doi.org/10.3168/jds.2015-9712. (http://www.sciencedirect.com/science/article/pii/S0022030216000515)

    15 University of Kentucky, “Preventing Milk Fat Depression in Dairy Cows,” https://afs.ca.uky.edu/dairy/preventing-milk-fat-depression-dairy-cows. Accessed September 8, 2018. On the herd level milk fats range from 3 to 5 percent normally. Oetzel, Garret R., “Subacute Ruminal Acidosis in Dairy Herds: Physiology, Pathophysiology, Milk Fat Responses, and Nutritional Management.” Preconference Seminar 7A: Dairy Herd Problem Investigation Strategies: Lameness, Cow Comfort, and Ruminal Acidosis, American Association of Bovine Practitioners, 40th Annual Conference, September 17, 2007—Vancouver, BC, Canada, https://www.vetmed.wisc.edu/dms/fapm/fapmtools/2nutr/sara1aabp.pdf pp.98.

    16 PennState Extension, “Troubleshooting Problems with Milkfat Depression,” August 14, 2017, https://extension.psu.edu/troubleshooting-problems-with-milkfat-depression. Accessed September 8, 2017.

    An impact on displacement rates may occur when reduced-oil instead of full-oil DGS are used for beef cattle, which has the ability to digest additional fat. Table IV.2 shows the displacement ratios for the livestock sectors where dried DGS (DDGS) are used. In this table, for instance, 1 pound of reduced-oil DDGS fed to beef cattle displaces 1.173 pounds of corn. A pound of full-oil and reduced-oil DDGS also displace equal portions (0.056 pounds) of urea. Urea is a non-protein nitrogen compound that is typically fed to cattle for aiding the production of protein by rumen microbes.17 These values show that for dairy, swine, and poultry, reduced-oil DDGS replace the same amounts of alternative feed despite containing less oil.

    17 PennState Extension, “Urea in Beef Cattle Rations,” August 8, 2017, https://extension.psu.edu/urea-in-beef-cattle-rations. Accessed October 18, 2017.

    Table IV.2—Full-Oil and Reduced-Oil Sorghum Distillers Grains With Solubles Displacement Ratios 18 [lb of ingredient/lb of sorghum distillers grains with solubles, dry matter basis] Ingredient Beef cattle Full-Oil Reduced-Oil Dairy cattle Full-Oil Reduced-Oil Swine Full-Oil Reduced-Oil Poultry 19 Full-Oil Reduced-Oil Corn 1.196 1.173 0.731 0.731 0.890 0.890 0.292 0.292 Soybean Meal 0.633 0.633 0.095 0.095 Urea 0.056 0.056

    We anticipate that sorghum oil producers will seek to sell reduced-oil DGS to poultry, swine, and dairy cow producers, as these markets allow them to obtain a higher value for their product. Dairy cattle producers may be willing to pay a premium for reduced-oil distillers grains, as data suggests lower oil DGs improve milk production. Sales of reduced-oil DGS to the beef cattle market are less likely, and in these cases we anticipate that should a higher fat product be required, the fat content of the DGS could be augmented through the addition of distillers sorghum oil, thereby reducing the volumes of biofuel produced from distillers sorghum oil but not causing additional indirect GHG emissions. Therefore, we do not expect that sorghum oil extraction will have a significant impact on the feed value of DGS and thus will have no significant indirect GHG impacts per pound of DGS. We welcome comment on this assessment.

    18 Information provided by National Sorghum Producers, using the following sources Arora et al., (2008). Argonne National Laboratory. “Update of distillers grains displacement ratios for corn ethanol life-cycle analysis”; Kerr et al., (2016). “Lipid digestibility and energy content of distillers' corn oil in swine and poultry,” Journal of Animal Science 94:2900-8.; Opheim et al., (2016). “Biofuel feedstock and blended coproducts compared with deoiled corn distillers grains in feedlot diets: Effects on cattle growth performance, apparent total tract nutrient digestibility, and carcass characteristics,” Journal of Animal Science 94:227.; Ramirez et al., (2016). “Reduced-fat dried distillers grains with solubles reduces the risk for milk fat depression and supports milk production and ruminal fermentation in dairy cows,” Journal of Dairy Science 99:1912-28. Poultry displacement ratios were provided by the National Sorghum Producers and calculated based on data from the Iowa State Extension Services, Agricultural Marketing and Resources Center, “Estimated U.S. Dried Distillers Grains with Solubles (DDGS) Production and Use, https://www.extension.iastate.edu/agdm/crops/outlook/dgsbalancesheet.pdf.

    19 Protein sources such as soybean meal can be used to supplement sorghum DGS for poultry.

    2. Feedstock Production

    Distillers sorghum oil is removed from DGS at dry mill ethanol plants using the same equipment and technologies used for corn oil extraction. Oil extraction requires thermal energy to heat the DGS and electricity to power centrifuges, pumps and other oil recovery equipment. Our analysis for the March 2010 RFS final rule,20 the NSP petition, and two studies,21 22 indicate that although extracting oil from DGS uses thermal energy, it also leads to relatively less thermal energy being used later in the process to dry the DGS, resulting in an overall negligible change in thermal energy requirements for plants that dry their DGS. Our analysis here includes both the thermal and electrical energy requirements to remove the distillers sorghum oil. We do not account for the reduction in thermal energy needed for DGS drying mentioned above, so this can be viewed as a conservative approach (i.e., resulting in higher estimated GHG emissions) for plants that dry their DGS.23 Based on data reviewed by EPA,24 we assume 200 Btu (British thermal units) of grid electricity and 800 Btu of natural gas are used to extract distillers sorghum oil from DGS, per pound of distillers sorghum oil extracted. These parameters are based on energy requirements associated with extracting oil from DGS at dry mill ethanol plants, but we believe they are also appropriate and conservative in cases where the oil is extracted at any point downstream from sorghum grinding.

    20 See section 1.4.1.3 of USEPA (2010). Renewable fuel standard program (RFS2) regulatory impact analysis. U.S. Environmental Protection Agency Office of Transportation Air Quality, EPA-420-R-10-006. Washington, DC. https://www.epa.gov/sites/production/files/2015-08/documents/420r10006.pdf.

    21 Wang, Z., et al. (2015). “Influence of corn oil recovery on life-cycle greenhouse gas emissions of corn ethanol and corn oil biodiesel.” Biotechnology for Biofuels 8(1): 178.

    22 Mueller, S., Kwik, J. (2013). “2012 Corn Ethanol: Emerging Plant Energy and Environmental Technologies.”

    23 The purpose of lifecycle assessment under the RFS program is not to precisely estimate lifecycle GHG emissions associated with particular biofuels, but instead to determine whether or not the fuels satisfy specified lifecycle GHG emissions thresholds to qualify as one or more of the four types of renewable fuel specified in the statute. Where there are a range of possible outcomes and the fuel satisfies the GHG reduction requirements when “conservative” assumptions are used, then a more precise quantification of the matter is not required for purposes of a pathway determination.

    24 See sources referenced in footnotes 20 and 21 for energy use associated with oil extraction, and California Air Resources Board (2014). “California-Modified GREET Fuel Pathway: Biodiesel Produced in the Midwestern and the Western U.S. from Corn Oil Extracted at Dry Mill Ethanol Plants that Produce Wet Distiller's Grains with Solubles.” Staff Summary, Method 1 Fuel Pathway.

    As discussed above, we do not expect sorghum oil extraction to significantly change the feed value of DGS on a per pound basis. According to the NSP petition, grain sorghum oil yields should be 0.67 pounds per bushel of grain sorghum feedstock.25 EPA's modeling for the December 2012 grain sorghum ethanol final rule (77 FR 74592) assumed average dried DGS yield of 17 pounds per bushel of grain sorghum feedstock. Thus, sorghum oil extraction may reduce the total mass of DGS produced by up to approximately 4 percent. If full-oil and reduced-oil DGS have equivalent feed value on a per pound basis, we would expect a reduction in the total mass of DGS produced to impact livestock feed markets and result in a net increase in GHG emissions if production of other feed crops (e.g., corn, soybeans) increased to backfill the lost DGS, given that producing additional corn and soybeans would result in more GHG emissions.26 However, if reduced-oil DGS are more beneficial than full oil DGS for dairy cows, on a per pound of DGS basis, that could offset some or all of the impacts associated with the DGS mass reduction. The information currently available makes the magnitude of these countervailing impacts difficult to determine, and we did not include any emissions impacts from DGS mass reduction in our lifecycle GHG analysis of biofuels produced from distillers sorghum oil. We invite comment on our analysis of the GHG emissions associated with extracting sorghum oil from DGS.

    25 NSP petition, section F.2.iv

    26 For example, the California Air Resources Board (CARB) estimated this impact would be approximately 10 kgCO2e/mmBtu of biodiesel produced from distillers corn oil (https://www.arb.ca.gov/fuels/lcfs/2a2b/apps/co_bd_wdgs-rpt-102414.pdf). Applying such an impact to our analysis of biofuels produced from distillers sorghum oil would not change the GHG thresholds results for the biofuels produced from distillers sorghum oil evaluated in this document.

    3. Feedstock Transport

    In our analysis, distillers sorghum oil is transported 50 miles by heavy duty truck from the dry mill ethanol plant to the biodiesel or hydrotreating facility where it is converted to transportation fuel. GHG emissions associated with feedstock transport are relatively small, and modest changes in transport distance are unlikely to affect the results of our analysis.

    4. Feedstock Pretreatment

    For emissions from feedstock pretreatment and fuel production, we perform two analyses. In the first analysis, we calculate the emissions from biodiesel produced using transesterification. In the second analysis, we calculate the emissions from renewable diesel, jet fuel, LPG, and naphtha, produced using hydrotreating. In Section V below, we then explain how similar results can be inferred for heating oil.

    Before distillers sorghum oil is converted to biodiesel via transesterification, it is processed to remove free-fatty acids. This process requires thermal energy. Our evaluation of yellow grease for the March 2010 RFS final rule included 14,532 Btu of natural gas per gallon of biodiesel produced for pretreatment, and we have applied the same assumption for this analysis. According to the NSP petition, distillers sorghum oil has free fatty acid content near or below 15 percent, which is in the range of yellow grease free fatty acid contents (<15 percent).27 This rate of thermal energy use for pretreatment is higher than thermal energy rates used in other lifecycle assessments EPA reviewed,28 and can be viewed as a conservative assumption (i.e., resulting in higher GHG emissions).

    27 See Table 15 in the January 5, 2012 Pathways I direct final rule (77 FR 722).

    28 See for example: https://www.arb.ca.gov/fuels/lcfs/2a2b/apps/co_bd_wdgs-rpt-102414.pdf.

    Pretreatment to remove free-fatty acids is not required when distillers sorghum oil is used to produce renewable diesel, jet fuel, LPG and naphtha through a hydrotreating process.

    5. Fuel Production

    For biodiesel production, we used the transesterification analysis for the March 2010 RFS rule for yellow grease biodiesel.29 Based on comparison of this yellow grease analysis and the mass and energy balance data in the NSP petition, submitted under claim of CBI, the conversion of yellow grease and distillers sorghum oil are expected to require similar energy inputs and yield similar amounts of biodiesel and methanol as outputs.

    29 For details see section 2.4 of the RIA for the March 2010 RFS final rule.

    For production of renewable diesel, jet fuel, naphtha and LPG via a hydrotreating process, we used the same data and approach as used in the March 2013 Pathways I rule (78 FR 14190, March 5, 2013), and subsequent facility-specific petitions involving hydrotreating processes.30 The March 2013 Pathways I rule evaluated two hydrotreating configurations: One optimized for renewable diesel production and one optimized for jet fuel production. For this analysis we evaluated a hydrotreating process maximized for renewable diesel production, as that is the most common configuration. The jet fuel configuration results in higher emissions (approximately 5 kgCO2e/mmBtu higher), but the threshold GHG reduction results discussed below are not sensitive to this assumption.

    30 For determination documents responding to facility specific petitions, see: https://www.epa.gov/renewable-fuelstandard-program/approved-pathways-renewable-fuel.

    Our previous analyses of hydrotreating processes have applied an energy allocation approach for RIN-generating co-products that qualify as renewable fuel.31 This approach results in higher lifecycle GHG emissions for each of the fuel products than other approaches considered, such as a displacement approach, and thus can be viewed as a conservative approach.

    31 See the March 2013 Pathways I rule, specifically 78 FR 14198-14200 (March 5, 2013).

    In the allocation approach, all the emissions from the hydrotreating process are allocated across all co-products. There are a number of ways to do the allocation, for example on the basis of energy, mass, or economic value. Consistent with the approach taken in the hydrotreating analysis for the March 2013 RFS rule, for this analysis of fuels produced from distillers sorghum oil feedstock through a hydrotreating process we allocated emissions to the renewable diesel, naphtha and LPG based on the energy content (using lower-heating values) of the products produced. Emissions from the process were allocated equally to all of the Btus of fuel produced. Therefore, on a per Btu basis, all of the primary products coming from the hydrotreating facility have the same emissions from the fuel production stage of the lifecycle. For this analysis, the energy content was the most appropriate basis for allocating emissions because all of the fuel products are used as sources of energy. Energy content also has the advantage of being a fixed factor as opposed to market prices which fluctuate over time.

    6. Fuel Distribution

    We used the fuel distribution results from the biodiesel analysis for the March 2010 RFS rule. Fuel distribution emissions are relatively small compared to baseline lifecycle GHG emissions (see Table IV.3 below), and although they may be different for different types of fuel, for the purposes of this analysis we assume that renewable diesel, jet fuel, LPG, and naphtha, have the same fuel distribution emissions per mmBtu of fuel used. Even if we applied a more precise value for fuel distribution emissions, we do not expect that revision to change our assessment that these fuels meet a 50 percent GHG emission reduction.

    7. Fuel Use

    For this analysis we applied fuel use emissions factors developed for the March 2010 RFS final rule. For biodiesel we used the biodiesel emissions factor. For renewable diesel and jet fuel we used the emissions factors for non-CO2 GHGs for baseline diesel fuel. For naphtha we used the emissions factors for non-CO2 GHGs for baseline gasoline fuel. For LPG we used the LPG non-CO2 emissions factor developed for the March 2010 RFS rule. The tailpipe emissions are relatively small, and the threshold GHG reduction results are not sensitive to these assumptions. More details on our analysis of fuel use emissions are described in a memo 32 to the rulemaking docket.

    32 See, “Summary of Key Assumptions for EPA's Analysis of the Lifecycle Greenhouse Gas Emissions Associated with Biofuels Produced from Distillers Sorghum Oil,” Air Docket EPA-HQ-OAR-2017-0655.

    8. Results of GHG Lifecycle Analysis

    Table IV.3 shows the lifecycle GHG emissions associated with biofuels produced from distillers sorghum oil that result from our assessment. The table also shows the percent reduction relative to the petroleum baseline. All of the fuels are compared to the diesel baseline, except for naphtha which is compared to the gasoline baseline.

     Table IV.3—Lifecycle GHG Emissions Associated With Biofuels Produced From Distillers Sorghum Oil (kgCO2-eq/MJ) Fuel Biodiesel Renewable diesel, jet fuel Naphtha LPG 2005 Diesel baseline 2005 Gasoline baseline Production process Transesterification Hydrotreating Refining Feedstock Production 5.6 6.2 6.2 6.2 18.0 19.2 Feedstock Transport 0.2 0.3 0.3 0.3 Feedstock Pretreatment 8.4 Fuel Production 1.2 8.0 8.0 8.0 Fuel Distribution 0.8 0.8 0.8 0.8 Fuel Use 0.7 0.7 1.7 1.5 79.0 79.0 Total 17.0 16.0 17.0 16.8 97.0 98.2 Percent Reduction 82 84 82 83 V. Consideration of Lifecycle Analysis Results

    Based on the lifecycle GHG emissions results presented above, all of the pathways evaluated would meet the 50 percent GHG reduction threshold required for advanced biofuel and biomass-based diesel.

    The results presented above would also justify qualifying heating oil produced from distillers sorghum oil as meeting the 50 percent GHG threshold. In previous rulemakings, EPA considered the lifecycle GHG impacts associated with heating oil and determined that heating oil produced from a range of feedstocks (e.g., soybean oil, distillers corn oil) via a transesterification or hydrotreating process satisfies the 50 percent lifecycle GHG reduction required for advanced biofuel.33 Based on the results presented above, we anticipate that biofuels such as heating oil produced from distillers sorghum oil have significantly lower lifecycle GHG emissions than the same fuels produced from soybean oil, when the same production processes are used.34 Therefore, based on EPA's previous lifecycle evaluations for heating oil produced from soybean oil, we believe that heating oil produced from distillers sorghum oil would also satisfy the 50 percent GHG reduction requirement.

    33 See the March 2013 RFS Pathway I rule (78 FR 14190, March 5, 2013).

    34 For example, in analysis for the March 2010 RFS rule, EPA found that soybean oil biodiesel achieves a 57 percent GHG reduction (based on the mean result from our uncertainty assessment), whereas the results in Table IV.3, above, show biodiesel produced from distillers sorghum oil achieve a greater than 80 percent reduction.

    VI. Summary

    Based on our GHG lifecycle evaluation described above, we propose to find that biodiesel and heating oil produced from distillers sorghum oil via a transesterification process, and renewable diesel, jet fuel and heating oil produced from distillers sorghum oil via a hydrotreating process meet the 50 percent GHG reduction threshold requirement for advanced biofuel and biomass-based diesel. This finding would support a determination that these fuels are eligible for biomass-based diesel (D-code 4) RINs if they are produced through a process that does not co-process renewable biomass and petroleum, and for advanced biofuel (D-code 5) RINs if they are produced through a process that does co-process renewable biomass and petroleum. EPA invites comment on all aspects of its analysis of these proposed biofuel pathways.

    VII. Statutory and Executive Order Reviews

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

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

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

    B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

    This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

    C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and therefore is not subject to these requirements.

    D. 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. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This rule proposes to provide a positive economic effect for distillers sorghum oil producers and producers of biofuels from distillers sorghum oil as they would be able to participate in the RFS program, see CAA section 211(o).

    E. Unfunded Mandates Reform Act (UMRA)

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

    F. 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.

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

    This action does not have tribal implications as specified in Executive Order 13175. This proposed rule would affect only producers of distillers sorghum oil and producers of biofuels made from distillers sorghum oil. Thus, Executive Order 13175 does not apply to this action.

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

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

    I. 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.

    J. National Technology Transfer Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This proposed rule does not affect the level of protection provided to human health or the environment by applicable air quality standards. This action does not relax the control measures on sources regulated by the fuel programs and RFS regulations and therefore will not cause emissions increases from these sources.

    List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedure, Air pollution control, Diesel Fuel, Fuel additives, Gasoline, Imports, Oil imports, Petroleum, Renewable fuel.

    Dated: December 19, 2017. E. Scott Pruitt, Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 80 as follows:

    PART 80—REGULATION OF FUEL AND FUEL ADDITIVES 1. The authority for part 80 continues to read as follows: Authority:

    42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).

    Subpart M—[Amended] 2. Section 80.1401 is amended by adding in alphabetical order a new definition for “distillers sorghum oil” to read as follows:
    § 80.1401 Definitions.

    Distillers sorghum oil means oil recovered at a point downstream of where a dry mill grain sorghum ethanol plant grinds the grain sorghum, provided that the grain sorghum is converted to ethanol, the oil is rendered unfit for food uses without further refining, and the distillers grains resulting from the dry mill and oil extraction processes are marketable as animal feed.

    3. Section 80.1426, paragraph (f)(1) is amended by revising entries F, H, and I in Table 1 to § 80.1426 to read as follows:
    § 80.1426 How are RINs generated and assigned to batches of renewable fuel by renewable fuel producers or importers?

    (f) * * *

    (1) * * *

    Table 1 to § 80.1426—Applicable D Codes for Each Fuel Pathway for Use in Generating RINs Entry Fuel type Feedstock Production process requirements D-code *         *         *         *         *         *         * F Biodiesel, renewable diesel, jet fuel and heating oil, biodiesel Soy bean oil; Oil from annual covercrops; Oil from algae grown photosynthetically; Biogenic waste oils/fats/greases; Non-food grade corn oil; Camelina sativa oil; Distillers sorghum oil One of the following: TransEsterification Hydrotreating Excluding processes that co-process renewable biomass and petroleum 4 *         *         *         *         *         *         * H Biodiesel, renewable diesel, jet fuel and heating oil Soy bean oil; Oil from annual covercrops; Oil from algae grown photosynthetically; Biogenic waste oils/fats/greases; Non-food grade corn oil; Camelina sativa oil; Distillers sorghum oil One of the following: TransEsterification Hydrotreating Includes only processes that co-process renewable biomass and petroleum 5 I Naphtha, LPG Camelina sativa oil; Distillers sorghum oil Hydrotreating 5 *         *         *         *         *         *         *
    [FR Doc. 2017-27946 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 [EPA-HQ-OW-2017-0010; FRL-9972-46-OW] RIN 2040-AF69 Water Quality Standards for the State of Missouri's Lakes and Reservoirs AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA or Agency) proposes to establish federal nutrient criteria to protect designated uses for the State of Missouri's lakes and reservoirs. On August 16, 2011, EPA disapproved most of the numeric criteria for total nitrogen, total phosphorus, and chlorophyll a that the State submitted to EPA in 2009. EPA acknowledged the importance of Missouri's proactive efforts to address nutrient pollution by adopting numeric nutrient criteria. However, EPA concluded that the Missouri Department of Natural Resources (MDNR) had failed to demonstrate the criteria would protect the State's designated uses and were not based on a sound scientific rationale. The Clean Water Act (CWA) directs EPA to promptly propose water quality standards (WQS) that meet CWA requirements if a state does not adopt WQS addressing EPA's disapproval. On February 24, 2016, the Missouri Coalition for the Environment (MCE) filed a lawsuit alleging that EPA failed to satisfy its statutory obligation to act “promptly.” On December 1, 2016, EPA entered into a consent decree with MCE committing to sign a notice of proposed rulemaking by December 15, 2017 to address EPA's 2011 disapproval, unless the State submits and EPA approves criteria that address the disapproval on or before December 15, 2017. As of the date of this proposed rule, Missouri has not submitted new or revised standards to address EPA's 2011 disapproval and EPA has not approved such water quality standards. Therefore, under the terms of the consent decree, EPA is signing a notice of proposed rulemaking that proposes new water quality standards addressing EPA's August 16, 2011 disapproval. In this proposal, EPA seeks comment on two primary alternatives. Under the first alternative, EPA proposes nutrient protection values and eutrophication impact factors in a combined criterion approach. Under the second alternative, EPA proposes a similar combined criterion approach that would mirror the State of Missouri's October 2017 proposal for lake nutrient water quality standards. EPA will not proceed with final rulemaking (or will withdraw its final rule, if applicable) to address its 2011 disapproval if Missouri adopts and submits criteria to address EPA's 2011 disapproval and EPA approves them as meeting CWA requirements.

    DATES:

    Comments must be received on or before February 26, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2017-0010, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from regulations.gov. 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. 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, 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.

    EPA is offering two online public hearings so that interested parties may provide verbal comments on this proposed rule. The first public hearing will be on February 7, 2018. The second public hearing will be on February 8, 2018. For more details on the public hearings and a link to register, please visit https://www.epa.gov/wqs-tech/proposed-nutrient-criteria-missouri-lakes-and-reservoirs.

    FOR FURTHER INFORMATION CONTACT:

    Mario Sengco, Standards and Health Protection Division, Office of Water, Mailcode: 4305T, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 202-566-2676; email address: [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. General Information A. Does this action apply to me? B. What action is EPA taking? II. Background A. Nutrient Pollution B. Statutory and Regulatory Background C. Deriving and Expressing Numeric Nutrient Criteria D. Missouri's 2009 Nutrient Criteria Submission and EPA's Clean Water Act Section 303(c) Action E. Missouri Coalition for the Environment (MCE) Lawsuit and Consent Decree F. Missouri's 2017 Proposed Nutrient WQS III. Proposed Nutrient Combined Criterion for Lakes and Reservoirs in Missouri A. Proposed Combined Criterion Approaches B. Proposed Combined Criterion Alternative 1 C. Derivation of Nutrient Protection Values for Alternative 1 D. Proposed Combined Criterion Alternative 2 E. Additional Alternative Approaches Considered F. Applicability of Combined Criterion When Final IV. Tributary Arms V. Endangered Species Act VI. Under what conditions will federal standards be either not finalized or withdrawn? VII. WQS Regulatory Approaches and Implementation Mechanisms A. Designating Uses B. Site-Specific Criteria C. WQS Variances D. NPDES Permit Compliance Schedules VIII. Economic Analysis IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs C. Paperwork Reduction Act D. Regulatory Flexibility Act E. Unfunded Mandates Reform Act F. Executive Order 13132 (Federalism) G. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) H. Executive Order 13045 (Protection of Children From Environmental Health and Safety Risk) I. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use) J. National Technology Transfer Advancement Act of 1995 K. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations) I. General Information A. Does this action apply to me?

    Citizens concerned with water quality in the State of Missouri may be interested in this proposed rulemaking. Entities discharging nitrogen or phosphorus to lakes and reservoirs, or to flowing waters emptying into lakes or reservoirs, could be affected directly or indirectly by this rulemaking because WQS are used in determining National Pollutant Discharge Elimination System (NPDES) permit effluent limits. Stakeholders that rely on lakes and reservoirs for recreation or as a source of drinking water likewise may be interested in the proposed criteria. Table 1 lists categories that ultimately may be affected by this proposal.

    Table 1—Categories Potentially Affected by Proposed Criteria Category Examples of potentially affected entities Industry Factories discharging pollutants to lakes/reservoirs or flowing waters emptying into downstream lakes/reservoirs in Missouri. Municipalities Publicly-owned treatment works discharging pollutants to lakes/reservoirs or flowing waters emptying into downstream lakes/reservoirs in Missouri. Stormwater Management Districts Entities responsible for managing stormwater runoff in Missouri.

    This table is not intended to be exhaustive; rather, it provides a guide for entities that may be affected directly or indirectly by this action. Nonpoint source contributors and other entities not listed in the table also could be affected indirectly. Any party or entity that conducts activities within the watersheds affected by this rule, or that relies on, depends upon, influences, or contributes to the water quality of the lakes, reservoirs and flowing waters of Missouri, also may be affected by this rule. To determine whether your facility or activities may be affected by this action, you should carefully examine this proposed rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

    B. What action is EPA taking?

    The EPA is proposing two alternatives to establish federal nutrient criteria to protect designated uses for the State of Missouri's lakes and reservoirs. Under the first alternative, EPA proposes nutrient protection values (total nitrogen, total phosphorus, chlorophyll a) and eutrophication impact factors in a combined criterion approach. Under the second alternative, EPA proposes a combined criterion approach that would mirror the State of Missouri's October 2017 proposal for lake nutrient water quality standards. This action fulfills EPA's obligation under its consent decree entered on December 1, 2016 to prepare and publish proposed regulations for nutrient criteria to address the Agency's August 16, 2011, disapproval of the State's nutrient criteria by December 15, 2017.

    II. Background A. Nutrient Pollution 1. What is nutrient (i.e., nitrogen and phosphorus) pollution?

    Excess loading of nitrogen and phosphorus compounds 1 is one of the most prevalent causes of water quality impairment in the United States. Nitrogen and phosphorus pollution problems have been recognized for some time in the U.S. For example, a 1969 report by the National Academy of Sciences 2 noted “[t]he pollution problem is critical because of increased population, industrial growth, intensification of agricultural production, river-basin development, recreational use of waters, and domestic and industrial exploitation of shore properties. Accelerated eutrophication causes changes in plant and animal life—changes that often interfere with use of water, detract from natural beauty, and reduce property values.” Inputs of nitrogen and phosphorus lead to over-enrichment in many of the Nation's waters and create a widespread, persistent, and growing problem. Nitrogen and phosphorus pollution in fresh water systems can significantly impact aquatic life and long-term ecosystem health, diversity, and balance. More specifically, high nitrogen and phosphorus loadings result in harmful algal blooms (HABs), reduced spawning grounds and nursery habitats, fish kills, and oxygen-starved hypoxic or “dead” zones. Public health concerns related to nitrogen and phosphorus pollution include impaired surface and groundwater drinking water sources from high levels of nitrate-nitrogen, formation of nitrogenous disinfection byproducts in drinking water, and increased exposure to toxic microbes such as cyanobacteria.3 4

    1 To be used by living organisms, nitrogen gas must be fixed into its reactive forms; for plants, this generally includes either nitrate or ammonia (Boyd, C.E. 1979. Water Quality in Warmwater Fish Ponds. Alabama Agricultural Experiment Station, Auburn, AL). Eutrophication is defined as the natural or artificial addition of nitrogen/phosphorus to bodies of water and to the effects of added nitrogen/phosphorus (National Academy of Sciences (U.S). 1969. Eutrophication: Causes, Consequences, Correctives. National Academy of Sciences, Washington, DC).

    2 National Academy of Sciences (U.S). 1969. Eutrophication: Causes, Consequences, Correctives. National Academy of Sciences, Washington, DC.

    3 Villanueva, C.M. et al., 2006. Bladder cancer and exposure to water disinfection by-products through ingestion, bathing, showering, and swimming in pools. American Journal of Epidemiology 165(2):148-156.

    4 USEPA. Environments and Contaminants: Drinking water contaminants U.S. Environmental Protection Agency, Office of Research and Development. Accessed December 2017. https://www.epa.gov/sites/production/files/2015-10/documents/ace3_drinking_water.pdf.

    Elevated nitrogen and phosphorus levels can occur locally in a stream or groundwater aquifer, or can accumulate much further downstream leading to degraded lakes, reservoirs, and estuaries and material impacts on fish and other aquatic life.5 6 Excess nitrogen and phosphorus in water bodies come from many sources, which can be grouped into five major categories: (1) Urban stormwater runoff—sources associated with urban land use and development, (2) municipal and industrial waste water discharges, (3) row crop agriculture, (4) livestock production, and (5) atmospheric deposition from the production of nitrogen oxides in electric power generation and internal combustion engines.

    5 National Research Council. 2000. Clean Coastal Waters: Understanding and Reducing the Effects of Nutrient Pollution. National Academies Press, Washington, DC.

    Howarth, R.W., A. Sharpley & D. Walker. 2002. Sources of nutrient pollution to coastal waters in the United States: Implications for achieving coastal water quality goals. Estuaries 25(4b):656-676.

    Smith, V.H. 2003. Eutrophication of freshwater and coastal marine ecosystems. Environmental Science and Pollution Research 10(2):126-139.

    Dodds, W.K., W.W. Bouska, J.L. Eitzmann, T.J. Pilger, K.L. Pitts, A.J. Riley, J.T. Schloesser & D.J. Thornbrugh. 2009. Eutrophication of U.S. freshwaters: Analysis of potential economic damages. Environmental Science and Technology 43(1):12-19.

    6 State-EPA Nutrient Innovations Task Group. 2009. An Urgent Call to Action: Report of the State-EPA Nutrient Innovations Task Group.

    2. Adverse Impacts of Nitrogen and Phosphorus Pollution on Aquatic Life, Human Health, and the Economy

    The causal pathways that lead from human activities to excess nutrients to impacts on designated uses in lakes and reservoirs are well established in the scientific literature (e.g., Vollenweider, 1968; NAS, 1969; Schindler et al., 1973; Schindler, 1974; Vollenweider, 1976; Carlson, 1977; Paerl, 1988; Elser et al., 1990; Smith et al., 1999; Downing et al., 2001; Smith et al., 2006; Elser et al., 2007).7 When excessive nitrogen and phosphorus loads alter a waterbody's complement of algal and plant species, the corresponding changes in habitat and available food resources can induce cascading effects on the entire food web. Algal blooms block sunlight that submerged plants need to grow, leading to a decline in the availability of submerged aquatic vegetation and a reduction in habitat for juvenile fish and some other aquatic organisms. Algal blooms can also increase turbidity and impair the ability of sight-feeding fish and other aquatic life to find food.8 Large concentrations of algae can also damage or clog the gills of fish and certain invertebrates.9 Excessive algal blooms can lead to shifts in a waterbody's production and consumption of dissolved oxygen (DO) resulting in reduced DO levels that are sufficiently low to harm or kill important recreational species such as walleye, striped bass, and black bass.

    7 Vollenweider, R.A. 1968. Scientific Fundamentals of the Eutrophication of Lakes and Flowing Waters, With Particular Reference to Nitrogen and Phosphorus as Factors in Eutrophication (Tech Rep DAS/CS/68.27, Organisation for Economic Co-operation and Development, Paris. National Academy of Science. 1969. Eutrophication: Causes, Consequences, Correctives. National Academy of Science, Washington, DC.

    Schindler D.W., H. Kling, R.V. Schmidt, J. Prokopowich, V.E. Frost, R. A. Reid & M. Capel. 1973. Eutrophication of Lake 227 by addition of phosphate and nitrate: The second, third, and fourth years of enrichment 1970, 1971, and 1972. Journal of the Fishery Research Board of Canada 30:1415-1440.

    Schindler D.W. 1974. Eutrophication and recovery in experimental lakes: Implications for lake management. Science 184:897-899.

    Vollenweider, R.A. 1976. Advances in Defining Critical Loading Levels for Phosphorus in Lake Eutrophication. Memorie dell'Istituto Italiano di Idrobiologia 33:53-83.

    Carlson R.E. 1977. A trophic state index for lakes. Limnology and Oceanography 22:361-369.

    Paerl, H.W. 1988. Nuisance phytoplankton blooms in coastal, estuarine, and inland waters. Limnology and Oceanography 33:823-847.

    Elser, J.J., E.R. Marzolf & C.R. Goldman. 1990. Phosphorus and nitrogen limitation of phytoplankton growth in the freshwaters of North America: A review and critique of experimental enrichments. Canadian Journal of Fisheries and Aquatic Science 47:1468-1477.

    Smith, V.H., G.D. Tilman & J.C. Nekola. 1999. Eutrophication: Impacts of excess nutrient inputs on freshwater, marine, and terrestrial ecosystems. Environmental Pollution 100:179-196.

    Downing, J. A., S. B. Watson & E. McCauley. 2001. Predicting cyanobacteria dominance in lakes. Canadian Journal of Fisheries and Aquatic Sciences 58:1905-1908.

    Smith, V.H., S.B. Joye & R.W. Howarth. 2006. Eutrophication of freshwater and marine ecosystems. Limnology and Oceanography 51:351-355.

    Elser, J.J., M.E.S. Bracken, E.E. Cleland, D.S. Gruner, W.S. Harpole, H. Hillebrand, J.T. Ngai, E.W. Seabloom, J.B. Shurin & J.E. Smith. 2007. Global analysis of nitrogen and phosphorus limitation of primary production in freshwater, marine, and terrestrial ecosystems. Ecology Letters 10:1135-1142.

    8 Hauxwell, J., C. Jacoby, T. Frazer, and J. Stevely. 2001. Nutrients and Florida's Coastal Waters. Florida Sea Grant Report No. SGEB-55. Florida Sea Grant College Program, University of Florida, Gainesville, FL.

    9 NOAA. 2017. Ocean Facts: Are All Algal Blooms Harmful? National Oceanic and Atmospheric Administration, National Ocean Service. <https://oceanservice.noaa.gov/facts/habharm.html>. Accessed December 2017.

    Excessive algal growth also contributes to increased oxygen consumption associated with decomposition (e.g., large quantities of senescing and decaying algal cells), in many instances reducing oxygen to levels below that needed for aquatic life to survive and flourish.10 11 Mobile species, such as adult fish, can sometimes survive by moving to areas with more oxygen. However, migration to avoid hypoxia depends on species mobility, availability of suitable habitat (i.e., refugia), and adequate environmental cues for migration. Less mobile or immobile species, such as mussels, cannot move to avoid low oxygen and are often killed during hypoxic events.12 While certain mature aquatic animals can tolerate a range of dissolved oxygen levels that occur in the water, younger life stages of fish and shellfish often require higher levels of oxygen to survive.13 Sustained low levels of dissolved oxygen cause a severe decrease in the amount of aquatic life in hypoxic zones and affect the ability of aquatic organisms to find necessary food and habitat.

    10 NOAA. 2017. Ocean Facts: Are All Algal Blooms Harmful? National Oceanic and Atmospheric Administration, National Ocean Service. https://oceanservice.noaa.gov/facts/habharm.html.

    11 USEPA. 2017. What is Hypoxia and What Causes It? U.S. Environmental Protection Agency. <https://www.epa.gov/ms-htf/hypoxia-101>. Accessed December 2017.

    12 ESA. 2017. Hypoxia. Ecological Society of America <https://www.esa.org/esa/wp-content/uploads/2012/12/hypoxia.pdf>. Accessed December 2017.

    13 USEPA. 1986. Ambient Water Quality Criteria for Dissolved Oxygen Freshwater Aquatic Life. EPA-800-R-80-906. Environmental Protection Agency, Office of Water, Washington, DC.

    In freshwater lakes and reservoirs, blooms of cyanobacteria (sometimes referred to as blue-green algae),14 can produce toxins that have been implicated as the cause of a number of fish and bird mortalities.15 These toxins have also been tied to the death of pets and livestock that may be exposed through drinking contaminated water or grooming themselves after bodily exposure.16 Cyanobacterial toxins can also pass through normal drinking water treatment processes and pose an increased risk to humans or animals.17

    14 CDC. 2017. Harmful Algal Bloom (HAB)-Associated Illness. Centers for Disease Control and Prevention. <https://www.cdc.gov/habs/> Accessed December 2017.

    15 Ibelings, B.W. & K.E. Havens. 2008. Chapter 32: Cyanobacterial toxins: A qualitative meta-analysis of concentrations, dosage and effects in freshwater, estuarine and marine biota. In: Cyanobacterial Harmful Algal Blooms: State of the Science and Research Needs. From the Monograph of the September 6-10, 2005 International Symposium on Cyanobacterial Harmful Algal Blooms (ISOC-HAB) in Durham, NC. <http://www.epa.gov/cyano_habs_symposium/monograph/Ch32.pdf>. Accessed August 19, 2010.

    16 WHOI. 2008. HAB Impacts on Wildlife. Woods Hole Oceanographic Institution. <http://www.whoi.edu/redtide/page.do?pid=9682>. Accessed December 2009.

    17 Carmichael, W.W. 2000. Assessment of Blue-Green Algal Toxins in Raw and Finished Drinking Water. AWWA Research Foundation, Denver, CO.

    Elevated nitrogen and phosphorus levels in lakes and reservoirs can impact human health and safety and otherwise detract from the outdoor recreational experience. For example, nutrient pollution in lakes typically promotes higher densities of phytoplankton, which can reduce the clarity of the water column to the detriment of swimmer safety. Cyanobacterial blooms frequently result in high algal toxin (e.g., microcystin) concentrations, leading to swimming beach closures and issuance of health advisories/warnings. In areas where recreation is determined to be unsafe because of algal blooms, warning signs often are posted to discourage human contact with the affected waters.

    Many other states, and countries for that matter, are experiencing problems with harmful algal blooms (HABs).18 19 Scientific assessments and numerous studies have shown an increase of HAB occurrence, distribution and persistence in the U.S. and globally in recent years.20 21 22 In a recent scientific assessment, reviewers found that observed increases in water temperatures alter the seasonal windows of growth and the geographic range of suitable habitat for freshwater toxin-producing harmful algae and marine toxin-producing harmful algae.23 These changes may increase the risk of exposure to waterborne pathogens and algal toxins that can cause a variety of illnesses. In addition, runoff from more frequent and intense extreme precipitation events may increasingly compromise recreational waters, shellfish harvesting waters, and sources of drinking water through increased prevalence of toxic algal blooms. An example of an algal bloom event occurred on August 10, 2017,24 when officials from the Oakland Country Health Division located near Detroit, Michigan issued a warning for residents and their pets to avoid two local lakes due to the presence of an algal bloom. People were advised to avoid contact with the water through recreation and to avoid drinking the water. In a July 7, 2017 article,25 the number of reports of harmful algal blooms affecting lakes and ponds in New York, as tracked by the New York State Department of Environmental Conservation, were increasing early in the season. Reducing nutrient input is one of the strategies lake managers are employing throughout the State to address the growing problem of algal blooms. Species of cyanobacteria commonly associated with freshwater algal blooms include: Microcystis aeruginosa, Anabaena circinalis, Anabaena flos-aquae, Aphanizomenon flos-aquae, and Cylindrospermopsis raciborskii. Under certain conditions, some of these species can release neurotoxins (affect the nervous system), hepatotoxins (affect the liver), lipopolysaccharide compounds inimical to the human gastrointestinal system, and tumor promoting compounds.26 One study showed that at least one type of cyanobacteria has been linked to cancer and tumor growth in animals.27

    18 FWCC. 2017. What is a Harmful Algal Bloom? <http://myfwc.com/research/redtide/general/harmful-algal-bloom/>. Accessed December 2017.

    19 Trevino-Garrison, I., DeMent, J., Ahmed, F.S., Haines-Lieber, P., Langer, T., Ménager, H., Neff, J., van der Merwe, D., Carney, E. 2015. Human illnesses and animal deaths associated with freshwater algal blooms—Kansas. Toxins 7:353-366.

    20 Scientific American (2016) https://blogs.scientificamerican.com/guest-blog/toxic-algae-blooms-are-on-the-rise/.

    21 Lopez, C.B., Jewett, E.B., Dortch, Q., Walton, B.T., Hudnell, H.K. 2008. Scientific Assessment of Freshwater Harmful Algal Blooms. Interagency Working Group on Harmful Algal Blooms, Hypoxia, and Human Health of the Joint Subcommittee on Ocean Science and Technology. Washington, DC.

    22 Lopez, C.B., Dortch, Q., Jewett, E.B., Garrison, D. 2008. Scientific Assessment of Marine Harmful Algal Blooms. Interagency Working Group on Harmful Algal Blooms, Hypoxia, and Human Health of the Joint Subcommittee on Ocean Science and Technology. Washington, DC.

    23 USGCRP, 2016: The Impacts of Climate Change on Human Health in the United States: A Scientific Assessment. Crimmins, A., J. Balbus, J.L. Gamble, C.B. Beard, J.E. Bell, D. Dodgen, R.J. Eisen, N. Fann, M.D. Hawkins, S.C. Herring, L. Jantarasami, D.M. Mills, S. Saha, M.C. Sarofim, J. Trtanj, and L. Ziska, Eds. U.S. Global Change Research Program, Washington, DC, 312 pp.

    24 The Detroit News. Toxic algal blooms spotted in Waterford, White Lake by Stephanie Steinberg. August 10, 2017. http://www.detroitnews.com/story/news/environment/2017/08/10/toxic-algal-blooms-spotted-waterford-white-lake/104463128/.

    25 The New York Times. Beware the Blooms: Toxic Algae Found in Some City Ponds by Lisa W. Foderaro. July 7, 2017. https://www.nytimes.com/2017/07/07/nyregion/beware-the-blooms-toxic-algae-found-in-some-city-ponds.html.

    26 CDC. 2017. Harmful Algal Bloom (HAB)-Associated Illness, Centers for Disease Control and Prevention. <https://www.cdc.gov/habs/>. Accessed December 2017.

    27 Falconer, I.R. & A.R. Humpage. 2005. Health risk assessment of cyanobacterial (blue-green algal) toxins in drinking water. International Journal of Research and Public Health 2(1):43-50.

    Human health also can be impacted by disinfection byproducts (DBPs), formed when disinfectants (such as chlorine) used to treat drinking water react with organic carbon produced by algae in source waters. Some DBPs have been linked to rectal, bladder, and colon cancers; reproductive health risks; and liver, kidney, and central nervous system problems.28 29 In their study of 21 water supply lakes and reservoirs in New York, Callinan et al. (2013) concluded that “autochthonous [algal] precursors contribute substantially to the DBP precursor pool in lakes and reservoirs and the . . . establishment of [numeric nutrient criteria] for the protection of [potable water supply] source waters is warranted and feasible.” 30

    28 USEPA. 2017. Drinking water Requirements for States and Public Water Systems, Public Water Systems, Disinfection Byproducts, and the Use of Monochloramine. U.S. Environmental Protection Agency. Accessed <https://www.epa.gov/dwreginfo/public-water-systems-disinfection-byproducts-and-use-monochloramine>. December 2017.

    29 National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule, 40 CFR parts 9, 141, and 142. U.S. Environmental Protection Agency, FR 71:2 (January 4, 2006). pp. 387-493. Available electronically at: <http://www.epa.gov/fedrgstr/EPA-WATER/2006/January/Day-04/w03.htm>. Accessed December 2009.

    30 Callinan, C.W., J.P. Hassett, J.B. Hyde, R.A. Entringer & R.K. Klake. 2011. Proposed nutrient criteria for water supply lakes and reservoirs. Journal of the American Water Works Association 105(4):E157-E172.

    Implementation of nutrient criteria help to protect lakes and reservoirs from the negative effects of nutrient pollution, which frequently include, but are not limited to (a) the occurrence and spread of toxic algae, (b) the proliferation of certain fish species that are less desirable to sport anglers (i.e., “rough” fish), (c) a general decline in sensitive aquatic plant and animal populations, (d) the occurrence of taste and odor problems in drinking water derived from lakes and reservoirs, (e) Safe Drinking Water Act violations related to the occurrence of disinfection by-products (e.g., trihalomethanes, haloacetic acids) in finished drinking water, (f) a decline in waterbody transparency with accompanying recreational safety concerns, (g) the occurrence of unsightly scums and objectionable odors, (h) the depreciation of lakefront property values,31 and (i) an overall reduction in the functional life expectancy of reservoirs, with a corresponding loss of return on society's economic investment in these systems.

    31 USEPA. 2015. A Compilation of Cost Data Associated with the Impacts and Control of Nutrient Pollution, EPA 820-F-15-096, United States Environmental Protection Agency, May 2015.

    3. Nutrient Pollution in Missouri Lakes and Reservoirs

    Lake water quality impairments attributable to nutrient pollution have not been quantified with any degree of precision in Missouri. Long-term monitoring data are available for about 10 percent of the State's classified lakes and reservoirs (representing approximately 90 percent of overall lake acreage), and about 15 percent of these monitored waters already have EPA-approved numeric nutrient criteria.

    Missouri adopted site-specific chlorophyll a, total phosphorus and total nitrogen criteria for 25 lakes and reservoirs on July 1, 2009, which were approved by EPA on August 16, 2011. Currently, eleven of these waterbodies (44 percent) are listed for nutrient pollution-related impairments. This percentage is consistent with nation-wide estimates of lakes in the most disturbed category obtained through the 2012 National Lakes Assessment (NLA). Specifically, the NLA estimates that 40 percent of all lakes and reservoirs in the conterminous U.S. are considered most disturbed based on elevated phosphorus concentrations, and 35 percent are considered most disturbed based on elevated nitrogen concentrations (https://www.epa.gov/national-aquatic-resource-surveys/nla).

    MDNR acknowledges that lake and reservoir eutrophication is occurring at a detectable rate throughout much of the state.32 Over the past 20 or more years, chlorophyll a levels in monitored waterbodies have increased by an average of 3.5, 13, 28 and 2.6 µg/L in the Glaciated Plains, Osage Plains, Ozark Border and Ozark Highlands, respectively.33

    32 MDNR. 2016. Missouri Integrated Water Quality Report and Section 303(d) List, 2016. Missouri Department of Natural Resources, Jefferson City, Missouri. http://dnr.mo.gov/env/wpp/waterquality/303d/docs/2016-ir-305b-report.pdf.

    33Id.

    B. Statutory and Regulatory Background

    Section 303(c) of the CWA (33 U.S.C. § 1313(c)) directs states and authorized tribes 34 to adopt WQS for their navigable waters. Section 303(c)(2)(A) and EPA's implementing regulations at 40 CFR part 131 require, among other things, that state WQS include the designated use or uses to be made of the waters and criteria that protect those uses. EPA regulations at 40 CFR § 131.11(a)(1) provide that states and authorized tribes shall “adopt those water quality criteria that protect the designated use” and that such criteria “must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use. For waters with multiple use designations, the criteria shall support the most sensitive use.”

    34 Hereafter referred to as “states and authorized tribes”. “State” in the CWA and in this document, refers to a state, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. “Authorized tribes” refers to those federally recognized Indian tribes with authority to administer a CWA WQS program.

    Additionally, 40 CFR § 130.10(b) provides that “[i]n designating uses of a waterbody and the appropriate criteria for those uses, the state shall take into consideration the water quality standards of downstream waters and ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.”

    States and authorized tribes also are required to hold one or more public hearings consistent with 40 CFR § 25.5 to review their WQS at least once every three years and, as appropriate, modify or adopt new standards and to hold public hearings when revising or adopting new WQS. (See 33 U.S.C. § 1313 (c)(1) and 40 CFR § 131.20). Any new or revised WQS must be submitted to EPA for review and approval or disapproval. 33 U.S.C. § 303(c)(2)(A), (3)). If EPA determines a state's new or revised standard does not meet the requirements of the CWA, EPA “must specify the changes to meet such requirements.” § 303(c)(3). If the state does not adopt such changes within ninety days, EPA “shall promptly prepare and publish proposed regulations” and promulgate any revised or new standard within ninety days unless the state has adopted and EPA has approved a WQS as meeting CWA requirements. Id.

    C. Deriving and Expressing Numeric Nutrient Criteria

    Under CWA section 304(a), EPA periodically publishes criteria recommendations for use by states and authorized tribes in setting water quality criteria for particular parameters to protect the designated uses for their surface waters. Where EPA has published nationally-recommended criteria, states and authorized tribes have the option of adopting water quality criteria based on EPA's CWA section 304(a) criteria guidance, section 304(a) criteria guidance modified to reflect site-specific conditions, or other scientifically defensible methods. (See 40 CFR 131.11(b)(1)). For nitrogen and phosphorus pollution, EPA finalized in 2001-2002 numeric nutrient criteria recommendations (i.e., total nitrogen, total phosphorus, chlorophyll a, and turbidity) for lakes and reservoirs, and for rivers and streams for most of the aggregated Level III Ecoregions in the United States. These were based on EPA's previously published series of peer-reviewed, water body specific technical guidance manuals regarding the development of numeric criteria for lakes and reservoirs 35 and rivers and streams.36

    35 USEPA. 2000a. Nutrient Criteria Technical Guidance Manual: Lakes and Reservoirs. EPA-822-B-00-001. U.S. Environmental Protection Agency, Office of Water, Washington, DC.

    36 USEPA. 2000b. Nutrient Criteria Technical Guidance Manual: Rivers and Streams. EPA-822-B-00-002. U.S. Environmental Protection Agency, Office of Water, Washington, DC.

    In general, there are three types of empirical analyses that provide distinctly different, independent and scientifically defensible, approaches for deriving nutrient criteria from field data. These include (1) the “reference condition approach,” which derives criteria based on the observed water quality characteristics of minimally disturbed or least disturbed waterbodies, (2) the “mechanistic modeling approach,” which employs mathematical representations of ecological systems, processes and parameters using equations that can be calibrated using site-specific data, and (3) the “stressor-response-based modeling approach,” 37 which uses available data to estimate statistical relationships between nutrient concentrations and response (ecological, recreational, human health) measures relevant to the designated use to be protected. Each of these approaches is appropriate for deriving scientifically defensible numeric nutrient criteria. Other approaches may be appropriate depending on specific circumstances. Numeric nutrient criteria also may be based on well-established (e.g., peer-reviewed, published, widely recognized) nutrient response thresholds relating to the protection of a given designated use.38

    37 USEPA. 2010. Using Stressor-response Relationships to Derive Numeric Nutrient Criteria. EPA-820-S-10-001. U.S. Environmental Protection Agency, Office of Water, Washington, DC.

    38 USEPA. 2000a. Nutrient Criteria Technical Guidance Manual: Lakes and Reservoirs. EPA-822-B-00-001. U.S. Environmental Protection Agency, Office of Water, Washington, DC.

    EPA has long recommended that states adopt numeric criteria for total nitrogen (TN) and total phosphorus (TP),39 the nutrients that in excess can ultimately cause adverse effects on designated uses. For this reason, TN and TP are often referred to as “causal” parameters. However, EPA recognizes that the specific levels of TN and TP that adversely affect designated uses, including harm to aquatic life as indicated by various measures of ecological responses, may vary from waterbody to waterbody, depending on many factors, including geomorphology and hydrology among others. As a result, EPA has worked with several states as they developed a combined criterion approach that allows a state to further consider whether a waterbody is meeting designated uses when elevated TN and TP levels are detected. Under this approach, an exceedance of a causal variable, acts as a trigger to consider additional physical, chemical, and biological parameters that serve as indicators to determine protection or impairment of designated uses; these additional parameters are collectively termed “response” parameters.

    39Id.

    EPA's articulation of this combined criterion approach 40 is intended to apply when states wish to rely on response parameters to determine whether a designated use is impaired, once a causal variable has been found to be above an adopted threshold. As with any criteria, states should make clear at what point it has determined that a waterbody is meeting or not meeting its designated use. EPA has expressed that numeric values for all parameters must be set at levels that protect these uses (i.e., before adverse conditions occur that would require restoration).41

    40 This approach is sometimes referred to as a “bioconfirmation” approach despite the fact that response parameters may not all be “biological,” although they typically do reflect biological activity.

    41 USEPA. Guiding Principles on an Optional Approach for Developing and Implementing a Numeric Nutrient Criterion that Integrates Casual and Response Parameters. September 2013.

    EPA has worked extensively with states that have adopted a combined criterion approach, resulting in CWA section 303(c) approvals of combined criterion approaches for Florida's streams,42 43 Minnesota's rivers and streams,44 and Vermont's lakes and reservoirs.45 Although each of these combined criterion approaches differ from one another in terms of the applicable causal parameters and suite of response parameters as applied to various waterbody types, the combined criterion construction can provide greater precision when there is heightened variability in waterbodies' responses to nutrients.

    42 USEPA. Letter from James D. Giattina, Director, Water Protection Division, EPA Region 4, to Herschel T. Vinyard, Secretary, Florida Department of Environmental Protection. November 30, 2012.

    43 USEPA. Letter from James D. Giattina, Director, Water Protection Division, EPA Region 4, to Herschel T. Vinyard, Secretary, Florida Department of Environmental Protection. June 27, 2013.

    44 USEPA. Letter from Tinka Hyde, Director, Water Division, EPA Region 5, to Commissioner John Line Stine, Minnesota Pollution Control Agency. January 23, 2015.

    45 USEPA. Letter from Kenneth Moraff, Director, Office of Ecosystem Protection, EPA Region 1 to Alyssa Schuren, Commissioner, Vermont Department of Environmental Conservation. September 15, 2015.

    EPA notes that once appropriate numeric criteria are developed, assessment of the impairment status of individual water bodies is dependent on data; this is true for any set of numeric criteria addressing any pollutant. EPA further recognizes that it is the responsibility of States to determine the pace and prioritization of data collection, as this is primarily an implementation issue rather than a criteria development issue. However, EPA recommends that states consider such implementation issues at the time of criteria development as this may lead to a more successful water quality standards program generally. In the case of nutrient criteria, EPA has recommended that states interested in this approach develop a biological assessment program that can measure biological responses and other nutrient-related response parameters with confidence through a robust monitoring program to account for spatial and temporal variability to document the effects of nutrient pollution. EPA reiterates, however, that States have significant discretion in determining the appropriate pace and prioritization of such a monitoring program.

    In developing combined criteria, States and EPA have previously identified the following as response parameters that are indicative of nutrient pollution in streams: measures of primary productivity (e.g. benthic chlorophyll a, percent cover of macrophytes), measures of algal assemblage (e.g. algal assemblage indices), and measures of ecosystem function (e.g. continuously monitored pH and dissolved oxygen). EPA recognizes that this may not be an exhaustive list of appropriate response parameters. The approach is generally applicable to lakes and reservoirs, as well as other waterbody types. For lakes and reservoirs, chlorophyll a has typically been measured as sestonic (open water) concentration rather than as a benthic (bottom surface) concentration. Appropriate biological response parameters should directly link nutrient concentrations to the protection of designated uses. The appropriate type and quantity of response parameters may vary by state, ecosystem, and waterbody type.

    In previous guidance, EPA has recommended that a combined criterion approach should make clear the impairment status of waterbodies in the following situations.46 Specifically, EPA has recommended that if all causal and response parameters are met, then the water quality criterion is met and the waterbody is deemed to be meeting its designated uses. If all response parameters are met, but one or more of the causal parameters is exceeded, then the criterion is met and the waterbody is deemed to be meeting its designated uses (though the state may wish to flag this water body for further scrutiny in the future). If a causal parameter is exceeded and any applicable response parameter is exceeded, then the criterion is not met and the waterbody is deemed to not be meeting its designated uses. If a causal parameter is exceeded and data are unavailable for any applicable response parameters, then the criterion is not met and the waterbody is deemed to not be meeting its designated uses. If a causal parameter is not exceeded but an applicable response variable is exceeded, then the criterion is not met and the waterbody is deemed to not be meeting its designated uses (in this scenario, further investigation may be warranted to determine if nutrient pollution is the cause).

    46 USEPA. Guiding Principles on an Optional Approach for Developing and Implementing a Numeric Nutrient Criterion that Integrates Casual and Response Parameters. September 2013.

    One situation deserves special consideration. If a causal parameter is exceeded and data are unavailable for any applicable response parameters, EPA has previously recommended that the criterion be deemed not met and the waterbody be deemed to not be meeting its designated uses. Under one of EPA's co-proposed approaches (which mirrors the State's 2017 proposal), such waterbodies would be deemed “undetermined” with respect to impairment status. Under the other co-proposed approach, which matches EPA's prior recommendations, the water body is deemed to be impaired, until all response variables have been assessed, at which point the water body status may be changed to non-impaired if no response variable is exceeded. EPA has recommended this approach in the past on the grounds that an exceedance of a causal variable will generally correlate with impairment of aquatic life uses, but we preserve the flexibility for states to conclude that a waterbody is not impaired if information indicates the absence of a response in the waterbody supporting the conclusion that the use is being protected. EPA recognizes there are alternative views of how this comports with requirements that criteria be based on a sound scientific rationale and protective of designated uses, believing if data on some response variables are missing, then it may not be known whether the water body is meeting its designated use or not, and an “undetermined” status with respect to impairment may be appropriate. EPA solicits comment on whether response variables are the best indicators of impairment or non-impairment, and the science policy considerations relevant to determining whether a water body is meeting its designated use if data on some or all response variables are missing.

    The approach described above ensures protection of designated uses by taking into account critical information about the pollutant load in the waterbody, as well as the response. Although the terminology of the combined criterion approach more closely aligns with assessment and listing terminology, the combined criterion is also the applicable WQS for NPDES permitting purposes whereby permits must contain limits for any pollutant parameters that are or may be discharged at levels that will cause, have reasonable potential to cause, or contribute to an excursion above any WQS (40 CFR 122.44(d)(1)).

    D. Missouri's 2009 Nutrient Criteria Submission and EPA's Clean Water Act Section 303(c) Action

    On November 5, 2009, Missouri submitted revised WQS containing nutrient criteria for a large subset of the State's classified lakes and reservoirs. These standards contained the following language at 10 CSR 20-7.031(4)(N)2: “This [nutrient criteria] rule applies to all lakes and reservoirs that are waters of the state and that are outside the Big River Floodplain Ecoregion and have an area of at least ten (10) acres during normal pool.” Table G in Missouri's WQS regulations listed 453 classified lakes and reservoirs, 25 of which were deemed “high quality” and were assigned site-specific nutrient criteria separately in Table M. Of the remaining waters, 96 were smaller than ten acres and/or located in the Big River Floodplain Ecoregion and exempted from the application of nutrient criteria under 10 CSR 20-7.031(4)(N)2. Conversely, 332 lakes and reservoirs not listed in Table M were subject to the application of nutrient criteria under 10 CSR 20-7.031(4)(N)2 and (4)(N)3 at the time Missouri submitted its nutrient criteria to EPA. On August 16, 2011, EPA approved all nutrient criteria assigned to the 25 waterbodies listed in Table M but disapproved nutrient criteria that would have applied to the remaining waterbodies. Additionally, EPA disapproved site-specific criteria for total phosphorus assigned to the tributary arms of two large reservoirs (Lake of the Ozarks and Table Rock Lake) per 10 CSR 20-7.031(4)(N)3.A.IV.

    The disapproved water quality standards defined “prediction values,” “reference values” and “site specific-values” and derived total phosphorus (TP) criteria based on how these values compared to one another. This approach involved a set of input variables and site-specific data requirements. For example, the regulation established that TP prediction values for lakes and reservoirs in the Plains must be calculated based on site-specific coefficients for the (a) percentage of watershed originally in prairie, (b) hydraulic residence time in years, and (c) dam height in feet. To apply the appropriate TP criterion, the State would have had to know how the TP prediction value compared to both the TP reference value and the actual (empirically determined) TP concentration. Total nitrogen (TN) and chlorophyll a criteria were calculated as multiples of the selected TP criterion.

    EPA's disapproval action was based on a determination that Missouri's proposal did not include the data and other necessary information needed for EPA to independently reproduce the State's work and that the State had failed to demonstrate that the criteria would protect the designated aquatic life support and recreational uses as required by 40 CFR 131.6(b) and (c).47

    47 US EPA. (2011) Letter to Sara Parker Pauley (Director, Missouri Department of Natural Resources) from Karl Brooks (USEPA Region 7), Decision document on Missouri Water Quality Standards, August 16, 2011.

    On March 19, 2014, Missouri submitted revised water quality standards (the designated uses component) that incorporated, for the first time, the Missouri Use Designation Dataset (MUDD) (10 CSR 20-7.031(2)(E); see also Table G of WQS which references the MUDD 48 ). This dataset assigned designated uses to the State's classified lakes and reservoirs (and streams) and was approved by EPA on October 22, 2014. Altogether, MUDD identified 3,081 waterbody segments, including 2,757 lakes and reservoirs, and assigned the following designated uses to these waters: aquatic life support, whole body contact recreation, secondary contact recreation, fish consumption, livestock and wildlife watering, irrigation, and industrial water supply. In addition to these uses, 123 lakes and reservoirs are also designated in the 2014 MUDD dataset for drinking water supply. Missouri also revised its water quality standards to provide that its specific criteria applies to all waters consistent with the designated uses identified in Table G and MUDD. 10 CSR 20-7.031(5). EPA approved this change on November 17, 2015. EPA's proposed rule addresses the same generic class of waters included in Missouri's disapproved rule. However, consistent with Missouri's subsequent actions, EPA's proposal would apply to a larger group of enumerated lakes and reservoirs, specifically those in Table G and MUDD that are ten acres or more, not located in the Big River Floodplain Ecoregion, and not otherwise listed in Table M of the WQS. This includes 967 waterbodies. EPA requests comment on whether this scope is appropriate for the current rule.

    48 The Water Body Name, Missouri Use Designation Dataset Version 1.0, August 20, 2013 (8202013 MUDD V1.0), refers to all lakes in the Missouri Use Designation Dataset Version 1.0, August 20, 2013, that are not otherwise listed in Table G.

    E. Missouri Coalition for the Environment (MCE) Lawsuit and Consent Decree

    On February 24, 2016, the Missouri Coalition for the Environment Foundation (MCE) filed a lawsuit alleging that EPA failed to perform its nondiscretionary duty to propose and promulgate new or revised water quality standards for lakes and reservoirs in Missouri after disapproving the State's submission in 2011. On December 1, 2016, EPA entered into a consent decree with MCE that stipulates that EPA shall sign a notice of proposed rulemaking by December 15, 2017, to address EPA's 2011 disapproval, unless the State submits and EPA approves new or revised standards that address the disapproval on or before December 15, 2017; and that EPA shall sign a notice of final rulemaking on or before December 15, 2018, unless the State submits and EPA approves new or revised standards that address the disapproval. In the years following the 2011 disapproval action, EPA has endeavored to work closely with Missouri to develop approvable nutrient criteria.

    F. Missouri's 2017 Proposed Nutrient WQS

    On October 16, 2017, MDNR continued to develop revised numeric nutrient criteria and formally issued its proposed WQS that are intended to address EPA's August 16, 2011 disapproval. Based on EPA's examination of the State's proposed rule, Missouri has characterized its revised nutrient WQS as a combined criterion. Missouri's proposed rule applies to lakes and reservoirs.49 The State's lakes and reservoirs are impounded and have been assigned an aquatic life use of either: Warm water habitat, cool water habitat, or cold water habitat. Each subcategory is defined as “waters in which naturally-occurring water quality and habitat conditions allow [for] the maintenance of a wide variety of [warm, cool or cold water] biota.” 50 The State takes the position that “health of sport fish populations can be interpreted as an indicator of overall ecosystem health and the presence of a “wide variety” of aquatic biota.” 51 Missouri's proposed rule establishes three ecoregions and sets forth for each ecoregion chl-a criteria above which waters would be deemed impaired, and a combination of TN, TP, and chl-a “screening values” and five “eutrophication impacts” (i.e., response parameters) where a waterbody would be deemed impaired if at least one screening value and at least one eutrophication impact are exceeded in the same year. When data are unavailable for the eutrophication impacts despite information indicating that at least one screening value is exceeded, Missouri intends waters to be listed on Category 3 of the 305(b)/303(d) Integrated Report, meaning there is insufficient information to determine impairment status. In Missouri's expression of the combined criterion approach, the chl-a parameter functions as both a screening value, requiring evaluation of the eutrophication impacts, and at a higher level as a stand-alone criterion that would determine in and of itself that a water body is impaired, without the need to further assess eutrophication impacts. If chl-a is exceeded at the screening level but there is inadequate information on the other response variables, the water is placed in category 3 and not listed as impaired.

    49See 10 CSR 20-7.031(5) and the October 2017 draft language proposed for 10 CSR 20-7.031(5)(N)(2) (“This rule applies to all lakes that are waters of the state and have an area of at least ten (10) acres during normal pool conditions. Big River Floodplain lakes shall not be subject to these criteria”).

    50 10 CSR 20-7.031(1)(C)1.A.VI, B.V and C.V.

    51 See Missouri Department of Natural Resources, Rationale for Missouri Reservoir Nutrient Criteria Development, November 2016, Section 6.1, pages 33-39.

    Table 2. Excerpts From Missouri's October 16, 2017 Nutrient Proposal Table L—Lake Ecoregion Chl-a Criteria and Nutrient Screening Values (μg/L) Lake Ecoregion Chl-a Criterion Screening Values (μg/L) TP TN Chl-a Plains 30 49 843 18 Ozark Border 22 40 733 13 Ozark Highland 15 16 401 6 5. Lakes with water quality that exceed Nutrient Criteria identified in Tables L and M are to be deemed impaired for excess nutrients. 6. Lakes with water quality that exceed screening values for Chl-a, TN, or TP are to be deemed impaired for excess nutrients if any of the following eutrophication impacts are documented for the respective designated uses within the same year. Eutrophication impacts for aquatic life uses include: (I) Occurrence of eutrophication-related mortality or morbidity events for fish and other aquatic organisms; (II) Epilimnetic excursions from dissolved oxygen or pH criteria; (III) Cyanobacteria counts in excess of 100,000 cells per milliliter (cells/ml); (IV) Observed shifts in aquatic diversity attributed to eutrophication; and (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1-September 30

    At the time of this proposal, Missouri's proposal is still under consideration and the State has not submitted to EPA for CWA 303(c) review a final rule with supporting information to address EPA's 2011 disapproval.

    III. Proposed Nutrient Combined Criterion for Lakes and Reservoirs in Missouri A. Proposed Combined Criterion Approaches

    Today EPA is proposing two alternatives to establish nutrient criteria in a combined criterion approach to address its 2011 disapproval. Under the first alternative, EPA proposes nutrient protection values and eutrophication impact factors in a combined criterion approach. Under the second alternative, EPA proposes a combined criterion approach that would mirror the State of Missouri's October 2017 proposal for lake nutrient water quality standards. EPA seeks public comment on the two alternatives described below in light of the federal regulations at 40 CFR part 131.11 requiring that criteria must be based on a sound scientific rationale and protective of the designated uses of the waters.

    B. Proposed Combined Criterion Alternative 1

    Alternative 1 is presented in Table 3 below and appears as regulatory text at the end of this proposal.

    Table 3—Alternative 1 Lake Ecoregion Nutrient Protection Values (µg/L) and Eutrophication Impacts Lake Ecoregion TP TN Chl-a Plains 44 817 14 Ozarks 23 500 7.1 (1) Lake and reservoir water quality must not exceed nutrient protection values for chlorophyll-a. (2) Lake and reservoir water quality must also not exceed nutrient protection values for total nitrogen and total phosphorus unless each of the following eutrophication impacts are evaluated and none occur within the same three-year rolling average period: (I) Eutrophication-related mortality or morbidity events for fish and other aquatic organisms; (II) An excursion from the DO or pH criteria in Missouri water quality standards applicable for Clean Water Act purposes; (III) Cyanobacteria counts equal to or greater than 100,000 cells per ml; (IV) Observed shifts in aquatic diversity directly attributable to eutrophication; or (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1-September 30, or Secchi disk measurements of turbidity equal to or less than EPA's recommended Level III Ecoregions IX (1.53 m) or IX (2.86 m).

    Alternative 1 is comprised of nutrient protection values and eutrophication impacts. Nutrient protection values are defined similarly as Missouri defines their “screening values”: maximum ambient concentrations of TP, TN, and chl-a based on the three-year rolling average geometric mean of nutrient data collected April through September. EPA has chosen the term “protection values,” rather than “causal” or “screening” values, to emphasize that in general, lakes and reservoirs that do not exceed these values may be assumed to meet designated uses without further assessment of eutrophication impacts. However, EPA recognizes, consistent with the logic of the combined criteria approach, that exceedance of such values does not necessarily mean that a water body is impaired. Alternative 1 uses nutrient protection values for TN, TP, and chl-a derived using a reference condition approach for the Plains ecoregion and a combined Ozarks ecoregion described in detail in the following section. These values are based on a reference condition approach using the 75th percentile of a distribution of values from a population of least disturbed lakes in each of the two ecoregions (Plains and Ozarks). The nutrient protection values for chl-a in Alternative 1 function as stand-alone criteria independent from the TN and TP protection values and other eutrophication impact factors. This approach gives additional weight to chl-a as a key early response indicator of adverse impact from excess nitrogen and phosphorus.

    Under Alternative 1, lake and reservoir water quality must not exceed protection values for TN or TP unless each of the eutrophication impacts are evaluated and data demonstrate that none occur within the same three-year rolling average period as a TN or TP exceedance. EPA included this presumption to address potential for data gaps for response parameters.52 As such, when TN and TP levels are exceeded, the designated uses would be considered impaired unless sufficient information exists demonstrating no eutrophication impacts are occurring. Eutrophication impacts include: (I) Eutrophication-related mortality or morbidity events for fish and other aquatic organisms; (II) An excursion from the dissolved oxygen (DO) or pH criteria in Missouri water quality standards applicable for Clean Water Act purposes; (III) Cyanobacteria counts equal to or greater than 100,000 cells per ml; (IV) Observed shifts in aquatic diversity directly attributable to eutrophication; or (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1-September 30, or Secchi disk measurements of turbidity equal to or less than EPA's recommended Level III Ecoregions IX (1.53 m) or IX (2.86 m). Alternative 1 does not include a qualifier of “epilimnetic” with respect to excursion of DO or pH criteria to reflect that aquatic habitat extends beyond the surficial layer of lakes and reservoirs, and to be consistent with the State's currently approved DO and pH criteria. Alternative 1 includes specific Secchi disk measurement thresholds as part of the turbidity component to provide a means of quantifying this eutrophication impact factor.53

    52 EPA recognizes that there are differences of opinion on whether addressing such data gaps is necessary in a combined criteria approach and that this presumption is not a feature of the co-proposed Alternative 2.

    53 Secchi disk measurement thresholds could be those presented in in EPA's Level III ecoregional criteria documents (1.53 m for Ecoregion IX and 2.86 for Ecoregion XI). See USEPA. December 2000. Ambient Water Quality Criteria Recommendations, Information Supporting the Development of State and Tribal Nutrient Criteria Lakes and Reservoirs in Nutrient Ecoregion IX. EPA 822-B-00-011. https://www.epa.gov/sites/production/files/documents/lakes9.pdf and USEPA. December 2000. Ambient Water Quality Criteria Recommendations Information Supporting the Development of State and Tribal Nutrient Criteria Lakes and Reservoirs in Nutrient Ecoregion XI. EPA 822-B-00-012. https://www.epa.gov/sites/production/files/documents/lakes11.pdf. An alternative Secchi disk measurement could be 1 meter based on the hypereutrophic boundary identified in Carlson, R.E. and J. Simpson. 1996. A Coordinator's Guide to Volunteer Lake Monitoring Methods. North American Lake Management Society. 96 pp., and further supported by the data used to derive reference condition values. A third set of alternatives appears in the Technical Support Document accompanying this rule describing reference condition values for Missouri lakes.

    C. Derivation of Nutrient Protection Values for Alternative 1

    EPA requests comment on a set of nutrient protection values as derived below. This methodology considered the water quality characteristics of lakes and reservoirs located in watersheds with comparatively low levels of human disturbance. This methodology, known as the reference condition approach, comports with longstanding Agency guidance 54 and builds on earlier collaborative efforts in the four-state region.55 This approach could be implemented using the State's existing water quality dataset 56 and key geographical concepts and interpretations supported previously by the State.57

    54 USEPA. 2000. Nutrient Criteria Technical Guidance Manual: Lakes and Reservoirs. EPA-822-B00-001. U.S. Environmental Protection Agency, Office of Water, Washington DC.

    55 RTAG. 2011. Nutrient Reference Condition Identification and Ambient Water Quality Benchmark Development Process: Freshwater Lakes and Reservoirs within USEPA Region 7. Regional Technical Advisory Group. Kansas Biological Survey, University of Kansas, Lawrence, KS.

    56 Obrecht, D. 2015. Statewide Lake Assessment Program. Quality assurance project plan. School of Natural Resources, University of Missouri, Columbia, MO.

    Thorpe, A. 2015. The Lakes of Missouri Volunteer Program. Quality assurance project plan. School of Natural Resources, University of Missouri, Columbia, MO.

    57 Nigh, T.A. and W.A. Schroeder. 2002. Atlas of Missouri Ecoregions. Missouri Department of Conservation, Jefferson City, MO.

    Protecting a waterbody at reference conditions should inherently protect all designated uses, and therefore, should support the most sensitive use.58 59 EPA is unaware of compelling scientific evidence that would suggest that the reference condition approach employed here would not protect Missouri's aquatic life, recreation, and drinking water designated uses, though EPA is not suggesting that there are no other approaches to protect applicable designated uses. EPA believes that the reference condition approach described here also comports with the State's regulatory definition for the aquatic life support use. This definition recognizes three subcategories under the aquatic life support header: Warm water habitat, cool water habitat, and cold water habitat.60 Each subcategory is described as “waters in which naturally-occurring water quality and habitat conditions allow [for] the maintenance of a wide variety of [warm, cool or cold water] biota.” This description is explicitly applied to lakes and reservoirs (10 CSR 20-7.031(1)(C)1.A.VI, B.V and C.V and 10 CSR 20-7.031(2)). Moreover, it links the aquatic life support use to the naturally occurring water quality condition, which is approximated by the reference condition. In the context of ambient nutrient concentrations, the accuracy of this approximation varies among regions depending on the prevailing extent of disturbance to natural land cover and other factors.61 Given the prevailing level of disturbance to natural land cover in Missouri, this approach could use nutrient protection values based on the least disturbed reference condition, which represents the best remaining condition in Missouri, rather than the historical or minimally disturbed reference condition.62

    58 USEPA. 2000a. Nutrient Criteria Technical Guidance Manual: Lakes and Reservoirs. EPA-822-B-00-001. U.S. Environmental Protection Agency, Office of Water, Washington, DC.

    59 Grubbs, Geoffrey. 2001. Development and Adoption of Nutrient Criteria into Water Quality Standards. WQSP-01-01. Policy memorandum signed on November 14, 2001, by Geoffrey Grubbs, Director, Office of Science and Technology, U.S. Environmental Protection Agency, Washington, DC.

    60 The same nutrient criteria apply to all three subcategories based on the way EPA aggregated data for purposes of deriving protective criteria using a reference condition approach.

    61 EPA Technical Support Document for this rule, Nutrient Criteria Recommendations for Lakes in Missouri, Section 2.4.

    62 Stoddard, J.L., D.P. Larsen, C.P. Hawkins, R.K. Johnson and R.H. Norris. 2006. Setting expectations for the ecological conditions of streams: The concept of reference condition. Ecological Applications 16:1267-1276. Stoddard et al. (2006) suggested that waters exhibiting comparatively little degradation could be placed into one of two categories: Minimally disturbed systems (those little affected by human actions); and least disturbed systems (those exhibiting the best remaining condition in a region widely impacted by human actions). The term historical was used by the same authors to denote a condition occurring at some specified point in the past (e.g., immediately prior to European settlement).

    In developing this Alternative 1 approach, EPA initially considered all readily available water quality data (i.e., TN, TP, total chlorophyll, chlorophyll a, Secchi transparency data) for lakes and reservoirs in Missouri. These records were accessed using the federal Water Quality Portal (WQP), which is maintained jointly by the EPA, the U.S. Geological Survey (USGS), and the National Water Quality Monitoring Council. The WQP integrates publicly available data from the EPA Storage and Retrieval Data Warehouse, the USGS National Water Information System, and the U.S. Department of Agriculture's Agricultural Research Database System.

    EPA subsequently reviewed sampling and analytical protocols employed by the various governmental agencies, academic institutions and private entities (e.g., consulting firms) contributing to the above-mentioned databases. Based on this review, EPA elected to confine its analysis to data derived from the Missouri Statewide Lake Assessment Program (SLAP) and the Lakes of Missouri Volunteer Monitoring Program (LMVP), both overseen by the University of Missouri-Columbia Limnology Laboratory. This decision ensured that all water quality data used in the reference condition analysis were obtained using comparable field and analytical methods and derived from the same sampling period, 1989-2015. The dataset was narrowed further by removing data for all waters smaller than ten acres or located in the Big River Floodplain Ecoregion, consistent with the scope of waters covered by this proposal. For consistency, only data from the main body of these lakes/reservoirs (i.e., from deeper, open water locations) were used in the reference condition analysis. Overall, this effort yielded suitable long-term data for 170 lakes/reservoirs in Missouri (119 located in the Plains Ecoregion and 51 located in the Ozarks Ecoregion). As explained in the Technical Support Document accompanying this proposal, EPA combined data obtained from the Ozark Border and the Ozark Highlands ecoregions identified in the State proposal because lakes in these two regions exhibited statistically similar concentrations for chlorophyll, total phosphorus and total nitrogen.

    In identifying candidate (least disturbed) reference sites, EPA used the following criteria as an initial screen to identify least disturbed waters, all previously included in the State's 2009 WQS submittal.

    Cropland and urban land combined accounted for less than twenty percent of the watershed land use. 63 64 This criterion was applied by EPA in all instances.

    63 Jones, J.R., M. F. Knowlton, and D.V. Obrecht. 2008. Role of land cover and hydrology in determining nutrients in mid-continent reservoirs: implications for nutrient criteria and management. Lake and Reservoir Management. 24:1, 1-9, DOI:10.1080/07438140809354045.

    64 W. K. Dodds and R. M. Oakes. 2004. A technique for establishing reference nutrient concentrations across watersheds affected by humans. Limnology and Oceanography: Methods. 2:333-341.

    No point source, to include concentrated animal feeding operation (CAFO), was located in the watershed. EPA applied this criterion to CAFOs and major wastewater treatment plants (WWTPs) permitted under the National Pollutant Discharge Elimination System (NPDES). Non-discharging facilities and smaller discharging facilities (e.g., mobile home parks) were evaluated individually based on their location in the watershed and other factors.

    If located in the Plains, more than fifty percent of the watershed was covered by grassland. 65 In applying this threshold, EPA considered grassland and all other forms of native land cover (e.g., forest, marshland).

    65 J.R. Jones, M.F. Knowlton, D.V. Obrecht, and E.A. Cook. 2004. Importance of landscape variables and morphology on nutrients in Missouri reservoirs. Canadian Journal of Fisheries and Aquatic Science. 61:1503-1512.

    If located in the Ozark Highlands, more than fifty percent of the watershed was forested. Forests in the Ozark Highlands are the equivalent to grasslands in the Plains in terms of native land cover and associated nutrient delivery. This selection criterion was applied by EPA to the Ozark Highlands and the adjoining Ozark Border, which collectively comprise the Ozarks Ecoregion.66

    66 EPA Technical Support Document for this rule, Nutrient Criteria Recommendations for Lakes in Missouri, Section 6.1.

    In order to identify waters meeting this initial screening criteria, EPA obtained digital watershed polygons from USGS's National Hydrography Dataset and a separate dataset maintained by the University of Missouri-Columbia. In about five cases, polygons were not available in either dataset and had to be digitized in ArcGIS.67 NHDPlus-V2 flowlines and medium resolution NHD (1:100,000 scale) elevation-derived catchments were used to identify the watersheds for each lake/reservoir. In cases where a watershed was represented by more than one catchment, the catchments were dissolved into one polygon. For many of the smaller lakes/reservoirs, watersheds were defined using the Water Erosion Prediction Project (WEPP) model.68 The Zonal Tabulate Area tool in ArcGIS Spatial Analyst and the 2014 edition of the 2011 National Land Cover (www.mrlc.gov) were used to calculate the percentage of each watershed in specific land cover types. These percentages, along with ArcGIS-generated maps depicting the locations of permitted point sources and CAFOs, were used to identify lakes/reservoirs meeting the aforementioned selection criteria.

    67 ArcGIS is a digital geographic information system (GIS) used for creating and using maps, compiling geographic data, analyzing mapped information, sharing and discovering geographic information, and managing geographic information in a database form.

    68 Flanagan, D.C., J.R. Frankenberger, T.A. Cochrane, C.S. Renschler & W.J. Elliot. 2011. Geospatial application of the water erosion prediction (WEPP) model. International Symposium on Erosion and Landscape Evolution (ISELE), Anchorage, Alaska. September 18-21, 2011. ISELE Paper Number 11084.

    Flanagan, D.C., J.R. Frankenberger, T.A. Cochrane, C.S. Renschler & W.J. Elliot. 2013. Geospatial application of the water erosion prediction (WEPP) model. Transactions of the American Society of Agricultural and Biological Engineers 50(2):591-601.

    After this initial screening exercise, EPA then subjected the identified candidate watersheds/lakes to further evaluation using aerial imagery, NPDES permit records, Missouri Department of Conservation (MDC) conservation area reports, and other available sources of information. EPA removed watersheds and lakes from further consideration if they (1) received substantial drainage from the Big River Floodplain Ecoregion (out of scope); (2) exhibited extensive shoreline residential development; (3) had received historical or recent manure applications from nearby feedlots; (4) had undergone deliberate (fisheries oriented) fertilization efforts; and (5) had been situated in an area of formerly cultivated fields.69 The latter four reasons relate to factors relate to disturbance.

    69 EPA Technical Support Document for this rule, Nutrient Criteria Recommendations for Lakes in Missouri, Section 6.1.

    Additionally, three isolated waterbodies in the Plains exhibited median chlorophyll a concentrations exceeding 40 µg/L.70 Based on earlier studies, hypereutrophic waters of this kind are not representative of the reference condition in the Central Irregular Plains 71 , a region encompassing much of the Plains Ecoregion in Missouri.72 Therefore, EPA evaluated these waters in greater detail. In one instance, historical and ongoing confined animal feeding operations (CAFOs) in an adjacent watershed likely explained the noted hypereutrophic condition.73 The other two instances involved state-managed fishing lakes, one situated in a formerly cultivated field and the other situated in a watershed extending into the heavily cultivated Big River Floodplain. A few other lakes on state-managed lands were disqualified based on disturbance related to reported sedimentation and algal bloom issues.74 EPA ultimately identified 21 reference lakes and reservoirs in the Plains and 27 in the Ozarks that met the criteria discussed above. EPA calculated seasonal geometric mean TN, TP, and chlorophyll a concentration values for each waterbody, then calculated the long-term median seasonal geometric means for each parameter/waterbody combination. These medians were partitioned by ecoregion, ranked, and used in the calculation of appropriate concentration percentiles.75 EPA invites public comment on the methodology to select reference lakes and reservoirs for this alternative's methodology.

    70Id.

    71 Dodds, W.K., C. Carney and R.T. Angelo. 2006. Determining ecoregional reference conditions for nutrients, Secchi depth and chlorophyll a in Kansas lakes and reservoirs. Lake and Reservoir Management 22(2):151-159.

    72 Omernik, J. M. 1987. Ecoregions of the conterminous United States. Annals of the Association of American Geographers 77:118-125.

    73 The hog CAFO in question generated an amount of waste equaling a human population of about 19,000. Owing to high transportation costs, manure from such facilities generally is applied to surrounding fields and cropland.

    74 This is illustrated by the following excerpt from the ten-year management plan for one of these areas: “Strategy 1: Sufficient phytoplankton densities will be maintained through artificial fertilization to shade and discourage the development of rooted plant growth. Successful artificial fertilization should limit the need for the extensive use of grass carp or herbicides while increasing phytoplankton blooms and zooplankton communities throughout the summer and into the early fall” (MDC. 2015. Lake Girardeau Conservation Area Management Plan. Missouri Department of Natural Resources, Southeast Region, Poplar Bluff, MO.)

    75 USEPA. 2000. Nutrient Criteria Technical Guidance Manual: Lakes and Reservoirs. EPA-822-B00-001. U.S. Environmental Protection Agency, Office of Water, Washington DC.

    To assist in the identification of appropriate concentration percentiles, land cover disturbance patterns in the three ecoregions were compared to patterns reported for the conterminous United States using ArcGIS. This comparison indicated that cropland and developed (urban) land collectively comprised 21.1 percent of the cover in the lower 48 states. This is comparable to the percentage reported for the Ozark Border (22.2 percent), higher than the percentage reported for the Ozark Highlands (6.9 percent), and lower than the percentage reported for the Plains (39.9 percent). Based on its review of the applicable federal guidance,76 EPA interpreted this to mean that application of the standard 75th percentile nutrient concentration would be appropriate for the Ozark Border, because this region has experienced a degree of land cover disturbance typifying that of the nation as a whole (excluding Alaska and Hawaii). The 75th percentile also was selected for the Ozark Highlands, and therefore appropriate for the combined Ozark ecoregion. In choosing this percentile, EPA was mindful of the limited number of potentially suitable reference waters in this region, and in turn, the difficulty in accurately estimating a higher percentile. EPA recognizes that there are higher levels of land cover disturbance in the Plains region relative to other locations in Missouri and most of the United States and considered using the 50th percentile for the Plains. However, EPA concluded that the screening criteria for reference sites (described above), already appropriately accounted for these differences by including the allowable percent of cropland and urban land in the lake watershed, is the same for each ecoregion. EPA decided to use of the 75th percentile for all ecoregions. EPA invites public comment on whether the use of the 75th percentile for these ecoregions was appropriate. EPA notes that using the 75th percentile of reference lakes to derive protection values implies that 25 percent of reference lakes would be deemed to exceed the protection values if assessed using the data used to derive the criteria. This could be interpreted to mean that 25 percent of the lakes meeting the reference condition selection criteria described above would none-the-less be determined to be impaired. This could also be interpreted as appropriately ensuring that high levels of nutrient parameters for lakes that, in fact, may or may not meet designated uses are not identified as protective for the vast majority of lakes that have much lower levels of nutrient parameters. A higher percentile value, such as the 90th or 95th percentile, would ensure that, at least based on the data used to derive the criteria, all or most of the reference lakes would in fact be found to meet designated uses. EPA invites public comment on whether the use of a higher percentile would be appropriate in the context of the selection criteria used by EPA to identify reference lakes and reservoirs for the purpose of calculating protective values indicative of meeting designated uses.

    76Id.

    In this alternative, these concentration percentiles would serve as nutrient protection values as part of a combined criterion approach for all classified lakes and reservoirs in Missouri that (1) are listed in Table G of the State's WQS and the Missouri Use Designation Dataset (10 CSR 20-7.031(2)(E)) with respect to use designations, (2) equal or exceed ten acres, (3) are located outside of the Big River Flood Plain Ecoregion and (4) are not already listed in Table M of the State's WQS. In all instances, these values are expressed as seasonal (April through September) geometric mean values and interpreted in the context of three-year rolling averages.77 EPA invites public comment on the use of moving averages versus fixed averaging periods.

    77 Use of a seasonal mean and three-year averaging period is consistent with recommendations set forth in: RTAG. 2011. Nutrient Reference Condition Identification and Ambient Water Quality Benchmark Development Process: Freshwater Lakes and Reservoirs within USEPA Region 7. Regional Technical Advisory Group, U.S. Environmental Protection Agency Region 7, Lenexa, KS.

    As described in the Technical Support Document accompanying this proposal, the resulting values are comparable in magnitude to those recommended by the Regional Technical Assistance Group (RTAG) for the four-state region, to criteria developed or adopted in neighboring Kansas, Nebraska and Oklahoma, and to TMDL targets adopted previously in Missouri. As such, EPA is confident that the nutrient protection values are protective of downstream lakes and reservoirs, though EPA emphasizes that this is not the only way of developing protective values. For protection of downstream rivers and streams, lakes often act as a “sink” for nutrients because of the relatively longer water residence time and associated physical processes and biochemical cycling. As such, lakes retain nutrients and outflow nutrient concentrations are generally lower than inflow nutrient concentrations. In terms of level of protection needed, nutrient criteria for lakes and reservoirs are generally lower than nutrient criteria for rivers and streams in the same ecoregion (see, for example, EPA's criteria published in 2000 for Ecoregion IX). For these reasons, EPA concludes that the values are protective of downstream waters and their assigned uses. EPA invites public comment on the derivation of EPA's proposed nutrient protection values based on least disturbed reference conditions. EPA specifically requests comments on the use of the 75th percentile of the reference lake values to establish the TN, TP, and chl-a nutrient protection values proposed for Alternative 1.

    D. Proposed Combined Criterion Alternative 2

    Alternative 2 is presented in Table 4 below.

    Table 4—Alternative 2 Lake Ecoregion Chl-a Criteria, Nutrient Screening Values (μg/L), and Eutrophication Impacts Lake ecoregion Chl-a criteria Screening Values (μg/L) TP TN Chl-a Plains 30 49 843 18 Ozark Border 22 40 733 13 Ozark Highland 15 16 401 6 Lakes with water quality that exceed Chl-a Criteria are to be deemed impaired for excess nutrients. Lakes with water quality that exceed screening values for Chl-a, TN, or TP are to be deemed impaired for excess nutrients if any of the following eutrophication impacts are documented for the respective designated uses within the same year. Eutrophication impacts for aquatic life uses include: (I) Occurrence of eutrophication-related mortality or morbidity events for fish and other aquatic organisms; (II) Epilimnetic excursions from dissolved oxygen or pH criteria; (III) Cyanobacteria counts in excess of 100,000 cells per milliliter (cells/ml); (IV) Observed shifts in aquatic diversity attributed to eutrophication; and (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1-September 30.

    As of the date of this proposal, Missouri has not finalized, and EPA has not made any determination with respect to, Missouri's proposed standards. Notwithstanding this, EPA believes it is appropriate to propose standards for consideration that are essentially identical to the proposed state standards, and is doing so in Alternative 2. Alternative 2 includes chl-a criteria for three ecoregions (Plains, Ozark Border, and Ozark Highland) that determine impairment independent of the screening values and eutrophication impact factors. Alternative 2, similarly to Alternative 1, includes screening values for TN, TP, and chl-a (at a lower level than the criteria for chl-a) that operate in coordination with five eutrophication impact factors to determine impairment. However, as explained above, one significant distinction is that Alternative 1 would treat the lower chl-a screening value (called a “protection value” in Alternative 1) as stand-alone criteria and deem any exceedance of this value as indicative of impairment without assessment of additional eutrophication impacts. Alternative 2 includes a qualifier of “epilimnetic” with respect to excursion of DO or pH criteria to mirror the State's proposal. EPA seeks comment on limiting application of DO and pH criteria to the epilimnion (surface layer) of lakes.

    The State of Missouri has documented a supporting rationale for the values proposed in Alternative 2 as part of a combined criterion structure.78 This document includes maps of the three ecoregions (Plains, Ozark Border, and Ozark Highland). In this document, Missouri describes how it considered input from a stakeholder group and “decided on an approach that provided for the most scientifically defensible protections for the underlying designated uses.” Missouri indicates that its approach “focuses on the biological response, considers ecoregional differences and existing trophic levels, and supplements criteria with conservative screening values coupled with weight of evidence analysis to better support determinations of impairment”. Missouri indicates that it reviewed several different sources of information to derive reservoir numeric nutrient criteria, including recent numeric nutrient criteria development activities in other states, Missouri-specific reservoir water chemistry data, literature reviews, and expert opinion.

    78 Missouri Department of Natural Resources. 2016. Missouri Lake Numeric Nutrient Criteria Rationale of Nov. 21, 2016.

    Missouri indicated the stand-alone independent chl-a criterion for the Plains “is conservatively set to support sport fisheries rather than maximizing sport fish harvest. Missouri maintains that using sport fishery status as an indicator of aquatic life use protection is ecologically justified because sport fish are generally apex predators in reservoir systems. Therefore, the health of sport fish populations can be interpreted as an indicator of overall ecosystem health and the presence a `wide variety' of aquatic biota, as defined in the existing regulations”.79 For the Ozark Highlands, Missouri identified “a lower chlorophyll concentration of 15 μg/L, which reflects the regional pattern of reservoir fertility associated with the different physiographic regions of the state”.80 Because the Ozark Border section represents a transition zone between the Plains and Ozark Highlands, Missouri identified a chl-a criterion intermediate to the other two sections. Missouri proposed chl-a screening values equal to the 50th percentile of the distribution of growing season chlorophyll data for each ecoregion, and back calculated TN and TP screening values using regression relationships with chl-a presented in their rationale document.

    79Id.

    80Id.

    EPA is seeking comment on whether the chl-a criteria in Alternative 2 would protect the State's designated uses for these lakes. EPA seeks comment on whether a different (i.e., more protective) level of chl-a as a eutrophication impact factor is necessary to protect the designated uses for these lakes. EPA further seeks comment on whether or not the hypothetical scenario pursuant to Alternative 2 is scientifically supportable as protecting the designated use: Not identifying a lake as impaired when it (1) exceeds a screening value for TP or TN, (2) exceeds a screening value for chl-a, and (3) there are no documented eutrophication impacts. In other words, EPA seeks comment on whether it is sufficient or insufficient to identify impairment if a water body exceeds a screening value for TN or TP and also exceeds a screening value for chl-a.

    The combined criterion could function in the manner proposed for Alternative 1, where a lake with water quality that exceeds protection values for TN or TP is deemed impaired for excess nutrients unless each of the eutrophication impacts are evaluated and none occur within the same evaluation period (or unless the chl-a protection value is exceeded). In contrast, the combined criterion could function in the manner proposed for Alternative 2, where a lake with water quality that exceeds a screening value for TN, TP, or chl-a (at a “screening” level) is deemed impaired for excess nutrients only if one or more of the eutrophication impacts are documented to occur within the same year. Using this Alternate 2 expression, a lake exceeding screening values for TN, TP, or chl-a (at a “screening” level) would not be considered to be impaired unless and until additional information is collected and evaluated to confirm the impairment. EPA has not separately prepared supporting documentation for Alternative 2 at the same level of detail as for Alternative 1, because as noted above, Alternative 2 is intended to closely mirror the State's 2017 proposed rule. Accordingly, EPA has placed documentation as provided by the State, in its own docket as an integral part of the supporting documentation for Alternative 2. EPA is asking for comment on this approach.

    EPA also has not provided proposed regulatory text for Alternative 2, because the regulatory text for this option would be largely identical to the regulatory text in the State's 2017 proposed rule. Rather, the Agency is providing notice of its consideration of Alternative 2 in the preamble to today's proposed rule. The Agency recognizes that, if the Agency were to adopt this alternative in the final rule, there may need to be formatting changes to the State regulatory text to conform to requirements applicable to codification in the Code of Federal Regulations.

    E. Additional Alternative Approaches Considered

    This federal action fulfills EPA's commitment under the consent decree with MCE to propose criteria addressing its 2011 disapproval by December 15, 2017. EPA acknowledges that the alternatives in the current proposal are not the only possible options that EPA could promulgate or Missouri could adopt to address the 2011 disapproval action. When promulgating federal water quality standards for a state, EPA's preference is to rely on state-specific data, where available, to derive criteria to protect the state's applicable designated uses. EPA solicits comment from the public and stakeholders on the Agency's co-proposals, in addition to other scientifically defensible options, to support a well-informed and robust final rule that reflects thoughtful consideration of Missouri's regulatory structure and implementation mechanisms.

    EPA considered several alternatives to the two alternatives proposed combined criterion approaches, component nutrient protection (or screening) values, and eutrophication impacts, and is interested in public comment on these approaches. First, EPA considered proposing the reference condition-derived nutrient protection values as stand-alone nutrient criteria (i.e., in absence of a combined criterion structure). However, given Missouri's interest in the combined criterion approach and EPA's position that such an approach can be appropriate and protective, EPA elected to structure the two alternatives in this proposal in a similar fashion. Second, EPA considered relying on fewer response parameters to avoid use of factors that may be onerous to routinely measure and assess, may be subject to various interpretations, and may not be necessary to indicate adverse impact. For example, EPA considered using only chl-a, DO, and pH as eutrophication impacts. EPA instead elected to include the full set Missouri identified in recognition that Missouri had concluded each was an appropriate eutrophication impact to be included in the State's proposed rule. Lastly, for Alternative 1, EPA considered using the 50th percentile of the data from reference lakes in the Plains ecoregion for deriving nutrient protection values; these values are 9.8 µg/L chl-a, 39 µg/L TP, and 690 µg/L TN. EPA decided to use the 75th percentile for the Plains ecoregion for this proposal because reference lakes in both ecoregions could have no greater than 20 percent cropland and urban land in their watershed based on EPA's screening procedure. EPA specifically solicits comment on the use of the 50th percentile for the Plains. As noted above, EPA is also requesting comment on using a higher percentile, such as 90th or 95th.

    F. Applicability of Combined Criterion When Final

    Unless EPA approves water quality standards addressing EPA's 2011 disapproval, EPA's proposed nutrient combined criterion for Missouri's lakes and reservoirs would be effective for CWA purposes 60 days after publication of a final rule. The proposed combined criterion in this rule, if finalized would be subject to Missouri's general rules of applicability in the same way and to the same extent as are other state-adopted criteria.

    EPA's proposed nutrient combined criterion, if finalized, would serve as a basis for development of new or revised National Pollutant Discharge Elimination System (NPDES) permit limits in Missouri for regulated dischargers found to have reasonable potential to cause or contribute to an excursion of the proposed nutrient combined criterion. Although EPA cannot be certain of whether a particular direct or indirect discharger would change their operations if these proposed criterion were finalized, EPA acknowledges that point source dischargers would need to be assessed to determine if they have a reasonable potential for the discharge to cause or contribute to an excursion of the water quality standard, and could well be subject to additional water quality-based effluent limits as a result. Nonpoint dischargers could also be subject to additional control requirements under Missouri law, perhaps in conjunction with a TMDL. Missouri has NPDES permitting authority, and retains discretion in issuing permits consistent with CWA permitting regulations, which require that permit limits be established such that permitted sources do not cause or contribute to a violation of water quality standards, including numeric nutrient criteria.

    IV. Tributary Arms

    As part of its efforts to establish its water quality standards, the State of Missouri established water quality criteria in its 2009 WQS submission to address nutrient-related pollutants for certain lakes, reservoirs and tributary arms. As mentioned previously, on August 16, 2011, EPA disapproved most numeric criteria for TN, TP, and chl-a for Missouri lakes and reservoirs and also disapproved TP criteria for tributary arms Grand Glaize, Gravois, and Nianga to the Lake of the Ozarks, and tributary arms James River, Kings River, and Long Creek to Table Rock Lake. In Missouri's disapproved rule (10 CSR 20-7.0314)(N)(1)(D)) and current proposed rule (10 CSR 20-7.031(N)(1)(E)), it considers a tributary arm to be a substantial segment of a Class L2 lake that is primarily recharged by a source or sources other than the main channel of the lake. EPA requests public comments on applying Alternative 1, Alternative 2, or any other appropriate alternative to the respective tributary arms to address EPA's 2009 disapproval. EPA invites the public to provide any data or scientific information to inform decision-making towards this option.

    V. Endangered Species Act

    Section 7(a)(2) of the Endangered Species Act (ESA) requires the EPA, in consultation with the U.S. Fish and Wildlife Service (USFWS) and/or the National Marine Fisheries Service (NMFS), to ensure that any action authorized by the Agency is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat for such species.

    Pursuant to this section, EPA intends to initiate consultation with USFWS regarding the effects that finalizing this rulemaking would have on federally-listed threatened and endangered species and designated critical habitat. EPA will subsequently conduct a biological evaluation to determine whether any federally-listed threatened or endangered species or their critical habitat are likely to be adversely affected by the finalization of this rulemaking.

    VI. Under what conditions will federal standards be either not finalized or withdrawn?

    Under the CWA, Congress gave states primary responsibility for developing and adopting WQS for their navigable waters. See CWA section 303(a)-(c). Although EPA is proposing nutrient criteria for Missouri's lakes and reservoirs, the State has the option of adopting and submitting revised nutrient criteria for these waters consistent with CWA section 303(c) and implementing regulations at 40 CFR part 131. Consistent with CWA section 303(c)(4) and the consent decree discussed in Section II, if Missouri adopts water quality criteria to address EPA's 2011 disapproval, and if EPA approves such criteria prior to the December 15, 2018 consent decree deadline to publish the final rule, EPA will not proceed with the final rulemaking.

    Pursuant to 40 CFR 131.21(c), if EPA does promulgate final criteria, they would be applicable for the purposes of the CWA. EPA could eventually withdraw any federally promulgated criteria through a rulemaking. EPA would undertake a withdrawal action if Missouri adopts and EPA approves water quality criteria to address EPA's 2011 disapproval as meeting CWA requirements.

    VII. WQS Regulatory Approaches and Implementation Mechanisms

    The Federal water quality standards regulation at 40 CFR part 131 provides several tools that Missouri has available to use at its discretion when implementing or deciding how to implement these numeric nutrient criteria, if finalized. Among other things, EPA's WQS regulation: (1) Specifies how states and authorized tribes establish, modify or remove designated uses, (2) specifies the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions, (3) authorizes and provides requirements for states and authorized tribes to adopt WQS variances that provide time to achieve the underlying WQS, and (4) allows states and authorized tribes to authorize the use of compliance schedules in NPDES permits to meet Water Quality Based Effluent Limits (WQBELs) derived from the applicable criteria. Each of these approaches is discussed in more detail in the next sections.

    A. Designating Uses

    Federal regulations at 40 CFR 131.10 provide regulatory requirements for establishing, modifying, and removing designated uses. If Missouri removes or modifies the aquatic life or recreational designated uses of a lake or reservoir subject to EPA's proposed nutrient criteria and adopts the highest attainable use,81 the state must also adopt criteria to protect the newly designated highest attainable use consistent with 40 CFR 131.11. Any designated use change must meet the requirements of 40 CFR part 131 and obtain EPA approval. If EPA finds removal or modification of the designated use, the adoption of the highest attainable use and criteria to protect that use is consistent with CWA section 303(c) and the implementing regulation at 40 CFR part 131 and thus approves the revised WQS, then the new or revised use and criteria would become effective for CWA purposes. As an additional step, EPA would initiate rulemaking to withdraw its promulgation of nutrient criteria in Missouri if the criteria to protect the new use is something other than the federally promulgated criteria.

    81 If a state or authorized tribe adopts a new or revised WQS based on a required use attainability analysis, then it must also adopt the highest attainable use (40 CFR 131.10(g)). Highest attainable use is the modified aquatic life, wildlife, or recreational use that is both closest to the uses specified in section 101(a)(2) of the Act and attainable, based on the evaluation of the factor(s) in 40 CFR 131.10(g) that preclude(s) attainment of the use and any other information or analyses that were used to evaluate attainability. There is no required highest attainable use where the state demonstrates the relevant use specified in section 101(a)(2) of the Act and sub-categories of such a use are not attainable (See 40 CFR 131.3(m)).

    B. Site-Specific Criteria

    The regulation at 40 CFR 131.11 specifies requirements for modifying water quality criteria to reflect site-specific conditions. In the context of this rulemaking, a site-specific criterion (SSC) is an alternative to a federally promulgated nutrient criterion that would be applied on a watershed, area-wide, or water body-specific basis, provided this alternative is protective of the designated use, is scientifically defensible, and provides for the protection and maintenance of downstream water quality. A SSC may be more or less stringent than the otherwise applicable federal criterion. A SSC may be appropriate when further scientific data and analyses more precisely define the concentration of a pollutant that is protective of the designated uses of a particular watershed, region, or water body. If Missouri adopts, and EPA approves, a SSC that fully meets the requirements of both section 303(c) of the CWA and EPA's implementing regulation at 40 CFR part 131, EPA would undertake a rulemaking to withdraw the corresponding federal criterion for the water(s) affected by the SSC.

    C. WQS Variances

    Federal regulations at 40 CFR 131.14 define a WQS variance as a time-limited designated use and criterion, for a specific pollutant or water quality parameter, that reflects the highest attainable condition during the term of the WQS variance. WQS variances adopted in accordance with 40 CFR 131.14 (including a public hearing consistent with 40 CFR 25.5) provide a flexible but defined pathway for states and authorized tribes to meet their NPDES permit obligations by allowing dischargers the time they need (as demonstrated by the state or authorized tribe) to make incremental progress toward meeting WQS that are not immediately attainable but may be in the future. When adopting a WQS variance, states and authorized tribes specify the interim requirements of the variance by identifying a quantitative expression that reflects the highest attainable condition (HAC) during the term of the variance, defining the term of the variance, and describing the pollutant control activities to achieve the HAC during the term of the variance. WQS variances will help states and authorized tribes focus on improving water quality, rather than pursuing a downgrade of the underlying water quality goals through modification or removal of a designated use, as a variance cannot lower currently attained water quality. As water quality standards, variances are submitted to EPA for review and approval under CWA section 303(c) which provides legal avenue by which NPDES permit limits can be written to derive from, and comply with, the WQS variance rather than the underlying WQS, for the term of the WQS variance. If dischargers are still unable to meet the WQBELs derived from the applicable WQS once a variance term is complete, the regulation allows the state to adopt a subsequent variance if it is adopted consistent with 131.14.

    EPA's proposed nutrient criterion applies to use designations that Missouri has already established. Missouri may adopt time-limited designated uses and criteria to apply for the purposes specified in 40 CFR 131.14(a)(3).

    D. NPDES Permit Compliance Schedules

    EPA's regulations at 40 CFR 122.47 and 40 CFR 131.15 address how states and authorized tribes include permit compliance schedules in their NPDES permits if dischargers need additional time to meet their WQBELs based on the applicable WQS. EPA's updated regulations at 40 CFR 131.15 require that states and authorized tribes that wish to allow the use of permit compliance schedules adopt specific provisions authorizing their use and obtain EPA approval under CWA section 303(c) to ensure that a decision to allow permit compliance schedules is transparent and allows for public input (80 FR 51022, August 21, 2015). On December 11, 2012, Missouri submitted a revised compliance schedule authorizing provision at 10 CSR 20-7.031(10). This revision was partly approved by EPA on January 25, 2015. Missouri is authorized to grant permit compliance schedules, as appropriate, to permitted facilities impacted by federally promulgated numeric nutrient criteria as long as such compliance schedules are consistent with EPA's permitting regulation at 40 CFR 122.47.

    VIII. Economic Analysis

    At this time, EPA has prepared only a preliminary economic analysis specifically for Alternative 1. This analysis will be further refined and an updated more comprehensive economic review will be put out for comment in a Notice of Data Availability at a later time. At that time, to best inform the public of the potential impacts of this rule, EPA will evaluate the potential benefits and costs associated with implementation of EPA's proposed criterion.

    The analysis of acres with BMPs to address nonpoint sources of nutrients was conducted at the HUC-12 level of resolution. Many of the potentially incrementally impaired lakes in Missouri are small, and their watersheds are smaller than the HUC-12 watershed in which they are located; thus, the estimated costs for these watersheds may be overstated. However, EPA did not initially include any costs for watersheds for which it does not have data, thus, at least some likely costs were not included in the preliminary analysis. Due to these and other limitations, EPA believes that its current draft analysis is too preliminary to adequately inform public comment on the rule. EPA will address these issues in the updated analysis provided in the NODA.

    EPA also preliminarily estimated the benefits from water quality improvements resulting from implementing the nutrient protection values in Missouri Lakes and reservoirs. However, due to data and resource limitations and other challenges, EPA believes that this benefits analysis is also too preliminary to be presented at this time. EPA will also include an updated analysis of benefits in the NODA.

    EPA seeks public comment to inform EPA's economic analysis. EPA is interested in public comment regarding how likely it is that lakes without water quality data may trigger the screening criteria; what practices the agricultural sector and cities may take to reduce nonpoint source discharges and the likelihood that such practices are implemented; what unit costs EPA should consider using in conducting this analysis; and what assumptions EPA should consider using for expected nutrient load reductions.

    EPA intends to make the revised analysis, including pre-publication peer review, available for public comment no later than six months after the date of publication of this proposed rule. In no circumstances will EPA issue a final rule without providing an economic analysis sufficiently in advance of the final rule for public comment on the analysis to meaningfully inform EPA's development of the rule.

    IX. 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 an economically significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. (Docket Id. No. EPA-HQ-OW-2009-0596) is available in the docket. A summary of the report can be found in Section VIII of this preamble.

    B. Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs

    This action is expected to be an Executive Order 13771 regulatory action. Details on the estimated costs of this proposed rule will be available for public comment in a subsequent Notice of Data Availability to be published no later than six months after this proposed rule (See summary at Section VIII. Economic Analysis, and full economic analysis report in the docket for this proposed rulemaking).

    C. Paperwork Reduction Act

    This action does not impose an information collection burden under the provisions of the PRA, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). This action does not include any information collection, reporting, or record-keeping requirements.

    D. Regulatory Flexibility Act

    For purposes of assessing the impacts of this action on small entities, a small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.

    Under the CWA, states must adopt WQS for their waters and submit these standards to EPA for approval. If the Agency disapproves a submitted standard and the state does not adopt revisions to address EPA's disapproval, EPA must promulgate standards consistent with the CWA requirements. State standards (or EPA-promulgated standards) are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters except in compliance with an NPDES permit. The CWA requires that all NPDES permits include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, EPA's promulgation of WQS establishes standards that the state implements through the NPDES permit process. The State has discretion in developing discharge limits, as needed to meet the standards. This proposed rule, as explained earlier, does not itself establish any requirements that are applicable to small entities. As a result of this action, the State of Missouri will need to ensure that permits it issues include any limitations on discharges necessary to comply with the standards established in the final rule. In doing so, the state will have a number of choices associated with permit writing. While Missouri's implementation of the rule may ultimately result in new or revised permit conditions for some dischargers, including small entities, EPA's action, by itself, does not impose any of these requirements on small entities; that is, these requirements are not self-implementing. Thus, I certify that this rule will not have a significant economic impact on a substantial number of small entities under the RFA.

    E. Unfunded Mandates Reform Act

    This proposed rule contains no federal mandates (under the regulatory provisions of Title II of the UMRA) for state, local, or tribal governments or the private sector.

    EPA determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small governments. Moreover, WQS, including those proposed here, apply broadly to dischargers and are not uniquely applicable to small governments. Thus, this proposed rule is not subject to the requirements of section 203 of UMRA.

    F. Executive Order 13132 (Federalism)

    This action does not have federalism implications as that term is used in EO 13132. Although section 6 of Executive Order 13132 does not apply to this action, EPA had extensive communication with the State of Missouri to discuss EPA's concerns with the State's previously submitted and disapproved criteria and the federal rulemaking process. In the spirit of Executive Order 13132, and consistent with EPA's policy to promote communications between EPA and state and local governments, EPA specifically solicits comment on this proposed rule from state and local officials.

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

    This action does not have any tribal implications as specified by Executive Order 13175. As there are no federally-recognized tribes in the State of Missouri, this executive order does not apply. Thus, Executive Order 13175 does not apply to this action.

    H. Executive Order 13045 (Protection of Children from Environmental Health and Safety Risk)

    Executive Order 13045 (62 FR 19885, April 23, 1997) requires agencies to identify and assess health and safety risks that may disproportionately affect children and ensure that activities address disproportionate risks to children. This action not subject to Executive Order 13045 because the EPA does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children.

    I. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use)

    This rule is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

    J. National Technology Transfer Advancement Act of 1995

    EPA is not aware of any voluntary consensus standards that address the numeric nutrient criteria in this proposed rule.

    K. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations)

    EPA has determined that this proposed rule does not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it would afford a greater level of protection to both human health and the environment if these nutrient criteria are promulgated in the State of Missouri.

    List of Subjects in 40 CFR Part 131

    Environmental protection, water quality standards, nutrients, Missouri.

    Dated: December 15, 2017. E. Scott Pruitt, Administrator.

    For the reasons set out in the preamble, EPA proposes to amend 40 CFR part 131 as follows:

    PART 131—WATER QUALITY STANDARDS 1. The authority citation for part 131 continues to read as follows: Authority:

    33 U.S.C. 1251 et seq.

    Subpart D—[Amended] 2. Section 131.47 is added as follows:
    § 131.47 Missouri.

    (a) Scope. This section promulgates a combined criterion for designated uses for all lakes and reservoirs in the State of Missouri that (1) are listed in Table G and the Missouri Use Designation Dataset) in the State's water quality standards (WQS) (10 CSR 20-7.031), (2) equal or exceed ten acres, (3) are located outside of the Big River Flood Plain Ecoregion and (4) are not listed as having site-specific criteria in Table M of the State's WQS.

    (b) Combined Criterion for Missouri lakes and reservoirs. In all instances, nutrient protection values are maximum ambient concentrations expressed as seasonal (April through September) geometric mean values on a three-year rolling average basis.

    Table 1—Lake Ecoregion Nutrient Protection Values (µg/L) and Eutrophication Impacts * Lake Ecoregion TP TN Chl-a Plains 44 817 14 Ozarks 23 500 7.1 * Table 1 also applies to tributary arms Grand Glaize, Gravois, and Nianga to the Lake of the Ozarks, and tributary arms James River, Kings River, and Long Creek to Table Rock Lake.

    (1) Lake and reservoir water quality must not exceed nutrient protection values for chlorophyll a.

    (2) Lake and reservoir water quality must also not exceed nutrient protection values for total nitrogen and total phosphorus unless each of the following eutrophication impacts are evaluated and none occur within the same three-year rolling average period: (I) Eutrophication-related mortality or morbidity events for fish and other aquatic organisms, (II) An excursion from the DO or pH criteria in Missouri water quality standards applicable for Clean Water Act purposes, (III) Cyanobacteria counts equal to or greater than 100,000 cells per ml, (IV) Observed shifts in aquatic diversity directly attributable to eutrophication, or (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1—September 30, or Secchi disk measurements of turbidity equal to or less than EPA's recommended Level III Ecoregions IX (1.53 m) or IX (2.86 m).

    (c) Applicability

    (1) The combined criterion in paragraph (b) of this section applies to waters discussed in paragraph (a) of this section and applies concurrently with other applicable water quality criteria.

    (2) The combined criterion established in this section is subject to Missouri's general rules of applicability in the same way and to the same extent as state-adopted and EPA-approved water quality criteria when applied to the waters discussed in paragraph (a).

    (d) Effective date. Section 131.47 will be in effect [date 60 days after publication of final rule].

    [FR Doc. 2017-27621 Filed 12-26-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General 42 CFR Part 1001 Solicitation of New Safe Harbors and Special Fraud Alerts AGENCY:

    Office of Inspector General (OIG), HHS.

    ACTION:

    Notification of intent to develop regulations.

    SUMMARY:

    In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti-kickback statute (§ 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

    DATES:

    To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 26, 2018.

    ADDRESSES:

    In commenting, please refer to file code OIG-127-N. Because of staff and resource limitations, we cannot accept comments by facsimile (fax) transmission.

    You may submit comments in one of three ways (no duplicates, please):

    1. Electronically. You may submit electronic comments on specific recommendations and proposals through the Federal eRulemaking Portal at http://www.regulations.gov.

    2. By regular, express, or overnight mail. You may send written comments to the following address: Patrice Drew, Office of Inspector General, Regulatory Affairs, Department of Health and Human Services, Attention: OIG-127-N, Room 5541C, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201. Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By hand or courier. If you prefer, you may deliver your written comments by hand or courier before the close of the comment period to Patrice Drew, Office of Inspector General, Department of Health and Human Services, Cohen Building, Room 5541C, 330 Independence Avenue SW, Washington, DC 20201. Because access to the interior of the Cohen Building is not readily available to persons without Federal Government identification, commenters are encouraged to schedule their delivery with one of our staff members at (202) 619-1368.

    For information on viewing public comments, please see the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Patrice Drew, Regulatory Affairs Liaison, Office of Inspector General, (202) 619-1368.

    SUPPLEMENTARY INFORMATION:

    Submitting Comments: We welcome comments from the public on recommendations for developing new or revised safe harbors and Special Fraud Alerts. Please assist us by referencing the file code OIG-127-N.

    Inspection of Public Comments: All comments received before the end of the comment period are available for viewing by the public. All comments will be posted on http://www.regulations.gov after the closing of the comment period. Comments received in a timely manner will also be available for public inspection as they are received at the Office of Inspector General, Department of Health and Human Services, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201, Monday through Friday, from 10 a.m. to 5 p.m. To schedule an appointment to view public comments, phone (202) 619-1368.

    I. Background A. OIG Safe Harbor Provisions

    Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 1320a-7b(b)) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward business reimbursable under Federal health care programs. The offense is classified as a felony and is punishable by fines of up to $25,000 and imprisonment for up to 5 years. OIG may also impose civil money penalties, in accordance with section 1128A(a)(7) of the Act (42 U.S.C. 1320a-7a(a)(7)), or exclusion from Federal health care programs, in accordance with section 1128(b)(7) of the Act (42 U.S.C. 1320a-7(b)(7)).

    Because the statute, on its face, is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction. In response to the above concern, section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93 § 14, specifically required the development and promulgation of regulations, the so-called “safe harbor” provisions, specifying various payment and business practices that, although potentially capable of inducing referrals of business reimbursable under Federal health care programs, would not be treated as criminal offenses under the anti-kickback statute and would not serve as a basis for administrative sanctions. OIG safe harbor provisions have been developed “to limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial and innocuous arrangements” (56 FR 35952, July 29, 1991). Health care providers and others may voluntarily seek to comply with these provisions so that they have the assurance that their business practices will not be subject to liability under the anti-kickback statute or related administrative authorities. OIG safe harbor regulations are found at 42 CFR part 1001.

    B. OIG Special Fraud Alerts

    OIG periodically issues Special Fraud Alerts to give continuing guidance to health care providers with respect to practices OIG considers to be suspect or of particular concern. The Special Fraud Alerts encourage industry compliance by giving providers guidance that can be applied to their own practices. OIG Special Fraud Alerts are published in the Federal Register and on our website and are intended for extensive distribution.

    In developing Special Fraud Alerts, OIG relies on a number of sources and consults directly with experts in the subject field, including those within OIG, other agencies of the U.S. Department of Health and Human Services (the Department), other Federal and State agencies, and those in the health care industry.

    C. Section 205 of the Health Insurance Portability and Accountability Act of 1996

    Section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191 § 205 (the Act), § 1128D, 42 U.S.C. 1320a-7d, requires the Department to develop and publish an annual notification in the Federal Register formally soliciting proposals for modifying existing safe harbors to the anti-kickback statute and for developing new safe harbors and Special Fraud Alerts.

    In developing safe harbors for a criminal statute, OIG thoroughly reviews the range of factual circumstances that may fall within the proposed safe harbor subject area so as to uncover potential opportunities for fraud and abuse. Only then can OIG determine, in consultation with the U.S. Department of Justice, whether it can effectively develop regulatory limitations and controls that will permit beneficial and innocuous arrangements within a subject area while, at the same time, protecting Federal health care programs and their beneficiaries from abusive practices.

    II. Solicitation of Additional New Recommendations and Proposals

    In accordance with the requirements of section 205 of HIPAA, OIG last published a Federal Register solicitation notification for developing new safe harbors and Special Fraud Alerts on December 28, 2016 (81 FR 95551). As required under section 205 of the Act, a status report of the proposals OIG received for new and modified safe harbors in response to that solicitation notification is set forth in Appendix F of OIG's Fall 2017 Semiannual Report to Congress. 1 OIG is not seeking additional public comment on the proposals listed in Appendix F at this time. Rather, this notification seeks additional recommendations regarding the development of new or modified safe harbor regulations and new Special Fraud Alerts beyond those summarized in Appendix F.

    1 The OIG Semiannual Report to Congress can be accessed through the OIG website at http://oig.hhs.gov/publications/semiannual.asp.

    A detailed explanation of justifications for, or empirical data supporting, a suggestion for a safe harbor or Special Fraud Alert would be helpful and should, if possible, be included in any response to this solicitation.

    A. Criteria for Modifying and Establishing Safe Harbor Provisions

    In accordance with section 205 of HIPAA, we will consider a number of factors in reviewing proposals for new or modified safe harbor provisions, such as the extent to which the proposals would affect an increase or decrease in:

    • Access to health care services,

    • the quality of health care services,

    • patient freedom of choice among health care providers,

    • competition among health care providers,

    • the cost to Federal health care programs,

    • the potential overutilization of health care services, and

    • the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

    In addition, we will consider other factors, including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may take into account their decisions whether to (1) order a health care item or service or (2) arrange for a referral of health care items or services to a particular practitioner or provider.

    B. Criteria for Developing Special Fraud Alerts

    In determining whether to issue additional Special Fraud Alerts, we will consider whether, and to what extent, the practices that would be identified in a new Special Fraud Alert may result in any of the consequences set forth above, as well as the volume and frequency of the conduct that would be identified in the Special Fraud Alert.

    Dated: December 12, 2017. Daniel R. Levinson, Inspector General.
    [FR Doc. 2017-27117 Filed 12-26-17; 8:45 am] BILLING CODE 4152-01-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-HQ-ES-2017-0047; 4500090024] RIN 1018-BC83 Endangered and Threatened Wildlife and Plants; Listing the Yangtze Sturgeon as an Endangered Species AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a proposed rule and a 12-month finding on a petition to list the Yangtze sturgeon (Acipenser dabryanus) as an endangered species under the Endangered Species Act of 1973, as amended (Act). Loss of individuals due to overharvesting on the Yangtze River is the main factor that contributed to the historical decline of the species. Despite conservation efforts, this species is still currently in decline due primarily to the effects of dams and bycatch. If we finalize this rule as proposed, it would extend the Act's protections to this species. We seek information from the public on this proposed rule and the status review for this species.

    DATES:

    We will consider comments and information received or postmarked on or before February 26, 2018. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES, below) must be received by 11:59 p.m. Eastern Time on the closing date. We must receive requests for public hearings, in writing, at the address shown in FOR FURTHER INFORMATION CONTACT by February 12, 2018.

    ADDRESSES:

    Document availability: This finding is available on the internet at http://www.regulations.gov at Docket No. FWS-HQ-ES-2017-0047.

    Written comments: You may submit comments by one of the following methods:

    (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-HQ-ES-2017-0047, which is the docket number for this rulemaking. Then, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!”

    (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-HQ-ES-2017-0047; U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see Public Comments, below, for more information).

    FOR FURTHER INFORMATION CONTACT:

    Janine Van Norman, Branch of Foreign Species, Ecological Services, U.S. Fish and Wildlife Service, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone, 703-358-2171; facsimile, 703-358-2499. If you use a telecommunications device for the deaf (TDD), call the Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Information Requested Public Comments

    Our intent, as required by the Act (16 U.S.C. 1531 et seq.), is to use the best available scientific and commercial data as the foundation for all endangered and threatened species classification decisions. Further, we want any final rule resulting from this proposal to be as accurate and effective as possible. Therefore, we invite the range country, governmental agencies, the scientific community, industry, and other interested parties to submit comments regarding this proposed rule. Comments should be as specific as possible.

    Before issuing a final rule to implement this proposed action, we will take into account all comments and any additional relevant information we receive. Such communications may lead to a final rule that differs from our proposal. For example, new information or analysis may lead to a threatened status instead of an endangered status for this species, or we may determine that this species does not warrant listing based on the best available information when we make our determination. All comments, including commenters' names and addresses, if provided to us, will become part of the administrative record. For this species, we particularly seek comments concerning:

    (1) The species' biology, ranges, and population trends, including:

    (a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

    (b) Genetics and taxonomy;

    (c) Historical and current range, including distribution patterns;

    (d) Historical and current population levels, and current and projected trends; and

    (e) Past and ongoing conservation measures for the species, its habitat, or both.

    (2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

    (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to the species and existing regulations that may be addressing those threats.

    (4) Additional information concerning the historical and current status, range, distribution, and population size of the species, including the locations of any additional populations of the species.

    Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

    Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”

    You may submit your comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

    If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

    Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Headquarters Office (see FOR FURTHER INFORMATION CONTACT).

    Public Hearing

    Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. Requests must be received by the date listed above in DATES. Such requests must be sent to the address shown in FOR FURTHER INFORMATION CONTACT. We will schedule public hearings on this proposal, if any are requested, and announce the dates, times, and places of those hearings, as well as how to obtain reasonable accommodations, in the Federal Register and local newspapers at least 15 days before the hearing.

    Peer Review

    In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we solicited the expert opinion of six appropriate and independent specialists for peer review of the Species Status Assessment (SSA) that provides the biological basis for this proposed listing determination. The purpose of peer review is to ensure that our listing determinations are based on scientifically sound data, assumptions, and analyses. Their comments and suggestions can be found at (https://www.fws.gov/endangered/improving_ESA/peer_review_process.html).

    Previous Federal Actions

    On March 12, 2012, the National Marine Fisheries Service (NMFS) received a petition dated March 8, 2012, from WildEarth Guardians and Friends of Animals to list as endangered or threatened under the Act the following 15 sturgeon species: Adriatic sturgeon (Acipenser naccarii); Baltic sturgeon (A. sturio); Russian sturgeon (A. gueldenstaedtii); ship sturgeon (A. nudiventris); Persian sturgeon (A. persicus); stellate sturgeon (A. stellatus); Siberian sturgeon (A. baerii); Yangtze sturgeon (A. dabryanus); Chinese sturgeon (A. sinensis); Sakhalin sturgeon (A. mikadoi); Amur sturgeon (A. schrenckii); Kaluga sturgeon (Huso dauricus); Syr Darya sturgeon (Pseudoscaphirhynchus fedtschenkoi); dwarf sturgeon (P. hermanni); and Amu Darya sturgeon (P. kaufmanni). The petition states that all 15 petitioned sturgeon species are affected by similar threats, which are primarily: Legal and illegal harvest for meat and/or roe; habitat loss and degradation, including dams or dam construction; and water pollution. The petition is available at https://www.regulations.gov/document?D=FWS-HQ-ES-2013-0051-0003.

    NMFS acknowledged receipt of this petition in a letter dated April 14, 2012, and informed the petitioners that NMFS would determine, under section 4 of the Act, whether the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted. Although the petition was initially sent to NMFS, as a result of subsequent discussions between NMFS and the Service regarding the August 28, 1974, Memorandum of Understanding pertaining to “Jurisdictional Responsibilities and Listing Procedures Under the Endangered Species Act of 1973,” we have determined that 10 of the 15 petitioned sturgeon species are within the jurisdiction of the Service. Therefore, in April 2012, the Service notified WildEarth Guardians that we have jurisdiction over the 10 sturgeon species, listed below.

    On September 24, 2013, we published in the Federal Register (78 FR 58507) a 90-day finding that found that the petition presented substantial scientific and commercial information indicating that the petitioned action may be warranted for the following 10 sturgeon species included in the petition: Siberian sturgeon (Acipenser baerii), Yangtze sturgeon (A. dabryanus), Russian sturgeon (A. gueldenstaedtii), ship sturgeon (A. nudiventris), Persian sturgeon (A. persicus), Amur sturgeon (A. schrenckii), stellate sturgeon (A. stellatus), Syr-Darya sturgeon (Pseudoscaphirhynchus fedtschenkoi), dwarf sturgeon (P. hermanni), and Amu Darya sturgeon (P. kaufmanni). This document constitutes our review and determination of the status of the Yangtze sturgeon, our publication of our 12-month finding on this species, and our proposed rule to list this species.

    Background

    A thorough review of the taxonomy, life history, ecology, and overall viability of the Yangtze sturgeon is presented in the Species Status Assessment (SSA) for the Yangtze sturgeon (Service 2017; available at http://www.regulations.gov at Docket No. FWS-HQ-ES-2017-0047). The SSA documents the results of the comprehensive biological status review for the Yangtze sturgeon and provides an account of the species' overall viability through forecasting of the species' condition in the future (Service 2017, entire). In the SSA, we summarize the relevant biological data and a description of past, present, and likely future stressors and conduct an analysis of the viability of the species. The SSA provides the scientific basis that informs our regulatory decision regarding whether this species should be listed as an endangered or threatened species under the Act. This decision involves the application of standards within the Act, its implementing regulations, and Service policies (see Determination, below). The SSA contains the risk analysis on which this determination is based, and the following discussion is a summary of the results and conclusions from the SSA. We solicited peer review of the draft SSA from six qualified experts. We received responses from one of the reviewers, and we modified the SSA as appropriate.

    Species Description

    The Yangtze sturgeon is a freshwater fish species that attains a maximum size of around 130 centimeters (4.3 feet (ft)) and a maximum weight of about 16 kilograms (35 pounds) (Billiard and Lecointre 2000, p. 368; Zhuang et al. 1997, pp. 257, 259). The species has a triangular head, an elongated snout, and large blowholes (Gao et al. 2009b, p. 117). Yangtze sturgeons have tactile barbels at the front of their mouths that they use to dig for food. On the dorsal side, the Yangtze sturgeons are dark gray, brownish-gray, or yellow-gray in color. The rest of the body is milky white in color (Zhuang et al. 1997, p. 259).

    Taxonomy

    Historically, the Yangtze sturgeon coexisted alongside the Chinese sturgeon in the Yangtze River. Initial attempts to differentiate the two species included using morphological measures. However, morphological characteristics can be influenced by differences in environmental conditions. For example, wild Yangtze sturgeon display grey color on the sides of their bodies while those bred in captivity sometimes display a darker color (Li et al. 2015, p. 186).

    Due to similarities in their morphology, the two sturgeons were not identified as separate species until 1869, based on collection of specimens obtained from the Yangtze River (Zhuang et al. 1997, p. 257). Multiple studies since have shown the Yangtze and Chinese sturgeons are very closely related and can be considered to be sister species (Krieger et al. 2008, p. 41; Zhu et al. 2008, p. 32; Zhang et al. 2000, p. 136). A study of mitochondrial DNA found that Yangtze and Chinese sturgeon have a divergence value of 0.3 percent. This is in contrast to Chinese sturgeon and starry sturgeon (Acipenser stellatus), which have a divergence value of 7.7 percent (Zhang et al. 2000, pp. 133-134). While these results suggest that Yangtze and Chinese sturgeon are closely related species, taxonomic confusion regarding the two species continued well into the 1960s (Li J. et al. 2015, p. 186). In addition to genetic similarities, Yangtze and Chinese sturgeon share the same habitat and multiple studies suggest that Yangtze sturgeon may be a landlocked ecotype of the Chinese sturgeon (Kynard 2016, pers. comm.; Li J. et al. 2015, p. 186; Krieger et al. 2008, p. 42; Zhang et al. 2000, p. 136).

    Despite similarities between Yangtze and Chinese sturgeon, there are differences between the two species. Yangtze and Chinese sturgeon can be differentiated by the different ecoregion they inhabit. The Chinese sturgeon is an anadromous species (species that spawn in freshwater and spend most of its life at sea) that migrates between coastal feeding grounds and spawning grounds in both the Yangtze River and the Pearl River. On the other hand, the Yangtze sturgeon is a potamodromous species (a species that conducts its entire life cycle in freshwater) that migrates between feeding grounds and spawning grounds entirely within the Yangtze River basin (Kynard et al. 2003, p. 28; Zhuang et al. 1997, pp. 257-295).

    In addition to differences in their life history, these two species can also be differentiated based on their mitochondrial and nuclear DNA (Li J. et al. 2015, pp. 185, 194). Therefore, despite possessing morphological and genetic similarities, there are differences in the habitat, life history characteristics, and genetic makeup between the two species. We thus accept the Yangtze sturgeon as a separate species as classified below:

    Class: Actinopterygii Order: Acipenseriformes Family: Acipenseridae Species: Acipenser dabryanus Duméril, 1869 Biology and Life History

    Although the Yangtze sturgeon's life history is similar to other sturgeon species, there are key differences. Based on the best available information, much of what is known about the Yangtze sturgeon's life history comes from research on the more numerous and studied Chinese sturgeon due to similarities in morphology, taxonomy, and life history between the two species. Yangtze sturgeons spawn in the spring from March to April, with a smaller late fall/early winter spawning period occurring from October to December (Qiwei 2010, p. 3; Gao et al. 2009b, p. 117; Kynard et al. 2003, p. 28). Spawning migration begins when water level, flow velocity, and silt content enters a downward trend (Zhang H. et al. 2012, p. 4).

    At the spawning site, female Yangtze sturgeons can lay between 57,000 to 102,000 eggs. These eggs, when mature, are gray to black and range from 2.7 to 3.4 millimeters (0.11 to 0.13 inches) in diameter. The eggs are sticky and firmly adhere to the space between pebbles and boulders, known as the “interstitial” space, on the riverbed (Gao et al. 2009b, p. 117; Zhuang et al. 1997, p. 261). Larvae emerge from the eggs about 115 to 117 hours after fertilization, and they remain at the spawning ground for around 12 to 30 days before dispersing downstream (Kynard et al. 2003, pp. 33-34; Zhuang et al. 1997, p. 262). Yangtze sturgeons do not start their migration downriver until they become juveniles.

    Juvenile sturgeons disperse around 100 to 200 kilometers (km) (62 to 124 miles (mi)) downstream from their spawning ground and arrive in backwater pools and sandy shallows with low velocity flow and rich mud and sand substrate where they feed on insects, aquatic plants, and small fish (Zhang et al. 2011, p. 184; Zhuang et al. 1997, p. 259). During the spring flood on the main stem of the Yangtze River, juveniles will move to the tributaries to feed. Young sturgeons will remain in these feeding reaches until they reach maturity (4 to 6 years for males and 6 to 8 years for females) after which they begin migrating upstream towards the spawning ground during the spring flood (Zhuang et al. 1997, p. 261).

    Habitat

    The Yangtze sturgeon is found in sandy shoal with silt ground and gentle to moderate water flow (Bemis and Kynard 1997, p. 169; Zhuang et al. 1997, p. 259). The spawning habitat for the Yangtze sturgeon is a riverbed that contains larger boulders, pebbles, clear water with a velocity of 1.2 to 1.5 meters (m) per second (3.9 to 4.9 ft per second), and a depth of 5 to 15 m (16 to 49 ft) (Zhuang et al. 1997, p. 261). The presence of large boulders ensures there is sufficient interstitial space between the rocks for eggs to adhere to. At the same time, smaller pebbles and gravel fill in the interstitial space so that water flowing through the space is not too high to prevent adherence (Du et al. 2011, p. 257). Sufficient velocity is also needed to prevent excess buildup of gravel in the interstitial space (Du et al. 2011, p. 262). If there is insufficient interstitial space, eggs will not adhere to the boulders on the riverbed. If there is too much space, the water current will be too strong and the eggs will be washed away. Therefore, suitable sturgeon habitat has specific requirements for velocity and riverbed composition to ensure successful spawning.

    Distribution Historical Range

    As its name implies, the Yangtze sturgeon is found in the Yangtze River (Wu et al. 2014, p. 5). The river is more than 6,397 km (3,975 mi) in length and is divided into three segments. The upper reach, which span a total of about 4,300 km (2,671 mi), is further sub-divided into two segments: the Jinsha River segment, which stretches from the headwater in Yushu in the Tibetan Plateau to Yibin, a distance of about 2,300 km (1,429 mi), and the upper Yangtze River, which stretches from Yibin to the Three Gorges region at Yichang, a distance of about 1,000 km (621 mi) (Cheng et al. 2015, p. 571; Jiang et al. 2008, p. 1471; Fu et al. 2003, p. 1651). Four major tributaries feed into the upper Yangtze. They are: the Min, Tuo, Jialing, and the Wu River (Chen Z. et al. 2001, p. 78). The middle reach is from Yichang to Hukou, a distance of about 950 km (590 mi). The Yangtze River widens in this segment and is identified by multiple large lakes, including Lake Dongting and Lake Poyang. The lower reach stretches from Hukou to the mouth of the river at Shanghai, a distance of about 930 km (577 mi) (Fu et al. 2003, p. 1651).

    Historically, the Yangtze sturgeon was found in the lower portion of the Jinsha River and the upper, middle, and lower reaches of the Yangtze River, a distance of about 1,300 km (807 mi) (Wu et al. 2014, p. 5). The majority of historical sightings occurred in the lower Jinsha and upper Yangtze River with occasional sightings in the middle and lower Yangtze (Zhuang et al. 1997, p. 259). The species has also been found in major tributaries that feed into the upper Yangtze including the Min, Tuo, and Jialing (Artyukhin et al. 2007, p. 370). There have also been sightings of the species in Dongting Lake and Poyang Lake in the middle and lower reaches, respectively (Zhuang et al. 1997, p. 259). One sighting took place as far downstream as Anhui province, a distance of more than 2,000 km (1,242 mi) downstream from Yibin (Zhuang et al. 1997, p. 261). The species' spawning reach is understood by Yangtze sturgeon researchers to have occurred from Maoshui in the lower Jinsha River to Hejiang in the upper Yangtze River (Zhang et al. 2011, p. 184).

    Current Range

    The Yangtze sturgeon's current range is limited to the upper Yangtze River and its tributaries in the reaches between Yibin and Yichang, a distance of about 1,000 km (Wu et al. 2014, p. 5; Dudgeon 2010, p. 128; Huang et al. 2011, p. 575; Zhang et al. 2011, p. 181; Artyukhin et al. 2007, p. 370). The completion of the Gezhouba Dam in 1981 at Yichang prevented the upstream migration of adults to the species' spawning ground (Zhuang et al. 1997, p. 261). As a result of the construction of Gezhouba Dam, the species may have been extirpated in reaches below the dam (Li et al. 2015, p. 186; Zhu et al. 2008, p. 30). That said, from 2014-2017, fishermen below Gezhouba Dam accidently captured four adult Yangtze sturgeons, suggesting the presence of a very small remnant population (Du 2017, pers. comm.). Due to Gezhouba Dam's smaller size, the reservoir for the Gezhouba Dam is relatively small (Kynard 2017, pers. comm.) However, the Three Gorges Dam, located slightly upstream from Gezhouba Dam, and its reservoir changed the hydrology of the Yangtze. Construction on the Three Gorges Dam began in 2003 and was completed in 2009. The reservoir, which extends 600 km (372 mi) upstream, further reduced the species' range by modifying reaches above Three Gorges Dam to a lentic (still water) system (Chen D. et al. 2009, p. 341; Fu et al. 2003, p. 1650). Loss of lotic (rapidly moving water) ecosystem reduces the quality of remaining habitat for the species (Kynard 2016, pers. comm.; Cheng et al. 2015, pp. 570, 576). On the lower Jinsha River, in the upstream portion of the species' historical range, the construction of the Xiangjiaba Dam, which was completed in 2008, limited the species' spawning ground to areas below the dam (Zhang et al. 2011, pp. 183-184). The species continues to ascend the major tributaries in the upper Yangtze, including the Min, Tuo, and Jialing River (Huang et al. 2011, p. 575; Artyukhin et al. 2007, p. 370).

    Historical and Current Population

    The Yangtze sturgeon was historically abundant and was commercially harvested up to the 1970s (Lu et al. 2015, p. 89; Zhang et al. 2013, p. 409; Kynard et al. 2003, p. 27). The majority (80 percent) of harvest of Yangtze sturgeon took place during the 1950s to the 1970s. However, overharvesting during this time period led to a sharp decline in the population size (Kynard et al. 2003, p. 27).

    While there may have been natural recruitment of the species in the 1990s, no natural recruitment has been observed in the wild since the 2000s (Du et al. 2014, p. 1; Wu et al. 2014, p. 1). The population is currently being sustained by artificial restocking. Between the years of 2010-2013, 7,030 Yangtze sturgeon juveniles were released into the middle and upper Yangtze River in two to three batches each year (Wu et al. 2014, p. 3). Restocking efforts have been ongoing in the reaches below Gezhouba Dam since 2014 (Hu 2017, pers. comm.). However, restocked sturgeons suffer from low fitness; most notably, they lack the ability to survive to reproductive age. Capture data obtained from the releases in 2010-2013 found that 95 days after restocking, no restocked sturgeons were caught either by researchers or by fishermen in the upper Yangtze River (Wu et al. 2014, pp. 3-5). These results indicate that restocked sturgeon have a very low survival rate. Although we do not have population estimates for the species, based on the fact that there has been no observable natural reproduction since the 2000s and the low survival rate of restocked sturgeon, the species population in the Yangtze River is likely to be very low when compared to historical numbers (Du et al. 2014, p. 1; Wu et al. 2014, p. 4).

    Summary of Threats and Conservation Measures That Affect the Species

    The Act directs us to determine whether any species is an endangered species or a threatened species because of any factors affecting its continued existence. We completed a comprehensive assessment of the biological status of the Yangtze sturgeon, and prepared a report of the assessment, which provides a thorough account of the species' overall viability. In this section, we summarize the conclusions of that species status assessment, which can be accessed at Docket No. FWS-HQ-ES-2017-0047 on http://www.regulations.gov.

    Dams on the Yangtze River and Its Effects

    The topography of the upper Yangtze River basin is characterized by mountains of varying heights. The change in elevation between the upper Yangtze to the lower Yangtze amounts to 3,280 m (10,761 ft), which makes the upper Yangtze River an ideal place for hydroelectric projects (Fan et al. 2006, p. 33). The growth of dam construction in China has accelerated during the past decades. From the 1970s to the 1990s, an average of 4.4 large reservoirs (capacity greater than 0.1 km3) were constructed per year. By the 2000s, this number had increased to an average construction rate of 11.8 large reservoirs per year. By 2011, China possessed 552 large reservoirs, 3,269 medium reservoirs (capacity of 0.01-0.1 km 3), and 84,052 small reservoirs (capacity of 0.0001-0.01 km 3); of this number, the Yangtze River basin contained 45,000 dams and reservoirs, including 143 dams having large reservoirs, or a quarter of all large reservoirs in China (Miao et al. 2015, p. 2350; Mueller et al. 2008, p. 233). The construction of dams and reservoirs have multiple and broad effects on the Yangtze sturgeon and its habitat, including limiting connectivity between spawning and feeding reaches; altering water temperature, water discharge, and velocity rates; and changing sediment concentration.

    Connectivity

    Dam construction on Yangtze River limits the ability of the Yangtze sturgeon to migrate between spawning and feeding reaches. Dam construction on the Yangtze occurs on both the upper and lower end of the species' current range. In the middle Yangtze River, the construction of Gezhouba Dam in 1981 prevented migration of adults downstream of the dam from being able to migrate to the species' spawning ground in the upper Yangtze near Yibin (Miao et al. 2015, p. 2351; Dudgeon 2010, p. 128; Fang et al. 2006, p. 375; Zhuang et al. 1997, p. 261). Although the reaches below Gezhouba Dam might be suitable for the species, at present there has been no observed natural reproduction below Gezhouba Dam (Du 2017, pers. comm.). The construction of Three Gorges Dam created a reservoir, which affected individuals of the species upstream. The Three Gorges Dam reservoir, which extended 600 km upstream from the dam, transformed the area into unsuitable habitat (Kynard 2016, pers. comm.; Cheng et al. 2015, p. 570; Miao et al. 2015, p. 2351). After the construction of the reservoir, the species rarely moves to reaches below Chongqing, a distance of approximately 500 km (Wu et al. 2015, p. 5).

    Meanwhile, the construction of Xiangjiaba Dam on the lower Jinsha River segment occurred on part of the historical spawning reach of the species. Xiangjiaba Dam is a barrier to all fish species and prevents the migration to areas above or the below the dam (Wu et al. 2014, p. 2). However, the species may be able to use spawning reaches below the dam (Fan et al. 2006, p. 36). That said, a dam located upstream from the species' habitat affects the species downstream by altering water temperature and sedimentation rate, which we discuss below (Fan et al. 2006, p. 36).

    In addition to dams currently present on the lower Jinsha and upper Yangtze River, in the early 2000s, a proposal was presented for the construction of the Xiaonanhai Dam, which is to be located upstream from Chongqing. If built, this dam will create a barrier between the species' last known spawning ground and feeding reach, which, depending on design, could have a negative impact on the species (Cheng et al. 2015, p. 579). However, at present, China's Ministry of Environmental Protection has rejected the proposal and any future dam projects on the last stretch of free-flowing Yangtze River due to environmental impacts (Chang 2016, pers. comm.; Kynard 2016, pers. comm.; Mang 2015, unpaginated).

    While the rejection of the proposal to construct the Xiaonanhai Dam is good for Yangtze sturgeon, the country's twelfth 5-year plan stated that renewable resources should make up 15 percent of all energy generated in China with 9 percent coming from hydroelectric source. This plan translates to an additional 230 gigawatt (GW) of power generated via hydroelectric dam. This target is a very ambitious one, given that Three Gorges Dam generates 18 GW of power per year (Dudgeon 2011, p. 1496). Furthermore, although the plan to construct the Xiaonanhai Dam has been rejected, plans to construct dams on the Jinsha River as part of a 12-dam cascade are still proceeding (Dudgeon 2010, p. 129).

    Water Temperature

    Historically, dams negatively affect the reproductive success of Yangtze sturgeon by altering water temperature flowing through the species' habitat. Water temperature influences the reproductive success of the Yangtze sturgeon at two stages in its life cycle: Commencement of spawning migration and egg survival. Spawning migration of the Yangtze sturgeon will not start until the water temperatures reach 18 degrees Celsius (°C) (64.4 degrees Fahrenheit (°F)) (Cheng et al. 2015, p. 578). Historically, before the construction of the Xiangjiaba and other dams on the lower Jinsha, water temperature reached 18 °C (64.4 °F) around April. However, the construction of the dams stratified the water table. As most dams on the Yangtze are designed to release cold water located at the bottom of the dams, the spawning season for the Yangtze sturgeon could be delayed by more than a month (Deng et al. 2006 and Wang et al. 2009, as cited in Cheng et al. 2015, p. 578). This delay shortens the maturing season for juveniles and is likely to reduce the species' survival rate. Additionally, if the water remains too cold for too long, sturgeon eggs will not mature, resulting in total loss of reproduction for that season (Kynard 2016, pers. comm.).

    Water Discharge and Velocity

    By altering discharge rates, dams affect the Yangtze sturgeon's reproductive success by affecting the timing of spawning migration. The species' spawning migration begins when flow rate increases during the spring flood (Zhuang et al. 1997, p. 261). At Yichang, the most downstream portion of the Yangtze sturgeon's current range, the mean discharge rate from 1983 to 2004 (before the construction of Three Gorges Dam) was between 10,000 m3/s and 17,000 m3/s. After the construction of the Three Gorges Dam, mean flow rate varies between 12,780 m3/s in high flow years and 6,414 m3/s in low flow years (Chen and Wu 2011, p. 384). For Chinese sturgeon, successful spawning occurs when water discharge is between 7,000 and 26,000 m3/s. This means that although flow rate during high flow years remains in the optimal discharge rate for Chinese sturgeon spawning, discharge rates during low flow years could have a negative impact on spawning success rates of both sturgeon species (Chen and Wu 2011, p. 385).

    While we do not have long-term historical data for water discharge rate for the Yangtze sturgeon at Yibin, the flow rate at Chongqing during the years 1950-2000 was between 4,540 m3/s and 11,000 m3/s (Zhang et al. 2011, p. 183). Since Chongqing is farther upstream from Yichang, this flow rate may be the river's natural rate at this section of the Yangtze. However, following the impoundment by the Xiangjiaba Dam in October 2012 and the Xiluodo Dam in May 2013, discharge in the lower Jinsha has declined more than 50 percent, suggesting that current flow rate is likely to be lower than the flow rate between 1950 and 2000 (Cheng et al 2015, p. 577). The Jinsha River feeds into the upper Yangtze River. This means that reduction in flow rate on the Jinsha will also reduce the flow rate on the upper Yangtze River. Given that the Yangtze sturgeon is closely related to the Chinese sturgeon, a reduction of flow rate by over 50 percent could have a significant negative impact on the reproductive success rate of the Yangtze sturgeon given its already tenuous biological status.

    Sedimentation Concentration

    In addition to affecting spawning of Yangtze sturgeon, dams affect the condition of the species' spawning ground through changes in the water velocity and sedimentation load. Because reproductive success of sturgeon is tied to the amount of suitable habitat, a reduction in habitat area can reduce the reproductive success of the species (Ban et al. 2011, p. 96; Bemis and Kynard 1997, p. 169). Specifically, flow rates affect the Yangtze sturgeon by affecting the sedimentation concentration in the water and on the riverbed. As noted before, Yangtze sturgeon lay their eggs on the interstitial spaces between rocks and boulders. The makeup of the riverbed needs to contain the right concentration of small pebbles and larger boulders to provide sufficient space for adherence and aeration of the eggs (Du et al. 2011, pp. 261-262; Bemis and Kynard 1997, p. 169).

    Historically, discharge rates and sedimentation load were in alignment with precipitation rates. A low discharge rate results in low sedimentation load. High discharge rates lead to higher sediment load, as high flows are able to transport more sediments downstream (Chen Z. et al. 2001, pp. 88-89). However, dams cause discharge and sedimentation rates to go out of alignment. While discharge rates remain aligned with precipitation rate, the sedimentation load pattern displays a 2-month delay due to sediment being trapped behind the dams. When the spring flood occurs, numerous dams release highly concentrated sediment downstream all at once, resulting in an asymmetrical sediment load pattern (Chen Z. et al. 2001, p. 90). The effects of sediment load patterns on the species' habitat occur at two stages: Release of sediments during high river stages and reduced sediment size and load over time (Dudgeon 2011, pp. 1488, 1495).

    The Jinsha River dams trap up to 82 percent of the sediment during the winter months, resulting in “clean” (i.e., sediment-free) water flowing downstream. This “clean” water lacks nutrients and may decrease the food supply of the Yangtze sturgeon over the winter months (Cheng et al. 2015, p. 578). During the subsequent spring flood, the release of concentrated sediment by dams likely results in sediments filling in all the interstitial spaces in spawning habitat, thereby reducing available spawning habitat for that season.

    Despite the spring release of concentrated sediments, sediment load is expected to decline over time. At Yichang, sediment load per year has decreased from 530 mega tons (Mt) per year in the 1950s-1960s, to 60 Mt per year after 2003. Additionally, suspended sediment at Yichang below Three Gorges Dam has decreased in size from 8-10 micrometers in 1987-2002 to 3 micrometers after 2003 (Yang et al. 2011, pp. 16-17). Reduction in sediment size can lead to increased embeddedness of available interstitial space. At the reaches below Gezhouba Dam, sedimentation has reduced available interstitial space by up to 50 to 70 percent (Du et al. 2011, p. 262). This prevents the adherence of eggs to the river bottom and reduces the quality of remaining spawning habitats.

    Summary of Effects of Dams on the Yangtze Sturgeon

    Dam construction in the middle Yangtze and lower Jinsha has restricted the species' range to the reaches of the Yangtze between Yibin and Yichang (Wu et al. 2014, p. 5). These projects prevented the migration of the species upstream and downstream of the dams. Although there is currently access between the species' remaining spawning and feeding grounds, the condition of remaining habitat is likely to be negatively affected by changes to the river flow and sedimentation rate. The formation of the Three Gorges reservoir has transformed the 600-km reach above the dam into a lentic system, resulting in unsuitable habitat for the species (Kynard 2016, pers. comm.; Cheng et al. 2015, pp. 570, 576). As a result, Yangtze sturgeon rarely use habitat downstream from Chongqing (Wu et al. 2014, p. 5).

    Upstream from the species' current range, the construction of the Xiluodu and Xiangjiaba Dam is likely to negatively affect the reproductive success of the Yangtze sturgeon. Through the release of cold water during the spring flood, the dam can delay the spawning migration of the sturgeon, which will either shorten the maturation time for juveniles or prevent the successful maturation of eggs altogether (Kynard 2016, pers. comm.; Cheng et al. 2015, p. 578). Alteration to sediment concentration in both the short term and long term reduces the quality of remaining habitat (Du et al. 2011, p. 262). Given the lack of observed natural reproduction of the species in the upper Yangtze, dams significantly affect the viability of the species.

    Overfishing (historical) and Bycatch (current)

    Historically, the Yangtze sturgeon was commercially harvested on the Yangtze River. In the 1960s, harvest of Yangtze sturgeon accounted for 10 percent of total harvest. In the 1970s, 5,000 kilograms (5.5 tons) of Yangtze sturgeons were caught in the spring season at Yibin (Zhuang et al. 1997, p. 262). Since then however, the population of Yangtze sturgeon has declined significantly (Zhang et al. 2013, p. 409). This decline is due to multiple reasons. Fishermen use fine mesh nets that prevent smaller fish, weighing as little as 50 grams (1.7 ounces), from being able to escape. The number of fishing boats increased from 500 in 1950s to 2,000 by 1985. More than 140,000 fishermen currently depend on the river for a living. Furthermore, the fishing season overlapped with the main spawning season of the Yangtze sturgeon (Yi 2016, p. 1; Fan et al. 2006, p. 37; Zhuang et al. 1997, p. 262). The replacement of bamboo and reed gear with gear made from synthetic fibers further contributed to a higher catch rate of sturgeons (Chen D. et al. 2009, p. 346).

    Despite attempts to help conserve the species by restocking, restocked juveniles experience very low survival rates (Wu et al. 2014, p. 4). From 2010 to 2013, restocking operations released 7,030 juveniles into the upper Yangtze River main stem. Subsequent bycatch between 2010 and 2013 recorded a total of 112 sturgeons caught, indicating a very low survival rate of stocked juveniles (Wu et al. 2014, p. 3). These results suggest very low survivability of restocked sturgeon, and the subsequent impacts from bycatch are too high for the species to persist (Wu 2016, pers. comm.; Wu et al. 2014, p. 4).

    Riverbed Modification

    The Yangtze sturgeon requires river substrate to contain suitable concentration to reproduce successfully (Du et al. 2011, p. 257). Alteration to the riverbed has reduced the reproductive success of this species. To improve navigation on the lower Jinsha and upper Yangtze River, multiple projects, including sand and gravel extraction operations, were implemented on the reaches between Shuifu and Yibin and Yibin and Chongqing (Zhang et al. 2011, p. 184). Between 2005 and 2009, $44 million (converted to U.S. dollars) were invested to improve the navigation between Yibin and Chongqing. These investments have led to the modification of 22 riffles (a shallow section of a stream or river with rapid current and a surface broken by gravel, rubble or boulders) on the upper Yangtze and the deepening of the channel from 1.8 m (5.9 ft) to 2.7 m (8.8 ft) (Zhang et al. 2011, p. 184). Additionally, up to 10, 6, and 3 river dredge ships operate in the Yangtze River, the Jinsha River, and the Min River, respectively. The operations of these ships alters the bottom topography of the riverbeds, which results in the loss of benthic habitat and spawning ground for many fish species, including the Yangtze sturgeon (Fan et al. 2006, p. 37). These projects are occurring on or near current Yangtze sturgeon spawning and feeding grounds from Yibin to Hejiang. Thus these operations will continue to reduce the quality and quantity of remaining habitat (Zhang et al. 2011, p. 184).

    Industrial Pollution

    As a benthic predator, the Yangtze sturgeon is exposed to higher concentrations of industrial pollution than many other fish species (Yujun et al. 2008, pp. 341-342). While we are not aware of any studies that analyze the impacts of industrial pollution on Yangtze sturgeon specifically, there have been studies on Chinese sturgeon and other sturgeon species. Industrial pollutants such as triphenyltin (TPT) affect reproductive success of the Chinese sturgeon. TPT, used in paint on ship hulls and in fishnets in China, can be absorbed into the eggs of Chinese sturgeon, resulting in increased deformities including abnormal development and skeletal and morphological deformities in embryos (Hu et al. 2009, pp. 9339-9340).

    A study on TPT exposure to 2- to 3-day-old Chinese sturgeon larvae found that 6.3 percent showed skeletal/morphological deformities and 1.2 percent had no eyes or only one eye. At the same time, larvae from spawning hatches of captured adults showed skeletal/morphological deformities of 3.9 percent and 1.7 percent that had only one eye or no eyes. Given the rate of deformities found in this study, the capability for the studied Chinese sturgeon to reproduce was reduced by 58.4 to 75.9 percent (Hu et al. 2009, p. 9342). Because the Yangtze and Chinese sturgeon are closely related species, the presence of TPT in the upper Yangtze River is likely reducing the reproductive success of the Yangtze sturgeon by a similar rate.

    In addition to TPT, the presence of endocrine disruptors compound (EDC) affects Chinese sturgeon by inducing declining sperm activity, intersex testis-ova, and a decline in male to female ratio in the population (An and Hu 2006, p. 381). A study on EDC found that the concentration of EDC in the Yangtze River (1.55 to 6.85 micrograms per liter) is very high and could have a detrimental impact on sturgeon in the river. This result suggests that industrial discharge of EDC is occurring in the Yangtze.

    As a result of rapid industrialization on the Yangtze River, higher concentration of heavy metals are found in the Yangtze River (Yujun et al. 2008, p. 338). High concentration of heavy metals leads to greater accumulation in all aquatic organisms (Yujun et al. 2008, p. 339). The toxicity effect of heavy metal accumulation is especially pronounced in zoobenthic predators, like the Yangtze sturgeon, because they occupy a higher position in the food chain. The result is that by consuming smaller prey species that have absorbed heavy metal, zoobenthic predator build up heavy metal accumulation inside their bodies (Yujun et al. 2008, p. 346). Given that heavy metal concentration is highest in benthic animals, especially zoobenthic predators like the sturgeon, the effect of heavy metals on the sturgeon could be more pronounced than other aquatic species (Yujun et al. 2008, p. 341; An and Hu 2006, p. 381). Despite the known impacts on captured Chinese sturgeon, we currently do not have evidence of population-level impacts of EDC or heavy metal on the wild Yangtze sturgeon population. That said, even though we have no evidence of morphological deformities in wild sturgeon, it is likely that industrial pollution does have an effect on the reproductive success of wild sturgeon.

    Hybridization With Displaced Native and Nonnative Sturgeon

    Despite decline in wild fishery yields, the Yangtze basin remains one of the major centers of China's aquaculture industry. Fishery yields from the basin accounts for 65 percent of total freshwater fisheries production in China (Shen et al. 2014, p. 1547; Chen D. et al. 2009, p. 338). In the past 30 years, sturgeon aquaculture in China has risen significantly. Although commercial aquaculturing of sturgeon only started in the 1990s, by 2006, production had reached 17,424 tons, which accounts for 80 percent of the world total production (Shen et al. 2014, p. 1548). The growth of the aquaculture industry in China saw aquaculture farms constructed across all branches of the Yangtze River (Li R. et al. 2009, p. 636). Sturgeon species that are commonly used in the aquacultural industry include A. schrenckii, Huso dauricus, and other Amur River sturgeon hybrids (Li R. et al. 2009, p. 636). However, none of these commonly cultured species are native to the Yangtze River. Additionally, there is a lack of regulation and enforcement of regulation to properly manage hybridization of sturgeon species. There is also the problem of aquaculture sturgeon escaping from sturgeon farms into the wider river system (Li R. et al. 2009, p. 636). The result is a comingling of native, exotic, and hybrid sturgeon species which could have a negative impact on the Yangtze sturgeon (Shen et al. 2014, p. 1549; Li R. et al. 2009, p. 636).

    There is currently no native-strain farm (farm that raises native species) for sturgeons in China. Because no farms in China focus on raising native stock in large enough number, this system creates shortages of parental stock of native sturgeons. In response to this shortage, farmers crossbreed wild-caught sturgeon with any sturgeon species available including nonnative species (Xiong et al. 2015, p. 658; Li R. et al. 2009, p. 636). For example, in 2006, there was a shortage of Siberian sturgeon in China (Acipenser baerii). Farmers then started crossbreeding Siberian sturgeon with Russian sturgeon (A. gueldenstaedtii), Sterlet sturgeon (A. ruthenus), and Amur sturgeon (A. schrenckii) (Li R. et al. 2009, p. 636). Crossbreeding of sturgeon species in China alters the wild population makeup. A study on the lower Yangtze River in 2006 found that of the 221 young sturgeons captured, 153 were hybrids, which accounted for 69.9 percent of total sturgeons caught (Li R. et al. 2009, p. 636). This information indicates that farmed hybrids are escaping into the river system. Although this study was conducted in the lower Yangtze River, because sturgeon aquaculture occurs across the Yangtze River system, it is likely that hybridization is occurring in the upper Yangtze River as well.

    The uncontrolled hybridization of native and nonnative species on the Yangtze alters the population dynamics between hybrids and native stocks. Hybridization may reduce the fitness of the overall population or replace a population of native fish with hybrids (Shen et al. 2014, p. 1549; Li R. et al. 2009, p. 636). Hybridization may also result in hybrids with better fitness than wild stock that outcompete wild native stock of Yangtze sturgeon for habitat and resources. When native fish are unavailable, farmers tend to import nonnative fish that have better characteristics, such as higher growth rate and better adaptability. These non-native sturgeons are bred with available native sturgeon to produce hybrids. These hybrids oftentimes escape or are accidentally introduced into the wild and then compete with the Yangtze sturgeon for resources (Xiong et al. 2015, pp. 657-658). Although hybridization is likely to be occurring all along the Yangtze River, we currently do not have information on the rates of hybridization of sturgeon in the upper Yangtze or how significant the effects are on the Yangtze sturgeon. That said, given that hybridized sturgeons make up 69.9 percent of sturgeons found in the studied area, it is likely that sturgeon hybrids are competing, and will likely continue to compete, with native stocks for habitat and resources throughout the Yangtze River system.

    Management Efforts

    As a result of overfishing and the construction of Gezhouba Dam in 1981, the population of Yangtze sturgeon has declined (Du et al. 2014, p. 1; Wu et al. 2014, p. 1; Zhang H. et al. 2011, p. 181). In response to the decline of the species, national and local officials have embarked on a number of initiatives to help conserve the species. These initiatives include increasing legal protection for the Yangtze sturgeon, creating and designating part of the species' range as a protected area, and repopulating the species in the wild through restocking (Zhang H. et al. 2011, p. 181; Fan et al. 2006, p. 35; Wei et al. 2004, p. 322).

    Legal Protections

    In response to the decline of the Yangtze sturgeon, in 1989, China's State Council added the Yangtze sturgeon to the National Red Data Book for Threatened Chinese Fish as a Class I Protected Animal (Wu et al. 2014, p. 1; Zhang H. et al. 2011, p. 181; Dudgeon 2010, p. 128; Wei et al. 2004, p. 322; Zhuang et al. 1997, p. 258). Animals listed as a Class I species are protected from certain activities, including hunting, capturing, or killing, for both commercial and personal uses. Scientific research, domestication, breeding, and exhibition are exempted (Wei et al. 2004, p. 322). Transportation of Class I-listed species requires approval from the Department of Wildlife Administration. Import or export of Class I aquatic species is regulated by the Fisheries Bureau of the Minister of Agriculture (Wei et al. 2004, p. 323).

    In addition to its listing under national law, the species has also been included in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) since 1998 (Ludwig 2008, p. 5; CITES 1997, pp. 152-153). The CITES trade database has recorded no international trade of this species going as far back as 1975 (the oldest date on CITES database) (CITES 2017). International trade in CITES species is regulated via a permit system. Under Article IV of CITES, export of an Appendix-II specimen requires the prior grant and presentation of an export permit. Export permits for Appendix-II specimens are only granted if the Management Authority of the State of export is satisfied that the specimens were lawfully obtained and if the Scientific Authority of the State of export has advised that the trade is not detrimental to the survival of the species in the wild. For any living specimen, the Management Authority of the State of export must also be satisfied that the specimen will be so prepared and shipped as to minimize the risk of injury, damage to health or cruel treatment. Re-export of an Appendix-II specimen requires the prior grant and presentation of a re-export certificate, which is only granted if the Management Authority of the State of re-export is satisfied that the specimen was imported into that State in accordance with CITES and, for any living specimen, that the specimen will be so prepared and shipped as to minimize the risk of injury, damage to health or cruel treatment. Certain exemptions and other special provisions relating to trade in CITES specimens are also provided in Article VII of CITES. In the United States, CITES is implemented through the Act and regulations at 50 CFR part 23.

    Additionally, since 2003, a fishing ban on all fish species has been implemented in the upper Yangtze River from February 1 to April 30. Starting in 2017, the fishing ban was extended from March to June (Du 2017, pers. comm.). One of the side effects of this ban is a reduction in the bycatch of Yangtze sturgeon since the time period of the ban coincides with the spawning season of the Yangtze sturgeon (Chen D. et al. 2012, p. 532; Chen D. et al. 2009, p. 348).

    Despite the implementation of legal protection for the species, there are several shortcomings with the current regulatory mechanisms for the species. China currently does not have a specialized, dedicated agency to manage fisheries resources across the country. Riverine resource management is maintained at local levels which are often located in major population center, far away from the fishery resource (Chen D. et al. 2012, p. 541). In the case of Yangtze sturgeon, these different jurisdictions have variations in regulation and conservation goals for the Yangtze River ecosystem, which limits coordination of species-conservation efforts and the overall effectiveness in managing species conservation across the Yangtze River basin (Chen D. et al. 2012, p. 541).

    In addition to a lack of a specialized body or other effective basin-wide conservation efforts, lack of funding is major problem for local jurisdictions. Enforcement officers often lack basic equipment, such as boats, to carry out fishing regulations within the fishery (Chen D. et al. 2012, p. 541). Additionally, while commercial harvesting of the species is prohibited, bycatch is still occurring and may still be too high to sustain a wild breeding population (Zhang H. et al. 2011, p. 184). The new fishing ban implemented in 2017 has the potential to reduce bycatch (Du 2017, pers. comm.). However, the positive effects from a fishing ban on the Yangtze may be limited, given the importance of the Yangtze to the economic well-being of riverside communities as entire stretches of the river cannot be closed off to fishing (Fan et al. 2006, p. 38).

    Protected Areas

    To offset the effects of habitat loss due to dams, China's State Department established in 2000 the National Reserve of Hejiang-Leibo Reaches of the Yangtze River for Rare and Endangered Fishes (Zhang H. et al. 2011, p. 181; Fan et al. 2006, p. 35). The reserve is located on the upper Yangtze River on the reaches between Xiangjiaba Dam and the city of Chongqing. This reserve is intended to protect three imperiled fish species, the Yangtze sturgeon, the Chinese paddlefish (Psephurus gladius), and the Chinese high-fin banded shark (Myxocyprinus asiaticus), as well as 37 other endemic fish species (Fan et al. 2006, p. 35). In 2005, the reserve was expanded to mitigate the impact from current and future hydroelectric projects (Zhang H. et al. 2011, pp. 181-182). While the reserve plays an important role in protecting wildlife within its borders, expansion of the hydroelectric project in the lower Jinsha River and upper Yangtze outside the protected area is likely to undermine the effectiveness of the reserve. In order to facilitate economic growth, China has decentralized authority for infrastructure development from the state to local municipalities. This decentralized model has resulted in provincial governments prioritizing economic growth over environmental impacts (Dudgeon 2011, p. 1496).

    Since 2003, hydroelectric projects in China are subjected to environmental assessments and approval from the Ministry of Environmental Protection (Ministry) (Dudgeon 2011, p. 1496). However, this approval is routinely ignored even by nationally owned corporations. For example, in 2004, China Three Gorges Corporation (CTGC) began construction of the Xiluodu Dam in the Lower Jinsha without obtaining permission from the Ministry (Dudgeon 2011, pp. 1496-1497). In response, the Ministry suspended work on the dam in 2005. However, despite initial reservation about the lack of an environmental impact assessment, the Ministry quickly compiled reports and allowed the dam construction to proceed (Dudgeon 2011, p. 1499). Additionally, in 2009 the Ministry gave the authority to build two additional dams on the Jinsha segment to other dam construction companies after a brief suspension (Dudgeon 2010, p. 129). Overall, these temporary suspensions of construction have done little to slow down the pace of dam development. In 2011, CTGC began constructing the Xiangjiaba Dam on the Lower Jinsha. The location of this dam would have occurred within the 500-km boundary of the National Reserve of Hejiang-Leibo Reaches. The CTGC successfully petitioned the State Council to redraw the boundaries of the reserve to exclude the section of the river where the Xiangjiaba Dam is located (Dudgeon 2011, p. 1500; Dudgeon 2010, p. 129). The reserve, now renamed the National Natural Reserve Area of Rare and Special Fishes of the Upper Yangtze River, encompasses the reaches below the Xiangjiaba Dam from Yibin to Chongqing as well the tributaries that feed into the Yangtze (Zhang H. et al. 2011, p. 182; Fan et al. 2006, p. 35). The redrawing of the area of the reserve to accommodate the construction of Xiangjiaba Dam lends further evidence that local governments are prioritizing growth over environmental impacts. The construction of the Xiangjiaba Dam led to the impoundment of the reach upriver, which will affect the flow and sedimentation rate downstream (Cheng et al. 2015, p. 577; Dudgeon 2011, p. 1500). Given the lack of natural reproduction of the Yangtze sturgeon and future impacts from the dam, it is unlikely that the current boundary of the reserve will be sufficient to maintain a wild breeding population of this species (Kynard 2016, pers. comm.; Dudgeon 2011, p. 1500).

    Restocking

    As a result of the decline of the species, controlled reproduction and release of juvenile Yangtze sturgeon has occurred every year since 2007 (Zhang H. et al. 2011, p. 181). Between 2007 and 2012, more than 10,000 Yangtze sturgeon juveniles were released into the upper Yangtze on reaches downstream from Xiangjiaba Dam (Wu et al. 2014, p. 1). In 2014, restocking was started on the reaches below Gezhouba Dam (Du 2017, pers. comm.). While this number pales in comparison to the six million Chinese sturgeon that have been released since 1983, the restocking of the Yangtze sturgeon represent an attempt by local and state officials to try to maintain the species in the wild (Chen D. et al. 2009, p. 349).

    Despite the efforts to restock the Yangtze sturgeon in the wild, current restocking efforts are unsuccessful (Wu et al. 2014, p. 4). No juveniles were caught 95 days after release, indicating that released sturgeon experienced a very high mortality rate (Wu et al. 2014, p. 4). There are multiple possible reasons for the limited success of current restocking efforts, including poor breeding and rearing techniques that result in progeny with low survival rates in the wild, high bycatch rate, and loss or deterioration of remaining habitats (Cheng et al. 2015, pp. 579-580; Du et al. 2014, p. 2; Shen et al. 2014, p. 1549; Zhang H. et al. 2011, p. 184). Thus, despite attempts to conserve the species in the wild through restocking, with all the other forces acting on the Yangtze sturgeon it is unlikely that current restocking efforts are adequate to improve the species' condition in the wild.

    Stochastic (Random) Events and Processes

    Species endemic to small regions, or known from few, widely dispersed locations, are inherently more vulnerable to extinction than widespread species because of the higher risks from localized stochastic (random) events and processes, such as industrial spills and drought. These problems can be further magnified when populations are very small, due to genetic bottlenecks (reduced genetic diversity resulting from fewer individuals contributing to the species' overall gene pool) and random demographic fluctuations (Lande 1988, p. 1455-1458; Pimm et al. 1988, p. 757). Species with few populations, limited geographic area, and a small number of individuals face an increased likelihood of stochastic extinction due to changes in demography, the environment, genetics, or other factors, in a process described as an extinction vortex (a mutual reinforcement that occurs among biotic and abiotic processes that drives population size downward to extinction) (Gilpin and Soule´ 1986, pp. 24-25). The negative impacts associated with small population size and vulnerability to random demographic fluctuations or natural catastrophes can be further magnified by synergistic interactions with other threats.

    The Yangtze sturgeon is known from a single geographic population in the upper Yangtze River and its tributaries (Zhang et al. 2011, pp 181-182; Zhuang et al. 1997, p. 259). As a result, the species is highly vulnerable to stochastic processes and is highly likely negatively affected by these processes. In March 2000, for example, the Jinguang Chemical Plant, located on the Dadu River (a tributary of the Yangtze River), was found to be releasing yellow phosphorous into the Yangtze. This substance is highly toxic to aquatic organisms including the Yangtze sturgeon (Chen D. et al. 2009, p. 343). Another spill in 2006 on the Yuexi River, which also feeds into the Yangtze, saw mercury being released into the river (Worldwatch Insitute 2006, npn). These and other incidents combined with the fact that the Yangtze River system is home to a large number of chemical plants suggest that risk of industrial spills is quite high. Therefore, it is likely that stochastic processes have negative impacts on the species in combination with other factors such as habitat modification and loss and bycatch.

    Determination

    Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination.

    We have carefully assessed the best scientific and commercial information available on the Yangtze sturgeon. While we do not know the exact population size of the Yangtze sturgeon, the species was historically abundant enough to be commercially viable up to the 1970s, after which it experienced a significant decline (Kynard et al. 2003, p. 27). Loss of individuals due to overharvesting by fishermen on the Yangtze (Factor B) is the main factor that contributed to the historical decline of the species. Subsequent construction of dams on the Yangtze prevented the migration in the middle Yangtze and lower Jinsha, which prevented recovery of the species in these areas (Miao et al. 2015, p. 2351; Wu et al. 2014, p. 2; Dudgeon 2010, p. 128; Fang et al. 2006, p. 375; Zhuang et al. 1997, p. 261). Additionally, dams affect the quality of the species' habitat through changes in discharge, temperature, and sedimentation rate (Zhang G. et al. 2012, p. 445; Du et al. 2011, p. 262; Chen Z. et al. 2001, p. 90). In addition to dams, the species' habitat is also adversely affected by riverbed modification to accommodate increasing boat traffic. The combined effects of dams and riverbed modification on the Yangtze include the loss and reduction in quality of remaining habitat (Factor A).

    Despite conservation efforts undertaken by local and national authorities such as fishing bans and restocking, current efforts do not appear to be successful in conserving the species. No natural reproduction has been documented in the wild since the 2000s (Wu et al. 2014, p. 1). Additionally, restocked juvenile sturgeon experience very high mortality rates due to a high bycatch rate and an inability to survive in wild conditions (Du et al. 2014, p. 1; Wu et al. 2014, p. 4).

    Industrial pollution and hybridization with displaced native and nonnative sturgeon species are also acting on the species (Factor E). Although we do not have information on the impact of industrial pollution on the species in the wild, studies in a laboratory environment found that pollutants such as TPT and EDC can reduce the reproductive success rate of adult sturgeons (Hu et al. 2009, p. 9342; An and Hu 2006, pp. 379-380). Additionally, there are high concentrations of TPT and EDC in the Yangtze River. While we do not have data on the hybridization of Yangtze sturgeon with other species, surveys conducted in the lower Yangtze River found that 69.9 percent of sturgeon species caught were hybrids (Li R. et al. 2009, p. 636). These results suggest that industrial pollution and hybridization, in tandem with other factors, are affecting the species.

    Therefore, for the following reasons we conclude that this species has been and continues to be significantly reduced to the extent that the viability of the Yangtze sturgeon is significantly compromised:

    (1) The species is limited to a single geographic population in the upper Yangtze main stem and its tributaries. There is also some evidence of a small remnant population in the middle Yangtze.

    (2) Loss of habitat and connectivity between the spawning and feeding reaches is having a significant adverse effect on the species, which appears to have low to no reproduction.

    (3) The cumulative effects of habitat modification and loss due to dams and riverbed projects, bycatch, industrial pollution, and hybridization are adversely affecting the species.

    (4) Current restocking and management efforts are inadequate to maintain the species' presence in the wild.

    (5) Stochastic events, such as industrial spills or drought, can reduce the survival rate of the species

    In section 3(6), the Act defines an “endangered species” as any species that is “in danger of extinction throughout all or a significant portion of its range” and in section 3(20), a “threatened species” as any species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” We find that the Yangtze sturgeon is presently in danger of extinction throughout its range based on the severity and immediacy of threats currently adversely affecting the species. The populations and distributions of the species have been significantly reduced to the point where there is no current reproduction in the wild which is indicative of a very high risk of extinction, and the remaining habitat and populations are threatened by a variety of factors acting alone and in combination to reduce the overall viability of the species.

    Based on the factors described above and their impacts on the Yangtze sturgeon, we find the following factors to be threats to this species (i.e., factors contributing to the risk of extinction of this species): Loss and modification of habitat due to dams and riverbed expansion (Factor A), bycatch (Factor C), and cumulative effects (Factor E) of these and other threats including industrial pollution and hybridization. Furthermore, current legal and management efforts over these practices are inadequate to conserve the species (Factor D).

    Therefore, on the basis of the best available scientific and commercial information, we propose listing Yangtze sturgeon as endangered in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for this species because of its restricted range, limited distribution, and vulnerability to extinction; and because the threats are ongoing throughout its range at a level that places this species in danger of extinction now.

    Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. Because we have determined that the Yangtze sturgeon is endangered throughout all of its range, we do not need to conduct an analysis of whether there is any significant portion of its range where the species is in danger of extinction or likely to become so in the foreseeable future. This is consistent with the Act because when we find that a species is currently in danger of extinction throughout all of its range (i.e., meets the definition of an “endangered species”), the species is experiencing high-magnitude threats across its range or threats are so high in particular areas that they severely affect the species across its range. Therefore, the species is in danger of extinction throughout every portion of its range and an analysis of whether there is any significant portion of the range that may be in danger of extinction or likely to become so would not result in a different outcome.

    Available Conservation Measures

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

    Our regulations at 50 CFR part 402 implement the interagency cooperation provisions found under ESA Section 7. Under section 7(a)(1) of the ESA, federal agencies are to utilize, in consultation with and with the assistance of the Service, their authorities in furtherance of the purposes of the Act. Section 7(a)(2) of the Act, as amended, requires Federal agencies to ensure, in consultation with the Service, that “any action authorized, funded, or carried out” by such agency is not likely to jeopardize the continued existence of a listed species or result in destruction or adverse modification of its critical habitat. An “action” that is subject to the consultation provisions of section 7(a)(2) has been defined in our implementing regulations as “all activities or programs of any kind authorized, funded, or carried out, in whole or in part, by Federal agencies in the United States or upon the high seas.” 50 CFR 402.02. With respect to this species, there are no “actions” known to require consultation under ESA Section 7(a)(2). Given the regulatory definition of “action,” which clarifies that it applies to “activities or programs . . . in the United States or upon the high seas,” the species is unlikely to be the subject of section 7 consultations, because the species conducts its entire life cycle in freshwater outside of the United States and is unlikely to be affected by U.S. Federal actions. Additionally, because the Yangtze sturgeon is not native to the United States, no critical habitat is being proposed for designation with this rule. 50 CFR 424.12(g).

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

    Section 9 of the Act and our implementing regulations at 50 CFR 17.21 set forth a series of general prohibitions that apply to all endangered wildlife. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to “take” (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or upon the high seas. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. In addition, it is illegal for any person subject to the jurisdiction of the United States to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

    We may issue permits under section 10 of the Act to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits for endangered species are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

    Required Determination Clarity of the Rule

    We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (1) Be logically organized;

    (2) Use the active voice to address readers directly;

    (3) Use clear language rather than jargon;

    (4) Be divided into short sections and sentences; and

    (5) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    National Environmental Policy Act (42 U.S.C. 4321 et seq.)

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

    References Cited

    A complete list of references cited in this rulemaking is available on the internet at http://www.regulations.gov and upon request from the Branch of Foreign Species, Ecological Services (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this proposed rule are the staff members of the Branch of Foreign Species, Ecological Services, Falls Church, VA.

    List of Subjects in 50 CFR Part 17

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

    Proposed Regulation Promulgation

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

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

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

    2. In § 17.11(h), add an entry for “Sturgeon, Yangtze” to the List of Endangered and Threatened Wildlife in alphabetical order under FISHES to read as set forth below:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Common name Scientific name Where listed Status Listing citations and applicable rules *         *         *         *         *         *         * Fishes *         *         *         *         *         *         * Sturgeon, Yangtze Acipenser dabryanus Wherever found E [Insert Federal Register citation when published as a final rule]. *         *         *         *         *         *         *
    Dated: November 15, 2017. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service, Exercising the Authority of the Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2017-27954 Filed 12-26-17; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 170720688-7688-01] RIN 0648-BH07 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Vermilion Snapper Management Measures; Amendment 47 AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to implement management measures described in Amendment 47 to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico Fishery Management Council (Council) (Amendment 47). For vermilion snapper, this proposed rule would revise the stock annual catch limit (ACL). Additionally, Amendment 47 would establish a proxy for the estimate of the stock maximum sustainable yield (MSY). The purpose of this proposed rule is to revise the stock ACL for vermilion snapper in the Gulf of Mexico (Gulf) consistent with the most recent stock assessment.

    DATES:

    Written comments must be received on or before January 26, 2018.

    ADDRESSES:

    You may submit comments on the amendment identified by “NOAA-NMFS-2017-0106” by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0106, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Lauren Waters, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Electronic copies of Amendment 47, which includes an environmental assessment, a fishery impact statement, a Regulatory Flexibility Act (RFA) analysis, and a regulatory impact review, may be obtained from the Southeast Regional Office website at http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/2017/am47/docs/PDFs/gulf_reef_am47_vermilion_final.pdf.

    FOR FURTHER INFORMATION CONTACT:

    Lauren Waters, Southeast Regional Office, NMFS, telephone: 727-824-5305; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    NMFS and the Council manage the Gulf reef fish fishery, which includes vermilion snapper, under the FMP. The Council prepared the FMP and NMFS implements the FMP through regulations at 50 CFR part 622 under the authority of the Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    Background

    The Magnuson-Stevens Act requires the Council to specify the MSY for managed stocks. The National Standard 1 Guidelines state that the Council should adopt a reasonable proxy for MSY if data are insufficient to estimate MSY directly.

    Status of the Vermilion Snapper Stock

    Amendment 23 to the FMP established MSY for vermilion snapper as the yield associated with FMSY when the stock is at equilibrium, where F is defined as fishing mortality (70 FR 109; June 8, 2005). The final rule for the Generic Annual Catch Limit (ACL) and Accountability Measures (AM) Amendment established the vermilion snapper stock ACL and set it equal to the ABC at 3.42 million lb (1.55 million kg), round weight (76 FR 82044, December 29, 2011).

    In 2016, a standard assessment for vermilion snapper was conducted (SEDAR 45) and the stock status was evaluated using several MSY proxies. Under all proxies evaluated in SEDAR 45, overfishing was not occurring and the stock was not overfished. The Council's Scientific and Statistical Committee (SSC) determined that the most appropriate proxy for MSY is the yield when fishing at a mortality rate corresponding to 30 percent spawning potential ratio (F30% SPR).

    SEDAR 45 also included projections for the overfishing limit and the ABC. The SSC provided the Council two recommendations for ABC: one that is derived from fishing at 75 percent of the MSY proxy (F30% SPR) and results in a declining ABC from 2017 through 2021, and one that is derived using the average of 2017-2021 ABCs and results in a constant ABC. The two ABC recommendations are equivalent in terms of maintaining the stock status and the Council selected the constant catch scenario that yielded an ABC of of 3.11 million lb (1.41 million kg).

    Management Measure Contained in This Proposed Rule

    This proposed rule would revise the stock ACL for Gulf vermilion snapper consistent with the results of SEDAR 45 and the SSC's new ABC recommendation. The current ACL of 3.42 million lb (1.55 million kg), round weight, exceeds the ABCs recommended by the Council's SSC. Therefore, the Council determined that the ACL for vermilion snapper should be decreased to equal the constant catch ABC and this proposed rule would set the stock ACL at 3.11 million lb (1.41 million kg), round weight.

    The current accountability measures for vermilion snapper require NMFS to close the commercial and recreational fishing seasons if the combined commercial and recreational landings reach or are projected to reach the stock ACL. Since 2013, combined landings have been less than 3.00 million lb (1.36 million kg), round weight, every year. Therefore, NMFS does not expect the combined landings of vermilion snapper to reach the proposed stock ACL and result in a closure before the end of the fishing year.

    Measures in Amendment 47 Not Codified Through This Proposed Rule

    In addition to the measure proposed to be implemented through this proposed rule, Amendment 47 would establish a proxy for vermilion snapper MSY.

    For vermilion snapper, the Council's SSC recommended that a proxy be used for MSY. The Council's SSC recommended F30% SPR as the MSY proxy for SEDAR 45, and the Council agreed. Under this proxy, the stock is not overfished or undergoing overfishing.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with Amendment 47, the FMP, the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

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

    The Magnuson-Stevens Act provides the statutory basis for this proposed rule. No duplicative, overlapping, or conflicting Federal rules have been identified. A description of this proposed rule and its purpose and need are contained in the SUMMARY section of the preamble.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is as follows.

    This proposed rule would directly affect commercial and recreational fishing for vermilion snapper in the Gulf exclusive economic zone (EEZ). Anglers (recreational fishers) are not considered small entities as that term is defined in 5 U.S.C. 601(6). Consequently, estimates of the number of anglers directly affected by the rule and the impacts on them are not provided here.

    Any commercial fishing business that operates a commercial fishing vessel that harvests vermilion snapper in the Gulf EEZ must have a valid Federal commercial Gulf reef fish permit that is specifically assigned to that vessel. The Gulf reef fish permit is a limited access permit. As of February 21, 2017, 848 vessels had a Federal Gulf reef fish permit and 795 of the permits were valid. NMFS estimates that 631 businesses own the 848 vessels with a Federal permit, and the size of their individual Gulf reef fish fleets vary from 1 to 17 vessels.

    The number of federally permitted vessels that land vermilion snapper is substantially less than the number of vessels with a Gulf reef fish permit. From 2011 through 2015, approximately 35 percent to 40 percent of the vessels with a Federal permit landed vermilion snapper in any given year. During that same 5-year period, an annual average of 342 federally permitted vessels landed vermilion snapper. NMFS estimates these 342 vessels are operated by 252 businesses.

    The 342 vessels landed an average of 4,914 lb (2,229 kg), gutted weight, of vermilion snapper with a dockside value of $15,293 (2015 dollars) annually. This average annual dockside revenue from landings of vermilion snapper represents approximately 12 percent of the average vessel's annual dockside revenue from all species. However, there are considerable differences in average annual landings of vermilion snapper by gear type from 2011 through 2015. For example, the average longline vessel annually landed 72 to 73 lb (32 to 33 kg), gutted weight, of the species, whereas the average hook-and-line vessel landed over 7,000 lb, (3,175 kg) gutted weight, annually. Hook-and-line is the primary gear type used by the commercial sector. The average federally permitted hook-and-line vessel landed 7,078 lb (3,211 kg), gutted weight, of vermilion snapper annually with a dockside value of $22,276 (2015 dollars), and those vermilion snapper landings represent approximately 17 percent of that average vessel's annual dockside revenue from all landings.

    For RFA purposes, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide. Based on the average annual revenue for a federally permitted vessel that lands vermilion snapper, regardless of gear used, it is concluded that most to all of the businesses that harvest vermilion snapper from the Gulf EEZ are small.

    Amendment 47 would establish an MSY proxy for vermilion snapper and that has no direct impact on any small business.

    This proposed rule would decrease the stock ACL of vermilion snapper. The stock ACL is currently 3.42 million lb (1.55 million kg), round weight, and has been in place since 2012. This proposed rule would decrease the stock ACL to 3.11 million lb (1.41 million kg), round weight.

    If combined landings reach or are projected to reach the stock ACL, the commercial and recreational fishing seasons are closed early as a result of accountability measures being triggered. Since 2012, there have been no early closures because combined commercial and recreational landings of vermilion snapper have been less than the stock ACL. From 2012 through 2015, combined landings varied from approximately 2.54 million lb (1.15 million kg) to 3.17 million lb (1.44 million kg), round weight, annually and averaged approximately 2.73 million lb (1.24 million kg). Since 2013, combined landings have been less than 3.00 million lb (1.36 million kg), round weight, every year, and preliminary data for 2016 indicate combined landings of approximately 2.63 million lb (1.19 million kg), round weight. Preliminary landings data for 2016 indicate combined landings of approximately 2.6 million lb (1.18 million kg), round weight. Moreover, as of November 27, 2017, for commercial landings and through the third wave for recreational landings, combined landings for 2017 are approximately 2.4 million lb (1.09 million kg), round weight. Based on recent landings data, it is expected that combined landings of vermilion snapper would be less than the proposed stock ACL of 3.11 million lb (1.41 million kg), round weight, and there would be no early closures. Therefore, NMFS expects the reduction of the stock ACL would have no economic impact on small businesses that harvest vermilion snapper from the Gulf EEZ.

    No new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this proposed rule does not implicate the Paperwork Reduction Act.

    In conclusion, NMFS expects this proposed rule would not have a significant economic impact on a substantial number of small entities, and an initial regulatory flexibility analysis is not required and none has been prepared.

    List of Subjects in 50 CFR Part 622

    Commercial, Fisheries, Fishing, Gulf, Recreational, Vermilion snapper.

    Dated: December 21, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.41, revise the last sentence of paragraph (j) to read as follows:
    § 622.41 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

    (j) * * * The stock ACL for vermilion snapper is 3.11 million lb (1.41 million kg), round weight.

    [FR Doc. 2017-27934 Filed 12-26-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170621579-7579-01] RIN 0648-BG96 Fisheries of the Exclusive Economic Zone Off Alaska; Nontrawl Lead Level 2 Observers AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes regulations to modify specific provisions of the North Pacific Observer Program. The first two elements of this proposed rule would modify the requirements for an observer to obtain a nontrawl lead level 2 (LL2) deployment endorsement and implement a pre-cruise meeting requirement for vessels required to carry an observer with a nontrawl LL2 deployment endorsement. These elements are intended to increase the number of observers that qualify for a nontrawl LL2 deployment endorsement and maintain observer safety and data quality. The third element of this proposed rule would make editorial changes, and modify observer coverage and reporting requirements for vessels when participating in the Western Alaska Community Development Quota (CDQ) Program. This element is intended to promote operational efficiency, and remove unnecessary requirements for specific vessels participating in the CDQ Program. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan (FMP) for Groundfish of the Gulf of Alaska, and the FMP for Groundfish of the Bering Sea and Aleutian Islands Management Area, and other applicable law.

    DATES:

    Comments must be received no later than January 26, 2018.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0071 by either of the following methods:

    Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0071, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.

    Instructions: NMFS may not consider comments if they are sent by any other method, to any other address or individual, or received after the comment period ends. All comments received are a part of the public record and NMFS will post the comments for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender is publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Electronic copies of the draft Regulatory Impact Review (RIR) and the Categorical Exclusion prepared for this action are available from www.regulations.gov or from the NMFS Alaska Region website at alaskafisheries.noaa.gov.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS at the above address; and to OIRA by email to [email protected] or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Alicia M Miller, 907-586-7228 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Authority for Action

    NMFS manages the groundfish fisheries in the exclusive economic zone under the Fishery Management Plan for Groundfish of the Gulf of Alaska and under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area. The North Pacific Fishery Management Council (Council) prepared the FMPs under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the FMPs appear at 50 CFR parts 600 and 679.

    Background

    Regulations at subpart E of 50 CFR part 679 require that most vessels fishing for groundfish or halibut must carry an observer onboard their vessel for some, or all, fishing activities to ensure the collection of data necessary to manage the groundfish and halibut fisheries. The following sections describe (1) the North Pacific Observer Program, (2) nontrawl lead level 2 observer requirements, (3) the need for this action, and (4) this proposed rule.

    North Pacific Observer Program

    The North Pacific Observer Program (Observer Program) is an integral component in the management of North Pacific fisheries. The Observer Program was created with the implementation of the Magnuson-Stevens Act in the mid-1970s and has evolved from primarily observing foreign fleets to observing domestic fleets. Regulations at subpart E of 50 CFR part 679 implement the Observer Program and prescribe how NMFS-certified observers (observers) will be deployed on board vessels and in processing plants to obtain information necessary for the conservation and management of the groundfish and halibut fisheries off Alaska. The information collected by observers contributes to the best available scientific information used to manage the fisheries in furtherance of the purposes and national standards of the Magnuson-Stevens Act.

    Observers collect biological samples and gather information on total catch, including bycatch, and interactions with protected species. Fishery managers use data collected by observers to manage groundfish catch and bycatch limits established in regulation and to document fishery interactions with protected species. Fishery managers also use data collected by observers to inform the development of management measures that minimize bycatch and reduce fishery interactions with protected resources. Scientists use observer-collected data for stock assessments and marine ecosystem research.

    On January 1, 2013, the Observer Program was restructured to establish two observer coverage categories: Partial and full (77 FR 70062; November 21, 2012). Regulations at 50 CFR 679.50 identify that all vessels and processors that participate in federally managed or parallel groundfish and halibut fisheries off Alaska, except catcher vessels delivering unsorted codends to mothership vessels, are subject to observer coverage in one of these two categories. Regulations at 50 CFR 679.51 require vessels and processors in the full coverage category to carry an observer at all times when fish are caught or processed. Importantly for this proposed rule, the full coverage category includes most catcher/processors (i.e., vessels that catch and process their own catch at-sea), and all motherships (i.e., those vessels that receive unsorted catch from other vessels and process that catch at-sea). Owners of vessels or processors in the full coverage category must contract directly with a permitted observer provider and pay for required observer coverage. Vessels affected by these proposed changes to nontrawl LL2 observer deployment endorsement requirements are in the full coverage category.

    Regulations at 50 CFR 679.51 describe the vessels and processing plants that are in the partial coverage category. Most catcher vessels using nontrawl gear are in the partial coverage category. NMFS, in consultation with the Council, develops an annual deployment plan for the Observer Program to determine when and where observer coverage is needed for vessels and processors in the partial coverage category. NMFS contracts with an observer provider to deploy observers based on the scientific sampling plan described in the annual deployment plan.

    Nontrawl Lead Level 2 Observer Requirements

    Two groups of vessels are required to carry an observer with a nontrawl LL2 deployment endorsement. The first group of vessels includes vessels named on a License Limitation Program (LLP) license with a Pacific cod catcher/processor hook-and-line endorsement for the Bering Sea, Aleutian Islands, or both the Bering Sea and Aleutian Islands. These vessels are subject to monitoring requirements at 50 CFR 679.100 and are referred to as “freezer longline vessels” throughout this proposed rule. Pursuant to 50 CFR 679.100, a freezer longline vessel must carry an observer with a nontrawl LL2 deployment endorsement when the vessel (1) operates in either the BSAI or Gulf of Alaska groundfish fisheries and directed fishing for Pacific cod is open in the BSAI, or (2) when the vessel participates in the CDQ groundfish fisheries. These monitoring requirements for freezer longline vessels were implemented in 2012 and require freezer longline vessel owners and operators to select between one of two monitoring options: Either carry two observers so that all catch can be sampled, or carry one observer and use a motion-compensated flow scale to weigh Pacific cod before it is processed. Both monitoring options require the vessel to carry one observer endorsed as a nontrawl LL2 observer. (77 FR 59053; September 26, 2012).

    The second group of vessels that are required to carry an observer with a nontrawl LL2 deployment endorsement includes catcher/processors that use pot gear when participating in the CDQ groundfish fisheries (groundfish CDQ fishing) (77 FR 6492; February 8, 2012). These pot catcher/processors are required to carry an observer with a nontrawl LL2 deployment endorsement when groundfish CDQ fishing and may participate in other fisheries that do not require a nontrawl LL2 observer. Regulations at 50 CFR 679.32 describe the specific monitoring requirements for vessels when participating in the sablefish CDQ, pollock CDQ, groundfish CDQ, and other CDQ fisheries.

    Regulations at 50 CFR 679.53 define the requirements for an observer to receive a nontrawl LL2 deployment endorsement. An observer obtains a nontrawl LL2 deployment endorsement when the observer meets minimum experience requirements for a level 2 deployment endorsement (has completed 60 days of data collection and met the Observer Program's performance expectations on their most recent evaluation) and has completed two cruises of at least 10 days each and sampled at least 30 sets on a vessel using nontrawl gear. This means that prior to gaining a nontrawl LL2 deployment endorsement, an observer must first deploy on a nontrawl vessel that is not required to carry a nontrawl LL2 observer and sample at least 30 sets.

    Need for This Action

    In 2014, observer providers and representatives of freezer longline vessels reported shortages of nontrawl LL2 observers for deployment on freezer longline vessels and that, in some cases, shortages delayed fishing operations (See section 3.3.4 of the Analysis). Since 2012, all active freezer longline vessels, except one, have chosen the option to carry one LL2 observer and weigh Pacific cod on a flow scale. This means that only one freezer longline vessel subject to the nontrawl LL2 observer requirement has chosen to carry two observers—one observer with a nontrawl LL2 endorsement, and one observer who will gain sampling experience to count toward the requirements for a nontrawl LL2 deployment endorsement. In addition, since 2013, there are few other nontrawl vessels in the full observer coverage category that do not require an LL2 observer. Therefore, the few observers deployed in the full coverage category are able to gain the sampling experience necessary to gain the nontrawl LL2 deployment endorsement. Observer providers contracted by vessels in the full coverage category have reported that they have been unable to create and retain an adequate pool of qualified nontrawl LL2 observers since 2014.

    In contrast, observers deployed on vessels in the partial coverage category have opportunities to gain nontrawl sampling experience to count toward the requirements for a nontrawl LL2 deployment endorsement on catcher vessels in the partial coverage category. However, until August 2016, the observer provider contracted to deploy observers in the partial coverage category did not have a permit to deploy observers in the full coverage category pursuant to regulations at 50 CFR 679.52. These conditions from 2013 through August 2016 resulted in a diminishing pool of qualified observers employed by permitted observer providers in the full coverage category (See Tables 11, 12, and 13 in the Analysis).

    Since 2014, NMFS, observer providers, and freezer longline vessels have undertaken a series of non-regulatory actions designed to build and retain a pool of qualified nontrawl LL2 observers available for the freezer longline vessels. For example, NMFS modified its policy on how sampled sets are credited to observers when determining the number of sampled sets for a nontrawl LL2 deployment endorsement, and some members of the freezer longline fleet voluntarily deployed a second observer on some freezer longline vessels to allow those observers to gain sampling experience necessary to receive a nontrawl LL2 deployment endorsement (See Section 3.3.5 of the Analysis for additional detail). However, these non-regulatory actions resulted in additional costs to the freezer longline fleet and did not fully address the industry's concerns about the limited availability of nontrawl LL2 observers.

    Between 2014 and 2017, the Council and its Observer Advisory Committee discussed and analyzed potential solutions to address industry concerns about the limited availability of nontrawl LL2 observers in the full coverage category. In June 2017, the Council recommended changes to regulations that would (1) allow trawl sampling experience to count toward a nontrawl LL2 deployment endorsement and authorize the observer program to require additional training as necessary to adequately prepare observers to perform data collection duties when deployed as a nontrawl LL2 observer, and (2) require the operator or manager of a vessel required to carry an observer with a nontrawl LL2 deployment endorsement to participate in a pre-cruise meeting with the observer if notified by NMFS to do so. These regulatory changes are intended to minimize additional costs to industry while also maintaining observer safety and data quality.

    This Proposed Rule

    This proposed rule includes three elements. The first element of this proposed rule would modify regulations at § 679.53(a)(5)(v)(C) to allow 100 sampled hauls on trawl catcher/processor or mothership vessel (equivalent to the required sampling experience for an observer to obtain a trawl LL2 deployment endorsement) to count toward a nontrawl LL2 deployment endorsement and authorize the observer program to require additional training for observers as necessary to adequately prepare them to safely perform data collection duties relevant to the nontrawl LL2 deployment endorsement.

    These changes are intended to reduce the potential for a shortage of nontrawl LL2 observers, because many observers deployed in the full coverage category qualify for a trawl LL2 deployment endorsement. This would allow observers that qualify as a trawl LL2 observer to potentially qualify as a nontrawl LL2 observer (See Table 11 and Section 3.3.3 of the Analysis for more information), and reduce the pressure for freezer longline vessels to voluntarily carry second observers for the purpose of providing opportunities for observers to gain sampling experience to count toward a nontrawl LL2 deployment endorsement. An observer with sampling experience on a trawl catcher/processor or mothership would be familiar with the pressures of data collection on vessels participating in a catch share program and would also be familiar with the use of a flow scale to weigh catch. These skills are important to successfully performing data collection duties when deployed as a nontrawl LL2 observer. Because these observers may not have nontrawl sampling experience, additional training and a pre-cruise meeting may be necessary to ensure that these observers are adequately prepared to handle the safety and sampling challenges that are unique to nontrawl LL2 deployments (See Section 4.3.2.2 of the Analysis).

    This proposed rule would implement regulations to authorize the Observer Program to require additional training for observers as necessary to adequately prepare them to perform data collection duties relevant to the nontrawl LL2 deployment endorsement. The Observer Program would develop and implement an observer training and also determine when this training would be required prior to receiving a nontrawl LL2 deployment endorsement. Potentially, NMFS would require observers without sampling experience on a nontrawl catcher/processor to attend a two or three day training class prior to receiving a nontrawl LL2 deployment endorsement for the first time.

    The Observer Program would use this training class to adequately prepare observers with different types of qualifying sampling experience to complete sampling duties when deployed as a nontrawl LL2 observer (See section 4.3.2 of the Analysis for additional detail). The nontrawl LL2 training class would be designed to address common safety and sampling challenges that are unique to nontrawl LL2 observer deployments. This training would prepare observers who do not have sampling experience on nontrawl catcher/processors for deployment on these vessels as a nontrawl LL2 observer. At a minimum, through existing trainings and briefings, the Observer Program would continue to train observers to follow the safety and data collection protocols established in the Observer Sampling Manual.

    The second element of this proposed rule would require the operator or manager of a vessel that carries nontrawl LL2 observers to participate in a pre-cruise meeting with the observer assigned to the vessel if notified to do so by NMFS. This proposed rule would add a paragraph at §§ 679.32(c)(3)(i)(E) and 679.100(b)(1) and (2) to require freezer longline vessels and pot catcher/processors when groundfish CDQ fishing to notify the Observer Program prior to embarking on a trip with a nontrawl LL2 observer who has not deployed on that vessel in the past 12 months. The Observer Program may contact the vessel and require the vessel operator or manager and the observer assigned to the vessel to participate in a pre-cruise meeting prior to embarking on a trip.

    This regulatory change would authorize the Observer Program to require a pre-cruise meeting as needed to address safety or sampling challenges on a specific vessel. Because vessel operations and individual observer's sampling history will vary, this would give the Observer Program the flexibility necessary to evaluate whether a pre-cruise meeting is necessary on a case-by-case basis between the observer and the vessel operator or manager to ensure the nontrawl LL2 observer is adequately prepared to collect high quality data in a safe manner. The Observer Program may consider the observer's deployment history or sampling experience, vessel specific information, or other relevant information to determine whether a pre-cruise meeting is necessary, and if so, the Observer Program would contact the vessels to arrange the pre-cruise meeting prior to the start of a trip (See section 4.3 of the Analysis for additional detail). This action would impose additional administrative costs for NMFS to process pre-cruise notifications, contact a vessel if a pre-cruise meeting is necessary, and participate in pre-cruise meetings if staff are available. Section 2.3.1 of the Analysis describes that these administrative costs are minimal relative to other alternatives considered.

    In addition to the two elements recommended by the Council, NMFS proposes the third element of this proposed rule to remove duplicative and unnecessary regulatory reporting requirements and make minor changes to observer coverage requirements for specific vessels participating in the CDQ Program. These proposed revisions are intended to (1) align regulations with Magnuson-Stevens Act section 305(i)(1)(B)(iv), (2) reduce observer coverage costs, (3) improve operational efficiency, and (4) reduce the reporting burden for catcher/processors and motherships when participating in CDQ fisheries (See Section 2.4 in the Analysis).

    This proposed rule would define the terms “cruise” and “Observer Program” in § 679.2. The term “cruise” is used to describe the minimum experience requirements for an observer to obtain LL2 deployment endorsements in § 679.53. This proposed rule would define a “cruise” to mean an observer deployment with a unique cruise number. This proposed definition would clarify that a cruise begins when an observer receives an endorsement to deploy and ends when the observer completes all debriefing responsibilities. The term “Observer Program” would replace and update the definition of “Observer Program Office,” because that term does not describe the Observer Program. This proposed rule would update corresponding references throughout part 679.

    This proposed rule would remove provisions at § 679.32(c)(3)(i) that require operators of catcher/processors and motherships to provide observers with prior notification of CDQ catch and CDQ group number associated with the CDQ catch before the CDQ catch is brought on board the vessel. This provision would be removed for all catcher/processors and motherships when participating in the pollock CDQ or groundfish CDQ fisheries. These notification requirements were implemented in 1998 (63 FR 30381; June 4, 1998) when observer sampling methods for CDQ hauls and sets were different than observer sampling methods for non-CDQ hauls and sets. At that time, an observer needed to know if a haul would be designated as a CDQ haul before it was brought on board the vessel so that they could apply the appropriate sampling methods. With implementation of other catch share programs since 1998 and overlap of vessel participation between CDQ and other catch share programs, observer sampling methods have been made consistent between CDQ and non-CDQ hauls and sets. Therefore, these prior notification requirements are unnecessary and duplicative. An observer does not need prior notice of CDQ haul designation to appropriately sample CDQ catch, and other regulations ensure that an observer has access to this information.

    This proposed rule would modify the heading for subpart E to part 679 from “Groundfish and Halibut Observer Program” to “North Pacific Observer Program” in order to be consistent with the term as used in the new definition of the Observer Program.

    This proposed rule also would modify § 679.50(a)(2) to clarify that a catcher vessel is not subject to the requirements of subpart E when delivering unsorted codends to a mothership. The existing wording is more restrictive than intended, and this proposed rule would clarify that a catcher vessel which, for some of its fishing activity, delivers unsorted codends to a mothership, would not be subject to the requirements of subpart E only during the fishing activity that results in delivering unsorted codends to a mothership.

    This proposed rule would modify § 679.51(a)(2)(vi)(A)(5) to update the observer coverage requirement for motherships that receive unsorted codends from catcher vessels groundfish CDQ fishing. This coverage requirement would be modified to no longer require that both observers deployed have a level 2 deployment endorsement. A mothership that receives unsorted codends from catcher vessels groundfish CDQ fishing would be required to carry two observers, one of which must have a LL2 deployment endorsement for a catcher/processor using trawl gear or a mothership. This would make observer coverage requirements for motherships participating in the groundfish CDQ fishery consistent with observer coverage requirements for catcher/processors participating in the Amendment 80 Program.

    This proposed rule would update the phone number that is currently provided in §§ 679.84(c)(7) and 679.93(c)(7) for notifying the Observer Program as required under regulations governing the Rockfish Program and Amendment 80 Program, in order to allow vessel operators or managers to contact the Dutch Harbor or Kodiak field offices directly.

    To improve clarity and consistency, this proposed rule would remove the term “certified” and replace it with the term “endorsed” when used to describe observer deployment endorsements throughout § 679.51. This proposed rule would also remove the provision at § 679.53(a)(5)(v)(B) that describes sampling experience requirements for an observer to obtain an LL2 deployment endorsement for a catcher vessel using trawl gear. This LL2 deployment endorsement is not required for any vessels that operate in the commercial groundfish or halibut fisheries, which makes this regulation unnecessary.

    Classification

    Pursuant to sections 304(b)(1)(A) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMPs, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration of comments received during the public comment period.

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

    Regulatory Impact Review (RIR or Analysis)

    An RIR was prepared to assess the costs and benefits of available regulatory alternatives. A copy of this Analysis is available from NMFS (see ADDRESSES). The Council and NMFS recommend this action based on those measures that maximize net benefits to the Nation. Specific aspects of the economic analysis related to the impact of the proposed rule on small entities are discussed below in the Initial Regulatory Flexibility Analysis section.

    Initial Regulatory Flexibility Analysis

    This Initial Regulatory Flexibility Analysis (IRFA) was prepared for this proposed rule, as required by section 603 of the Regulatory Flexibility Act (RFA), to describe the economic impact this proposed rule, if adopted, would have on small entities. An IRFA describes why this action is being proposed; the objectives and legal basis for the proposed rule; the number of small entities to which the proposed rule would apply; any projected reporting, recordkeeping, or other compliance requirements of the proposed rule; any overlapping, duplicative, or conflicting Federal rules; and any significant alternatives to the proposed rule that would accomplish the stated objectives, consistent with applicable statutes, and that would minimize any significant adverse economic impacts of the proposed rule on small entities. Descriptions of this proposed rule, its purpose, and the legal basis are contained earlier in this preamble and are not repeated here.

    Number and Description of Small Entities Regulated by This Proposed Rule

    This proposed rule would directly regulate observers and owners and operators of the following vessels: (1) Freezer longline vessels that participate in the BSAI hook-and-line Pacific cod fishery; and (2) pot catcher/processors, trawl catcher/processors, nontrawl catcher/processors, and motherships when groundfish CDQ fishing. Observer providers are impacted by the limited availability of nontrawl LL2 observers, but the proposed rule would not modify regulations that directly apply to observer provider firms. Observers are individuals and not entities, so they do not meet the Small Business Administration (SBA) definition of a small entity. Therefore, neither observer providers nor observers are considered directly regulated entities in this IRFA.

    This proposed rule would directly regulate the activities of 29 BSAI freezer longline vessels, two pot catcher/processors, and 22 trawl catcher/processors and motherships. Two questions must be considered in classifying catcher/processors under the RFA. First, are the individual vessels independently owned and operated and not dominant in their field of operation, or are these vessels affiliated under the RFA? Second, which industry classification is appropriate to use for vessels that conduct both fish harvesting and fish processing?

    Freezer longline vessels directly regulated by this action are all members of the Freezer Longline Conservation Cooperative (FLCC), a voluntary fishing cooperative operating through a contract among all parties, whose members have a de facto catch share program because they effectively control fishing for the freezer longline vessel subsector's allocation of Pacific cod in the BSAI. NMFS has determined that vessels that are members of a fishing cooperative, including members of the FLCC, are affiliated when classifying them for the RFA analyses. In making this determination, NMFS considered SBA's “principles of affiliation” at 13 CFR 121.103. Specifically, in § 121.103(f), SBA refers to “[A]ffiliation based on identity of interest,” which states “[A]ffiliation may arise among two or more persons with an identity of interest. Individuals or firms that have identical or substantially identical business or economic interests (such as family members, individuals or firms with common investments, or firms that are economically dependent through contractual or other relationships) may be treated as one party with such interests aggregated.” If business entities are affiliated, then the threshold for identifying small entities is applied to the group of affiliated entities rather than on an individual entity basis.

    In addition, distinct from their affiliation through the FLCC, vessels regulated by this proposed rule also may be affiliated through ownership. NMFS has reviewed cooperative membership and available ownership data to assess ownership and affiliations among vessels. Based on this information, NMFS estimates that the 29 active FLCC vessels and two pot catcher/processors affected by this action are owned and operated by no more than 11 separate entities. Of these 11 entities, 6 entities own 26 freezer longline vessels and one pot catcher/processor vessel.

    The thresholds applied to determine if an entity or group of entities are “small” under the RFA depend on the industry classification for the entity or entities. Businesses classified as primarily engaged in commercial fishing are considered small entities if they have combined annual gross receipts not in excess of $11.0 million for all affiliated operations worldwide (81 FR 4469; January 26, 2016). Businesses classified as primarily engaged in fish processing are considered small entities if they employ 750 or fewer persons on a full-time, part-time, temporary, or other basis, at all affiliated operations worldwide. Since at least 1993, NMFS Alaska Region has considered catcher/processors to be predominantly engaged in fish harvesting rather than fish processing. Under this classification, the threshold of $11.0 million in annual gross receipts is appropriate.

    By applying the $11.0 million annual gross receipts threshold collectively to the vessels affiliated through the FLCC, all of the members of the FLCC are considered large entities under the RFA. The two pot catcher/processors are affiliated with additional vessels that, when interests are aggregated, exceed the $11.0 million threshold and are considered large entities under the RFA. NMFS considered vessel affiliation independent of the FLCC contracts and concluded that if not for FLCC affiliation, five vessels owned by four entities would be considered small entities under the SBA. Additional detail about data sources used to prepare this IRFA and the analysis of vessel affiliation independent of FLCC contract are available in Section 4.6 of the RIR prepared for this proposed rule (see ADDRESSES).

    The proposed regulatory change to modify observer coverage requirements for motherships receiving unsorted codends from catcher vessels groundfish CDQ fishing and to remove prior notification of CDQ catch and CDQ number would affect 19 nontrawl catcher/processors and 22 trawl catcher/processors, 4 of which also act as a mothership to receive unsorted codends from catcher vessels groundfish CDQ fishing. As described above, the 19 nontrawl catcher/processors are considered large entities under the RFA. All of the trawl catcher/processors and motherships affected by this proposed rule are affiliated as members of either an American Fisheries Act or an Amendment 80 cooperative with a combined average annual gross revenue above the $11.0 million threshold, classifying them as large entities under the RFA.

    Based on this analysis, NMFS preliminarily determines that there are no small entities that would be affected by this proposed rule. However, due to the complexity of the affiliation among the entities and the overlay of affiliation due to ownership and affiliation based on the contractual relationship among members of cooperatives, NMFS has prepared this IRFA. This provides potentially affected entities an opportunity to provide comments on this IRFA. NMFS will evaluate any comments received on the IRFA and may consider certifying that this action will not have a significant economic impact on a substantial number of small entities prior to publication of the final rule.

    To the degree that this proposed rule would increase the pool of available nontrawl LL2 observers, the primary economic impact of this proposed rule would be to reduce costs to vessel owners. Costs would be reduced by the amount vessel owners would otherwise pay to deploy second observers on some freezer longline vessels to allow those observers to gain sampling experience to count toward a nontrawl LL2 deployment endorsement. In addition, an increase in the number of available nontrawl LL2 observers would reduce the potential costs associated with a shortage of nontrawl LL2 observers. This proposed rule would add new costs for freezer longline vessels and pot catcher/processors to comply with pre-cruise meeting requirements. NMFS estimates the cost savings associated with the increase in the pool of qualified nontrawl LL2 observers is expected to exceed the relatively small costs that would be associated with the pre-cruise meeting requirements.

    The proposed regulatory change to modify observer coverage requirements for motherships receiving unsorted codends from catcher vessels groundfish CDQ fishing could reduce costs by allowing less experienced observers to deploy, and would increase operational flexibility for vessels that operate in the CDQ and non-CDQ fisheries. The proposed regulatory change to remove the prior notification of CDQ catch and CDQ number would reduce costs to the owners of catcher/processors when pollock CDQ fishing, catcher/processors and motherships when groundfish CDQ fishing, and catcher/processors using nontrawl gear when groundfish CDQ fishing. All vessels affected by this action would benefit by reducing recordkeeping and reporting requirements with no negative impacts on affected entities.

    Recordkeeping, Reporting, and Other Compliance Requirements

    This proposed rule adds additional reporting, recordkeeping, and other compliance requirements for freezer longline vessels and pot catcher/processors that are required to carry a nontrawl LL2 observer. Vessel operators would be responsible to ensure that the Observer Program is notified by phone 24 hours prior to departure when a vessel will be carrying a nontrawl LL2 observer that has not previously been deployed on that vessel in the last 12 months. Vessel operators contract directly with permitted observer providers to procure observer coverage. The Observer Program could be notified by anyone with knowledge of the upcoming observer assignment, including the vessel operator, a crew member, or the observer provider. The person notifying the Observer Program would need knowledge of the vessel's prior observer assignment history and the upcoming observer assignment 24 hours in advance of a trip.

    No small entity is subject to reporting requirements that are in addition to or different from the requirements that apply to all directly regulated entities. No unique professional skills are needed for the vessel operators to comply with any of the reporting and recordkeeping requirements associated with this proposed rule.

    Duplicate, Overlapping, or Conflicting Federal Rules

    No duplication, overlap, or conflict between this proposed rule and existing Federal rules has been identified.

    Description of Significant Alternatives That Minimize Adverse Impacts on Small Entities

    No significant alternatives were identified that would accomplish the stated objectives for placing observers on fishing vessels, are consistent with applicable statutes, and that would reduce costs to potentially affected small entities more than the proposed rule. The Council and NMFS considered three alternatives. Alternative 1, the no action alternative, would not reduce the potential for a shortage of nontrawl LL2 observers and would continue to impose additional costs on the industry. Alternative 2 would create a process to allow a vessel to go fishing without a nontrawl LL2 observer if there were no nontrawl LL2 observers available. Alternative 3 included two options. Option 1 would allow a vessel required to carry one LL2 observer to choose between carrying two level 2 observers or one LL2 observer. Option 2 would modify the training and experience requirements necessary for an observer to obtain the nontrawl LL2 deployment endorsement.

    The preferred alternative, Alternative 3 Option 2 was designed to minimize the impacts to small entities from the status quo requirement by increasing the pool of qualified observers and reducing the need for vessels to voluntarily carry second observers for the purpose of gaining the necessary experience to obtain a nontrawl LL2 deployment endorsement. Alternative 3 Option 2 includes additional observer training and a pre-cruise meeting as necessary to ensure that observers are adequately prepared to fulfill the data collection responsibilities.

    Relative to Alternative 1, the preferred alternative would increase the recordkeeping burdens on small entities by requiring the Observer Program be notified prior to a vessel embarking on a trip with an observer who has not previously deployed on that vessel in the past 12 months, and by requiring, if necessary, the vessel operator or manager to participate in a pre-cruise meeting with the observer, which could delay fishing activity by the amount of time necessary to complete a pre-cruise meeting.

    Collection-of-Information Requirements

    This proposed rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). These requirements have been submitted to OMB for approval under OMB control number 0648-0318 (North Pacific Observer Program). The public reporting burden for the collection-of-information requirements in this proposed rule includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    This proposed rule would require that the Observer Program be notified by phone at least 24 hours prior to departure when a vessel will carry an observer who had not deployed on that vessel in the past 12 months. Public reporting burden per response to notify the Observer Program by phone is estimated to be five minutes.

    Public comment is sought regarding (1) whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (2) the accuracy of the burden estimate; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to NMFS Alaska Region at the ADDRESSES above, and to OIRA by email to [email protected] or by fax to (202) 395-5806.

    Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to 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. All currently approved NOAA collections of information may be viewed at http://www.cio.noaa.gov/services_programs/prasubs.html.

    List of Subjects in 50 CFR Part 679

    Alaska, Fisheries, Recordkeeping and reporting requirements.

    Dated: December 21, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 679 is proposed to be amended as follows:

    PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 1. The authority citation for 50 CFR part 679 continues to read as follows: Authority:

    16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447; Pub. L. 111-281.

    2. In § 679.2, a. Remove the definition for “Observer Program Office”; and b. Add the definitions for “Cruise” and “Observer Program” in alphabetical order to read as follows:
    § 679.2 Definitions.

    Cruise means an observer deployment with a unique cruise number. A cruise begins when an observer receives an endorsement to deploy and ends when the observer completes all debriefing responsibilities.

    Observer Program means the administrative office of the North Pacific Observer Program located at the Alaska Fisheries Science Center (See § 679.51(c)(3) for contact information).

    3. In § 679.32, a. Remove and reserve paragraphs (c)(3)(i)(B)(2), (c)(3)(i)(C)(2), and (c)(3)(i)(E)(2); and b. Add paragraph (c)(3)(i)(E)(4) to read as follows:
    § 679.32 Groundfish and halibut CDQ catch monitoring.

    (c) * * *

    (3) * * *

    (i) * * *

    (E) * * *

    (4) Notify the Observer Program by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.

    4. In part 679, revise subpart E heading to read as follows: Subpart E—North Pacific Observer Program 5. In § 679.50, revise paragraph (a)(2) to read as follows:
    § 679.50 Applicability.

    (a) * * *

    (2) Exceptions. A catcher vessel is not subject to the requirements of this subpart when delivering unsorted codends to a mothership.

    6. In § 679.51, revise paragraph (a)(2)(vi)(A)(5) to read as follows:
    § 679.51 Observer and Electronic Monitoring System requirements for vessels and plants.

    (a) * * *

    (2) * * *

    (vi) * * *

    (A) * * *

    (5) Motherships. A mothership that receives unsorted codends from catcher vessels groundfish CDQ fishing must have at least two observers aboard the mothership, at least one of whom must be endorsed as a lead level 2 observer. More than two observers must be aboard if the observer workload restriction would otherwise preclude sampling as required.

    7. In § 679.53, a. Remove and reserve paragraph (a)(5)(v)(B); and b. Revise paragraph (a)(5)(v)(C) to read as follows:
    § 679.53 Observer certification and responsibilities.

    (a) * * *

    (5) * * *

    (v) * * *

    (C) A lead level 2 observer on a vessel using nontrawl gear must have completed the following:

    (1) Two observer cruises (contracts) of at least 10 days each; and

    (2) Successfully completed training or briefing as prescribed by the Observer Program; and

    (3) Sampled at least 30 sets on a vessel using nontrawl gear; or

    (4) Sampled 100 hauls on a catcher/processor using trawl gear or on a mothership.

    8. In § 679.84, revise paragraph (c)(7) to read as follows:
    § 679.84 Rockfish Program Recordkeeping, permits, monitoring, and catch accounting.

    (c) * * *

    (7) Pre-cruise meeting. The Observer Program is notified by phone at 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.

    9. In § 679.93, revise paragraph (c)(7) to read as follows:
    § 679.93 Amendment 80 Program recordkeeping, permits, monitoring, and catch accounting.

    (c) * * *

    (7) Pre-cruise meeting. The Observer Program is notified by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.

    10. In § 679.100, add paragraphs (b)(1)(v) and (b)(2)(i)(E) to read as follows:
    § 679.100 Applicability.

    (b) * * *

    (1) * * *

    (v) The Observer Program is notified by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.

    (2) * * *

    (i) * * *

    (E) The Observer Program is notified by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.

    11. In the table below, for each section indicated in the “Location” column, remove the phrase indicated in the “Remove” column and replace it with the phrase indicated in the “Add” column from wherever it appears in the “Frequency” column. Location Remove Add Frequency § 679.51(a)(2)(vi)(B)(1), (a)(2)(vi)(B)(3),(a)(2)(vi)(B)(4), (a)(2)(vi)(C), (a)(2)(vi)(D)(1), (a)(2)(vi)(D)(2), and (a)(2)(vi)(E)(1) certified endorsed 1 § 679.51(c)(3), (a)(2), (b)(1)(iii)(A), (b)(2)(iv), (b)(3)(ii)(B), and (b)(8) introductory text Observer Program Office Observer Program 1 § 679.52(b)(11) introductory text Observer Program Office Observer Program 2 § 679.52(b)(11)(i) introductory text, (b)(11)(ii), (b)(11)(iii), and (b)(11)(vi) introductory text Observer Program Office Observer Program 1 § 679.52(b)(11)(vii) introductory text Observer Program Office Observer Program 3 § 679.52(b)(11)(viii) introductory text, (b)(11)(viii)(A), (b)(11)(ix), (b)(11)(x) introductory text, and (b)(12) Observer Program Office Observer Program 1 § 679.53(a)(1) Observer Program Office Observer Program 1 § 679.53(a)(5)(v) introductory text, and (a)(5)(v)(A) “lead” lead 1 § 679.53(b)(2)(i) Observer Program Office Observer Program 1
    [FR Doc. 2017-27935 Filed 12-26-17; 8:45 am] BILLING CODE 3510-22-P
    82 247 Wednesday, December 27, 2017 Notices COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Montana Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Montana Advisory Committee (Committee) to the Commission will be held at 11:00 a.m. (Mountain Time) Friday, January 5, 2018. The purpose of the meeting is for the Committee to discuss preparations to hear testimony on border town discrimination.

    DATES:

    The meeting will be held on, Friday, January 5, 2018 at 11:00 a.m. MT.

    Public Call Information

    Dial: 877-856-1956.

    Conference ID: 5797044.

    FOR FURTHER INFORMATION CONTACT:

    Angelica Trevino at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 877-856-1956, conference ID number: 5797044. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Angelica Trevino at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=259.

    Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome and Rollcall II. Approval of minutes from December 14, 2017 meeting III. Discussion of panelists and logistics for hearing testimony on border town discrimination IV. Public Comment V. Adjournment

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of the committee needing to plan a briefing on border town discrimination.

    Dated: December 21, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-27941 Filed 12-26-17; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meetings of the South Dakota Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meetings.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that planning meetings of the South Dakota Advisory Committee to the Commission will convene at 2:00 p.m. (CST) on Wednesday, January 10, 2018 and Wednesday, January 24, 2018, via teleconference. The purpose of the meeting on Jan 10 is review an advisory memorandum culminating from the subtle racism briefing in March 2017. The purpose of the meeting on January 24 is to vote on aforementioned advisory memorandum.

    DATES:

    Wednesday, January 10, 2018, at 3:00 p.m. (CST) and Wednesday, January 24, 2018, at 3:00 p.m. (CST).

    ADDRESSES:

    To be held via teleconference:

    Conference Call Toll-Free Number for both meetings: 1-888-267-6301, Conference ID: 8658344.

    TDD: Dial Federal Relay Service 1-800-877-8339 and give the operator the above conference call number and conference ID.

    FOR FURTHER INFORMATION CONTACT:

    David Mussatt, DFO, [email protected], 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-267-6301; Conference ID: 8658344. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-877-8339 and provide the FRS operator with Conference Call Toll-Free Number: 1-888-267-6301; Conference ID: 8658344. Members of the public are invited to submit written comments; the comments must be received in the regional office by Friday, February 24, 2018. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=274 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

    Jan 10, 2018 Agenda • Welcome and Roll-call • Review Advisory Memorandum on Subtle Racism in South Dakota • Public Comment • Adjourn Jan 24, 2018 Agenda • Welcome and Roll-call • Vote on Advisory Memorandum on Subtle Racism in South Dakota • Public Comment • Adjourn Dated: December 21, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-27940 Filed 12-26-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-105-2017] Approval of Subzone Status; R.W. Smith & Co/TriMark USA, LLC; Lewisville, Texas

    On July 11, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Metroplex International Trade Development Corporation, grantee of FTZ 168, requesting subzone status subject to the existing activation limit of FTZ 168, on behalf of R.W. Smith & Co/TriMark USA, LLC, in Lewisville, Texas.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (82 FR 32530, July 14, 2017). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval. Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 168C was approved on August 25, 2017, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 168's 1,909-acre activation limit.

    Dated: December 20, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-27883 Filed 12-26-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-164-2017] Approval of Subzone Status; North American Hoganas Company Johnstown, Hollsopple and St. Mary's, Pennsylvania

    On October 19, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Pennsylvania Foreign Trade Zone Corporation, grantee of FTZ 295, requesting subzone status subject to the existing activation limit of FTZ 295, on behalf of North American Hoganas Company, in Johnstown, Hollsopple and St, Mary's, Pennsylvania.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (82 FR 49586-49587, October 26, 2017). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval. Pursuant to the authority delegated to the FTZ Board Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 295B was approved on December 19, 2017, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 295's 2,000-acre activation limit.

    Dated: December 20, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-27881 Filed 12-26-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-56-2017] Foreign-Trade Zone (FTZ) 122—Corpus Christi, Texas; Authorization of Production Activity, Voestalpine Texas, LLC, Subzone 122T (Hot Briquetted Iron and By-Products) Portland, Texas

    On August 18, 2017, the Port of Corpus Christi Authority, grantee of FTZ 122, submitted a notification of proposed production activity to the FTZ Board on behalf of voestalpine Texas, LLC, within Subzone 122T, in Portland, Texas.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (82 FR 42647-42648, September 11, 2017). On December 18, 2017, the applicant was notified of the FTZ Board's decision that no further review of the activity is warranted at this time. The production activity described in the notification was authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14.

    Dated: December 21, 2017. Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2017-27882 Filed 12-26-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-122-860] 100- to 150-Seat Large Civil Aircraft From Canada: Final Affirmative Countervailing Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of 100- to 150-seat large civil aircraft (aircraft) from Canada. The period of investigation (POI) is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates, see the “Final Determination” section of this notice.

    DATES:

    Applicable December 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Medley or Ross Belliveau, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4987, or (202) 482-4952, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    The petitioner in this investigation is The Boeing Company. In addition to the Governments of Canada, Quebec and the United Kingdom, the mandatory respondent in this investigation is Bombardier Inc. (Bombardier).

    The events that occurred since the Department published the Preliminary Determination1 on October 2, 2017, are discussed in the Issues and Decision Memorandum, which is hereby adopted by this notice.2 The Issues and Decision Memorandum also details the changes we made since the Preliminary Determination to the subsidy rates calculated for the mandatory respondent and all other producers/exporters. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    1See 100- to 150-Seat Large Civil Aircraft from Canada: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination with Final Antidumping Duty Determination, 82 FR 45807 (October 2, 2017) (Preliminary Determination), and accompanying Preliminary Decision Memorandum.

    2See Memorandum from James P. Maeder, Senior Director performing the duties of the Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to P. Lee Smith, Deputy Assistant Secretary for Policy and Negotiations performing the duties of Deputy Assistant Secretary for Enforcement and Compliance, entitled, “Issues and Decision Memorandum for the Final Determination in the Countervailing Duty Investigation of 100- to 15-Seat Large Civil Aircraft from Canada,” dated concurrently with this notice (Issues and Decision Memorandum).

    Scope of the Investigation

    The scope of the investigation is aircraft from Canada. For a complete description of the scope of the investigation, see Appendix I.

    Analysis of Subsidy Programs and Comments Received

    The subsidy programs under investigation and the issues raised in the case and rebuttal briefs by parties in this investigation are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice as Appendix II.

    Verification

    As provided in section 782(i) of the Tariff Act of 1930, as amended (the Act), during September and October 2017, the Department verified the subsidy information reported by the Governments of Canada, Quebec and the United Kingdom, and Bombardier. We used standard verification procedures, including an examination of relevant accounting records and original source documents provided by the respondents.3

    3See Memorandum “Verification of the Questionnaire Responses of Caisse de dépôt et placement du Québec (CDPQ, or Caisse),” dated October 17, 2017; Memorandum “Verification of the Questionnaire Responses of the Government of Canada (GOC),” dated October 23, 2017; Memorandum “Verification of the Questionnaire Responses of Bombardier, Inc. Pertaining to Short Brothers PLC,” dated November 1, 2017; Memorandum “Verification of the Questionnaire Responses of the Government of Québec (GOQ),” dated November 3, 2017; Memorandum “Verification of the Questionnaire Responses of the Government of the United Kingdom,” dated November 3, 2017; and Memorandum “Verification of the Questionnaire Responses of Bombardier, Inc. and the C Series Aircraft Limited Partnership,” dated November 7, 2017.

    Changes Since the Preliminary Determination

    Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to Bombardier's subsidy rate calculations since the Preliminary Determination. As a result of these changes, the Department has also revised the “all-others” rate. For a discussion of these changes, see the Issues and Decision Memorandum and the Final Analysis Memorandum.4

    4See Memorandum “Countervailing Duty Investigation of 100- to 150-Seat Large Civil Aircraft from Canada: Final Determination Calculation Memorandum for Bombardier, Inc. and the C Series Aircraft Limited Partnership,” dated concurrently with this notice (Final Analysis Memorandum).

    Final Determination

    In accordance with section 705(c)(1)(B)(i)(I) of the Act, we calculated a rate for Bombardier (the only individually investigated exporter/producer of subject merchandise). Section 705(c)(5)(A)(i) of the Act states that, for companies not individually investigated, we will determine an “all others” rate equal to the weighted-average countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and de minimis countervailable subsidy rates, and any rates determined entirely under section 776 of the Act. Where the rates for investigated companies are zero or de minimis, or based entirely on facts otherwise available, section 705(c)(5)(A)(ii) of the Act instructs the Department to establish an “all others” rate using “any reasonable method.”

    Because the only individually calculated rate is not zero, de minimis, or based entirely on facts otherwise available, in accordance with 705(c)(5)(A)(i) of the Act, the rate calculated for Bombardier is assigned as the all-others rate. We determine the total estimated net countervailable subsidy rates to be:

    5 The Department found the following companies to be cross-owned with Bombardier: C Series Aircraft Limited Partnership; Short Brothers PLC (Shorts); and BT (Investment) UK Limited. Additionally, the Department found that Bombardier and Short Brothers PLC comprise an international consortium within the meaning of section 701(d) of the Act.

    Company Subsidy rate
  • (percent)
  • Bombardier, Inc. 5 212.39 All-Others 212.39
    Disclosure

    The Department will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

    Continuation of Suspension of Liquidation

    In accordance with section 703(d) of the Act, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of subject merchandise entered, or withdrawn from warehouse, on or after October 2, 2017, the date of publication of the Preliminary Determination.

    International Trade Commission (ITC) Notification

    In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.

    Because the final determination in this proceeding is affirmative, in accordance with section 705(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of aircraft from Canada no later than 45 days after our final determination. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all cash deposits will be refunded. If the ITC determines that such injury does exist, the Department will issue a CVD order directing CBP to assess, upon further instruction by the Department, countervailing duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.

    Notification Regarding Administrative Protective Orders

    In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to the APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.

    Dated: December 18, 2017. P. Lee Smith, Deputy Assistant Secretary for Policy and Negotiations performing the duties of Deputy Assistant Secretary for Enforcement and Compliance. Appendix I Scope of the Investigation

    The merchandise covered by this investigation is aircraft, regardless of seating configuration, that have a standard 100- to 150-seat two-class seating capacity and a minimum 2,900 nautical mile range, as these terms are defined below.

    “Standard 100- to 150-seat two-class seating capacity” refers to the capacity to accommodate 100 to 150 passengers, when eight passenger seats are configured for a 36-inch pitch, and the remaining passenger seats are configured for a 32-inch pitch. “Pitch” is the distance between a point on one seat and the same point on the seat in front of it.

    “Standard 100- to 150-seat two-class seating capacity” does not delineate the number of seats actually in a subject aircraft or the actual seating configuration of a subject aircraft. Thus, the number of seats actually in a subject aircraft may be below 100 or exceed 150.

    A “minimum 2,900 nautical mile range” means:

    (i) Able to transport between 100 and 150 passengers and their luggage on routes equal to or longer than 2,900 nautical miles; or

    (ii) covered by a U.S. Federal Aviation Administration (FAA) type certificate or supplemental type certificate that also covers other aircraft with a minimum 2,900 nautical mile range.

    The scope includes all aircraft covered by the description above, regardless of whether they enter the United States fully or partially assembled, and regardless of whether, at the time of entry into the United States, they are approved for use by the FAA.

    The merchandise covered by this investigation is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 8802.40.0040. The merchandise may alternatively be classifiable under HTSUS subheading 8802.40.0090. Although these HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.

    Appendix II List of Topics Discussed in the Issues and Decision Memorandum Summary Background Case History Period of Investigation Scope of the Investigation I. Scope Comments Subsidies Valuation Information A. Allocation Period B. Attribution of Subsidies C. Denominators D. Creditworthiness E. Equityworthiness F. Loan Benchmarks and Interest Rates Analysis of Programs A. Programs Determined To Be Countervailable B. Programs Determined Not to Provide Countervailable Benefits During the POI C. Programs Determined Not To Be Used During the POI D. Programs Determined To Be Not Countervailable Analysis of Comments Comment 1: Countervailability of the CDPQ Equity Infusion Comment 2: Whether CDPQ Is an Authority Comment 3: Whether the Department Should Accept the Petitioner's Rebuttal Factual Information Regarding the CDPQ Verification Report Comment 4: Equityworthiness of IQ's Investment in CSALP Comment 5: Whether To Revise the Calculation of the IQ Equity Infusion Comment 6: Whether the International Consortia Provision of the Act Applies to This Investigation Comment 7: Creditworthiness of Bombardier, Shorts, and the C Series Program Comment 8: Whether the U.K. Launch Aid Provides a Market Rate of Return Comment 9: Analyzing the U.K. Launch Aid Separately From the GOC and GOQ Launch Aid Comment 10: The Appropriate Denominator for the GOC Launch Aid Comment 11: Capping the Launch Aid Benefit Amounts Comment 12: The Appropriate Benchmark for the U.K., GOC, and GOQ Launch Aid Comment 13: Whether To Adjust the Benefit Streams for the U.K., GOC, and GOQ Launch Aid Comment 14: The Appropriate Benchmark for the Land Provided at Mirabel for LTAR Comment 15: Whether ADM Is an Authority Comment 16: Emploi-Québec Grants: Specificity and Benefit Calculation Comment 17: Whether the GOQ and GOC SR&ED Tax Credits Are Countervailable Comment 18: Bombardier's Federal SR&ED Tax Credit Comment 19: Specificity and Benefits of U.K. Tax Credits Comment 20: Specificity of INI, Resource Efficiency, Innovate UK and ATI Grants Comment 21: Removal of the Nautical Mile Range Criterion Comment 22: Revision of the Seating Capacity Comment 23: Bombardier-Airbus Transaction Conclusion
    [FR Doc. 2017-27875 Filed 12-26-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Advisory Committee on Supply Chain Competitiveness: Notice of Public Meetings AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of open meetings.

    SUMMARY:

    This notice sets forth the schedule and proposed topics of discussion for public meetings of the Advisory Committee on Supply Chain Competitiveness (Committee).

    DATES:

    The meetings will be held on January 17, 2018, from 12:00 p.m. to 3:00 p.m., and January 18, 2018, from 9:00 a.m. to 4:00 p.m., Eastern Standard Time (EST).

    ADDRESSES:

    The meetings on January 17 and 18 will be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Research Library (Room 1894), Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Richard Boll, Office of Supply Chain, Professional & Business Services (OSCPBS), International Trade Administration. (Phone: (202) 482-1135 or Email: [email protected])

    SUPPLEMENTARY INFORMATION:

    Background: The Committee was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App.). It provides advice to the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and provides advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. For more information about the Committee visit: http://trade.gov/td/services/oscpb/supplychain/acscc/.

    Matters To Be Considered: Committee members are expected to continue to discuss the major competitiveness-related topics raised at the previous Committee meetings, including trade and competitiveness; freight movement and policy; trade innovation; regulatory issues; finance and infrastructure; and workforce development. The Committee's subcommittees will report on the status of their work regarding these topics. The agenda may change to accommodate other Committee business. The Office of Supply Chain, Professional & Business Services will post the final detailed agendas on its website, http://trade.gov/td/services/oscpb/supplychain/acscc/, at least one week prior to the meeting.

    The meetings will be open to the public and press on a first-come, first-served basis. Space is limited. The public meetings are physically accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Mr. Richard Boll, at (202) 482-1135 or [email protected] five (5) business days before the meeting.

    Interested parties are invited to submit written comments to the Committee at any time before and after the meeting. Parties wishing to submit written comments for consideration by the Committee in advance of this meeting must send them to the Office of Supply Chain, Professional & Business Services, 1401 Constitution Ave. NW, Room 11014, Washington, DC 20230, or email to [email protected]

    For consideration during the meetings, and to ensure transmission to the Committee prior to the meetings, comments must be received no later than 5:00 p.m. EST on January 10, 2018. Comments received after January 10, 2018, will be distributed to the Committee, but may not be considered at the meetings. The minutes of the meetings will be posted on the Committee website within 60 days of the meeting.

    Dated: December 20, 2017. Maureen Smith, Director, Office of Supply Chain.
    [FR Doc. 2017-27866 Filed 12-26-17; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-122-859] 100- to 150-Seat Large Civil Aircraft From Canada: Final Affirmative Determination of Sales at Less Than Fair Value AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) determines that 100- to 150-seat large civil aircraft (aircraft) from Canada are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2016, through March 31, 2017. The final estimated dumping margins of sales at LTFV are listed below in the section entitled “Final Determination.”

    DATES:

    Applicable December 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Drew Jackson or Lilit Astvatsatrian, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4406 or (202) 482-6412, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On October 13, 2017, the Department published the Preliminary Determination in this LTFV the investigation, as provided by section 733 of the Tariff Act of 1930, as amended (Act), in which the Department found that aircraft from Canada were sold at LTFV.1 A summary of the events that have occurred since the Department published the Preliminary Determination, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum, which is hereby adopted by this notice.2 The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

    1See 100- to 150-Seat Large Civil Aircraft from Canada: Preliminary Affirmative Determination of Sales at Less Than Fair Value, 82 FR 47697 (October 13, 2017) (Preliminary Determination) and accompanying memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of 100- to 150-Seat Large Civil Aircraft from Canada,” dated October 4, 2017 (Preliminary Decision Memorandum).

    2See Memorandum, “Issues and Decision Memorandum for the Final Affirmative Determination in the Less Than Fair Value Investigation of 100- to 150-Seat Large Civil Aircraft from Canada” dated concurrently with this notice (Issues and Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are aircraft from Canada. For a complete description of the scope of the investigation, see Appendix I.

    Scope Comments

    Since issuing the Preliminary Determination, the Department received scope comments from interested parties, including scope comments in case briefs. Although certain parties requested that the Department modify the scope, the Department has not revised the scope of this investigation.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs that were submitted by parties in this investigation are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice at Appendix II.

    As discussed in the Issues and Decision Memorandum, for the final determination the Department continues to base Bombardier Inc's estimated weighted-average dumping margin on facts otherwise available with an adverse inference (AFA), pursuant to sections 776(a)-(b) of the Act.3

    3See Issues and Decision Memorandum.

    All-Others Rate

    As discussed in the Preliminary Determination, the Department based the “All-Others” rate on the dumping margin alleged in the Petition in accordance with section 735(c)(5)(B) of the Act.4

    4See Preliminary Determination.

    Final Determination

    The Department determines that the following estimated weighted-average dumping margins exist:

    Exporter/
  • producer
  • Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Cash deposit
  • rate
  • (adjusted
  • for subsidy
  • offset(s))
  • (percent)
  • Bombardier, Inc 79.82 Not Applicable. All-Others 79.82 Not Applicable.
    Continuation of Suspension of Liquidation

    Pursuant to section 735(c)(1)(B) of the Act, the Department will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of aircraft from Canada, as described in Appendix I of this notice, which were entered, or withdrawn from warehouse, for consumption on or after October 13, 2017, the date of publication of the Preliminary Determination of this investigation in the Federal Register.

    Further, pursuant to section 735(c)(1)(B)(ii) of the Act and 19 CFR 351.210(d), CBP shall require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margin determined in this final determination; (2) if the exporter is not the respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. However, because the Department did not make an affirmative determination for countervailable export subsidies in the companion CVD proceeding, the Department has not adjusted the estimated weighted-average dumping margin to offset countervailable export subsidies.

    Disclosure

    Normally, the Department discloses to interested parties the calculations performed in connection with a final determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final determination in the Federal Register, in accordance with 19 C