Federal Register Vol. 81, No.164,

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range57743-58380
FR Document

81_FR_164
Current View
Page and SubjectPDF
81 FR 57743 - National Employer Support of the Guard and Reserve Week, 2016PDF
81 FR 57801 - Safety Zone; Nahant Bay, Marblehead, MAPDF
81 FR 57995 - Southeastern Land, LLC-Acquisition and Operation Exemption-Vaughan Railroad CompanyPDF
81 FR 57910 - Agency Information Collection Activities; Proposed Collection; Comment RequestPDF
81 FR 57994 - Culturally Significant Objects Imported for Exhibition Determinations: “Yves Saint Laurent: The Perfection of Style” ExhibitionPDF
81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Fragonard: Drawing Triumphant-Works from New York Collections” ExhibitionPDF
81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Beckmann in New York” ExhibitionPDF
81 FR 57994 - Culturally Significant Objects Imported for Exhibition Determinations: “Drawings for Paintings in the Age of Rembrandt” ExhibitionPDF
81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Degas: A New Vision” ExhibitionPDF
81 FR 57887 - Regulations and Procedures Technical Advisory Committee; Notice of MeetingPDF
81 FR 57888 - Materials Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 57854 - Protective Regulations for Hawaiian Spinner Dolphins Under the Marine Mammal Protection ActPDF
81 FR 57907 - Issuance of National Pollutant Discharge Elimination System (NPDES) General Permit (GP) for Idaho Drinking Water Treatment FacilitiesPDF
81 FR 57914 - Submission for OMB Review; Nondiscrimination in Federal Financial Assistance Programs, GSA Form 3702PDF
81 FR 57806 - Fisheries of the Exclusive Economic Zone Off Alaska; Atka Mackerel in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 57911 - Information Collection; Alliant2 Greenhouse Gas DisclosurePDF
81 FR 57846 - Significant New Use Rule on Certain Chemical SubstancesPDF
81 FR 57807 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 57891 - Defense Advisory Committee on Women in the Services; Notice of Federal Advisory Committee MeetingPDF
81 FR 57902 - Public Meeting; Data That Support the Registration of Plant-Incorporated Protectants (PIPs)PDF
81 FR 57903 - Certain New Chemicals; Receipt and Status Information for July 2016PDF
81 FR 57761 - IFR Altitudes; Miscellaneous AmendmentsPDF
81 FR 57998 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NISSI; Invitation for Public CommentsPDF
81 FR 57890 - Agency Information Collection Activities Under OMB ReviewPDF
81 FR 57901 - Combined Notice of FilingsPDF
81 FR 57896 - Combined Notice of FilingsPDF
81 FR 57897 - Combined Notice of FilingsPDF
81 FR 57901 - Pacific Gas & Electric Company; Notice of Intent To File License Application, Filing of Pre-Application Document, Approving Use of the Traditional Licensing ProcessPDF
81 FR 57896 - Boyce Hydro Power, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 57899 - Duke Energy Carolinas, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 57902 - EnLink Crude Pipeline, LLC; Notice of Petition for Declaratory OrderPDF
81 FR 57896 - Combined Notice of Filings #1PDF
81 FR 57898 - Notice of Commission Staff AttendancePDF
81 FR 57900 - Huskilson, Christopher G.; Blunden, Gregory W.; Notice of FilingPDF
81 FR 57899 - California Independent System, Operator Corporation; Supplemental Notice of Agenda and Discussion Topics for Staff Technical ConferencePDF
81 FR 57900 - National Fuel Gas Supply Corporation; Notice of Request Under Blanket AuthorizationPDF
81 FR 57898 - Combined Notice of Filings #1PDF
81 FR 57936 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
81 FR 57810 - Special Conditions: Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 Airplanes, Lithium BatteriesPDF
81 FR 57942 - Pacific Gas and Electric Company; Diablo Canyon Power Plant, Units 1 and 2; Annual Updates to License Renewal ApplicationPDF
81 FR 57995 - BNSF Railway Company-Discontinuance of Trackage Rights Exemption-in Big Stone, Swift, Chippewa, Yellow Medicine, and Renville Counties, Minn.PDF
81 FR 57942 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on T-H Phenomena; Notice of MeetingPDF
81 FR 57945 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Planning and Procedures; Notice of MeetingPDF
81 FR 57893 - Reopening the Fiscal Year 2016 Competition for Certain Eligible Applicants; Investing in Innovation Fund-Development Grants Full ApplicationPDF
81 FR 57887 - Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 57941 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Reliability and PRA; Notice of MeetingPDF
81 FR 57801 - Drawbridge Operation Regulation; Upper Mississippi River, Rock Island, ILPDF
81 FR 57807 - Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of AlaskaPDF
81 FR 57893 - Agency Information Collection Activities; Comment Request; 2012/17 Beginning Postsecondary Students Longitudinal Study: (BPS:12/17)PDF
81 FR 57937 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claim for Compensation by a Dependent Information ReportsPDF
81 FR 57944 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Digital I&C Systems; Notice of MeetingPDF
81 FR 57945 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Metallurgy & Reactor Fuels; Notice of MeetingPDF
81 FR 57915 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 57985 - Proposed Collection; Comment RequestPDF
81 FR 57946 - Submission for OMB Review; Comment RequestPDF
81 FR 57963 - Proposed Collection; Comment RequestPDF
81 FR 57937 - Meeting of the Federal Advisory Committee on Juvenile JusticePDF
81 FR 57877 - United States Standards for Grades of Carcass BeefPDF
81 FR 57889 - Proposed Information Collection; Comment Request; Green Sturgeon ESA 4(d) Rule Take Exceptions and ExemptionsPDF
81 FR 57888 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to BlueCrest Alaska Operating LLC Drilling Activities at Cosmopolitan State Unit, Alaska, 2016PDF
81 FR 58001 - BMW of North America, LLC, Denial of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 57895 - Agency Information Collection Activities; Comment Request; EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19PDF
81 FR 58003 - Request for Applications; Tribal Issues Advisory GroupPDF
81 FR 57881 - Yavapai Resource Advisory CommitteePDF
81 FR 58004 - Final Priorities for Amendment CyclePDF
81 FR 57908 - Agency Information Collection Activities: Information Collection Revision; Comment Request (3064-0200)PDF
81 FR 57880 - Assessment of Fees for Dairy Import Licenses for the 2017 Tariff-Rate Import Quota YearPDF
81 FR 57940 - Notice of Intent to Prepare a Comprehensive Environmental Evaluation Under the Antarctic Conservation Act of 1978, as amendedPDF
81 FR 57932 - Bulk Manufacturer of Controlled Substances Application: Chattem ChemicalsPDF
81 FR 58002 - Proposed Renewal Without Change; Comment Request; Imposition of Special Measure Against Commercial Bank of Syria, Including Its Subsidiary Syrian Lebanese Commercial Bank, as a Financial Institution of Primary Money Laundering ConcernPDF
81 FR 57927 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 57932 - Importer of Controlled Substances Application: Noramco, Inc.PDF
81 FR 57933 - Importer of Controlled Substances Application: Cerilliant CorporationPDF
81 FR 57935 - Importer of Controlled Substances Application: Akorn, Inc.PDF
81 FR 57936 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.PDF
81 FR 57997 - Buy America Waiver NotificationPDF
81 FR 57996 - Emergency Route Working Group (ERWG)-Federal Advisory CommitteePDF
81 FR 57800 - Drawbridge Operation Regulation; Trent River, New Bern, NCPDF
81 FR 57891 - Notice of Intent To Prepare a Supplemental Environmental Impact Statement (EIS) to the Land Acquisition and Airspace Establishment Final EIS at the Marine Corps Air Ground Combat Center, Twentynine Palms, CaliforniaPDF
81 FR 57996 - Buy America Waiver NotificationPDF
81 FR 57930 - Notice of Public Meeting, Idaho Falls District Resource Advisory Council MeetingPDF
81 FR 57879 - Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg ProductsPDF
81 FR 57999 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel KIA ORA; Invitation for Public CommentsPDF
81 FR 58000 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel OCEANFLYER; Invitation for Public CommentsPDF
81 FR 57998 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel JULIA; Invitation for Public CommentsPDF
81 FR 57999 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ANGARI; Invitation for Public CommentsPDF
81 FR 57919 - Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; AvailabilityPDF
81 FR 57908 - Petition of APL Co. PTE Ltd; for An Exemption From Commission Regulations; Notice of Filing and Request for CommentsPDF
81 FR 58005 - Privacy Act of 1974; System of RecordsPDF
81 FR 57916 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 57977 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options FacilityPDF
81 FR 57948 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Rule Change as Modified by Amendment Nos. 1 and 2 To Adopt FINRA Capital Acquisition Broker RulesPDF
81 FR 57968 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend Nasdaq Rule 5735 To Adopt Generic Listing Standards for Managed Fund SharesPDF
81 FR 57986 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE Arca Equities Rules 7.35P, 7.34P, 7.18P and 7.31P Regarding Order Processing Following an Auction or When Transitioning From One Trading Session to AnotherPDF
81 FR 57981 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares of the AdvisorShares KIM Korea Equity ETFPDF
81 FR 57967 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the JPMorgan Global Bond Opportunities ETFPDF
81 FR 57984 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rules 803 and 1308PDF
81 FR 57960 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Consisting of Proposed Amendments to Rule G-12, on Uniform Practice, Regarding Close-Out Procedures for Municipal SecuritiesPDF
81 FR 57960 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the JPMorgan Diversified Event Driven ETF Under NYSE Arca Equities Rule 8.600PDF
81 FR 57964 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Use of the Alternative Display Facility for Trade Reporting Purpose OnlyPDF
81 FR 57909 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding CompaniesPDF
81 FR 57909 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 57931 - Certain Inflatable Products With Tensioning Structures and Processes for Making the Same; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on a Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the InvestigationPDF
81 FR 57931 - Certain Nanopores and Products Containing Same Commission Determination Not To Review an Initial Determination Terminating the Investigation Based Upon Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the InvestigationPDF
81 FR 57922 - Advisory Council on Blood Stem Cell Transplantation; Notice of MeetingPDF
81 FR 57992 - Louisiana Disaster Number LA-00066PDF
81 FR 57993 - Louisiana Disaster Number LA-00065PDF
81 FR 57992 - West Virginia Disaster Number WV-00043PDF
81 FR 57992 - LOUISIANA Disaster #LA-00065PDF
81 FR 57912 - Privacy Act of 1974; Notice of an Updated System of Records of RecordsPDF
81 FR 57946 - Revision of Information Collection: Combined Federal Campaign ApplicationsPDF
81 FR 57923 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment RequestPDF
81 FR 57917 - Health Insurance MarketplaceSMPDF
81 FR 57881 - Lyon-Mineral Resource Advisory CommitteePDF
81 FR 57928 - Agency Information Collection Activities: Application To Use the Automated Commercial Environment (ACE)PDF
81 FR 57994 - SJI Board of Directors Meeting, NoticePDF
81 FR 57809 - Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage AreasPDF
81 FR 57882 - Opportunity for Designation in Amarillo, TX Area; Request for Comments on the Official Agency Servicing This AreaPDF
81 FR 57816 - Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; AvailabilityPDF
81 FR 57784 - The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing RulesPDF
81 FR 57939 - Notice of Intent To Grant an Exclusive LicensePDF
81 FR 57886 - Notice of Intent To Certify Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin); Request for CommentsPDF
81 FR 57745 - Prevailing Rate Systems; Redefinition of the Asheville, NC, and Charlotte, NC, Appropriated Fund Federal Wage System Wage AreasPDF
81 FR 57884 - Designation for the Cedar Rapids, IA; Fremont, NE; State of Maryland; and West Lafayette, IN AreasPDF
81 FR 57884 - Opportunity for Designation in Cairo, IL Area; Request for Comments on the Official Agency Servicing This Area.PDF
81 FR 57889 - State Alternative Plan Program (SAPP) and the First Responder Network Authority Nationwide Public Safety Broadband NetworkPDF
81 FR 57885 - Opportunity for Designation in North Carolina Area; Request for Comments on the Official Agency Servicing This Area.PDF
81 FR 57882 - Opportunity for Designation in Louisiana Area; Request for Comments on the Official Agency Servicing This AreaPDF
81 FR 57883 - Designation for the Fargo, ND; Urbana, IL; Sandusky, MI; Davenport, IA; Enid, OK; Keokuk, IA; Marshall, MI; and Omaha, NE AreasPDF
81 FR 57894 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of the ESSA Title I, Part D, Neglected or Delinquent ProgramsPDF
81 FR 57927 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 57925 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 57926 - Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of ReportPDF
81 FR 57924 - Agency Information Collection Activities; Proposed Collection; Public Comment RequestPDF
81 FR 57803 - Atlantic Highly Migratory Species (HMS); Porbeagle Shark Management MeasuresPDF
81 FR 57886 - Advisory Committee on Supply Chain Competitiveness: Notice of Public MeetingPDF
81 FR 57925 - Center For Scientific Review; Notice of Closed MeetingsPDF
81 FR 57925 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingPDF
81 FR 57818 - New Animal Drugs for Use in Animal Feed; Category DefinitionsPDF
81 FR 57796 - New Animal Drugs for Use in Animal Feed; Category DefinitionsPDF
81 FR 58003 - Proposed Collection Of Information: CMIA Annual Report and Direct Cost ClaimsPDF
81 FR 57921 - Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; AvailabilityPDF
81 FR 57922 - Agency Information Collection Activities; Proposed Collection; Public Comment RequestPDF
81 FR 57822 - Revisions to the Petition Provisions of the Title V Permitting ProgramPDF
81 FR 57758 - Special Conditions: The Boeing Company, Boeing Model 767-2C Airplane; Non-Rechargeable Lithium Battery InstallationsPDF
81 FR 57745 - Energy Conservation Program: Notice of Partial Grant and Partial Denial of Petitions To Amend the Error Correction RulePDF
81 FR 57929 - Agency Information Collection Activities: Request for Comments on the Assessing Public Views of Waterfowl-Related Topics To Inform the North American Waterfowl Management PlanPDF
81 FR 57812 - Disqualification of a Clinical InvestigatorPDF
81 FR 58341 - Good Laboratory Practice for Nonclinical Laboratory StudiesPDF
81 FR 57851 - Structure and Practices of the Video Relay Service ProgramPDF
81 FR 58269 - Use of Spectrum Bands Above 24 GHz for Mobile Radio ServicesPDF
81 FR 58309 - Amendments Relating to Disclosure of Records and InformationPDF
81 FR 58163 - Energy Conservation Program: Test Procedures for Central Air Conditioners and Heat PumpsPDF
81 FR 58009 - Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan RequirementsPDF
81 FR 57938 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks ClaimedPDF
81 FR 57764 - Federal-State Unemployment Compensation Program; Implementing the Total Unemployment Rate as an Extended Benefits Indicator and Amending for Technical Corrections; Final RulePDF

Issue

81 164 Wednesday, August 24, 2016 Contents Agricultural Marketing Agricultural Marketing Service NOTICES Grade Standards; Petitions: Carcass Beef, 57877-57879 2016-20254 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Food Safety and Inspection Service

See

Foreign Agricultural Service

See

Forest Service

See

Grain Inspection, Packers and Stockyards Administration

Consumer Financial Protection Bureau of Consumer Financial Protection PROPOSED RULES Disclosure of Records and Information, 58310-58340 2016-19594 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57915-57916 2016-20259 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57916-57917 2016-20216 Meetings: Advisory Panel on Outreach and Education, 57917-57919 2016-20187 Coast Guard Coast Guard RULES Drawbridge Operations: Trent River, New Bern, NC; Deviation, 57800 2016-20232 Upper Mississippi River, Rock Island, IL, 57801 2016-20265 Safety Zones: Nahant Bay, Marblehead, MA, 57801-57803 2016-20389 Commerce Commerce Department See

Industry and Security Bureau

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

NOTICES Meetings: Advisory Committee on Supply Chain Competitiveness, 57886-57887 2016-20154
Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57890-57891 2016-20288 Defense Department Defense Department See

Navy Department

NOTICES Meetings: Defense Advisory Committee on Women in the Services, 57891 2016-20306
Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Applications: Akorn, Inc., 57935-57936 2016-20236 Cerilliant Corp., 57933-57935 2016-20237 Noramco, Inc., 57932-57933 2016-20238 Manufacturers of Controlled Substances; Applications: Chattem Chemicals, 57932 2016-20241 Noramco, Inc., 57936 2016-20235 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57893 2016-20263 Agency Information Collection Activities; Proposals, Submissions, and Approvals: EDFacts Data Collection School Years 2016-2017, 2017-2018, 2018-2019, 57895 2016-20249 Evaluation of the Every Student Succeeds Act Neglected or Delinquent Programs, 57894-57895 2016-20163 Applications for New Awards: Investing in Innovation Fund--Development Grants, 57893-57894 2016-20268 Employment and Training Employment and Training Administration RULES Federal-State Unemployment Compensation Program: Implementing the Total Unemployment Rate as an Extended Benefits Indicator and Technical Corrections, 57764-57784 2016-18382 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Programs: Partial Grant and Partial Denial of Petitions to Amend the Error Correction Rule, 57745-57758 2016-19968 PROPOSED RULES Energy Conservation Programs: Test Procedures for Central Air Conditioners and Heat Pumps, 58164-58268 2016-18993
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Fine Particulate Matter National Ambient Air Quality Standards, 58010-58162 2016-18768 PROPOSED RULES Revisions to the Petition Provisions of the Title V Permitting Program, 57822-57846 2016-20029 Significant New Use Rule on Certain Chemical Substances, 57846-57851 2016-20310 NOTICES Certain New Chemicals: Receipt and Status Information for July 2016, 57903-57907 2016-20303 Meetings: Data that Support the Registration of Plant-Incorporated Protectants, 57902-57903 2016-20305 National Pollutant Discharge Elimination System General Permits: Idaho Drinking Water Treatment Facilities, 57907-57908 2016-20322 Federal Aviation Federal Aviation Administration RULES IFR Altitudes; Miscellaneous Amendments, 57761-57764 2016-20292 Special Conditions: The Boeing Company, Boeing Model 767-2C Airplane; Non-Rechargeable Lithium Battery Installations, 57758-57761 2016-19991 PROPOSED RULES Special Conditions: Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, PC-12/47 Airplanes; Lithium Batteries, 57810-57812 2016-20273 Federal Communications Federal Communications Commission PROPOSED RULES Structure and Practices of the Video Relay Service Program, 57851-57854 2016-19845 Use of Spectrum Bands above 24 GHz for Mobile Radio Services, 58270-58308 2016-19793 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57908 2016-20244 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Boyce Hydro Power, LLC, 57896-57897 2016-20283 Duke Energy Carolinas, LLC, 57899 2016-20282 Pacific Gas and Electric Co., 57901-57902 2016-20284 Combined Filings, 57896-57899, 57901 2016-20275 2016-20280 2016-20285 2016-20286 2016-20287 Filings, 57900 2016-20278 Meetings: California Independent System Operator Corp.; Agenda and Discussion Topics for Staff Technical Conference, 57899-57900 2016-20277 Midcontinent Independent System Operator, Inc.; PJM Interconnection, LLC; Joint and Common Market Initiative, 57898 2016-20279 Petitions for Declaratory Orders, 57902 2016-20281 Requests under Blanket Authorizations: National Fuel Gas Supply Corp., 57900-57901 2016-20276 Federal Highway Federal Highway Administration NOTICES Buy American Waivers, 2016-20230 57996-57998 2016-20234 Requests for Nominations: Emergency Route Working Group, 57996-57997 2016-20233 Federal Maritime Federal Maritime Commission NOTICES Petitions for Exemptions: APL CO. PTE LTD, 57908-57909 2016-20220 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 57909 2016-20201 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 57909-57910 2016-20202 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57910-57911 2016-20356 Financial Crimes Financial Crimes Enforcement Network NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Imposition of Special Measure Against Commercial Bank of Syria as a Financial Institution of Primary Money Laundering Concern, 58002-58003 2016-20240 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: CMIA Annual Report and Direct Cost Claims, 58003 2016-20147 Food and Drug Food and Drug Administration RULES Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules, 57784-57796 2016-20176 New Animal Drugs: Use in Animal Feed; Category Definitions, 57796-57800 2016-20148 PROPOSED RULES Disqualification of a Clinical Investigator, 57812-57816 2016-19876 Good Laboratory Practice for Nonclinical Laboratory Studies, 58342-58380 2016-19875 Guidance: Hazard Analysis and Risk-Based Preventive Controls for Human Food, 57816-57818 2016-20177 New Animal Drugs: Use in Animal Feed; Category Definitions, 57818-57822 2016-20149 NOTICES Guidance: Bioequivalence Recommendations for Fidaxomicin, 57921-57922 2016-20146 Patient Preference Information; Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling, 57919-57921 2016-20221 Food Safety Food Safety and Inspection Service NOTICES Guidance: Statements that Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products, 57879-57880 2016-20227 Foreign Agricultural Foreign Agricultural Service NOTICES Fee Assessments: Dairy Import Licenses for the 2017 Tariff-Rate Import Quota Year, 57880-57881 2016-20243 Forest Forest Service NOTICES Meetings: Lyon-Mineral Resource Advisory Committee, 57881-57882 2016-20185 Yavapai Resource Advisory Committee, 57881 2016-20246 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alliant2 Greenhouse Gas Disclosure, 57911-57912 2016-20314 Nondiscrimination in Federal Financial Assistance Programs, 57914 2016-20319 Privacy Act; Systems of Records, 57912-57914 2016-20191 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Assessing Public Views of Waterfowl-Related Topics to Inform the North American Waterfowl Management Plan, 57929-57930 2016-19879 Grain Inspection Grain Inspection, Packers and Stockyards Administration NOTICES Designations and Delegations: Amarillo, TX Area; Opportunity for Designation, 57882-57883 2016-20178 Cairo, IL Area; Opportunity for Designation, 57884-57885 2016-20170 Cedar Rapids, IA; Fremont, NE; State of Maryland; and West Lafayette, IN Areas; Designation, 57884 2016-20171 Fargo, ND; Urbana, IL; Sandusky, MI; Davenport, IA; Enid, OK; Keokuk, IA; Marshall, MI; and Omaha, NE Areas; Designation, 57883-57884 2016-20164 Louisiana Area; Opportunity for Designation, 57882 2016-20166 North Carolina Area; Opportunity for Designation, 57885-57886 2016-20167 Proposed Certifications: Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin), 57886 2016-20173 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57922-57925 2016-20129 2016-20158 2016-20188
Health Resources Health Resources and Services Administration NOTICES Meetings: Advisory Council on Blood Stem Cell Transplantation, 57922 2016-20198 Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Industry Industry and Security Bureau NOTICES Meetings: Materials Technicial Advisory Committee, 57888 2016-20332 Regulations and Procedures Technical Advisory Committee, 57887-57888 2016-20336 Transportation and Related Equipment Technical Advisory Committee, 57887 2016-20267 Interior Interior Department See

Geological Survey

See

Land Management Bureau

International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Inflatable Products with Tensioning Structures and Processes for Making the Same; Termination of Investigation, 57931-57932 2016-20200 Certain Nanopores and Products Containing Same; Termination of Investigation, 57931 2016-20199 Justice Department Justice Department See

Drug Enforcement Administration

See

Justice Programs Office

NOTICES Proposed Consent Decrees under the Clean Air Act, 57936-57937 2016-20274
Justice Programs Justice Programs Office NOTICES Meetings: Federal Advisory Committee on Juvenile Justice, 57937 2016-20255 Labor Department Labor Department See

Employment and Training Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Claim for Compensation by a Dependent Information Reports, 57937-57938 2016-20262 Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed, 57938-57939 2016-18418
Land Land Management Bureau NOTICES Meetings: Idaho Falls District Resource Advisory Council, 57930-57931 2016-20228 Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel ANGARI, 57999-58000 2016-20222 Vessel JULIA, 57998-57999 2016-20223 Vessel KIA ORA, 57999 2016-20226 Vessel NISSI, 57998 2016-20289 Vessel OCEANFLYER, 58000-58001 2016-20224 NASA National Aeronautics and Space Administration NOTICES Exclusive Licenses, 57939-57940 2016-20175 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Decisions of Inconsequential Noncompliance: BMW of North America, LLC, 58001-58002 2016-20250 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 57925-57927 2016-20160 2016-20162 Interagency Coordinating Committee on the Validation of Alternative Methods: Biennial Progress Report; 2014-2015, 57926-57927 2016-20159 Meetings: Center for Scientific Review, 57925 2016-20151 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 57925 2016-20150 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Porbeagle Shark Management Measures, 57803-57806 2016-20157 Fisheries of the Exclusive Economic Zone Off Alaska: Atka Mackerel in the Bering Sea and Aleutian Islands Management Area, 57806 2016-20317 Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska, 57807-57808 2016-20264 Pacific Ocean Perch in the Bering Sea and Aleutian Islands Management Area, 57807 2016-20308 PROPOSED RULES Protective Regulations for Hawaiian Spinner Dolphins under the Marine Mammal Protection Act, 57854-57876 2016-20324 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Green Sturgeon Take; Exceptions and Exemptions, 57889 2016-20252 Takes of Marine Mammals Incidental to Specified Activities: BlueCrest Alaska Operating, LLC Drilling Activities at Cosmopolitan State Unit, AK, 2016; Withdrawal, 57888 2016-20251 National Science National Science Foundation NOTICES Comprehensive Environmental Evaluations: U.S. Antarctic Program Activities, 57940-57941 2016-20242 National Telecommunications National Telecommunications and Information Administration NOTICES State Alternative Plan Program and the First Responder Network Authority Nationwide Public Safety Broadband Network, 57889-57890 2016-20169 Navy Navy Department NOTICES Environmental Impact Statements; Availability, etc.: Land Acquisition and Airspace Establishment Final Environmental Impact Statement at the Marine Corps Air Ground Combat Center, Twentynine Palms, CA; Supplement, 57891-57893 2016-20231 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Renewals; Applications: Pacific Gas and Electric Co.; Diablo Canyon Power Plant, Units 1 and 2, 57942-57944 2016-20272 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Digital I and C Systems, 57944-57945 2016-20261 Advisory Committee on Reactor Safeguards Subcommittee on Metallurgy and Reactor Fuels, 57945 2016-20260 Advisory Committee on Reactor Safeguards Subcommittee on Planning and Procedures, 57945-57946 2016-20269 Advisory Committee on Reactor Safeguards Subcommittee on Reliability and PRA, 57941-57942 2016-20266 Advisory Committee on Reactor Safeguards Subcommittee on T-H Phenomena, 57942 2016-20270 Personnel Personnel Management Office RULES Prevailing Rate Systems: Asheville and Charlotte, NC, Appropriated Fund Federal Wage System Wage Areas, 57745 2016-20172 PROPOSED RULES Prevailing Rate Systems: Kent County, MI; Cameron County, TX: Nonappropriated Fund Federal Wage System Wage Areas, 57809-57810 2016-20179 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Combined Federal Campaign Applications, 57946 2016-20190 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Employer Support of the Guard and Reserve Week (Proc. 9474), 57743-57744 2016-20394 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57946-57948, 57963-57964, 57985-57986 2016-20256 2016-20257 2016-20258 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 57967-57968 2016-20207 BOX Options Exchange, LLC, 57977-57981 2016-20212 Financial Industry Regulatory Authority, Inc., 57948-57960, 57964-57967 2016-20203 2016-20211 Miami International Securities Exchange, LLC, 57984-57985 2016-20206 Municipal Securities Rulemaking Board, 57960-57963 2016-20205 NASDAQ Stock Market, LLC, 57968-57977 2016-20210 NYSE Arca, Inc., 2016-20204 57960, 57981-57983, 57986-57992 2016-20208 2016-20209 Small Business Small Business Administration NOTICES Disaster Declarations: Louisiana, 57992 2016-20192 Louisiana; Amendment 1, 2016-20194 57992-57993 2016-20195 West Virginia; Amendment 5, 57992 2016-20193 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Beckmann in New York, 57993 2016-20351 Degas: A New Vision Exhibition, 57993-57994 2016-20349 Drawings for Paintings in the Age of Rembrandt, 57994 2016-20350 Fragonard: Drawing Triumphant—Works from New York Collections, 57993 2016-20353 Yves Saint Laurent: The Perfection of Style, 57994 2016-20354 State Justice State Justice Institute NOTICES Meetings: Board of Directors, 57994 2016-20181 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 57927-57928 2016-20239 Surface Transportation Surface Transportation Board NOTICES Acquisitions and Operation Exemptions: Southeastern Land, LLC from Vaughan Railroad Co., 57995 2016-20377 Discontinuance of Trackage Rights Exemptions: BNSF Railway Co.; Big Stone, Swift, Chippewa, Yellow Medicine, Renville Counties, MN, 57995 2016-20271 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Maritime Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Financial Crimes Enforcement Network

See

Fiscal Service

Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application to Use Automated Commercial Environment, 57928-57929 2016-20184 U.S. Sentencing United States Sentencing Commission NOTICES Final Priorities for Amendment Cycle, 58004-58005 2016-20245 Requests for Nominations: Tribal Issues Advisory Group, 58003-58004 2016-20247 Veteran Affairs Veterans Affairs Department NOTICES Privacy Act; Systems of Records, 58005-58008 2016-20217 Separate Parts In This Issue Part II Environmental Protection Agency, 58010-58162 2016-18768 Part III Energy Department, 58164-58268 2016-18993 Part IV Federal Communications Commission, 58270-58308 2016-19793 Part V Bureau of Consumer Financial Protection, 58310-58340 2016-19594 Part VI Health and Human Services Department, Food and Drug Administration, 58342-58380 2016-19875 Reader Aids

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

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81 164 Wednesday, August 24, 2016 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 532 RIN 3206-AN37 Prevailing Rate Systems; Redefinition of the Asheville, NC, and Charlotte, NC, Appropriated Fund Federal Wage System Wage Areas AGENCY:

U.S. Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

The U.S. Office of Personnel Management (OPM) is issuing a proposed rule to redefine the geographic boundaries of the Asheville, NC, and Charlotte, NC, appropriated fund Federal Wage System (FWS) wage areas. The final rule will redefine Alexander and Catawba Counties, NC, from the Charlotte wage area to the Asheville wage area. These changes are based on a consensus recommendation of the Federal Prevailing Rate Advisory Committee (FPRAC) to best match the counties proposed for redefinition to a nearby FWS survey area.

DATES:

Effective date: This regulation is effective on August 24, 2016. Applicability date: This change applies on the first day of the first applicable pay period beginning on or after September 23, 2016.

FOR FURTHER INFORMATION CONTACT:

Madeline Gonzalez, by telephone at (202) 606-2858 or by email at [email protected]

SUPPLEMENTARY INFORMATION:

On April 27, 2016, OPM issued a proposed rule (81 FR 24737) to redefine Alexander and Catawba Counties, NC, from the Charlotte, NC, wage area to the Asheville, NC, wage area. FPRAC, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, reviewed and recommended these changes by consensus. There are no FWS employees stationed in Alexander or Catawba Counties.

The proposed rule had a 30-day comment period, during which OPM received no comments.

Regulatory Flexibility Act

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will affect only Federal agencies and employees.

List of Subjects in 5 CFR Part 532

Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.

U.S. Office of Personnel Management. Beth F. Cobert, Acting Director.

Accordingly, OPM amends 5 CFR part 532 as follows:

PART 532—PREVAILING RATE SYSTEMS 1. The authority citation for part 532 continues to read as follows: Authority:

5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.

2. Appendix C to subpart B is amended by revising the wage area listings for the Asheville, NC and Charlotte, NC, wage areas to read as follows: Appendix C to Subpart B of Part 532—Appropriated Fund Wage and Survey Areas NORTH CAROLINA Asheville Survey Area North Carolina: Buncombe Haywood Henderson Madison Transylvania Area of Application. Survey area plus: North Carolina: Alexander Avery Burke Caldwell Catawba Cherokee Clay Graham Jackson McDowell Macon Mitchell Polk Rutherford Swain Yancey *    *    *    *    * Charlotte Survey Area North Carolina: Cabarrus Gaston Mecklenburg Rowan Union Area of Application. Survey area plus: North Carolina: Anson Cleveland Iredell Lincoln Stanly Wilkes South Carolina: Chester Chesterfield Lancaster York
[FR Doc. 2016-20172 Filed 8-23-16; 8:45 am] BILLING CODE 6325-39-P
DEPARTMENT OF ENERGY 10 CFR Parts 430 and 431 RIN 1904-AD63 [Docket Number EERE-2016-BT-PET-0016] Energy Conservation Program: Notice of Partial Grant and Partial Denial of Petitions To Amend the Error Correction Rule AGENCY:

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

ACTION:

Final rule; partial grant and partial denial of petitions.

SUMMARY:

The U.S. Department of Energy (“DOE”) is granting in part and denying in part a series of petitions to amend a recently published rule that established a procedure through which a party can, within a prescribed period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before the rule is published in the Federal Register (“error correction rule”). DOE also provided an opportunity for the public to comment on these petitions. This document responds to both the petitions and related comments that were submitted and received in accordance with the timelines established in a prior Federal Register notice inviting such petitions and comments.

DATES:

This partial grant and partial denial is effective September 23, 2016.

ADDRESSES:

All petitions and comments filed in accordance with the timelines set forth in the prior Federal Register notice have been entered into docket number EERE-2016-BT-PET-0016. The docket is available for review at http://www.regulations.gov. For further information on how to review the docket, contact Mr. John Cymbalsky at (202) 287-1692 or by email: [email protected]ov.

FOR FURTHER INFORMATION CONTACT:

Mr. John Cymbalsky, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-1692 or [email protected]

SUPPLEMENTARY INFORMATION: I. Background

The Department of Energy (“DOE” or the “Department”) recently published a final rule establishing a procedure through which an interested party can, within a 30-day period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before its publication in the Federal Register. See 81 FR 26998 (May 5, 2016). In that same issue of the Federal Register, DOE also invited the public to submit petitions to amend the error correction rule. DOE provided that it would use its best efforts to issue a public document by August 10, 2016, responding to any such petitions submitted by June 6, 2016, and any timely filed comments responding to those petitions. See 81 FR 27054 (May 5, 2016).

DOE received four petitions to amend the rule and several comments responding to those petitions. The submitters of these documents, along with their affiliations, are identified in Table 1.

Table 1—List of Petitioners/Commenters Petitioners (P)/Commenters (C) Organization type Identifier/Acronym Air Conditioning, Heating and Refrigeration Institute (P, C) Heating, Ventilation and Air Conditioning (“HVAC”) Industry Trade Organization AHRI. American Gas Association and American Public Gas Association (C) Energy Industry Trade Organization AGA-AGPA. Appliance Standards Awareness Project, Earth Justice, and Natural Resources Defense Council (P, C) Energy Efficiency Advocates Joint Advocates. Association of Home Appliance Manufacturers (C) Home Appliance Industry Trade Organization AHAM. Hussmann Corporation (P, C) Refrigeration Equipment Manufacturer Hussmann. Lennox International (P, C) HVAC Manufacturer Lennox. Traulsen and Kairak (C) Refrigeration Product and Equipment Manufacturers Traulsen-Kairak. Zero Zone (C) Refrigeration Equipment Manufacturer Zero Zone. Note: AHAM filed both joint comments with AHRI as well as separate comments on its own behalf. II. Summary of and Responses to Comments

At the outset, DOE notes that the petitioners agreed with the fundamental underpinnings supporting the basis for the error correction rule. First, the petitioners—AHRI, Hussmann, the Joint Advocates, and Lennox—all agreed with the stated purpose of the error correction rule—that is, to prevent errors from affecting energy conservation standards applicable to consumer products or commercial equipment. AHRI Petition to Amend, EERE-2016-BT-PET-0016-0005, at 1-2; Hussmann Petition to Amend, EERE-2016-BT-PET-0016-0003, at 1; Joint Advocates Petition to Amend, EERE-2016-BT-PET-0016-0006, at 1; and Lennox Petition to Amend, EERE-2016-BT-PET-0016-0004, at 1. They also generally agreed that errors in need of correction are not common, see Lennox Petition, No. 0004, at 1 and Joint Advocates Petition, No. 0006, at 1, and that the process laid out in the error correction rule should not be used as a means to revisit and re-argue issues that have already been raised and addressed during the rulemaking process. See AHRI Petition, No. 0005, at 1-2 and Lennox Petition, No. 0004, at 1. AHRI and Lennox also acknowledged that applying the error correction process to direct final rules established under 42 U.S.C. 6295(p)(4) was not warranted, assuming that identification of an error would qualify as an “adverse comment” for purposes of 6295(p)(4). See AHRI Petition, No. 0005, at 10-11 and Lennox Petition, No. 0004, at 4.

While the petitioners agreed with the need and rationale for the error correction rule, they also suggested several changes to the rule. These suggestions are discussed in the following sections.

A. Time Within Which To File an Error Correction Request, Statutory Deadlines

The error correction rule requires that a party must submit a request for correction “within 30 calendar days of the posting of the rule.” 10 CFR 430.5(d)(1). The timelines also prescribe a period within which DOE will submit any corrected rule for publication in the Federal Register. See 10 CFR 430.5(d) through (f). Petitioners and commenters responded to each of these issues.

First, with respect to potential modifications to the rule, each of the industry petitioners asked that DOE consider providing a longer period of time than the 30 days prescribed by the rule within which to submit an error correction request. See 81 FR at 27005. The petitioners asserted that because DOE's standards rulemakings are often both complex and lengthy, additional time beyond the prescribed 30 days should be provided to ensure that any errors in the standards final rule are identified to DOE. The suggested timelines from these petitioners ran from 45 days up to 60 days. See Hussmann Petition, No. 0003, at 1; Lennox Petition, No. 0004, at 3; and AHRI Petition, No. 0005, at 8. Among these petitioners, one—AHRI—also suggested that DOE consider extending the time period for submitting error correction requests until the effective date of a rule. According to AHRI, extending the period in this way would “not further delay the effective date of the rule,” although AHRI also stated that its approach is “consistent with the APA power to postpone effective dates.” AHRI Petition, No. 0005, at 8-9. In AHRI's view, such an option would also be consistent with DOE's prior view of the meaning of the term “effective date” and is supported by the fact that a rule is not necessarily effective upon publication in the Federal Register. AHRI Petition, No. 0005, at 8-9. AHRI also asserted that the inadequacy of a 30-day review period is recognized in EPCA by virtue of its inclusion of a 60-day period for parties to challenge a final rule establishing an energy conservation standard in court. Id. at 8.

Second, the Joint Advocates argued in favor of an exception to the error correction rule when following the rule's timing provisions for review would conflict with statutorily mandated rulemaking deadlines. In their view, case law suggests that there are only limited circumstances when federal agencies can extend statutory deadlines, none of which apply in the case of an error correction rule. In the event it is needed to avoid potential timing conflicts with statutory deadlines, the Joint Advocates suggested that DOE publicly post a draft of a standards final rule once it is transmitted to the Office of Management and Budget for pre-posting review, in order to provide more lead-time for parties to check for errors. Joint Advocates Petition, No. 0006, at 1-2.

Others disagreed with the Joint Advocates' suggestion. See Zero Zone, No. 0007, at 1; Lennox, No. 0009, at 2-3; AHRI-AHAM, No. 0012, at 2-5. Zero Zone argued that the Secretary should not be held to an exact time period because it is better to achieve a correct rule through an error correction process than through a court challenge. Zero Zone, No. 0007, at 1. Lennox as well as AHRI and AHAM raised several criticisms of the Joint Advocates' approach. First, they commented that the Joint Advocates' approach would result in prioritizing statutory mandates regarding timing over the statutory mandate providing that DOE may not adopt energy conservation standards unless it finds that the standards are technologically feasible and economically justified. Lennox, AHRI, and AHAM suggest that this statutory conflict should be resolved by prioritizing the correction of errors, particularly because of EPCA's anti-backsliding provision, 42 U.S.C. 6295(o)(1). AHRI and AHAM further stated that this position is supported by case law. See AHRI-AHAM, No. 0012, at 3-4. Second, these commenters asserted that rushing to meet a deadline is a type of situation that could lead to rulemaking errors. Third, they warned that not allowing for the correction of errors in a rule could lead to errors resulting in litigation, which could lead to a delay in implementing new standards and result in less energy savings. Fourth, they argued that DOE would be able to manage the competing needs of satisfying any relevant statutorily mandated lead-times and the reviewing period provisions under the error correction rule. Finally, the commenters stated that allowing deadlines to prevail over the error correction process could create an incentive for DOE to delay rulemaking in order to avoid addressing errors. Lennox, No. 0009, at 2-3; AHRI-AHAM, No. 0012, at 2-5.

After further consideration, DOE is extending the amount of time for the submission of error correction requests by 15 additional days—for a total of 45 days after the posting of a final rule. Providing this additional time will better ensure that any potential errors are addressed and corrected prior to the publication of a standards final rule, which will reduce the possibility of promulgating an incorrect energy conservation standard. By taking this step, DOE seeks to increase the likelihood that the public will identify any errors of the types addressed by the error correction rule. Correction of these errors will be beneficial for the reasons discussed in the Final Rule. With respect to providing a longer period of time, such as the 60 days suggested by industry petitioners, in DOE's view, offering a 60-day period as a matter of routine practice for identifying the types of errors addressed by this rule is unnecessary, as these kinds of errors typically can be readily identified well within the time period provided in this rule. DOE also notes that, contrary to AHRI's contention, its approach is consistent with the provision in EPCA that provides entities with 60 days from the date a rule is published in the Federal Register1 to file a petition for review in a court of appeals. Such petitions may address a range of grounds for challenging a final rule, whereas the error correction rule is limited in scope.2 Accordingly, it should take parties substantially less time to identify errors as defined in the error correction rule and to prepare an error correction request.

1 Henceforward in this document, the words “published” and “publication” refer to a document being published in the Federal Register.

2 AHRI's request for a reconsideration process that would allow for the consideration of any type of issue with a posted rule is discussed infra.

AHRI also suggested that DOE extend the period for submitting error correction requests until the effective date of a rule. This suggestion misapprehends the purpose and operation of the error correction rule. AHRI's request, by its nature, would permit error correction requests to be submitted after publication of a rule in the Federal Register, because the effective date of a rule necessarily occurs after such publication. But applying the error correction rule to rules that have already been published in the Federal Register would make little sense, because the central features of the error correction rule are that DOE delays publishing a rule in the Federal Register (for 45 days after posting the rule) to allow for the submission of error correction requests, and that DOE commits to considering properly submitted error correction requests before publishing the rule in the Federal Register. After DOE has published a rule in the Federal Register, neither outcome is available. As DOE explained in establishing the error correction rule, the anti-backsliding provision in EPCA, 42 U.S.C. 6295(o)(1), makes it particularly important to be able to correct regulatory text before DOE publishes a rule in the Federal Register. By contrast, a person submitting an error correction request after publication could just as easily make use of existing statutory mechanisms to ask DOE to amend the published rule. DOE does not see, and AHRI did not explain, why those mechanisms would be inadequate so that a special post-publication error correction process would be warranted.3

3 DOE recognizes that because the error correction rule required parties to submit error correction requests within 30 days of a rule's posting (45 days per the amendment described above), while DOE might not publish the rule in the Federal Register until later (pursuant to § 430.5(f)), there may, for a given rule, be a period of time in which DOE has not yet published a rule in the Federal Register but is not accepting requests under the error correction process. That period is important, because DOE must have some time in which it is able to conclude its consideration of error correction requests and proceed to publish a rule. If DOE committed that it would not publish a rule until it had considered every error correction request submitted before publication—even those submitted well after the 30-day (now 45-day) period—the publication of rules could be significantly delayed. Because compliance dates depend on the dates of publication, that outcome would upset the balance that DOE has struck in committing to a short delay for the sake of correcting errors.

DOE believes that the pre-publication error correction process set forth in the amended rule is superior to an error correction process permitting the submission of error correction requests during the existing 30-day pre-publication period through the effective date of a rule, which post-dates the publication of a rule in the Federal Register. The Joint Advocates argue that “[e]xtending the error correction process beyond a rule's publication in the Federal Register would ignore that DOE lacks the authority to weaken or postpone a standard beyond that point” under 42 U.S.C. 6295(o)(1), EPCA's anti-backsliding provision. Joint Advocates, No. 0013, at 1. If the Joint Advocates are correct, then AHRI's suggestion that DOE extend the time period for submitting error correction requests beyond publication of a rule in the Federal Register is obviously unworkable because DOE would be precluded from granting error correction requests unless doing so resulted in more stringent energy conservation standards.

DOE need not, however, decide in this rulemaking whether the Joint Advocates are correct because, even if EPCA and the APA granted DOE the authority to grant any error correction request submitted after the publication of a standards rule in the Federal Register, DOE would still decline to adopt AHRI's suggestion that it extend the current 30-day pre-publication period for submitting error correction requests until the effective date of a rule. Contrary to AHRI's assertion (AHRI Petition, No. 0005, at 8), adopting that suggestion would further delay the energy savings benefits of a standards rule where, among other circumstances, DOE decides to change a standards rule in response to an error correction request submitted after publication of a rule in the Federal Register. That is so because such a changed rule would need to be published in the Federal Register, and EPCA provides that compliance dates must be set a certain period of time after the “publication” of rules in the Federal Register. See 81 FR at 27,002; see also supra note 2. Such a delay is unacceptable, particularly given that DOE has determined that the 45-day period DOE is adopting for the submission of error correction requests is sufficient to permit the public to identify possible errors in its standards rules. Moreover, AHRI's approach would result in substantial uncertainty for the regulated community because manufacturers would not know whether they would be required to conform to standards set forth in rules published in the Federal Register until DOE subsequently announced its decision on pending error correction requests. But the very purpose of the EPCA provisions setting compliance dates a certain amount of time after publication of a standard in the Federal Register is to provide manufacturers enough time to prepare to implement the new standards. AHRI's suggestion would effectively reduce this period of time in many circumstances (such as where DOE decides, after a rule is published in the Federal Register, that it will make no changes to a rule), to the detriment of the regulated community. For all of these reasons, even if DOE could adopt AHRI's suggestion without running afoul of the anti-backsliding provision and other requirements set forth in EPCA and the APA (a question that DOE need not decide), it would not—and does not—adopt that approach.

DOE is also declining to adopt the approach suggested by the Joint Advocates. In DOE's view, ensuring that its energy conservation standards published in the Federal Register comport with the judgments DOE has made heavily outweighs the potential costs associated with a modest delay in the Federal Register publication of a given standards rule. Moreover, the error correction rule promotes compliance with the statutory mandate that DOE not adopt a standard unless it determines, inter alia, that the standard is technologically feasible and economically justified. See, e.g., 42 U.S.C. 6295(o)(2) and 6316(a). By providing the opportunity to file an error correction request to notify DOE of potential errors in the final rule's regulatory text, DOE can more readily identify and correct these errors prior to the rule's publication in the Federal Register. An error that could have been identified, if given this opportunity, might otherwise become the basis of a legal challenge that could delay the rule yet further. DOE's error correction process seeks to avoid those legal challenges. In addition, as noted earlier, correcting an error means bringing the regulatory text into harmony with DOE's policy judgment, as reflected in the rest of the rulemaking documents. The resulting regulatory text can be expected to fulfill and balance the multiple goals of EPCA better than the erroneous text would have.

While providing a pre-publication error correction process may require the expenditure of a modest amount of additional time, in DOE's view, weighing the potential energy savings losses of this relatively small delay against the benefits of correcting errors, given that errors, on occasion, can occur, cuts in favor of providing potential error correction requesters with the additional time provided by the error correction rule to review and identify errors to the Secretary.

B. Overly Narrow Definitions

The error correction rule defined a number of terms related to the error correction process. Among these terms were definitions for “Error,” “Party,” and “Rule.” The rule defined “Error” as “an aspect of the regulatory text of a rule that is inconsistent with what the Secretary intended regarding the rule at the time of posting.” 10 CFR 430.5(b). That definition also provided three examples of possible mistakes that could give rise to “Errors”—typographical mistakes, calculation mistakes, and numbering mistakes. See id. The term “Party” was defined as “any person who has provided input during the proceeding that led to a rule by submitting timely comments (including ex parte communications properly made within the relevant comment period) in response to a notice seeking comment or by providing substantive input at a public meeting regarding the rulemaking.” Id. Finally, a “Rule” was defined as “a rule establishing or amending an energy conservation standard under the Act.” 10 CFR 430.5(b).

Industry petitioners viewed these definitions as overly narrow. First, in their view, the definition for “Error” should be broadened to include not only the regulatory text of a final rule but errors contained within the accompanying Technical Support Document (“TSD”) and the final rule's preamble discussion. With respect to TSD-related errors, the petitioners noted that the analysis within the TSD may be needed to help identify potential errors, which would necessitate including these TSD-related errors as part of the error correction rule. Additionally, they noted that new information presented in the preamble should be subject to comment since that information is often intertwined with the regulatory text itself. Lennox argued that errors in the preamble should be included because stakeholders will not have had a prior opportunity to comment on new information presented in the preamble discussion of a final rule. AHRI argued that the definition should be amended to make it objective, not subjective, and that stakeholders cannot guess the “intent” of the Secretary. Furthermore, AHRI expressed concern that a subjective definition could give rise to unfairness if DOE makes “post hoc assertions” about the Secretary's intent that did not in fact exist at the time of the posting of a final rule. See AHRI Petition, No. 0005, at 11-13; Lennox Petition, No. 0004, at 5.

Second, some industry petitioners suggested that the rule's definition of the term “Party” was too narrow. See Hussmann Petition, No. 0003, at 2; Lennox Petition, No. 0004, at 5-6. In their view, this term should be expanded to include contributors to group responses that are filed as comments during an on-going rulemaking and should not be limited to only the organizations that filed comments responding to a proposal. Lennox stated that an individual's status as a commenter in a rulemaking is irrelevant if the goal of the error correction rule is to correct errors in a given rule. Citing 42 U.S.C. 6305(b), in Lennox's view, the ability to file an error correction request should not hinge on whether a potential error correction requester filed comments in the underlying rulemaking proceeding. It also suggested that both this term and the related requirement that an individual demonstrate how it satisfies the “Party” requirement when submitting an error correction request (see 10 CFR 430.5(d)(4)) be dropped from the rule. Lennox Petition, No. 0004, at 5-6.

Finally, the industry petitioners viewed the definition of “Rule” as too narrow. In their view, this term should include rules besides energy conservation standard rulemakings. The petitioners asserted that this term should include test procedure rulemakings in addition to energy conservation standard rulemakings. According to Lennox, test procedure rules are complex and can have an impact on efficiency ratings when intertwined with energy conservation standards. Lennox Petition, No. 0004, at 2-3. In AHRI's view, adding test procedure rules to the definition would promote transparency. It asserted that test procedure rulemakings are intertwined with efficiency standards and contain voluminous, technical data; are often not issued until after, or simultaneously with, efficiency standards; and have the same “real-world effect” as do energy conservation standards. AHRI Petition, No. 0005, at 4-5 n.2 & 7; Lennox Petition, No. 0004, at 2-3. Hussmann suggested that “all rule types” should be included as part of this definition. Hussmann Petition, No. 0003, at 1-2.

Commenters responding to these points largely agreed with the industry petitioners. Most commenters generally agreed with AHRI's criticisms of the definition for “Error.” Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1. Most commenters also agreed that the definition of “Party” is too narrow. Zero Zone, No. 0007, at 1; Lennox, No. 0009, at 2; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1; AHRI-AHAM, No. 0012, at 2. Zero Zone stated that someone seeing the information for the first time might catch errors that someone familiar with the subject might miss. Zero Zone, No. 0007, at 1. Lennox agreed with Hussmann's petition, stating that the definition should be eliminated entirely because the goal of error correction is to detect errors. Lennox, No. 0009, at 2. AHRI and AHAM added that the source reporting an error is irrelevant because the purpose of error correction is to identify errors. AHRI-AHAM, No. 0012, at 2. Most commenters also agreed that the definition of “Rule” is too narrow. Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009 at 1; AGA-APGA, No. 0010, at 2; Traulsen-Kairak, No. 0011, at 1. Zero Zone commented that expanding the definition to include “[a]ll rules and test procedures” would ensure accurate federal documents. Zero Zone, No. 0007, at 1. AHAM echoed AHRI's petition, commenting that the error correction process will be more transparent if the definition is broadened. AHAM, No. 0008, at 2.

DOE is declining to adopt any of the suggested changes to the definitions of “Error” and “Rule,” but it is amending the rule in accordance with the suggested changes regarding the rule's definition of “Party.” With respect to the definition of “Error,” DOE disagrees that the error correction process should be available to correct mistakes that are not in the regulatory text itself. The purpose of the error correction rule is to prevent an erroneous energy conservation standards regulation from being published because after the compliance date, products (or equipment) subject to a standard may not be sold in the United States unless they meet the standard. As a result, errors in the standards adopted in an energy conservation standards rulemaking can have large economic consequences. By contrast, preambles and technical support documents are generally not legally binding in the same way. An error in one of those documents would not have the consequences that an error in the regulatory text might.

DOE does not rule out the possibility that a mistake contained in a preamble, TSD, or other supporting material might lead the resulting regulatory text to be inconsistent with DOE's determinations in the rulemaking. In such a case, a person might properly file an error correction request that pointed out the mistake in the supporting material in the course of identifying the error in the regulatory text. But accepting input, during the brief error correction window, on mistakes in a preamble, TSD, or other supporting document that did not result in errors in the regulatory text would either be pointless (because the error was harmless) or would essentially mean being open to revisiting the entirety of the rulemaking. DOE declines to establish a general procedure, applicable to every standards rulemaking, requiring it to reconsider every aspect of the rulemaking documents. As discussed in this preamble, having such a general reconsideration procedure would create substantially more delay than the error correction rule; and the delay would not be warranted, because DOE would generally adhere to the policy decisions it has already made.

Because the regulatory text forms the basis of what a regulated entity is legally obligated to perform, this aspect of the final rule should, in DOE's view, remain the focus of the error correction process. While DOE acknowledges that there may be potential value in addressing issues that may arise in the context of the preamble discussion or TSD (and related supporting documents), these documents, by themselves, do not impose any legal requirements on the affected regulated entities. And, to the extent that certain information in these documents creates a question regarding the validity of a particular rule, individuals are free to exercise their options under 42 U.S.C. 6306 to seek a remedy to address any applicable issues that would fall outside of the ambit of the error correction rule.

While DOE appreciates the value of ensuring that the preamble discussion and other supporting documents are free from potential errors, DOE emphasizes that, because regulated entities are held accountable for the provisions contained within the regulatory text, it is vital that this aspect of a standards final rule be correct. To the extent that a given preamble discussion warrants further clarification, DOE is willing—and has—provided supplemental guidance regarding its views. As for corrections to erroneous items within a given TSD or related DOE supporting document, DOE may address these types of issues on a case-by-case basis to eliminate any potential confusion that may arise from conflicts between those supporting documents and the final rule's regulatory text.

AHRI also criticized the definition of “Error” as involving an assessment of DOE's “intent” regarding a rule. AHRI urged DOE to adopt a definition of “Error” that is objective. Although AHRI did not suggest an alternative definition, AHRI contends that without some different definition DOE will be encouraged to provide post hoc rationalizations if litigation over a rule arises. DOE does not agree that the definition of “Error,” as it stands, encourages post hoc rationalizations during litigation. In the error correction rule, DOE explained that petitions for judicial review of standards rules should be filed after publication of the rule. Consequently, litigation over a given standards rule would arise, if at all, only after the conclusion of the error correction process.

Moreover, DOE does not agree that because the definition of “Error” refers to what DOE “intended,” the concept of “Error” is inherently subjective. Objective conceptions of intent are common in the law. For example, in interpreting a contract, objective manifestations of intent ordinarily prevail over any contrary claims about what one or the other party actually subjectively intended. With respect to the error correction process, the rule states that a claim of error must be based on evidence in the rulemaking record. Thus, the objective evidence in the rulemaking record will ordinarily illustrate whether the regulatory text contained an Error.

Finally, AHRI noted that in some circumstances a person may conclude that a regulation contains an Error but may not be able to determine what the correct version of the regulation should be. DOE acknowledges that such a situation is in principle possible, and the Department's being notified of the potential Error would be valuable even if the submitter could not state what the correction version of the rule should be. Accordingly, DOE is amending paragraph (d)(2)(i) to permit a person to submit an error correction request without stating the correct substitute text, so long as the person states that it is unable to determine the correct text and explains why.

With respect to the definition of “Party,” which delineates who can file an error correction request, DOE is adopting the suggestion that the rule should not restrict to commenters alone the opportunity to submit such requests. As the error correction rule explained, DOE believes that individuals who have availed themselves of the opportunity to comment on DOE's standards rulemakings, at public meetings or via written comments, are in the best position to identify potential errors with a given final rule. Those participating individuals who have provided comments to assist the agency in crafting the final rule's standards have demonstrated both the interest and requisite familiarity with the relevant rulemaking and its underlying analyses and data to help DOE in readily identifying errors that may appear in the final rule's regulatory text. However, DOE recognizes that other persons may, on occasion, be able to identify errors. DOE's original decision to define “Party” based on prior participation was based on a desire to avoid the burden of responding to voluminous input from persons who, generally lacking familiarity with a rulemaking, might submit suggestions that were really revisiting the substantive decisions behind the rule rather than error correction requests. In light of the petitions and comments, DOE has become convinced that such improper submissions would probably not be as common as it had thought. A person will likely not undertake the effort to prepare and submit a request during the error correction period without making some assessment that the submission will probably be proper. Improper submissions might occur, of course, but because they would represent unfruitful effort, DOE expects that submitters will try to avoid them. In light of this revised balancing of the considerations related to the term “Party,” DOE is dropping the definition and modifying its regulations to reflect that any person may submit an error correction request.

Finally, with respect to which rules would be subject to the error correction rule's provisions, DOE is declining to extend the rule's application beyond rulemakings that establish or amend energy conservation standards. While it is also important to ensure that other rules such as those for test procedures are error-free, DOE has more flexibility to address errors in such rulemakings because there is no question that test procedures can be modified without regard to whether they have already been published or become effective. Accordingly, in DOE's view, while test procedure rulemakings can be complex, potential problems that are discovered in a test procedure's regulatory text can be addressed more readily than with standards rules. DOE also notes that the complexity of test procedure rules, which stems in large part from the very detailed and comprehensive text of the test procedure itself—along with related industry-based testing protocols that are often incorporated by reference—weighs in favor of not including test procedure rulemakings as part of the error correction process. While DOE believes that errors contained in the regulatory text of a standards final rule can be identified within the window prescribed in this rule, the variations in both length and complexity of the regulatory text of test procedures makes the application of this process less workable for these rulemakings. And if a person believed that DOE needed to correct an error discovered in the test procedure, it would be free to file a petition for rulemaking asking DOE to initiate a rulemaking to correct that rule. See 5 U.S.C. 553(e).

C. Publication Timing

The error correction rule prescribes a timeline under which DOE will submit a rule to the Office of the Federal Register for publication. If the Secretary determines that a correction is necessary after receipt of a properly filed request, the Secretary will submit a corrected rule for publication in the Federal Register within 30 days after the 30-day Request for Correction window (which, as noted above, is being changed to a 45-day window), “absent extenuating circumstances.” 10 CFR 430.5(f)(3).

The Joint Advocates objected to the quoted language and argued that the error correction rule should contain a more definitive statement regarding when the corrected rule will be submitted for publication in the Federal Register. In their view, DOE's use of the phrase “absent extenuating circumstances” in this context creates an ambiguity with respect to when DOE will submit a corrected rule for publication. The Joint Advocates suggested that DOE either drop this phrase or specify exactly how much time the Secretary will take to submit a corrected rule for publication. See Joint Advocates Petition, No. 0006, at 2-3.

Lennox indicated in its comments that DOE cannot foresee every possible error and that the complexity of past DOE rulemaking analyses suggests that more than 30 days may sometimes be needed to resolve a given error correction request. In its view, devoting an additional amount of time in favor of ensuring that a standard is correct is preferable to the alternative of having a permanently flawed standard. Lennox, No. 0009, at 3.

DOE is declining to make any change in response to this part of the Joint Advocates' petition. The language in 10 CFR 430.5(f)(3) was crafted to ensure that DOE could adjust to potential situations where additional time beyond the 30-day period for submitting a corrected rule to the Federal Register may be required. While DOE will make every effort to adhere to this 30-day timeline, it is not inconceivable that there may be occasions in which an unexpected delay may occur that would necessitate the need for additional time, such as where an error relates to particularly complex engineering analysis. Having this flexibility will help ensure that DOE has sufficient time to thoroughly review all timely error requests it receives and make any necessary corrections that may be required to the final rule prior to its publication in the Federal Register.

D. Clarifying Certain Text

The error correction rule uses the term “posting” to refer to the Secretary's action causing a rule under the Act to be posted on a publicly-accessible Web site. See 10 CFR 430.5(c)(1). Related provisions at 10 CFR 430.5(d)(3) and 10 CFR 430.5(f)(3) refer to the Secretary's “issuance” of a rule. Under the former provision, the rule notes that the evidence to substantiate an error correction request or evidence of the error must be in the rulemaking record “at the time of the rule's issuance”; under the latter, the rule indicates that upon receipt of a properly filed correction request “after issuance of a rule,” DOE will follow a prescribed timeline for submitting a corrected rule to the Federal Register for publication.

The Joint Advocates stated that, based on this definition, DOE should replace “issuance” with “posting” in these two instances in the error correction rule, namely, at 10 CFR 430.5(d)(3) (which describes the point by which evidence supporting an error correction request must be entered into the rulemaking record) and 10 CFR 430.5(f)(3) (which describes the point by which DOE must receive a properly filed error correction request). The Joint Advocates asserted that the term “issuance” means publication in the Federal Register, which was not what DOE intended at those instances, but rather “posting.” The Joint Advocates suggested that the language be corrected to avoid confusion. Joint Advocates Petition, No. 0006, at 3.

Zero Zone commented that it generally disagreed with the Joint Advocates' Petition. Zero Zone, No. 0007, at 1. AHRI and AHAM commented that they agreed with the Joint Advocates that “issuance” of a final rule does not occur until publication in the Federal Register. AHRI-AHAM, No. 0012, at 5.

In response to the petition and comments, DOE is amending its error correction rule to clarify the point by which evidence supporting an error correction request must be in the rulemaking record (10 CFR 430.5(d)(3)) and the point after which a properly filed error correction request is submitted to DOE (10 CFR 430.5(f)(3)). DOE is clarifying that these points are denoted by the posting date of the final rule. Making this change will help ensure that there is no confusion as to when the supporting evidence must be in the rulemaking record and after which a properly filed request is submitted. DOE notes that it is also clarifying 10 CFR 430.5(c)(3) to more clearly indicate that errors must be identified as provided in 10 CFR 430.5 and that DOE may make any necessary corrections in the regulatory text submitted to the Office of the Federal Register.

E. Evidence That May Be Relied Upon in Error Correction Requests and the Scope of the Administrative Record That Would Be Filed in Any Court Challenge to a Final Rule

The error correction rule states that to substantiate an error correction request, the evidence relied upon must be evidence that is “in the record of the rulemaking at the time of the rule's issuance, which may include the preamble accompanying the rule. The Secretary will not consider new evidence submitted in connection with the request.” 10 CFR 430.5(d)(3). AHRI petitioned to broaden the scope of evidence that the Secretary could consider to include any new evidence. AHRI Petition, No. 0005, at 6. According to AHRI, there is no precedent for excluding “new evidence.” Id.

In addition, the preamble to the error correction rule stated that DOE “consider[ed] the record with respect to a rule subject to the error correction process [to be] closed upon the posting of the rule.” 81 FR at 26999. AHRI construed this sentence to mean that, in the event of a court challenge to a standards rule, no documents postdating the posting of a rule would be included in the administrative record filed in a court of appeals. AHRI Petition, No. 0005, at 9-10. AHRI argued that exclusion of such documents from an administrative record filed in court would be contrary to the Administrative Procedure Act. Id.

Industry commenters agreed with AHRI's suggested approach. Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1. AHRI also commented that the Joint Advocates indirectly supported AHRI's Petition. According to AHRI, when the Joint Advocates stated that a final rule is not “issued” until it is published in the Federal Register, their statement supported AHRI's view that the rulemaking record is not yet closed when a rule is “posted.” AHRI-AHAM, No. 0012, at 5.

With respect to AHRI's distinct concern about the scope of the administrative record that would be filed in a court of appeals in the event of a challenge to a final standards rule published in the Federal Register, DOE notes that it did not intend for the preamble to the error correction rule to make any statements about the contents of such an administrative record. DOE clarifies that an administrative record filed in a court reviewing a final standards rule published in the Federal Register would include all documents that are required by law to be part of such a record, including (1) all properly filed error correction requests (including any supporting materials submitted to DOE); (2) DOE's responses to such requests; and (3) the final rule published in the Federal Register. DOE believes that this clarification addresses the concerns articulated by AHRI and others that the administrative record not be closed upon the posting of a standards rule. DOE emphasizes, however, that inclusion in the administrative record of supporting materials attached to an error correction request does not mean that DOE must substantively consider such materials. To the contrary, DOE is only obligated to consider such materials if they satisfy all regulatory requirements, including the requirements of Section 430.5(d)(3) discussed in this preamble.

In DOE's view, the posting of an energy conservation standards rule signals the end of DOE's substantive analysis and decision-making regarding the applicable standards. The purpose of the error correction rule is to ensure that the legal requirements that regulated entities will need to meet—as detailed in the regulatory text of a given standards rule—accurately reflect that completed substantive analysis and decision-making. It is not possible for a regulation to be in error, as defined for purposes of the error correction rule, based on evidence first introduced after the substantive decision has been made. Accordingly, such a consideration would be beyond the scope of the error correction process that DOE has developed. It would, essentially, be akin to a request for reconsideration; the submitter would be arguing that, in light of additional evidence, DOE should alter its decision. For the reasons discussed elsewhere in this preamble, DOE declines to expand the scope of the error correction process to encompass requests for reconsideration of its standards rules on any ground.

F. DOE Responses to Error Correction Requests

The error correction rule describes three potential options that could occur after the period for submitting error correction requests expires. See 10 CFR 430.5(f). First, if one or more “properly filed requests” are submitted and the Secretary determines that no correction is necessary, the Secretary has discretion on whether to provide a written response. The Secretary may, for example, submit the final rule for Federal Register publication as posted, thereby effectively denying any requests. See 10 CFR 430.5(f)(1). Second, if no properly filed requests are submitted and the Secretary does not identify any errors, the Secretary will submit the final rule for publication as it was posted. See 10 CFR 430.5(f)(2). Finally, if the Secretary receives a properly filed request and determines that a correction is necessary, the Secretary will submit the final rule for publication with the correction included. See 10 CFR 430.5(f)(3).

Several petitioners stated that DOE should provide a public response to requests for correction, regardless of whether the Secretary deems that any correction is merited. Hussmann Petition, No. 0003, at 1; Lennox Petition, No. 0004, at 4; AHRI Petition, No. 0005, at 10. Hussmann stated that DOE should do so, either before or at the time of publication of a final rule in the Federal Register. Hussmann Petition, No. 0003, at 1. Lennox and AHRI stated that providing a response will promote transparency and should not take much additional time for DOE to prepare, assuming that DOE already analyzed any requests. Lennox Petition, No. 0004, at 4; AHRI Petition, No. 0005, at 10. Lennox added that rejecting an error correction request through a non-response is not acceptable because petitioners incur real costs when submitting a request. Lennox Petition, No. 0004, at 4.

Related to the Secretary's options under 10 CFR 430.5(f), petitioners made reference to a statement in the preamble to the error correction rule under the “Publication in the Federal Register” section. In particular, DOE indicated that there may be instances where DOE “may choose not to correct the regulation because it concludes the regulatory text is nonetheless acceptable; for instance, because it considers the error insignificant.” 81 FR at 27002. Both Lennox and AHRI stated that, especially when an error is considered “insignificant” by the Secretary, DOE should provide a public response not only to promote transparency but also to reduce subsequent litigation. AHRI argued that DOE should furnish a rationale or justification explaining why an error is deemed to be insignificant, while Lennox asserted that if DOE is mistaken about an error being insignificant and does not publish a response, the absence of a response could lead “to unintended actions by stakeholders, including the exploitation of perceived loopholes.” Lennox Petition, No. 0004, at 4; AHRI Petition, No. 0005, at 10.

Most commenters generally agreed with the petitioners who urged DOE to provide a public response to requests for error correction, including when DOE deems an error to be “insignificant.” Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 2; Traulsen-Kairak, No. 0011, at 1.

After giving careful consideration to this issue, DOE has decided to make public brief written indications of its handling of all properly-filed error correction requests. DOE will ordinarily summarize these indications in a single document. In DOE's view, the vast majority of cases in which it grants an error correction request are likely to involve a request that DOE correct a typographical error that appears in a posted, pre-publication version of a rule. In such cases, DOE's written indication addressing the request may note only that DOE made the requested change because the reason for the change may be readily apparent to the public. When requesters have sought to identify a potential error in a posted standards rule and DOE has decided not to make the requested change, an explanation as to why that correction request has not been adopted will usually be helpful in assisting the public with understanding DOE's reasoning, and DOE will provide a brief explanation in those circumstances. Accordingly, DOE is modifying the regulatory text under 10 CFR 430.5(f) to include a provision indicating that DOE will make available a brief written statement indicating the agency's treatment of the error correction requests it received. DOE expects to make such a statement available at around the same time it publishes the rule.

G. Notice and Comment

In a separately filed comment, AHAM asked that the error correction final rule be treated as a proposed rule. It further asked that, upon granting the petition from AHRI, DOE seek stakeholder input in order to ensure that the next version of the error correction process does not suffer from the same deficiencies as the first version. AHAM Comments, No. 0008, at 2.

As an initial matter, DOE notes that the error correction rule was published as a final rule and has already taken effect. Moreover, DOE is not required to provide the public with an opportunity to comment on the error correction rule or any amendments to that rule because it is a rule of agency procedure and practice. See 5 U.S.C. 553(b)(A). However, as indicated elsewhere in this document, DOE is amending the error correction rule in part to address some of the suggestions offered by both petitioners and commenters. Accordingly, interested members of the public have been afforded the opportunity to provide input into shaping the final version of the error correction rule being adopted in this document.

H. Response to Petitions Seeking Full Reconsideration Procedures

AHRI's principal request is for DOE to replace the error correction rule with a process that “provide[s] for the posting of a pre-publication version of final rules under 42 U.S.C. 6293 and 6295 (and the corresponding provisions applicable to commercial equipment, sections 6313 and 6314) for a period of 60 days and allow[s] petitions for reconsideration under the APA during that prepublication period.” AHRI Petition, No. 0005, at 2-3. Embedded in this request, it appears, are the following five suggested changes to the current error correction rule, all of which AHRI also separately requests, in the alternative, in the event that DOE denies its principal request: (1) Broaden the types of arguments that may be asserted in error correction requests to encompass any grounds for changing a rule, not just arguments identifying an “error” as defined in the current rule, id. at 3-6; (2) allow the introduction of evidence that is not in the rulemaking record to support error correction requests, id. at 6; (3) expand the error correction process to include errors appearing in Technical Support Documents and perhaps other parts of the regulatory record, id. at 12-13; (4) expand the error correction process to include rules establishing test procedures, id. at 7-8; and (5) extend the 30-day period for submitting error correction requests (prior to publication in the Federal Register) to 60 days (also prior to publication in the Federal Register),4 id. at 8-9. Lennox supported AHRI's principal request, as did other industry commenters. See Lennox Petition, No. 0004, at 2 (supporting “a 60 day pre-publication period” for “Petitions for Reconsideration, as provided for under the [APA]”); AGA-APGA, No. 0010, at 1-2 (supporting pre-publication “petitions for reconsideration, as provided for under the [APA]” and including “the full range of reconsideration petitions that the APA contemplates”); AHRI-AHAM, No. 0012, at 5 (reiterating AHRI's view that “many of the main purposes articulated in the Final Rule are best met by allowing for a 60-day pre-publication period in which Petitions for Reconsideration, as provided for under the [APA], will be considered”).

4 AHRI's request in the alternative pertaining to timing also argues that DOE could instead allow error correction requests to be submitted during the existing 30-day pre-publication period and continuing until the effective date of the rule, which follows publication in the Federal Register. AHRI Petition, No. 0005, at 8-9; see also AGA-APGA, No. 0010, at 2.

DOE has explained above why it is rejecting (in part) AHRI's second through fifth requests embedded in its principal suggestion. For the reasons explained below, DOE also rejects AHRI's first request embedded in its principal suggestion (and offered as a standalone request)—that DOE expand the error correction process to encompass requests alleging any grounds for changing a rule.

DOE understands that the “full” reconsideration procedure that AHRI describes in its principal request, as well as in item 1 under its alternative request, would encompass the full range of issues germane to a given rulemaking. DOE has considered whether to adopt a reconsideration procedure along the lines suggested by AHRI. Given the practical implications of crafting an error correction process that would allow for full reconsideration of any factual or legal issue implicated by the rulemaking, as discussed in this preamble, DOE declines to broaden the error correction rule to permit petitions asserting any ground for changing a rule.

As AHRI acknowledges, energy conservation rulemakings are an “enormous undertaking . . . in terms of time, effort and cost, both on the part of stakeholders and DOE.” AHRI Petition, No. 0005, at 2. In addition, these rulemakings tend to involve an extensive opportunity for comment, both through written submissions in response to notices of proposed rulemaking and notices releasing additional technical information, as well as through oral participation at public meetings held by DOE. Adding a full reconsideration process, in which the Department would specifically review a further round of comment on any matter, would substantially increase the cost of energy conservation rulemakings and the length of time they take. See Lennox Petition, No. 0004, at 5 (acknowledging that it is “important to bring finality to a given rulemaking”). Meanwhile, in DOE's view, given the opportunities for public input that the process already provides, a mandatory general reconsideration period covering all topics would, in many instances, not significantly increase meaningful public participation in rulemakings.

By contrast, DOE developed the error correction rule to invite public input on a narrow but challenging category of problems, namely errors that may occur in formulating the text of regulations and that, if left uncorrected, could result in standards that would be binding on regulated parties but would not accurately reflect DOE's judgment about the appropriate standard level. Obtaining public input on “errors” as defined by the rule is particularly valuable because, by their nature, such errors are inadvertent, and thus DOE is unaware of them. In addition, the narrow error correction rule helps avoid the possibility that DOE might inadvertently adopt an energy conservation without having determined that it meets the statutory standards. That is so because many “errors” (as defined by the error correction rule) may, if uncorrected, result in the promulgation of standards that DOE did not intend to adopt. For example, if DOE's calculations in the preamble to a final rule suggested that the standard for a given product should be set at one level, but a more stringent standard was inadvertently presented in the regulatory text, that standard would not have been the one DOE intended to adopt as being technologically feasible and economically justified. By contrast, a request to change a rule on a ground other than the identification of an “error” (as defined by the error correction rule) does not raise the possibility that DOE adopted a standard in the regulatory text without determining that it was technologically feasible and economically justified. Moreover, reviewing and responding to requests to correct errors as defined in the error correction rule should not be too burdensome because DOE will need to review only a limited scope of materials for each submission. Thus, the error correction rule is specifically tailored to address what the agency views as a critical class of inadvertent errors warranting the creation of an additional limited administrative process apart from the procedures already afforded by EPCA and the APA.

In contrast, the full reconsideration process that AHRI suggests is not closely tailored to address this key problem and would represent a commitment by DOE to revisiting the entire rulemaking record in order to assess the particulars of any issue a person might raise in a reconsideration request. Because of the open-ended nature of such a process, DOE would need to provide interested persons with a period of time to submit reconsideration petitions that is longer than the 45-day period established by the error correction rule (as amended in this document). In addition, it would take DOE significantly more time to consider such petitions and to determine whether to change the rule in response to the petitions. Furthermore, DOE's preparation and issuance of a written response to any such reconsideration requests, as suggested by industry petitioners, would extend the process further. See AHRI Petition, No. 0005, at 3.

DOE declines to extend its rulemaking procedures in that fashion. Many standards-setting rules are subject to a statutory deadline. See, e.g., 42 U.S.C. 6295(m)(1) (DOE must determine whether to amend an energy conservation standard for consumer products not later than six years after issuance of a final rule establishing or amending a standard); 42 U.S.C. 6295(m)(3)(A) (under which DOE must issue a rule within two years of the notice of proposed rulemaking for an amended standard); see also 42 U.S.C. 6316 (applying section 6295(m), including its two-year window, to a variety of industrial equipment-related energy conservation standards, including (1) electric motors and pumps, (2) commercial refrigerators, freezers, and refrigerator-freezers, (3) automatic commercial ice makers, (4) walk-in coolers and walk-in freezers, and (5) commercial clothes washers). Given the complexity of these rulemakings, these statutory deadlines are difficult to meet in current circumstances, which include considerable periods of time that lie outside of DOE's control. Trying to fit a broad reconsideration process within these already limited time periods would be even more difficult. The broader the issues available for review through an administrative reconsideration process, the greater the strain on departmental resources and the agency's ability to complete its portfolio of rulemaking proceedings within statutory deadlines. See Joint Advocates Petition, No. 0006, at 1-2. In addition, DOE takes the timelines in EPCA as signals of congressional concern that standards rulemakings should not be unnecessarily delayed. As the preamble to the error correction rule observed, postponing the publication of a standards rule in the Federal Register means delaying the benefits to consumers and to the economy that the new standard will achieve; and it prolongs the uncertainty for manufacturers about what the standard will eventually be. Accordingly, in DOE's view, the benefits AHRI attributes to a full reconsideration option are limited and outweighed by the delay and resource strain that would follow from the implementation of such a reconsideration process.

DOE also finds unpersuasive AHRI's argument that DOE must entertain pre-publication petitions for reconsideration alleging any grounds for changing a rule because “5 U.S.C. 553(e) does not limit the grounds on which reconsideration can be pursued.” AHRI Petition, No. 0005, at 5. Reliance on section 553(e) is inapposite here because DOE is not establishing the error correction process under this section. Through the error correction rule, DOE established a new procedure in addition to and independent of any statutory rights to petition for rulemaking afforded to persons under the APA and EPCA. See 5 U.S.C. 553(e) (“Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.”); 42 U.S.C. 6295(n) (“[A]ny person may petition the Secretary to conduct a rulemaking to determine for a covered product if the standards contained either in the last final rule required under subsections (b) through (i) of this section or in a final rule published under this section should be amended.”). To the extent that those authorities permit the filing of petitions seeking to change a rule, that option remains available to the public and is not superseded or limited by the error correction rule in any way. Thus, contrary to AHRI's position, DOE is not required by any statutory, regulatory, or other requirement to broaden the error correction procedure to encompass any ground for changing a standards rule. It is in DOE's sole discretion to determine the scope of the error correction procedure, and, for the reasons described in this preamble, the Department has reasonably concluded that this process should be limited to “errors” as defined in the rule. See Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 543-44 (1978) (“Absent constitutional constraints or extremely compelling circumstances the `administrative agencies “should be free to fashion their own rules of procedure and to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties.”'”) (internal citations omitted).

In its petition to amend the error correction rule, AHRI refers back to certain arguments raised in its brief to the Fifth Circuit in Lennox Int'l, Inc. v. U.S. Dep't. of Energy, No. 14-60535, concerning AHRI's underlying July 30, 2014 Petition for Reconsideration of DOE's Rule for Walk-In Coolers and Freezers (WICFs), Docket No. EERE-2010-BT-STD-0003, and AHRI argues that DOE must respond to those legal arguments here in order to determine whether the pre-publication error correction process should be broadened to encompass requests to change a posted rule on any ground. See AHRI Petition, No. 0005, at 5 (contending that DOE wrongly “expressed the view in denying [reconsideration of] the walk in cooler/freezer rule that it lacked the power to grant reconsideration petitions”); see also id. (arguing that “DOE must . . . set[] out its current position as to what [Natural Resources Defense Council v. Abraham, 355 F.3d 179 (2d Cir. 2004),] says about DOE's EPCA reconsideration powers”). However, the relevant parts of DOE's denial of the petition for reconsideration of the Walk-In Coolers and Freezers Rule and AHRI's subsequent Fifth Circuit brief dealt solely with the issue of DOE's authority to grant petitions for reconsideration filed after publication of a rule in the Federal Register and before its effective date. The legal arguments raised in that context have no bearing on the validity of DOE's rule establishing a process for correcting errors before publication in the Federal Register. Moreover, even if AHRI is correct that DOE has the authority to consider reconsideration petitions submitted after a rule is published in the Federal Register, it does not follow that DOE should expand the pre-publication error correction process to encompass petitions alleging any ground as a basis for changing a posted rule, which is a distinct question. Accordingly, DOE declines in this rulemaking to definitively resolve the legal arguments AHRI advanced in its Fifth Circuit brief regarding DOE's authority to consider petitions for reconsideration submitted after a rule is published in the Federal Register.

AHRI argued in its Fifth Circuit brief in Lennox that 42 U.S.C. 6295(o)(1)—which provides that DOE may not prescribe any amended standard that “increases the maximum allowable energy use . . . or decreases the minimum required energy efficiency” of a product—does not prevent DOE from reconsidering EPCA standards to make them less stringent when reconsideration is sought after publication in the Federal Register but before the effective date of the relevant rule. See AHRI Brief in Lennox, at 28-38. But see Natural Resources Defense Council v. Abraham, 355 F.3d 179 (2d Cir. 2004) (interpreting section 6295(o)(1) as applying as of Federal Register publication of a standards rule); Joint Advocates, No. 0013, at 1 (same). As the preamble to the error correction rule noted, section 6295(o)(1) does not unambiguously indicate the relevant reference point (e.g., a publication in the Federal Register) for determining the “maximum allowable energy use” and the “minimum required energy efficiency.” 81 FR at 27002.

However, because DOE has established a pre-publication error correction procedure, DOE can leave for another day the questions AHRI has raised about DOE's authority to reconsider rules that have already been published in the Federal Register. That is so because, regardless of whether section 6295(o)(1) bars DOE from considering some or all reconsideration petitions submitted after Federal Register publication, section 6295(o)(1) does not bar DOE from correcting errors prior to publication in the Federal Register. See 81 FR 26998, 27002-27003 (May 5, 2016) (discussing § 430.5(g) of the error correction rule and why pre-publication error correction requests do not implicate EPCA's anti-backsliding provision).5 Indeed, neither AHRI nor any other petitioner or commenter has contended that the error correction rule is inconsistent with section 6295(o)(1).6

5 To the extent that the preamble to the error correction rule could be construed as having definitively taken a position on whether the anti-backsliding provision is triggered by publication of final rule in the Federal Register, see 81 FR at 27002, DOE now clarifies that it meant to express the more limited proposition that the anti-backsliding provision permits the pre-publication correction of errors in the manner that the error correction rule establishes.

6 AHRI “note[s]” that “it would [be] just as consistent with DOE's construction of [section 6295(o)(1)] for DOE to allow for a process for full reconsideration (to any degree, of any aspect) of an energy conservation standard, as contrasted with the limited scope of the error correction rule”—i.e., to allow pre-publication petitions seeking to change a standards rule on any ground. AHRI Petition, No. 0005, at 6 (internal quotation marks omitted). Nonetheless, it is within DOE's discretion to determine the scope of the error correction procedure, and DOE has reasonably concluded that the procedure should be limited to “errors” as defined in the rule.

Similarly, AHRI's Fifth Circuit brief in Lennox argued that 42 U.S.C. 6295(n) does not bar DOE from making a standards rule less stringent in response to a petition for reconsideration filed after the rule was published in the Federal Register but before the effective date of the relevant rule. See AHRI Brief in Lennox, at 39-41. Section 6295(n), which addresses “[p]etition[s] for amended standards,” applies to “petition[s] . . . to conduct a rulemaking to determine . . . if the standards contained either in the last final rule required under [42 U.S.C. 6295(b)-(i)] or in a final rule published under [section 6295] should be amended.” DOE need not, however, resolve the question raised in the Lennox briefs of whether section 6295(n) applies to post-publication reconsideration petitions because, regardless of whether section 6295(n) applies to such petitions, 42 U.S.C. 6295(n) is not implicated by the pre-publication error correction procedures established under the error correction rule.

That conclusion follows from the text of section 6295(n). DOE has, for the most part, already published the “last final rule[s] required” by subsections (b) through (i) of section 6295. Thus, for nearly all new standards rules for consumer products and for any standards applicable to commercial equipment, a petition under section 6295(n) would be submitted under the second clause of that subsection, applicable to “published” rules. Regardless which clause of 6295(n) may be the basis for a rule (i.e., the “required” rules clause or the “published” rules clause), DOE interprets that provision to apply no earlier than the date a rule is published in the Federal Register. Because error correction requests submitted pursuant to the error correction rule seeking to change a standard in a rule posted on DOE's Web site based on an “error” are filed before the rule is published in the Federal Register, such requests do not qualify as section 6295(n) petitions. Section 6295(n) thus is irrelevant to whether DOE may consider and grant any given error correction request, and no petitioner or commenter (including AHRI) has argued to the contrary.7

7 Accordingly, DOE rejects AHRI's argument that it “must reject the 42 U.S.C. 6295(n) rationale it adopted” when it denied reconsideration of the WICF rule. AHRI Petition, No. 0005, at 6. As explained in this document, 42 U.S.C. 6295(n) plainly does not apply to pre-publication error correction requests, and there is no need to substantively resolve in this rulemaking whether it applies to post-publication reconsideration petitions like the petition filed with respect to the WICF rule.

For similar reasons, DOE rejects AHRI's suggestion that it must substantively resolve the argument AHRI advanced in its Lennox brief that DOE “acted inconsistently with its own action on prior reconsideration petitions” when it denied reconsideration of the WICF rule on the ground that it lacked authority to consider that petition. AHRI Petition, No. 0005, at 5. The alleged inconsistency concerns DOE's handling of reconsideration petitions submitted after rules are published in the Federal Register. See id. at 5 & n.3 (citing DOE's actions on reconsideration petitions submitted after rules were published in the Federal Register). As explained above, there is no need to substantively resolve in this rulemaking how DOE responds to such post-publication reconsideration petitions. DOE's response to the submission at issue in the Lennox case nowhere suggested that DOE would be unable to establish a mechanism like the error correction process, as an exercise of its authority to engage in administrative and procedural rulemaking regarding its implementation of EPCA.

As explained in this preamble, DOE has fully considered but is declining to adopt the full reconsideration procedure that AHRI suggests—irrespective of what DOE's legal authority to accept a post-publication petition would be. Because resolution of those legal arguments is not determinative of DOE's basis for rejecting a full reconsideration procedure in the matter at hand, DOE declines to definitively resolve the questions AHRI raises about the Department's authority to reconsider rules that have already been published in the Federal Register and is reserving judgment until a more appropriate time on whether and, if so, to what extent it possesses the legal authority to create a reconsideration procedure after a rule's publication in the Federal Register. The Department notes, however, that, regardless of the exact point in time when the anti-backsliding provision in section 6295(o)(1) and the amendment provision in section 6295(n) are triggered so as to have an impact on reconsideration requests, as DOE reads the provisions, they do not restrict DOE's correction of rules pursuant to the error correction process it has established. As such, DOE's error correction rule is consistent with both EPCA and the rationale expressed by DOE in its order denying AHRI's petition for reconsideration in the WICF rulemaking.

It is DOE's position that a process to correct errors such as typographical mistakes or calculation errors can be resolved at the administrative level without causing an undue burden on agency resources or the agency's ability to comply with statutory deadlines. The error correction rule, as amended, reflects DOE's balancing between the resource-intensive rulemaking process and its ability to offer an additional administrative process to stakeholders that will reduce the need to pursue judicial review in instances where it is clear that the relevant standard in the posted rule is not the standard the agency had intended to select.

DOE has carefully considered petitioners' request for a full reconsideration procedure but concludes that agency and stakeholder interests will be best served by a streamlined process for correcting the errors described in the amended error correction rule.8

8 AHRI asserts various arguments about how DOE must respond to its petition to amend the error correction rule under two settlement agreements in Lennox Int'l, Inc. v. U.S. Dep't of Energy, No. 14-60535 (5th Cir.). See AHRI Petition, No. 0005, at 2-5. DOE has complied with both settlement agreements because, inter alia, this document responding to petitions to amend the error correction rule “address[es]” AHRI's request that DOE “consider establishing a process for full reconsideration (to any degree, of any aspect) of an energy conservation standard.” Joint Motion Embodying Further Settlement Agreement of All Parties for Dismissal Without Prejudice, Lennox Int'l Inc. v. U.S. Dep't of Energy, No. 14-60535 (5th Cir.) (filed April 28, 2016). Indeed, for the reasons identified in this document, DOE declines to adopt AHRI's principal suggestion for expanding the error correction rule, and DOE also rejects AHRI's related request that parties be permitted to assert any grounds for changing a rule in their error correction requests.

III. Procedural Issues and Regulatory Review A. Administrative Procedure Act

This rule of agency procedure and practice is not subject the requirement to provide prior notice and an opportunity for public comment pursuant to authority at 5 U.S.C. 553(b)(A). The Administrative Procedure Act's exception to the notice-and-comment rulemaking requirement for rules of agency procedure and practice reflects Congress's judgment that such rules typically do not significantly benefit from notice-and-comment procedures, and that judgment is particularly applicable here, where the agency perceives no specific need for notice and comment. In addition, DOE has concluded that seeking further input on this rule—beyond that which has already been provided through the submitted petitions to amend and comments responding to them—would inappropriately divert valuable agency resources from other rulemakings that Congress has directed DOE to complete according to certain statutory timelines.

This rule is also not a substantive rule subject to a 30-day delay in effective date pursuant to 5 U.S.C. 553(d).

B. Review Under Executive Orders 12866 and 13563

This regulatory action is not a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, this action was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs (“OIRA”) of the Office of Management and Budget (“OMB”). DOE has also reviewed this regulation pursuant to Executive Order 13563, issued on January 18, 2011. 76 FR 3281 (January 21, 2011). EO 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. As a result, EO 13563 also does not apply to this rule.

C. Review Under the Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires preparation of an initial regulatory flexibility analysis (“IRFA”) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. Because this rule is not subject to the requirement to provide prior notice and an opportunity for public comment, it is not subject to the analytical requirements of the Regulatory Flexibility Act.

D. Review Under the Paperwork Reduction Act

This rule does not contain a collection of information for purposes of the Paperwork Reduction Act.

E. Review Under the National Environmental Policy Act of 1969

DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule is strictly procedural and is covered by the Categorical Exclusion in 10 CFR part 1021, subpart D, paragraph A6. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

F. Review Under Executive Order 13132

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE examined this final rule and determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the equipment that are the subject of this final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

G. Review Under Executive Order 12988

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. 61 FR 4729 (February 7, 1996). Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.

H. Review Under the Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at http://energy.gov/gc/office-general-counsel. DOE examined this final rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply

I. Review Under the Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

J. Review Under Executive Order 12630

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

K. Review Under the Treasury and General Government Appropriations Act, 2001

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

L. Review Under Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

This final rule is not a significant energy action because the ability to correct regulations will not, in itself, have a significant adverse effect on the supply, distribution, or use of energy. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

M. Congressional Notification

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

IV. Approval of the Office of the Secretary List of Subjects 10 CFR Part 430

Administrative practice and procedure, Energy conservation test procedures, Household appliances.

10 CFR Part 431

Administrative practice and procedure, Energy conservation test procedures, Commercial and industrial equipment.

Issued in Washington, DC, on August 10, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.

For the reasons set forth in the preamble, DOE amends parts 430 and 431 of chapter II of title 10 of the Code of Federal Regulations as set forth below:

PART 430—ENERGY CONSERVATION STANDARDS FOR CONSUMER PRODUCTS 1. The authority citation for part 430 continues to read as follows: Authority:

42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.

2. Section 430.5 is revised to read as follows:
§ 430.5 Error correction procedures for energy conservation standards rules.

(a) Scope and purpose. The regulations in this section describe procedures through which the Department of Energy accepts and considers submissions regarding possible Errors in its rules under the Energy Policy and Conservation Act, as amended (42 U.S.C. 6291-6317). This section applies to rules establishing or amending energy conservation standards under the Act, except that this section does not apply to direct final rules issued pursuant to section 325(p)(4) of the Act (42 U.S.C. 6295(p)(4)).

(b) Definitions.

Act means the Energy Policy and Conservation Act of 1975, as amended (42 U.S.C. 6291-6317).

Error means an aspect of the regulatory text of a rule that is inconsistent with what the Secretary intended regarding the rule at the time of posting. Examples of possible mistakes that might give rise to Errors include:

(i) A typographical mistake that causes the regulatory text to differ from how the preamble to the rule describes the rule;

(ii) A calculation mistake that causes the numerical value of an energy conservation standard to differ from what technical support documents would justify; or

(iii) A numbering mistake that causes a cross-reference to lead to the wrong text.

Rule means a rule establishing or amending an energy conservation standard under the Act.

Secretary means the Secretary of Energy or an official with delegated authority to perform a function of the Secretary of Energy under this section.

(c) Posting of rules. (1) The Secretary will cause a rule under the Act to be posted on a publicly-accessible Web site.

(2) The Secretary will not submit a rule for publication in the Federal Register during 45 calendar days after posting the rule pursuant to paragraph (c)(1) of this section.

(3) Each rule posted pursuant to paragraph (c)(1) of this section shall bear the following disclaimer:

NOTICE: The text of this rule is subject to correction based on the identification of errors as defined in 10 CFR 430.5 before publication in the Federal Register. Readers are requested to notify the United States Department of Energy, by email at [EMAIL ADDRESS PROVIDED IN POSTED NOTICE], of any typographical or other errors, as described in such regulations, by no later than midnight on [DATE 45 CALENDAR DAYS AFTER DATE OF POSTING OF THE DOCUMENT ON THE DEPARTMENT'S WEBSITE], in order that DOE may make any necessary corrections in the regulatory text submitted to the Office of the Federal Register for publication.

(d) Request for correction. (1) A person identifying an Error in a rule subject to this section may request that the Secretary correct the Error. Such a request must be submitted within 45 calendar days of the posting of the rule pursuant to paragraph (c)(1) of this section.

(2)(i) A request under this section must identify an Error with particularity. The request must state what text is claimed to be erroneous. The request must also provide text that the requester argues would be a correct substitute. If a requester is unable to identify a correct substitute, the requester may submit a request that states that the requester is unable to determine what text would be correct and explains why the requester is unable to do so. The request must also substantiate the claimed Error by citing evidence from the existing record of the rulemaking that the text of the rule as issued is inconsistent with what the Secretary intended the text to be.

(ii) A person's disagreement with a policy choice that the Secretary has made will not, on its own, constitute a valid basis for a request under this section.

(3) The evidence to substantiate a request (or evidence of the Error itself) must be in the record of the rulemaking at the time of the rule's posting, which may include the preamble accompanying the rule. The Secretary will not consider new evidence submitted in connection with a request.

(4) A request under this section must be filed in electronic format by email to the address that the rule designates for correction requests. Should filing by email not be feasible, the requester should contact the program point of contact designated in the rule regarding an appropriate alternative means of filing a request.

(5) A request that does not comply with the requirements of this section will not be considered.

(e) Correction of rules. The Secretary may respond to a request for correction under paragraph (d) of this section or address an Error discovered on the Secretary's own initiative by submitting to the Office of the Federal Register either a corrected rule or the rule as previously posted.

(f) Publication in the Federal Register. (1) If, after receiving one or more properly filed requests for correction, the Secretary decides not to undertake any corrections, the Secretary will submit the rule for publication to the Office of the Federal Register as it was posted pursuant to paragraph (c)(1) of this section.

(2) If the Secretary receives no properly filed requests after posting a rule and identifies no Errors on the Secretary's own initiative, the Secretary will in due course submit the rule, as it was posted pursuant to paragraph (c)(1) of this section, to the Office of the Federal Register for publication. This will occur after the period prescribed by paragraph (c)(2) of this section has elapsed.

(3) If the Secretary receives a properly filed request after posting a rule pursuant to (c)(1) and determines that a correction is necessary, the Secretary will, absent extenuating circumstances, submit a corrected rule for publication in the Federal Register within 30 days after the period prescribed by paragraph (c)(2) of this section has elapsed.

(4) Consistent with the Act, compliance with an energy conservation standard will be required upon the specified compliance date as published in the relevant rule in the Federal Register.

(5) Consistent with the Administrative Procedure Act, and other applicable law, the Secretary will ordinarily designate an effective date for a rule under this section that is no less than 30 days after the publication of the rule in the Federal Register.

(6) When the Secretary submits a rule for publication, the Secretary will make publicly available a written statement indicating how any properly filed requests for correction were handled.

(g) Alteration of standards. Until an energy conservation standard has been published in the Federal Register, the Secretary may correct such standard, consistent with the Administrative Procedure Act.

(h) Judicial review. For determining the prematurity, timeliness, or lateness of a petition for judicial review pursuant to section 336(b) of the Act (42 U.S.C. 6306), a rule is considered “prescribed” on the date when the rule is published in the Federal Register.

PART 431—ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT 3. The authority citation for part 431 continues to read as follows: Authority:

42 U.S.C. 6291-6317.

4. Section 431.3 is revised to read as follows:
§ 431.3 Error Correction procedure for energy conservation standards rules.

Requests for error corrections pertaining to an energy conservation standard rule for commercial or industrial equipment shall follow those procedures and provisions detailed in 10 CFR 430.5 of this chapter.

[FR Doc. 2016-19968 Filed 8-23-16; 8:45 am] BILLING CODE 6450-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2015-5391; Special Conditions No. 25-630-SC] Special Conditions: The Boeing Company, Boeing Model 767-2C Airplane; Non-Rechargeable Lithium Battery Installations AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions.

SUMMARY:

These special conditions are issued for the Boeing Model 767-2C airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is associated with non-rechargeable lithium battery installations. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

Effective April 22, 2017.

FOR FURTHER INFORMATION CONTACT:

Nazih Khaouly, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2432; facsimile 425-227-1149.

SUPPLEMENTARY INFORMATION: Future Requests for Installation of Non-Rechargeable Lithium Batteries

The FAA anticipates that non-rechargeable lithium batteries will be installed in other makes and models of airplanes. We have determined to require special conditions for all applications requesting non-rechargeable lithium battery installations, except the installations excluded in the Applicability section, until the airworthiness requirements can be revised to address this issue. Applying special conditions to these installations across the range of all transport-airplane makes and models ensures regulatory consistency among applicants.

The FAA issued special conditions no. 25-612-SC to Gulfstream Aerospace Corporation for their GVI airplane. Those are the first special conditions the FAA issued for non-rechargeable lithium battery installations. We explained in that document our determination to make those special conditions effective one year after publication of those special conditions in the Federal Register, and our intention for other special conditions for other makes and models to be effective on this same date or 30 days after their publication, whichever is later.

Background

On January 18, 2010, The Boeing Company (Boeing) applied for an amendment to type certificate no. A1NM to include a new Model 767-2C airplane. The Model 767-2C airplane is a twin-engine, transport-category freighter derivative of the Model 767-200 airplane currently approved under type certificate no. A1NM. This freighter has a maximum takeoff weight of 415,000 pounds and can be configured to carry up to 11 supernumeraries.

The Model 767-2C airplane incorporates provisions to support subsequent supplemental type certificate (STC) modifications, which are intended to provide additional mission capabilities, including provisions to support conversion into an aerial refueling platform (i.e., tanker) configuration.

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations, (14 CFR) 21.101, Boeing must show that the Model 767-2C airplane meets the applicable provisions of the regulations listed in type certificate no. A1NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations listed in type certificate no. A1NM are 14 CFR part 25, effective February 1, 1965, including Amendments 25-1 through 25-37, with exceptions listed in the type certificate. In addition, the certification basis includes other regulations, special conditions, and exemptions that are not relevant to these special conditions. Type certificate no. A1NM will be updated to include a complete description of the certification basis for this airplane model.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model 767-2C airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the airplane model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model 767-2C airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

Novel or Unusual Design Features

The Boeing Model 767-2C airplane will incorporate non-rechargeable lithium batteries.

A battery system consists of the battery and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a “battery” and “battery system” are referred to as a battery.

Discussion

The FAA derived the current regulations governing installation of batteries in transport-category airplanes from Civil Air Regulations (CAR) 4b.625(d) as part of the re-codification of CAR 4b that established 14 CFR part 25 in February 1965. We basically reworded the battery requirements, which are currently in § 25.1353(b)(1) through (b)(4), from the CAR requirements. Non-rechargeable lithium batteries are novel and unusual with respect to the state of technology considered when these requirements were codified. These batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.

Recent events involving rechargeable and non-rechargeable lithium batteries prompted the FAA to initiate a broad evaluation of these energy-storage technologies. In January 2013, two independent events involving rechargeable lithium-ion batteries demonstrated unanticipated failure modes. A National Transportation Safety Board (NTSB) letter to the FAA, dated May 22, 2014, which is available at http://www.ntsb.gov, filename A-14-032-036.pdf, describes these events.

On July 12, 2013, an event involving a non-rechargeable lithium battery in an emergency-locator-transmitter installation demonstrated unanticipated failure modes. The United Kingdom's Air Accidents Investigation Branch Bulletin S5/2013 describes this event.

Some known uses of rechargeable and non-rechargeable lithium batteries on airplanes include:

• Flight deck and avionics systems such as displays, global positioning systems, cockpit voice recorders, flight data recorders, underwater locator beacons, navigation computers, integrated avionics computers, satellite network and communication systems, communication-management units, and remote-monitor electronic line-replaceable units;

• Cabin safety, entertainment, and communications equipment, including emergency-locator transmitters, life rafts, escape slides, seatbelt air bags, cabin management systems, Ethernet switches, routers and media servers, wireless systems, internet and in-flight entertainment systems, satellite televisions, remotes, and handsets;

• Systems in cargo areas including door controls, sensors, video surveillance equipment, and security systems.

Some known potential hazards and failure modes associated with non-rechargeable lithium batteries are:

Internal failures: In general, these batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure (i.e., thermal runaway) than their nickel-cadmium or lead-acid counterparts. The metallic lithium can ignite, resulting in a self-sustaining fire or explosion.

Fast or imbalanced discharging: Fast discharging or an imbalanced discharge of one cell of a multi-cell battery may create an overheating condition that results in an uncontrollable venting condition, which in turn leads to a thermal event or an explosion.

Flammability: Unlike nickel-cadmium and lead-acid batteries, lithium batteries use higher energy and current in an electrochemical system that can be configured to maximize energy storage of lithium. They also use liquid electrolytes that can be extremely flammable. The electrolyte, as well as the electrodes, can serve as a source of fuel for an external fire if the battery casing is breached.

Special condition no. 1 requires that each individual cell within a non-rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special condition no. 2 addresses these same issues but for the entire battery. Special condition no. 2 requires that the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.

Special condition nos. 1 and 2 are intended to ensure that the non-rechargeable lithium battery and its cells are designed to eliminate the potential for uncontrolled failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special condition nos. 3, 7, and 8 are self-explanatory, and the FAA does not provide further explanation for them at this time.

Special condition no. 4 makes it clear that the flammable-fluid fire-protection requirements of § 25.863 apply to non-rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Non-rechargeable lithium batteries contain electrolyte that is a flammable fluid.

Special condition no. 5 requires each non-rechargeable lithium battery installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape. Special condition no. 6 requires each non-rechargeable lithium battery installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting these special conditions may be the same, but they are independent requirements addressing different hazards. Special condition no. 5 addresses corrosive fluids and gases, whereas special condition no. 6 addresses heat.

These special conditions will apply to all non-rechargeable lithium battery installations in lieu of § 25.1353(b)(1) through (b)(4) at Amendment 25-123. Sections 25.1353(b)(1) through (b)(4) at Amendment 25-123 will remain in effect for other battery installations.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Discussion of Comments

Notice of proposed special conditions no. 25-16-01-SC, for the Boeing 767-2C airplane, was published in the Federal Register on January 27, 2016 [81 FR 4596]. We received four substantive comments.

The Aerospace Industries Association (AIA) provided several comments that were identical to their comments for special conditions no. 25-612-SC, which we issued to Gulfstream Aerospace Corporation for non-rechargeable lithium battery installations on Gulfstream GVI airplanes. The FAA responded to each of these comments in that final special conditions document. We incorporated the same revisions into these Boeing 767-2C special conditions that we incorporated into the Gulfstream GVI special conditions as a result of AIA's comments.

Boeing commented that they fully support AIA's comments.

Boeing requested that the FAA provide adequate time before non-rechargeable lithium battery special conditions become effective to support validation activities by foreign civil airworthiness authorities (FCAA) and to not adversely impact future airplane deliveries by all applicants. The FAA considered this same comment from Boeing for special conditions no. 25-612-SC and provided a detailed response in that document. We determined the effective date for these Boeing 767-2C special conditions based on Boeing's comment and other factors stated in special conditions no. 25-612-SC.

Boeing commented that the FAA needs to clearly define the applicability of these special conditions. Boeing's comment is similar to their comment on special conditions no. 25-612-SC. We provided a detailed response in special conditions no. 25-612-SC and have clearly defined the applicability for these Boeing 767-2C special conditions. One aspect of Boeing's comment that we did not address in special conditions no. 25-612-SC is that some design changes may not change a lithium battery installation but affect it, which results in these special conditions being applicable. For example, adding a heat source next to a lithium battery can increase its possibility of entering into thermal runaway. Lithium battery installations affected by design changes must meet these special conditions. Some examples of changes that affect lithium battery installations are those that:

• Increase the temperatures or pressures in a battery,

• Increase the electrical load on a battery,

• Increase potential for imbalance between battery cells,

• Modify protective circuitry for a lithium battery,

• Increase the airplane level risk due to the location of an existing lithium battery. An example is installation of a new oxygen line next to an existing part that has a lithium battery. The airplane level risk may increase due to the potential hazard of a lithium battery fire in the proximity of oxygen.

Gulfstream Aerospace Corporation commented that they agree with Boeing's comments and requested that the FAA consider incorporating their proposed changes into this document.

AmSafe recommended that the FAA state in the preamble that design mitigation or analysis at the airplane level may be applied to show that designs meet these special conditions. The FAA has determined that these special conditions are to require the battery to be designed to minimize the potential of uncontrollable failure, and to not only rely on mitigation of a battery failure at the airplane level. Therefore, we have not incorporated the proposed revision into the preamble of these special conditions.

AmSafe commented that they concur with proposed special condition no. 1 with an understanding that “foreseeable operating conditions” equates to the full normal operating envelope of the airplane. However, this is not a correct understanding of proposed special condition no. 1. The FAA intends for the term “foreseeable operating conditions,” in these special conditions, to apply at the cell level and not only at the airplane level. In addition, “foreseeable” includes anticipated abnormal operating conditions.

AmSafe recommended revising proposed special condition no. 2 to read, “Battery installation and/or equipment containing any non-rechargeable lithium battery must preclude the occurrence of, or mitigate the effect of self-sustaining, uncontrolled increases in temperature or pressure.” Amsafe's rationale was based on their recommendation that design mitigation or analysis at the airplane level be acceptable. As explained above, the FAA has determined that these special conditions are to require the battery to be designed to minimize the potential of uncontrollable failure, and to not only rely on mitigation of a battery failure at the airplane level. The FAA has not incorporated the proposed revision into special condition no. 2.

AmSafe recommended adding the phrase “. . . failure which is not shown to be extremely remote . . .” to proposed special condition no. 3. The FAA responds that service history shows that battery failure is not extremely remote. Therefore, to ensure that failures are properly anticipated and accounted for, we have not revised proposed special condition no. 3 to include these words.

AmSafe recommended deleting § 25.863(c)(d) from proposed special condition no 4. The FAA does not concur. Section 25.863 already applies to non-rechargeable lithium batteries since they contain electrolyte that is a flammable fluid. Since § 25.863 has historically been applied to flammable fluids related to propulsion and hydraulic systems, the FAA is including special condition no. 4 to ensure that there is no misunderstanding that § 25.863 also applies to these batteries.

AmSafe recommended revising proposed special condition no. 5 to prohibit damage to surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape “in such a way as to cause a hazardous or catastrophic failure condition.” AIA also recommended this revision. The FAA intends for special condition no. 5 to be consistent with § 25.1309. So, we added the words “. . . in such a way as to cause a major or more-severe failure condition.” The revised special condition now reads, “. . . each non-rechargeable lithium battery installation must not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.” The FAA does not concur with excluding major failure conditions.

AmSafe concurred with proposed special condition no. 6.

AmSafe concurred with proposed special condition no. 7 and recommended revising proposed special condition no. 8. However, the FAA deleted these proposed special conditions as explained in our response to AIA's comments in special conditions no. 25-612-SC.

AmSafe recommended revising “safe operation of the airplane” in proposed special condition nos. 9 and 10 to “continued safe operation of the airplane.” The phrase “continued safe operation of the airplane” is used to refer to safe operation of the airplane after a failure has occurred. The phrase “safe operation of the airplane” is more general and appropriate for these special conditions. We did not incorporate AmSafe's proposed revision into these special conditions.

The FAA has determined that “uncontrolled” in special condition no. 2 should be “uncontrollable” to more accurately describe the concern. This revision does not change the intended meaning of this special condition.

Except as discussed above, the special conditions are adopted as proposed.

Applicability

As discussed above, these special conditions are applicable to the Model 767-2C airplane. Should the applicant apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

These special conditions are only applicable to design changes applied for after their effective date. The existing airplane fleet and follow-on deliveries of airplanes with previously certified non-rechargeable lithium battery installations are not affected.

These special conditions are not applicable to previously certified non-rechargeable lithium battery installations where the only change is either cosmetic or relocating the installation to improve the safety of the airplane and occupants. The FAA determined that this exclusion is in the public interest because the need to meet all of the special conditions might otherwise deter such design changes that involve relocating batteries. A cosmetic change is a change in appearance only, and does not change any function or safety characteristic of the battery installation.

Conclusion

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and record keeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, the following special conditions are part of the type certification basis for the Boeing Model 767-2C airplane.

Non-Rechargeable Lithium Battery Installations

In lieu of § 25.1353(b)(1) through (b)(4) at Amendment 25-123, each non-rechargeable lithium battery installation must:

1. Maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.

2. Prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure, that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of § 25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure sensing and warning system to alert the flightcrew if its failure affects safe operation of the airplane.

8. Have a means for the flightcrew or maintenance personnel to determine the battery charge state if the battery's function is required for safe operation of the airplane.

Note: A battery system consists of the battery and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a “battery” and “battery system” are referred to as a battery.

Issued in Renton, Washington, on August 11, 2016. Paul Bernado, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-19991 Filed 8-23-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 95 [Docket No. 31093; Amdt. No. 528] IFR Altitudes; Miscellaneous Amendments AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule

SUMMARY:

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.

DATES:

Effective Date: 0901 UTC, September 15, 2016.

FOR FURTHER INFORMATION CONTACT:

Richard A. Dunham, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954-4164.

SUPPLEMENTARY INFORMATION:

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The Rule

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

Conclusion

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

List of Subjects in 14 CFR Part 95

Airspace, Navigation (air).

Issued in Washington, DC on August 12, 2016. John Duncan, Director, Flight Standards Service. Adoption of the Amendment

Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, July 21, 2016.

1. The authority citation for part 95 continues to read as follows: Authority:

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

2. Part 95 is amended to read as follows: Revisions to IFR Altitudes & Changeover Point [Amendment 528, Effective Date September 15, 2016] From To MEA § 95.6001 VICTOR ROUTES-U.S § 95.6005 VOR Federal Airway V5 Is Amended To Read in Part Pecan, GA VORTAC Vienna, GA VORTAC *2000 *1900-MOCA § 95.6006 VOR Federal Airway V6 Is Amended To Read in Part Liter, WY FIX Sidney, NE VORTAC *9500 *7600—MOCA Sidney, NE VORTAC North Platte, NE VORTAC *6000 *5700-MOCA Grand Island, NE VORTAC HUSKR, NE FIX *4000 *3200—MOCA § 95.6008 VOR Federal Airway V8 Is Amended To Read in Part Grand Island, NE VORTAC Huskr, NE FIX *4000 *3200—MOCA § 95.6020 VOR Federal Airway V20 Is Amended To Read in Part Maddi, GA FIX Athens, GA VOR/DME *3000 *2200-MOCA Athens, GA VOR/DME Electric City, SC VORTAC *2800 *2300—MOCA § 95.6025 VOR Federal Airway V25 Is Amended To Read in Part Santy, CA FIX Woodside, CA VORTAC 5100 § 95.6035 VOR Federal Airway V35 Is Amended To Read in Part *Saler, GA FIX Pecan, GA VORTAC **2000 *3000-MRA **1700-MOCA Maddi, GA FIX Athens, GA VOR/DME *3000 *2200-MOCA Athens, GA VOR/DME Electric City, SC VORTAC *2800 *2300-MOCA § 95.6039 VOR Federal Airway V39 Is Amended To Read in Part Lancaster, PA VORTAC Boyer, PA FIX 2900 § 95.6066 VOR Federal Airway V66 Is Amended To Read in Part Maddi, GA FIX Athens, GA VOR/DME *3000 *2200-MOCA Athens, GA VOR/DME Greenwood, SC VORTAC *2500 *2200-MOCA § 95.6087 VOR Federal Airway V87 Is Amended To Read in Part Santy, CA FIX Woodside, CA VORTAC 5100 § 95.6109 VOR Federal Airway V109 Is Amended To Read in Part Salad, CA FIX *Oakland, CA VORTAC 4000 *4700-MCA Oakland, CA VORTAC, NE BND § 95.6138 VOR Federal Airway V138 Is Amended To Read in Part Piety, WY FIX Sidney, NE VORTAC *7600 *7000-MOCA Grand Island, NE VORTAC Brady, NE FIX *3600 *3200-MOCA § 95.6159 VOR Federal Airway V159 Is Amended To Read in Part *Saler, GA FIX Pecan, GA VORTAC **2000 *3000-MRA **1700-MOCA Pecan, GA VORTAC *Shany, GA FIX **2000 *2800-MRA **1800-MOCA § 95.6169 VOR Federal Airway V169 Is Amended To Read in Part Akron, CO VOR/DME Sidney, NE VORTAC *6400 *6200-MOCA § 95.6197 VOR Federal Airway V197 Is Amended To Read in Part Palmdale, CA VORTAC *Fisch, CA FIX 5000 *8300-MCA Fisch, CA FIX, NW BND § 95.6325 VOR Federal Airway V325 Is Amended To Read in Part Vesto, GA FIX Athens, GA VOR/DME *2500 *2200-MOCA § 95.6380 VOR Federal Airway V380 Is Amended To Read in Part Wolbach, NE VORTAC Grand Island, NE VORTAC *4000 *3300-MOCA § 95.6417 VOR Federal Airway V417 Is Amended To Read in Part Athens, GA VOR/DME Colliers, SC VORTAC *2500 *2100-MOCA § 95.6457 VOR Federal Airway V457 Is Amended To Read in Part Broadway, NJ VOR/DME Lancaster, PA VORTAC 3000 § 95.6499 VOR Federal Airway V499 Is Amended To Read in Part Lancaster, PA VORTAC Binghamton, NY VORTAC 4500 § 95.6578 VOR Federal Airway V578 Is Amended To Read in Part Pecan, GA VORTAC Tift Myers, GA VOR *2500 *2300-MOCA § 95.6579 VOR Federal Airway V579 Is Amended To Read in Part Viola, FL FIX Sarasota, FL VORTAC *3000 *1600-MOCA § 95.6440 Alaska VOR Federal Airway V440 Is Amended To Read in Part Nome, AK VOR/DME *Golos, AK FIX 3000 *4500-MRA *Golos, AK FIX Unalakleet, AK VOR/DME 3000 *4500-MRA Unalakleet, AK VOR/DME Yucon, AK FIX W BND 4600 E BND 8000 From To Changeover points Distance From § 95.8003 VOR Federal Airway Changeover Point Airway Segment Alaska V440 Is Amended To Add Changeover Point Nome, AK VOR/DME Unalakleet, AK VOR/DME 45 Nome
[FR Doc. 2016-20292 Filed 8-23-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF LABOR Employment and Training Administration 20 CFR Part 615 RIN 1205-AB62 Federal-State Unemployment Compensation Program; Implementing the Total Unemployment Rate as an Extended Benefits Indicator and Amending for Technical Corrections; Final Rule AGENCY:

Employment and Training Administration, Labor.

ACTION:

Final rule.

SUMMARY:

The Employment and Training Administration (ETA) of the U.S. Department of Labor (Department) issues this final rule to implement statutory amendments to the Extended Benefits (EB) program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the Total Unemployment Rate (TUR) indicator which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.

DATES:

This rule is effective October 24, 2016.

FOR FURTHER INFORMATION CONTACT:

Gay Gilbert, Administrator, Office of Unemployment Insurance, Employment and Training Administration, (202) 693- 3029 (this is not a toll-free number) or 1-877-889-5627 (TTY). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at (800) 877- 8339.

SUPPLEMENTARY INFORMATION: Executive Summary I. Purpose of the Regulatory Action

a. ETA issues this final rule to implement statutory amendments to the EB program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the TUR indicator, which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.

b. The Unemployment Compensation Amendments of 1992, Public Law 102-318, added Section 203(f), EUCA, to provide for an optional alternative indicator that States may use to trigger “on” EB based on the TUR. That indicator requires that, for the most recent 3 months for which data for all States is published, the average TUR in the State (seasonally adjusted) for the most recent 3-month period equals or exceeds 6.5 percent and the average TUR in the State (seasonally adjusted) equals or exceeds 110 percent of the average TUR for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The 1992 amendments also provided for a calculation of a “high unemployment period” when the TUR in a State equals or exceeds 8 percent and meets the 110-percent look-back described above, permitting the payment of additional weeks of EB. Section 203(f)(3), EUCA, provides that “determinations of the rate of total unemployment in any State for any period . . . shall be made by the Secretary.” An EB period ends when the State no longer meets any of the “on” triggers provided for in State law.

II. Summary of the Major Provisions of the Regulatory Action in Question

To conform the regulations to current practice, the Department is issuing this final rule to describe how the TUR indicators are computed for purposes of determining whether a State meets the 110 percent look-back requirements. The final rule regulations at 20 CFR 615 implement the provisions of EUCA relating to the insured unemployment rate (IUR) indicators, including how they will be computed. The regulation, at 20 CFR 615.12, explains the IUR triggers and how the rates are computed. Until this final rule, the regulation did not address the TUR indicator although the Department issued UIPLs No. 45-92 and No. 16-11, respectively, addressing the TUR indicator and its computation.

Because of these differences in the calculation of the insured and total unemployment rates, the appropriate methodology for computing the look-back percentage for the TUR indicator is to switch from truncation at the second decimal place, which is used for calculating the IUR indicator, to rounding to the second decimal place.

III. Costs and Benefits

This rule has not been designated an economically significant rule under section 3(f) of Executive Order 12866. However, the Department provides an analysis of the impact of the final rule, including a costs and benefits analysis under Executive Order 13563, in the Administrative Section of this final rule. This costs and benefits analysis was conducted for the proposed rule. Since the Department made no changes in the final rule, a new analysis was not conducted.

The Preamble to this final rule is organized as follows:

I. Background—provides a brief description of the development of the final rule. II. Review of the Final Rule—analyzes comments and summarizes and discusses changes to the Federal-State Unemployment Compensation Program. III. Administrative Information—sets forth the applicable regulatory requirements. I. Background

An understanding of the basic elements that comprise the mechanisms used to determine if EB is payable in a State is necessary to appreciate the dynamics of the EB program. EB programs can be triggered by two different measures for unemployment: The IUR and TUR. The table below compares the characteristics of each.

Characteristics IUR TUR Type of Data Administrative Sample. Definition Continued Claims/Covered Employment Unemployed/Employed+Unemployed. Seasonally Adjusted No Yes. Data Source States Bureau of Labor Statistics. Collection Frequency Weekly Monthly. Trigger Value Computation 13-Week Moving Average 3-Month Moving Average.

EB is payable in a State only during an EB period of unusually high unemployment in the State. Section 203 of the Federal-State Extended Unemployment Compensation Act of 1970 (EUCA), Public Law 91-373, provides methods for determining whether a State's current unemployment situation qualifies as an EB period. EB periods are determined by “on” and “off” indicators (commonly referred to as triggers) in the State. Section 203(d), EUCA, provides for an “on” indicator based on the IUR. The IUR is computed weekly by the States using administrative data on State unemployment compensation claims filed and the total population of employed individuals covered by unemployment insurance. States trigger “on” EB if the IUR trigger value for the most recent 13-week period equals or exceeds 5 percent and equals or exceeds 120 percent of the average of such trigger values for the corresponding 13-week period ending in each of the preceding 2 calendar years. The calculation of the relationship between the current rate and prior 2 years' rates is commonly referred to as the “look-back.”

The Unemployment Compensation Amendments of 1992, Public Law 102-318, added Section 203(f), EUCA, to provide for an optional alternative indicator that States may use to trigger “on” EB based on the TUR. That indicator requires that, for the most recent 3 months for which data for all States is published, the average TUR in the State (seasonally adjusted) for the most recent 3-month period equals or exceeds 6.5 percent and the average TUR in the State (seasonally adjusted) equals or exceeds 110 percent of the average TUR for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The 1992 amendments also provided for a calculation of a “high unemployment period” when the TUR in a State equals or exceeds 8 percent and meets the 110 percent look-back described above, permitting the payment of additional weeks of EB. Section 203(f)(3), EUCA, provides that “determinations of the rate of total unemployment in any State for any period . . . shall be made by the Secretary.” An EB period ends when the State no longer meets any of the “on” triggers provided for in State law.

Regulations at 20 CFR part 615 implement the provisions of EUCA relating to the IUR indicators, including how they will be computed. The regulation at 20 CFR 615.12 explains the IUR triggers and how the rates are computed. The regulation does not address the TUR indicator although the Department issued UIPLs No. 45-92 and No. 16-11, respectively, addressing the TUR indicator and its computation. To conform the regulations to current practice, the Department is issuing this final rule to describe how the TUR indicators are computed for purposes of determining whether a State meets the 110 percent look-back requirements.

In the absence of explicit guidance and regulation, the Department previously adapted a portion of the existing guidance for the IUR look-back as a basis for calculating the TUR look-back. Specifically, in computing the look-back percentage for the TUR trigger the procedure for determining the number of significant digits from the resulting fraction followed 20 CFR 615.12(c)(3).

The TUR indicator uses total unemployment rates determined by the Bureau of Labor Statistics (BLS). These rates are measured using sampled data and therefore are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth, or second decimal place. Additionally, rounding, rather than truncating, is consistent with BLS practices in treating the TUR data. UIPL No. 16-11, dated May 20, 2011, informed the State Workforce Agencies (SWAs) that the full effect of this new rounding procedure was implemented retroactive to April 16, 2011.

General

Section 3304(a)(11) of the Federal Unemployment Tax Act (26 U.S.C. 3301 et seq.) (FUTA) requires, as a condition of employers in States receiving credits against the Federal unemployment tax, that the States' unemployment compensation laws provide for the payment of extended unemployment compensation during periods of high unemployment to eligible individuals. EUCA established the EB Program by which, if certain conditions are met in a State under its law, extended unemployment compensation is provided to workers in the State who have exhausted their regular compensation during a period of high unemployment referred to as an EB period. EUCA provides methods for determining whether an EB period exists in the State. These methods are referred to as “on” or “off” indicators.

There were two “on” and “off” indicators in existence before the enactment of the UC Amendments. These indicators were based on the IUR. The IUR indicator's trigger value is, under section 203(e) of EUCA, the ratio of the average number of unemployment claims filed in a State during the most recent 13 weeks to the average monthly number of employed individuals covered by UC in that State during the first four of the last six completed calendar quarters. The first indicator has two conditions which must be met and is required to be in State law. Under section 203(d) of EUCA, the EB Program is activated if a State's IUR trigger value (first condition) is at least 5 percent (referred to as the regular IUR trigger threshold with “look-back”), and is at least 120 percent of the average of the trigger values in the prior 2 years for the corresponding 13-week calendar periods (second condition). The second condition—that the most recent 13-week period must be at least 120 percent of the average of the corresponding periods in the last 2 years—is commonly referred to as the “look-back” provision. (The Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312, allowed States to temporarily modify provisions in their EB laws to use the prior 3 years in applying the look-back.) The look-back provision supports activation of a State's EB Program only when the current unemployment rate is both high and increasing, which indicates that the State's labor market is worsening and additional compensation is warranted. Under the second indicator, which is an option for a State, section 203(d) of EUCA provides the EB Program may be triggered “on” with an IUR trigger value of at least 6 percent regardless of its relation to the IUR trigger values in the preceding 2 years. The 6 percent value is referred to as the regular IUR trigger threshold without look-back.

Alternative Indicator

Because the IUR indicator failed to trigger many States “on” to the EB Program during the recession of the early 1990s, the UC Amendments amended the EUCA to permit States to adopt an alternative, more labor market sensitive, indicator based on the TUR to trigger “on” and “off” the EB Program. Specifically, paragraph (f) of section 203 of EUCA provides for a TUR indicator comprised of a Trigger Value and look-back provision. The Trigger Value for this indicator is the 3-month average of seasonally adjusted TURs for the most recent 3 months for which data for all States is published. The regular TUR trigger threshold is 6.5 percent. The look-back provision requires that the Trigger Value equals or exceeds 110 percent of the TUR Trigger Values for either or both of the corresponding 3-month periods in the 2 preceding calendar years. The TUR Trigger Value is determined by the Department based on data from BLS.

As with the IUR indicator, the look-back provision ensures that the State's TUR Trigger Value is both high and increasing, indicating that the State's labor market is worsening and additional compensation is warranted. A State will trigger “off” its EB Program when either the TUR Trigger Value falls below 6.5 percent, or the requirements pertaining to the look-back provision are not satisfied.

Regardless of whether a State's EB Program is triggered “on” based on the IUR or TUR indicators, sections 203(d)(2) and 203(f)(1)(B) of EUCA provide that the EB period is triggered “off' when the conditions supporting the activation of the EB Program are no longer satisfied. Additionally, when the program triggers “on” or “off” EB payments, it must remain in the new status (“on” or “off” EB payments) for a minimum of 13 weeks regardless of changes in future trigger values.

The Department implemented EUCA's provisions on the IUR indicator at 20 CFR part 615, published in 53 FR 27928, Jul. 25, 1988. The Department implemented the alternative TUR indicator provided by the UC Amendments through guidance on August 31, 1993 (UIPL No. 45-92). The Department now incorporates the TUR indicator into regulations.

Payments of Additional Weeks of Extended Benefits

The UC Amendments provided that States electing to use the new TUR indicator must also provide for the payment of additional weeks of EB during a “high unemployment period” that occurs during an EB period. These additional weeks of EB are available if State law provides for the use of the alternative TUR indicator.

Consistent with EUCA § 203(b)(1), no EB period or high unemployment period may begin in any State by reason of a State “on” indicator before the 13-week minimum status period expires after the ending of a prior EB period with respect to such State. Conversely, no EB period or high unemployment period may end in any State by reason of a State “off” indicator before the 13-week minimum status period expires after the beginning of an EB period with respect to such State.

EUCA originally provided for the establishment of an EB account, and the amount in the account is the least of one of three amounts which is payable for regular extended compensation. The UC amendments added a new paragraph to section 202(b) of EUCA that increases the amount in these accounts during a high unemployment period. The amount payable in a high unemployment period is equal to whichever of the following is the least and is referred to as “high unemployment extended compensation”:

—80 percent (as opposed to 50 percent in a “normal” EB period) of the total amount of regular UC (including dependent's allowances) payable to the individual during the benefit year; —20 (as opposed to 13) times the individual's weekly benefit amount; or —46 (as opposed to 39) times the individual's weekly benefit amount, reduced by the regular UC paid (or deemed paid) during the benefit year.

The term “high unemployment period” is defined in Section 202(b)(3)(B), EUCA, as any period during which an EB Program would be in effect if the TUR indicator equaled or exceeded 8 percent and the TUR indicator equals or exceeds 110 percent of the TUR indicators for either or both the corresponding 3-month periods in the 2 previous calendar years.

Whether a high unemployment period exists in a State for a particular week is determined in accordance with provisions of State law implementing sections 202(b)(3) and 203(f) of EUCA and the seasonally adjusted TUR indicator determined by BLS. When this determination is made, the State follows the requirements of sections 203(a) and (b) of EUCA for determining the first and last week for which high unemployment EB is payable. Specifically, a high unemployment EB period begins on the first day of the third calendar week after the TUR indicator requirements are satisfied, and ends on the last day of the third week after the first week for which the TUR indicator requirements are not met. However, as stated above, no EB period or high unemployment period may begin in any State by reason of a State “on” indicator before the 13-week minimum status period expires after the ending of a prior EB period with respect to such State.

Alternative Indicator Rounding Methodology

Before April 16, 2011, in absence of explicit statutory guidance and regulation, the Department adapted a portion of the requirement (in 20 CFR 615.12) for calculating the look-back percentage for the IUR indicator as a basis for determining the significant number of digits from the look-back percentage for the TUR indicator. Specifically, the quotient is computed to two decimal places and multiplied by 100 with all numbers to the right of the decimal point being dropped (known as “truncation”). The result is expressed as a percentage.

The UC Amendments provide for a State to trigger “on” EB using the TURs determined by BLS. As discussed above, because the TUR indicator uses unemployment rates determined by BLS using sampled data, the rates are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth. In contrast, the IUR indicator values are computed from administrative data and thus represent the full universe. Because of these differences in the calculation of the insured and total unemployment rates, on May 20, 2011 the Department announced, in UIPL No. 16-11, that an appropriate methodology for computing the look-back percentage for the TUR indicator is to switch from truncation at the second decimal place to rounding to the second decimal place.

UIPL No. 16-11 informed States of the new rounding methodology the Department now employs when computing the current trigger rate as a percent of the comparable trigger rates in prior years for the TUR indicator. Since TURs have been rounded, an expression of a ratio of two TURs must also be rounded.

On a monthly basis, the 3-month average of the seasonally adjusted TUR is divided by the same measure for the corresponding 3 months in each of the applicable 2 prior years. The resulting decimal fraction is then rounded to the hundredths place (the second digit to the right of the decimal place). The resulting number is multiplied by 100, reported as an integer, and compared to the statutory threshold to determine if the State triggers “on” EB. UIPL No. 16-11 informed the SWAs that the full effect of this new rounding procedure was implemented retroactive to April 16, 2011.

II. Review of the Final Rule

The Department published the Notice of Proposed Rulemaking (NPRM) on the subject of this final rule in the Federal Register on October 27, 2014 at 79 FR 63859. The NPRM had a 60-day public comment period and allowed for the submission of comments by hand delivery or U.S. Mail or by electronic submission at www.regulations.gov.

At the close of the 60-day public comment period at midnight on December 26, 2014, the Department had received one public comment. After a careful analysis of the comment, which was posted on www.regulations.gov, the Department determined that the comment did not raise any substantive issues that required a response in the final rule. In addition, the Department received no requests for extensions of the public comment period.

Therefore, because the Department did not receive any comments that required a response on the NPRM, this final rule adopts the regulation as proposed, with minor technical corrections explained below.

The final rule updates 20 CFR part 615 so that it includes the TUR indicator. In addition, the final rule updates Part 615 to incorporate the rounding method adopted for the look-back. Also, the final rule makes technical amendments to this part to update its provisions since the last regulatory revision and to correct minor errors in the text of the existing regulations.

However, since the NPRM publication, the Department discovered that minor technical corrections were needed. A non-substantive technical addition of a phrase was made in the definition of “Department” in § 615.2 to acknowledge that a Secretary's Order delegating authority to ETA can be superseded. A non-substantive technical addition was made in the definition of “Extended compensation” in § 615.2 to clarify that “extended benefits” can be used interchangeably with “extended compensation.” Non-substantive deletions were made, in the definition of “Extended unemployment compensation” in § 615.2, of paragraphs (3) and (4). Paragraph (3) of § 615.2 in the NPRM was deleted because it redundantly repeats the substance in paragraph (1) of that section. Paragraph (4) of § 615.2 was deleted because it was placed in this location of the NPRM erroneously, simply as a typographical error.

For ease of reading § 615.2, the definitions in this section have been printed in their entirety. The following definitions are unchanged with the exception of changing Act to EUCA where appropriate: Additional compensation; And; Applicable State; Applicable State law; Average weekly benefit amount; Base period; Benefit structure; Benefit year; Claim filed in any State under the interstate benefit payment plan; Compensation and unemployment compensation; Date; Employed; Gross average weekly remuneration; Hospitalized for treatment of an emergency or life-threatening condition; Individual's capabilities; Jury duty; Reasonably short period; Regular compensation; Secretary; State; State agency; State law; systematic and sustained effort; Tangible evidence; and Week of unemployment. Also, an “s” was removed from the word “mean” in the definition of “Employed,” and since the paragraph designations were removed in order to reorder the definitions alphabetically, the phrase “(n)(2) of this section” was replaced with “(2) of this definition” in paragraph (1), and the phrase “(n)(1) of this section” was replaced with “(1) of this definition” in paragraph (2) in the definition of “Week of unemployment.”

Paragraph (a) of § 615.7 in the NPRM was revised in the final rule to delete the following language—

Removing the term “Extended Benefits” wherever it appears and replacing it with the term “Extended compensation” throughout.

This is no longer necessary since a technical correction was made in the definition of “Extended compensation” in § 615.2 to clarify that “extended benefits” can be used interchangeably with “extended compensation.”

Non-substantive deletions were made in paragraph (d) of § 615.11, which discusses the limitations in an extended benefit period. The paragraph was revised to delete from the NPRM language which reads—

extended benefit period or high unemployment period may begin in any State by reason of a State “on” indicator before the 14th week after the ending of a prior extended benefit period or high unemployment period in such State. Conversely, no extended benefit period or high unemployment period may end in any State by reason of a State “off” indicator before the 14th week after the beginning of an extended benefit period or high unemployment period in such State. In addition, no . . . since this criteria is covered in paragraph (c) of the same section.

Three technical corrections were made in § 615.12. First, “our concurrence” was replaced with “the concurrence of the Department” in paragraph (d)(1). Second, in paragraph (d)(2), “Bureau of Labor Statistics” was spelled out since it is the first use in the rule text, and the paragraph was slightly revised to clarify that unemployment data released by BLS for each month have an initial release and then regular revisions. Third, an identical sentence in paragraphs (e)(1)(ii) and (e)(2)(ii) referencing the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312, was deleted from both paragraphs because it describes a temporary provision of law that no longer applies. Several non-substantive additions and deletions were made in § 615.13. The first was to clarify that paragraphs (a) and (b) were revised by adding paragraphs (a)(1), (a)(2), (b)(1), (b)(2), and (b)(3). Second, the phrase “the Department determines” was added after the word “which” in paragraph (a)(1). Third, the phrase “or high unemployment period” was added in paragraphs (a)(1) and (a)(2). Fourth, “a result of our determination” was replaced with “determined by the Department to be” in paragraph (a)(1).

Finally, typographical errors were corrected in §§ 615.2, 615.12, 615.13, 615.14, and 615.15. In § 615.2, a comma was added after the word “published” in the definition of “High unemployment period,” and “is” was replaced with “as” before the word “described” in the definition of “Trigger Value.” In § 615.12, an “s” was added to the word “State” in paragraph (e)(2)(i), and “However” was deleted and the “t” in the word “the” was capitalized to begin the sentence in paragraph (f). In paragraph (a)(1) of § 615.13, “the” was replaced with “a” before the word “notice”; “to us” located after the word “acceptable” was deleted; “we” was replaced with “the Department”; “will” was added before the phrase “publish in the Federal Register”; and the word “publish” was revised to read “publishes” before the phrase “that information”. In paragraph (a)(2) of § 615.13, “our” was replaced with “of the Department's” before the word “determination”. In § 615.14, the citation to paragraph (a) was corrected to paragraph (c), and the citation to paragraph (a)(4) was corrected to paragraph (c)(4). In § 615.15, “we” was replaced with “the Department,” and “require” was revised to read “requires”.

The final rule, as explained also in the discussion of Paperwork Reduction Act requirements below, retains proposed revisions in the NPRM to regulatory requirements at § 615.15, pertaining to records and reports State agencies must submit. Paragraphs (a) and (b) are revised for clarity by deleting unnecessary language regarding the Secretary's authority to request Extended Benefit Program reports and to appoint audit officials for those reports. Furthermore, the final rule deletes paragraphs (c) and (d). In reference to reporting guidelines discussed in the Paperwork Reduction Act, the ET Handbook is a more effective way to communicate reporting requirements, because codifying the reporting requirements in paragraphs (c) and (d) of § 615.15 prevents the Department from adapting reporting instructions to changing conditions or needs. The ET Handbook requires the weekly submission of Forms ETA-538 and ETA-539. These forms have been computerized and contain information on initial Unemployment Insurance claims and continued weeks claimed. These figures are important economic indicators. Form ETA-538 provides information allowing release of advance unemployment claims information to the public five days after the close of the reference period. Form ETA-539 contains more detailed weekly claims information and the State's 13-week IUR that is used to determine eligibility for the Extended Benefits program. The reporting requirements in paragraphs (c) and (d) of the old regulation are included in the ET Handbook, and elimination of the requirements in regulation allow for ease in making future modifications by simply updating the ET Handbook.

Furthermore, paragraph (d) existed during the implementation phase of the IUR indicator and required States to submit the method used to identify and select the weeks used for EB trigger purposes to ensure that States were consistent and comparable in their methods. With 30 years of experience, as well as numerous data validation and data quality programs in effect, the Department has determined it is unnecessary to compel State administrators to provide this information. Current reporting guidelines contained in the ET Handbook are clear enough that States continue to have clear standards about which claims are used for constructing totals used to compute trigger values, thus permitting the deletion of this paragraph. The NPRM did not change the existing reporting requirements for Forms ETA-538 or ETA-539, and the Department received no substantive comments on the NPRM during the public comment period.

III. Administrative Information Executive Orders 12866 and 13563

Executive Orders (E.O.) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.

Section 3(f) of E.O. 12866 defines a “significant regulatory action” as an action that is likely to result in a rule that: (1) Has an annual effect on the economy of $100 million or more or adversely and materially affects a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities (also referred to as “economically significant”); (2) creates serious inconsistency or otherwise interferes with an action taken or planned by another agency; (3) materially alters the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866. Regarding item (4), any novel legal or policy issues raised by this rule do not arise from legal mandates, Presidential priorities, or the principles set forth in E.O. 12866.

For a “significant regulatory action,” E.O. 12866 asks agencies to describe the need for the regulatory action and explain how the regulatory action will meet that need, as well as assess the costs and benefits of the regulation.1 In the Unemployment Compensation Amendments of 1992 (UC Amendments), Congress adopted an optional indicator for the existing EB Program that is based on both the level of the TUR Trigger Value and the percentage the Trigger Value is of Trigger Values in comparable periods in each of the prior years (referred to as the look-back).2 Although the TUR indicator was implemented in the early 1990s, there was never any regulation put in place defining its computation and its application. The Department is establishing regulations for the TUR indicator which interpret the law related to the TUR indicator and clarify the computation of its look-back provision. As discussed in more detail in the Background section above, the Department uses rounding to calculate the TUR because it is consistent with the BLS's calculation of unemployment rates. Based on the economic impact analysis that follows, the Department believes this is not an economically significant regulatory action.

1 Executive Order No. 12866, § 6(a)(3)(B).

2 Unemployment Compensation Amendments of 1992, Public Law 102-318 (1992). This law added Section 203(f) to EUCA to provide for an optional alternative indicator that States may use to trigger “on” or “off” EB based on the total unemployment rate. EUCA originally provided for an “on” indicator based only on the IUR. EUCA, § 203(d)-(e).

EUCA, as amended by the UC Amendments, requires two conditions be met for a TUR-based “on” indicator to occur in a State: (1) For the most recent 3 months for which data for all States is published, the 3-month average seasonally adjusted TUR in the State equals or exceeds 6.5 percent, and (2) that the Trigger Value equals or exceeds 110 percent of the Trigger Values for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The UC Amendments also provide for a “high unemployment period” when the TUR Trigger Value in a State equals or exceeds 8 percent and meets the 110 percent look-back described above, permitting the payment of additional weeks of compensation.3 States that want to use the optional TUR indicator must have authority under State law which may require States to enact legislation that implements the Federal requirements. An EB period ends when the State no longer meets any of the “on” requirements provided for in State law.

3 EUCA, § 202(b)(3)(B). Meeting the 6.5 percent TUR indicator permits eligible claimants to receive up to an additional 50 percent of their regular entitlement during an EB period. Meeting the 8.0 percent indicator permits eligible claimant to receive up to a total of 80 percent of their regular entitlement during a high EB period.

Under the original methodology by which the Department determined the look-back criterion for the optional TUR indicator, the indicator's Trigger Value was divided by the indicator's Trigger Value for the comparable period in the preceding year and 2nd preceding year. Digits beyond the hundredths place (the second digit to the right of the decimal place) in the resultant decimal fractions were truncated and the results multiplied by 100 to determine the percent the current indicator Trigger Value was of the indicator Trigger Value in the comparable periods in the prior years. If the result was greater than or equal to 110 for one of the fractions, the look-back criterion was met. This approach paralleled the method used for the IUR look-back computation established in regulations at 20 CFR 615.12(c)(3); however, neither the law nor regulations specify the method for computing the TUR indicator look-back.4

4 EUCA provides that “determinations of the rate of total unemployment in any State for any period . . . shall be made by the Secretary.” EUCA, § 203(f)(3).

The Department is changing the method for computing the TUR look-back by rounding to the hundredths place, rather than truncating. The TUR indicator uses total unemployment rates determined by BLS. These rates are measured using sampled data and therefore are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth, or second decimal place. In contrast, IUR indicators are computed from administrative data and thus represent the full universe. Because of these differences in the computation of the insured and total unemployment rates, the Department has determined that an appropriate methodology for computing the look-back for the TUR indicator is to switch from truncation at the second decimal place, to rounding to the second decimal place. Rounding, rather than truncating, is consistent with BLS practices for TUR data. UIPL No. 16-11, dated May 20, 2011, informed the SWAs that the full effect of this new rounding procedure was implemented retroactive to April 16, 2011.

Rounding Change in the TUR Look-Back Computation ER24AU16.122 Where: Three Mo. SATUR = 3-month average seasonally adjusted total unemployment rate. Three Mo. SATUR (−1) = 3-month average seasonally adjusted total unemployment rate for the corresponding period in the prior year period. Potential Impacts

Changing the look-back computational method will have a marginal economic impact because of the new rounding method and no increased operational burden because it would result in no change in claimant behavior or in procedure from the existing process.5 The TUR indicator and new rounding method are currently implemented for the States to use; however, because the Department is implementing in regulations the TUR indicator as well as the new rounding method for the TUR look-back, the Department offers estimates of both impacts.

5 The process of look-back calculation is done in the Division of Fiscal and Actuarial Services, Employment and Training Administration of the U.S. Department of Labor, using data from the Bureau of Labor Statistics which calculates the trigger values. The operational procedure will remain exactly the same as done previously by State and Federal staff.

The UI program is a transfer payment program. For the purposes of a cost-benefit analysis under E.O.s 13563 and 12866, transfer payments are not considered a cost. Therefore, the analysis will be on the possible redistribution of wealth that may take place, as opposed to any impact on aggregate social welfare.6 In this case, the redistribution is primarily one that takes place over time rather than between groups. More specifically, the UI program is structured to act as a counter-cyclical program in terms of its impact on the economy—during recessions increased benefit payments (much higher than taxes paid) provide temporary income support and greater economic stimulus which prevents greater economic distress, while during expansions the program acts through higher taxes to lower overall employment and demand levels. Because a State whose Trigger Value meets or exceeds the threshold and whose look-back falls short of meeting the requirement by 0.05 percentage point or less would trigger “on” under the rounding computation while under the truncation method would keep the State “off,” the change marginally increases extended compensation as the TUR Trigger Value increases in a recession. A change to increase the duration of benefits during recessions will ultimately increase the counter-cyclical nature of the program by increasing stimulus during recessions while slightly decreasing economic activity during expansions. Following is an impact analysis which estimates the change in the level and timing of the UI benefits paid and taxes collected as a result of the change for the look-back provision of the TUR indicator.

6See Office of Management and Budget, Circular A-4: Regulatory Analysis, p. 46 (Sept. 17, 2003), available at http://www.whitehouse.gov/omb/circulars_default.

The actual future impacts of changing the look-back calculation on the flow of UI benefits and taxes are dependent upon the unemployment rate in relation to the TUR trigger threshold and the number of States that have actually implemented the optional TUR indicator. Historically, the proportion of months that the EB Program has been in effect was extremely low, due primarily to a relatively high threshold in relation to the level of unemployment, unwillingness by States to adopt the optional indicators, and Federal emergency benefit programs that at times can and have supplanted the EB Program. For example, on average for the 1991 and 2001 high unemployment periods, State indicators were “on” in roughly 3 percent of the State trigger months.7 In contrast, this past recession's high unemployment period (2007-2011) has been quite unique: In over 40 percent of the State trigger months, the EB Program has been “on,” due primarily to the large number of States adopting the optional TUR indicator once the Federal Government began paying 100 percent of the costs (see Table 1).

7 State trigger months are the number of months during high unemployment periods (see notes to Table 1) multiplied by the number of States, i.e., 53. During non-recessionary the percentage would be even less and close to zero. Extended Benefit Program data is found in the DOL ETA-394 annual report. http://www.workforcesecurity.doleta.gov/unemploy/hb394.asp.

Table 1—How Often the Extended Benefit Program is “On” High unemployment periods State trigger months State trigger months EB was “on” Percent of
  • trigger months
  • EB was “on”
  • 1991-1994 1 2,226 111 5.0 2001-2004 2 2,438 38 1.4 2007-2011 3 2,392 1,055 44 1 Period begins in July 1991 and goes to Dec. 1994 to include the post recessionary period of high unemployment. 2 Period begins in Mar. 2001 and goes to Dec. 2004 to include the post recessionary period of high unemployment. 3 Period begins in Dec. 2007 and goes to Sept. 2011 to include the post recessionary period of high unemployment.

    Only seven States adopted the optional TUR indicator upon its introduction in 1993. Then from 1994 through 2008, only four more States added the TUR indicator to their State law, bringing the number to 11 at the start of 2009 (see Table 2). The number of States implementing the optional TUR indicator and how often the EB Program is actually activated are critical pieces of information for estimating the impacts of the look-back rounding methodology change. In 2009, as part of the American Recovery and Reinvestment Act (Recovery Act), the Federal government began paying 100 percent of extended compensation and high unemployment extended compensation, so the number of States that adopted the optional TUR indicator went up to 38 in 2009, then 39 in 2011.8 All of the 28 States that adopted the TUR indicator post-Recovery Act instituted the TUR indicator on a temporary basis—for as long as the Federal government was paying 100 percent of the compensation for the EB Program.

    8 An additional feature of the TUR trigger that should be noted is that for claims beginning after December, 2010, Congress added a 3rd year to the look-back calculation, so that if for the most recent three-month period the TUR equals or exceeds 6.5 percent (or 8.0 percent) and the average TUR in the State equals or exceeds 110 percent of the average TUR for any or all three of the corresponding three-month periods in the 3 preceding calendar years, then EB will trigger “on.” Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Pub. L. 111-312, § 502 (Dec. 17, 2010). This feature expired on January 1, 2012, and was not included in the impact analysis.

    Table 2—States That Have Adopted the Optional EB TUR Indicator Years Total TUR
  • indicator states
  • 1993-1998 7 1999-2001 8 2002 9 2003-2004 10 2005-2008 11 2009-2010 38 2011 39
    States Alaska New Hampshire North Carolina New Mexico New Jersey Alabama Maryland. Connecticut Arizona Kansas California Oregon Colorado Rhode Island Delaware Vermont District of Columbia Washington Florida Georgia Idaho Illinois Indiana Kentucky Maine Massachusetts Michigan Minnesota Missouri Nevada New York Ohio Pennsylvania South Carolina Tennessee Texas Virginia West Virginia Wisconsin
    Impact Assessment Methodology

    ETA used two distinct methodologies, a time-series simulation and a Monte Carlo-type simulation analysis (each explained more fully below), to provide quantitative impact estimates for the change in the level and timing of the UI benefits paid and taxes collected as a result of the change in formulation of the TUR indicator. The specific goal of these two analyses is to provide a quantitative measure for: (1) The increased probability of a State turning “on” the EB Program under the new rounding rules, and (2) the likely change in the aggregate level of UI benefits and taxes with each instance of additional EB benefits paid. The results of these measures will allow a determination of the economic impact of that occurrence of additional EB benefits paid on the overall economy and on any subgroups.

    The time-series simulation estimates are developed using a historical simulation methodology: By first applying the existing TUR indicator computation, and then applying the new rounding rules to data from a specified period of time and measuring the difference in outcomes. To examine the impact on outcomes, the data used is from the introduction of the optional TUR indicator in 1993 through September 2011 when this analysis was completed. This period encompasses two recessions of varying severity, two complete economic cycles, and a large number of States turning “on” the EB Program. This period also includes the temporary period of 100 percent Federal reimbursement of EB benefit payments when a majority of States, 39, adopted the TUR indicator.9

    9 The analysis does not include the computation of the 3 year look-back or the periods under which any State may have triggered “on” the EB Program by using the 3 year look-back. State data on adoption of the TUR trigger can be found on the weekly trigger notice at http://www.workforcesecurity.doleta.gov/unemploy/claims_arch.asp.

    The baseline case is considered to be the simulated outcomes under the current TUR look-back computation for the States that had adopted the optional TUR indicator. For each month during this historical period (January 1993 through September 2011), the actual seasonally adjusted 3-month average TUR 10 was used as well as the actual look-back percentages for each State that had adopted the TUR indicator. The number of months in EB periods was then estimated for each state.11 The TUR look-back percentage was then computed using the new rounding methodology and the analysis rerun. These computations enabled measurement of the differences between the two types of trigger formulations in the number months when the EB Program is triggered “on,” and then the amount of extended benefits paid.12

    10 The data for monthly seasonally adjusted State total unemployment rates is from Bureau of Labor Statistics LASST01000006 (http://data.bls.gov/timeseries/LASST01000006). The total amount of monthly EB benefits paid is from the Division of Fiscal and Actuarial Services in the Employment and Training Administration of the Department of Labor report 394 can be found here: http://www.workforcesecurity.doleta.gov/unemploy/hb394.asp.

    11 The “on” period was computed for each state rather than using the actual historical outcome.

    12 Under the new rounding of the look-back formulation there will only be cases when the look back percentage in either of the 2 years, will be higher than the original so the EB Program will turn “on” while the original method will have the EB Program as “off.”

    Probability of Turning “On” EB. Using just the States that had adopted the TUR indicator, there were 2,271 monthly observations in this simulation, of which there were 1,170 instances when a State triggered “on” the EB Program by using the TUR indicator under the current methodology. When the new rounding rules were applied there were 1,177 instances—only 7 additional instances when a State would have triggered “on” EB, an increase of 0.6 percent (see Table 3).

    Table 3—Extended Benefit Periods Under the Old and New TUR Indicator 1 [1993-2011] Estimated # of instances of EB “on” # of instances of EB w/TUR indicator
  • ≥ 6.0%
  • # of instances of EB w/TUR indicator
  • ≥ 8.0%
  • Old Method 1,170 362 808 New Method 1,177 365 812 Source: Periods of EB are estimated using federal law and data from the Bureau of Labor Statistics seasonally adjusted Total Unemployment Rate series by State LASST01000006. 1 Data consists of measuring only the periods when the EB Program triggered “on” based on the TUR indicator and included only the States that had adopted the optional TUR indicator. The number of instances refers to the number of State months.

    The seven instances included six different States. In four of the instances, the State was triggering “on” because of the 8.0 percent high unemployment period. In none of the instances were there two consecutive months in which a State had a different EB triggering outcome under the new rounding methodology compared to the truncation method. Two of the instances when States triggered “on” EB due to the rounding calculation occurred following the 1991 recession, one occurred following the 2001 recession, and four occurred following the 2007 recession when 39 States had adopted the optional TUR indicator (see Table 4). In six of the seven occurrences, the difference in the look-back calculation occurred in the 2nd prior year look-back calculation.

    Table 4—Periods When EB was Triggered “on” Under the New Rounding Formulation State EB Trigger date Rounded
  • 3-month SATUR
  • First year
  • look-back
  • truncated
  • Second year look-back
  • truncated
  • First year look-back rounded Second year look-back rounded
    Alaska 2/28/1993 8.0 86.02 109.58 86 110 Connecticut 5/31/1993 6.8 91.89 109.67 92 110 Oregon 11/30/2003 8.0 106.66 109.58 107 110 Alaska 1/31/2009 6.8 109.67 109.67 110 110 Alabama 3/31/2011 9.2 90.19 109.52 90 110 Kansas 3/31/2011 6.8 94.44 109.67 94 110 Georgia 4/30/2011 10.0 98.03 109.89 98 110

    The 0.6 percent increase in the EB Program's being “on” in this simulation represents the percentage likelihood change in the number of times that the EB Program would trigger “on” due solely to the change in formulation of the look-back mechanism for, on average, 13 States having the TUR indicator in place. Therefore, the likelihood of a State turning “on” the EB Program with the new rounding formulation may be represented by .05 percent (.6/13).

    The time series estimates used the actual State unemployment rates as they occurred from 1993 through September 2011 and include only the States which had adopted the optional TUR indicator. To provide further support for the estimate of the difference in the number of times the EB Program may trigger “on” due to rounding in the look-back calculation during a recession, an additional analysis was employed based on a Monte Carlo-type methodology. The Monte-Carlo methodology allows the simulation of thousands of possible State TUR values rather than just the historical values used in the time series analysis. Thirteen States—the seven original States that adopted the optional TUR indicator and six additional randomly selected States—were chosen,13 and then, using the mean and standard deviation of their total unemployment rates during the past four recessions,14 one thousand TUR periods were created for each State using a random number generator with a normal distribution. The number of periods when the EB Program would trigger “on” by rounding as opposed to truncating was computed. Of the 13,000 total State observation periods (each representing recessionary periods), the EB Program would have triggered “on” in 4,822 periods using the original method of truncation for the look-back computation, while the EB Program would have triggered “on” in 4,903 periods using the method of rounding, an increase of 81 additional periods (see Table 5).

    13 Thirteen States were used as a number of States likely to maintain the TUR indicator in the future. The six States were randomly selected to insure a representative group from the remaining States. The six States randomly chosen were: Colorado; Delaware; Illinois; Kentucky; Maine; and Maryland.

    14 The mean and standard deviation were taken from actual monthly observations over the recession and post-recession periods of: 1980-1983; 1991-1993; 2001-2003; and 2008-2011.

    Table 5—Difference Between EB Trigger Formulations Under Simulated Recessionary TURs [For 1,000 simulations for each State] State 1 Mean TUR in recession
  • periods
  • (%) 2
  • Standard
  • deviation of
  • recession
  • period 2
  • Instances when EB “on” w/truncating Instances when EB “on” w/rounding Difference % increase due to
  • rounding
  • Alaska 8.14 1.21 448 459 11 2.40 Colorado 6.35 1.48 226 229 3 1.31 Connecticut 6.31 1.59 363 375 12 3.20 Delaware 6.23 1.80 367 371 4 1.62 Illinois 8.22 1.98 499 507 8 1.58 Kansas 5.32 1.08 119 120 1 0.83 Kentucky 8.04 2.07 510 517 7 1.35 Maine 6.70 1.48 418 425 7 1.65 Maryland 5.24 1.30 183 185 2 1.08 Oregon 8.53 2.03 512 521 9 1.73 Rhode Island 8.01 2.08 497 506 9 1.78 Vermont 5.66 1.21 221 223 2 0.90 Washington 8.06 1.95 459 465 6 1.29 1 Original seven States to adopt the optional TUR indicator are in bold. 2 The mean and standard deviation were taken from actual monthly TUR observations over the recession and post-recession periods of: 1980-1983; 1991-1993; 2001-2003; 2008-2011.

    Across the States this represents, on average, a 1.7 percent (81/4822) increase in the likelihood of turning “on” the EB Program under the new rounding rules (see Table 6). This also represents the cumulative difference of the 13 States, meaning that each State in this simulation could be considered to have added a 0.13 percent increase of an added instance of turning “on” the EB Program (1.7/13). This value will be used as the per-State increase in the likelihood of turning “on” the EB Program under the new rounding rules in this simulation.

    Table 6—Monte Carlo-Type Analysis of Difference in EB Trigger Formulation [For 1,000 simulated monthly trigger values per State] State # Instances EB “on”
  • w/truncating
  • # Instances EB “On”
  • w/rounding
  • Difference % Difference
    13 States 4,822 4,903 81 1.7 Per State Average 371 377 6 Source: Computations made by U.S. DOL ETA/OUI/DFAS.
    Transfer to EB Recipients: Temporary Income Support (During Recession)

    The revision to the TUR indicator computation methodology will result in increased benefits payments during a recession, which provide temporary income support and greater economic stimulus than would otherwise exist during that economic time period. This increased economic stimulus will prevent greater economic distress during a recession. This impact is not a true benefit of the rule because, as explained above, the TUR indicator formulation would redistribute existing transfer payments only over time. That is, a change to increase extended benefits during recessions will ultimately increase the counter-cyclical nature of the program by increasing stimulus during recessions while doing the opposite during expansions.

    Increased Compensation. A value for the amount of additional extended compensation and number of people who would receive the extended compensation under the rounding rules was estimated using a time-series methodology. The estimated total level of extended compensation that would have been paid under the look-back computation was estimated using a weekly survival rate method. In this methodology, for each week that the EB Program is “on,” the number of State EB claimants is multiplied by the State average weekly benefit amount to get the weekly total benefit amount. To arrive at the weekly number of EB claimants, a weekly survival rate is applied for each week of EB to a beginning number of regular UI program exhaustees.15 This was done for each week of the EB period (either 13 or 20 weeks) and aggregated to get total EB payments for the applicable period, i.e., the period during which each State was “on” EB. This computation is represented in the formula below.

    15 Survival rate is the probability that a claimant will collect Unemployment Compensation from one week to the next. An exhaustee is a person collecting Unemployment Compensation who would be in their last week of compensation but for the EB Program.

    Computation of Total Extended Compensation Paid

    Total Wkly Extended Compensation EB Benefits = Σ (Reg. Program Wkly Exhaustions 16 * Wkly Survival Rate 17 ) * Avg. Wkly Benefit 18 (Summed over each week of the EB period.)

    16 ETA-5159 report includes monthly regular program exhaustees which were divided by the number of weeks in a month to get weekly data.

    17 The weekly survival rate is the proportion of individuals claiming unemployment compensation in week n that will also claim unemployment compensation in week n+1. A weekly survival rate of 0.97 was used as a constant for each week of extended benefits. This level is derived from the Division of Fiscal and Actuarial Services State Benefit Forecasting Model.

    18 State average weekly benefit is derived from the ETA-5159 monthly claims report: http://www.workforcesecurity.doleta.gov/unemploy/finance.asp.

    Applying this computation to the seven State periods that turned “on” the EB Program under the rounding formulation in the time series simulation, it was estimated that in total $294 million 19 more would have been paid out in extended compensation, and there would be an increase of 148,000 20 new first payments in the EB Program. This translates into an estimated 1.2 percent increase ($294 million/$24,897 million—total extended compensation in the simulation) in extended compensation and a 1.5 percent increase ($148,000/$9.6 million—total EB first pays in the simulation) of EB first payments under the rounding rules compared to the current methodology (i.e., truncating the look-back computation after two decimal places).

    19 This amount is, of course, dependent on the size of the States, but it does represent a reasonable estimate since these are the States most likely to have the TUR indicator in the future. Also, this amount is considered a high estimate, since 4 of the States triggered on to 20 weeks of benefits, and the average is a reasonable expected value for the level of per State extended benefits. For all of the periods except one (Alaska, 1/2009) during the State EB period triggered on by the rounding calculation, there was no “on” period for the truncation calculation. The Alaska data was adjusted for the truncation period.

    20 Estimated increase in the number of first payments in the seven state periods of triggering on EB found in the Time-series analysis.

    Again, dividing these results into the per State added percentage point increase for each instance of triggering “on” the EB Program means there would be a 0.17 percent increase in extended compensation paid 21 and a 0.22 percent increase 22 in first payments.

    21 Total additional extended compensation from rounding, $294 million divided by the number of State periods, 7, and then divided by the total extended compensation for the entire period, $24,897 million.

    22 The increase in first pays due to rounding, 148,000, divided by the number of State periods, 7, and then dividing by the total number of EB first pays during the period of 9.6 million.

    In terms of how the increased extended compensation paid would be distributed among subgroups of EB recipients, attempting to disaggregate this level of benefits into numerically small select subgroups of claimants such as low-wage workers, or minority claimants, would mean working with monetary flows of very little statistical consequence. Therefore, the Department has determined that no distributional analysis is necessary.

    Transfer From State Unemployment Insurance Accounts: Increased Employer Taxes (During Expansions)

    The revision to the TUR indicator computation methodology will result in increased economic stimulus during recessions. However, a significant increase in extended compensation may result in a State UI tax increase on employers. An increased UI tax on employers might result in dampened overall economic activity as employers postpone equipment purchases or hiring. This impact does not represent a true cost of the changes made in this rule because it is associated with a corresponding transfer of payments to EB recipients during recessions. That is, the regulation would result in redistribution of wealth over time (based on the counter-cyclical nature of the EB Program), rather than have a net social welfare impact.

    UI Taxes. Except for the temporary provisions that are no longer in effect, Federal statutes specify that 50 percent of extended compensation is paid from the Extended Unemployment Compensation Account (EUCA) in the Unemployment Trust Fund (UTF), which is funded through the Federal Unemployment Tax Act (FUTA), and 50 percent is paid by the liable State from its account in the UTF.

    The Federal monies for extended compensation flow from EUCA, which is also used to fund additional Federal emergency benefit programs. Historically, the balance of this account has been sufficient to pay the level of extended compensation during a recession and would therefore be much greater than the estimated amounts that may result from the change in the look-back mechanism.23 Nevertheless, even if EUCA, together with the other Federal accounts in the UTF is depleted, the account can obtain advances from the General Fund with no impact on the FUTA tax, which means there would be no expected increase in Federal taxes from the change in formulation of the TUR indicator.

    23 Historical balances of the EUCA fund can be found here: http://www.treasurydirect.gov/govt/reports/tfmp/tfmp_utf.htm.

    On the State side, every State has a tax structure that responds with higher taxes when the amount of reserves in its UTF account declines.24 Thus, a significant increase in paid extended compensation may result in a State UI tax increase on employers. However, the tax response takes place only with relatively large changes in the State trust fund account balance, and differs by State depending on the size of the account balance; small changes in a State trust fund account balance may actually have no impact in a State's UI taxes. To gauge the magnitude of the tax impact from an increase in extended compensation paid, a generalized rule of State UI tax collections can be applied: For any specified increase in unemployment compensation, 100 percent of the increase will be collected in UI taxes over a 10-year period.25

    24 For applicable State triggering laws see Comparison of State UI Laws: http://www.workforcesecurity.doleta.gov/unemploy/comparison2011.asp.

    25 Recoupment rule of UI taxes in response to a compensation increase is from an Office of Unemployment Insurance, Division of Fiscal and Actuarial Services State Revenue model run over a range of scenarios, 12/2011.

    Using the estimated increase of extended compensation paid (due to the TUR indicator rounding computation) from the time-series simulation, $294 million, an estimate was derived for the amount of potential State tax increases by assuming the increase in extended compensation was divided among the average number of States that experienced an increase in extended EB compensation paid over a 10-year period. To arrive at an estimate for the expected increase in State unemployment compensation taxes due to a change in the rounding rule for the look-back feature of the TUR indicator, 50 percent of the total extended compensation, $147 million, is assumed to be financed by seven States for an average of $21 million per State. The amount is assumed to be financed by increased State taxes over a 10-year period for an average of $2.1 million per year. This amount represents an estimated increase of 0.14 percent 26 in State unemployment compensation taxes for each State that turns “on” the EB Program under the new rounding rules.

    26 Derived by taking the average estimated yearly tax increase per State, $2.1 million, divided by the estimated amount of contributions per State per year, $1.4 billion. This is certainly a very rough estimate that depends on the size of the States having the optional TUR indicator in the simulation. However, because those States would be expected to continue having the indicator, it is considered a reasonable level.

    Table 7—Estimated Increase in State Taxes Collected Under New Rounding Formulation [Based on the estimated extended compensation from the Time-Series data, 1993-2011] Period Est. amt. of added extended
  • compensation
  • to finance 1
  • (mil.)
  • Amt. financed per state 2
  • (mil.)
  • Avg. amt. financed per year
  • (mil.)
  • % Increase in taxes per state 3
    1993-2011 data period $147 $21 $2.1 0.14 1 Fifty percent of total estimated amount of increased extended compensation paid due to rounding from the Time-Series Data. 2 Derived from 50 percent of the estimated increase in extended compensation payments under the Time Series data divided by the number of States that experienced an increase. 3 Total extended compensation to be financed divided by the total unemployment compensation contributions over the period: http://www.workforcesecurity.doleta.gov/unemploy/hb394.asp.

    In terms of specific distribution of these impacts, disaggregating the tax increases into subgroups of employers such as small businesses would mean working with monetary flows of very little consequence. Therefore, the Department has determined that no distributional analysis is necessary.

    Non-Quantified Impacts

    OMB Circular No. A-4 requires the identification of any non-quantifiable benefits and costs that cannot be reasonably measured.27 One primary non-quantifiable benefit of implementing regulations for the TUR indicator and the associated rounding rule, and which is a driving factor for its adoption, is that by codifying the TUR indicator the Department will explicitly clarify a methodology for computing the TUR look-back that regulations previously left unspecified. This final rule will remove the potential for future misunderstanding in the computation of the optional TUR indicator, as compared to the current status quo where the TUR look-back computation method is not specified in Department regulations.

    27See Office of Management and Budget, Circular A-4: Regulatory Analysis, pp. 2-3, 10, 26-27 (Sept. 17, 2003), available at http://www.whitehouse.gov/omb/circulars_default.

    Regarding the secondary impacts from increased temporary income during recessions and increased employer taxes during expansions, the Department has determined that the estimates of extended compensation and UI tax increases are too small to meaningfully model their impact on the macro economy. With a likely impact of increasing the number of instances the EB Program triggers “on” by two during an average recession and nine instances during a severe recession (as computed in detail in the scenarios below), these impact numbers are too small to model any stimulus impact during a recession or a dampening effect of the tax increases during expansions. Not only are the impacts on extended compensation and taxes small compared to the U.S. economy (e.g., far below the $1 billion limit for use of an economic multiplier effect on the level of employment or economic activity 28 ), but even compared to aggregate unemployment compensation payments and taxes the numbers are rather insignificant.

    28 In OMB Circular A-4 in reference to the size of stimulative impacts: “. . . that rules with annual costs that are less than one billion dollars are likely to have a minimal effect on economic growth.”

    Potential Future Stimulative and Distributional Impacts Scenarios

    By increasing the overall level of benefits paid by States during recessionary periods, the change in TUR indicator computation methodology would aid in the counter-cyclical nature of the Unemployment Compensation program by increasing the economic stimulus during recessions and possibly dampening overall activity with possible higher taxes. The estimates for the increased probability of States triggering “on” the EB Program, increased benefits, higher first payments, and potential changes to UI taxes, can provide estimates for the change in flows of the Unemployment Compensation program that this proposal may cause under various future recessionary scenarios.

    Scenario 1 (11 States with the optional TUR indicator; typical severity 3-year recession and post-recession period).29 In a likely scenario, assuming a recession and post-recession high unemployment period lasting 3 years, with 11 States having the optional TUR indicator in place, it would mean 396 possible State months (11 States * 36 months) of high enough unemployment for the EB Program to trigger “on.” Using the results from the high unemployment periods in the Monte Carlo-type analysis, the Department could expect approximately 147 periods of the EB Program to be triggered “on” in States with the optional TUR indicator (37 percent 30 * 396 State months) using the original truncation methodology. With 11 States having the optional TUR indicator, the likelihood of turning “on” the EB Program under the rounding methodology would be 1.4 percent (11 States * 0.13 percent per State likelihood), this would increase the number of EB Program periods by two instances (1.4 percent * 147 periods). Assuming a recession with $2 billion in total extended compensation paid and 1.5 million first payments in the EB Program, then with two more instance of the EB Program triggering “on” the Department would expect an increase in extended compensation paid of $7 million (0.34 percent * $2 billion) and an increase of 7,000 in the number of first payments (1.5 million * 0.44 percent). The resulting tax increases spread over a 10-year period in one State would then be expected to be approximately $350,000 per year (($7 million * 0.5 State cost)/10 years).

    29 Similar in severity to the 1991 recession.

    30 A value similar to the percentage of State months that triggered on to EB in the 1991 and 2001 recessions.

    Scenario 2 (20 States with optional TUR indicator; more severe 3-year recession and post-recession period).31 In a less likely scenario, but one with possibly the highest expected impact, assuming a recession and post-recession period lasting 3 years, with 20 States having the optional TUR indicator in place—720 State months (20 States * 36 months). In a more severe recession the Department could expect 360 periods of the EB Program to be triggered “on” with the optional TUR indicator (720 * 50 percent 32 ). With 20 States having the optional TUR indicator the likelihood of triggering “on” the EB Program under the new rounding rules would be 2.6 percent (20 States * 0.13 percent 33 ) this would increase the number of periods the EB Program would be triggered “on” by nine instances (2.6 percent * 360 periods). Assuming a recession with $5 billion in total extended compensation paid and 3.0 million first payments for the program,34 with nine more instances of the EB Program triggering “on,” the Department would expect an increase in extended compensation of $77 million (0.17 percent 35 * 9 periods * $5 billion) and an increase of 59,000 in the number of first payments for the program (3 million * 9 periods * 0.22 percent). The resulting tax increases spread over a 10-year period in one State would then be expected to be approximately $190,000 per year ($77 million * 0.5 State cost)/20 States)/10 years).

    31 Similar in severity to the 2007 recession.

    32 Assumed likelihood of triggering on EB in a severe recession.

    33 Calculated likelihood of triggering on EB in the severe recession for States with optional TUR trigger under the new rounding rules.

    34 Calculated from average costs and payments made during recessions 1980-2001.

    35 Assumed likelihood of triggering on EB in this type of recession.

    Impact of the TUR Option

    The preceding impact analysis focused on changing the computational methodology of the TUR look-back provision. Since the Department is not considering the removal of the optional TUR indicator, the analysis does not measure the impact of the original adoption of the TUR indicator in 1992. However, it should be noted that a review of the most evident differences caused by the implementation of this option shows a rather small impact.

    From 1993 to 2006, for the 11 States that adopted the TUR indicator by 2006 (Table 2), EB costs are totaled for each period when one of these States triggered on to the EB Program with the TUR option but would not have turned on extended compensation under the IUR option.36 During this 14-year period, there were 28 instances when a State triggered on to the EB Program using the TUR option and would not have triggered on using the IUR trigger. The total extended compensation costs of these instances were approximately $310 million and the number of First Payments was 330,000.

    36 For a state to trigger on extended compensation using the IUR, its insured unemployment rate (IUR) for the previous 13 weeks is at least 5 percent and is 120 percent of the average of the rates for the corresponding 13-week period in each of the 2 previous years.

    Table 8—States Triggering on to the EB Program Using the TUR Option [Without qualifying with the IUR Option] 1993 1994 1995 1996 1997 1998 1999 Alaska
  • Oregon
  • Rhode Is
  • Washington.
  • Alaska
  • Oregon
  • Rhode Is,
  • Alaska
  • Rhode Is.
  • Alaska Alaska Alaska Alaska,
    2000 2001 2002 2003 2004 2005 2006 Alaska Alaska Alaska Alaska
  • N. Carolina
  • Oregon
  • Alaska
  • Michigan
  • N. Carolina
  • Oregon
  • Washington.
  • Alaska.
  • Michigan.
  • Oregon.
  • Washington.
  • This is a relatively small number of States and amount spent, on average approximately $22 million per year, and in no year did the amount spent on extended compensation from States that triggered on using the TUR option ever exceed $100 million. Indeed, measuring the change in cyclical financial flows of the UI program does not seem necessary under these aggregates.

    Conclusion

    Placing the optional TUR indicator in regulations does not impose any additional change in burden, since no change in the operational procedure will occur. In addition, it incorporates in regulations the computational methodology previously communicated in UIPL No. 16-11 for the TUR's look-back.

    Changing the look-back computation does have an impact, although it is estimated to be small. For each State that adopted the optional TUR indicator, it was found that the new rounding rule would likely add a 0.13 percentage point increase in the likelihood of a single State triggering “on” the EB Program during a recession. For each State that triggered “on” the EB Program, it would likely add a 0.17 percent increase in the level of extended compensation paid, a 0.22 percent increase in people receiving extended compensation, and a per State increase in unemployment compensation taxes of 0.14 percent per year. These numbers indicate a negligible impact on the redistribution of the flows (unemployment compensation and taxes) in the Unemployment Compensation program. These impacts are so small that any stimulative or distributional effects would be considered of little consequence. Indeed, the probable economic impact encompasses the likely possibility (depending on the future level of the TUR) that there would be no measurable impact from a change in the derivation of the TUR indicator due to rounding the look-back proportion as opposed to truncating that value.

    Paperwork Reduction Act

    The purposes of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., include minimizing the paperwork burden on affected entities. The PRA requires certain actions before an agency can adopt or revise a collection of information, including publishing a summary of the collection of information and a brief description of the need for and proposed use of the information.

    A Federal agency may not conduct or sponsor a collection of information unless it is approved by OMB under the PRA, and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number. Also, notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512).

    The Department published an NPRM on October 27, 2014, in the Federal Register (79 FR 63859). The NPRM proposed to amend 20 CFR 615, Extended Benefits, by implementing the TUR indicator, an optional calculation methodology for triggering on Extended Benefits, in regulations. The NPRM also proposed to revise the regulatory requirements at § 615.15, pertaining to records and reports State agencies must submit. More specifically, paragraphs (a) and (b) were proposed to be revised for clarity by deleting unnecessary language regarding the Secretary's authority to request Extended Benefit Program reports and to appoint audit officials for those reports. Furthermore, for reasons discussed in the Review of the Final Rule, the Department proposed to delete paragraphs (c) and (d). The reporting instructions for the proper and timely submission of data are provided in ET Handbook No. 401, which governs Unemployment Compensation required reporting.

    The preamble to the NPRM stated that the Department had determined the proposed rule did not contain new information collections. However, to ensure transparency and full opportunities for public participation under all appropriate authorities, the Department is submitting an Information Collection Request (ICR) to the Office of Management and Budget (OMB) to revise the PRA approval for the information collections to reflect this rulemaking. See 44 U.S.C. 3506(c)(2)(B); 5 CFR 1320.11. As part of that process, the Department sought public comments on the removal of specific information collection requirements in the NPRM and on the general Extended Benefit reporting requirements in Handbook 401 and Forms ETA 538 and 539 in light of specific areas of interest to minimize so-called “paperwork” burdens on the public. The Department published a notice in the Federal Register on July 7, 2015 (80 FR 38747) to provide the public a 60-day opportunity to comment on the information collections as described in the rule. No comments on the ICR were received during the public comment period.

    Concurrent with the publication of this final rule, the Department is submitting an ICR to OMB for approval. The Department will publish a Federal Register notice upon receipt of OMB's notice of approval.

    Overview of the Information Collection

    Agency: DOL-ETA.

    Action: ICR Revision.

    Title of Collection: Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed.

    OMB Control Number: 1205-0028.

    Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Respondents: 53.

    Total Estimated Number of Responses: 5,512.

    Total Estimated Annual Time Burden: 3,675 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Executive Order 13132

    Section 6 of Executive Order 13132 requires Federal agencies to consult with State entities when a regulation or policy may have a substantial direct effect on the States or the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of the Executive Order. Section 3(b) of the Executive Order further provides that Federal agencies must implement regulations that have a substantial direct effect only if statutory authority permits the regulation and it is of national significance.

    This final rule does not have a substantial direct effect on the States or the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of Government, within the meaning of the Executive Order 13132. Any action taken by a State as a result of the final rule would be at its own discretion as the rule imposes no requirements.

    Unfunded Mandates Reform Act of 1995

    This regulatory action has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (Reform Act). Under the Reform Act, a Federal agency must determine whether a regulation proposes a Federal mandate that would result in the increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any single year. The Department has determined this final rule does not include any Federal mandate that may result in increased expenditure by State, local, and Tribal governments in the aggregate of more than $100 million, or increased expenditures by the private sector of more than $100 million.

    Accordingly, it is unnecessary for the Department to prepare a budgetary impact statement. Further, as noted above in the conclusion of the economic impact analysis, the impact is positive for State UTF accounts.

    Effect on Family Life

    The Department certifies that this final rule has been assessed according to section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681), for its effect on family well-being. It will not adversely affect the well-being of the nation's families. Therefore, the Department certifies that this final rule does not adversely impact family well-being.

    Regulatory Flexibility Act/SBREFA

    The Regulatory Flexibility Act (RFA) at 5 U.S.C. 603(a) requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis which will describe the impact of the final rule on small entities. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the final rulemaking is not expected to have a significant economic impact on a substantial number of small entities. Furthermore, under the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 (SBREFA), an agency is required to produce compliance guidance for small entities if the rule has a significant economic impact on a substantial number of small entities.

    The RFA defines small entities as small business concerns, small not-for-profit enterprises, or small governmental jurisdictions. The final rule does not regulate small entities. As a result, any indirect impact on small entities would be from a tax increase resulting from a State triggering “on” because of the new computation method for the look-back. Therefore, the Department certifies that the final rule will not have a significant economic impact on a substantial number of these small entities.

    Plain Language

    The Department drafted this final rule in plain language.

    List of Subjects in 20 CFR Part 615

    Grant programs-labor; Reporting and recordkeeping requirements; Unemployment compensation.

    For the reasons discussed in the preamble, ETA amends 20 CFR part 615 as follows:

    PART 615—EXTENDED BENEFITS IN THE FEDERAL-STATE UNEMPLOYMENT COMPENSATION PROGRAM 1. The authority citation for part 615 is revised to read as follows: Authority:

    26 U.S.C. 7805; 26 U.S.C. 1102; Secretary's Order No. 6-10.

    2. Revise § 615.1 to read as follows:
    § 615.1 Purpose.

    This part implements the “Federal-State Extended Unemployment Compensation Act of 1970” (EUCA). Under the Federal Unemployment Tax Act, 26 U.S.C. 3304(a)(11), an approved State law must provide for the payment of extended compensation to eligible individuals who have exhausted all rights to regular compensation during specified periods of unemployment, as prescribed in EUCA and this part.

    §§ 615.3, 615.4, 615.7, 616.8, 615.9, 615.12, and 615.14 [Amended]
    3. In part 615 remove the words “the Act” and add in their place the acronym “EUCA” in the following places: a. Section 615.3 (four places); b. Section 615.4(a) and (b) introductory text; c. Section 615.8(a) introductory text; d. Section 615.8(c) introductory text; e. Section 615.8(c)(2); f. Section 615.8(d) introductory text; g. Section 615.8(d)(3) (two places); h. Section 615.8(d)(4); i. Section 615.8(e) introductory text; j. Section 615.8(e)(8); k. Section 615.8(f)(1) introductory text; l. Section 615.8(f)(1)(ii); m. Section 615.8(f)(4); n. Section 615.8(g)(1) and (5); o. Section 615.9(d); p. Section 615.14(a)(1) through (4); q. Section 615.14(b) introductory text; r. Section 615.14(c)(1); s. Section 615.14(c)(2) (two places); t. Section 615.14(c)(3) introductory text; u. Section 615.14(c)(5) and (6); v. Section 615.14(c)(7)(i) through (iii); w. Section 615.14(d)(1); x. Section 615.14(d)(2) (two places); y. Section 615.14(d)(3)(four places); z. Section 615.14(d)(6); and 4. Revise § 615.2 to read as follows:
    § 615.2 Definitions.

    For the purposes of the EUCA and this part—

    Additional compensation means compensation totally financed by a State and payable under a State law by reason of conditions of high unemployment or by reason of other special factors and, when so payable, includes compensation payable pursuant to 5 U.S.C. chapter 85.

    And, as used in section 202(a)(3)(D)(ii), shall be interpreted to mean “or”.

    Applicable benefit year means, with respect to an individual, the current benefit year if, at the time an initial claim for extended compensation is filed, the individual has an unexpired benefit year only in the State in which such claim is filed, or, in any other case, the individual's most recent benefit year. For this purpose, the most recent benefit year for an individual who has unexpired benefit years in more than one State when an initial claim for extended compensation is filed, is the benefit year with the latest ending date or, if such benefit years have the same ending date, the benefit year in which the latest continued claim for regular compensation was filed. The individual's most recent benefit year which expires in an extended benefit period, when either extended compensation or high unemployment extended compensation is payable, is the applicable benefit year if the individual cannot establish a second benefit year or is precluded from receiving regular compensation in a second benefit year solely by reason of a State law provision which meets the requirement of section 3304(a)(7) of the Internal Revenue Code of 1986 (26 U.S.C. 3304(a)(7)).

    Applicable State means, with respect to an individual, the State with respect to which the individual is an “exhaustee” as defined in § 615.5, and in the case of a combined wage claim for regular compensation, the term means the “paying State” as defined in § 616.6(e) of this chapter.

    Applicable State law means the law of the State which is the applicable State for an individual.

    Average weekly benefit amount, for the purposes of section 202(a)(3)(D)(i), means the weekly benefit amount (including dependents' allowances payable for a week of total unemployment and before any reduction because of earnings, pensions or other requirements) applicable to the week in which the individual failed to take an action which results in a disqualification as required by section 202(a)(3)(B) of the EUCA.

    Base period means, with respect to an individual, the base period as determined under the applicable State law for the individual's applicable benefit year.

    Benefit structure as used in section 204(a)(2)(D), for the requirement to round down to the “nearest lower full dollar amount” for Federal reimbursement of sharable regular and sharable extended compensation means all of the following:

    (1) Amounts of regular weekly benefit payments,

    (2) Amounts of additional and extended weekly benefit payments,

    (3) The State maximum or minimum weekly benefit,

    (4) Partial and part-total benefit payments,

    (5) Amounts payable after deduction for pensions, and

    (6) Amounts payable after any other deduction required by State law.

    Benefit year means, with respect to an individual, the benefit year as defined in the applicable State law.

    Claim filed in any State under the interstate benefit payment plan, as used in section 202(c), means:

    (1) Any interstate claim for a week of unemployment filed pursuant to the Interstate Benefit Payment Plan, but does not include—

    (i) A claim filed in Canada,

    (ii) A visiting claim filed by an individual who has received permission from his/her regular reporting office to report temporarily to a local office in another State and who has been furnished intrastate claim forms on which to file claims, or

    (iii) A transient claim filed by an individual who is moving from place to place searching for work, or an intrastate claim for Extended Benefits filed by an individual who does not reside in a State that is in an Extended Benefit Period,

    (2) The first 2 weeks, as used in section 202(c), means the first 2 weeks for which the individual files compensable claims for Extended Benefits under the Interstate Benefit Payment Plan in an agent State in which an Extended Benefit Period is not in effect during such weeks.

    Compensation and unemployment compensation means cash benefits (including dependents' allowances) payable to individuals with respect to their unemployment, and includes regular compensation, additional compensation and extended compensation as defined in this section.

    Date of a disqualification, as used in section 202(a)(4), means the date the disqualification begins, as determined under the applicable State law.

    Department means the United States Department of Labor, and shall include the Employment and Training Administration, the agency of the United States Department of Labor headed by the Assistant Secretary of Labor for Employment and Training to whom has been delegated the Secretary's authority under the EUCA in Secretary's Order No. 6-2010 (75 FR 66268) or any subsequent order.

    Eligibility period means, for an individual, the period consisting of—

    (1) The weeks in the individual's applicable benefit year which begin in an extended benefit period or high unemployment period, or for a single benefit year, the weeks in the benefit year which begin in more than one extended benefit period or high unemployment period, and

    (2) If the applicable benefit year ends within an extended benefit period or high unemployment period, any weeks thereafter which begin in such extended benefit period or high unemployment period,

    (3) An individual may not have more than one eligibility period for any one exhaustion of regular benefits, or carry over from one eligibility period to another any entitlement to extended compensation.

    Employed, for the purposes of section 202(a)(3)(B)(ii) of the EUCA, and employment, for the purposes of section 202(a)(4) of the EUCA, mean service performed in an employer-employee relationship as defined in the State law; and that law also shall govern whether that service must be covered by it, must consist of consecutive weeks, and must consist of more weeks of work than are required under section 202(a)(3)(B) of the EUCA.

    EUCA means the Federal-State Extended Unemployment Compensation Act of 1970, title II of Public Law 91-373, 84 Stat. 695, 708 (codified in note to 26 U.S.C. 3304), as amended.

    Extended benefit period means the weeks during which extended compensation is payable in a State in accordance with § 615.11.

    Extended Benefits Program or EB Program means the entire program under which monetary payments are made to workers who have exhausted their regular compensation during periods of high unemployment.

    Extended compensation or extended benefits means the funds payable to an individual for weeks of unemployment which begin in a regular EB period or high unemployment period (HUP), under those provisions of a State law which satisfy the requirements of EUCA and this part with respect to the payment of extended unemployment compensation, and, when so payable, includes compensation payable under 5 U.S.C. chapter 85, but does not include regular compensation or additional compensation.

    Extended compensation account is the account established for each individual claimant for the payment of regular extended compensation or high unemployment extended compensation.

    Extended unemployment compensation means:

    (1) Regular extended compensation paid to an eligible individual under those provisions of a State law which are consistent with EUCA and this part, and that does not exceed the smallest of the following:

    (i) 50 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or

    (ii) 13 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or

    (iii) 39 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year; or

    (2) High unemployment extended compensation paid to an eligible individual under an optional TUR indicator enacted under State law when the State is in a high unemployment period, in accordance with § 615.11(e) of this part, and that does not exceed the smallest of the following:

    (i) 80 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or

    (ii) 20 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or

    (iii) 46 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.

    Gross average weekly remuneration, for the purposes of section 202(a)(3)(D)(i), means the remuneration offered for a week of work before any deductions for taxes or other purposes and, in case the offered pay may vary from week to week, it shall be determined on the basis of recent experience of workers performing work similar to the offered work for the employer who offered the work.

    High unemployment extended compensation means the benefits payable to an individual for weeks of unemployment which begin in a high unemployment period, under those provisions of a State law which satisfy the requirements of EUCA and this part for the payment of high unemployment extended compensation. When so payable, high unemployment extended compensation includes compensation payable under 5 U.S.C. chapter 85, but does not include regular compensation or additional compensation. Regular extended unemployment compensation, along with high unemployment extended compensation, are part of the program referred to in this part as Extended Benefits.

    High unemployment period (or HUP) means a period where the Department determines that the Trigger Value in a State, which has enacted the alternative Total Unemployment Rate indicator in law, for the most recent 3 months for which data for all States is published, equals or exceeds 8 percent and such Trigger Value equals or exceeds 110 percent of such Trigger Value for either or both of the corresponding 3-month periods ending in the 2 preceding calendar years.

    Hospitalized for treatment of an emergency or life-threatening condition, as used in section 202(a)(3)(A)(ii), has the following meaning: “Hospitalized for treatment” means an individual was admitted to a hospital as an inpatient for medical treatment. Treatment is for an “emergency or life threatening condition” if determined to be such by the hospital officials or attending physician that provide the treatment for a medical condition existing upon or arising after hospitalization. For purposes of this definition, the term “medical treatment” refers to the application of any remedies which have the objective of effecting a cure of the emergency or life-threatening condition. Once an “emergency condition” or a “life-threatening condition” has been determined to exist by the hospital officials or attending physician, the status of the individual as so determined shall remain unchanged until release from the hospital.

    Individual's capabilities, for the purposes of section 202(a)(3)(C), means work which the individual has the physical and mental capacity to perform and which meets the minimum requirements of section 202(a)(3)(D).

    Insured Unemployment Rate means the percentage derived by dividing the average weekly number of individuals filing claims for regular compensation in a State for weeks of unemployment in the most recent 13-consecutive-week period as determined by the State on the basis of State reports to the United States Secretary of Labor by the average monthly employment covered under State law for the first 4 of the most recent 6 completed calendar quarters before the end of such 13-week period.

    Jury duty, for purposes of section 202(a)(3)(A)(ii), means the performance of service as a juror, during all periods of time an individual is engaged in such service, in any court of a State or the United States pursuant to the law of the State or the United States and the rules of the court in which the individual is engaged in the performance of such service.

    Provisions of the applicable State law, as used in section 202(a)(3)(D)(iii) of EUCA, means that State law provisions must not be inconsistent with sections 202(a)(3)(C) and 202(a)(3)(E). Therefore, decisions based on State law provisions must not require an individual to take a job which requires traveling an unreasonable distance to work, or which involves an unreasonable risk to the individual's health, safety or morals. Such State law provisions must also include labor standards and training provisions required under sections 3304(a)(5) and 3304(a)(8) of the Internal Revenue Code of 1986 and section 236(d) of the Trade Act of 1974.

    Reasonably short period, for the purposes of section 202(a)(3)(C), means the number of weeks provided by the applicable State law.

    Regular compensation means compensation payable to an individual under a State law, and, when so payable, includes compensation payable pursuant to 5 U.S.C. chapter 85, but does not include extended compensation or additional compensation.

    Regular extended compensation means the benefits payable to an individual for weeks of unemployment which begin in an extended benefit period, under those provisions of a State law which satisfy the requirements of EUCA and this part for the payment of extended unemployment compensation, and, when so payable, includes compensation payable under 5 U.S.C. chapter 85, but does not include regular compensation or additional compensation. Regular extended compensation, along with high unemployment extended compensation, are part of the program referred to in this part as Extended Benefits.

    Regular EB period means a period in which a state is “on” the EB Program because either the mandatory or optional IUR indicator satisfies the criteria to be “on” and the state is not in a 13-week mandatory “off” period; or the State is “on” the EB Program because the TUR indicator's Trigger Value is at least 6.5 percent and it is at least 110 percent of the Trigger Value for the comparable 3 months in either of the prior 2 years.

    Secretary means the Secretary of Labor of the United States.

    Sharable compensation means:

    (1) Extended compensation paid to an eligible individual under those provisions of a State law which are consistent with EUCA and this part, and that does not exceed the smallest of the following:

    (i) 50 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or

    (ii) 13 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or

    (iii) 39 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.

    (2) Extended compensation paid to an eligible individual under an optional TUR indicator enacted under State law when the State is in a high unemployment period, in accordance with § 615.12(f) of this part, and that does not exceed the smallest of the following:

    (i) 80 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or

    (ii) 20 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or

    (iii) 46 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.

    (3) Regular compensation paid to an eligible individual for weeks of unemployment in the individual's eligibility period, but only to the extent that the sum of such compensation, plus the regular compensation paid (or deemed paid) to the individual for prior weeks of unemployment in the applicable benefit year, exceeds 26 times and does not exceed 39 times the average weekly benefit amount (including allowances for dependents) for weeks of total unemployment payable to the individual under the State law in such benefit year: Provided, that such regular compensation is paid under provisions of a State law which are consistent with EUCA and this part.

    (4) Notwithstanding the preceding provisions of this paragraph, sharable compensation does not include any regular or extended compensation for which a State is not entitled to a payment under section 202(a)(6) or 204 of EUCA or § 615.14 of this part.

    State means the States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, and the U. S. Virgin Islands.

    State agency means the State unemployment compensation agency of a State which administers the State law.

    State law means the unemployment compensation law of a State, approved by the Secretary under section 3304(a) of the Internal Revenue Code of 1986 (26 U.S.C. 3304(a)).

    A systematic and sustained effort, for the purposes of section 202(a)(3)(E), means—

    (i) A high level of job search activity throughout the given week, compatible with the number of employers and employment opportunities in the labor market reasonably applicable to the individual,

    (ii) A plan of search for work involving independent efforts on the part of each individual which results in contacts with persons who have the authority to hire or which follows whatever hiring procedure is required by a prospective employer in addition to any search offered by organized public and private agencies such as the State employment service or union or private placement offices or hiring halls,

    (iii) Actions by the individual comparable to those actions by which jobs are being found by people in the community and labor market, but not restricted to a single manner of search for work such as registering with and reporting to the State employment service and union or private placement offices or hiring halls, in the same manner that such work is found by people in the community,

    (iv) A search not limited to classes of work or rates of pay to which the individual is accustomed or which represent the individual's higher skills, and which includes all types of work within the individual's physical and mental capabilities, except that the individual, while classified by the State agency as provided in § 615.8(d) as having “good” job prospects, shall search for work that is suitable work under State law provisions which apply to claimants for regular compensation (which is not sharable),

    (v) A search by every claimant, without exception for individuals or classes of individuals other than those in approved training, as required under section 3304(a)(8) of the Internal Revenue Code of 1986 or section 236(e) of the Trade Act of 1974,

    (vi) A search suspended only when severe weather conditions or other calamity forces suspension of such activities by most members of the community, except that

    (vii) The individual, while classified by the State agency as provided in § 615.8(d) as having “good” job prospects, if such individual normally obtains customary work through a hiring hall, shall search for work that is suitable work under State law provisions which apply to claimants for regular compensation (which is not sharable).

    Tangible evidence of an active search for work, for the purposes of section 202(a)(3)(E), means a written record which can be verified, and which includes the actions taken, methods of applying for work, types of work sought, dates and places where work was sought, the name of the employer or person who was contacted and the outcome of the contact.

    Total Unemployment Rate means the number of unemployed individuals in a State (seasonally adjusted) divided by the civilian labor force (seasonally adjusted) in the State for the same period.

    Trigger Value or average rate of total unemployment means the ratio computed using 3 months of the level of seasonally adjusted unemployment in a State in the numerator and 3 months of the level of the seasonally adjusted civilian labor force in the State in the denominator. This rate is used for triggering States “on” and “off” the optional Total Unemployment Rate indicator as described in § 615.12(e).

    Week means:

    (1) For purposes of eligibility for and payment of extended compensation, a week as defined in the applicable State law.

    (2) For purposes of computation of extended compensation “on” and “off” and “no change” indicators and insured unemployment rates and the beginning and ending of an EB Period or a HUP, a calendar week.

    Week of unemployment means:

    (1) A week of total, part-total, or partial unemployment as defined in the applicable State law, which shall be applied in the same manner and to the same extent to the Extended Benefit Program as if the individual filing a claim for Extended Benefits were filing a claim for regular compensation, except as provided in paragraph (2) of this definition.

    (2) Week of unemployment in section 202(a)(3)(A) of the EUCA means a week of unemployment, as defined in paragraph (1) of this definition, for which the individual claims Extended Benefits or sharable regular benefits.

    5. Amend § 615.3 by revising the third sentence to read as follows:
    § 615.3 Effective period of the program.

    * * * Conformity with EUCA and this part in the payment of regular compensation, regular extended compensation, and high unemployment extended compensation (if State law so provides) to any individual is a continuing requirement, applicable to every week as a condition of a State's entitlement to payment for any compensation as provided in EUCA and this part.

    6. Amend § 615.7 by adding paragraph (b)(3) and revising paragraph (d) introductory text to read as follows:
    § 615.7 Extended Benefits; maximum amount.

    (b) * * *

    (3) If State law provides, in accordance with § 615.12(e), for a high unemployment period for weeks of unemployment beginning after March 6, 1993, the provisions of paragraph (b)(1) of this section are applied by substituting:

    (i) 80 percent for 50 percent in (b)(1)(i),

    (ii) 20 for 13 in (b)(1)(ii), and

    (iii) 46 for 39 in (b)(1)(iii).

    Note to paragraph (b)(3).

    Provided, that if an individual's extended compensation account is determined in accordance with the provisions of paragraphs (b)(3)(i) through (b)(3)(iii) (for a “high unemployment period” as defined in § 615.2) during the individual's eligibility period, upon termination of the high unemployment period, such individual's account must be reduced by the amount in the account that is more than the maximum amount of extended compensation or high extended compensation payable to the individual. Provided further, if the account balance is equal to or less than the maximum amount of extended compensation or high unemployment extended compensation payable, there will be no reduction in the account balance upon termination of a high unemployment period. In no case will the individual receive more regular extended compensation or high unemployment extended compensation than the amount determined in accordance with paragraphs (b)(1)(i) through (iii) of this section, nor more extended compensation or high unemployment extended compensation than as provided in paragraphs (b)(2)(i) through (iii) of this section.

    (d) Reduction because of trade readjustment allowances. Section 233(c) of the Trade Act of 1974 (and section 204(a)(2)(C) of EUCA), requiring a reduction of extended compensation because of the receipt of trade readjustment allowances, must be applied as follows:

    7. Amend § 615.8 by revising paragraphs (e)(5)(iii), (f)(2)(i) and (iii), and (h)(3) and (4) to read as follows:
    § 615.8 Provisions of State law applicable to claims.

    (e) * * *

    (5) * * *

    (iii) The work pays less than the higher of the minimum wage set in section 6(a)(1) of the Fair Labor Standards Act of 1938, or any applicable State or local minimum wage, without regard to any exemption elsewhere in those laws, or

    (f) * * *

    (2) * * *

    (i) The gross average weekly remuneration for the work for any week does not exceed the sum of the individual's weekly benefit amount plus any supplemental unemployment compensation benefits (as defined in section 501(c)(17)(D) of the Internal Revenue Code of 1986) payable to the individual,

    (iii) The work pays less than the higher of the minimum wage set in section 6(a)(1) of the Fair Labor Standards Act of 1938, or any applicable State or local minimum wage, without regard to any exemption elsewhere in those laws, or

    (h) * * *

    (3) What kind of jobs he/she must be actively engaged in seeking each week depending on the classification of his/her job prospects, and what tangible evidence of such search must be furnished to the State agency with each claim for benefits. In addition, the State must inform the claimant that he/she is required to apply for and accept suitable work, and

    (4) The resulting disqualification if he/she fails to apply for work to which referred, or fails to accept work offered, or fails to actively engage in seeking work or to furnish tangible evidence of such search for each week for which extended compensation or sharable regular benefits is claimed, beginning with the week following the week in which such information shall be furnished in writing to the individual.

    8. Revise § 615.11 to read as follows:
    § 615.11 Extended Benefit Periods.

    (a) Beginning date. Except as provided in paragraph (d) of this section, an extended benefit period or high unemployment period begins in a State on the first day of the third calendar week after a week for which there is a State “on” indicator in that State under either § 615.12(a) or (b).

    (b) Ending date. Except as provided in paragraphs (c) and (e) of this section, an extended benefit period or high unemployment period in a State ends on the last day of the third week after the first week for which there is a State “off” indicator in that State, unless another indicator is in “on” status.

    (c) Duration. When an extended benefit period and/or high unemployment period becomes effective in any State, or triggers “off,” the attained status must continue in effect for not less than 13 consecutive weeks.

    (d) Limitation. No extended benefit period or high unemployment period may begin or end in any State before the most recent week for which data used to trigger the State “on” or “off” or “no change” indicator has been published.

    (e) Specific applications of the 13-week rule. (1) If a State concludes a 13-week mandatory “on” period by virtue of the IUR indicator which, at the end of the 13-week period no longer satisfies the requirements for a State to be “on,” the extended benefit period continues if the TUR indicator is “on” during the 11th week of the 13-week mandatory “on” period.

    (2) If a State concludes a 13-week mandatory “on” period by virtue of the TUR indicator which, at the end of the 13-week period no longer satisfies the requirements for a State to be “on,” the extended benefit period continues if the IUR indicator is “on” during the 11th week of the 13-week mandatory “on” period.

    (f) Determining if a State remains “off” as a result of a total unemployment rate indicator after the 13-week mandatory “off” period ends. (1) The State remains “off” if there is not an IUR “on” indicator the 11th week of the 13-week mandatory “off” period, and there is a TUR “off” indicator for the third week before the last week of the 13-week mandatory “off” period.

    9. Amend § 615.12 by: a. Revising paragraphs (d)(1) and (2); b. Adding paragraph (d)(3); c. Redesignating paragraph (e) as paragraph (f) and revising it; and d. Adding new paragraph (e).

    The additions and revisions read as follows:

    § 615.12 Determination of “on” and “off” indicators.

    (d) * * *

    (1) Any determination by the head of a State agency of an “on” or “off” or “no change” IUR indicator may not be corrected more than three weeks after the close of the week to which it applies. If any figure used in the computation of a rate of insured unemployment is later found to be wrong, the correct figure must be used to redetermine the rate of insured unemployment and the 120 percent factor for that week and all later weeks, but no determination of previous “on” or “off” or “no change” indicator shall be affected unless the redetermination is made within the time the indicator may be corrected under the first sentence of this paragraph (d)(1). Any change is subject to the concurrence of the Department as provided in paragraph (e) of this section.

    (2) The initial release of the TUR by the Bureau of Labor Statistics (BLS) is subject to revision. However, once a State's TUR indicator is determined using the initial release of the TUR data, it is not subject to revision even if the BLS TUR for that period of time is revised.

    (3) The “on” period under a State's optional IUR or TUR indicator may not begin before the later of the date of the State's adoption of the optional insured unemployment rate or total unemployment rate indicator, or the effective date of that enactment. The “off” period under a State's optional insured unemployment rate or total unemployment rate indicator may not occur until after the effective date of the repeal of the optional insured unemployment rate or total unemployment rate indicator from State law.

    (e) Other optional indicators. (1) A State may, as an option, in addition to the State indicators in paragraphs (a) and (b) of this section, provide by its law that there is a State “on” or “off” indicator in the State for a week if we determine that—

    (i) The Trigger Value in such State computed using the most recent 3 months for which data for all States are published before the close of such week equals or exceeds 6.5 percent; and

    (ii) The Trigger Value computed using data from the 3-month period referred to in paragraph (e)(1)(i) of this section equals or exceeds 110 percent of the Trigger Value for either (or both) of the corresponding 3-month periods ending in the 2 preceding calendar years. This “look-back” is computed by dividing the Trigger Value by the same measure for the corresponding 3 months in each of the applicable prior years, and the resulting decimal fraction is rounded to the hundredths place, multiplied by 100 and reported as an integer and compared to the statutory threshold to help determine the State's EB Program status; and

    (iii) There is a State “off” indicator for a week if either the requirements of paragraph (e)(1)(i) or (ii) of this section are not satisfied.

    (2) Where a State adopts the optional indicator under paragraph (e)(1) of this section, there is a State “on” indicator for a high unemployment period (as defined in § 615.2) under State law if—

    (i) The Trigger Value in the State computed using the most recent 3 months for which data for all States are published before the close of such week equals or exceeds 8.0 percent, and

    (ii) The Trigger Value in the State computed using data from the 3-month period referred to in paragraph (e)(2)(i) of this section equals or exceeds 110 percent of the Trigger Value for either (or both) of the corresponding 3-month periods ending in the 2 preceding calendar years. This “look-back” is computed by dividing the Trigger Value by the same measure for the corresponding 3 months in each of the applicable prior years, and the resulting decimal fraction is rounded to the hundredths place, multiplied by 100 and reported as an integer and compared to the statutory threshold to help determine the State's EB Program status; and

    (iii) There is a State “off” indicator for high unemployment period for a week if either the requirements of paragraph (e)(2)(i) or (ii) of this section are not satisfied.

    (3) Method of computing the average rate of total unemployment. The average rate of total unemployment is computed by dividing the average of 3 months of the level of seasonally adjusted unemployment in the State by the average of 3 months of the level of seasonally adjusted unemployment and employment in the State. The resulting rate is multiplied by 100 to convert it to a percentage basis and then rounded to the tenths place (the first digit to the right of the decimal place).

    (4) Method of computing the State ”look-back.” The average rate of total unemployment, ending with a given month, is divided by the same measure for the corresponding 3 months in each of the applicable prior years. The resultant decimal fraction is then rounded to the hundredths place (the second digit to the right of the decimal place). The resulting number is then multiplied by 100 and reported as an integer (no decimal places) and compared to the statutory threshold to help determine the State's EB Program status.

    (f) Notice to Secretary. Within 10 calendar days after the end of any week for which the head of a State agency has determined that there is an “on,” or “off,” or “no change” IUR indicator in the State, the head of the State agency must notify the Secretary of the determination. The notice must state clearly the State agency head's determination of the specific week for which there is a State “on” or “off” or “no change” indicator. The notice must include also the State agency head's findings supporting the determination, with a certification that the findings are made in accordance with the requirements of § 615.15. The Secretary may provide additional instructions for the contents of the notice to assure the correctness and verification of notices given under this paragraph. The Secretary will accept determinations and findings made in accordance with the provisions of this paragraph and of any instructions issued under this paragraph. A notice does not become final for purposes of EUCA and this part until the Secretary accepts the notice.

    10. Revise § 615.13 to read as follows:
    § 615.13 Announcement of the Beginning and Ending of Extended Benefit Periods or High Unemployment Periods.

    (a) State indicators—(1) Extended benefit period. Upon receipt of a notice required by § 615.12(f) which the Department determines is acceptable, the Department will publish in the Federal Register a notice of the State agency head's determination that there is an “on” or an “off” indicator in the State, as the case may be, the name of the State and the beginning or ending of the extended benefit period, or high unemployment period, whichever is appropriate. If an “on” or “off” EB period is determined by the Department to be based on a State's TUR Trigger Value, the Department publishes that information in the Federal Register as well.

    (2) Notification. The Department also notifies the heads of all other State agencies, and the Regional Administrators of the Employment and Training Administration of the State agency head's determination of the State “on” or “off” indicator for an extended benefit period, or high unemployment period (based on the insured unemployment rate in the State), or of the Department's determination of an “on” or “off” indicator (based on the total unemployment rate in a State) for an extended benefit period or high unemployment period and of the indicator's effect.

    (b) Publicity by State. (1) Whenever a State agency head determines that there is an “on” indicator in the State by reason of which an extended benefit period (based on the insured unemployment rate in the State) will begin in the State, or an “off” indicator by reason of which an extended benefit period in the State (based on the insured unemployment rate) will end, the head of the State agency must promptly announce the determination through appropriate news media in the State after the Department accepts notice from the agency head in accordance the 615.12(f).

    (2) Whenever the head of a State agency receives notification from the Department in accordance with § 615.12(f) that there is an “on” indicator by reason of which an extended benefit period or high unemployment period (based on the total unemployment rate in the State) will begin in the State, or an “off” indicator by reason of which a regular extended benefit period or high unemployment period (based on the total unemployment rate) will end, the head of the State agency must promptly announce the determination through the appropriate news media in the State.

    (3) Announcements made in accordance with paragraphs (b)(1) or (b)(2) of this section must include the beginning or ending date of the extended benefit period or high unemployment period, whichever is appropriate. In the case of a regular EB period or high unemployment period that is about to begin, the announcement must describe clearly the unemployed individuals who may be eligible for extended compensation or high extended compensation during the period, and in the case of a regular EB period or high unemployment period that is about to end, the announcement must also describe clearly the individuals whose entitlement to extended compensation or high extended compensation will be terminated. If a high unemployment period is ending, but an extended benefit period will remain “on,” the announcement must clearly state that fact and the effect on entitlement to extended compensation.

    (c) Notice to individuals. (1) Whenever there has been a determination that a regular extended benefit period or high unemployment period will begin in a State, the State agency must provide prompt written notice of potential entitlement to Extended Benefits to each individual who has established a benefit year in the State that will not end before the beginning of the regular extended benefit period or high unemployment period, and who exhausted all rights under the State law to regular compensation before the beginning of the regular extended benefit period or high unemployment period.

    (2) The State agency must provide the notice promptly to each individual who begins to claim sharable regular benefits or who exhausts all rights under the State law to regular compensation during a regular extended benefit period or high unemployment period, including exhaustion by reason of the expiration of the individual's benefit year.

    (3) The notices required by paragraphs (c)(1) and (2) of this section must describe the actions required of claimants for sharable regular compensation and extended compensation and those disqualifications which apply to the benefits which are different from those applicable to other claimants for regular compensation which is not sharable.

    (4) Whenever there is a determination that a regular extended benefit period or high unemployment period will end in a State, the State agency must provide prompt written notice to each individual who is currently filing claims for extended compensation of the forthcoming end of the regular extended benefit period or high unemployment period and its effect on the individual's right to extended compensation.

    11. Amend § 615.14 by revising paragraph (c)(4) to read as follows:
    § 615.14 Payments to States.

    (c) * * *

    (4) As provided in section 204(a)(2)(C) of EUCA, for any week in which extended compensation is not payable because of the payment of trade readjustment allowances, as provided in section 233(c) of the Trade Act of 1974, and § 615.7(d).

    12. Revise § 615.15 to read as follows:
    § 615.15 Records and reports.

    (a) General. State agencies must furnish to the Secretary such information and reports and make such studies as the Secretary decides are necessary or appropriate for carrying out the purposes of this part.

    (b) Recordkeeping. Each State agency must make and maintain records pertaining to the administration of the Extended Benefit Program as the Department requires, and must make all such records available for inspection, examination and audit by such Federal officials or employees as the Department may designate or as may be required by law.

    Portia Wu Assistant Secretary for Employment and Training.
    [FR Doc. 2016-18382 Filed 8-23-16; 8:45 am] BILLING CODE 4510-FW-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, and 507 [Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143] RIN 0910-AG10, 0910-AG35, 0910-AG36, 0910-AG64 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule; extension and clarification of compliance dates for certain provisions.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.

    DATES:

    This final rule is effective August 24, 2016. See sections III.C, IV.A.2, IV.B, and V through VIII for the extended compliance dates.

    FOR FURTHER INFORMATION CONTACT:

    For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

    For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246.

    For questions relating to Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Rebecca Buckner, Office of Food and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.

    For questions relating to Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.

    SUPPLEMENTARY INFORMATION: I. Background: The Four Related Rules Implementing the FDA Food Safety Modernization Act

    This extension and clarification of compliance dates concerns four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). The four final rules are entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the Federal Register of September 17, 2015, 80 FR 55908) (http://www.fda.gov/fsma); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (published in the Federal Register of September 17, 2015, 80 FR 51670) (http://www.fda.gov/fsma); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (published in the Federal Register of November 27, 2015, 80 FR 74226) (http://www.fda.gov/fsma); and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (published in the Federal Register of November 27, 2015, 80 FR 74354) (http://www.fda.gov/fsma).

    In part 117 (21 CFR part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (80 FR 55908, September 17, 2015). Among other things, the rulemaking to establish part 117 amended our current good manufacturing practice (CGMP) regulation for manufacturing, packing, or holding human food to modernize it and establish it in new part 117, subparts A, B, and F. Part 117 also includes new requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) in subparts A, C, D, E, F, and G to establish and implement hazard analysis and risk-based preventive controls for human food (the human food preventive controls requirements). In the preamble of the final rule establishing part 117, we stated that the rule is effective November 16, 2015, and provided for compliance dates of 1 to 3 years from the date of publication in most cases (see table 53 in the preamble of the final rule establishing part 117, 80 FR 55908 at 56128). In the rulemaking to establish part 117, we also amended the “farm” definition in our regulations implementing section 415 of the FD&C Act (the section 415 registration regulation; 21 CFR part 1, subpart H) to clarify the scope of the exemption from registration requirements provided for “farms” and, in so doing, to clarify which human food establishments are subject to the human food preventive controls requirements, and which human food establishments are exempt from those requirements because they are “farms.”

    In part 507 (21 CFR part 507), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (80 FR 56170, September 17, 2015). Among other things, the rulemaking to establish part 507 established new requirements for CGMPs in subparts A, B, and F (CGMP requirements) and also established requirements for hazard analysis and risk-based preventive controls for food for animals in subparts A, C, D, E, and F (the animal food preventive controls requirements). The part 507 requirements apply to domestic and foreign facilities that are required to register under the section 415 registration regulation and, thus, the “farm” definition that we amended as part of the rulemaking to establish part 117 also clarifies which animal food establishments are subject to the part 507 requirements, and which animal food establishments are exempt from those requirements because they are “farms.” In the preamble of the final rule establishing part 507, we stated that the rule is effective November 16, 2015 (80 FR 56170). We provided for compliance dates of 1 to 3 years from the date of publication in most cases for compliance with the CGMP requirements, with an additional year beyond that for compliance with the animal food preventive controls requirements (see table 32 in the preamble of the final rule establishing part 507, 80 FR 56170 at 56329).

    In part 1, subpart L (21 CFR part 1, subpart L), we have established our regulation entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (the FSVP regulation; 80 FR 74226, November 27, 2015). The FSVP regulation requires importers to establish foreign supplier verification programs to verify that their foreign suppliers are using processes and procedures that provide the same level of public health protection as those required under the provisions on hazard analysis and risk-based preventive controls and standards for produce safety in the FD&C Act, that the imported food is not adulterated, and that food is not misbranded with respect to food allergen labeling. In the preamble of the final rule establishing the FSVP regulation, we stated that the rule is effective January 26, 2016, and provided for varying compliance dates based in part on the size of the foreign supplier, the nature of the importer, and whether the foreign supplier is subject to certain other FSMA regulations (80 FR 74226 at 74332 to 74333, as corrected in a technical amendment (81 FR 25326, April 28, 2016)).

    In part 112 (21 CFR part 112), we have established our regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the produce safety regulation; 80 FR 74354, November 27, 2015). Among other things, the rulemaking to establish the produce safety regulation set forth in a new part 112 procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. The produce safety regulation applies to certain produce farms, and does not apply to activities of facilities that are subject to part 117 (as established in part 117). In the preamble of the final rule establishing the produce safety regulation, we stated that the produce safety regulation is effective January 26, 2016, and provided for compliance dates of 1 to 6 years from the effective date depending on the commodity and the provision(s) (see table 30 in the preamble of the final rule establishing the produce safety regulation, 80 FR 74354 at 74527, as corrected in a technical amendment at 81 FR 26466, May 3, 2016). (Some of the compliance dates identified in the technical amendment fall on weekends (i.e., January 26, 2019, is a Saturday and January 26, 2020, is a Sunday) and should therefore be read as referring to the next business day (i.e., January 28, 2019, and January 27, 2020, respectively). We use the latter dates throughout this document.)

    II. Summary of Compliance Date Extensions in This Rule

    We are extending the dates for compliance with certain provisions in four final rules to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. First, we are extending the compliance dates for certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. Second, we are extending the compliance dates for part 117 and part 507 for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. Third, we are extending the compliance dates for part 117 for certain facilities that color RACs. Fourth, we are extending the compliance dates for part 507 for facilities solely engaged in the ginning of cotton. Fifth, we are extending the compliance dates for the FSVP regulation for importation of food contact substances. Sixth, we are extending the date for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

    Finally, we are clarifying how we interpret the compliance dates for certain provisions related to agricultural water testing in the produce safety regulation.

    III. Extension of Compliance Dates for “Customer Provisions” in Part 117 and Related Rules A. Background

    In a supplemental notice of proposed rulemaking for part 117 (79 FR 58524, September 29, 2014), we proposed several exceptions to the requirement for a manufacturer/processor to establish and implement a supply-chain program. Under one proposed exception, a receiving facility would not have been required to have a supply-chain program if it relied on its customer to control the hazard and annually obtained from its customer written assurance that the customer had established and was following procedures (identified in the written assurance) that would significantly minimize or prevent the hazard (see the discussion in the preamble of the final rule at 80 FR 55908 at 56036; see the proposed regulatory text at 79 FR 58524 at 58565).

    After considering comments, we replaced this proposed provision with several provisions (§§ 117.136(a)(2) through (4) and 117.137) (referred to collectively as “customer provisions”) that apply when a manufacturer/processor identifies a hazard requiring a preventive control (“identified hazard”), does not control the identified hazard, and relies on an entity in its distribution chain to address the hazard (80 FR 55908 at 56037 to 56039). (In these provisions, “customer” means a commercial customer, not a consumer.) A manufacturer/processor that complies with the customer provisions is not required to implement a preventive control for the identified hazard. The combination of three requirements in the customer provisions is intended to provide assurance that the food will be processed to control the identified hazard before it reaches consumers:

    • Documentation provided by the manufacturer/processor to its direct customer that the food is “not processed to control [identified hazard]” (the disclosure statement provisions; § 117.136(a)(2)(i), (3)(i), and (4)(i));

    • Written assurance provided by the customer to the manufacturer/processor that the customer is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements (the written assurance provisions; § 117.136(a)(2)(ii), (3)(ii), and (4)(ii)); and

    • Provisions relating to accountability for written assurances (the accountability provision; § 117.137).

    We established similar requirements in three other FSMA rules (“related rules”): Part 507 (§§ 507.36 (a)(2) through (4) and 507.37); the FSVP regulation (§§ 1.507(a)(2) through (4), and 1.507(c)); and the produce safety regulation (§ 112.2(b)(2) through (4), and (6)).

    B. Written Assurances From Customers

    On March 23, 2016, FDA met with the Grocery Manufacturers Association (GMA) at their request to listen to concerns regarding the customer provisions in the part 117 rule (Ref. 1). GMA provided examples of product distribution chains that would require vastly more written assurances and consequently resources to comply with the requirement than anticipated by FDA. For example, a manufacturing facility may sell such foods to a distributor, who may sell numerous items requiring assurances to multiple restaurants, cafeterias, delicatessens, and other distributors. GMA estimated that this could result in hundreds or even thousands of written assurances needed by a single distributor. A similar concern exists for the related rules.

    After considering the information presented by GMA, FDA believes that the requirement for written assurance in the customer provisions of part 117 significantly exceeds the current practices of even the largest facilities; compliance by those facilities by September 19, 2016, may not be feasible; and it is appropriate to extend the compliance dates for 2 years for the written assurance requirements for part 117 and the related rules while FDA considers the best approach to address feasibility concerns.

    We believe it continues to be appropriate to provide for an entity earlier in the distribution chain to disclose that a hazard has not been controlled and rely on a subsequent entity to control a hazard in human or animal food. For example, it would not make sense to require a facility that chops nuts to have a preventive control for Salmonella if the nuts are going to be used by customers in baked goods in accordance with a process validated to adequately control the hazard. In addition, it would not make sense to require a facility that manufactures a rendered meat ingredient for pet food to have a preventive control for Salmonella when the final pet food will go through an extrusion process at a customer's facility to control Salmonella. A manufacturer/processor under part 117 or part 507 that relies on a customer to control a hazard will continue to be required to comply with the disclosure statement provisions and disclose that the food has not been processed to control the hazard on the compliance date originally specified (we note that FDA will soon be making available for public comment draft guidance on the disclosure statement provisions). Subsequent entities in the distribution chain will continue to be subject to applicable requirements related to food adulteration in Federal and/or state and local laws and regulations, e.g., part 117, part 507, and the Retail Food Code.

    C. Extension of Compliance Dates

    Table 1 provides a summary of the revised compliance dates.

    Table 1—Extension of Compliance Dates for the Written Assurances in the Customer Provisions in Part 117 and Related Rules Previously announced compliance date Compliance date with extension Human Food—§ 117.136(a)(2)(ii), (3)(ii), and (4)(ii) Small Business (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 September 18, 2019. Business that is neither small or very small (a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g. held for a fee)) September 19, 2016 September 19, 2018. Animal Food—§ 507.36(a)(2)(ii), (3)(ii), and (4)(ii) Small Business (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 17, 2018 September 17, 2020. Business that is neither small or very small ((a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale)) September 18, 2017 September 18, 2019. FSVP—§ 1.507(a)(2)(ii), (3)(ii), and (4)(ii)) Latest date of: 18 months after the publication of the final rule May 30, 2017 May 28, 2019. Importers of food from foreign supplier subject to preventive controls regulation for human food, the preventive controls or CGMP requirements in part 507, or the produce safety regulation: 6 months after supplier is required to comply with the relevant regulations 30 months after previously announced compliance date for the relevant regulations. Produce Safety—§ 112.2(b)(3) Very small businesses relying on the exemption in § 112.2(b) for sprouts that would otherwise be subject to subpart M (those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period) January 28, 2019 January 26, 2021. Small businesses relying on the exemption in § 112.2(b) for sprouts that would otherwise be subject to subpart M (those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period) January 26, 2018 January 27, 2020. All other businesses relying on the exemption in § 112.2(b) for sprouts that would otherwise be subject to subpart M January 26, 2017 January 28, 2019. Very small businesses relying on the exemption in § 112.2(b) for all other produce that would otherwise be covered (those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period) January 27, 2020 January 26, 2022. Small businesses relying on the exemption in § 112.2(b) for all other produce that would otherwise be covered (those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period) January 28, 2019 January 26, 2021. All other businesses relying on the exemption in § 112.2(b) for all other produce that would otherwise be covered January 26, 2018 January 27, 2020.

    We are extending the compliance date by 2 years for the written assurance requirement in the customer provisions in part 117. With the extension, facilities that are small businesses must comply with § 117.136(a)(2)(ii), (3)(ii), and (4)(ii) by September 18, 2019, and other facilities subject to the requirements must comply with those provisions by September 19, 2018. As a result of the extension, the compliance date for certain associated requirements that are contingent on the specified delayed provisions are also delayed (i.e., the recordkeeping requirements in §§ 117.136(b)(2) through (4) and 117.335 and the requirements in § 117.137 for a facility that provides a written assurance under § 117.136(a)(2), (3), or (4)). We are not extending the compliance date for qualified facilities (including very small businesses) as defined in § 117.3 because they are not subject to the requirements in § 117.136(a)(2)(ii), (3)(ii), and (4)(ii).

    We are also extending the compliance date by 2 years for the written assurance requirement in the customer provisions in part 507. With the extension, facilities that are small businesses must comply with § 507.36(a)(2)(ii), (3)(ii), and (4)(ii) by September 17, 2020, and other facilities subject to the requirements must comply with those provisions by September 18, 2019. As a result of the extension, the compliance dates for certain associated requirements that are contingent on the specified delayed provisions are also delayed (i.e., the recordkeeping requirements in §§ 507.36(b)(2) through (4) and 507.215 and the requirements in § 507.37 for a facility that provides a written assurance under § 507.36(a)(2), (3), or (4)). We are not extending the compliance date for qualified facilities (including very small businesses) as defined in § 507.3 because they are not subject to the requirements in § 507.36(a)(2)(ii), (3)(ii), and (4)(ii).

    In addition, we are extending the compliance date under the FSVP regulation for complying with the written assurance requirements in § 1.507(a)(2)(ii), (3)(ii), and (4)(ii) by 2 years beyond the dates established in the final rule (as corrected in the technical amendment). In the preamble of the final rule, as corrected by the technical amendment, we stated that importers would need to comply with the FSVP regulation by the latest of the following:

    • 18 months after the publication of the final rule;

    • For importers of food from a foreign supplier that is subject to part 117, the CGMP requirements or the preventive controls requirements for animal food in part 507, or the produce safety regulation, 6 months after the supplier was required to comply with the relevant regulations; or

    • For an importer subject to the supply-chain program provisions of the human or animal food preventive controls regulations, the date the importer, as a receiving facility, was required to comply with the supply-chain program provisions of the relevant regulation.

    As a result of this extension, the earliest that an importer would be required to comply with the written assurance requirements in the customer provisions in § 1.507 would be May 28, 2019. When an importer's compliance date is determined by when the foreign supplier must comply with the preventive controls regulation for human food, the preventive controls or CGMP requirements in part 507, or the produce safety regulation (i.e., when the importer must comply with FSVP 6 months after the foreign supplier is required to come into compliance), the importer's compliance date for the written assurance requirements in § 1.507 will be 2 years and 6 months after the previously-announced compliance dates for the relevant regulations. That is, the other changes we are making to compliance dates for the human and animal food preventive controls and produce safety regulations will not impact when an FSVP importer must comply with the written assurance requirements in the customer provisions in § 1.507. For example, although this rule extends the compliance dates for part 117 and part 507 for facilities solely engaged in packing and/or holding activities conducted on RACs that are produce that would qualify as secondary activities farms except for the ownership of the facility, an importer whose foreign supplier is such a facility will be required to comply with the assurance requirements in § 1.507 2 years and 6 months after the foreign supplier would have been required to comply with part 117 or part 507 under the final rules published on September 17, 2015 (80 FR 55908; 80 FR 56170). The importer's compliance date for the assurance requirements in § 1.507 is not 2 years and 6 months after the newly-established part 117 and part 507 compliance dates announced in this rule. As a result of the extension, the compliance dates for certain associated requirements that are contingent on the specified delayed provisions are also delayed (i.e., the requirements in § 1.507(c) for a customer or subsequent entity that provides a written assurance under § 1.507(a)(2), (3), or (4)).

    Finally, we are extending by 2 years the compliance dates for the written assurance requirements in the customer provisions of the produce safety regulation in § 112.2(b)(3). With the extension, sprout operations wishing to rely on the exemption in § 112.2(b) with respect to sprouts that would otherwise be subject to subpart M of part 112 must comply with the written assurances provisions in § 112.2(b)(3) by January 26, 2021 (very small businesses); January 27, 2020 (small businesses); and January 28, 2019 (all other businesses). With the extension, operations wishing to rely on the exemption in § 112.2(b) with respect to other types of produce that would otherwise be covered must comply with the written assurances provisions in § 112.2(b)(3) by January 26, 2022 (very small businesses); January 26, 2021 (small businesses), and January 27, 2020 (all other businesses). As a result of the extension, the compliance dates for certain associated requirements that are contingent on the specified delayed provisions are also delayed (i.e., § 112.2(b)(4) and (6)).

    IV. Extension of Certain Compliance Dates for Both Part 117 and Part 507 A. Facilities Solely Engaged in Packing and/or Holding Activities Conducted on Produce RACs and/or Nut Hulls and Shells

    Some facilities that are subject to part 117 are solely engaged in packing and/or holding RACs that are produce (“produce RACs”). These activities are similar to packing and holding activities commonly conducted on produce RACs by farms subject to the produce safety regulation. Examples of such facilities are produce packinghouses, warehouses that hold produce RACs, and facilities that hull, shell, pack and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). (We note that FDA will soon be making available for public comment a draft guidance on classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities). During the rulemaking to establish part 117, we received comments asking us to revise the regulatory text to ensure that similar activities would be treated similarly under either the produce safety regulation or part 117. (See Comment 25, 80 FR 55908 at 55927 to 55928.)

    We received comments that expressed concern about how the requirements in part 117 for environmental monitoring and product testing would apply to off-farm facilities that pack or hold produce RACs. (See Comment 524, 80 FR 55908 at 56062.) In responding to those comments, we stated that we were considering developing a separate guidance on packing and holding operations for produce RACs in light of the questions we have received regarding similarities and differences for off-farm packing and holding compared to on-farm packing and holding. In a letter to us dated April 19, 2016, the United Fresh Produce Association and 21 other organizations (UFPA et al.) noted that such guidance has not been issued, and the September 19, 2016, compliance date for part 117 is approaching (Ref. 2).

    1. Similarities of Packing and Holding Activities Conducted on Produce RACs

    In the preamble of the final rule establishing part 117, we described several changes to the regulatory text in response to comments asking us to consider revisions to ensure that similar activities would be treated the same way under either the produce safety regulation or part 117. (See Response 25, 80 FR 55908 at 55928 to 5929.) For example, we revised the “farm” definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see §§ 1.227 and 117.3). With the added definition of “secondary activities farm,” some packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition and, thus, not be subject to the human food preventive controls requirements. We also established a new provision to allow off-farm establishments that package, pack, and hold produce RACs to comply with the CGMPs in part 117 by complying with the relevant requirements for packing and holding in the final produce safety regulation (see § 117.8).

    In responding to these comments, we noted that the revised “farm” definition did not, as requested, provide for all off-farm operations such as certain packinghouses and hulling/shelling operations to be subject to the produce safety regulation rather than part 117. We explained that the statutory framework does not provide for entities such as packinghouses and hulling/shelling operations that do not have a sufficient connection to a farm to be subject to the requirements of the produce safety regulation. However, we stated that we continued to believe that an off-farm packinghouse that is subject to the human food preventive controls requirements in part 117 will be able to draw from the provisions of the produce safety regulation in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, we stated our expectation that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the produce safety regulation, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under § 112.48(c) in the produce safety regulation). We also expected that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see, e.g., §§ 112.111(b) and 112.123(d)(1) for cleanliness of food-contact surfaces, and §§ 112.113 and 112.132 for protection against contamination).

    We agree that certain activities conducted on produce RACs are similar regardless of where they happen. Therefore, facilities for which the packing and/or holding of produce RACs is subject to the human food preventive controls requirements may nonetheless still be able to draw from the provisions of the produce safety regulation in developing their food safety plans and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. We acknowledge that we have not yet issued guidance with specific recommendations for how packinghouses subject to the human food preventive controls requirements could comply with those requirements.

    2. Extension of Compliance Dates for Facilities Solely Engaged in Packing and/or Holding Produce RACs and/or Nut Hulls and Shells

    Table 2 provides a summary of the revised compliance dates.

    Table 2—Extension of Compliance Dates for Both Part 117 and Part 507 for Facilities Solely Engaged in Packing and/or Holding Produce RACs and/or Nut Hulls and Shells Previously announced compliance date Compliance date with extension Human Food—Facilities solely engaged in packing and/or holding activities on produce RACs (part 117) Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g. held for a fee)) September 17, 2018 January 27, 2020. Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 January 28, 2019. Other Businesses September 19, 2016 January 26, 2018. Animal Food—Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells that are used as animal food (part 507) Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale)) September 17, 2018 (CGMPs)
  • September 17, 2019 (preventive controls)
  • January 27, 2020 (CGMPs)
  • January 26, 2021 (preventive controls).
  • Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 (CGMPs)
  • September 17, 2018 (preventive controls)
  • January 28, 2019 (CGMPs)
  • January 27, 2020 (preventive controls).
  • Other Businesses September 19, 2016 (CGMPs)
  • September 18, 2017 (preventive controls)
  • January 26, 2018 (CGMPs).
  • January 28, 2019 (preventive controls).
  • We published the final rule establishing part 117 more than 2 months before we published the final rule establishing the produce safety regulation and, thus, the compliance dates for the produce safety regulation had not yet been established. To provide facilities that are solely engaged in packing and/or holding activities on produce RACs the same time to understand the applicable provisions of the produce safety regulation as farms that conduct similar packing and holding activities, and to enable such facilities to develop a food safety plan that builds on the requirements of the produce safety regulation, where applicable, we are extending the date for facilities that are solely engaged in packing and/or holding activities on produce RACs to comply with part 117 by approximately 16 months to make the compliance dates the same as for businesses in the same size categories in the produce safety regulation. For example, the new compliance date for a facility that is a small business under part 117 is the compliance date for a small business under the produce safety regulation, regardless of whether the facility subject to part 117 would be considered a small business under the produce safety regulation. (Note that the produce safety regulation has different compliance dates associated with sprouts but for the purposes of this extension we are not establishing different dates for sprouts.) This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document.

    With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018. We are extending compliance dates for very small businesses because, although they are not required to comply with subparts C and G (e.g., they are not required to have food safety plans), one of their options for compliance includes identifying the potential hazards associated with the food being produced, implementing preventive controls to address the hazards, and monitoring the performance of the preventive controls to ensure that such controls are effective (21 CFR 117.201(a)(2)(i)).

    To maintain the intended alignment between part 117 and part 507, we also are making a parallel extension to the dates for facilities that are solely engaged in packing and/or holding activities on produce RACs that are used as animal food to comply with part 507 requirements. While there may be limited facilities that pack and hold produce RACs exclusively for animal food, the by-products, such as culls, from packing and holding of produce RACs for human food are often used as animal food. The rulemaking to establish part 507 included a provision for certain human food by-products used as animal food (§ 507.12). To qualify for § 507.12, the human food facility whose packing or holding of produce results in by-products for use as animal food must be in compliance with the part 117 CGMPs or in compliance with the applicable requirements for packing and holding in part 112. The extension of compliance dates allows for facilities that are providing by-products for use as animal food time to implement the applicable part 117 or part 112 requirements. The parallel 16 month compliance date extension for part 507 is staggered to allow time for such operations to first comply with the part 507 CGMP requirements, including the related requirement in § 507.12. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply with the CGMP requirements of part 507 by January 26, 2018, and with the preventive controls requirements of part 507 by January 28, 2019.

    In addition, nut hulls and shells are used for animal food and result from some activities performed by those facilities that are receiving an extension to comply with part 117. Therefore, we are extending the compliance dates for animal food preventive controls requirements for facilities solely engaged in packing and/or holding activities conducted on nut hulls and shells. Facilities that are solely engaged in hulling, shelling, drying, packing, and/or holding of nuts and hulls are exempt from the part 507 CGMP requirements (§ 507.5(h)(2)) and will continue to remain exempt. With the extension, eligible facilities that are very small businesses must comply with animal food preventive controls requirements by January 26, 2021; eligible facilities that are small businesses must comply by January 27, 2020, and all other eligible facilities must comply by January 28, 2019.

    The extended compliance dates do not apply to facilities that manufacture/process produce RACs or nut hulls and shells in addition to packing and/or holding produce RACs or nut hulls and shells, because such facilities must come into compliance with part 117 and part 507 with respect to their manufacturing/processing as well as their packing and holding. Examples of facilities to which the extended compliance dates apply are packinghouses that solely pack and/or hold produce RACs; and facilities that solely hull, shell, pack, and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). Examples of manufacturing/processing facilities to which the extended compliance dates do not apply are a “fresh-cut” processing facility, such as a facility that produces bagged salad mixes or packages of sliced fruit, and a facility that grinds nut shells to make an animal food ingredient.

    B. Certain Facilities That Would Qualify as Secondary Activities Farms Except for the Ownership of the Facility

    Table 3 provides a summary of the revised compliance dates.

    Table 3—Extension of Compliance Dates for Certain Facilities That Would Qualify as Secondary Activities Farms Except for Ownership of the Facility Previously announced compliance date Compliance date with extension Human Food—Facilities that would qualify as secondary activities farms except for ownership of the facility (part 117) Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., held for a fee)) September 17, 2018 January 27, 2020. Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 January 28, 2019. Other Businesses September 19, 2016 January 26, 2018. Animal Food—Facilities that would qualify as secondary activities farms except for ownership of the facility (part 507) Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale)) September 17, 2018 (CGMPs)
  • September 17, 2019 (preventive controls)
  • January 27, 2020 (CGMPs).
  • January 26, 2021 (preventive controls).
  • Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 (CGMPs)
  • September 17, 2018 (preventive controls)
  • January 28, 2019 (CGMPs).
  • January 27, 2020 (preventive controls).
  • Other Businesses September 19, 2016 (CGMPs)
  • September 18, 2017 (preventive controls)
  • January 26, 2018 (CGMPs).
  • January 28, 2019 (preventive controls).
  • The rulemaking to establish part 117 created a “secondary activities farm” definition within the “farm” definition to cover certain operations that are not located on a primary production farm but are sufficiently related to a primary production farm so that it is appropriate to consider the operations to be farms (§ 1.227). A secondary activities farm is devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs (such as produce, grains, and eggs). Further, a majority interest in a secondary activities farm must be majority-owned (singly or jointly) by the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the secondary activities farm (§ 1.227).

    We have received questions via our Technical Assistance Network regarding whether certain operations qualify as secondary activities farms under part 117 and part 507. These questions describe a variety of business structures that may satisfy our intention to require a close relationship regarding ownership of the primary and secondary activities farms but the business structures do not meet the ownership requirement as codified in the “farm” definition. For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Other operations that might otherwise qualify as a secondary activities farm are operations that are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm. For example, Farm A is a primary production farm. Facility B is a produce packinghouse that packs only produce from Farm A. Farm A and Facility B are both part of Corporation C. Despite the close relationship, Facility B is not a secondary activities farm under the current definition because Farm A does not own a majority interest in Facility B.

    We are extending the compliance dates for certain operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition. The extension is applicable only to an operation satisfying all of the following requirements: (1) The operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of RACs (including operations that hull, shell, and/or dry nuts without additional manufacturing); and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the operation. Examples of common ownership include an operation that is owned by (or that owns) one or more primary production farms (e.g., a packinghouse owned by a cooperative of individual farms) and an operation under common ownership with a primary production farm, such as operations that are managed within the same business structure as the primary production farm (e.g., the farm and packinghouse are separate operations owned by parents and their children, respectively, and both operations are part of the same business jointly owned by the parents and children). Other limitations on secondary activities farms remain. For example, feed mills manufacturing animal food for contract farms would not qualify because, among other reasons, those feed mills are conducting manufacturing/processing outside the farm definition.

    We are extending the compliance dates for part 117 for operations satisfying all of the requirements by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation (note that the produce safety regulation has different compliance dates associated with sprouts but for purposes of this extension we are not establishing different dates for sprouts). This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document. With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018.

    The parallel 16 month compliance date extension for part 507 is staggered to allow time for operations satisfying all of the requirements to first comply with the CGMP requirements. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply by with the CGMP requirements of part 507 by January 26, 2018, and with the preventive controls requirements of part 507 by January 28, 2019.

    V. Extension of Compliances Dates for Certain Facilities That Color RACs Under Part 117

    Table 4 provides a summary of the revised compliance dates.

    Table 4—Extension of Compliance Dates in Part 117 for Certain Facilities That Color RACs Previously announced compliance date Compliance date with extension Human Food—Facilities that color RACs under part 117 Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., held for a fee)) September 17, 2018 January 27, 2020. Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 18, 2017 January 28, 2019. Other Businesses September 19, 2016 January 26, 2018.

    The definition of RAC in section 201(r) of the FD&C Act includes “fruits that are . . . colored . . . in their unpeeled natural form prior to marketing.” (21 U.S.C. 321(r)). As we noted in the proposed rule to establish part 117 (78 FR 3646 at 3678 to 3679, January 16, 2013), FDA does not consider the activity of coloring a RAC to result in the transformation of the RAC into a processed food. However, this does not mean that coloring a RAC is not manufacturing/processing. The activity classification “manufacturing/processing” is broader than just activities that transform a RAC into a processed food. It includes most food-handling activities because it is satisfied by any degree of “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food” (§ 1.227). In contrast, transforming a RAC into a processed food generally requires meeting a threshold of altering the general state of the commodity. In the proposed rule, coloring was provided as an example of an activity that is manufacturing/processing but does not transform a RAC into a processed food (78 FR 3646 at 3678 to 3679).

    An establishment that conducts manufacturing/processing activities other than those specified as being within the “farm” definition generally is a facility that is required to register and is subject to the human food preventive controls requirements in part 117. The “farm” definition provides for farms to do several manufacturing/processing activities, including treating RACs to manipulate ripening and packaging and labeling RACs. These are all manufacturing/processing activities that do not transform a RAC into a processed food. However, FDA did not include coloring, another manufacturing/processing activity that does not transform a RAC into a processed food, within the “farm” definition. Therefore, currently coloring triggers the registration requirement and application of the human food preventive controls requirements in part 117 (except where other exemptions apply). We are considering whether future rulemaking to modify the “farm” definition is appropriate to address the issue.

    Therefore, we are extending the compliance dates for facilities that would qualify as farms if they did not color RACs. We are extending the compliance dates for such operations by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation. (Note that the produce safety regulation has different compliance dates associated with sprouts but for purposes of this extension, we are not establishing different dates for sprouts.) This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document. With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018. We are not extending the compliance dates for facilities that engage in additional manufacturing/processing activities currently outside of the “farm” definition because we expect such facilities to come into compliance with part 117 as a result of those other activities.

    VI. Extension of Compliances Dates for Facilities Solely Engaged in the Ginning of Cotton Under Part 507

    Table 5—provides a summary of the revised compliance dates.

    Table 5—Extension of Compliance Dates for Facilities Solely Engaged in the Ginning of Cotton Under Part 507 Previously announced compliance date for part 507 Compliance date
  • for part 507 with
  • extension
  • Animal Food—Facilities solely engaged in the ginning of cotton under part 507 Very Small Businesses (a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale)) September 17, 2019 January 26, 2021. Small Businesses (a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) September 17, 2018 January 27, 2020. Other Businesses September 18, 2017 January 28, 2019.

    Cotton ginning is considered part of harvesting and thus within the “farm” definition when done on a farm (and when done for safe or effective packing, it may also be considered a packing activity on a farm). When done off-farm, cotton ginning is either a packing activity (if done for safe or effective packing), or a manufacturing/processing activity, depending on the circumstances. Ginning cotton does not transform a RAC into a processed food but results in component RACs, some of which (e.g., cotton seed, lint, gin trash) are used for animal food. Therefore, currently off-farm cotton ginning in the production of animal food generally triggers the food facility registration requirement and application of the animal food preventive controls requirements in part 507 (facilities solely engaged in the ginning of cotton remain exempt from the CGMP requirements in part 507). Since publication of the final rule establishing part 507, we have received communications from the cotton industry expressing concern that the part 507 rule does not apply to the vast majority of cotton ginners that are part of a farm, while it does apply to the minority of cotton ginners that do not meet the “farm” definition, despite the fact that both types of operations perform the same activities (Ref. 3). We are considering whether and how FDA should address these concerns.

    Therefore, we are extending the compliance dates for animal food preventive controls requirements for facilities subject to part 507 that solely engage in the ginning of cotton. We are extending the compliance dates for such operations by approximately 16 months to match the other extension dates that relate to the “farm” definition. With the extension, eligible facilities that are very small businesses must comply with the animal food preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the animal food preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply with the animal food preventive controls requirements of part 507 by January 28, 2019. We are not extending the compliance dates for facilities that engage in additional animal food manufacturing/processing activities of cotton currently outside of the “farm” definition (e.g., crushing cotton seed to make cotton seed oil) because we expect such facilities to come into compliance with the animal food preventive controls requirements of part 507 as a result of those other activities.

    In addition, some cotton ginners may be operations that would be secondary activities farms except that they do not meet the ownership criterion in the current “farm” definition. For further discussion of the compliance date extension for these types of operations see section IV.B. Certain Facilities That Would Qualify as Secondary Activities Farms Except for the Ownership of the Facility.

    VII. Extension of Compliance Dates for Importation of Food Contact Substances Under the FSVP Regulation

    Table 6 provides a summary of the revised compliance dates.

    Table 6—Extension of Compliance Dates for Importation of Food Contact Substances Under the FSVP Regulation Previously announced earliest compliance date Earliest compliance date with extension Importation of Food Contact Substances under the FSVP Regulation May 30, 2017 May 28, 2019.

    In the preamble of the final rule establishing the FSVP regulation, we stated that the definition of “food” for purposes of FSVP (§ 1.500) includes food contact substances that are considered “food” in section 201(f) of the FD&C Act. A food contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food (21 CFR 170.3(e)(3)). The term “food” is defined in section 201(f)(3) of the FD&C Act to include articles used as components of food. Therefore, we concluded that importers must have an FSVP for a food contact substance that they import that meets the definition of “food” in section 201(f) of the FD&C Act (80 FR 74226 at 74233).

    Since we published the final rule establishing the FSVP regulation, our Technical Assistance Network has received inquiries regarding the applicability of the FSVP regulation to food contact substances. In addition, on June 16, 2016, FDA met with representatives of the food packaging manufacturing industry at their request to listen to concerns regarding the applicability of the FSVP regulation to the importation of food contact substances (Ref. 4). The industry representatives stated that the supply chain associated with imported substances used to manufacture food contact substances is highly complex and very different from other foods subject to the FSVP regulation. The industry representatives also asserted that the hazards associated with food contact substances are already adequately addressed through the food additive petition and food contact substance notification processes under section 409 of the FD&C Act (21 U.S.C. 348).

    After considering the information presented by the industry representatives, FDA believes that compliance with the requirement to conduct verification activities under the FSVP regulation for food contact substances by May 30, 2017, might not be feasible. Accordingly, we are extending the compliance date for the importation of food contact substances by 2 years so that we can consider how best to address the feasibility concerns. We note the relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances and FDA's extensive premarket approval and review processes for these substances under section 409 of the FD&C Act provide some assurances regarding safety during this time. As a result of this extension, the earliest that an importer would be required to comply with FSVP for the importation of food contact substances would be May 28, 2019.

    VIII. Extension of Compliance Date for the CGMP Requirements of Part 117 for Facilities Producing Grade “A” Milk and Milk Products Covered by NCIMS Under the PMO

    In the preamble of the final rule establishing part 117, we established a compliance date of September 17, 2018, for “PMO facilities” (see Response 214, 80 FR 55908 at 55987 to 55988). As we discussed in Response 214, we agreed that we should make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. We described our reasons for deciding to extend the compliance date for “PMO-regulated facilities” to comply with the human food preventive controls requirements to September 17, 2018. Those reasons related to the current provisions of the PMO, the work already begun by NCIMS to modify the PMO to include all of the human food preventive controls requirements established in part 117, and complex implementation issues concerning the interstate movement of milk and milk products and imported milk.

    In the Federal Register of November 18, 2015 (80 FR 71934), we clarified that the extended compliance date of September 17, 2018, for “PMO facilities” applies only to Grade “A” milk and milk products covered by NCIMS under the PMO, and not to the manufacturing, processing, packing, or holding of other food produced in such facilities. In the November 18, 2015, clarification, we did not discuss the date for “PMO facilities” to be in compliance with the CGMP requirements of part 117. During our outreach activities for implementation of part 117 we have received questions about when “PMO facilities” must comply with the modernized CGMP requirements of part 117 (primarily located in subpart B).

    We have not established compliance dates for the modernized CGMPs that are different from the general compliance dates for the preventive controls requirements in part 117 with one exception related to “PMO facilities” (see table 53 in the preamble of the final rule establishing part 117, 80 FR 55908 at 56128). Specifically, we provided that the extension of the compliance date for “PMO facilities” until September 17, 2018, applied only to “subparts C and G” (the principal provisions of the human preventive controls requirements) (see Response 214, 80 FR 55908 at 55987 to 55988). In this document, we are extending the date for compliance with the modernized CGMPs by “PMO facilities” until September 17, 2018. We will continue to work with the NCIMS to modify the PMO to reflect the modernized CGMPs and the preventive control requirements. The extension will create a single compliance date for the Grade “A” milk and milk products covered by the PMO. Note that this extension applies only to Grade “A” milk and milk products covered by NCIMS under the PMO, and not to the manufacturing, processing, packing, or holding of other food produced in such facilities.

    IX. Clarification of Compliance Dates for Certain Agricultural Water Testing Provisions in Produce Safety Regulation

    In this final rule, we are also clarifying our intent regarding the meaning of the compliance dates with respect to certain testing requirements related to agricultural water in the produce safety regulation.

    Specifically, in the preamble of the final rule establishing the produce safety regulation (at 80 FR 74354 at 74453 to 74454) we explained that we excluded § 112.46(b)(1), with respect to untreated surface water only, from the 2-year extended compliance period provided for the remainder of § 112.46 because, in order to comply with the microbial quality criteria in § 112.44(b), farms must have developed a microbial water quality profile (MWQP) based on the initial survey conducted over a minimum of 2 years and not greater than 4 years. We stated that to develop the MWQP prior to the point at which they must comply with all of the requirements of subpart E, covered farms must begin water sampling and subsequent testing not later than 4 years after issuance of the rule for very small farms; not later than 3 years after issuance of the rule for small farms; and not later than 2 years after issuance of the rule for all other farms. As an example we stated that initiating water sampling upon publication of the rule would allow covered farms that are not small or very small to collect 5 samples per year over the next 4 years, sufficient to make up the minimum 20 samples necessary to develop the MWQP required under § 112.46(b) at the point at which they must comply with all of the requirements of subpart E. We also stated that if these covered farms initiated water sampling 2 years after issuance of the rule, the farms would need to collect 10 samples per year over the next 2 years to make up the minimum 20 samples necessary to develop the MWQP.

    We want to clarify and correct these earlier statements. We note that § 112.46(b)(1)(i)(A) allows covered farms discretion as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples; and (2) the time period over which such samples are taken, provided that the period must be at least 2 years and no more than 4 years. For each business size category, the compliance date for § 112.46(b)(1) with respect to untreated surface water testing is 2 years before the compliance date for the § 112.44(b) microbial quality criteria for such water. This does not mean that covered farms have only 2 years in which to conduct their initial surveys for untreated surface water under § 112.46(b)(1) if they begin testing on the compliance date for that provision. Covered farms have 2 to 4 years in which to fulfill that requirement, per § 112.46(b)(1)(i)(A). This means that, for example, a farm that is not small or very small must begin sampling and testing untreated surface water in accordance with § 112.46(b)(1)(i)(A), as applicable, no later than January 26, 2018. The relevant compliance date for the related microbial quality criteria is 2 years later, on January 27, 2020. However, the farm has discretion under § 112.46(b)(1)(i)(A) as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples; and (2) the time period over which such samples are taken, provided that the period must be at least 2 years and no more than 4 years. Therefore, to provide a few examples, all of the following possible approaches are acceptable for farms that are not small or very small:

    • Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 2 years (10 in 2018 and 10 in 2019) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2019, early 2020); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2020-2021).

    • Beginning in 2018, conducting an initial survey consisting of taking 5 samples per year over 4 years (5 in 2018, 5 in 2019, 5 in 2020, and 5 in 2021) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2022-2023).

    • Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 4 years (10 in 2018, 10 in 2019, 10 in 2020, and 10 in 2021) for a total of 40 samples; calculating the MWQP for the first time upon completing the 40-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2022-2023).

    For small and very small farms, the same approaches are acceptable, and the relevant dates are 1 and 2 years later, respectively.

    X. Economic Analysis of Impacts

    In the final regulatory impact analysis (FRIA) for part 117, we concluded that extension of the compliance dates would be unlikely to significantly affect the cost estimates made (Ref. 5). In the FRIA for the produce safety regulation, we noted that extended compliance dates would result in a decrease in costs as smaller operations would have additional time to fully and correctly implement the rule's requirements (Ref. 6). We did not quantify the potential impact of extended compliance periods on the costs of part 507 or the FSVP regulation but expect the impacts would be similar to those of part 117 or the produce safety regulation.

    We are extending the compliance dates by 2 years for the written assurances in the customer provisions in part 117 and part 507, the produce safety regulation, and the FSVP regulation. Although none of the FRIAs provided a separate cost analysis for the written assurance provisions, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with the written assurances during the compliance delay period, we believe that a 2-year delay in the compliance dates for the written assurances in the customer provisions for these rules is unlikely to significantly affect the costs of the rules.

    We are extending the compliance dates in part 117 and part 507 for facilities that are solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells. The new compliance dates for part 117 are the same as the compliance dates under the produce safety regulation for the same size categories: January 27, 2020 (very small businesses), January 28, 2019 (small businesses), and January 26, 2018 (other businesses). The new compliance dates for part 507 are staggered to allow for compliance with CGMP requirements first followed by the animal food preventive controls requirements 1 year later. The part 507 CGMP compliance dates for these facilities are the same as the compliance dates under the produce safety regulation for the same size categories: January 27, 2020 (very small businesses), January 28, 2019 (small businesses), and January 26, 2018 (other businesses). The part 507 animal food preventive controls requirements for the same size categories are: January 26, 2021 (very small businesses), January 27, 2020 (small businesses), and January 28, 2019 (other businesses). Although the FRIAs for part 117 and part 507 did not provide a separate compliance cost analysis for facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rules.

    We are similarly extending the compliance dates in part 117 and part 507 for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. Although the FRIAs for part 117 and part 507 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rules.

    We are similarly extending the compliance dates in part 117 for certain facilities that color RACs. Although the FRIA for part 117 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rule.

    We are similarly extending the compliance dates in part 507 for facilities that are solely engaged in the ginning of cotton. Although the FRIA for part 507 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the cost of the rule.

    We are extending the compliance date for the importation of food contact substances by 2 years, such that the earliest that an importer would be required to comply with the FSVP regulation for the importation of food contact substances would be May 28, 2019. Although the FRIA for the FSVP regulation did not provide a separate compliance cost analysis for importers of food contact substances, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the cost of the rule.

    We are extending the compliance date for the CGMP Requirements of part 117 for facilities producing Grade “A” milk and milk products covered by NCIMS under the PMO. Although the FRIA for part 117 did not provide a separate compliance cost analysis for these facilities to comply with subpart B of part 117, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rule.

    We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13563 states the importance of quantifying costs and benefits, reducing costs and burdens, and harmonizing rules. We believe this final rule will not increase compliance costs and will serve an important purpose of providing us an opportunity to consider how to reduce burdens on the public and maintain or improve coordination among the four rules affected. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule only extends various compliance dates for certain provisions and/or certain entities with respect to the four rules discussed here, we have determined that the final rule will not have a significant economic impact on a substantial number of small entities.

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

    XI. Analysis of Environmental Impact

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

    XII. Paperwork Reduction Act of 1995

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

    XIII. Federalism

    We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    XIV. Executive Order 13175

    We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies 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. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.

    XV. References

    The following references are on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov.

    1. Grocery Manufacturers Association, “21 CFR 117.136. Industry Impacts from Disclosure and Written Assurance Requirements,” 2016. 2. Letter dated April 19, 2016, from United Fresh Produce Association and 21 other organizations to Michael Taylor and Stephen Ostroff of FDA. 3. Letter dated May 20, 2016, from Roger A. Isom of the California Cotton Ginners Association to Jeanette Murphy of FDA. 4. Letter dated May 3, 2016, from Society of Plastics Industry, Inc., and other organizations to Michael Taylor and Stephen Ostroff of FDA. 5. FDA, “Part 117. FSMA Final Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food: Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, Final Unfunded Mandates Reform Act Analysis, and Final Paperwork Reduction Act Analysis,” 2015. (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472884.pdf). 6. FDA, “Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” 2015. (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf). Dated: August 18, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-20176 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-1896] New Animal Drugs for Use in Animal Feed; Category Definitions AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Direct final rule.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.

    DATES:

    This rule is effective December 1, 2016. Submit either electronic or written comments by November 7, 2016. See Section IV for further discussion of the effective date.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1896 for “Category Definitions For Minor Species.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205, [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Executive Summary A. Purpose of the Direct Final Rule B. Summary of the Major Provisions of the Direct Final Rule C. Legal Authority D. Costs and Benefits II. Background III. Provisions of the Regulation IV. Direct Final Rulemaking V. Legal Authority VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. References I. Executive Summary A. Purpose of the Direct Final Rule

    FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by the FDA Center for Veterinary Medicine (CVM) to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobial drugs in animal agriculture. Under this program, sponsors of antimicrobial new animal drugs that also have importance in human medicine were requested to voluntarily withdraw approval of production (e.g., growth production, feed efficiency) indications for their drug products that are intended for use in the feed or water of food-producing animals. Based on the existing drug category definitions, the voluntary withdrawal of production indications by these drug sponsors would, in some cases, result in a change to a medicated feed drug's category, potentially leading to additional consequences not foreseen at the time the program was initiated.

    The category in which a new animal drug used in medicated feeds is placed is based on their likelihood of producing unsafe residues in the edible products of treated animals. Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

    New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

    Certain Category I Type A medicated articles would be recategorized to Category II when a production indication is voluntarily withdrawn by a sponsor as part of the judicious use initiative that is currently underway, based on the next lowest use level that remains once the production use is withdrawn having a withdrawal period such that the drug would then meet the definition for Category II. For Category I Type A medicated articles that include indications for minor species, FDA is concerned that if such a Type A medicated article is recategorized to Category II based on a withdrawal period for an approved therapeutic use in a minor species, sponsors may opt to request withdrawal of approval of these minor species indications in order to ensure the Type A medicated article can remain in Category I. Sponsors may also decline to pursue development of additional therapies for minor species if these uses would require a withdrawal period that would trigger a recategorization to Category II.

    This direct final rule revises the category definitions such that they will be based only on whether a withdrawal period is required for a major species.1 Under this new definition, a Category I Type A medicated article will not be recategorized to Category II based on the existence of a withdrawal period for an approved indication in a minor species, even if that minor species indication is the next lowest approved use level that remains after the production indication has been withdrawn. However, if the next lowest use level (apart from the minor species indication) is an indication approved for use in a major species that has a withdrawal period, under the new definition the drug will move to Category II.

    1 As a practical matter, categorization under the revised definitions in this direct final rule will be driven by approved indications for major food-producing species (cattle, poultry, swine, and turkeys). While the definition for major species includes horses, dogs, and cats, they are not regulated as food-producing major species and thus drugs approved for use in these species do not require an assessment of human food safety that may result in assignment of a withdrawal period. Minor species are defined as animals, other than humans, that are not major species. Minor species include animals such as sheep, goats, ducks, geese, and aquaculture species such as catfish, salmon, and trout.

    The purpose of this revision is to preserve the present availability of medicated feeds intended for therapeutic uses in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe this revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.

    B. Summary of the Major Provisions of the Direct Final Rule

    FDA is amending 21 CFR 558.3 Definitions and general considerations applicable to this part (§ 558.3) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. Definitions for “major species” and “minor species” are also being added to this section.

    C. Legal Authority

    FDA is issuing these regulations based on its authority under the new animal drug provisions in sections 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) and under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

    D. Costs and Benefits

    The revisions made by this direct final rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.

    II. Background

    FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the Federal Register of March 3, 1986 (51 FR 7382), which, among other things, established two categories of new animal drugs used in medicated feeds. As discussed in the final rule, the Agency placed these drugs into categories based on their likelihood of producing unsafe residues in the edible products of treated animals (51 FR 7382). Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

    New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

    This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by CVM to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobials of importance to human medicine (i.e., medically important antimicrobials) in animal agriculture. Specifically, CVM's initiative to ensure the judicious use of medically important antimicrobial drugs in animal agriculture advocates two specific changes to the approved conditions of use of medically important antimicrobials that are administered through the medicated feed or water of food-producing animals.

    These changes, which are described in Guidance for Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), are intended to reduce the development of antimicrobial resistance and thereby preserve the effectiveness of these important drugs for use in treating infections in humans. Following publication of GFI #213, all sponsors of these medically important antimicrobial new animal drug products approved for use in the feed or water of food-producing animals notified FDA in writing of their intent to voluntarily make changes to their affected products as outlined in the guidance.

    Under GFI #213, sponsors of medically important antimicrobial new animal drugs approved for over-the-counter use in the feed or water of food-producing animals were asked to change the marketing status of their products to veterinary prescription (Rx) marketing status in the case of new animal drugs administered in water, or to veterinary feed directive (VFD) marketing status for drugs administered in or on animal feed. New animal drugs with Rx or VFD marketing status can legally only be used with a veterinarian's oversight. Prescription animal drugs require a veterinarian's prescription, while use of VFD drugs requires a VFD; both types of orders must be issued by a licensed veterinarian in the course of the veterinarian's professional practice.

    In addition, under GFI #213 sponsors of medically important new animal drugs used in animal feed or water that have production indications were requested to voluntarily withdraw these indications; approved therapeutic indications for use of these drugs would remain.

    In some instances, once a sponsor withdraws the production indication from a drug approved for use in animal feed (which is generally the lowest use level of the drug), the remaining lowest therapeutic use level will require a withdrawal period. Based on the existing definitions of the feed drug categories, this results in a Category I new animal drug being recategorized as a Category II drug, the more restrictive of the two possible categories of drugs used in medicated feed. Category II drugs require that the manufacture of Type B and Type C medicated feeds from Type A medicated articles be done in facilities possessing a medicated feed mill license, which number roughly 900 in the United States. In contrast, there are tens of thousands of unlicensed feed mills in this country. Such a recategorization to Category II, thereby limiting the use of the Type A medicated article to a much smaller subset of feed mills, may disrupt the existing movement of these medicated feeds through distribution channels.

    FDA believes that sponsors may request voluntary withdrawal of those specific therapeutic indications as a way to keep their products in the less restrictive Category I when the recategorization of a drug to Category II is triggered by a therapeutic indication for a minor species. For certain drug products, the only therapeutic indications requiring a withdrawal period that would remain following the voluntary withdrawal of approval of production uses are those for minor species. The loss of therapeutic indications for minor species would adversely affect the availability of therapeutic medicated feeds necessary for the health of minor species, which is a matter of significant concern for the Agency.

    This foreseeable adverse effect on the health of minor species would directly undermine the intent of Congress in passing the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as well as to our intent in establishing the implementing regulations under that statute. The Category I drugs likely to be affected have been safely used in this category for decades, and we have no reason to believe they would not continue to be safely used in this category moving forward.

    Under the current category definitions in § 558.3 for feed use drugs, a drug will be included in Category II if the lowest use level of the drug in any approved species requires a withdrawal period. This approach equates the existence of a withdrawal period for a particular use with the potential risk that edible tissues from animals administered a medicated feed might contain a residue of concern.

    However, the toxicological analysis of animal drugs used to calculate a withdrawal period is based on lifetime exposure by humans to potential drug residues. This assessment of lifetime exposure does not consider the lower risk to the public health from the use of these same new animal drugs in food-producing minor species attributable to the lower human consumption over time of edible tissues from food-producing minor species (Refs. 1 and 2). For this reason, FDA does not at this time believe this revision of the category definitions presents a risk to the public health.

    In a manner similar to its effect on drug indications that are already approved, CVM believes the existing categorization scheme would pose a significant disincentive for future development of additional minor species therapies for existing Category I drugs if those new uses would require a withdrawal period and thus trigger a change to Category II for that drug.

    Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 are being revised to base category assignment only on uses in major species. This revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.

    III. Provisions of the Regulation

    We are amending paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (Definitions and general considerations applicable to this part.) to base the definition for each of the two categories of new animal drugs (Category I and Category II) used in medicated feeds only on approved uses in major species. Section 558.3(b) is further amended to add definitions for “major species” and “minor species” that are identical to the definitions of those terms found in FDA's regulations for new animal drugs for minor use and minor species (21 CFR 516.3). We are revising the feed drug category definitions in § 558.3 to preserve the availability of medicated feeds intended for use in minor species and prevent a likely disincentive for development of additional therapies for minor species.

    IV. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable for a direct final rule. FDA is amending § 558.3(b)(1) by revising the definitions of Category I and Category II new animal drugs administered in or on medicated feed. This rule is intended to make noncontroversial changes to existing regulations. The Agency does not anticipate receiving any significant adverse comments on this rule.

    Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the Federal Register a companion proposed rule. The companion proposed rule and this direct final rule are substantively identical. The companion proposed rule provides the procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. Any comments received in response to the companion proposed rule will also be considered as comments regarding this direct final rule.

    FDA is providing a comment period for the direct final rule of 75 days after the date of publication in the Federal Register. If FDA receives a significant adverse comment, we intend to withdraw this direct final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, the Agency will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553).

    Comments that are frivolous, insubstantial, or outside the scope of this direct final rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, FDA may adopt as final those provisions of the rule that are not the subject of a significant adverse comment.

    If FDA withdraws the direct final rule, all comments received will be considered under the companion proposed rule in developing a final rule under the usual notice-and-comment procedures under the APA (5 U.S.C. 552 et seq.). If FDA does not receive a significant adverse comment in response to the direct final rule, the Agency will publish, within 30 days after the comment period ends, a document in the Federal Register confirming the effective date of the final rule. The Agency intends to make the direct final rule effective December 1, 2016.

    A full description of FDA's policy on direct final rule procedures may be found in a guidance document announced in the Federal Register of November 21, 1997 (62 FR 62466). The guidance document may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

    V. Legal Authority

    We are issuing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

    VI. Economic Analysis of Impacts

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

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this direct final rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.

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

    This direct final rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.

    Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that will be recategorized from Category II to Category I as a result of this direct final rule. No compliance costs will be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.

    VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) 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.

    VIII. Paperwork Reduction Act of 1995

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

    IX. Federalism

    We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. We have determined that this direct final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that this direct final rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

    X. References

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

    1. U.S. Department of Agriculture, “Livestock & Meat Domestic Data,” http://www.ers.usda.gov/data-products/livestock-meat-domestic-data (accessed on June 23, 2016). 2. “Food Fish Production and Sales by Species, by Size Category, by State and United States: 2005,” http://www.agcensus.usda.gov/Publications/2002/Aquaculture/aquacen2005_08.pdf (accessed on June 23, 2016). List of Subjects in 21 CFR Part 558

    Animal drugs, animal feeds.

    Therefore, under the Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    2. In § 558.3, revise paragraphs (b)(1)(i) and (ii); and add paragraphs (b)(13) and (14) to read as follows:
    § 558.3 Definitions and general considerations applicable to this part.

    (b) * * *

    (1) * * *

    (i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.

    (ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.

    (13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.

    (14) “Minor species” means animals, other than humans, that are not major species.

    Dated: August 18, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-20148 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0814] Drawbridge Operation Regulation; Trent River, New Bern, NC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70/Alfred A. Cunningham Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to facilitate safe participation in the Multiple Sclerosis Society's Historic New Bern Bike Ride. This deviation allows the bridge to remain in the closed-to-navigation position.

    DATES:

    The deviation is effective from 8 a.m. on Saturday, September 10, 2016, to 9:30 a.m. Sunday, September 11, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0814] 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. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The North Carolina Department of Transportation, who owns and operates the U.S. 70/Alfred A. Cunningham Bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.843(a), to ensure the safety of the cyclists and spectators that are associated with the Multiple Sclerosis Society's Historic New Bern Bike Ride.

    Under this temporary deviation, the bridge will be maintained in the closed position from 8 a.m. to 9:30 a.m. on Saturday, September 10, 2016, and from 8 a.m. to 9:30 a.m. on Sunday, September 11, 2016. The bridge is a double bascule drawbridge and has a vertical clearance in the closed position of 14 feet above mean high water.

    The Trent River is used by small commercial vessels and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open in case of emergencies, there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessel operators 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 effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: August 17, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2016-20232 Filed 8-23-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket Number USCG-2016-0707] Drawbridge Operation Regulation; Upper Mississippi River, Rock Island, IL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Rock Island Railroad and Highway Drawbridge across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois. The deviation is necessary to facilitate a charity marathon race. This deviation allows the bridge to be maintained in the closed-to-navigation position for four and a half hours.

    DATES:

    This deviation is effective from 7 a.m. to 11:30 a.m., September 25, 2016.

    ADDRESSES:

    The docket for this deviation, (USCG-2016-0707) 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 Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois to remain in the closed-to-navigation position for four and a half hours from 7 a.m. to 11:30 a.m., September 25, 2016 to facilitate the Quad City Marathon.

    The Rock Island Railroad and Highway Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal. There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.

    The Rock Island Railroad and Highway Drawbridge provides a vertical clearance of 23.8 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received. 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 vessel operators 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 effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: August 19, 2016. Eric A. Washburn, Bridge Administrator, Western Rivers.
    [FR Doc. 2016-20265 Filed 8-23-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0735] RIN 1625-AA00 Safety Zone; Nahant Bay, Marblehead, MA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the navigable waters of the Captain of the Port (COTP) Boston Zone within a 2,500-yard radius around a position approximately 6nm Northeast of Nahant Bay, MA, for a Department of Defense (DOD) Training Exercise. The safety zone is needed to protect Navy personnel, support vessels, and the maritime public from the hazards associated with this training exercise. Entering into, transiting through, mooring, or anchoring within this safety zone during periods of enforcement is prohibited unless authorized by the Coast Guard Sector Boston COTP or the COTP's designated representative.

    DATES:

    This rule is effective on August 24, 2016 from 7:00 p.m. through 10:00 p.m.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0735 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email, Mark Cutter, Sector Boston Waterways Management Division, U.S. Coast Guard; telephone 617-223-4000, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations COTP Captain of the Port CFR Code of Federal Regulations DHS Department of Homeland Security DOD Department of Defense FR Federal Register NPRM Notice of Proposed Rulemaking NAD 83 North American Data of 1983 § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because publishing a NPRM would be impracticable. DOD Training Exercise will take place on August 24, 2016. The DOD Exercise will consist of High-altitude military parachuting freefall insertion approximately 6nm Northeast of Nahant, MA, in position 42° 27.000′ N., 070° 50.000′ W. This exercise will present safety hazards and risks to Navy personnel, support vessels, and the maritime public during the exercise. It would be impracticable to delay promulgating this rule, as it would not be possible to conduct notice and comment rulemaking before the date of the exercise. For this reason, the Coast Guard finds it impracticable to delay this regulation.

    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable for the same reasons specified above.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that the potential hazards associated with this DOD Training Exercise create a serious safety concern for anyone transiting within a 2,500-yard radius of position 42° 27.000′ N., 070° 50.000′ W. This rule is needed to protect Navy personnel, vessels, and the normal marine traffic in the navigable waters within the safety zone while this exercise is be being conducted.

    IV. Discussion of Rule

    This rule establishes a safety zone from 7:00 p.m. until 10:00 p.m. on August 24, 2016. The safety zone will cover all navigable waters within a 2,500-yard radius of position 42° 27.000′ N., 070° 50.000′ W. The duration of the zone is intended to protect Navy personnel, vessels, and normal marine traffic in these navigable waters during the DOD training exercise. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size, location, and duration of the safety zone. The implementation of this temporary safety zone is necessary for the protection of all waterway users. The size of the zone is the minimum necessary to provide adequate protection for the waterway users, adjoining areas, and the public. Vessel traffic will be able to safely transit around this safety zone. Any hardships experienced by persons or vessels are considered minimal compared to the interest in protecting the public.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry within 2,500 yards of position 42° 27.000′ N., 070° 50.000′ W. during the DOD training exercise. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T01-0735 to read as follows:
    § 165.T01-0735 Safety Zone; DOD Training Exercise, Nahant Bay, Marblehead, MA.

    (a) Location. The following area is a safety zone: All navigable waters within 2,500-yards of 42° 27.000′ N., 070° 50.000′ W. while the DOD Training Exercise is underway.

    (b) Regulations. While this security zone is being enforced, the following regulations, along with those contained in § 165.33, apply:

    (1) Under the general safety zone regulations in subpart B of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or a COTP designated representative.

    (2) To seek permission to enter, contact the COTP or the COTP's representative by VHF-FM channel 16 or by phone at (617) 223-5757 (Sector Boston Command Center). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or a COTP designated representative.

    (c) Enforcement period. This section will be enforced from 7:00 p.m. until 10:00 p.m. on August 24, 2016.

    (d) Definitions. As used in this section, designated representative means is any Coast Guard commissioned, warrant, or petty officer or any federal, state, or local law enforcement officer who has been designated by the COTP to act on the COTP's behalf. The COTP's representative may be on a Coast vessel, a Coast Guard Auxiliary vessel, state or local law enforcement, or a location on shore.

    (e) Penalties. Those who violate this section are subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: August 19, 2016. C. C. Gelzer, Captain, U.S. Coast Guard, Captain of the Port Boston.
    [FR Doc. 2016-20389 Filed 8-22-16; 4:15 pm] BILLING CODE 9110-04-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 160328287-6745-02] RIN 0648-BF94 Atlantic Highly Migratory Species (HMS); Porbeagle Shark Management Measures AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule implements the International Commission for the Conservation of Atlantic Tunas (ICCAT) Recommendation 15-06 regarding porbeagle sharks (Lamna nasus) caught in association with ICCAT fisheries. Recommendation 15-06 requires, among other things, fishing vessels to promptly release unharmed, to the extent practicable, porbeagle sharks caught in association with ICCAT fisheries when brought alive alongside for taking on board the vessel. This action affects fishermen fishing in the commercial highly migratory species (HMS) pelagic longline fishery and the HMS recreational fisheries for tunas, swordfish, and billfish in the Atlantic Ocean, including the Caribbean Sea and Gulf of Mexico. This action implements an ICCAT recommendation, consistent with the Atlantic Tunas Convention Act (ATCA), and will further domestic management objectives under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    DATES:

    Effective on September 23, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Larry Redd, Carrie Soltanoff, or Karyl Brewster-Geisz by phone at 301-427-8503.

    SUPPLEMENTARY INFORMATION: Background

    Atlantic HMS are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP). Implementing regulations at 50 CFR part 635 are issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq., and Atlantic Tunas Convention Act (ATCA), 16 U.S.C. 927 et seq. ATCA requires the Secretary of Commerce (Secretary) to promulgate regulations as may be necessary and appropriate to implement ICCAT recommendations.

    At its 24th Annual Meeting in 2015, ICCAT adopted Recommendation 15-06 on “Porbeagle [Sharks] Caught in Association with ICCAT Fisheries.” Recommendation 15-06 requires, among other things, fishing vessels “. . . to promptly release unharmed, to the extent practicable, porbeagle sharks caught in association with ICCAT fisheries when brought alive alongside for taking on board the vessel.” Recommendation 15-06 notes that, according to the ICCAT Standing Committee for Research and Statistics (SCRS), biomass of northwest Atlantic and northeast Atlantic porbeagle sharks is depleted to well below the biomass at maximum sustainable yield, but recent fishing mortality is below the fishing mortality at maximum sustainable yield (i.e., the stocks are overfished but overfishing is not occurring). Recommendation 15-06 further notes that the 2008 and 2012 Ecological Risk Assessments concluded that the porbeagle shark was among the most vulnerable of shark species, which, even at low fishing mortality levels, makes it more susceptible to overfishing. Thus, Recommendation 15-06 was adopted by ICCAT to reduce fishing mortality of porbeagle sharks caught in association with ICCAT fisheries in order to reduce porbeagle shark fishing even further, and thus assist in rebuilding stocks which are currently overfished. On June 15, 2016 (81 FR 39017), NMFS published a proposed rule to consider changes to the regulations at 50 CFR part 635 consistent with Recommendation 15-06. The proposed rule contains details that are not repeated here. The comment period on the proposed rule ended on July 15, 2016.

    Domestically, porbeagle sharks are managed pursuant to a rebuilding plan established in Amendment 2 to the 2006 Consolidated HMS FMP (73 FR 35788, June 24, 2008 as corrected at 73 FR 40658, July 15, 2008). Under current regulations, commercial and recreational HMS fishermen that operate in ICCAT fisheries are authorized to retain any porbeagle shark, regardless of whether the shark is dead or alive at haulback. In this final rule, NMFS requires, to the extent practicable, all live porbeagle sharks to be released by commercial and recreational HMS fishermen operating in ICCAT fisheries, as determined by the permits they hold or, in the case of recreational fisheries, whether they have also retained tuna-like species on a given trip.

    Response to Comments

    During the proposed rule stage, NMFS received 28 written comments. The comments received on the proposed rule during the public comment period can be found at http://www.regulations.gov/ by searching for NOAA-NMFS-2016-0066. A summary of the relevant comments on the proposed rule are shown below with NMFS' response.

    Comment 1: NMFS received comments both in support of, and opposed to, implementing the ICCAT recommendation. Commenters who supported this action stated that the proposed rule was necessary to be consistent with the recommendation adopted by ICCAT. Commenters opposing the proposed rule stated that the porbeagle population in waters off the northeast United States was abundant.

    Response: NMFS agrees that this action is consistent with the ICCAT recommendation. Regarding the status of porbeagle sharks, as described in the proposed rule, according to the most recent stock assessment in 2009, which was a joint stock assessment between ICCAT and the International Council for the Exploration of the Sea (ICES), the Northwest Atlantic porbeagle shark stock is depleted well below the biomass at maximum sustainable yield, and recent fishing mortality is below the fishing mortality at maximum sustainable yield. Based on these results, porbeagle sharks are considered to be overfished with no overfishing occurring both domestically and internationally. As cited in Recommendation 15-06, porbeagle sharks are among the most vulnerable shark species, which means that even at low fishing mortality levels, the species is more susceptible to overfishing than other less vulnerable shark species. ICCAT has provisionally scheduled the next porbeagle shark stock assessment for 2019. More information regarding the 2009 stock assessment can be found at http://www.iccat.int/Documents/SCRS/DetRep/DET-POR.pdf.

    Comment 2: Some commenters noted the need for complete prohibition of porbeagle sharks caught in association with non-ICCAT fisheries given the overfished status of the stock.

    Response: This comment is outside the scope of this rulemaking because the purpose of this rulemaking only pertains to implementing ICCAT Recommendation 15-06, consistent with ATCA. ICCAT Recommendation 15-06 pertains to the live release of porbeagle sharks caught in association with ICCAT fisheries and does not address possession of the species in non-ICCAT fisheries. Domestically, porbeagle sharks are managed pursuant to a rebuilding plan established in 2008 in Amendment 2 to the 2006 Consolidated HMS FMP, consistent with the requirements of the Magnuson-Stevens Act.

    Comment 3: NMFS received comments stating that NMFS should issue its 12-month finding regarding listing porbeagle sharks under the Endangered Species Act (ESA).

    Response: This comment is outside the scope of this rulemaking because the purpose of this rulemaking is to implement ICCAT Recommendation 15-06. The 12-month finding regarding listing porbeagle sharks under the ESA very recently published on August 1, 2016 (81 FR 50463). Any further information regarding the 12-month finding and any subsequent related agency action can be found at www.federalregister.gov/.

    Comment 4: NMFS received a comment stating that current low interactions between recreational fishermen and porbeagle sharks, in combination with high release rates of the species, does not warrant additional regulations for the recreational fishery.

    Response: Under the authority of ATCA and the Magnuson-Stevens Act, NMFS is obligated to promulgate such regulations as may be necessary and appropriate to carry out ICCAT recommendations. Additionally, as stated above, porbeagle sharks are overfished without overfishing occurring. ICCAT Recommendation 15-06 was designed in part to aid in rebuilding this vulnerable shark species. NMFS acknowledges that recreational fishermen interact with few porbeagle sharks and that most fishermen who catch porbeagle sharks release the majority of those sharks alive. Furthermore, the measures in this rulemaking only apply to recreational fishermen that catch porbeagle sharks while also retaining swordfish, billfish, or tuna. This rulemaking does not apply to recreational fishermen that catch porbeagle sharks and do not retain swordfish, billfish, or tuna. As such, this regulation, which requires the live release of porbeagle sharks caught in association with ICCAT fisheries, should have few overall impacts on the recreational fishery.

    Comment 5: NMFS received public comments regarding handling and release practices of porbeagle sharks. The commenters highlighted that the proposed changes could result in anglers switching to fishing practices that would ensure porbeagle sharks are dead at haulback in order to allow for retention of any porbeagle shark caught. Other commenters were concerned that the data indicating high release rates of porbeagle sharks in commercial and recreational fisheries were inaccurate because the data were self-reported and did not consider post-release mortality rates of porbeagle sharks.

    Response: As described in the proposed rule, HMS logbook and pelagic observer program data indicate that approximately 97 percent of porbeagle sharks were released (alive and dead) from 2010-2015. Additionally, recreational data indicate approximately 90 percent of porbeagle sharks were released from 2010-2015. These data, which are a mix of self-reported and observer data are the best scientific data available and indicate that most porbeagle sharks have not been retained. While the data do not indicate how many sharks released alive would subsequently die as a result of being caught, the ICCAT Recommendation will increase the numbers of porbeagle sharks released alive and thereby likely increase the survival of those sharks and aid in rebuilding.

    Regarding handling and release practices, U.S. fishermen who interact with porbeagle sharks have historically followed safe handling and release practices. This regulation requires U.S. fishermen to release live porbeagle sharks in a manner that is largely consistent with the safe handling and release practices that most fishermen employ. NMFS believes and expects that fishermen will continue to follow these safe handling and release practices after implementation of the ICCAT Recommendation 15-06. NMFS will continue to monitor potential violations of Atlantic HMS regulations to ensure that both commercial and recreational fishermen maintain proper catch and release practices.

    Comment 6: Several commenters expressed concern that implementing ICCAT Recommendation 15-06 would result in a complete closure of the recreational porbeagle shark fishery.

    Response: This final rule will not result in the closure of the recreational porbeagle shark fishery. As described in the proposed rule, implementation of ICCAT Recommendation 15-06 would impact HMS recreational fishermen who retain porbeagle sharks while also retaining swordfish, billfish, or tuna. Under these circumstances, recreational fishermen would have to either discard live porbeagle sharks or the swordfish, billfish, or tuna. If a porbeagle shark were caught that was dead at the time of haulback, a recreational HMS fisherman with swordfish, billfish, or tuna onboard could retain the porbeagle, consistent with all other regulations such as the retention and size limits. Similarly, if a recreational HMS fisherman did not have swordfish, billfish, or tuna onboard, and was not intending to retain any swordfish, billfish, or tunas, that fisherman could retain any porbeagle shark that met the retention and size limits, regardless of the disposition of the shark.

    Changes From the Proposed Rule

    NMFS made one change to the proposed regulations. At § 635.22 (a)(3), NMFS has added text specifying that the permit holders subject to the applicable requirements of this rulemaking include fishermen who hold a Swordfish General Commercial permit when they are participating in an HMS registered tournament. The proposed rule clearly stated that recreational fishing for porbeagle sharks would be affected when swordfish, tuna, or billfish are retained or possessed on board, or offloaded from, the vessel on a trip. We inadvertently did not list the Swordfish General Commercial permit, even though participation in an HMS registered recreational tournament with such a permit is clearly recreational fishing, and such permit holders had notice of the proposed rule's effect on recreational fishing both through the Federal Register Notice and through NMFS outreach, including NMFS' HMS-specific email listserv and NMFS' general email listserv.

    It is generally understood that the Swordfish General Commercial permit is similar to the HMS General Category commercial permit in that the permit is considered recreational when the vessel owner or operator is using that vessel in an HMS registered tournament and landings of HMS are allowed, consistent with the regulations. While the regulatory language in the proposed rule did not specifically include this category of permit when listing the permit titles, the rule did repeatedly refer to recreational fisheries, and permit holders could reasonably have anticipated that the prohibition would apply to them given the rule's overall context and content and thus had sufficient notice. The underlying NEPA analysis associated with this rulemaking is not affected by this correction. These fishermen are considered recreational when fishing during a registered HMS tournament, and all such fishing in tournaments was within the scope of what was analyzed; any harvest of porbeagle sharks by these fishermen was analyzed at the proposed rule stage as recreational data. The Regulatory Flexibility Act (RFA) certification is similarly unaffected by this correction. It was based on the recreational information about porbeagle sharks received through the Large Pelagics Survey, which does not distinguish among permit types. Therefore, any recreational harvest of porbeagle sharks by Swordfish General Category permit holders was considered at the proposed rule stage. Furthermore, recreationally-caught porbeagle sharks cannot be sold, limiting the effects analyzed under the RFA.

    Classification

    The NMFS Assistant Administrator has determined that the final rule is consistent with the 2006 Consolidated HMS FMP and its amendments, the Magnuson-Stevens Act, ATCA, and other applicable law.

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

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

    On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016. Id. at 81194.

    Pursuant to the Regulatory Flexibility Act, and prior to July 1, 2016, a certification was developed for this regulatory action using SBA's former size standards. NMFS has reviewed the analyses prepared for this regulatory action in light of the new size standard. All of the entities directly regulated by this regulatory action are commercial finfish fishing businesses. The new standard could result in fewer commercial finfish businesses being considered small. However, NMFS has determined that the new size standard does not affect its decision to certify this regulatory action. NMFS considers all HMS longline permit holders to be small entities because these vessels have reported annual gross receipts of less than $11 million for commercial fishing. The average annual gross revenue per active pelagic longline vessel was estimated to be $187,000 based on the 170 active vessels between 2006 and 2012 that produced an estimated $31.8 million in revenue annually. The maximum annual revenue for any pelagic longline vessel between 2006 and 2015 was $1.9 million, well below the NMFS small business size threshold of $11 million in gross receipts for commercial fishing. Therefore, NMFS considers all Atlantic Tunas Longline category permit holders to be small entities. Since the annual revenue for Atlantic Tunas Longline category permit holders is well below both the former and new SBA size standard, there continues to be no significant economic impact on a substantial number of small entities.

    List of Subjects in 50 CFR Part 635

    Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.

    Dated: August 18, 2016. 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 635 is amended as follows:

    PART 635—ATLANTIC HIGHLY MIGRATORY SPECIES 1. The authority citation for part 635 continues to read as follows: Authority:

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

    2. In § 635.21, add paragraph (c)(1)(iii) to read as follows:
    § 635.21 Gear operation and deployment restrictions.

    (c) * * *

    (1) * * *

    (iii) Has pelagic longline gear on board, persons aboard that vessel are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback.

    3. In § 635.22, add paragraph (a)(3) to read as follows:
    § 635.22 Recreational retention limits.

    (a) * * *

    (3) Vessels issued an HMS General Category permit under § 635.4(d) that are participating in an HMS registered tournament, vessels issued a Swordfish General commercial permit under § 635.4(f) that are participating in an HMS registered tournament, vessels issued a HMS Angling category permit under § 635.4(c), or vessels issued a HMS Charter/Headboat permit under § 635.4(b) are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback if swordfish, tuna, or billfish are retained or possessed on board, or offloaded from, the vessel during that trip.

    4. In § 635.24, add paragraph (a)(10) to read as follows:
    § 635.24 Commercial retention limits for sharks, swordfish, and BAYS tunas.

    (a) * * *

    (10) Notwithstanding other provisions in this paragraph (a), vessels issued a permit under this part that have pelagic longline gear on board or on vessels issued both an HMS Charter/Headboat permit and a commercial shark permit when tuna, swordfish, or billfish are on board the vessel, offloaded from the vessel, or being offloaded from the vessel, are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback.

    5. In § 635.71, add paragraph (d)(20) to read as follows:
    § 635.71 Prohibitions.

    (d) * * *

    (20) Retain, possess, or land porbeagle sharks that were alive at the time of haulback as specified in §§ 635.21(c)(1)(iii), 635.22(a)(3), and 635.24 (a)(10).

    [FR Doc. 2016-20157 Filed 8-23-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE833 Fisheries of the Exclusive Economic Zone Off Alaska; Atka Mackerel 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; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian district (CAI) of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2016 total allowable catch (TAC) of Atka mackerel in this area allocated to vessels participating in the BSAI trawl limited access fishery.

    DATES:

    Effective 1200 hrs, Alaska local time (A.l.t.), August 19, 2016, through 2400 hrs, A.l.t., December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the BSAI exclusive economic zone 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 2016 TAC of Atka mackerel, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 1,421 metric tons by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).

    In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the CAI by vessels participating in the BSAI trawl limited access fishery.

    After the effective dates of this closure, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    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 a 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 closure of the Atka mackerel directed fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016. 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: August 19, 2016. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-20317 Filed 8-19-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE832 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch 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; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Pacific ocean perch in the Central Aleutian district (CAI) of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2016 total allowable catch (TAC) of Pacific ocean perch in the CAI allocated to vessels participating in the BSAI trawl limited access fishery.

    DATES:

    Effective 1200 hrs, Alaska local time (A.l.t.), August 19, 2016, through 2400 hrs, A.l.t., December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the BSAI exclusive economic zone 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 2016 TAC of Pacific ocean perch, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 618 metric tons by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).

    In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the CAI by vessels participating in the BSAI trawl limited access fishery.

    After the effective dates of this closure, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    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 a 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 closure of the Pacific ocean perch directed fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016. 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: August 19, 2016. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-20308 Filed 8-19-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE822 Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the third seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), August 20, 2016, through 1200 hours, A.l.t., September 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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 third seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species in the GOA by vessels not participating in the cooperative fishery in the Rockfish Program of the Central GOA, is 159 metric tons (mt). This apportionment was established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and reapportionment (81 FR 45423, July 14, 2016), for the period 1200 hours, A.l.t., July 1, 2016, through 1200 hours, A.l.t., September 1, 2016.

    In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the third seasonal apportionment of Pacific halibut bycatch allowance specified for deep-water species by vessels using trawl gear in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    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 closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016.

    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 § 679.21 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 19, 2016. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-20264 Filed 8-19-16; 4:15 pm] BILLING CODE 3510-22-P
    81 164 Wednesday, August 24, 2016 Proposed Rules OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 532 RIN 3206-AN40 Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage Areas AGENCY:

    U. S. Office of Personnel Management.

    ACTION:

    Proposed rule with request for comments.

    SUMMARY:

    The U.S. Office of Personnel Management (OPM) is issuing a proposed rule that would define Kent County, Michigan, as an area of application county to the Macomb, MI, nonappropriated fund (NAF) Federal Wage System (FWS) wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area. These changes are necessary because there are NAF FWS employees working in Kent and Cameron Counties, and the counties are not currently defined to NAF wage areas.

    DATES:

    We must receive comments on or before September 23, 2016.

    ADDRESSES:

    You may submit comments, identified by “RIN 3206-AN40,” using any of the following methods:

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

    Mail: Brenda L. Roberts, Deputy Associate Director for Pay and Leave, Employee Services, U.S. Office of Personnel Management, Room 7H31, 1900 E Street NW., Washington, DC 20415-8200.

    Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Madeline Gonzalez, by telephone at (202) 606-2838 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    OPM is issuing a proposed rule that would define Kent County, MI, as an area of application county to the Macomb, MI, NAF FWS wage area and Cameron County, TX, as an area of application county to the Nueces, TX, NAF FWS wage area. The Veterans Canteen Service (VCS) now employs one NAF FWS employee at VCS #315 in the Wyoming Health Care Center in Kent County and two NAF FWS employees at VCS #740 in the Veterans Affairs Health Care Center at Harlingen in Cameron County.

    Under § 532.219 of title 5, Code of Federal Regulations, each NAF wage area “shall consist of one or more survey areas, along with nonsurvey areas, if any, having nonappropriated fund employees.” Kent and Cameron Counties do not meet the regulatory criteria under 5 CFR 532.219 to be established as separate NAF wage areas; however, nonsurvey counties may be combined with a survey area to form a wage area. Section 532.219 lists the regulatory criteria that OPM considers when defining FWS wage area boundaries.

    OPM recently completed reviews of the definitions of Kent and Cameron Counties and is proposing the changes described below. The Federal Prevailing Rate Advisory Committee, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended these changes by consensus. These changes would apply on the first day of the first applicable pay period beginning on or after 30 days following publication of the final regulations.

    Kent County, MI

    Kent County would be defined as an area of application county to the Macomb, MI, NAF FWS wage area. The closest NAF wage area to Kent County is the Macomb wage area. There are no other NAF wage areas in the immediate vicinity of Kent County. VCS #315 is located approximately 175 miles from Selfridge Air National Guard Base, the Macomb wage area's host activity.

    With the definition of Kent County to the Macomb NAF wage area, the Macomb wage area would consist of 1 survey county, Macomb County, MI, and 13 area of application counties: Alpena, Calhoun, Crawford, Grand Traverse, Huron, Iosco, Kent, Leelanau, Ottawa, Saginaw, Washtenaw, and Wayne Counties, MI; and Ottawa County, OH.

    Cameron County, TX

    Cameron County would be defined as an area of application county to the Nueces, TX, NAF FWS wage area. The closest NAF wage area to Cameron County is the Nueces wage area. There are no other NAF wage areas in the immediate vicinity of Cameron County. VCS #740 is located approximately 148 miles from Naval Air Station Corpus Christi, the Nueces wage area's host activity.

    With the definition of Cameron County to the Nueces NAF wage area, the Nueces wage area would consist of one survey county, Nueces County, TX, and six area of application counties: Bee, Calhoun, Cameron, Kleberg, San Patricio, and Webb Counties, TX.

    Regulatory Flexibility Act

    I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would affect only Federal agencies and employees.

    List of Subjects in 5 CFR Part 532

    Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.

    U.S. Office of Personnel Management. Beth F. Cobert, Acting Director.

    Accordingly, OPM is proposing to amend 5 CFR part 532 as follows:

    PART 532—PREVAILING RATE SYSTEMS 1. The authority citation for part 532 continues to read as follows: Authority:

    5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.

    2. Appendix D to subpart B is amended by revising the wage area listing for the Macomb, MI, and Nueces, TX, wage areas to read as follows: Appendix D to Subpart B of Part 532—Nonappropriated Fund Wage and Survey Areas MICHIGAN Macomb Survey Area Michigan: Macomb Area of Application. Survey area plus: Michigan: Alpena Calhoun Crawford Grand Traverse Huron Iosco Kent Leelanau Ottawa Saginaw Washtenaw Wayne Ohio: Ottawa *    *    *    *    * TEXAS *    *    *    *    * Nueces Survey Area Texas: Nueces Area of Application. Survey area plus: *    *    *    *    * Texas: Bee Calhoun Cameron Kleberg San Patricio Webb
    [FR Doc. 2016-20179 Filed 8-23-16; 8:45 am] BILLING CODE 6325-39-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 23 [Docket No. FAA-2016-9001; Notice No. 23-16-02-SC] Special Conditions: Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 Airplanes, Lithium Batteries AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed special conditions.

    SUMMARY:

    This action proposes special conditions for the Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 airplanes. This airplane as modified by Finnoff Aviation will have a novel or unusual design feature associated with the installation of a rechargeable lithium battery. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    Send your comments on or before October 11, 2016.

    ADDRESSES:

    Send comments identified by docket number FAA-2016-9001 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery of Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://regulations.gov, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Ruth Hirt, Federal Aviation Administration, Programs and Procedures, ACE-114, Small Airplane Directorate, Aircraft Certification Service, 901 Locust; Kansas City, Missouri 64106; telephone (816) 329-4108; facsimile (816) 329-4090.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

    We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

    Background

    On September 28, 2015, Finnoff Aviation applied for a supplemental type certificate for installation of a rechargeable lithium battery in the Model PC-12, PC-12/45, PC-12/47 airplanes. The Model PC-12, PC-12/45, PC-12/47 airplanes are single-engine turboprop-powered business aircraft that can accommodate up to nine passengers with a take-off weight up to 10,450 lbs.

    The current regulatory requirements for part 23 airplanes do not contain adequate requirements for the application of rechargeable lithium batteries in airborne applications. This type of battery possesses certain failure and operational characteristics with maintenance requirements that differ significantly from that of the nickel-cadmium (Ni-Cd) and lead-acid rechargeable batteries currently approved in other normal, utility, acrobatic, and commuter category airplanes. Therefore, the FAA is proposing this special condition to address (1) all characteristics of the rechargeable lithium batteries and their installation that could affect safe operation of the modified Model PC-12, PC-12/45, and PC-12/47 airplanes, and (2) appropriate Instructions for Continued Airworthiness (ICAW) that include maintenance requirements to ensure the availability of electrical power from the batteries when needed.

    Type Certification Basis

    Under the provisions of § 21.101, Finnoff Aviation must show that the Model PC-12, PC-12/45, and PC-12/47, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A78EU 1 or the applicable regulations in effect on the date of application for the change.

    1http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgMakeModel.nsf/0/6BCB00B1F3CA4EF886257FED0069EF2D?OpenDocument.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the Model PC-12, PC-12/45, and PC-12/47 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Model PC-12, PC-12/45, and PC-12/47 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

    Novel or Unusual Design Features

    The Model PC-12, PC-12/45, and PC-12/47 airplanes will incorporate the following novel or unusual design feature: Installation of a rechargeable lithium battery as the main or engine start aircraft battery.

    Discussion

    Presently, there is limited experience with use of rechargeable lithium batteries and rechargeable lithium battery systems in applications involving commercial aviation. However, other users of this technology, ranging from personal computers, wireless telephone manufacturers to the electric vehicle industry, have noted safety problems with lithium batteries. These problems include overcharging, over-discharging, flammability of cell components, and cell internal defects described in the following paragraphs:

    1. Overcharging: In general, lithium batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure (i.e., thermal runaway) than the Ni-Cd or lead-acid counterparts. This is especially true for overcharging which causes heating and destabilization of the components of the cell, leading to the formation (by plating) of highly unstable metallic lithium. The metallic lithium may ignite, resulting in a fire or explosion. Finally, the severity of thermal runaway due to overcharging increases with increasing battery capacity and due to a higher amount of electrolyte in large batteries.

    2. Over-discharging: Discharge of some types of lithium battery cells beyond a certain voltage (typically 2.4 volts) can cause corrosion of the electrodes of the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crews as a means of checking battery status, which is a problem shared with Ni-Cd batteries.

    3. Flammability of Cell Components: Unlike Ni-Cd and lead-acid batteries, some types of lithium batteries use liquid electrolytes that are flammable. The electrolyte may serve as a source of fuel for an external fire, if there is a breach of the battery container.

    4. Cell Internal Defects: The rechargeable lithium batteries and rechargeable battery systems have a history of undetected cell internal defects. These defects may or may not be detected during normal operational evaluation, test, and validation. This may lead to unsafe conditions when operating in service.

    These problems experienced by users of lithium batteries raise concern about the use of these batteries in commercial aviation. The intent of the special condition is to establish appropriate airworthiness standards for lithium battery installations in the Model PC-12, PC-12/45, and PC-12/47 airplanes and to ensure, as required by §§ 23.1309 and 23.601, that these battery installations are neither hazardous nor unreliable.

    In summary, the lithium battery installation will consider the following items:

    (a) The flammable fluid fire protection requirement is § 23.863. In the past, this rule was not applied to batteries of normal, utility, acrobatic, and commuter category airplanes since the electrolytes utilized in Ni-Cd and lead-acid batteries are not flammable.

    (b) New Instructions for Continuous Airworthiness that include maintenance requirements to ensure that batteries used as spares have been maintained in an appropriate state of charge and installed lithium batteries have been sufficiently charged at appropriate intervals. These instructions must also describe proper repairs, if allowed, and battery part number configuration control.

    (c) The applicant must conduct a system safety assessment for the failure condition classification of a failure of the battery charging and monitoring functionality (per Advisory Circular AC 23.1309-1E 2 ), and develop mitigation to preclude any adverse safety effects. Mitigation may include software, Airborne Electronic Hardware (AEH) or a combination of software and hardware, which should be developed to the appropriate Design Assurance Level(s) (DALs), respectively (per Advisory Circular AC 20-115C 3 and Advisory Circular AC 20-152 4 ).

    2http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/719e41e1d26099108625795d005d5302/$FILE/23.1309-1E.pdf.

    3http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/e35fbc0060e2159186257bbe00719fb3/$FILE/AC20-115C.pdf.

    4http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/6d4ae0bf1bde3579862570360055d119/$FILE/AC%2020-152.pdf.

    (d) New requirements, in the proposed special conditions section, address the hazards of overcharging and over-discharging that are unique to lithium batteries, which should be applied to all rechargeable lithium battery and battery installations on the Model PC-12, PC-12/45, and PC-12/47 airplanes in lieu of the requirements of § 23.1353(a)(b)(c)(d)(e), amendment 23-49.

    Note 1:

    These special conditions are not intended to replace § 23.1353(a)(b)(c)(d)(e) at amendment 23-49 in the certification basis of Model PC-12, PC-12/45, and PC-12/47 airplanes. These special conditions apply only to rechargeable lithium batteries and lithium battery systems and their installations. The requirements of § 25.1353 at amendment 23-49 remains in effect for batteries and battery installations on Model PC-12, PC-12/45, and PC-12/47 airplanes that do not use rechargeable lithium batteries.

    Applicability

    As discussed above, these special conditions are applicable to the Model PC-12, PC-12/45, and PC-12/47 airplanes. Should Finnoff Aviation apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A78EU 5 to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well.

    5http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgMakeModel.nsf/0/6BCB00B1F3CA4EF886257FED0069EF2D?OpenDocument.

    Conclusion

    This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

    List of Subjects in 14 CFR Part 23

    Aircraft, Aviation safety, Signs and symbols.

    The authority citation for these special conditions is as follows: Authority:

    49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

    The Proposed Special Conditions Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 airplanes modified by Finnoff Aviation.

    1. Installation of Lithium Batteries must show compliance to the following requirements:

    (1) Safe cell temperatures and pressures must be maintained during—

    i. Normal operations;

    ii. Any probable failure conditions of charging or discharging or battery monitoring system;

    iii. Any failure of the charging or battery monitoring system not shown to be extremely remote.

    (2) The rechargeable lithium battery installation must be designed to preclude explosion or fire in the event of (1)(ii) and (1)(iii) failures.

    (3) Design of the rechargeable lithium batteries must preclude the occurrence of self-sustaining, uncontrolled increases in temperature or pressure.

    (4) No explosive or toxic gasses emitted by any rechargeable lithium battery in normal operation or as the result of any failure of the battery charging system, monitoring system, or battery installation which is not shown to be extremely remote, may accumulate in hazardous quantities within the airplane.

    (5) Installations of rechargeable lithium batteries must meet the requirements of § 23.863(a) through (d) at amendment 23-34.

    (6) No corrosive fluids or gases that may escape from any rechargeable lithium battery may damage surrounding structure or any adjacent systems, equipment, electrical wiring, or the airplane in such a way as to cause a major or more severe failure condition, in accordance with § 23.1309(c) at amendment 23-62 and applicable regulatory guidance.

    (7) Each rechargeable lithium battery installation must have provisions to prevent any hazardous effect on structure or essential systems that may be caused by the maximum amount of heat the battery can generate during a short circuit of the battery or of its individual cells.

    (8) Rechargeable lithium battery installations must have—

    i. A system to automatically control the charging rate of the battery to prevent battery overheating and overcharging, or;

    ii. A battery temperature sensing and over-temperature warning system with a means for automatically disconnecting the battery from its charging source in the event of an over-temperature condition, or;

    iii. A battery failure sensing and warning system with a means for automatically disconnecting the battery from its charging source in the event of battery failure.

    (9) Any rechargeable lithium battery installation functionally required for safe operation of the airplane must incorporate a monitoring and warning feature that will provide an indication to the appropriate flight crewmembers whenever the State of Charge (SOC) of the batteries has fallen below levels considered acceptable for dispatch of the airplane.

    (10) The Instructions for Continued Airworthiness required by § 23.1529 at amendment 23-26 must contain maintenance requirements to assure that the battery has been sufficiently charged at appropriate intervals specified by the battery manufacturer and the equipment manufacturer that contain the rechargeable lithium battery or rechargeable lithium battery system. This is required to ensure that lithium rechargeable batteries and lithium rechargeable battery systems will not degrade below specified ampere-hour levels sufficient to power the aircraft system. The Instructions for Continued Airworthiness must also contain procedures for the maintenance of replacement batteries in spares storage to prevent the installation of batteries that have degraded charge retention ability or other damage due to prolonged storage at a low state of charge. Replacement batteries must be of the same manufacturer and part number as approved by the FAA.

    Note 2:

    The term “sufficiently charged” means that the battery will retain enough of a charge, expressed in ampere-hours, to ensure that the battery cells will not be damaged. A battery cell may be damaged by lowering the charge below a point where there is a reduction in the ability to charge and retain a full charge. This reduction would be greater than the reduction that may result from normal operational degradation.

    (11) In showing compliance with the proposed special conditions herein, paragraphs (1) through (8), and the RTCA document, Minimum Operational Performance Standards for Rechargeable Lithium Battery Systems, DO-311, may be used. The list of planned DO-311 tests should be documented in the certification or compliance plan and agreed to by the Denver ACO. Alternate methods of compliance other than DO-311 tests must be coordinated with the directorate and Denver ACO.

    Issued in Kansas City, Missouri, on August 18, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-20273 Filed 8-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 511 [Docket No. FDA-2011-N-0079] Disqualification of a Clinical Investigator AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.

    DATES:

    Submit either electronic or written comments on the proposed rule by November 22, 2016. See section VII of this document for the proposed effective date of a final rule based on this document.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2011-N-0079 for “Disqualification of a Clinical Investigator.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Vernon Toelle, Center for Veterinary Medicine (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-402-5637.

    SUPPLEMENTARY INFORMATION: I. Introduction

    The current regulations in part 511 (21 CFR part 511) prohibit a disqualified clinical investigator from conducting any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. We propose to expand the current clinical investigator disqualification regulations in part 511 by providing that a disqualified investigator also is ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. In this document, consistent with our proposal in part 58 (21 CFR part 58) published elsewhere in this issue of the Federal Register, the term “nonclinical laboratory study” means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions or in the applicable environment to determine their safety or toxicity or both. The term does not include studies involving human subjects, clinical studies, or clinical investigational use in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or basic exploratory studies to determine the physical or chemical characteristics of a test article.

    Under current § 511.1(c) (21 CFR 511.1(c)), a clinical investigator disqualified by the Commissioner is ineligible to receive the test article regulated in part 511 (i.e., a new animal drug for investigational use). Also, under the current regulations in § 511.1(c), a disqualified clinical investigator is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. However, under the current regulations, a disqualified clinical investigator continues to be eligible to conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

    In order to conclude that a clinical investigator is no longer eligible to receive new animal drugs for investigational use, the Commissioner must find that the investigator repeatedly or deliberately failed to comply with the conditions of the exempting regulations or repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report (§ 511.1(c)(2)). When a clinical investigator is disqualified under part 511, the basis for disqualification typically is the repeated or deliberate submission of false information to FDA or a sponsor in a required report. For new animal drugs, the same clinical investigator could conduct both nonclinical laboratory studies and clinical investigations.

    In the new animal drug approval process, nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. Therefore, this proposal to expand § 511.1(c) to include nonclinical laboratory studies is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA for the approval of a new animal drug.

    Consistent with the proposed changes to the provisions in part 511, we propose amending the list of regulatory provisions under which a part 16 (21 CFR part 16) informal regulatory hearing is available. In part 16, we propose changing the scope of the relevant provision for part 511 to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.”

    Concurrent with this proposal, FDA is publishing elsewhere in this issue of the Federal Register a related provision in part 58. We propose in § 58.206 (21 CFR 58.206) that a disqualified person under part 58, who is a clinical investigator, would be notified that they are ineligible to receive a test article under part 511. Thus, where this part 511 proposal would make a disqualified clinical investigator ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, the proposal in § 58.206 would make a disqualified person under part 58, who is a clinical investigator, ineligible to receive a test article under part 511. An investigator ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. We propose this action in § 58.206 to help protect the safety and welfare of animal research subjects involved in FDA-regulated nonclinical laboratory studies and clinical investigations, and to help ensure the reliability and integrity of the data submitted to FDA to support FDA decisions concerning new animal drugs.

    II. Background

    FDA may consider disqualification of a clinical investigator when FDA has information that an investigator has repeatedly or deliberately failed to comply with applicable requirements for the conduct of clinical investigations, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report. Disqualification of an investigator is initiated by the appropriate FDA Center depending upon the particular type of test article (e.g., new animal drug for investigational use) under study by the investigator in the clinical investigation. For example, the Center for Veterinary Medicine (CVM) may pursue disqualification of a clinical investigator who conducted a new animal drug clinical investigation and allegedly submitted to FDA or the sponsor false information in a required report.

    The regulations provide the investigator, who is subject to disqualification, an opportunity to be heard and explain the matter complained of, i.e., explain the alleged violations. If the explanation offered is not accepted by the Center, the investigator will be given an opportunity for an informal regulatory hearing under part 16. After evaluating all available information, including any explanation presented by the investigator, the Commissioner issues a Commissioner's decision regarding the eligibility of the investigator to receive a particular type of test article (e.g., a new animal drug for investigational use). When disqualified by a Commissioner's decision, the investigator is no longer eligible to receive the particular type of test article under study when the violations occurred (e.g., new animal drugs). Also, under current regulations, an investigator disqualified by a Commissioner's decision is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

    Because CVM regulates drugs for animal use, the study subjects are animals in both nonclinical laboratory studies and clinical investigations intended to support the approval of a new animal drug. Nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. For animal drug products regulated by CVM, the same investigator may conduct both nonclinical laboratory studies and clinical investigations. For example, CVM's two most recent clinical investigator disqualification matters involved investigators who were also study directors on nonclinical laboratory studies submitted to CVM in support of applications for a new animal drug. In addition, CVM is aware of multiple persons that conduct both clinical investigations and nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Therefore, it is critical for CVM to have the authority to disqualify an investigator from conducting nonclinical laboratory studies when that same investigator is disqualified from conducting clinical investigations, particularly when the basis for disqualification is the repeated or deliberate submission of false information to FDA or the sponsor in a required report.

    This proposal to amend part 511 to expand a disqualified investigator's ineligibility to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug would help to ensure adequate protection of animal research subjects and data integrity. This action also may lead to improved public confidence in the nonclinical and clinical data supporting FDA decisions for new animal drug approvals.

    We therefore propose that when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511 and is therefore ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, the investigator also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

    To effect this change, FDA proposes to amend the current regulations in § 511.1(c).

    III. Description of the Proposed Rule A. Disqualification Proceedings (§ 511.1(c)(1))

    Proposed Revisions to § 511.1(c)(1): We propose to change the scope of the question addressed during a part 16 hearing, should the investigator request and be granted an informal hearing, also to include whether the investigator is eligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.

    B. Ineligibility To Receive Any Test Article (§ 511.1(c)(2))

    Proposed Revisions to § 511.1(c)(2): We propose that an investigator disqualified by a Commissioner's decision also will be ineligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.

    Therefore, as proposed, an investigator determined to be ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. This proposal expands the scope of the current regulations in § 511.1(c)(2) which states that a disqualified clinical investigator is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

    C. Reinstatement (§ 511.1(c)(6))

    FDA proposes amending § 511.1(c)(6) for consistency with our proposal to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to the part 511 investigator disqualification regulations. Therefore, for consistency with the proposed changes in § 511.1(c)(2), we propose adding in § 511.1(c)(6) that the investigator has presented adequate assurances that the investigator will conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug solely in compliance with the applicable provisions of chapter I.

    IV. Regulatory Hearing before the Food and Drug Administration

    We propose to revise § 16.1(b)(2) to amend the entry for § 511.1(c)(1) to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to be consistent with the other proposed amendments in this rulemaking.

    V. Environmental Impact

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

    VI. Legal Authority

    Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. Section 512(j) of the FD&C Act (21 U.S.C. 355(j)) authorizes FDA to issue regulations for exempting from the operation of section 512 of the FD&C Act new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. An investigator who repeatedly or deliberately violates the regulations or who repeatedly or deliberately submits to FDA or the sponsor false information in a required report would not be considered a qualified expert with the experience required to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. This proposed rulemaking would disqualify a clinical investigator from conducting nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511. FDA's legal authority to promulgate this proposal regarding clinical investigators exists under sections 512(j) and 701(a) of the FD&C Act, as essential to protection of the public health and safety and to enforcement of the Agency's responsibilities under sections 201, 501, 502, 503, 512, and 701 of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 360b, and 371).

    VII. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this proposal become effective 30 days after the date of publication of the final rule in the Federal Register.

    VIII. Preliminary Economic Analysis

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

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule does not impose new requirements on any entity and therefore has no associated compliance costs, the Agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

    This proposed rule seeks to expand the scope in part 511 of disqualification of a clinical investigator to include ineligibility to conduct nonclinical laboratory studies. A final rule (77 FR 25353), published on April 30, 2012, prevents a disqualified investigator from conducting any clinical investigation, and therefore applies explicitly to clinical investigations. However, the rule is silent on nonclinical laboratory studies. Thus, under the current regulation in part 511, a disqualified investigator could conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. Because the reason typically for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is essential to adequate protection of animal research subjects and data integrity.

    The Agency would not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator. Similarly, we do not expect that industry would incur additional costs because the proposed rule would not require sponsors to perform additional tasks. For instance, upon disqualification, the respective investigator's name is posted on FDA's Web page, and this helps mitigate the employment of the investigator for clinical investigations or nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Because the typical reason for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, the benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is enhanced protection of animal research subjects and data integrity.

    IX. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.

    X. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    List of Subjects 21 CFR Part 16

    Administrative practice and procedure.

    21 CFR Part 511

    Animal drugs, Medical research, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that parts 16 and 511 be amended as follows:

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

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

    2. In § 16.1, in paragraph (b)(2), revise the numerically sequenced entry for § 511.1(c)(1) to read as follows:
    § 16.1 Scope.

    (b) * * *

    (2) * * *

    § 511.1(c)(1), relating to whether an investigator is eligible to receive test articles under part 511 and eligible to conduct:

    (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and

    (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

    PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE 3. The authority citation for part 511 continues to read as follows: Authority:

    21 U.S.C. 321, 351, 352, 353, 360b, 371.

    4. In § 511.1, revise the section heading, the last sentences in paragraphs (c)(1) and (2), and revise paragraph (c)(6) to read as follows:
    § 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.

    (c) * * *

    (1) * * * If an explanation is offered but not accepted by the Center for Veterinary Medicine, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct:

    (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA; and

    (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

    (2) * * * The notification also will explain that an investigator determined to be ineligible to receive a test article under this part will be ineligible to conduct

    (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products, and

    (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

    (6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, solely in compliance with the applicable provisions of this chapter.

    Dated: August 16, 2016. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis.
    [FR Doc. 2016-19876 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2016-D-2343] Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-2343 for “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the draft guidance to Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

    FOR FURTHER INFORMATION CONTACT:

    Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

    SUPPLEMENTARY INFORMATION: I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production.

    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117).

    We are announcing the availability of several chapters of a multi-chapter draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

    The multi-chapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapters that we are announcing in this document are as follows:

    • Introduction • Chapter One—The Food Safety Plan • Chapter Two—Conducting a Hazard Analysis • Chapter Three—Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food • Chapter Four—Preventive Controls • Chapter Five—Application of Preventive Controls and Preventive Control Management Components

    We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in 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 part 117 have been approved under OMB control number 0910-0751.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

    Dated: August 18, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-20177 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-1896] New Animal Drugs for Use in Animal Feed; Category Definitions AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.

    DATES:

    Submit either electronic or written comments by November 7, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1896 for “Category Definitions for Minor Species.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205, email: [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Background III. Proposed Regulation IV. Companion Document to Direct Final Rulemaking V. Legal Authority VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. References I. Executive Summary A. Purpose of the Proposed Rule

    FDA proposes to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision is being proposed to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by the FDA Center for Veterinary Medicine (CVM) to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobial drugs in animal agriculture. Under this program, sponsors of antimicrobial new animal drugs that also have importance in human medicine were requested to voluntarily withdraw approval of production (e.g., growth production, feed efficiency) indications for their drug products that are intended for use in the feed or water of food-producing animals. Based on the existing drug category definitions, the voluntary withdrawal of production indications by these drug sponsors would, in some cases, result in a change to a medicated feed drug's category, potentially leading to additional consequences not foreseen at the time the program was initiated.

    The category in which a new animal drug used in medicated feeds is placed is based on their likelihood of producing unsafe residues in the edible products of treated animals. Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

    New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

    Certain Category I Type A medicated articles would be recategorized to Category II when a production indication is voluntarily withdrawn by a sponsor as part of the judicious use initiative that is currently underway, based on the next lowest use level that remains once the production use is withdrawn having a withdrawal period such that the drug would then meet the definition for Category II. For Category I Type A medicated articles that include indications for minor species, FDA is concerned that if such a Type A medicated article is recategorized to Category II based on a withdrawal period for an approved therapeutic use in a minor species, sponsors may opt to request withdrawal of approval of these minor species indications in order to ensure the Type A medicated article can remain in Category I. Sponsors may also decline to pursue development of additional therapies for minor species if these uses would require a withdrawal period that would trigger a recategorization to Category II.

    The proposed revisions would revise the category definitions such that they would be based only on whether a withdrawal period is required for a major species.1 Under the proposed definition, a Category I Type A medicated article would not be recategorized to Category II based on the existence of a withdrawal period for an approved indication in a minor species, even if that minor species indication is the next lowest approved use level that remains after the production indication has been withdrawn. However, if the next lowest use level (apart from the minor species indication) is an indication approved for use in a major species that has a withdrawal period, under the new definition the drug would move to Category II.

    1 As a practical matter, categorization under the revised definitions in this direct final rule will be driven by approved indications for major food-producing species (cattle, poultry, swine, and turkeys). While the definition for major species includes horses, dogs, and cats, they are not regulated as food-producing major species and thus drugs approved for use in these species do not require an assessment of human food safety that may result in assignment of a withdrawal period. Minor species are defined as animals, other than humans, that are not major species. Minor species include animals such as sheep, goats, ducks, geese, and aquaculture species such as catfish, salmon, and trout.

    The purpose of the proposed revision is to preserve the present availability of medicated feeds intended for therapeutic use in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe the proposed revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.

    B. Summary of the Major Provisions of the Proposed Rule

    FDA proposes to amend 21 CFR 558.3 Definitions and general considerations applicable to this part (§ 558.3) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. Definitions for “major species” and “minor species” are also being added to this section.

    C. Legal Authority

    We are proposing these regulations based on our authority under the new animal drug provisions in section 512 (21 U.S.C. 360b) and section 701 (21 U.S.C. 371) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

    D. Costs and Benefits

    The revisions made by this proposed rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these proposed revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.

    II. Background

    FDA is proposing to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the Federal Register of March 3, 1986 (51 FR 7382), which, among other things, established two categories of new animal drugs used in medicated feeds. As discussed in the final rule, the Agency placed these drugs into categories based on their likelihood of producing unsafe residues in the edible products of treated animals (51 FR 7382). Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

    New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

    This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by CVM to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobials of importance to human medicine (i.e., medically important antimicrobials) in animal agriculture. Specifically, CVM's initiative to ensure the judicious use of medically important antimicrobial drugs in animal agriculture advocates two specific changes to the approved conditions of use of medically important antimicrobials that are administered through the medicated feed or water of food-producing animals.

    These changes, which are described in Guidance for Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), are intended to reduce the development of antimicrobial resistance and thereby preserve the effectiveness of these important drugs for use in treating infections in humans. Following publication of GFI #213, all sponsors of these medically important antimicrobial new animal drug products approved for use in the feed or water of food-producing animals notified FDA in writing of their intent to voluntarily make changes to their affected products as outlined in the guidance.

    Under GFI #213, sponsors of medically important antimicrobial new animal drugs approved for over-the-counter use in the feed or water of food-producing animals were asked to change the marketing status of their products to veterinary prescription (Rx) marketing status in the case of new animal drugs administered in water, or to veterinary feed directive (VFD) marketing status for drugs administered in or on animal feed. New animal drugs with Rx or VFD marketing status can legally only be used with a veterinarian's oversight. Prescription animal drugs require a veterinarian's prescription, while use of VFD drugs requires a VFD; both types of orders must be issued by a licensed veterinarian in the course of the veterinarian's professional practice.

    In addition, under GFI #213 sponsors of medically important new animal drugs used in animal feed or water that have production indications were requested to voluntarily withdraw these indications; approved therapeutic indications for use of these drugs would remain.

    In some instances, once a sponsor withdraws the production indication from a drug approved for use in animal feed (which is generally the lowest use level of the drug), the remaining lowest therapeutic use level will require a withdrawal period. Based on the existing definitions of the feed drug categories, this results in a Category I new animal drug being recategorized as a Category II drug, the more restrictive of the two possible categories of drugs used in medicated feed. Category II drugs require that the manufacture of Type B and Type C medicated feeds from Type A medicated articles be done in facilities possessing a medicated feed mill license, which number roughly 900 in the United States. In contrast, there are tens of thousands of unlicensed feed mills in this country. Such a recategorization to Category II, thereby limiting the use of the Type A medicated article to a much smaller subset of feed mills, may disrupt the existing movement of these medicated feeds through distribution channels.

    FDA believes that sponsors may request voluntary withdrawal of those specific therapeutic indications as a way to keep their products in the less restrictive Category I when the recategorization of a drug to Category II is triggered by a therapeutic indication for a minor species. For certain drug products, the only therapeutic indications requiring a withdrawal period that would remain following the voluntary withdrawal of approval of production uses are those for minor species. The loss of therapeutic indications for minor species would adversely affect the availability of therapeutic medicated feeds necessary for the health of minor species, which is a matter of significant concern for the Agency.

    This foreseeable adverse effect on the health of minor species would directly undermine the intent of Congress in passing the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as well as to our intent in establishing the implementing regulations under that statute. The Category I drugs likely to be affected have been safely used in this category for decades, and we have no reason to believe they would not continue to be safely used in this category moving forward.

    Under the current category definitions in § 558.3 for feed use drugs, a drug will be included in Category II if the lowest use level of the drug in any approved species requires a withdrawal period. This approach equates the existence of a withdrawal period for a particular use with the potential risk that edible tissues from animals administered a medicated feed might contain a residue of concern.

    However, the toxicological analysis of animal drugs used to calculate a withdrawal period is based on lifetime exposure by humans to potential drug residues. This assessment of lifetime exposure does not consider the lower risk to the public health from the use of these same new animal drugs in food-producing minor species attributable to the lower human consumption over time of edible tissues from food-producing minor species (Refs. 1 and 2). For this reason, FDA does not at this time believe this revision of the category definitions presents a risk to the public health.

    In a manner similar to its effect on drug indications that are already approved, CVM believes the existing categorization scheme would pose a significant disincentive for future development of additional minor species therapies for existing Category I drugs if those new uses would require a withdrawal period and thus trigger a change to Category II for that drug.

    Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, we propose to revise the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 to base category assignment only on uses in major species. This proposed revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.

    III. Proposed Regulation

    FDA proposes to amend paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (Definitions and general considerations applicable to this part) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. We further propose to amend § 558.3(b) by adding definitions for “major species” and “minor species” that are identical to the definitions of those terms found in FDA's regulations for new animal drugs for minor use and minor species (21 CFR 516.3). We are proposing to revise the feed drug category definitions in § 558.3 to preserve the availability of medicated feeds intended for use in minor species and to prevent a likely disincentive for development of additional therapies for minor species.

    IV. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. FDA proposes to amend § 558.3(b)(1) to revise the definitions of Category I and Category II new animal drugs administered in medicated feed. This proposed rule is intended to make noncontroversial changes to existing regulations. The Agency does not anticipate receiving any significant adverse comment on this rule.

    Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the Federal Register a companion direct final rule. The direct final rule and this companion proposed rule are substantively identical. This companion proposed rule provides the procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this proposed rule runs concurrently with the comment period of the companion direct final rule. Any comments received in response to the companion direct final rule will also be considered as comments regarding this proposed rule.

    FDA is providing a comment period for the proposed rule of 75 days after the date of publication in the Federal Register. If FDA receives a significant adverse comment, we intend to withdraw the direct final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, the Agency will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).

    Comments that are frivolous, insubstantial, or outside the scope of the proposed rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the proposed rule would not be considered a significant adverse comment unless the comment states why the proposed rule would be ineffective without the additional change.

    If FDA does not receive significant adverse comment in response to the companion direct final rule, the Agency will publish, within 30 days after the comment period ends, a document in the Federal Register confirming the effective date of the final rule. The Agency intends to make the direct final rule effective on December 1, 2016.

    A full description of FDA's policy on direct final rule procedures may be found in a guidance document announced in the Federal Register of November 21, 1997 (62 FR 62466). The guidance document may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

    V. Legal Authority

    We are proposing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

    VI. Economic Analysis of Impacts

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

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.

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

    This proposed rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.

    Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that would be recategorized from Category II to Category I as a result of this proposed rule, if finalized. No compliance costs would be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.

    VII. Analysis of Environmental Impact

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

    VIII. Paperwork Reduction Act of 1995

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

    IX. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    X. References

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

    1. U.S. Department of Agriculture, “Livestock & Meat Domestic Data,” http://www.ers.usda.gov/data-products/livestock-meat-domestic-data (accessed on June 23, 2016).

    2. “Food Fish Production and Sales by Species, by Size Category, by State and United States: 2005,” http://www.agcensus.usda.gov/Publications/2002/Aquaculture/aquacen2005_08.pdf (accessed on June 23, 2016).

    List of Subjects in 21 CFR Part 558

    Animal drugs, animal feeds.

    Therefore, under the Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, it is proposed that part 558 be amended as follows:

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    2. In § 558.3, revise paragraphs (b)(1)(i) and (ii) and add paragraphs (b)(13) and (14) to read as follows:
    § 558.3 Definitions and general considerations applicable to this part.

    (b) * * *

    (1) * * *

    (i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.

    (ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.

    (13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.

    (14) “Minor species” means animals, other than humans, that are not major species.

    Dated: August 18, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-20149 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 70 [EPA-HQ-OAR-2016-0194; FRL-9951-09-OAR] RIN 2060-AS61 Revisions to the Petition Provisions of the Title V Permitting Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) proposes to revise its regulations to streamline and clarify processes related to submission and review of title V petitions. This notice covers five key areas, each of which should increase stakeholder access to and understanding of the petition process and aid the EPA's review of petitions. First, the EPA is proposing regulatory provisions that provide direction as to how petitions should be submitted to the agency. Second, the EPA is proposing regulatory provisions that describe the expected format and minimum required content for title V petitions. Third, the proposal clarifies that permitting authorities are required to respond to significant comments received during the public comment period for draft title V permits, and to provide that response with the proposed title V permit to the EPA for the agency's 45-day review period. Fourth, guidance is provided in the form of “recommended practices” for various stakeholders to help ensure title V permits have complete administrative records and comport with the requirements of the Clean Air Act (CAA or Act). Fifth, to increase familiarity with the post-petition process, this notice presents information on the agency's interpretation of certain title V provisions of the CAA and its implementing regulations regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders.

    DATES:

    Comments: Comments must be received on or before October 24, 2016.

    Public Hearing: If anyone contacts EPA requesting a public hearing on or before September 6, 2016, we will hold a public hearing. Additional information about the hearing would be published in a subsequent Federal Register notice.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0194, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information the disclosure of which 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 http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Questions concerning these proposed rule revisions should be addressed to Ms. Carrie Wheeler, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Air Quality Planning Division, (C504-05), Research Triangle Park, NC 27711, telephone number (919) 541-9771, email at [email protected] To request a public hearing or information pertaining to a public hearing on the proposed regulatory revisions, contact Ms. Pamela Long, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Air Quality Policy Division, (C504-01), Research Triangle Park, NC 27711; telephone number (919) 541-0641; fax number (919) 541-5509; email address: [email protected] (preferred method of contact).

    SUPPLEMENTARY INFORMATION:

    The information presented in this document is organized as follows:

    I. General Information A. Does this action apply to me? B. What should I consider as I prepare my comments for the EPA? C. How can I find information about a possible hearing? D. Where can I obtain a copy of this document and other related information? II. Overview of Proposed Regulatory Revisions and Information in This Notice III. Background A. The Title V Operating Permits Program B. Statutory and Regulatory Basis for This Proposal C. Title V Petition Process and Content D. Prior Interpretations and Applications of the Title V Provisions IV. Proposed Revisions to Title V Regulations A. Additional Legal Background for the Proposed Revisions to the Part 70 Rules B. Electronic Submittal of Petitions C. Required Petition Content and Format D. Proposed Administrative Record Requirements V. Pre- and Post-Petition Process Information/Guidance A. Recommended Practices for Complete Permit Records B. Post-Petition Process VI. Implementation VII. Proposed Determination of Nationwide Scope and Effect VIII. Environmental Justice Considerations IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations. K. Determination Under Section 307(d) X. Statutory Authority I. General Information A. Does this action apply to me?

    Entities potentially affected directly by the proposed revisions to the EPA's regulations include anyone who intends to submit a title V petition on a proposed title V permit prepared by a state, local or tribal title V permitting authority pursuant to its EPA-approved title V permitting program. Entities also potentially affected by this rule include state, local and tribal permitting authorities responsible for implementing the title V permitting program. Entities not directly affected by this proposed rule include owners and operators of major stationary sources or other sources that are subject to title V permit requirements, as well as the general public who would have an interest in knowing about title V permitting actions and associated public hearings but do not intend to submit a petition.

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

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

    2. Tips for preparing comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    C. How can I find information about a possible public hearing?

    To request a public hearing or information pertaining to a public hearing, contact Ms. Pamela Long, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-0641 or by email at [email protected]

    D. Where can I obtain a copy of this document and other related information?

    In addition to being available in the docket, an electronic copy of this Federal Register document will be posted at the regulations section of our Title V Operating Permits Web site, under Regulatory Actions, at http://www.epa.gov/title-v-operating-permits/current-regulations-and-regulatory-actions. A “track changes” version of the full regulatory text that incorporates and shows the full context of the proposed changes to the existing regulations in this proposal is also available in the docket for this rulemaking.

    II. Overview of Proposed Regulatory Revisions and Information in This Notice

    Title V of the CAA establishes an operating permit program. Section 505 of the CAA requires permitting authorities to submit a proposed title V permit to the EPA Administrator for review for a 45-day review period before issuing the permit as final. The Administrator shall object to issuance of the permit within that 45-day review period if the Administrator determines that the permit contains provisions that are not in compliance with the applicable requirements under the CAA. If the Administrator does not object to the permit during the 45-day EPA review period, any person may petition the Administrator within 60 days after the expiration of the 45-day review period to take such action (hereinafter “title V petition” or “petition”). The title V petition provisions of the current implementing regulations found at 40 CFR part 70 largely mirror the CAA, and have not been revised since original promulgation in 1992. With 20 years of experience with title V petitions as well as feedback from various stakeholders, the agency is now proposing changes to 40 CFR part 70 intended to provide clarity and transparency to the petition process, and to improve the efficiency of that process.1

    1 The revisions proposed in this rule only impact 40 CFR part 70, which applies to federally-approved state, local, and tribal operating permit programs; 40 CFR part 71, which covers the title V operating permit program for permits issued under the EPA's federal permitting authority, utilizes a different administrative review process, through the Environmental Appeals Board (EAB). The EAB has its own review process for title V permits issued under 40 CFR part 71 that is separate and distinct from the process of petitioning the Administrator for an objection to a 40 CFR part 70 permit; thus, these proposed changes are intended to streamline and clarify the EPA's title V petition review process under 40 CFR part 70 only.

    The changes proposed and the information provided in the preamble to the proposal are intended to benefit permitting authorities, permitted sources, and potential petitioners, as well as the EPA. Permitting authorities and permitted sources are expected to benefit by early consultation with the appropriate EPA Regional Office when the permitting authority is preparing a permit to ensure it includes conditions that assure compliance with applicable requirements under the CAA and part 70). These early actions should minimize potential permit deficiencies and reduce the associated likelihood that a petition will be submitted on that title V permit.

    Potential petitioners are expected to benefit by having better notification of permits and review deadlines (e.g., the EPA is proposing to post on EPA Regional Web sites when a proposed permit is received and the corresponding 60-day deadline for submitting a petition) and by better access to permitting decision information (e.g., the permitting authority's written response to comments). These updates will clarify the expected minimum content of petitions and provide a standardized format, simplifying the process and enhancing the likelihood that petitions will be clear and complete. In addition, potential petitioners may also derive a benefit from more efficient responses to petitions and a better understanding of the process.

    The EPA is expected to benefit by improving the agency's ability to meet its statutory obligations to review proposed permits, respond to title V petitions and provide more transparency in the title V petition process. These were concerns expressed by a Clean Air Act Advisory Committee task force in recommendations provided to the agency in 2006.2 The EPA believes that the proposed regulatory revisions and shared information are responsive to these concerns and could, if finalized, improve the efficiency of the agency's response.

    2 In 2004, the Clean Air Act Advisory Committee (CAAAC) established a Task Force to evaluate the title V program. The 18-member panel, comprised of industry, state, and environmental group representatives, identified what Committee members believed was and was not working well. After hosting public meetings and receiving written feedback, and compiling the information with the personal experience of panel members, the Title V Task Force issued a final report that highlighted concerns and recommendations for improvement. See, Final Report to the Clean Air Act Advisory Committee on the Title V Implementation Experience: Title V Implementation Experience (April 2006). The Title V Task Force Final Report is available at: https://www.epa.gov/caaac/caaac-reports.

    The proposed regulatory revisions described in Section IV of this notice would, among other things: (1) Provide direction as to how title V petitions should be submitted to the agency, including encouraging the use of an electronic submittal system as the preferred (but not exclusive) method to submit title V petitions; (2) describe mandatory content and format for title V petitions, which is intended to clarify the process for petitioners and improve the EPA's ability to review and act on petitions efficiently; and (3) require permitting authorities to respond in writing to significant comments received during the public comment period on a draft title V permit and to provide that written response to the EPA along with the proposed title V permit at the start of the EPA's 45-day review period. This proposal also requests comment on the proposed revisions to the regulations governing the CAA title V petition process, as well as comment on questions related to potentially establishing page limits on title V petitions. The proposed revisions to the 40 CFR part 70 regulations are described more fully in Section IV of this notice.

    Separate from the regulatory revisions proposed in Section IV, Section V.A of this notice provides guidance on “recommended practices” for permit development for various stakeholders that, when followed, helps to ensure permits have complete administrative records and comport with the requirements of the CAA. Lastly, to increase stakeholder familiarity with the post-petition process, Section V.B. provides information concerning the agency's interpretation of certain provisions of title V of the CAA and the implementing regulations at part 70 regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders. The following paragraphs briefly provide additional information on each area.

    First, in order to reduce confusion with and add clarity to the process of submitting title V petitions, the EPA has developed a centralized point of entry for all title V petitions using an electronic submittal system. As described in Section IV.A of this notice, the EPA encourages petitioners to use this electronic system when submitting title V petitions, which will improve customer service by allowing for better access to and tracking of petitions. This is the preferred method identified in the proposed regulatory revisions that would be acceptable to use to submit a title V petition to the agency. Alternative methods for submittal are also identified in this notice.

    Second, with regard to petition content, the EPA is proposing regulatory revisions that would specify requirements for mandatory petition content and standard formatting for all petitions. This is expected to benefit potential petitioners by ensuring completeness while promoting streamlining and improving the EPA's ability to review and act on petitions efficiently. In its orders responding to title V petitions, the EPA has already identified key elements that are critical for demonstrating that a title V permit does not assure compliance with applicable requirements under the CAA or under the part 70 regulations, and has explained their relevance to its determinations. In this proposal, the EPA is proposing new regulatory language to codify what has already been discussed in prior orders. If finalized, petitioners would be expected to follow these requirements and include this content following a standard format. As described later in this notice and in the proposed regulatory text, this content includes identifying where the issue being raised in the title V petition was raised during the public comment period on the draft title V permit and addressing the permitting authority's response to the comment in the petition in order to demonstrate that an objection is warranted.

    Along with the proposed changes and requests for comment regarding petition content and format in Section IV.B of this notice, the EPA proposes to add new regulatory language to 40 CFR 70.8 that would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions implementing this requirement of section 505(b)(2) of the Act. Therefore, this rule proposes to insert a requirement into the part 70 rules mirroring the Act's requirement in order to ensure consistency with this provision of the statute.

    Third, Section IV.C of this notice contains requirements for certain procedures related to responding to significant public comments on the draft title V permit, as well as the administrative record for and submittal of proposed title V permits to the EPA by permitting authorities. The changes being proposed now would require that all permitting authorities respond to significant comments received on draft permits. The EPA is also proposing that the 45-day review period under section 505(b)(1) would not begin until the permitting authority forwards the proposed permit, the written response to comments (RTC) or statement that no public comments were received, and the statement of basis document, to the EPA for its review. These changes are expected to benefit permitting authorities and permitted sources by resulting in a more complete permit record and greater clarity for all stakeholders. If finalized, these changes may result in a need to revise at least some state, local and tribal part 70 programs.

    In addition to these three areas, as part of the agency's effort to share information with stakeholders about the title V petition process, this notice includes guidance to help ensure permits have complete administrative records and comport with the requirements of the CAA. Presented in the form of “recommended practices” for stakeholders, this guidance is shared in the spirit of providing information and context to give a more comprehensive view of the title V petition process, including the time before a petition may be filed. Following the suggested recommended practices contained in Section V.A of this notice is expected to positively affect the permit issuance process resulting in better permits and may reduce the likelihood that a title V petition will be submitted on a title V permit.

    All four of the previously mentioned areas should help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions. The proposed revisions to the part 70 regulations associated with the first three key areas are anticipated to increase transparency and add clarity to the title V petition submittal, review, and response processes. Codifying existing practices into title V regulations of the CAA is also expected to make the EPA petition review process more efficient. In addition, providing “recommended practices” for stakeholders, including some related to permit issuance, also increases transparency and clarity to further improve the stakeholder experience and understanding surrounding title V petitions.

    Section V.B of this notice discusses steps following the EPA's issuance of an objection in response to a title V petition, particularly where the state, local, or tribal permitting authority subsequently amends the permit terms and conditions and/or the permit record in response to the EPA's objection. This process is often referred to as the post-petition process. The information provided in Section V.B reflects interpretations of certain statutory and regulatory provisions related to this aspect of the title V petition process that have previously been discussed by the EPA, including in title V petition orders. This information is repeated as a convenience to stakeholders and the general public: The agency is not proposing to alter its interpretation of that process in this notice and the regulatory revisions proposed in this notice do not relate to or modify this interpretation. The agency is not soliciting comment on this interpretation or otherwise reopening or revising the already-issued title V petition orders or other EPA documents in which it has previously been discussed. Rather, this discussion is included to provide additional transparency and clarity.

    Finally, as a convenience to stakeholders and the general public, and to provide context and background that informs how the EPA determines whether to grant an objection and to promote awareness of the EPA's existing interpretation of key provisions of section 505(b)(2) of the Act, Section III.D of this notice includes a summary of some past orders responding to title V petitions and court decisions addressing the burden on a title V petitioner to demonstrate that an objection is warranted.

    III. Background A. The Title V Operating Permits Program

    Congress amended the CAA in 1990 to add title V, now found at 42 U.S.C. 7661-7661f, to assist in compliance and enforcement of air pollution controls. CAA Amendments of 1990, Public Law 101-549, sections 501-507, 104 Stat. 2399, 2635-48 (1990). Before this, the CAA pollution control requirements that might apply to a particular source could be found in many different provisions of the Act and its numerous regulations. As one court opinion has described it: “Before 1990, regulators and industry were left to wander through this regulatory maze in search of the emission limits and monitoring requirements that might apply to a particular source. Congress addressed this confusion in the 1990 Amendments by adding title V of the Act, which created a national permit program that requires many stationary sources of air pollution to obtain permits that include relevant emission limits and monitoring requirements.” Sierra Club v. EPA, 536 F.3d 673, 674 (D.C. Cir. 2008).

    Accordingly, title V of the Act establishes an operating permits program for major sources of air pollutants, as well as certain other sources. CAA section 502(a). Under title V of the CAA, states were required to develop and submit to EPA for approval title V permitting programs consistent with program requirements promulgated by the EPA. Those requirements are now found in 40 CFR part 70. Most states, certain local agencies, and one tribe have approved part 70 programs.3 As part of an approved part 70 program, title V of the CAA requires every major source and certain other sources to apply for and operate pursuant to an operating permit. CAA sections 502(a) and 503; see also 40 CFR 70.5(a) and 70.1(b). It further requires that the permits contain conditions that assure compliance with all of the sources' applicable requirements under the Act, including the requirements of the applicable implementation plan. CAA section 504(a); see also 40 CFR 70.1(b) and 70.6(a)(1).

    3 The Southern Ute Indian Tribe has an EPA-approved operating permit program under 40 CFR part 70.

    Prior to the title V program, CAA requirements for major sources of air pollutants were implemented in multiple and various ways. As a lawmaker involved in the 1990 CAA Amendments explained:

    Title V creates, for the first time, a unifying permit program for facilities subject to the [A]ct's various control requirements. In the past, some provisions of the Clean Air Act—for example, the nonattainment and PSD new source requirements—were, and will continue to be, implemented through preconstruction permits. Other control requirements were effected without Federal, or in some cases, State permits—for example, NESHAPS and NSPS—although States often incorporated these requirements into their own permit programs.4

    4 136 Cong. Rec. E3663, E3673 (1990) (Speech of Rep. Michael Bilirakis), reprinted in Environment and Natural Resources Policy Division of the Congressional Research Service of the Library of Congress, 6 A Legislative History of the Clean Air Act Amendments of 1990, at 10768 (1993) [hereinafter CAAA Leg. Hist.].

    More specifically, a title V permit must contain enforceable emission limits and standards, including operational requirements and limitations, and such other conditions as necessary to assure compliance with all applicable requirements that apply to the source at the time of permit issuance, as well as the monitoring, recordkeeping, and reporting requirements to assure compliance. In sum, the title V permit program is a vehicle for ensuring that air quality control requirements are appropriately applied to a source's emission units and for assuring compliance with such requirements.

    For the most part, title V of the CAA does not impose new pollution control requirements on sources. The definition of “applicable requirements” in the part 70 regulations includes many standards and requirements that are established through other CAA programs, such as standards and requirements under sections 111 and 112 of the Act, and terms and conditions of preconstruction permits issued under the New Source Review programs. 40 CFR 70.2. Once those air quality control requirements are established in those other programs, they are incorporated into a source's title V permits as appropriate. Hence, a title V permit is a comprehensive document that identifies all the specific CAA requirements that must be met by a source in order to operate. Developing such a comprehensive document can be a complex process that involves some harmonization of all the source's applicable requirements. As a lawmaker involved in the 1990 CAA Amendments explained:

    The creation of the new permit program in title V provides an opportunity and an obligation for EPA to harmonize the substantive provisions of the other titles in this complex legislation. Many of the same sources and pollutants will be controlled under multiple titles—the same facilities and pollutants will often be controlled under the hazardous air pollutant, nonattainment, and acid rain programs. EPA must make every effort to harmonize and prevent unproductive duplication among those titles. The permit provisions of title V provide a focus for this harmonization, although title V does not change, and gives EPA no authority to modify, the substantive provisions of these other titles.5

    5 136 Cong. Rec. E3663, E3673 (1990) (Speech of Rep. Michael Bilirakis), reprinted in 6 CAAA Leg. Hist., at 10768 (1993).

    As this language suggests, in providing an opportunity for harmonization through title V of the CAA, Congress did not replace or remove the procedures and requirements for establishing substantive requirements that exist in other provisions of the CAA. Nor did Congress alter or supplant the opportunities for public participation and administrative and judicial review that are found in other CAA programs, such as those for public participation and judicial review of certain final agency actions under section 307 of the Act. In addition, the Act requires that title V permitting programs provide opportunities for public participation in title V permitting processes and an opportunity for judicial review in state court. CAA section 502(b)(6); see also 40 CFR 70.4(b)(3)(x) (judicial review) and 70.7(h) (public participation). The petition process co-exists with those provisions, without superseding them.

    Although title V of the CAA does not generally impose new pollution control requirements on sources, it does require that certain procedural measures be followed especially with respect to assuring compliance with underlying applicable requirements, and it also requires sources to pay certain fees. For example, title V of the CAA requires permits to contain adequate monitoring, recordkeeping, and reporting provisions to assure sources' compliance with permit terms and conditions. See CAA 504(c); Sierra Club v. EPA, 536 F.3d 673 (D.C. Cir. 2008). The part 70 regulations contain monitoring rules designed to satisfy this statutory requirement. Finally, as an additional measure to ensure permits are in compliance with the CAA, the title V program provides for public participation at various steps in the permitting process, including the opportunity to submit a title V petition.

    B. Statutory and Regulatory Basis for This Proposal

    In general terms, as noted above, the title V permit program was a significant development that established new procedural requirements for permitting authorities and sources. In crafting the program, Congress balanced the benefit of a single document that contains all applicable requirements of the Act with the need to process these complex documents in an efficient manner. As part of the effort to promote efficient implementation of the operating permits program, the provisions relating to title V objections establish an orderly process with specific deadlines, which give the EPA an opportunity to raise objections to a title V permit before it is issued and which give any person the opportunity to timely raise specific issues to the EPA through a title V petition. In light of the complexities of implementing a program of title V's scope, a statement of one lawmaker in the legislative history indicates that the opportunity to “challenge EPA's failure to object” through the petition process was “designed to avoid delays” while preserving the discretion of both the EPA and the states.6

    6 136 Cong. Rec. E3663, E3675 (1990) (Speech of Rep. Michael Bilirakis), reprinted in 6 CAAA Leg. Hist. at 10774.

    More specifically, under CAA section 505(a), and the current implementing regulations found at 40 CFR 70.8(a), permitting authorities are required to submit each proposed title V permit to the EPA for review.7 Upon receipt of a proposed permit and all necessary supporting information, the Administrator has 45 days in which to object to the final issuance of the permit if he/she determines that the proposed permit is not in compliance with applicable requirements of the Act, including the requirements of the applicable state implementation plan (SIP), or part 70 requirements. CAA section 505(b)(1) and 40 CFR 70.8(c)(1).

    7 As the part 70 rules in 70.8(c) and (d) largely mirror the Act's provisions, the statutory and regulatory requirements are addressed together in this background discussion.

    As the EPA explained when proposing the initial title V regulations in 1991, the Act limits the EPA's opportunity for its initial review and an objection based on that review to 45 days in order to minimize delays. 56 FR 21749 (May 10, 1991). If the Administrator objects under CAA 505(b)(1), he/she must provide a statement of the reasons for the objection, providing a copy of both the objection and the statement to the permit applicant. CAA 505(b)(1); see also 40 CFR 70.8(c)(1).

    If the Administrator does not object during the 45-day review period, consistent with section 505(b)(2) of the CAA and 40 CFR 70.8(d), any person may petition the Administrator within 60 days after the expiration of the EPA's 45-day review period to object to the permit. The Administrator shall grant or deny such a petition within 60 days after it is filed. CAA section 505(b)(2) establishes several requirements related to such petitions. Among other things, it provides that such a petition shall be based only on objections to the permit that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise objections during that period or the grounds for objection arose after completion of the public comment period. It also provides that the Administrator shall issue an objection if the petitioner demonstrates that the permit is not in compliance with the requirements of the CAA, including the requirements of the applicable implementation plan.

    The implementing regulations are found in 40 CFR 70.8(d) and largely mirror this provision. As the EPA explained in proposing the initial title V regulations, the title V petition opportunity serves an important purpose because title V permits are frequently complex documents, and given the brevity of the agency review period there may be occasions when the EPA does not recognize that certain permit provisions are not in compliance with applicable requirements of the Act. 56 FR 21751 (May 10, 1991). CAA section 505(b)(2) states that the Administrator “shall” object if the petitioner makes the required demonstration. If the Administrator denies a petition for an objection, CAA 505(b)(2) provides that denial is subject to judicial review under CAA section 307; however, under CAA section 505(c), no objection is subject to judicial review until the Administrator has taken final action to issue or deny the permit. Further, the requirements under CAA section 505(b)(2) may not be delegated by the Administrator.

    In addition to the provisions of title V, the rulemaking of provisions under CAA section 307(d) are relevant to this notice. The Administrator is applying the rulemaking provisions of CAA section 307(d) to the rulemaking discussed in this notice, pursuant to CAA section 307(d)(1)(V), which provides that the provisions of 307(d) apply to “such other actions as the Administrator may determine.”

    C. Title V Petition Process and Content

    After 20 years of experience in implementing the title V petition process, the EPA has identified some general trends in petition content and aspects of the petition review process that pose challenges for potential petitioners in preparing petitions and for the EPA in providing an efficient response to petitions. These are described in this section of the notice to provide additional context for this proposal. This proposed rulemaking is aimed in part at increasing stakeholder access to and understanding of the petition process and increasing the efficiency of the agency's response to petitions received and at mitigating some of the factors that contribute to poorly prepared or incomplete petitions, misunderstanding of applicable permit and CAA requirements, and longer response times. These factors include: (1) The lack of administrative requirements around petition submittals, which results in a variety of inconsistent methods used by petitioners; (2) the lack of specific rules regarding petition content, which results in considerable inconsistency in the format and content of petitions; and (3) the need to often deal with numerous and highly complex issues that arise in title V petitions given that title V permits must address many applicable requirements. These include issues relating to compliance with the requirements of the prevention of significant deterioration (PSD) permitting program, the hazardous air pollutant program (i.e., requirements implementing the provisions of CAA 112), and other air quality issues. For example, petitioners often raise issues related to compliance with the requirements of the major and minor preconstruction permit programs, such as the PSD permitting requirements found in part C of Title I of the Act. This permitting program has a separate process under the CAA, its implementing regulations and SIPs, for evaluating applicability of the permitting requirements, determining the appropriate terms and conditions for permits, and for public participation and administrative and/or judicial review of those permits. At times, the PSD issues raised in the context of a title V petition relate to projects that occurred a considerable time in the past, and in some situations, the title V permit record may not contain all the relevant information for understanding the determinations that were made. For these reasons, consideration of these issues in the title V petition context can be time-consuming to research and complex to resolve, even to come to the seemingly simple determination that the permit record is inadequate. Further, title V petitions frequently include lengthy arguments that primarily concern CAA programmatic or policy issues, rather than the terms of a particular permit.

    Over time, petitions have raised increasingly more complex policy, legal, and technical matters. Through the review of such extensive and complicated petitions, the petition review process has evolved into a resource-intensive effort by the EPA. To increase stakeholder understanding of the title V petition process, help ensure consistent presentation of critical information in such petitions, and facilitate more efficient review of them, the EPA is proposing to revise its regulations to establish procedural parameters which, if finalized, would govern the title V petition process moving forward. As described in more detail in Section IV of this notice, this proposal includes proposed requirements for petition submittal, petition content and format, and certain administrative record requirements. As mentioned previously, one of the primary goals of the proposed changes is to improve stakeholder access to and understanding of the petition process and improve the agency's ability to meet its statutory obligations to review proposed permits and respond to title V petitions, in light of the overall structure of the CAA.

    Yet another overarching factor that hampers the current petition review process is the confusion or lack of familiarity with the process itself. In the 2006 Title V Task Force Final Report noted earlier, for example, the CAAAC task force expressed a concern with the lack of transparency in the title V petition process. This concern has been echoed in the years since the 2006 report through feedback the agency has received from various stakeholders. In response, the EPA has tried to provide more explanation and insight into the title V petition process in the administrative orders it issues in responding to petitions. Some of these issues have also been discussed in the opinions courts have issued in reviewing such EPA orders. However, the EPA expects that not all stakeholders, including the public, may have read these response orders or related court decisions.

    Therefore, the next section of this notice seeks to provide additional transparency concerning the petition process by repeating some of the relevant interpretations of statutory and regulatory provisions that the EPA has previously explained in title V petition orders, as well as interpretations of certain provisions related to the title V petition process provided in judicial opinions. Reiterating these prior statements concerning the EPA's application and interpretation of the statute to reviewing title V petitions may also provide useful context for the proposed changes to 40 CFR part 70, which are discussed in Section IV of this notice.

    D. Prior Interpretations and Applications of the Title V Provisions

    This section includes a discussion of certain aspects of the statutory elements of CAA section 505(b)(2) as well as the implementing regulations that have previously been interpreted by the EPA and/or courts. The discussion that follows serves to inform the public, stakeholders, permitting authorities, and other interested parties of these interpretations. Although the matters discussed in this section are available to the public,8 and in some cases have been available for years and/or already subject to judicial review, in the interest of transparency and clarity, the agency is collecting these interpretations and judicial decisions in this notice. That information is repeated here merely as a convenience for the public. The agency is not in this notice proposing to change these previously-presented interpretations, soliciting comments on these interpretations, or reopening the already-issued title V orders or other EPA documents in which these interpretations were discussed. None of the regulatory revisions proposed in this notice would alter these interpretations or the prior title V orders or other EPA documents in which these interpretations were discussed.

    8 The Title V Petitions Database contains petitions and EPA Orders responding to petitions and is available at: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

    1. “Threshold” Requirements

    Certain of the requirements under CAA section 505(b)(2) related to petitions are sometimes referred to as “threshold” requirements, which provide some procedural requirements and some limitations on the scope of title V petitions. These include, for example, that the petition be filed within 60 days following the agency's 45-day review period. Another example is the requirement that the petition be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the permitting agency. The agency has previously addressed these “threshold” issues in prior title V orders, and some of those statements are reiterated in this section.

    a. Timeliness

    Generally speaking, the first step in the petition response process is for the agency to ascertain if the petition was timely filed pursuant to CAA section 505(b)(2). The Act and implementing regulations at 40 CFR 70.8(d) provide for a 60-day window in which to file a title V petition, which runs from the expiration of the EPA's 45-day review period. A petition received after the 60-day petition deadline is not timely. The agency is aware that because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. The agency currently encourages permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example making that information available either online, such as Region 4 has done on the EPA Web site, “Region 4 Proposed Title V Permits and State Contacts,” 9 or in the publication in which public notice of the draft permit was given.

    9 EPA Region 4's Web site provides links with lists of permits that have been proposed and are still under the public petition deadline, organized by state: https://www.epa.gov/caa-permitting/region-4-proposed-title-v-permits-and-state-contacts.

    b. Reasonable Specificity

    The second “threshold” requirement described in the statute regards the content of a petition. CAA section 505(b)(2) requires that, unless one of the enumerated exceptions applies, the petition must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the permitting agency. Subject to the exceptions contained in the provision, the EPA understands this statutory language to require that the issues presented in a petition be raised during the public comment process with reasonable specificity. Such issues could, however, be raised in comments filed by a commenter other than the petitioner.

    The EPA continues to believe that, as stated in the preamble to the 1991 part 70 proposal, Congress did not intend for petitioners to create an entirely new record before the EPA that the permitting authority had no opportunity to address. The requirement to raise issues “with reasonable specificity” places the burden on the petitioner. Unless there are unusual circumstances, the Petitioner needs to provide evidence that would support a finding of noncompliance with the Act to the permitting authority before it is raised in a petition. See, 56 FR 21712, 21750 (1991).

    Where an issue is raised to the EPA in a title V petition without first raising it with reasonable specificity to the permitting authority to give it the opportunity to address the issue, the Administrator has generally denied such claims consistent with the statutory requirements. The EPA has specifically addressed the reasonable specificity threshold requirement in a number of title V petition orders. Some key highlights are summarized next.

    In 2013 in the Luminant Order, the EPA responded to a petition that raised a number of issues, including several that were raised only in general terms or not raised at all during the public comment period by any commenter. See, In the Matter of Luminant Generating Station, Petition, Order on Petition No. VI-2011-05 (January 15, 2013). For example, the petitioners claimed that the permit in question failed to identify emission units that were associated with permit by rules to which the facility was subject. The EPA noted that no mention was made in the public comments concerning the lack of identification of emission units, and denied the claim. Id. at 12. The Administrator similarly denied other claims not raised with reasonable specificity during the public comment period: The comments did not present evidence or analysis to support these petition claims, and thus the state had no opportunity to consider and respond to those claims. Id. at 6, 11, 13, 15. The Luminant Order also included a discussion of the reasonable specificity standard, that absent unusual circumstances, the requirement to raise issues “with reasonable specificity” places the burden on the petitioner to bring forward evidence before the State that would support a finding of noncompliance with the CAA. See id. at 5.

    As noted above, the Act contains two enumerated exceptions to the “reasonable specificity” requirement. Namely, issues that were not raised with reasonable specificity during the public comment period can be raised in a petition if the petitioner demonstrates that it was impracticable to raise such objections within such period or unless the grounds for such objection arose after such period. CAA section 505(b)(2). For an issue to fit within one of these exceptions, the petitioner would have to demonstrate the impracticality, or show that the grounds arose after the comment period. The EPA has also addressed this issue in petition orders.

    One example is in the 2012 San Juan Generating Station Order, where the EPA responded to a petition claim that the permit failed to assure compliance with PSD applicable requirements because it did not address significant increase of a specific pollutant after a change at the facility. See In the Matter of Public Service Company Of New Mexico, San Juan Generating Station (SJGS), Order on Petition VI-2010 (February 15, 2012) at 10. According to the petitioners, these concerns were not raised during the comment period because the State did not make the information about the significant emission increase available until after the public comment period, when the permitting authority noted in its response to the EPA that the change triggered PSD and expressed its intent to add a title V compliance schedule to the permit. The Administrator found that in this case, the petitioners demonstrated that the grounds arose after the comment period and therefore, the EPA would consider their claim on this matter. See id. at 10.

    c. Scope of Permit Action

    Petitions may be submitted on several types of proposed title V permits, such as proposed initial permits, permit renewals, or permit revisions, which may include minor or significant modifications to the title V permit. Some stakeholders have indicated there may be confusion on the matter of petition opportunities, particularly for minor modification actions. In cases where the permitting authority has not provided for a prior public comment period on a minor permit modification, petitioners can still submit a petition to the Administrator. 57 FR 32283; see also 40 CFR 70.7(e)(2)(iv) (for a minor modification, the permitting authority may not issue a final permit until after EPA's 45-day review period or until EPA has notified the permitting authority that it will not object, whichever is earlier) and 70.8(e) (a part 70 permit, including a modification, may not be issued until after EPA has had an opportunity to review the proposed permit as required under this section). As the EPA may receive a petition on different types of proposed title V permits, it is important for the agency to be able to identify the particular action of concern to the petitioner.

    Under CAA section 505(b)(2), a petition pertains to a particular permit. Thus, the EPA must be able to discern from the petition what permit action the petition is based on in order to review and respond to it. The EPA has interpreted the potential scope of the petition as related to the scope of the permit action that is the basis of the petition. In the 1992 preamble to the final part 70 rule, the EPA explained that public objections to an initial permit, permit revision, or permit renewal must be germane to the applicable requirements implicated by the permitting action in question. For example, objections raised on a portion of an existing permit that would not in any way be affected by a proposed permit revision would not be germane. 57 FR 32250, 32290/3 (July 21, 1992). Consistent with CAA section 505(b)(2), the EPA has considered the scope of the permit proceeding in reviewing petitions and denied petitions that concern issues that are outside the scope of the permit proceeding. See, e.g., In the Matter of Wisconsin Public Service Corporation's JP Pulliam Power Plant (Order in response to Petition Number V-2012-01) (January 7, 2013) at 8; In the Matter of Consolidated Environmental Management, Inc.—Nucor Steel Louisiana, Order on Petition Numbers VI-2010-05, VI-2011-06 and VI-2012-07 (January 30, 2014) (Nucor III Order) at 12.

    One such denial can be found in the 2007 Weston Order, in which the EPA received a petition that claimed that the proposed modification permit was deficient because it did not incorporate limits from PSD and preconstruction permit applications for a particular unit at the Weston facility. See, In the Matter of Wisconsin Public Service Corporation—Weston Generating Station (Order in response to Petition) (December 19, 2007). The EPA denied the claim because the unit in question had not been affected by or related to the significant modification on which the title V permitting action was based. The Order stated:

    EPA interprets its title V regulations at 40 CFR part 70 to require different opportunities for citizens to petition on initial permit issuance, permit modifications, and renewals. The regulations state that a permit, permit modification, or renewal may be issued if specified conditions are met, 40 CFR 70.7(a)(1), including a requirement that `[t]he permitting authority shall provide a statement that sets forth the legal and factual basis for the draft permit conditions.' 40 CFR 70(a)(1)(ii) and 70.7(a)(5) (emphasis added). Further, 40 CFR 70.7(h), in requiring the permitting authority to provide adequate procedures for public notice and comment for permit proceedings that qualify as significant modifications, provides that the notice shall identify `the activity or activities involved in the permit action; the emissions change involved in any permit modification; . . . and all other materials available to the permitting authority that are relevant to the permit decision . . .' 40 CFR 70.7(h)(2) (emphasis added). We interpret these provisions to limit petitions on significant modifications to issues directly related to those modifications. Id. at 5.

    The Weston Order further noted that this limitation on petitions for title V significant modifications did not affect the public's ability to participate in the permit issuance or enforcement processes. When a title V permit is renewed, all aspects of the title V permit are subject to public comment and petition as part of the process to issue a renewal permit. Generally speaking, members of the public can also bring an enforcement action in situations of alleged noncompliance with any permit terms. Furthermore, if the public is concerned that the permit fails to incorporate all applicable requirements, a petition may be submitted to the Administrator to reopen the permit for cause under CAA section 505(e). Id. at 7.

    2. Demonstration Requirement

    In addition to the threshold requirements, the statute identifies another general guideline for the EPA's consideration. Specifically, to compel an objection by the EPA, CAA section 505(b)(2) requires the petitioner to demonstrate that a permit is not in compliance with requirements of the Act, including the requirements of the applicable implementation plan. The EPA has interpreted the demonstration burden under CAA section 505(b)(2) in numerous title V petition orders and court opinions have also interpreted it. What follows is a brief restatement of interpretations previously articulated in some of those orders and opinions.

    In the 2013 Nucor II Order the EPA stated:

    The petitioner demonstration burden is a critical component of CAA section 505(b)(2). As courts have recognized, CAA section 505(b)(2) contains a “discretionary component” that requires the exercise of the EPA's judgment to determine whether a petition demonstrates noncompliance with the Act, as well as a nondiscretionary duty to object where such a demonstration is made. Sierra Club v. Johnson, 541 F.3d at 1265-66 (“it is undeniable [CAA section 505(b)(2)] also contains a discretionary component: it requires the Administrator to make a judgment of whether a petition demonstrates a permit does not comply with clean air requirements”); NYPIRG, 321 F.3d at 333. Courts have also made clear that the Administrator is only obligated to grant a petition to object under CAA section 505(b)(2) if the Administrator determines that the petitioners have demonstrated that the permit is not in compliance with requirements of the Act. See, e.g., Citizens Against Ruining the Environment, 535 F.3d at 667 (section 505(b)(2) “clearly obligates the Administrator to (1) determine whether the petition demonstrates noncompliance and (2) object if such a demonstration is made”) (emphasis added); NYPIRG, 321 F.3d at 334 (“Section 505(b)[2] of the CAA provides a step-by-step procedure by which objections to draft permits may be raised and directs the EPA to grant or deny them, depending on whether non-compliance has been demonstrated.”) (emphasis added); Sierra Club v. Johnson, 541 F.3d at 1265 (“Congress's use of the word `shall' . . . plainly mandates an objection whenever a petitioner demonstrates noncompliance”) (emphasis added). Courts reviewing the EPA's interpretation of the ambiguous term “demonstrates” and its determination as to whether the demonstration has been made have applied a deferential standard of review. See, e.g., Sierra Club v. Johnson, 541 F.3d at 1265-66; Citizens Against Ruining the Environment, 535 F.3d at 678; MacClarence [v. EPA], 596 F.3d [1123] at 1130-31 [9th Cir. 2010)].

    See, In the Matter of Consolidated Environmental Management, Inc.—Nucor Steel Louisiana, Order on Petition Numbers VI-2011-06 and VI-2012-07 (June 19, 2013) (Nucor II Order) at 4-5.

    The EPA highlighted in the Nucor II Order several reasons why the petitioner's demonstration is important in the context of a title V petition, including first, the relatively short time frames title V of the CAA provides for the EPA to review title V permits and petitions. As previously explained, under CAA section 505(b)(1), the Administrator has only 45 days after receiving a copy of the proposed permit to review that permit and object if she determines that the permit is not in compliance with the CAA. If the Administrator does not object, then any petition for an objection must be filed within 60 days after the expiration of the 45-day review period, and the agency is required to grant or deny that petition within 60 days. See CAA section 505(b)(2). Given these short time frames, the Nucor II Order explained that EPA does not believe it is reasonable to conclude that Congress would have intended for the EPA to engage in extensive fact-finding or investigation to analyze contested petition claims, and in support of this interpretation it cited Citizens Against Ruining the Environment, 535 F.3d at 678, which noted that because the limited time frame Congress gave the EPA for permit review “may not allow the EPA to fully investigate and analyze contested allegations, it is reasonable in this context for the EPA to refrain from extensive fact-finding.” Nucor II Order at 5. Therefore, it is imperative that the petitioner make the demonstration.

    After discussing the relatively short time frames for the EPA to review as the first point, the Nucor II Order continued:

    Second, the Act is structured so that the EPA's evaluation of a petition under CAA section 505(b)(2) follows and is distinct from its review of a proposed permit under section 505(b)(1), which requires the Administrator to object on his own accord if he determines the permit is not in compliance with the Act. By contrast, under section 505(b)(2), the Administrator is compelled to object only if the necessary demonstration has been made.[10]

    10 Footnote 3 of the Nucor II Order explained: “Further, CAA section 505(b)(2) provides that `the Administrator may not delegate the requirements of this paragraph.' This reflects the significance Congress attached to the decision on whether or not to object in response to a petition, and means the process requires additional time.”

    Third, the EPA is also sensitive to the fact that its response to title V petitions often comes late in the title V permitting process and often after the title V permit has been issued. See CAA section 505(b)(3) (acknowledging that the EPA's response to a petition may occur after the permit has been issued). The EPA's evaluation of the petitioners' demonstration can have consequences, as a determination by the EPA that the petition demonstrates the permit is not in compliance with the Act requires the Administrator and the state permitting authority to take certain actions. MacClarence, 596 F.3d at 1131. The EPA also acknowledges Congress' direction that permitting authorities must provide “streamlined” procedures for issuing title V permits, indicating that the title V permitting process should proceed efficiently and expeditiously. CAA section 502(b)(6); 40 CFR part 70.4(d)(3)(ix). These circumstances make it all the more important that the EPA carefully evaluate the petition's demonstration and not issue an objection under section 505(b)(2) unless the petition demonstrates that one is required.

    Fourth, and consistent with its importance in CAA section 505(b)(2), the petitioner demonstration requirement helps to ensure the equity, procedural certainty, efficiency, and viability of the title V petition process for petitioners, state and local permitting authorities, the EPA and source owner/operators. This petitioner demonstration requirement helps to ensure that each and every petitioner is treated equitably in the petition process because the same standard for demonstration applies to each petitioner. Where petitioners meet their burden, the EPA will grant the petition. Where they do not, the EPA will not grant the petition. In this way, the EPA gives equal consideration to the petitioner's arguments, as appropriate.

    In addition, the petitioner burden requirement also helps to ensure that the title V petition process is consistent with the division of responsibilities and co-regulator relationship between the EPA and state or local permitting authorities established in the CAA. When carrying out our title V review responsibilities under the CAA, it is our practice, consistent with that relationship, to defer to permitting decisions of state and local agencies with approved title V programs where such decisions are not inconsistent with the requirements under the CAA. The EPA does not seek to substitute its judgment for the state or local agency. As we discuss above in this section, sections 505(b)(1) and (2) of the Act, require the EPA to object to the issuance of a title V permit if it determines that the title V permit contains provisions that are not in compliance with applicable requirements of the Act, including the requirements of the applicable SIP. State and local agencies must ensure that the title V permit includes all applicable requirements under the CAA for that source, and provide an adequate rationale for the permit requirements in the public record, including the response to comment. When the EPA grants a particular title V petition under CAA section 505(b)(2), the EPA directs the state or local agency regarding actions necessary to ensure that the title V permit meets the applicable requirements with regard to the particular issue(s) that was raised, including appropriate and necessary changes to the permit.

    The petitioner burden requirement assures that petitioners have clearly and sufficiently articulated the basis for an objection before a title V petition is granted. Thus, state and local agencies have certainty regarding the standard against which petitions on their title V permits and permit records will be assessed. The petitioner burden requirement also helps to ensure that the EPA does not have to spend significant time and resources responding to ungrounded claims regarding the title V permit or permit record. For example, petitioners might include claims in petitions unrelated to applicable requirements for the title V permit at issue or that do not provide sufficient information for the EPA to analyze the claim. Without the petitioner demonstration burden, the EPA could be required to investigate and respond to claims that ultimately prove to be ungrounded or frivolous. This would increase the complexity and uncertainty of the title V permit process, and would be burdensome and unproductive for the EPA, as well as for state and local agencies. The petitioner burden standard also helps to ensure certainty of the permitting process for source owner/operators, because it provides a consistent standard against which petitions on their title V permits will be assessed.

    Nucor II Order at 5-7.

    In light of the EPA's interpretation of the demonstration requirement and its importance to the implementation of the statutory structure that Congress created for addressing objections to title V permits, the EPA has discussed and applied its interpretation of the demonstration burden in numerous title V orders. Examples of the EPA's application of this standard can be found in: In the Matter of Scherer Steam-Electric Generating Plant Juliette, Georgia, et al., Order on Petition Nos. IV-2012-1, IV-2012-2, IV-2012-3, IV-2012-4, and IV-2012-5 (Apr. 14, 2014) at 12-13; In the Matter of Hu Honua Bioenergy Facility, Order on Petition No. IX-2001-1 (July 2, 2014) (Hu Honua Order) at 25-27; In the Matter of EME Homer City Generation LP, et al., Order on Petition No. III-2012-06, III-2012-07, and III-2013-02 (July 30, 2014) at 24-25; In the Matter of Public Service of New Hampshire Schiller Station, Order on Petition No. VI-2014-04 (July 28, 2015) at 11-12.

    The interpretation quoted from the Nucor II Order is based on the discussion of the demonstration burden in opinions from federal courts of appeal. These courts have recognized that the term “demonstrates” in CAA section 505(b)(2) is ambiguous and have accordingly deferred to the EPA's interpretation. See Wildearth Guardians v. EPA, 728 F.3d 1075, 1081-1082 (10th Cir. 2013); MacClarence v. EPA, 596 F.3d 1123, 1130-1131 (9th Cir. 2010); Sierra Club v. Johnson, 541 F.3d 1257, 1265-1267 (11th Cir. 2008); Citizens Against Ruining the Env't v. EPA, 535 F.3d 670, 677-678 (7th Cir. 2008). In so deferring, these courts have discussed the seminal Supreme Court decision, Chevron USA, Inc. v. Natural Res. Def. Council Inc., 467 U.S. 837, 842-843 (1984), which provides guiding principles for judicial review of agency interpretations and determinations under statutes that the agency administers.11 Chevron establishes a well-known two-step test: First, if the Congress has “directly spoken to the precise question at issue” both the court and the agency must “give effect to the unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-843. Second, if the statute is ambiguous, courts will generally defer to the agency's interpretation and uphold it so long as it “is based on a permissible construction of the statute.” Id. at 843.

    11 The principle of deference named after this decision—Chevron deference—is discussed in more detail in Section IV.A of this notice.

    Several federal courts of appeal have agreed with the EPA's position that the term “demonstrates” in CAA section 505(b)(2) is ambiguous. MacClarence, 596 F.3d at 1130 (collecting cases). As one opinion pointed out, “[n]either the Clean Air Act nor its regulations define the term `demonstrates' or give context to how the Administrator should make this judgment.” Sierra Club v. Johnson, 541 F.3d at 1266; see also Citizens Against Ruining the Env't, 535 F.3d at 677-678. After considering the plain meaning of the term “demonstrates” as shown by various dictionary definitions, courts have agreed that the plain meaning “does not resolve important questions that are part and parcel of the Administrator's duty to evaluate the sufficiency of a petition, for example, the type of evidence a petitioner may present and the burden of proof guiding the Administrator's evaluation of when a sufficient demonstration has occurred.” Sierra Club v. Johnson, 541 F.3d at 1266; MacClarence, 596 F.3d at 1131 (same). Similarly, another court observed that the Act “does not set forth any factors the EPA must take into account in determining whether a petitioner has demonstrated noncompliance under [CAA 505(b)(2)].” Wildearth Guardians, 728 F.3d at 1082.

    This recognition of the ambiguity in CAA section 505(b)(2) leads to the conclusion that “the statute's silence on these important issues means Congress has delegated to the EPA some discretion in determining whether, in its expert opinion, a petitioner has presented sufficient evidence to prove a permit violates clean air requirements.” Sierra Club v. Johnson, 541 F.3d at 1266. Accordingly, as one opinion put it, “the EPA has discretion under the statute to determine what a petition must show in order to make an adequate `demonstration.' ” Citizens Against Ruining the Env't, 535 F.3d at 678. Similarly, another court explained, “because we conclude [section 505(b)(2)] is ambiguous when it comes to defining the type of demonstration required to trigger the Administrator's duty to object, we are willing to defer to a reasonable interpretation by the agency as to when a petitioner has sufficiently demonstrated noncompliance with PSD requirements.” Sierra Club v. Johnson, 541 F.3d at 1267. In so deferring to the EPA's interpretation of the demonstration standard under CAA section 505(b)(2) some courts have noted that they need not resolve the question of the exact degree of deference to be accorded to the EPA because its “interpretation is persuasive even under [the] less deferential standard of review” under Skidmore v. Swift, 323 U.S. 134 (1944) and “would thus prevail under either standard.” Wildearth Guardians, 728 F.3d at 1082; MacClarence, 596 F.3d at 1131 (same).

    In the context of reviewing particular applications of the demonstration burden in title V petition orders, courts have also deferred to the agency's interpretation as to whether or not a petition had adequately demonstrated that an objection was warranted. For example, in MacClarence, the petition was denied in part because it “failed to provide adequate information to support [a claim]” and made “only generalized statements . . . and did not provide adequate references, legal analysis, or evidence in support of these general assertions.” 596 F.3d at 1131 (internal marks omitted). The court found the EPA's construction of the burden under CAA section 505(b)(2) as encompassing an expectation that a petition provide “references, legal analysis, or evidence” a reasonable interpretation, which comported with both the plain meaning of the term “demonstrates” and with CAA section 505(b)(2). Id. In addition, in MacClarence, the petitioner argued that the EPA should not have denied his petition for failing to address the permitting authority's reasoning in the final permitting decision and documents, which differed from the draft documents and explained why the changes had been made. The court upheld the EPA's decision, determining that it was reasonable for the EPA to expect the petitioner to address the permitting authority's final decision. Id. at 1132-33. As another example of the deference that courts have accorded the EPA's application of the demonstration standard, in the Wildearth Guardians case cited above, the court found reasonable the EPA's determination that the petitioner could not rely solely on the fact that a Notice of Violation (NOV) had been previously issued to demonstrate noncompliance. Wildearth Guardians, 728 F.3d at 1082. The court noted that the EPA had explained that an NOV may be a relevant factor in “ `determining whether the overall information presented by Petitioner—in light of all the factors that may be relevant—demonstrates the applicability of a requirement for the purposes of title V' ” but explained that other factors may also be relevant. Id. The EPA further explained that if the petitioner had not addressed other relevant factors, it could find that petitioner “ `failed to present sufficient information to demonstrate that the requirement is applicable.' ” Id. Finding this interpretation of the demonstration requirement persuasive, the court deferred to it. Id.

    3. Raising PSD Issues in a Petition

    As noted earlier, many petitions raise numerous and highly complex issues around PSD permitting, a separate permitting program under the CAA. Because of the frequency with which title V petitions raise PSD claims, statements in prior petition orders regarding such claims is worth a separate mention here. In the Meraux Refinery Order, In the Matter of Meraux Refinery, Order on Petition Number VI-2012-04 (May 29, 2015), at 3-4, the EPA stated:

    Where a petitioner's request that the Administrator object to the issuance of a title V permit is based in whole, or in part, on a permitting authority's alleged failure to comply with the requirements of its approved PSD program (as with other allegations of noncompliance with the Act), the burden is on the petitioner to demonstrate to the Administrator that the permitting decision was not in compliance with the requirements of the Act, including the requirements of the SIP. CAA section 505(b)(2). . . . Such requirements, as the EPA has explained in describing its authority to oversee the implementation of the PSD program in states with approved programs, include the permitting authority: (1) following the required procedures in the SIP; (2) making PSD determinations on reasonable grounds properly supported on the record; and (3) describing the determinations in enforceable terms. See, e.g., In the Matter of Wisconsin Power and Light, Columbia Generating Station, Order on Petition No. V-2008-01 (October 8, 2009) at 8. The permitting authority for a State's SIP-approved PSD program has substantial discretion in issuing PSD permits. Given this discretion, in reviewing a PSD permitting decision, the EPA will not substitute its own judgment for that of the State. Rather, consistent with the decision in Alaska Dep't of Envt'l Conservation v. EPA, 540 U.S. 461 (2004), in reviewing a petition to object to a title V permit raising concerns regarding a state's PSD permitting decision, the EPA generally will look to see whether the petitioner has shown that the state did not comply with its SIP-approved regulations governing PSD permitting or whether the state's exercise of discretion under such regulations was unreasonable or arbitrary. See, e.g., In re Louisville Gas and Electric Company, Order on Petition No. IV-2008-3 (Aug. 12, 2009); In re East Kentucky Power Cooperative, Inc. Hugh L. Spurlock Generating Station, Order on Petition No. IV-2006-4 (Aug. 30, 2007); In re Pacific Coast Building Products, Inc. (Order on Petition) (Dec. 10, 1999); In re Roosevelt Regional Landfill Regional Disposal Company (Order on Petition) (May 4, 1999).

    As is indicated by the internal citations to a number of other title V orders in the Meraux Refinery Order, the agency has made similar statements in several previous orders over the years. 4. Raising Emissions Monitoring Issues in a Petition

    Many petitions also raise issues surrounding emissions monitoring, recordkeeping and reporting in title V permits. Title V of the CAA requires permits to contain adequate emissions monitoring, recordkeeping, and reporting to assure sources' compliance with applicable requirements. 57 FR 32250, 32251 (July 1, 1992). Because of the frequency with which monitoring claims are raised, statements in prior petition orders regarding such claims are also worth a separate mention here. As an example, In the Matter of the Premcor Refining Group, Inc., Order on Petition Number VI-2007-02 (May 28, 2009), at 7, the EPA stated:

    As a general matter, permitting authorities must take three steps to satisfy the monitoring requirements in the EPA's part 70 regulations. First, a permitting authority must ensure that monitoring requirements contained in applicable requirements are properly incorporated into the title V permit. 40 CFR 70.6(a)(3)(i)(A). Second, if the applicable requirements contain no periodic monitoring, permitting authorities must add monitoring “sufficient to yield reliable data from the relevant time period that are representative of the source's compliance with the permit.” 40 CFR 70.6(a)(3)(i)(B). Third, if the applicable requirement has associated periodic monitoring but the monitoring is not sufficient to assure compliance with permit terms and conditions, a permitting authority must supplement monitoring to assure compliance. See 40 CFR 70.6(c)(1).

    5. Addressing Permitting Authority's Rationale

    The EPA has previously noted that as part of the CAA section 505(b)(2) demonstration requirement, the petitioner is expected to address the permitting authority's final decision, and the permitting authority's final reasoning (including the RTC), where these documents were available during the timeframe for filing the petition. Where a permitting authority has articulated its rationale for the permit terms and conditions concerning an applicable requirement in its record (RTC and statement of basis) and the petitioner did not adequately address that rationale in its petition, the EPA has often denied the petition, at least in part, on that basis. See e.g., In the Matter of Noranda Alumina, LLC, Order on Petition No. VI-2011-04 (December 14, 2012) at 20-21 (denying title V petition issue where petitioners did not respond to state's explanation in response to comments or explain why the state erred or the permit was deficient); In the Matter of Kentucky Syngas, LLC, Order on Petition No. IV-2010-9 (June 22, 2012) at 41 (denying title V petition issue where petitioners did not acknowledge or reply to state's response to comments or provide a particularized rationale for why the state erred or the permit was deficient). Caselaw supports this interpretation. See MacClarence, 596 F.3d at 1132-33 (the Administrator “reasonably expected” the petitioner to challenge the state permitting authority's explanation and reasoning for final permit).

    IV. Proposed Revisions to Title V Regulations

    This notice proposes several changes to part 70. Many of the proposed revisions fall within three key areas. First, regulatory language is proposed that encourages the use of the agency's electronic submittal system for title V petitions. Alternative methods for submittal are also identified in this notice. Petitioners who experience technical difficulty when attempting to submit a petition through the electronic submittal system may send it to the designated email address, while those without access to the Internet or unable to access email for other reasons may send a paper copy to the specific physical address identified in this proposal.

    Second, this rule proposes mandatory petition content requirements and standard formatting for title V petitions. The EPA has identified key pieces of information that are critical when assessing claims and potential flaws in a title V permit or permit process, and these pieces are now proposed as required content for petitions and would be a new provision, 40 CFR 70.12. Under the proposed revisions, in order to demonstrate a flaw in the permit, permit record, or permit process that warrants an objection under CAA section 505(b)(2), the petition would present the required content in the same manner and order as contained in the new section of the title V regulations, 40 CFR 70.12.

    A related change is proposed that would add new regulatory language to 40 CFR 70.8, which would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions effectuating this requirement of section 505(b)(2) of the Act. Therefore, this proposal would insert a requirement into the regulation identical to the one in the Act in order to ensure consistency with this provision of the statute.

    Third, the agency proposes to require that permitting authorities respond in writing to significant comments received during the public comment period on a draft title V permit. Further, the EPA proposes regulatory language stating that this response to significant comments, often referred to as the RTC, must be sent with the proposed permit and statement of basis for the 45-day EPA review period of the proposed permit.12 Under the proposed revisions, the EPA 45-day review period would not commence until the proposed permit and all necessary supporting information, including the written RTC, are received. Finally, the EPA proposes to require that within 30 days of sending the proposed permit to the EPA, that permitting authorities must provide notification that the proposed permit and the response to significant public comments are available to the public. Such notice must explain how these materials may be accessed.

    12 The statement of basis is a statement that “sets forth the legal and factual basis . . . (including references to the applicable statutory or regulatory provisions)” for terms and/or conditions in a permit. 40 CFR 70.7(a)(5). Often a separate document, the statement of basis is intended to provide information to facilitate the EPA's review of permit terms and conditions and also to provide information that supports public participation in the permitting process.

    These proposed revisions to part 70 provide increased transparency and clarity to the title V petition preparation, submittal, review, and response processes. Improved interactions with stakeholders that participate in the title V process and more accurate tracking of petitions may also result from the establishment of the preferred petition submittal method. If finalized, the proposed rule revisions would help facilitate a more effective process for the development of title V petitions and a more efficient process for the review and response to title V petitions. Overall, the EPA is intending that these rule revisions along with other shared information will help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions.

    For each of the three key areas, the agency describes the proposed regulatory changes, rationale for proposing the changes, and request for comment in the sections that follow. Before discussing each of the three key areas of this proposal, however, this notice provides some additional legal background related to these proposals.

    A. Additional Legal Background for the Proposed Revisions to the Part 70 Rules

    To provide context for the statutory and regulatory interpretations discussed below, the EPA first discusses some additional legal background, including principles generally applied by courts in reviewing agency interpretations.

    The Supreme Court decision, Chevron USA, Inc. v. Natural Res. Def. Council Inc., 467 U.S. 837, 842-843 (1984), establishes principles that guide judicial review of agency interpretations of statutes that the agency administers. Under Chevron courts apply a well-known two-step test: First, if the Congress has “directly spoken to the precise question at issue” both the court and the agency must “give effect to the unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-843. Second, if the statute is ambiguous, courts will generally defer to the agency's interpretation and uphold it so long as it “is based on a permissible construction of the statute.” Id. at 843. At the second step of this inquiry, also referred to as “Chevron Step 2,” courts such as the D.C. Circuit have frequently explained that “ `Chevron requires that we defer to the agency's reasonable interpretation of the term.' ” Miss. Comm'n on Envtl. Quality v. EPA, 790 F.3d 138, 151 (D.C. Cir. 2015) (quoting Pennsylvania Dept. of Envtl. Protection v. EPA, 429 F.3d 1125, 1130 (D.C. Cir. 2005)). In other words, under Chevron the agency's interpretation “ `governs if it is a reasonable interpretation of the statute—not necessarily the only possible interpretation, nor even the interpretation deemed most reasonable by the courts.' ” Entergy Corp. v. Riverkeeper, Inc., 556 U.S. 208, 218 (2009) (quoted in Airlines for Am. v. Transp. Sec. Admin., 780 F.3d 409, 413 (D.C. Cir. 2015)).

    Similarly, courts accord deference to an administrative agency's interpretations of its own regulations under principles enunciated in Auer v. Robbins, 519 U.S. 452, 462-63 (1997). This type of deference is frequently referred to as Auer deference. When an agency's interpretation of a regulation receives Auer deference, the court accepts the agency's interpretation “unless the interpretation is plainly erroneous or inconsistent with the regulations or there is any other reason to suspect that the interpretation does not reflect the agency's fair and considered judgment on the matter in question.” Rural Cellular Ass'n & Universal Serv. v. FCC, 685 F.3d 1083, 1093-1094 (D.C. Cir. 2012) (internal marks and citations omitted).

    Finally, the EPA notes that administrative agencies have broad discretion to adopt procedures to discharge their obligations under the statutes they implement. In the words of the U.S. Supreme Court: “[T]he formulation of procedures [is] basically to be left within the discretion of the agencies to which Congress [has] confided the responsibility for substantive judgments.” Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, 435 U.S. 519, 524 (1978). Later in the same case, the Court observed that “[a]bsent constitutional constraints or extremely compelling circumstances the administrative agencies should be free to fashion their own rules of procedure to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties.” Id. at 543-544. Relatedly, courts have emphasized the inherent authority that administrative agencies have “to control the disposition of their caseload” and manage their own dockets. See, e.g., GTE Service Corp. v. FCC, 782 F.2d 263, 273-274 (D.C. Cir. 1986).

    B. Electronic Submittal System for Petitions 1. Proposed Revisions a. Petition Submission to the EPA

    In this notice, the EPA is proposing to revise part 70 to add a new provision that would require petitions to be submitted using one of three identified methods. Among those three methods, the agency encourages petitioners to submit title V petitions through the electronic submittal system, the agency's preferred method. The EPA has developed a title V petitions submittal system through the Central Data Exchange (CDX) and information on how to access and use the system is available at the title V petitions Web site: http://www.epa.gov/title-v-operating-permits/title-v-petitions. While the current submittal system was designed using CDX, the EPA recognizes that adjustments to the system or a different submittal system entirely may be needed in the future. Therefore, the title V petitions Web site will provide access to the designated electronic submittal system in use at any given time, which will remain the primary and preferred method for receiving title V petitions. The electronic submittal system allows for a direct route to the appropriate agency staff. It also provides immediate confirmation that the EPA has received the petition and any attachments.

    If a petitioner experiences technical difficulties when trying to submit a petition through the electronic submittal system identified on the title V petitions Web site, the petition may also be submitted to the agency through the following email address: [email protected] This address is being established as an alternative method for use in instances when the electronic submittal system is not available. For petitioners without access to the Internet at the time of petition submittal, this notice also announces the establishment of one specific physical address to which all paper copies of petitions should be sent. Paper copies of all petitions unable to be sent electronically may be sent by mail or by courier to the following address: U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Policy Division, Operating Permits Group Leader, 109 T.W. Alexander Dr. (C504-05), Research Triangle Park, NC 27711. Additional information on these alternative methods for submittal will also be available at the title V petitions Web site.

    Although regulatory changes are being proposed to integrate these methods of submission into the part 70 rules, all three of these methods are currently available for petition submission, and petitioners may elect to use any one of them now. Furthermore, although the proposed changes to the regulatory provisions identify three possible means to submit petitions, for any particular petition, once a petition and any attachments have been successfully submitted using one method, there is no need to submit a duplicate copy via another method. The EPA requests that petitioners only submit a petition using one method, which will expedite the administrative process and improve the EPA's efficiency in reviewing petitions. Finally, if these regulatory revisions are finalized, the agency would not be obligated to consider petitions submitted through any means other than the three identified in the rule.

    b. Required Copy of the Petition to the Permitting Authority and Applicant

    Section 505(b)(2) of the Act requires that the petitioner provide copies of its petition to the permitting authority and the permit applicant. This requirement does not currently appear in the part 70 rules. The EPA is proposing to revise the part 70 regulations in order to fill this gap in the regulations. Specifically, in this notice, the EPA proposes to add language to 40 CFR 70.8(d) that is identical to the statutory language.

    2. Why is the EPA proposing this change?

    In general, feedback from stakeholders, as well as the EPA's experience in receiving petitions, indicate there is confusion at present as to where a petition should be submitted. While section 505(b)(2) of the CAA and 40 CFR 70.8(d) provide that any person may petition the Administrator to object within 60 days after the expiration of the EPA's 45-day review period for the proposed permit, both the statute and the regulations are currently silent as to how a petition should be submitted to the EPA. Because the regulations do not dictate a specific address, title V petitions have been received in a number of different offices within the agency. Most of the recent petitions have been sent to the agency through email, in some cases with a duplicate paper copy sent to a physical address somewhere within the EPA. For example, the agency has received petitions that were sent directly to a staff person in a Regional office, as well as petitions sent directly to the Administrator, either by email or courier. One complication presented by this current practice is that by sending petitions via email, attachments supplied by petitioners as supporting materials may become separated from the petition or lost entirely. In addition, and potentially because of this fact, petition attachments are frequently submitted by mail or courier, while the petition itself is submitted by email. These various submission practices require additional administrative processing within the EPA and can delay the initiation of the substantive petition review process.

    One goal of this proposal is to clarify where and how title V petitions should be submitted. Another goal of this proposal is to announce the establishment of an electronic submittal system and promote its use as the preferred method for the submittal of petitions to the EPA. These proposed changes are expected to allow for more accurate tracking of petitions and to increase the agency's efficiency and effectiveness in responding to petitions by ensuring the timely receipt of petitions and any attachments in a central location.

    The EPA has identified several benefits of establishing the electronic submittal system as the preferred submittal method for receiving title V petitions. For petitioners, the electronic submittal system will provide immediate confirmation to the petitioner that the petition was received by the agency. In contrast to the size limitations that can be experienced when sending title V petitions through email, petitioners will be able to see that all intended supporting materials are attached to the petition and are submitted in one entry. Thus, submitting a petition and attachments via the electronic submittal system would avoid the need to send multiple emails to transmit the entire petition package. Sending petitions through the electronic submittal system also eliminates timeliness issues from potential mishandling due to courier issues.

    For the agency, there is a time savings as petitions and any attachments submitted through the electronic submittal system will be immediately and directly available to the agency. This saves administrative time otherwise spent processing the incoming petition and any attachments, especially those submitted separately from the petition. Thus, the EPA anticipates that using this system will facilitate more efficient processing for incoming petitions. Further, the electronic submittal system in its current form identifies the number of attachments a petitioner intends to submit, which can alert the EPA to any missing attachments.

    More information about the electronic submittal system, including information about security concerns regarding providing personal information, uploading and/or downloading files, personally identifiable information (PII), and CBI is available at the CDX Web site: https://cdx.epa.gov/. If this rule is finalized and there is interest from commenters, the EPA will consider developing training webinars on the use of the electronic submittal system.

    These proposed rule revisions to identify specific methods for petition submittal fall within the EPA's inherent discretion to formulate procedures to meet its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. In addition, the Act is silent as to the methods that should be used for title V petition submittal but imposes a 60-day deadline for granting or denying such petitions. Accordingly, these proposed changes to improve the efficiency of the EPA's initial processing of petitions and to support the agency's efforts to satisfy that obligation are based on a reasonable interpretation of CAA section 505(b)(2), including the relatively short timeframe for the EPA to grant or deny a petition.

    3. Request for Comment

    Comments are requested on all aspects of these proposed revisions. The EPA is also specifically soliciting comment on our proposal to add language to part 70 that identifies the electronic submittal of petitions through the agency's identified electronic submittal system as the preferred primary method for submitting a title V petition, as well as identifying two alternative methods that could be used in case of technical difficulties or by a petitioner without Internet access. Commenters are encouraged to address in their comments whether additional specification or direction is needed to ensure all stakeholders are aware and have a better understanding of the preferred electronic submittal process. The EPA is expressly requesting comment on whether the proposed regulatory revisions are necessary, or whether the same effect could be achieved through the direction provided in this preamble and through the title V petitions Web site. Further, the EPA is requesting comment on what, if any, outreach methods or training materials (e.g., written instructions) would assist users with submitting petitions through the CDX system.

    C. Required Petition Content and Format 1. Proposed Revisions

    The following proposed regulatory changes are designed to assist the public with preparing their petitions, as well as to assist the EPA in its review of petitions. In this notice, the agency proposes to establish in the part 70 regulations key mandatory content requirements for title V petitions. These proposed requirements are based on statutory requirements under CAA section 505(b)(2) and aspects of the demonstration standard interpreted by the EPA in numerous title V petition orders and restated in Section III.D of this notice. By proposing to codify what has already been discussed in prior orders, the EPA aims to help all stakeholders understand the criteria that the EPA applies in reviewing a title V petition. The EPA also proposes to establish requirements to encourage similar formats for all petitions to further assist the agency in its review process.

    a. Required Petition Content

    The EPA is proposing to revise part 70 to require standard content that must be included in a title V petition, laying out the agency's expectations with more specificity to assist petitioners in understanding how to make their petitions complete and to enhance the EPA's ability to review and respond to them promptly. Under this proposal, a new section of the title V regulations, 40 CFR 70.12, would add the following list of required elements:

    • Identification of the proposed permit on which the petition is based. The proposed permit is the version of the permit the permitting authority forwards to the EPA for the agency's 45-day review under CAA section 505(b)(1).13 A petition would be required to provide the permit number, version number, and/or any other information by which the permit can be readily identified. In addition, the petition must specify whether the relevant permit action is an initial issuance, renewal, or modification/revision, including minor modifications/revisions.

    13 A proposed permit may be any of the following permit actions: Initial permit, renewal permit, or permit modification/revision.

    • Sufficient information to show that the petition was timely filed. A petition must be filed within 60 days after the expiration of the Administrator's 45-day review period, as required by section 505(b)(2) of the Act. Timeliness may be demonstrated by the electronic receipt date generated upon submittal of the petition through the agency's electronic submittal system, the date and time the emailed petition was received, or the postmark date generated for a paper copy mailed to the agency's designated physical address. It is helpful if the petition provides key dates, such as the end of the public comment period provided under 40 CFR 70.7(h), (or parallel regulations in an EPA-approved state, local or tribal title V permitting program), or the conclusion of the EPA 45-day review period for the proposed permit.

    • Identification of Petition Claims. Any issue raised in the petition as grounds for an objection must be based on a claim that the permit, permit record, or permit process is not in compliance with the applicable requirements under the Act or requirements under part 70. All pertinent information in support of each issue raised as a petition claim must be included within the body of the petition. In determining whether to object, the Administrator would not consider information incorporated into the petition by reference (for example, comments offered during the public comment period on the draft permit that are incorporated by reference into the petition on the proposed permit, or, as another example, claims raised in one title V petition that are incorporated by reference into a different title V petition). However, petitions may and should still provide citations to support each petition claim (e.g., citations to caselaw, statutory and regulatory provisions, or portions of the permit record). For each claim raised, the petition would need to identify the following:

    ○ The specific grounds for an objection, citing to a specific permit term or condition where applicable.

    ○ The applicable requirement under the CAA or requirement under part 70 that is not met. Note that the term “applicable requirement” refers to Clean Air Act requirements only, and does not include other requirements (e.g., Endangered Species Act, Clean Water Act) to which a source may be subject. The term “applicable requirement” of the CAA for title V purposes is defined in 40 CFR 70.2.

    ○ An explanation of how the term or condition in the proposed permit, or relevant portion of the permit record or permit process, is not adequate to comply with the corresponding applicable requirement under the CAA or requirement under part 70.

    ○ If the petition claims that the permitting authority did not provide for the public participation procedures required under 40 CFR 70.7(h), the petition must identify specifically the required public participation procedure that was not provided.

    ○ Identification of where the issue in the claim was raised with reasonable specificity during the public comment period provided for in 40 CFR 70.7(h), citing to any relevant page numbers in the public comment as submitted and attaching the submitted public comment to the petition. If the grounds for the objection were not raised during the public comment period, the petitioner must demonstrate that it was impracticable to raise such objections within the period or that they arose after such a period, as required by section 505(b)(2) of the Act and 40 CFR 70.8(d).

    ○ Unless the exception under CAA section 505(b)(2) and 40 CFR 70.8(d) discussed in the immediately preceding bullet applies, the petition must identify where the permitting authority responded to the public comment, including the specific page number(s) in the document where the response appears, and explain how the permitting authority's response to the comment is inadequate to address the claimed deficiency. If the written RTC does not address the public comment at all or if there is no RTC, the petition should state that.

    In addition to including all specified content, it is important that the information provided or any analysis completed by the petitioner must also be accurate. However, including this content would not necessarily result in the Administrator granting an objection on any particular claim raised in a petition. For example, a petitioner could include all this information but not demonstrate noncompliance, or the petition might point to a specific permit term as not being adequate to comply with an air emission limit, but may not have identified the appropriate applicable requirement.

    One impediment to the EPA's review process is the use of incorporation by reference of other documents, in whole or in part, into petitions. As noted earlier in this section, under “identification of petition issues” in the new proposed mandatory content requirements, the EPA would require all pertinent information in support of each issue raised as a petition claim to be included in the body of a petition. Incorporating information into a petition by reference is inconsistent with the demonstration obligations in the statute and would extend the petition review time as the agency spends time searching for and then attempting to decipher the petitioner's intended claim. In practice, the EPA often finds that where claims have been incorporated by reference it is not clear that the specific grounds for objection have been raised by the petitioner, which could lead to the EPA denying for failure to meet the demonstration burden. Relatedly, petitioners have sometimes used incorporation by reference to include comments from a comment letter, but a comment letter alone would typically not address a state's response to the comment. See, e.g. Nucor III Order at 16 (noting that the “mere incorporation by reference . . . without any attempt to explain how these comments relate to an argument in the petition and without confronting [the State's] reasoning supporting the final permit is not sufficient to satisfy the petitioner's demonstration burden”). In practice, the EPA has found that the incorporation of comments by reference into a petition can lead to confusion concerning the rationale for the petitioner's arguments, as it is frequently unclear which part of the comment is incorporated, how it relates to the particular argument in the petition, and the precise intent of the incorporation. In addition, the incorporation of comments by reference increases the agency's review time, as the EPA must review more than one document to try to determine the complete argument that a petitioner is making. Therefore, the EPA is proposing to revise the regulations to state that the Administrator will not consider information incorporated by reference into a petition. However, a petition should still provide citations as needed to support its legal and factual assertions.

    For further transparency and clarity, the EPA in this notice gives examples of types of information that are not necessary to include when preparing an effective petition. In doing so, the EPA hopes to ease the effort associated with preparing a petition while promoting succinctness. For example, while a petitioner needs to cite to the legal authority supporting its specific claim, a petition does not need to include pages of background or history on aspects of the CAA. If a petitioner wishes to include additional information for an alternate purpose unrelated to the EPA's review of the specific petition claim, the EPA recommends appending this information to the petition as a separate document and identifying the purpose for which it is provided.

    b. Required Petition Format

    Even with all necessary information provided, a petition may still require substantial time to review because of how it is organized. Therefore, the EPA is also proposing and taking comment on format requirements. If information is presented in the same format, including the same order, in all petitions, the EPA anticipates this standard organization could reduce review time as the general location of specific details would be the same in every petition received. These proposed format requirements could also help petitioners better understand what is, and what isn't, necessary in an effective title V petition. To that end, the EPA proposes the use of a standard format following the same order as previously identified in the list of required petition content. Regulatory language to this effect is included in the proposed new provision, 40 CFR 70.12. If finalized, templates and/or guidance are planned for development for inclusion on the title V petitions Web site.

    Further, the EPA is requesting input from the public on several specific questions related to potentially establishing page limits for title V petitions, as explained further in Section IV.C.4 of this notice. While the EPA has received petitions ranging from approximately 3 to 82 pages (excluding attachments), the length for most petitions is in the range of 20 to 30. The amount of detail required to successfully raise a claim and meet the demonstration standard may depend on the complexity of the issue. However, we expect that most claims could be written effectively and succinctly, as demonstrated in the example claim that follows.

    2. Example Claim

    The following paragraphs contain an example of a concise and effective presentation of a hypothetical single claim that would be part of a larger petition—one that includes all pieces of required content for a claim proposed in this rule. Because this is only a sample claim, not a sample petition, it does not include some of the required content that relates to the petition as a whole (such as identifying information for the proposed permit). This example is organized following the order presented in the proposed required content changes identified previously, which is also the proposed standard format. The bullets highlight each element of the proposed content requirements.

    Although EPA is providing this sample claim to illustrate how the material that would be required under the proposed regulatory revisions could be presented succinctly and effectively, the information that is needed to satisfy the demonstration burden for any given petition claim will vary depending on the specifics of the claim, the applicable requirements, and the underlying permit terms and record. The following hypothetical claim is provided solely for purposes of illustration:

    • Specific Grounds for Objection, Including Citation to Permit Term

    Facility X's title V permit lacks monitoring sufficient to assure compliance with the 4.5 pound per hour (lb/hr) nitrogen dioxide (NOX) emission limitation of the approved State Implementation Plan (SIP) at 30 State Administrative Code 66.54.2. Specifically, Permit Condition I.D.26 requires that NOX emissions from Facility X's combustion units (Units 1-6 and 11-14) cannot exceed 4.5 pounds of NOX per hour. Permit Condition II.D.105 requires once-per-year portable analyzer monitoring for Units 1-6 and 11-14. The permit contains no other testing, monitoring, recordkeeping, or reporting requirements on these units, and contains no other monitoring that could be used determine compliance with the 4.5 lb/hr NOX emission limit for the units.

    • Applicable Requirement or Part 70 Requirement Not Met

    CAA section 504(c), and the implementing regulations in 40 CFR 70.6(c)(1) and 70.6(a)(3)(i)(B), requires all title V permits to contain monitoring requirements to assure compliance with permit terms and conditions. See also 30 State Administrative Code 66.55.5(b) and (c) (same requirements in state's approved title V program). The permit does not meet this requirement as explained in the following analysis.

    • Inadequacy of the Permit Term

    The SIP-approved NOX limitation does not include any periodic monitoring requirements, so 40 CFR 70.6(a)(3)(i)(B) requires state agency to add periodic monitoring sufficient to yield reliable data from the relevant time period that are representative of the source's compliance with the permit. The monitoring added by the state in Permit Condition II.D.105 fails to satisfy that requirement under part 70 because monitoring only once annually for the engines units is inadequate to assure compliance with an hourly emission limit.

    • Public Participation Procedure Not Provided

    This petition does not claim that any public participation procedures were not provided.

    • Issue Raised in Public Comments

    Public Group Y (Petitioners) raised this issue on page 5 of the July 31, 2015 comment letter it submitted on Facility X's July 1, 2015 draft title V permit. (See Public Group Y Comments at 5; Petition Exhibit A at 5.)

    • Analysis of State's Response

    In responding to Petitioners' comment stating that the frequency of the permit's compliance monitoring for the compressor engines' 4.5 lb/hour NOX limit was inadequate to assure compliance with the permit term, state agency asserted that “all that the title V provisions in 30 State Administrative Code 66.55.5(b) and the parallel requirements in 40 CFR 70.6(a)(3)(i)(B) require is periodic monitoring sufficient to yield reliable data that are representative of the source's compliance with the permit. Continuous monitoring is not required.” [RTC) at 8; Petition Exhibit B at 8]. The RTC states that state agency's monitoring protocol for this unit type requires “quarterly portable analyzer testing on units with catalytic converters and annual testing on units without controls.” Id. The RTC then concludes that “[b]ecause the portable analyzer test is a short term test, it demonstrates compliance with the emission limits for that time period. Due to the steady state operation of these units, state agency believes that the portable analyzer testing along with proper operation and maintenance of the units provides reasonable demonstration of compliance with hourly NOX and CO emission limits.” Id. Although state agency asserts that it included NOX monitoring in accordance with its monitoring protocols for engines, state agency's RTC does not adequately explain how the monitoring in Facility X's permit is sufficient to assure compliance with the hourly NOX limit in Permit Condition I.D.26.

    As explained, state agency is relying on the portable analyzer test results as a snapshot sampling of emissions to confirm annually whether the units continue to meet their 4.5 lb/hour NOX limits. Between annual portable analyzer tests, state agency relies on assumptions of steady state operation and “proper operation and maintenance of the units” to provide a “reasonable” demonstration of compliance with hourly NOX emission limits. The RTC, however, does not identify any permit terms or conditions that require proper operation and maintenance of the units; nor does it provide an explanation (or appropriate citation to the technical discussion) of why it believes its assumptions about steady-state operations are reasonable for this equipment, or explain how such assumptions, in conjunction with an annual emissions test, constitute monitoring that demonstrates compliance with a short term limit. Accordingly, the EPA must grants the petition on this claim.

    3. Why is the EPA proposing this change?

    The CAA and part 70 regulations currently provide little information on what a title V petition must or should contain. In fact, the primary requirement in CAA section 505(b)(2) is that a petition (with a few identified exceptions) must be based on objections that were raised with reasonable specificity during the public comment period for the permit, and that is the only specific requirement for petition content in the relevant regulation. See CAA section 505(b)(2) and 40 CFR 70.8(d). As a result, the content and format of petitions have varied widely. In the agency's experience, many petitions fail to include key pieces of information, making it more time-consuming and resource-intensive for the EPA to assess the claim. Many petitions are also convoluted, include extraneous or irrelevant information, or fail to present the key information in a logical progression, making it difficult for the agency to ascertain the specific issue being raised. Contributing to the confusion, petitions frequently include large sections of text that appear to have been developed for other reasons and are not relevant to raising or evaluating a claim about a specific flaw in the title V permit or permitting process.

    One of the EPA's desired outcomes for this proposed rule is to provide direction to petitioners that will assist them with preparing petitions. The agency anticipates receiving petitions that are both more concise and clear and that contain all the key relevant material, so that the EPA does not have to search for fundamental information or attempt to decipher the petitioner's intent. These proposed revisions are intended to facilitate a more effective petition development process and a more efficient petition review and response process, which are critical in this context because CAA section 505(b)(2) requires the agency to grant or deny a petition within 60 days. Similarly, this tight timeframe makes it imperative that a petitioner make a clear and concise demonstration that can be efficiently evaluated. By proposing to create obligations related to the content and structure of a petition, the EPA anticipates receiving petitions that more clearly articulate the petition claim and the basis for it, focusing on key information, including the alleged deficiency in the permit or permit process; the applicable requirements under the CAA or requirements under part 70 that are in question; and where the issue was raised during the public comment period (or a demonstration as to why it was impracticable to do so or that the grounds for the objection arose after the public comment period closed), how the state responded, and why that response did not adequately address the issue.

    These proposed rules are consistent with statements and conclusions that the EPA has made in previous orders responding to title V petitions. The EPA has identified and emphasized the importance of such key pieces of information in assessing petitioners' claims that a title V permit or permit process does not assure compliance with applicable requirements under the CAA or under part 70. For context, examples of some of these orders were discussed in Section III.D of this notice. The EPA is proposing to add petition content requirements that would make certain information mandatory in petitions. These requirements would help clarify for petitioners specific information that is useful or necessary to evaluate a petition claim. The EPA anticipates that these mandatory petition content requirements and standard formatting would help petitioners to succinctly focus their claims and present them effectively. The EPA anticipates that these proposed changes could also decrease the instances in which the Administrator denies a petition because the petitioner did not provide an adequate demonstration. The agency believes these changes would help petitioners to hone their claims to include the appropriate information and to realize when a claim does not meet the mandatory requirements and should not be included in the petition (e.g., the state adequately addressed the issue in its RTC).

    The EPA expects the proposed revisions to require mandatory content to improve the efficiency of the agency's review process for title V petitions, as the key information would be presented in a clear and succinct fashion. Similarly, the agency expects that the proposed revisions to require similar organization for all petitions could reduce agency review time as a result of having the specific information in the same format in every petition received. Increasing the efficiency of the review process, and more specifically reducing the time it takes to review petitions, are consistent with Congress's intent that the petition process proceed in a timely and expeditious fashion, as indicated by the 60-day time frame for the Administrator to grant or deny petitions provided in CAA section 505(b)(2). See Citizens Against Ruining the Environment, 535 F.3d at 678 (noting that because the limited time frame Congress gave the EPA for permit review “may not allow the EPA to fully investigate and analyze contested allegations, it is reasonable in this context for the EPA to refrain from extensive fact-finding”).

    Moreover, as discussed in more detail in Section III.D of this notice, the EPA has explained in previous title V orders the importance of the demonstration burden in determining whether or not to grant an objection in response to a petition. See, e.g., Nucor II Order at 4-7. The Act does not dictate all the information that must be included or the format in which that information should be presented; nor does it address what kind of showing must be made in order to demonstrate that an objection is warranted. Courts have determined that the term “demonstrates” in CAA section 505(b)(2) is ambiguous and have accordingly deferred to the EPA's reasonable interpretation of that term. See, e.g., MacClarence, 596 F.3d at 1131 (finding the EPA's expectation that a petition provide “references, legal analysis, or evidence” a reasonable interpretation of the term “demonstrates” under CAA section 505(b)(2)). The proposed changes are aimed in part at helping petitioners ensure that they are including information in their petitions that is necessary to satisfy the demonstration burden, under the EPA's interpretation.

    Furthermore, these proposed revisions to the part 70 rules related to mandatory petition content and format fall within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. Similar procedural requirements have been established for other EPA programs and processes, including the procedures for appeals filed with the Environmental Appeals Board (EAB). See 78 FR 5281 (2013) (adopting revisions to “codify current procedural practices, clarify existing review procedures, and simplify the permit review process”).

    4. Request for Comment

    Comments are requested on all aspects of these proposed revisions. The EPA is proposing changes to part 70 to include mandatory petition content and format to facilitate the efficient review of issues raised in petitions. The EPA requests comment on all aspects of the required petition content in the proposed 40 CFR 70.12, including the requirement to provide all key information, arguments, or analysis in the petition, rather than incorporating it by reference. The agency also requests comments on the proposed requirement that the petition format follow the same order as the proposed list of required content, as well as the proposed revision to the regulatory language in 40 CFR 70.8(d) that requires that copies of the petition be provided to the permitting authority and the applicant.

    The EPA is also requesting comment on whether or not page limits should be established for title V petitions, as a means of promoting concise petitions and to further facilitate efficient and expeditious review of petitions by the EPA. Procedural requirements specifying the maximum length of submissions have been instituted for processes such as the EAB appeal process, where petitions and response briefs may not exceed an identified word or page limit. See 40 CFR 12419(d)(3) (limiting petitions and response briefs to either 14,000 words or alternatively, a 30-page limit). Based on the EPA's assessment of petitions received to date, most claims could be written effectively and succinctly in one or two pages. However, we recognize that some claims are more complex and could benefit from more space for an effective demonstration. If page limits were established in the final rules, petitioners would need to include the mandatory required content (if finalized) while adhering to a specified page limit. We also request comments on the following questions: if a page limit is established, what would be an adequate number of pages, excluding attachments, for a complete but concise petition? Would a page limit in the range of 15-20 or 20-30 pages be reasonable excluding attachments? What would be an adequate number of pages for a complete but concise claim? When responding to these questions, the EPA requests that commenters provide a rationale or basis for their responses.

    D. Proposed Administrative Record Requirements 1. Proposed Revisions

    The EPA proposes to revise 40 CFR 70.7 to require a permitting authority to respond in writing to significant comments received during the public participation process for a draft permit. The agency is proposing a regulatory revision to 40 CFR 70.8 that would require a written response to all significant comments (RTC) and the statement of basis document to be included as part of the proposed permit record that is sent to the EPA for its review under CAA section 505(b)(1).14 Finally, the EPA proposes to revise 40 CFR 70.4(b), 70.7(h), and 70.8(a) to specifically identify the statement of basis document as a necessary part of the permit record throughout the permitting process. If no significant comments are received during the public comment period, the permitting authority should prepare and submit to EPA for its 45-day review a statement to that effect.

    14 While most permitting authorities prepare a separate RTC document, the response to significant comments may also be included within a statement of basis. Likewise, the statement of basis may be part of the title V permit, rather than a separate document. As long as there is clear indication that the RTC and statement of basis are provided along with the proposed permit, and where they can be found in the submission, the EPA will commence its 45-day review period.

    a. Response to Comments

    Under the existing 40 CFR 70.7(h)(5), a permitting authority is required to keep a record of the commenters and also of the issues raised during the public participation process so that the Administrator may fulfill the obligation under CAA section 505(b)(2) of the Act to determine whether a title V petition may be granted. This provision also requires that such records shall be available to the public. The EPA is proposing regulatory language to revise 40 CFR 70.7 to add a new requirement that a permitting authority respond in writing to significant comments from the public participation process for a draft title V permit.15 Significant comments in this context include, but are not limited to, comments that concern whether the title V permit includes terms and conditions addressing federal applicable requirements, including monitoring and related recordkeeping and reporting requirements. If no significant comments are received during the public comment period the permitting authority should prepare a statement to that effect.

    15 The EPA is aware that many permitting authorities elect to respond to all comments. While the EPA is proposing to require that permitting authorities must respond to all significant comments, the Agency's proposal is not intended to discourage permitting authorities from that practice.

    b. Statement of Basis

    The statement of basis document, which provides the legal and factual basis for the permit terms or conditions, is a necessary component for an effective permit review. Under the current regulations, permitting authorities are required to send this “statement of basis” to the EPA and “to any other person who requests it.” 40 CFR 70.7(a)(5). The EPA recently compiled best practices for developing and preparing statement of basis documents in the April 2014 guidance document, Implementation Guidance on Statement of Basis Requirements Under the Clean Air Act Title V Operating Permits Program. 16 In most situations, the permitting authority makes the statement of basis document available for the public comment period on the draft permit (at least 30 days long), for the EPA's 45-day review, and during the 60-day petition period.

    16 Memorandum from Stephen D. Page, Director, Office of Air Quality Planning and Standards, U.S. EPA, to Regional Air Division Directors, April 30, 2014. Available at: https://www.epa.gov/sites/production/files/2015-08/documents/20140430.pdf.

    To address any occasions where it may be absent during the permit issuance process, the EPA now proposes to add language to the part 70 regulations that would reaffirm its importance and require its inclusion at all points in the permit review process for every permit. To that end, we are proposing that 40 CFR 70.4(b), 70.7(h) and 70.8(a) would be revised to specifically identify the statement of basis document as a required document.

    c. Incorrect Reference

    The EPA proposes one additional change to 40 CFR 70.4(b) to amend an incorrect reference. Specifically, the language in 40 CFR 70.4(b)(3)(viii) currently reads: “[t]he contents of a part 70 permit shall not be entitled to protection under section 115(c) of the Act.” However, section 115(c) of the Act pertains to reciprocity related to statutory provisions addressing endangerment of public health or welfare in foreign countries from air pollution emitted in the United States.

    Therefore, the EPA proposes to revise the citation in 40 CFR 70.4(b)(3)(viii) to section 114(c) of the Act, which pertains to the availability of records, reports, and information to the public. This change ensures the regulations comport with the parallel provision in the section 503(e) of the CAA, which states that: “The contents of a permit shall not be entitled to protection under section 7414(c) of this title.”

    d. Commencement of EPA 45-Day Review Period

    The agency considers both the statement of basis and the written RTC to be integral components of the permit record. Having access to these documents during the agency's 45-day review period could improve the efficiency of the review, and also ensures that the agency has these critical parts of the record before it in reviewing a proposed permit under CAA section 505(b)(1). Further, it ensures that these documents are completed and available during the petition period under CAA section 505(b)(2). The EPA is proposing revisions to part 70 to require that any proposed permit that is transmitted to the agency must include both the statement of basis and written RTC among the necessary information as described in 40 CFR 70.8. The agency is proposing that the 45-day review period would not begin until all the supporting information listed in the proposed revisions to 40 CFR 70.8(a)(1)(i) has been received by the EPA. This includes the proposed permit, statement of basis, and the written RTC (or when no significant comments are received during the public comment period a statement to that effect). Finally, the EPA proposes to revise 40 CFR 70.7(h)(7) to require that within 30 days of sending the proposed permit to the EPA, that permitting authorities must provide notification that the proposed permit and the response to significant public comments are available to the public. Such notice must explain how these materials may be accessed.

    The EPA recognizes that some permitting authorities run the 30-day public comment period and 45-day EPA review period concurrently, as long as no significant comments are received. Under this proposal such a practice could continue, but if a significant public comment is received, the Administrator would no longer consider the submitted permit as a proposed permit. In such instances, the permitting authority must make any necessary revisions to the permit or permit record, and per the regulations proposed in this notice, resubmit the proposed permit to EPA with the RTC and statement of basis, and any other required supporting information, with any revisions that were made to address the public comments, to re-start the EPA's 45-day review period. This reflects the EPA's understanding of how such concurrent permitting programs currently operate.

    e. Notification to the Public

    Because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. To date, the agency has encouraged permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example by making that information available either online or in the publication in which public notice of the draft permit was given. At this time, the agency is considering and requests comment on the best method for the public to be made aware of the date that a proposed permit is received by the EPA, as well as the deadline to submit a petition on a particular proposed permit. The EPA proposes to post when a proposed permit is received and the corresponding 60-day deadline for submitting a petition on the EPA Regional Office Web sites.

    2. Why is the EPA proposing this change?

    Section 505(a)(1)(B) of the CAA requires in relevant part that permitting authorities transmit to the Administrator each proposed permit. The current regulations contain the same requirement in 40 CFR 70.8(a)(1). Failure to submit any information necessary for the adequate review of the proposed permit is grounds for an objection. See 40 CFR 70.8(c)(3)(ii). Part 70 also currently requires that the permitting authority provide a statement of basis that sets forth the legal and factual basis for the draft permit conditions (including references to the applicable statutory and regulatory provisions). See 40 CFR 70.7(a)(5).

    As a general matter, initial and renewed title V permits are developed by a permitting authority and then go through a public notice and comment period. The draft permit may undergo some revisions based on the public comment period and this updated version of the permit, referred to as the proposed permit, is sent to the EPA for a 45-day review period per CAA section 505(b)(1). Many permitting authorities already send a written RTC and a statement of basis along with the proposed permit for the EPA 45-day review. However, there are other permitting authorities that do not; instead this information may be provided by these permitting authorities at some point later in the permitting process. When these documents, and the RTC document in particular, are unavailable for the EPA review period, the EPA cannot provide a fully effective review. Moreover, when these documents are unavailable to the public following the EPA's review, potential petitioners may be missing necessary information to determine whether to submit a petition or to provide a full argument in support of any issues they may raise in a petition.

    Notably, the EPA's 45-day review period under the current rules begins when the EPA has received the proposed permit and “all necessary information” from the permitting authority. 40 CFR 70.8(c). With regard to the availability of necessary information for the agency's 45-day review of a proposed permit, the EPA stated in the proposal to the original title V regulations that the agency believes it can object to the issuance of permit where the materials submitted by the permitting authority do not provide enough information to allow a meaningful EPA review of whether the proposed permit is in compliance with requirements of the Act (including the SIP). If the agency was not able to object under these circumstances, the EPA's oversight rule could be severely hampered. 56 FR 21750 (1991). The EPA continues to interpret the Act in this way and provides part of the rationale for these proposed revisions to the regulations.

    In reviewing title V petitions, the EPA generally pays careful attention to the permitting authority's RTC. The EPA also explained the benefits of making the written RTC available during its 45-day review period in 2014 in the Hu Honua Order:

    [P]roviding the entire record for a Proposed Permit at the beginning of the EPA's 45-day review period serves to enhance the EPA's review of the Proposed Permit by providing a fuller understanding of the permitting history and the state's rationale for its permitting decisions. Where the entire record is available at the beginning of the 45-day review period, the EPA has the benefit of understanding the permitting history and the state's rationale for its permitting decisions. Likewise, where the entire record is available at the beginning of the public's 60-day window to submit petitions to the Administrator, the public has the benefit of understanding the permitting history and the state's rationale for its permitting decisions. Providing the entire record before the start of the public's 60-day petition period would allow the public to better assess any issues with the permit that they may have identified.

    See, In the Matter of Hu Honua Bioenergy Facility, Order on Petition No. IX-2001-1 (July 2, 2014) at 30.

    As noted in Section III.D.5 of this notice under general principles of administrative law, it is incumbent upon an administrative agency to respond to significant comments raised during the public comment period. See, e.g., Home Box Office v. FCC, 567 F.2d 9, 35 (D.C. Cir. 1977) (“the opportunity to comment is meaningless unless the agency responds to significant points raised by the public.”) It is to the benefit of the permitting authority to respond to significant comments, as it is an opportunity to further refine the permit record and/or articulate the authority's rationale. As the issues raised in a title V petition must generally be raised with reasonable specificity during the comment period, responding to comments gives the permitting authority a chance to address any issues that may become the basis for a petition. Generally speaking, in order to make the demonstration required under CAA 505(b)(2), a petitioner is expected to address the permitting authority's final decision and reasoning, including any response in the RTC. See MacClarence, 596 F.3d at 1132-33; see also, e.g., In the Matter of Noranda Alumina, LLC, Order on Petition No. VI-2011-04 (December 14, 2012) at 20-21 (denying title V petition issue where petitioners did not respond to state's explanation in response to comments or explain why the state erred or the permit was deficient); In the Matter of Kentucky Syngas, LLC, Order on Petition No. IV-2010-9 (June 22, 2012) at 41 (denying title V petition issue where petitioners did not acknowledge or reply to state's response to comments or provide a particularized rationale for why the state erred or the permit was deficient). However, if the state has not responded to the comment, there is nothing for the petitioner to address. If the written RTC is not available during the petition period, it may not be clear how the petitioner would be able to address the permitting authority's response in its petition. Similarly, if a permitting authority has not adequately articulated its rationale for a particular permitting action that rationale may not be evident to the EPA from the permit record and a petitioner may be able to easily demonstrate that the articulated rationale is inadequate to support the action. For these reasons, without the availability of the written RTC during the petition period, there may be an increased likelihood of granting a particular claim on the basis that the state provided an inadequate rationale or permit record.

    While many permitting authorities submit the RTC and statement of basis with a title V proposed permit, these proposed revisions, if finalized, would promote national consistency and the availability of the RTC document during the EPA 45-day review and the 60-day window in which a petition may be submitted on the proposed permit. This proposed requirement would allow a petitioner to better determine whether flaws in the permit, permit record, or public participation procedures raised during the public comment period had been adequately addressed. In turn, this would enhance a petitioner's confidence in its judgment whether a title V petition is warranted, because it would have the benefit of the permitting authority's rationale for permit terms and permit actions. Thus, it could facilitate resolution of issues earlier in the permitting process and may reduce the number of petitions or petition claims filed. Further, when properly implemented by permitting authorities, the agency anticipates that this proposed requirement would likely reduce the number of EPA determinations to grant a petition because a permitting authority's rationale is inadequate. The EPA is proposing this regulatory change to ensure that petitioners have the opportunity to address the permitting authority's response to comment in order to meet their demonstration burden. As such, these proposed revisions are supported by and would help implement the EPA's interpretation in this context of the ambiguous term “demonstrate” under CAA section 505(b)(2). See MacClarence, 596 F.3d at 1132-33 (finding the EPA's expectation that a petitioner challenge a permitting authority's final reasoning as reflected in the statement of basis of the permit a reasonable interpretation of the demonstration requirement).

    These proposed changes are responsive to recommendations from the CAAAC Title V Task Force Final Report. The 2006 report included a number of recommendations for implementation improvements, including specific recommendations regarding public notification and public participation in the title V process. The majority of Task Force members agreed that if a permitting authority receives comments on a draft permit, it is essential that the permitting authority prepare a written response to comments. See Title V Task Force Final Report Recommendation 1 at page 238. The majority of Task Force members also recommended that if a permitting authority received public comments (from anyone other than the permittee) during the public comment period, the RTC described in Recommendation 1 should be provided to the EPA for consideration during its 45-day review period. See Title V Task Force Final Report Recommendation 2 at 239.

    While the Act does not expressly require the submission of the RTC and statement of basis together with the proposed permit, it also does not preclude such a requirement or prescribe the specific materials that are needed to review a proposed permit. In light of the focus of CAA section 505(b)(2) on issues raised with reasonable specificity during the comment period, it is reasonable to interpret the Act to include a requirement that would allow the EPA and the public access to materials such as the RTC and statement of basis that would allow them to evaluate the issues raised with reasonable specificity during the comment period and the permitting authority's response.

    The agency believes these proposed revisions to the part 70 rules are within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA sections 505(b)(1) and 505(b)(2), as discussed in Section IV.A of this notice. If finalized, it would help the EPA more efficiently review both proposed permits and title V petitions.

    3. Request for Comment

    Comments are requested on all aspects of these proposed revisions. Comments are specifically requested on the proposed regulatory language requiring the preparation of a written RTC. Additionally, the EPA requests comment on all aspects of the proposal to require both the written RTC and statement of basis be included in the record that is sent with the proposed title V permit for the EPA's 45-day review. The EPA is expressly taking comment on the best method(s) for proposed permits to be made available so that the public is aware when a proposed permit is received by the EPA for its 45-day review. States are also encouraged to provide information on whether any changes to state rules and programs would be necessary if this proposed revision to part 70 were finalized. The EPA is also expressly taking comment on the practices of permitting authorities that conduct concurrent review and is particularly interested in what processes or steps should be followed to allow for concurrent review, even if the permitting authority is not aware of whether or not it will receive comment on the title V permit when that permit is initially submitted to EPA. Finally, the EPA solicits comments on the proposed regulatory language in 40 CFR 70.4, 70.7, and 70.8 requiring the statement of basis is necessary or appropriate to ensure the document is available at all stages of the permit issuance process, or whether including it in fewer provisions would be adequate (and if so, which ones).

    V. Pre- and Post-Petition Process Information/Guidance

    In this section of the notice, the EPA is providing information on certain steps in the title V petition process, namely the permit issuance process that occurs before a petition is submitted, and the post-petition process, which occurs after the EPA grants an objection on at least one issue in a petition. The EPA anticipates this information will help stakeholders gain a better understanding of the role a petition might play in the development of a permit that assures compliance with applicable requirements under the CAA and part 70. Most of what follows has been addressed publicly in various formats, but the EPA believes that repeating this information here for the public's convenience will provide stakeholders with a comprehensive look at the petition opportunity in CAA section 505(b)(2) and 40 CFR 70.

    A. Recommended Practices for Complete Permit Records 1. Recommended Practices for Permitting Authorities

    The proposed changes in Section IV.D of this notice are intended to increase the effectiveness of the EPA 45-day review as well as ensure that the full permit record is before petitioners during the 60-day petition period. Making these documents available also provides an opportunity for a permitting authority to ensure that they have fully responded to comments when preparing the proposed permit. Permitting authorities have at least three opportunities to provide the permit record and ensure that it comports with the CAA: the draft, proposed, and final permit.

    While the EPA is not requiring the following actions, the agency is recommending practices for permitting authorities when preparing title V permits. In the agency's experience, these practices can minimize the likelihood that a petition will be submitted on a title V permit. Many involve taking action at an appropriate time to ensure that the permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In addition, many focus on consulting with the appropriate EPA Regional Office early when preparing and issuing permits. These “recommended practices” include:

    ○ Consulting with the appropriate EPA Regional Office as needed on key aspects of the permit before the draft permit stage, especially if the permit is expected to be highly visible or contested.

    ○ On a case-by-case basis, considering whether a particular draft permit warrants outreach to the community.

    ○ On a case-by-case basis, considering whether it is appropriate to provide for a public participation opportunity on a revised draft permit.

    ○ Fully addressing significant comments on draft permits and ensuring the permit or permit record includes adequate rationale for the decisions made. For example, permitting authorities should provide sufficient rationale for selected monitoring to assure compliance. The EPA's objections based on an inadequate record most often occur when the EPA finds that a permitting authority did not sufficiently explain why the monitoring was sufficient to assure compliance with a particular limit.

    ○ Consulting with the appropriate EPA Regional Office as needed to resolve issues related to comments on draft permits and incorporating those resolutions into the proposed permits.

    ○ Consulting with the appropriate EPA Regional Offices as needed to resolve issues related to the EPA objections or comments on proposed permits and incorporating those resolutions into the final permits.

    ○ For petitions on which the EPA grants an objection on a claim because the record is inadequate, revising the record and permit as necessary and in a timely manner to resolve the objection.

    ○ Reviewing permits that are the subject of a petition and revising or reopening for cause to address any issues raised by the petition that have not been resolved.

    ○ Posting the proposed permit and RTC online where possible.

    2. Recommended Practices for Permit Applicants

    The EPA is providing the following recommended practices for a source to consider to help ensure that its permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In some cases, this may minimize the likelihood that a petition will be submitted on its title V permit. These “recommended practices” include:

    ○ Submitting permit applications that include all information required under the approved title V permit program.

    ○ Consulting with the permitting authority when any discrepancy or inaccuracy is identified in the permit, at any stage of the permitting process.

    ○ Promptly providing any updates to the permit application to the permitting authority.

    ○ If public comments identify an issue in the draft permit, contacting the permitting authority to make revisions to address the concern before the permit is proposed to the EPA.

    ○ Timely responding to inquiries from the permitting authority at each stage in the permitting process, including the draft, proposed, and final stages.

    B. Post-Petition Process

    The following discussion provides information about the activities that occur, or may occur, after the EPA responds to a title V petition. Various stakeholders have indicated there can be confusion around the appropriate steps following an EPA petition order, particularly when the Administrator granted the petition in whole or in part. The summary below describes EPA's interpretation of key provisions of the CAA and implementing regulations. This interpretation has already been shared publicly in title V orders responding to petitions. See, e.g., In the Matter of Public Service of New Hampshire Schiller Station, Order on Petition Number VI-2014-04 (July 28, 2015) at 4; In the Matter of Meraux Refinery, Order on Petition Number VI-2012-04 (May 29, 2015) at 7-10. In the interest of providing additional transparency and clarity for the title V petition process, and for the public's convenience, the EPA repeats that interpretation in the following paragraphs.

    When the EPA objects to a proposed permit under CAA section 505(b), section 505(b)(3) instructs that a permitting authority “may not issue the permit unless it is revised and issued” in accordance with section 505(c) of the Act. If the permit has already been issued by the permitting authority before it receives the objection, then the EPA “shall modify, terminate, or revoke” the permit, and the permitting authority may then only issue a revised permit in accordance with section 505(c) of the Act.

    Under CAA section 505(c), if the permitting authority fails to submit a permit revised to meet the Administrator's objection within 90 days after the objection, the Administrator must issue or deny the permit in accordance with the requirements under title V. Section 505(c) further provides that no objection is subject to judicial review until the Administrator takes final action to issue or deny the permit.

    Neither CAA section 505(b)(3) nor section 505(c) provide express direction as to the specific procedures and steps the EPA must use to “modify, terminate, or revoke” or “issue or deny” the permit, though section 505(c) points generally to the requirements under title V. Although the Act is ambiguous, the implementing regulations shed some light on the process. Those regulations provide a state with 90 days to resolve the EPA's objection and terminate, modify, or revoke and reissue the permit, before the EPA would need to begin to act on the permit. 40 CFR 70.8(d), 70.7(g)(4)-(5); see also 40 CFR 71.4(e) (the EPA will take permitting action under part 71, when, among other things, a state fails to respond to the EPA's objection). A permitting authority may address an EPA objection by, among other things, providing the EPA with a revised permit. See, e.g., 40 CFR 70.7(g)(4). In some cases, the permitting authority's response to an EPA objection may not involve a revision to the permit terms and conditions themselves, but may instead involve revisions to the permit record. As an example, a permitting authority might opt to include additional rationale and detail to support its decision in response to the EPA's objection if such objection was based on the grounds that the permit record does not adequately support the permitting authority's decision. Whether the permitting authority submits revised permit terms, a revised permit record, or other revisions to the permit, the permitting authority's response is generally treated as a new proposed permit.17

    17 When the permitting authority decides to modify a permit in order to resolve an EPA objection, it must go through the appropriate procedures for that modification. For example, when the permitting authority's response to an objection is a change to the permit terms or conditions or a revision to the permit record, the permitting authority should determine whether its response is a minor modification or a significant modification to the title V permit, as described in 40 CFR 70.7(e)(2) and (4) or the corresponding regulations in the state's EPA-approved title V program. If the permitting authority determines that the modification is a significant modification, then the permitting authority must provide for notice and opportunity for public comment for the significant modification consistent with 40 CFR 70.7(h). In other words, EPA's view that the state's response to an EPA objection is a generally treated as a new proposed permit does not alter the procedures for making the changes to the permit terms or condition or permit record that are intended to resolve EPA's objection.

    As described in previous title V orders, such as the 2013 Nucor II Order, the EPA has generally treated the permitting authority response as a new proposed permit which is subject to the agency's opportunity to conduct a 45-day review per CAA 505(b)(1) and 40 CFR 70.8(c), and an opportunity for a petition if the EPA does not object. As stated in the Nucor II Order:

    [T]he EPA viewed the revised permit as providing the EPA an opportunity to object to the permit under CAA section 505(b)(l) and 40 CFR 70.8(c), and, when the EPA did not object, an opportunity for a citizen to petition the EPA to object under CAA section 505(b)(2) and 40 CFR 70.8(d). The EPA has also treated state responses to EPA objections that revised the permit record to provide further support for its decision as constituting new proposed permits subject to review by the EPA under CAA section 505(b)(1) and 40 CFR 70.8(c), and, absent an EPA objection, citizen petition under CAA section 505(b)(2) and 40 CFR 70.8(d). See, e.g., In the Matter of KerrMcGee/Anadarko Petroleum Corp., Frederick Compressor Station, Order on Petition VIII-2008-02, at 2-3 (Oct. 8, 2009); In the Matter of Anadarko Petroleum Corp., Frederick Compressor Station, Order on Petition VIII-2010-4, at 4-5 (Feb. 2, 2011). A permitting authority's rationale for its permit terms is a fundamental component of its permit decision. Accordingly, the EPA has viewed a state response to an EPA objection that buttresses its basis for its permit decision as a new proposed permit for purposes of CAA section 505(b) and 40 CFR 70.8(c) and (d).

    Nucor II Order at 14.

    The EPA's interpretation that a state's response to an EPA objection generally triggers a new EPA review and petition opportunity is consistent with, and a reasonable interpretation of, the statutory and regulatory process for addressing objections by the EPA, as explained previously. Accordingly, at the end of the 45-day review period, if the EPA does not object, there is a 60-day window in which there is an opportunity for a second petition. If a second petition is received, the EPA must respond to the petition within 60 days under CAA section 505(b)(2).

    VI. Implementation

    Costs associated with this proposed rule are expected to be minimal. Much of the focus in this proposal is to codify the established practice that has been publicly discussed and evolved over time. If finalized, the revisions should impose no costs on petitioners, and may reduce confusion over and the time necessary for preparing a title V petition. The agency anticipates that a small number of permitting authorities may need to amend their rules regarding permit issuance to require responses to significant comments and the submittal of those responses with the proposed permit that is sent to the EPA for review.

    The existing part 70 regulations provide for state program revisions if part 70 is revised and the EPA determines such conforming changes are necessary. 40 CFR 70.4(a) and 70.4(i). The EPA is soliciting comment as to whether revisions to any approved state programs would be necessary if the revisions to part 70 regulations proposed in this notice are finalized. States are expressly encouraged to provide information on any changes to state rules and programs that may be necessary if the proposed revisions to 40 CFR 70.7(h) and 70.8 are finalized to require permitting authorities to respond in writing to all significant comments raised during the public participation process and to provide that response to the EPA for the agency's 45-day review period.

    VII. Proposed Determination of Nationwide Scope and Effect

    Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of nationally applicable regulations promulgated, or final actions taken, by the Administrator; or (ii) when such action is locally or regionally applicable, if the action is determined to be of nationwide scope or effect and the Administrator publishes such a determination. The EPA proposes to find and publish that this rule is based on a determination of nationwide scope and effect. This proposed rule concerns revisions to the EPA's regulations in part 70 for operating permit programs, and these regulations apply to permitting programs across the country. Accordingly, we propose to determine that this is a rulemaking of nationwide scope or effect such that any petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit.

    VIII. Environmental Justice Considerations

    This action proposes certain revisions to part 70 regulations to improve the title V petition submittal, review and response processes. The proposed revisions and guidance provided in this rule should increase the transparency and clarity of the petition process for all stakeholders. First, the establishment of centralized petition submittal is expected to reduce or eliminate confusion over where to submit a petition. When using the preferred method of an electronic petition submittal through the agency's electronic submittal system, a petitioner will also have immediate assurance that the petition and any attachments were received. However, alternative submittal methods are still available options for members of the public that experience technical difficulties when trying to submit a petition or for those that do not have access to electronic submittal mechanisms. Second, the proposed required content and format provides instruction and clarity on what must be included in a petition. This change is anticipated to assist petitioners in providing all the critical information in their petitions in an effective manner, which may increase the agency's efficiency in responding to petitions. Third, the proposed regulatory changes would require permitting authorities to respond to public comments in a written document that is provided to the EPA for the agency's 45-day review and is available during the 60-day opportunity to file a title V petition, which will provide increased availability of information regarding permits for the public in general and petitioners specifically. Further, this change may provide more timely notification of pertinent steps and documents in the permit issuance process. Fourth, the recommended practices for permitting authorities and sources, if followed, may improve the quality of public participation and the operating permits being issued. Finally, the description of the post-petition process is anticipated to reduce confusion regarding the appropriate steps when the EPA grants a petition for an objection on a particular issue. This proposed action does not compel any specific changes to the requirements to provide opportunities for public participation in permitting nor does it finalize any particular permit action that may affect the fair treatment and meaningful involvement of all people. Further, this proposed action is responsive to some of the feedback received during the Environmental Justice in Permitting workshops the agency provided in the North Birmingham area on September 15 and 16, 2014 and other such meetings held in EPA's Region 4.

    In preparation for this proposal, the agency participated in community calls where the EPA presented a brief overview and announcement of the rulemaking effort. The EPA provided additional details about a planned webinar that will describe the title V petition process, the content of this proposal, and when and how to submit comments.

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

    B. Paperwork Reduction Act (PRA)

    This action would not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0243 for the title V part 70 program. To the extent that a SIP revision or a title V program revision is necessary to effect the changes being proposed, we believe that the burden is already accounted for under the approved information collection requests noted earlier.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This proposed action would not impose any requirements directly on small entities. Entities potentially affected directly by this proposal include anyone that chooses to submit a title V petition on a proposed title V permit prepared by an EPA-approved state, local or tribal title V permitting authority. Other entities directly affected may include state, local, and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this action.

    D. Unfunded Mandates Reform Act (UMRA)

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

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct 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.

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

    This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. The Southern Ute Indian Tribe has an EPA-approved operating permit program under 40 CFR part 70 and could be impacted. The EPA conducted outreach to the tribes through a call with the National Tribal Air Association. Further, the agency plans to offer consultation to all tribal governments, and will specifically offer to consult with the Southern Ute Indian tribe. The EPA solicits comment from affected tribal governments on the implications of this proposed rulemaking.

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

    The EPA interprets Executive Order 13045 as applying 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 proposed action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

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

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

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    The EPA believes the human health and environmental risk addressed by this proposed action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained in Section VIII of this notice titled, “Environmental Justice Considerations.”

    K. Determination Under Section 307(d)

    Section 307(d)(1)(V) of the CAA provides that the provisions of CAA section 307(d) apply to “such other actions as the administrator may determine.” Pursuant to CAA section 307(d)(1)(V), the Administrator determines that this proposed action is subject to the provisions of CAA section 307(d).

    VIII. Statutory Authority

    The statutory authority for this proposed action is provided by 42 U.S.C. 7401 et seq.

    List of Subjects in 40 CFR Part 70

    Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.

    Dated: August 15, 2016. Gina McCarthy, Administrator.

    For the reasons stated in the preamble, title 40, Chapter I of the Code of Federal Regulations is proposed to be amended as set forth below.

    PART 70—STATE OPERATING PERMIT PROGRAMS 1. The authority citation for the part 70 continues to read as follows: Authority:

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

    2. Section 70.4 is amended by revising paragraph (b)(3)(viii) to reads as follows:
    § 70.4 State program submittals and transition.

    (b) * * *

    (3) * * *

    (viii) Make available to the public any permit application, statement of basis, compliance plan, permit, and monitoring and compliance certification report pursuant to section 503(e) of the Act, except for information entitled to confidential treatment pursuant to section 114(c) of the Act. The contents of a part 70 permit itself shall not be entitled to protection under section 114(c) of the Act.

    3. Section 70.7 is amended by: a. Revising paragraphs (h)(2) and (5); and b. Adding paragraphs (h)(6) and (7).

    The revisions and additions read as follows:

    § 70.7 Permit issuance, renewal, reopenings, and revisions.

    (h) * * *

    (2) The notice shall identify the affected facility; the name and address of the permittee; the name and address of the permitting authority processing the permit; the activity or activities involved in the permit action; the emissions change involved in any permit modification; the name, address, and telephone number of a person from whom interested persons may obtain additional information, including copies of the draft permit, statement of basis for the draft permit, the application, all relevant supporting materials, including those set forth in § 70.4(b)(3)(viii), and all other materials available to the permitting authority that are relevant to the permit decision; a brief description of the comment procedures required by this part; and the time and place of any hearing that may be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled);

    (5) The permitting authority shall keep a record of the commenters and of the issues raised during the public participation process, as well as records of the written comments submitted during that process, so that the Administrator may fulfill his obligation under section 505(b)(2) of the Act to determine whether a citizen petition may be granted, and such records shall be available to the public.

    (6) The permitting authority shall respond in writing to all significant comments raised during the public participation process, including any such written comments submitted during the public comment period and any such comments raised during any public hearing on the permit. If no significant comments are raised during the public participation process, the permitting authority shall prepare a written statement to that effect.

    (7) The permitting authority shall give notice within 30 days of transmitting the proposed permit to the Administrator, consistent with the procedures under paragraph (h)(1) of this section, that the proposed permit in accordance with § 70.8(a)(1) and responses to public comments in accordance with paragraph (h)(6) of this section have been transmitted to the EPA, the date of the transmission, and that these documents are available to the public. Such notice shall explain how the public may access the proposed permit and responses to comments. When possible, such notice shall include notification in the same manner used to announce the availability of the draft permit for public comment.

    4. Section 70.8 is amended by revising paragraphs (a)(1), (c)(1) and (d) to read as follows:
    § 70.8 Permit review by EPA and affected States.

    (a) Transmission of information to the Administrator. (1) (i) The permit program shall require that the permitting authority provide to the Administrator a copy of each permit application (including any application for significant or minor permit modification), the statement of basis for each proposed permit and for each final permit, each proposed permit, each final permit, the written response to comments (which shall include a written response to all significant comments raised during the public participation process on the draft permit and recorded under § 70.7(h)(5), or if no significant comments are received, a statement to that effect), and an explanation of how those public comments and the permitting authority's responses are available to the public. The applicant may be required by the permitting authority to provide a copy of the permit application (including the compliance plan) directly to the Administrator. Upon agreement with the Administrator, the permitting authority may submit to the Administrator a permit application summary form and any relevant portion of the permit application and compliance plan, in place of the complete permit application and compliance plan. To the extent practicable, the preceding information shall be provided in computer-readable format compatible with EPA's national database management system. The Administrator's 45-day review period for this proposed permit will not begin until the proposed permit and all necessary supporting material required under this paragraph have been received by the EPA.

    (ii) In instances where the Administrator has received a proposed permit from a permitting authority before the public participation process on the draft permit has been completed, and the permitting authority receives a significant comment on the draft permit after the submission of the proposed permit to the Administrator, the Administrator will no longer consider the submitted proposed permit as a permit proposed to be issued under section 505 of the Act. In such instances, the permitting authority must make any revisions to the permit or permit record necessary to address the public comments, including preparation or revision of the response to comment document, and must re-submit the proposed permit and all necessary supporting material required in paragraph (a)(1)(i) of this section to the Administrator after the public comment period has closed. The Administrator's 45-day review period for this proposed permit will not begin until the proposed permit and all necessary supporting material required under paragraph (a)(1)(i) of this section have been received by the EPA.

    (c) * * *

    (1) The Administrator will object to the issuance of any proposed permit determined by the Administrator not to be in compliance with applicable requirements or requirements under this part. No permit for which an application must be transmitted to the Administrator under paragraph (a) of this section shall be issued if the Administrator objects to its issuance in writing within 45 days of receipt of the proposed permit and all necessary supporting information required under paragraph (a)(1) of this section.

    (d) Public petitions to the Administrator. The program shall provide that, if the Administrator does not object in writing under paragraph (c) of this section, any person may petition the Administrator within 60 days after the expiration of the Administrator's 45-day review period to make such objection. The petitioner shall provide a copy of such petition to the permitting authority and the applicant. Any such petition shall be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided for in § 70.7(h), unless the petitioner demonstrates that it was impracticable to raise such objections within such period, or unless the grounds for such objection arose after such period. If the Administrator objects to the permit as a result of a petition filed under this paragraph, the permitting authority shall not issue the permit until EPA's objection has been resolved, except that a petition for review does not stay the effectiveness of a permit or its requirements if the permit was issued after the end of the 45-day review period and prior to an EPA objection. If the permitting authority has issued a permit prior to receipt of an EPA objection under this paragraph, the Administrator will modify, terminate, or revoke such permit, and shall do so consistent with the procedures in § 70.7(g) (4) or (5) (i) and (ii) except in unusual circumstances, and the permitting authority may thereafter issue only a revised permit that satisfies EPA's objection. In any case, the source will not be in violation of the requirement to have submitted a timely and complete application.

    5. Section 70.12 is added to read as follows:
    § 70.12 Public Petition Requirements.

    Standard petition requirements. Each public petition sent to the Administrator under 70.8(d) of this part shall include the following elements in the following order:

    (a) Identification of the proposed permit on which the petition is based. The petition shall provide the permit number, version number, or any other information by which the permit can be readily identified. The petition shall specify whether the permit action is an initial permit, a permit renewal, or a permit modification/revision, including minor modifications/revisions.

    (b) Sufficient information to show that the petition was timely filed.

    (c) Identification of Petition Claims. Any issue raised in the petition as grounds for an objection shall be based on a claim that the permit, permit record, or permit process is not in compliance with applicable requirements or requirements under this part. All pertinent information in support of each issue raised as a petition claim shall be contained within the body of the petition. In determining whether to object, the Administrator will not consider arguments, assertions, claims, or other information incorporated into the petition by reference. For each claim raised, the petition shall identify the following:

    (1) The specific grounds for an objection, citing to a specific permit term or condition where applicable.

    (2) The applicable requirement as defined in § 70.2, or requirement under part 70, that is not met.

    (3) An explanation of how the term or condition in the permit, or relevant portion of the permit record or permit process, is not adequate to comply with the corresponding applicable requirement or requirement under part 70.

    (4) If the petition claims that the permitting authority did not provide for a public participation procedure required under § 70.7(h), the petition must identify specifically the required public participation procedure that was not provided.

    (5) Identification of where the issue was raised with reasonable specificity during the public comment period provided for in § 70.7(h), citing to any relevant page numbers in the public comment submitted to the permitting authority and attaching this public comment to the petition. If the grounds for the objection were not raised with reasonable specificity during the public comment period, the petitioner must demonstrate that such grounds arose after that period, or that it was impracticable to raise such objections within that period, as required under § 70.8(d).

    (6) Unless the grounds for the objection arose after the public comment period or it was impracticable to raise the objection within that period such that the exception under § 70.8(d) applies, the petition must identify where the permitting authority responded to the public comment, including page number(s) in the publicly available written response to comment, and explain how the permitting authority's response to the comment is inadequate to address the issue raised in the public comment. If the response to comment document does not address the public comment at all, the petition shall state that.

    6. Section 70.13 is added to read as follows:
    § 70.13 Documents that May be Considered in Reviewing Petitions.

    The information that the Administrator considers in making a determination whether to grant or deny a petition submitted under § 70.8(d) on a proposed permit generally includes, but is not limited to, the Administrative Record for the proposed permit and the petition, including attachments to the Petition. For purposes of this paragraph, the Administrative Record for a particular proposed permit includes the draft and proposed permits; any permit applications that relate to the draft or proposed permits; the statement of bases for the draft and proposed permits; the permitting authority's written responses to comments, including responses to all significant comments raised during the public participation process on the draft permit; relevant supporting materials made available to the public according to § 70.7(h)(2); and all other materials available to the permitting authority that are relevant to the permitting decision and that the permitting authority made available to the public according to § 70.7(h)(2). If a final permit and a statement of basis for the final permit are available during the agency's review of a petition on a proposed permit, those documents may also be considered as part of making a determination whether to grant or deny the petition.

    7. Section 70.14 is added to read as follows:
    § 70.14 Submission of Petitions.

    Any petition to the Administrator shall be submitted through the Operating Permits Group in the Air Quality Policy Division in the Office of Air Quality Planning and Standards, using one of the three following methods identified at the Title V Petitions Web site: An electronic submission through the EPA's designated submission system (the agency's preferred method); an electronic submission through the EPA's designated email address listed on that Web site; or a paper submission to the EPA's designated physical address listed on that Web site. Any necessary attachments shall be submitted together with the petition, using the same method as for the petition. Once a petition has been successfully submitted using one of these three methods, the petitioner should not submit additional copies of the petition using another method. The Administrator is not obligated to consider petitions submitted to the agency using any method other than the three identified in this paragraph.

    [FR Doc. 2016-20029 Filed 8-23-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2016-0491; FRL-9951-06] RIN 2070-AB27 Significant New Use Rule on Certain Chemical Substances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of premanufacture notices (PMNs). This action would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.

    DATES:

    Comments must be received on or before September 23, 2016.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0491, by one of the following methods:

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

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

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

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]

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

    SUPPLEMENTARY INFORMATION:

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

    You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    Manufacturers (including importers) or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

    This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 23, 2016 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

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

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Background A. What action is the agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for two chemical substances which were the subject of PMNs P-14-321 and P-14-323. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

    B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.

    C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.

    III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

    • The projected volume of manufacturing and processing of a chemical substance.

    • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

    • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

    • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

    In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

    To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

    IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements for two chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

    • PMN number.

    • Chemical name (generic name, if the specific name is claimed as CBI).

    • Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities).

    • Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).

    • CFR citation assigned in the regulatory text section of this proposed rule.

    The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI.

    PMN Number P-14-321 and P-14-323

    Chemical name: Hydrochlorofluoropropane and Hydrochlorofluoropropene (generic).

    CAS number: Claimed confidential.

    Effective date of TSCA section 5(e) consent order: August 12, 2016.

    Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substances will be as site-limited, isolated and recycled intermediates. Based on test data on the PMN substances, EPA identified concerns for acute toxicity including lethality to animals. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires:

    1. Submission of certain toxicity testing on the PMN substances prior to exceeding the time trigger specified in the consent order of the PMN substances.

    2. Use of impervious gloves and protective clothing where dermal exposure is reasonably likely for workers.

    3. Use of respirators with an APF of 1000, in conjunction with a minimum set of engineering controls to prevent inhalation exposure for workers, or, as an alternative to using respirators, maintain workplace airborne concentrations of the PMN substances at or below a specified New Chemical Exposure Limit (NCEL) of 130 parts per million (ppm) for P-14-321 and 33 parts per billion (ppb) for P-14-323 as an 8-hour time-weighted average, where inhalation exposure is reasonably likely for workers.

    4. Use of engineering controls to limit worker exposure and air release of the PMN substances to the environment.

    5. Label containers of the PMN substances and provide Safety Data Sheets and worker training.

    6. Manufacture, process and use the PMN substances only in an enclosed process.

    7. Use of the PMN substances only as chemical intermediates.

    8. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States that result in surface water concentrations exceeding 8 ppb.

    9. Prohibition on the distribution of the PMN substances.

    The SNUR designates as a “significant new use” the absence of these protective measures.

    Recommended testing: EPA has determined that the results of a subacute inhalation toxicity: 28-day study (OECD Test Guideline 412) in three species: Mouse, rat, and rabbit (6 studies total) and a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422) would help characterize the human health effects of the PMN substances. The submitter has agreed to complete this testing by the production limits identified in the consent order.

    V. Rationale and Objectives of the Proposed Rule A. Rationale

    During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to §  721.160 (see Unit VI.).

    B. Objectives

    EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule:

    • EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

    • EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

    • EPA would be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

    Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at https://www.epa.gov/tsca-inventory.

    VI. Applicability of the Proposed Rule to Uses Occurring Before the Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

    When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of the two chemical substances subject to this proposed rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

    Therefore, EPA designates August 15, 2016 (the date of public release/web posting of this proposal) as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of Federal Register publication as the date for making this determination. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule. In developing this proposal, EPA has recognized that, given EPA's practice of now posting proposed rules on its Web site a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. Thus, EPA has slightly modified its approach in this rulemaking and plans to follow this modified approach in future significant new use rulemakings.

    Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of August 15, 2016 would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.

    VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing new information (e.g., generating test data) before submission of a SNUN. There is an exception:

    1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule, order, or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

    2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

    In the absence of a test rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Guidelines for Pesticides and Toxic Substances.”

    The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN that does not itself include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.

    SNUN submitters should be aware that EPA will be better able to evaluate SNUNs and define the terms of any potentially necessary controls if the submitter provides detailed information on:

    • Human exposure and environmental release that may result from the significant new use of the chemical substances.

    • Potential benefits of the chemical substances.

    • Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

    VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what information may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

    IX. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket.

    The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.

    X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule, during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0491.

    XI. Statutory and Executive Order Reviews A. Executive Order 12866

    This proposed rule would establish SNURs for two chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

    B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

    The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule would not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

    Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

    C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

    1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

    A copy of that certification is available in the docket for this proposed rule.

    This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

    • A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

    • Submission of the SNUN would not cost any small entity significantly more than $8,300.

    Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

    D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

    E. Executive Order 13132

    This proposed rule would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

    F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this proposed rule.

    G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this proposed rule does not address environmental health or safety risks disproportionately affecting children.

    H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this proposed rule.

    J. Executive Order 12898

    This proposed rule does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: August 15, 2016. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as follows:

    PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES 1. The authority citation for part 721 continues to read as follows: Authority:

    15 U.S.C. 2604, 2607, and 2625(c).

    2. Add §  721.10926 to subpart E to read as follows:
    §  721.10926 Hydrochlorofluoropropane and Hydrochlorofluoropropene (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as hydrochlorofluoropropane and hydrochlorofluoropropene (generic) (PMNs P-14-321 and P-14-323) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

    (2) The significant new uses are:

    (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), and (c). When determining which persons are reasonably likely to be exposed as required for §  721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an Assigned Protection Factor (APF) of at least 1000 meet the requirements of §  721.63(a)(4):

    (A) Any NIOSH-certified powered air purifying full facepiece respirator equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges.

    (B) Any NIOSH-certified powered air-purifying respirator equipped with a hood or helmet and appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges with evidence demonstrating protection level of 1,000 or greater. (Note: OSHA has assigned APFs of 1000 for certain types of hoods and helmets with powered air purifying respirators (PAPRs) or supplied air respirators (SARs) where the manufacturer can demonstrate adequate air flows to maintain positive pressure inside the hood or helmet in normal working conditions. However, the employer must have evidence provided by the respirator manufacturer that the testing of these respirators demonstrates performance at a level of protection of 1,000 or greater to receive an APF of 1,000. This level of performance can best be demonstrated by performing a Workplace Protection Factor (WPF) or Simulated Workplace Protection Factor (SWPF) study or equivalent testing. Without testing data that demonstrates a level of protection of 1,000 or greater, all PAPRs and SARs with helmets/hoods are to be treated as loose-fitting facepiece respirators, and receive an APF of 25.)

    (C) Any NIOSH-certified continuous flow supplied-air respirator equipped with a full facepiece.

    (D) Any NIOSH-certified continuous flow supplied-air respirator equipped with a hood or helmet with evidence demonstrating protection level of 1,000 or greater. (See Note under (II), above)

    (E) Any NIOSH-certified pressure-demand or other positive pressure mode supplied-air respirator equipped with a full facepiece.

    (1) As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 130 parts per million for P-14-321 and 33 parts per billion for P-14-323 as an 8-hour time weighted average (TWA) verified by actual monitoring data.

    (ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(fatal if inhaled), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(2)(do not release to water).

    (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(a) and (g). It is a significant new use to manufacture, process, or use the PMN substances without the engineering controls described in the consent order to prevent worker and environmental exposures. It is a significant new use to manufacture the PMN substances for more than one year.

    (iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=8).

    (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

    (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are applicable to manufacturers and processors of this substance.

    (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

    [FR Doc. 2016-20310 Filed 8-23-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [CG Docket Nos. 10-51 and 03-123; DA 16-893] Structure and Practices of the Video Relay Service Program AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Consumer and Governmental Affairs Bureau (CGB or Bureau) of the Federal Communications Commission (FCC or Commission), pursuant to a delegation of authority, proposes to incorporate into the Commission's rules the Video Relay Service (VRS) interoperability and portability standards developed by the VRS Task Group of the Session Initiation Protocol (SIP) Forum and a successor group, the Relay User Equipment (RUE) Forum.

    DATES:

    Comments are due on or before September 14, 2016.

    ADDRESSES:

    You may submit comments, identified by CG Docket Nos. 10-51 and 03-123, by any of the following methods:

    Electronic Filers: Comments may be filed electronically using the Internet by accessing the Commission's Electronic Comment Filing System (ECFS): http://apps.fcc.gov/ecfs//. Filers should follow the instructions provided on the Commission's Web site for submitting comments. For ECFS filers, in completing the transmittal screens, filers should include their full name, U.S. Postal Service mailing address, and CG Docket Nos. 10-51 and 03-123.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.
    FOR FURTHER INFORMATION CONTACT:

    Eliot Greenwald, Consumer and Governmental Affairs Bureau, at phone: (202) 418-2235 or email: [email protected], or Robert Aldrich, Consumer and Governmental Affairs Bureau, at phone (202) 418-0996 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Further Notice of Proposed Rulemaking (Further Notice), document DA 16-893, adopted on August 4, 2016, and released on August 4, 2016. The full text of this document is available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document can also be downloaded in Word or Portable Document Format (PDF) at: https://www.fcc.gov/general/disability-rights-office-headlines. The proceeding initiated by the Further Notice shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with 47 CFR 1.1206(b). In proceedings governed by 47 CFR 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (844) 432-2275 (videophone), or (202) 418-0432 (TTY).

    Initial Paperwork Reduction Act of 1995 Analysis

    The Further Notice does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    Synopsis

    1. In 2013, the Commission amended its rules to improve the effectiveness of its interoperability and portability rules for video relay service (VRS), in order to improve functional equivalence and VRS availability for consumers, ease of compliance by providers, and overall efficiency in the operation of the telecommunications (TRS) program. The Commission directed Commission staff to support and participate in the ongoing Session Initiation Protocol (SIP) Forum's VRS Task Group process in order to ensure the timely development of such consensus standards. Structure and Practices of the Video Relay Service Program; Telecommunications Relay Services and Speech-to-Speech Services for Individuals With Hearing and Speech Disabilities, published at 78 FR 40582, July 5, 2013 (VRS Reform Order).

    2. The Further Notice, issued by CGB pursuant to a delegation of authority in the VRS Reform Order, proposes to incorporate by reference into the Commission's VRS interoperability rule the interoperability and portability standards produced by the VRS Task Group of the SIP Forum and a successor group, the Relay User Equipment (RUE) Forum, along with a process that will readily enable revisions to this rule to reflect future amendments or changes in these standards. In addition, this document proposes guidance on implementation of the standards, including the need for a transition period for existing VRS access technologies to achieve interoperability and portability.

    3. Since 2006, the Commission has required VRS providers to (i) allow VRS users to make and receive calls through any VRS provider, and to choose a different default provider, without changing the VRS access technology they use to place calls, and (ii) ensure that VRS users can make point-to-point calls to all other VRS users, irrespective of the default provider of the calling and called party. Providers also must ensure that videophone equipment that they distribute retains certain features when a user ports his or her ten-digit VRS number to a new default provider. 47 CFR 64.611(e); VRS Reform Order.

    4. In order to improve the effectiveness of these interoperability and portability requirements, the Commission delegated “to the Chief of CGB, after consultation with the CTO [Chief Technology Officer] and the Chief of OET [Office of Engineering and Technology], the authority to conduct rulemaking proceedings to incorporate into the Commission's rules by reference any interoperability and portability standards developed under the auspices of the SIP Forum, now or in future, or such other voluntary, consensus standard organization as may be formed to address these issues.” VRS Reform Order. The VRS Reform Order further provided: “Recognizing that the scope of the SIP Forum VRS Task Group charter extends beyond the Commission's current mandatory minimum standards, the Commission also delegates to Chief of CGB, after consultation with the CTO and the Chief of OET, the authority to conduct rulemaking proceedings to incorporate into the Commission's rules by reference as new or updated mandatory minimum standards any standards or recommended standards developed by the SIP Forum (or such other voluntary, consensus standard organization as may be formed to address these issues) that the Chief of CGB finds will advance the statutory functional equivalency mandate or improve the availability of TRS, in the most efficient manner. In conducting such rulemakings, the Chief of CGB shall provide guidance on implementation, including the need for a transition period for existing VRS access technologies, complaint resolution, or other actions necessary to ensure full interoperability and portability.”

    5. In August 2015, the SIP Forum published the Video Relay Service (VRS) Provider Interoperability Profile (VRS Provider Interoperability Profile), a consensus document developed by the SIP Forum's VRS Task Group. The VRS Provider Interoperability Profile provides technical specifications for the interface between VRS providers and the interface between a VRS provider and the TRS Numbering Directory. In July 2016, the Relay User Equipment Forum (RUE Forum) published a second consensus document, the Interoperability Profile for Relay User Equipment (RUE Profile) on the Internet Engineering Task Force (IETF) Web site. The RUE Profile provides technical specifications that define a standard interface between a relay user's equipment and the services offered by relay service providers.

    6. The Bureau tentatively concludes that the VRS Provider Interoperability Profile and the RUE Profile will effectively meet the Commission's goals of ensuring interoperability and portability, as required by the VRS Reform Order. Specifically, these standards will enable a VRS user to place and receive calls through any VRS provider and make point-to-point calls to all other VRS users, irrespective of the default provider of the parties to the call, and without the caller having to change the VRS access technology used to make such calls. Additionally, as required by the VRS Reform Order, these standards will support a standard data interchange format for exporting and importing private data contained in a user's personal contacts list (also referred to as an address book) and the user's speed dial list between the VRS user's access technology and the access technology of other VRS providers. In these various ways, these standards will “advance the statutory functional equivalency mandate [and] improve the availability of TRS, in the most efficient manner,” in accordance with the VRS Reform Order. The Bureau further notes that all current VRS providers participated in the process leading to adoption of the standards, and that all providers appear to have reached a consensus on these standards. For all of these reasons, the Bureau tentatively concludes that these standards meet the Commission's objective of facilitating interoperability and portability for VRS, and should be incorporated by reference into the Commission's rules. The Bureau seeks comment on this tentative conclusion and its rationale. The Bureau also seeks comment on whether any modified version of the standards that results from the continued work of the RUE Forum, which is published subsequent to the Commission's release of the Further Notice and during the pendency of this proceeding, should be adopted in lieu of the versions of the standards discussed above.

    7. The Bureau also proposes to follow, in the future, a procedure that permits amendments or changes to the standards to be incorporated into the Commission's rules in a timely and efficient manner. The Bureau believes that a voluntary, consensus standards process that results in amendments or changes to the standards will, as is the case for the standards proposed for incorporation herein, allow for widespread participation by the affected parties, and in particular VRS providers. In the event of such amendments or changes, the Bureau will issue a public notice seeking comment on such modifications, followed by an order incorporating into the VRS rules amendments or changes by reference if justified based on the resulting record. When such revised standards are completed and accepted by the Bureau, a second public notice will be issued containing information on how to access the modified standards and establishing an implementation schedule. To facilitate ready access to such standards, the Bureau further proposes that the Commission make them available to the public online. The Bureau believes that this process will allow interested parties to have the opportunity to participate in the standards-setting process, comment on the inclusion of such standards in the Commission's rules, and receive notice about the implementation of any amendments or changes to the standards. The Bureau seeks comment on this approach and on any alternatives.

    8. As to the timing of the implementation of the recently developed standards, the Bureau believes that insofar as all current VRS providers participated in developing these standards and had an opportunity to debate the various technical issues over a period of several years, as a practical matter, all providers have become familiar with the content of the standards, have had ample opportunity to incorporate the standards into their software development processes, and have had sufficient opportunity to familiarize their suppliers with any necessary design changes. The Bureau therefore proposes that the rule amendment incorporating the standards into 47 CFR 64.621 shall become effective 60 days after publication in the Federal Register of the amended rule. The Bureau seeks comment on this proposed implementation schedule. To the extent that any commenter seeks a later effective date, the Bureau requests that such commenter describe the specific products or features and functions for which a later effective date is needed and the reasons why compliance is not achievable at an earlier date.

    9. As the Commission contemplated in the VRS Reform Order, once incorporated into the Commission's rules, compliance with the standards “shall be a prerequisite for compensation from the Fund. No VRS provider shall be compensated for minutes of use generated by non-standards compliant VRS access technologies or otherwise generated in a manner inconsistent with the Commission's rules. If a provider cannot reliably separate minutes of use generated through standards compliant VRS access technologies from those generated through non-standards compliant VRS access technologies, the provider will not receive compensation for any of the minutes.” VRS Reform Order.

    10. The Office of Federal Register (OFR) recently revised its regulations to require that agencies must discuss in the preamble of a proposed rule ways that the materials the agency proposes to incorporate by reference are reasonably available to interested parties or how it worked to make those materials reasonably available to interested parties. In addition, the preamble of the proposed rule must summarize the material. 1 CFR 51.5(a). In accordance with OFR's requirements, the discussion in the following two paragraphs summarizes and indicates the availability of the VRS Provider Interoperability Profile and the RUE Profile.

    11. The U.S. Video Relay Service (VRS) Provider Interoperability Profile, Version 15, SIP Forum Document Number: VRS U.S. Providers Profile TWG-6-0.15 (Sept. 23, 2015) (VRS Provider Interoperability Profile), is available from SIP Forum LLC, 733 Turnpike Street, Suite 192, North Andover, MA 01845 USA, (203) 829-6307, at http://www.sipforum.org/component/option,com_docman/task,cat_view/gid,160/Itemid,75/. The Provider Interoperability Profile provides technical specifications for the interface between VRS providers and the interface between a VRS provider and the TRS Numbering Directory.

    12. The Interoperability Profile for Relay User Equipment, draft-vrs-rue-dispatch-00 (July 20, 2016) (RUE Profile), is available from IETF Secretariat, 5177 Brandin Court, Fremont, CA 94538, 510-492-4080, at https://www.ietf.org/id/draft-vrs-rue-dispatch-00.txt. The RUE Profile provides technical specifications that define a standard interface between a relay user's equipment and the services offered by relay service providers.

    Initial Regulatory Flexibility Analysis

    13. As required by the Regulatory Flexibility Act (RFA), the Bureau has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in the Further Notice. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments specified in the Further Notice.

    14. Need For, and Objectives of, the Proposed Rules. In the VRS Reform Order, the Commission strongly encouraged the continuation of efforts by the SIP Forum's VRS Task Group to develop voluntary, consensus standards to facilitate interoperability and portability of VRS and directed Commission staff to support and participate in the SIP Forum process. The SIP Forum and a successor group, the RUE Forum, have now produced interoperability and portability standards, making it possible to achieve the improvements sought in the VRS Reform Order. The Further Notice proposes to incorporate those interoperability and portability standards by reference into 47 CFR 64.621, the Commission's VRS interoperability rule, along with guidance on implementation, including the need for a transition period for existing VRS access technologies to achieve interoperability and portability. In addition, the Further Notice proposes a process that will readily enable revisions to this rule to reflect future amendments or changes in these standards by issuing a public notice seeking comment on such modifications, followed by an order incorporating into the VRS rules amendments or changes by reference if justified based on the resulting record, after which a second public notice will be issued containing information on how to access the modified standards online and establishing an implementation schedule.

    15. Legal Basis. The legal basis for any action that may be taken pursuant to the Further Notice is contained in 47 U.S.C. 151, 152, 154(i), 154(j), 225, 303(r).

    16. Types of Small Entities to Which the Proposed Rules May Apply. All Other Telecommunications.

    17. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements. If the Commission were to incorporate the SIP Forum and RUE Forum standards by reference into the Commission's VRS interoperability rule and provide guidance on implementation, VRS providers, including small entities, would need to take steps to comply with such standards.

    18. Steps Taken to Minimize Significant Economic Impact on Small Entities and Significant Alternatives Considered. In general, alternatives to proposed rules are discussed only when those rules pose a significant adverse economic impact on small entities. In this context, however, the proposed rules generally confer benefits. In particular, interoperability requirements benefit the smaller providers because consumers find the services of smaller providers to be more attractive when these services are interoperable than when they are not interoperable. These benefits outweigh any burdens associated with compliance. Moreover, because all of the VRS providers participated in the discussions associated with the development of the standards, the Commission believes that these standards are acceptable to all VRS providers, including small entities. Lastly, the Further Notice seeks comment on the proposed implementation schedule to ensure that such implementation schedule is achievable.

    19. Federal Rules that May Duplicate, Overlap, or Conflict with Proposed Rules. None.

    List of Subjects in 47 CFR Part 64

    Telecommunications relay services, Individuals with disabilities.

    Federal Communications Commission. Karen Peltz Strauss, Deputy Chief, Consumer and Governmental Affairs Bureau.

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 64 as follows:

    PART 64—MISCELLANEOUS RULES RELATING TO COMMON CARRIERS 1. The authority citation for part 64 continues to read as follows: Authority:

    47 U.S.C. 154, 254(k); 403(b)(2)(B), (c), Public Law 104-104, 110 Stat. 56. Interpret or apply 47 U.S.C. 201, 218, 222, 225, 226, 227, 228, 254(k), 616, and 620, and the Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112-96, unless otherwise noted.

    2. Amend § 64.621 by revising paragraph (b) to read as follows:
    § 64.621 Interoperability and portability.

    (b) Technical Standard for Interoperability and Portability.

    (1) VRS providers shall ensure that their provision of VRS and video communications, including their access technology, meets the requirements of the U.S. Video Relay Service (VRS) Provider Interoperability Profile Version 15, SIP Forum Document Number: VRS U.S. Providers Profile TWG-6-0.15 (Sept. 23, 2015) (VRS Provider Interoperability Profile), http://www.sipforum.org/component/option,com_docman/task,cat_view/gid,160/Itemid,75/, and the Interoperability Profile for Relay User Equipment (RUE Profile), draft-vrs-rue-dispatch-00 (July 20, 2016), https://www.ietf.org/id/draft-vrs-rue-dispatch-00.txt.

    (2) This incorporation by reference of the VRS Provider Interoperability Profile and the RUE Profile was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the VRS Provider Interoperability Profile may be obtained from SIP Forum LLC, 733 Turnpike Street, Suite 192, North Andover, MA 01845 U.S.A., (203) 829-6307, at http://www.sipforum.org/component/option,com_docman/task,cat_view/gid,160/Itemid,75/. Copies of the RUE Profile may be obtained from IETF Secretariat, 5177 Brandin Court, Fremont, CA 94538, 510-492-4080, at https://www.ietf.org/id/draft-vrs-rue-dispatch-00.txt. Copies of these publications also may be inspected during normal business hours at the following locations: Consumer and Governmental Affairs Bureau, Reference Information Center, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554; and the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    [FR Doc. 2016-19845 Filed 8-23-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 216 [Docket No. 080302361-6677-01] RIN 0648-AU02 Protective Regulations for Hawaiian Spinner Dolphins Under the Marine Mammal Protection Act AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    We, the National Marine Fisheries Service (NMFS), propose regulations under the Marine Mammal Protection Act (MMPA) to prohibit swimming with and approaching a Hawaiian spinner dolphin within 50 yards (45.7 m) (for persons, vessels, and objects), including approach by interception. These proposed regulatory measures are intended to prevent take of Hawaiian spinner dolphins from occurring in marine areas where viewing pressures are most prevalent; prohibitions would apply in waters within 2 nautical miles (nm; 3.7 km) of the Hawaiian Islands and in the waters between the islands of Lanai, Maui, and Kahoolawe. This proposed rule to establish 50-yard swim-with and approach regulations would help ensure public compliance by providing clear notice of prohibited conduct that results in take, including harassment and disturbance.

    Although unauthorized take of marine mammals, including harassment of spinner dolphins, already is and continues to be prohibited under the MMPA throughout their range, the purpose of this regulation is to identify and prohibit specific human activities that result in take (including harassment) of spinner dolphins, and thus reduce disturbance and disruption of important Hawaiian spinner dolphin behaviors in areas where human-dolphin interactions are most likely to occur. These proposed regulations would reduce take of Hawaiian spinner dolphins and the impact of human viewing and interaction on these animals in the Main Hawaiian Islands (MHI). We developed this proposed rule after considering comments submitted in response to an Advance Notice of Proposed Rulemaking (ANPR), as well as information received during the public scoping period for the Draft Environmental Impact Statement (DEIS), from community meetings, and from a dedicated scientific research project.

    Although not currently part of this proposal, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats that are regularly targeted by humans for dolphin-directed activities. Accordingly, we are soliciting public comment on the proposed swim-with and approach regulations, as well as alternative management options discussed in this rule and in detail in the DEIS.

    DATES:

    Comments must be received no later than 5 p.m. on October 23, 2016.

    Public meetings will provide the public with an opportunity to provide comments on any portion of the proposed rule or DEIS. These meetings are scheduled for:

    September 7, 2016, 5:30-9:30 p.m. at Konawaena High School Cafeteria, 81-1043 Konawaena School Rd., Kealakekua, HI 96750;

    September 8, 2016, 5:30-9:30 p.m. at Kealakehe High School Cafeteria, 74-5000 Puohulihuli St., Kailua Kona, HI 96740;

    September 21, 2016, 5:30-9:00 p.m. at Kauai High School Cafeteria, 3577 Lala Rd., Lihue, HI 96766;

    September 22, 2016, 5:30-9:00 p.m. at the Hawaiian Islands Humpback Whale National Marine Sanctuary Visitor Center, 726 South Kihei Rd., Kihei, HI 96753;

    September 27, 2016, 5:30-9:30 p.m. at Roosevelt High School Dining Hall, 1120 Nehoa Street, Honolulu, HI 96822; and

    September 28, 2016, 5:30-9:30 p.m. at Waianae High School Cafeteria, 85-251 Farrington Hwy., Waianae, HI 96792.

    ADDRESSES:

    You may submit comments, information, or data on this document, identified by NOAA-2005-0226, and on the DEIS by either of the following methods:

    Electronic Submission: Submit all electronic comments via the Federal eRulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-2005-0226, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Susan Pultz, Chief, Conservation Planning and Rulemaking Branch, Protected Resources Division, National Marine Fisheries Service, Pacific Islands Regional Office, 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818, Attn: Hawaiian Spinner Dolphin Proposed Rule.

    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. We will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    The Draft Environmental Impact Statement (DEIS) and references can be found online at http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html. Additionally, copies of the DEIS are available in print at the following libraries:

    Hilo Library, 300 Waianuenue Ave., Hilo, HI 96720;

    Kailua-Kona Library, 75-138 Hualalai Rd., Kailua Kona, HI 96740;

    Kealakekua Library, 81-6619 Mamalahoa Hwy., Kealakekua, HI 96750;

    Pahoa Library, 15-3070 Pahoa-Kalapana Rd., Pahoa, HI 96778;

    Kihei Library, 35 Waimahaihai St., Kihei, HI 96753;

    Lahaina Library, 680 Wharf St., Lahaina, HI 96761;

    Lanai Library, 555 Fraser Ave., Lanai City, HI 96763;

    Hawaii State Library, 478 S. King St., Honolulu, HI 96813;

    Molokai Public Library, 15 Ala Malama, Kaunakakai, HI 96748;

    Waianae Library, 85-625 Farrington Hwy., Waianae, HI 96792; and

    Lihue Library, 4344 Hardy St., Lihue, HI 96766; or upon request from the Conservation Planning and Rulemaking Branch Chief (see ADDRESSES).

    FOR FURTHER INFORMATION CONTACT:

    Susan Pultz, NMFS, Pacific Islands Region, Chief, Conservation Planning and Rulemaking Branch, 808-725-5150; or Trevor Spradlin, NMFS, Office of Protected Resources, Acting Chief, Marine Mammal and Sea Turtle Conservation Division, 301-427-8402.

    SUPPLEMENTARY INFORMATION Background

    Viewing wild marine mammals in Hawaii has been a popular recreational activity for both tourists and residents over the past several decades. Historically, most marine mammal viewing focused on humpback whales (Megaptera novaeangliae) during the winter months when the whales migrate from their feeding grounds off the coast of Alaska to Hawaii's warm and protected waters to breed and calve. However, increased viewing has focused on small cetaceans, with a particular emphasis on Hawaiian spinner dolphins (Stenella longirostris), which can be predictably found close to shore in shallow waters throughout the MHI.

    The number of commercial operators engaged in wild dolphin viewing has grown dramatically in Hawaii in recent years (O'Connor 2009), putting new pressures on easily accessible groups of resting Hawaiian spinner dolphins. In addition, a number of residents and visitors venture on their own, independent of commercial operators, to view and interact with spinner dolphins. The expectation for close interactions with wild dolphins has been encouraged by some operators and various media outlets, which routinely contradict established wildlife viewing guidelines by promoting close vessel or in-water encounters with the dolphins.

    We have received many complaints that spinner dolphins are being routinely disturbed by people attempting to closely approach and interact with the dolphins by boat or other watercraft (e.g., kayaks), or in the water (e.g., snorkel or “swim-with-wild-dolphins” activities). In addition, concerns over human-dolphin interactions have been expressed by officials from the Hawaii Department of Land and Natural Resources (DLNR) and the U.S. Marine Mammal Commission (MMC), as well as various members of the public, including representatives of the Native Hawaiian community, scientific researchers, wildlife conservation organizations, public display organizations, and some commercial tour operators.

    In 2010, we recognized five island-associated stocks and one pelagic stock of Hawaiian spinner dolphins in our annual Stock Assessment Report, identifying genetic distinctions and site fidelity differences as reasons to separately manage stocks found in waters surrounding the Hawaiian Islands (Carretta et al. 2010). Three of the five island-associated stocks (the Kauai/Niihau stock, Oahu/4 Islands (i.e., Maui County) stock, and Hawaii Island stock) are found near the MHI and are considered resident stocks. These three stocks reside in waters surrounding their namesake islands out to approximately 10 nm (18.5 km) (Hill et al. 2010), and population estimates for each stock are relatively small. Recent research indicates that the Hawaii Island stock, which is thought to be the largest stock, has an estimated 631 individuals (Coefficient of Variation (CV) = 0.09) (Tyne et al. 2014, Carretta et al. 2016). Data for other stocks in the MHI is limited; however, using the best available information, the Kauai/Niihau and Oahu/4 Islands stocks are estimated to be around 601 (CV = 0.20) and 355 (CV = 0.09) individuals, respectively (Carretta et al. 2016).

    Island-associated spinner dolphins, such as those found in the MHI, have complex social structures and behavioral patterns linked to specific habitats that support their high energetic demands. The rigid, cyclical, and patterned behavior of a Hawaiian spinner dolphin's day is well documented from decades of scientific research on spinner dolphins off the Kona coast on the island of Hawaii (Norris and Dohl 1980, Norris et al. 1994). The daily pattern of Hawaiian spinner dolphins has been characterized as “working the night shift,” because the energetically demanding task of foraging is accomplished nightly when spinner dolphins move offshore in large groups to feed. Spinner dolphins feed on fish, shrimp, and squid found in the mesopelagic boundary community, part of the pelagic zone that extends from a depth of 200 to 1,000 m (~660 to 3,300 feet) below the ocean surface. Spinner dolphins maximize their foraging time by actively moving with, or tracking, the horizontal migration of the mesopelagic boundary community throughout the night, as it moves inshore until midnight and then offshore around sunrise (Benoit-Bird and Au 2003). Spinner dolphins are acoustically very active during foraging activities (Norris et al. 1994), working cooperatively in large groups using coordinated movements to maximize foraging potential (Benoit-Bird 2004).

    During the day, spinner dolphins return in smaller groups to areas closer to shore to socialize, nurture their young, and rest in preparation for nightly foraging (Norris et al. 1994). These smaller groups visit specific habitats that are located along the coastlines of the MHI. These preferred daytime habitats of spinner dolphins are areas that provide space with optimal environmental conditions for resting, socializing, and nurturing young, and are referred to hereafter as “essential daytime habitats.” Spinner dolphins' essential daytime habitats are located close to offshore feeding areas, which minimizes the energetic cost of nightly travel to these areas (Norris et al. 1994, Thorne et al. 2012). Additionally, essential daytime habitats have large patches of sand bottom habitat, which increases the dolphins' ability to visually (instead of acoustically) detect predators while resting, and thus minimizes the energetic costs of vigilance (Norris et al. 1994). Throughout the day, spinner dolphins take advantage of the physical characteristics of essential daytime habitats to engage in specific patterned resting behaviors to recuperate between foraging bouts. The physical characteristics of these essential daytime habitats, combined with specific patterned resting behaviors, play an important role in supporting the dolphins' activity and energetic budgets.

    Essential daytime habitats have been targeted by commercial operators and individuals interested in viewing or interacting with Hawaiian spinner dolphins because encounters with dolphins in these areas are virtually guaranteed. At some locations, up to 13 tour boats have been observed jockeying for position on a single dolphin group, with up to 60 snorkelers in the water (Heenehan et al. 2014). Apart from commercial tour operations, people also swim, kayak, or paddle into essential daytime habitats to seek interactions with the dolphins (Sepez 2006). In addition, organized retreats centered on dolphin encounters, dolphin-assisted therapy, and dolphin-associated spiritual practices have flourished in certain areas, further increasing the intensity of dolphin-directed activities in nearshore areas and especially within essential daytime habitats (Sepez 2006).

    There is a growing body of scientific evidence documenting the effects of dolphin-directed activities on spinner dolphins, especially activities that involve close approaches by humans. Peer-reviewed scientific literature documents disturbance of individual spinner dolphins as well as changes to spinner dolphin group behavioral patterns. Individual dolphin responses to these activities vary, and in some cases may not be apparent to an observer (e.g., elevated heart rates or increased watchfulness). However, discernable responses may include aerial displays when closely approached by vessels and swimmers (Forest 2001, Courbis and Timmel 2008); avoidance behaviors, including moving around and away from swimmers and vessels, or leaving the area in response to human pursuit (Ostman-Lind et al. 2004, Courbis 2004, Courbis and Timmel 2008); and aggressive behaviors directed at people, including charging or threat displays (Norris et al. 1985, Norris et al. 1994).

    Effects have been documented in the form of changes over time to spinner dolphins' behavioral patterns in essential daytime habitats, where spinner dolphins' behavioral patterns are easily observed. Courbis and Timmel (2008) reported differences in peak aerial activity throughout the day in comparison with earlier studies (Forrest 2001) and noted that dolphins may have reduced aerial behavior when entering and exiting bays to avoid human notice and approaches. Timmel et al. (2008) noted the dolphins' direction of travel altered more frequently as the number of swimmers and/or vessels near to them increased. Symons (2013) found that spinner dolphins are less likely to rest when swimmers are present within 150 m. Numerous studies report changes in dolphin residence time within essential daytime habitats compared to earlier studies (Courbis 2004, Courbis and Timmel 2008, Ostman-Lind 2007, Forest 2001). In addition, human activities within essential daytime habitats may be affecting where spinner dolphins engage in their daytime behaviors within these areas. Courbis and Timmel (2008) reported changes in the location of resting spots within Kealakekua Bay from previous studies by Doty (1968) and Norris and Dohl (1980), and warned that changes in locations within the bay could be a precursor to abandonment of the bay with future increases in traffic.

    Hawaiian spinner dolphin studies off the island of Oahu also demonstrate the effects of swimmers on dolphins' daily resting behavioral patterns. As the number of swimmers increased in an essential daytime habitat off the west coast of Oahu, the dolphins departed the area at earlier times during the day, possibly indicating reduced rest periods in response to swimmer presence (Danil et al. 2005). Additionally, Danil et al. (2005) noted that on several occasions, smaller spinner dolphin groups (<25 animals) refrained from entering an essential daytime habitat when swimmer presence was high, suggesting that the observed spinner dolphin rest patterns were altered in order to accommodate and adapt to the swimmers' occurrence. The authors predicted that swimmer presence keeps the dolphins in a constant state of alertness and vigilance, and that delayed diving behavior (in the morning during swimmers' presence) may indicate a diminished quality of rest (Danil et al. 2005).

    When marine mammals respond to disturbance events, they incur a cost in the form of the energy expended to respond as well as the lost opportunity to engage in natural fitness-enhancing behavior. For example, spinner dolphins disturbed during rest may engage in avoidance or distress behaviors, which require energy, and disturbance detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. In this example, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young.

    The predictable patterns of MHI resident spinner dolphins' nearshore distribution and daytime behaviors result in concentrated daily viewing and interaction pressure on individual dolphins and groups over extended periods of time. In other small cetacean populations, chronic disturbance to natural behavioral patterns has been linked to biologically significant impacts such as habitat abandonment and reduced female reproductive success (Bejder 2005; Bejder et al. 2006a, 2006b; Lusseau and Bejder 2007). Similarly, over time, chronic disturbance to the MHI's resident spinner dolphins could ultimately lead to habitat displacement and/or long term impacts to their individual fitness. These types of impacts may be amplified in resident, closed or isolated populations (local populations with barriers to gene flow) (Bejder 2005) because the impacts to multiple individuals' health and fitness are quickly reflected in the overall fitness of the population. Accordingly, the small resident spinner dolphin populations of the MHI may be more vulnerable to negative impacts from human disturbance.

    Disturbances to dolphins' daily behavioral patterns may result in “take,” as defined and prohibited under the MMPA and its implementing regulations, and the chronic nature of these problems in Hawaii and observed changes to spinner dolphin behavioral patterns over time are a cause for concern.

    Current MMPA Prohibitions and NMFS Guidelines and Regulations

    Under section 102 of the MMPA, 16 U.S.C. 1361 et seq., it is unlawful for any person, vessel, or other conveyance to “take” any marine mammal in waters under the jurisdiction of the United States (16 U.S.C. 1372). The prohibition against take includes acts that “harass” marine mammals (16 U.S.C. 1362(13)). Harassment means any act of pursuit, torment, or annoyance which has the potential to injure a marine mammal in the wild (Level A Harassment), or has the potential to disturb a marine mammal in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B Harassment) (16 U.S.C. 1362(18); see also 50 CFR 216.3).

    In addition, NMFS' regulations implementing the MMPA further define the term “take” to include “the negligent or intentional operation of an aircraft or vessel, or the doing of any other negligent or intentional act which results in disturbing or molesting a marine mammal; and feeding or attempting to feed a marine mammal in the wild” (50 CFR 216.3).

    Section 112 of the MMPA authorizes NOAA to implement regulations that are “necessary and appropriate to carry out the purpose” of the MMPA (16 U.S.C. 1382).

    To date, NMFS has developed specific approach distance regulations for certain species of marine mammals listed under the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.). Each rule was based on the biology of the marine mammals and the best available scientific information on the nature of the threats. Examples of these types of regulations include a 100-yard (91.4 m) approach limit for humpback whales in Hawaii (60 FR 3775; January 19, 1995); a 100-yard approach limit for humpback whales in Alaska, which includes a speed restriction in the vicinity of the whale (66 FR 29502; May 31, 2001); a 500-yard (457.2 m) approach limit for North Atlantic right whales (62 FR 6729; February 13, 1997); size-specific vessel speed restrictions within specific areas in waters off the U.S. East Coast to protect North Atlantic right whales (73 FR 60173; October 10, 2008); and a 200-yard (182.9 m) approach limit for killer whales with prohibitions against vessels intercepting a killer whale or positioning the vessel in its path in the inland waters of Washington State (76 FR 20870; April 14, 2011).

    In addition to the specific ESA regulations mentioned above, NMFS has developed guidelines for conducting responsible marine wildlife viewing to help the public avoid causing any take (harassment or disturbance) of protected wildlife species (http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_wildlife.pdf); these guidelines have been available since 2004. On human interactions with marine mammals in the wild, NMFS states the following: “The MMPA does not provide for a permit or other authorization to view or interact with wild marine mammals, except for specific listed purposes such as scientific research. Therefore, interacting with wild marine mammals should not be attempted and viewing marine mammals must be conducted in a manner that does not harass the animals. NMFS does not support, condone, approve, or authorize activities that involve closely approaching, interacting, or attempting to interact with whales, dolphins, porpoises, seals, or sea lions in the wild. This includes attempting to swim with, pet, touch, or elicit a reaction from the animals” (http://www.nmfs.noaa.gov/pr/dontfeedorharass.htm).

    In addition to the national guidelines, each of the five NMFS Regions has developed recommended viewing guidelines relevant to protected species within their region to assist the general public with information on how to responsibly view and act around these animals in the wild. The guidelines are aimed at assisting the public in meeting their obligations under the MMPA and ESA. Although some guidelines address activities that are prohibited under law, others address activities that are not expressly prohibited.

    The NMFS Pacific Islands Regional Office's viewing guidelines for Hawaii recommend that people view wild dolphins from a safe distance of at least 50 yards (45.7 m) and advise against trying to chase, closely approach, surround, swim with, or touch the animals. To support the guidelines in Hawaii, NMFS has partnered with the State of Hawaii and the Hawaiian Islands Humpback Whale National Marine Sanctuary over the past several years to promote safe and responsible wildlife viewing practices through the development of outreach materials, training workshops, signage, and public service announcements. NMFS' education and outreach efforts have also been supported by a partnership with the Watchable Wildlife program, a consortium of Federal and State wildlife agencies and wildlife interest groups that encourages passive viewing of wildlife from a distance for the safety and well-being of both animals and people (Duda 1995, Oberbillig 2000, Clark 2006). In addition to the guidance provided to the general public on protected wildlife viewing, several tour industry-specific programs have been initiated in various NMFS regions to further support protection of marine mammals targeted for wildlife viewing. In Hawaii this includes administration of the voluntary Dolphin SMART program for commercial operators who pledge to comply with safe and responsible wildlife viewing practices.

    Dolphin SMART is a model wildlife viewing stewardship program developed by NMFS and NOAA's Office of National Marine Sanctuaries in partnership with Whale and Dolphin Conservation, the Dolphin Ecology Project, local businesses, and members of the public, who have teamed up to support responsible viewing of wild dolphins. The program was launched in 2007 in Key West, Florida, was subsequently expanded to the Central and Southwest Florida coast, and established in Hawaii in 2011.

    The NMFS Pacific Islands Regional Office developed the Dolphin SMART program in Hawaii to aid education and outreach efforts for Hawaiian spinner dolphin conservation and management. Three businesses on Oahu, one on Kauai, and two on Maui are currently recognized as Dolphin SMART participants.

    The Dolphin SMART program goals are to minimize the potential of wild dolphin harassment caused by commercial viewing activities, reduce expectations of close interaction with wild dolphins in a manner that may cause harassment, address advertising that creates expectations of engaging in activities that may cause harassment, and promote responsible stewardship of dolphins in local coastal waterways. The “SMART” acronym stands for:

    S—Stay back 50 yards from dolphins M—Move cautiously away if dolphins show signs of disturbance A—Always put your engine in neutral when dolphins are near R—Refrain from feeding, touching, or swimming with wild dolphins T—Teach others to be Dolphin SMART

    More information on the Dolphin SMART program can be found at the following Web sites: www.dolphinsmart.org and www.facebook.com/OfficialDolphinSmart.

    Need for Additional Action

    Despite the prohibitions, guidelines, outreach, and stewardship efforts currently in place, close interactions between humans and spinner dolphins continue to occur in Hawaii's waters and are especially prevalent in essential daytime habitats (see Background). In April 2000, the MMC released a literature review of scientific publications that evaluated the impacts of swimming with wild dolphins worldwide (Samuels et al. 2000). The authors of this review noted the prevalence of disturbances by tourist activities in areas critical to the animals' well-being, and recommended that precautions be taken to protect the dolphins (Samuels et al. 2000).

    The concerns about disturbance to spinner dolphins by boaters and swimmers prompted NMFS to raise the topic of enhancing protections for these animals in an Advanced Notice of Proposed Rulemaking (ANPR) (70 FR 73426, December 12, 2005). Public comments received in 2005 reiterated and reinforced the concerns expressed by the MMC. In the years since the 2000 Samuels et al. review, additional scientific evidence has documented disturbances or disruptions to spinner dolphins by boaters or swimmers (Forest 2001; Courbis 2004, 2007; Danil et al. 2005; Timmel 2005; Courbis and Timmel 2009; Ostman-Lind 2009; Symons 2013; Heenehan et al. 2014; Tyne et al. 2015). This problem is pronounced in essential daytime habitats that are targeted for dolphin-directed activities, and animals that use these areas are exposed to intense activity on a daily basis. For example, a recent study found that human activities took place within 100 m of spinner dolphins 83 percent of the time the animals were using four essential daytime habitats on the island of Hawaii (Tyne 2015).

    Based on extensive review and analysis through internal scoping, external scoping via the ANPR, public scoping for the DEIS, and the best available scientific information, we have determined that the existing prohibitions, regulations, and guidelines need to be strengthened to protect Hawaiian spinner dolphins from various forms of take from human activities that cause harassment or disturbance. Dolphins' response to disturbance varies among individuals, but in most cases it includes a departure from natural behavioral patterns that support the animal's health and fitness, and chronic disturbance may result in negative impacts to the fitness of individuals and/or populations. We therefore deem it necessary and appropriate to adopt additional regulations to clarify human activities that result in take of Hawaiian spinner dolphins, including harassment or other forms of disturbance as currently defined by statute and regulation.

    Although unauthorized take of dolphins continues to be illegal wherever it occurs, we are focusing these regulations in nearshore areas, out 2 nm (3.7 km) from shore of the MHI and including designated waters between Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e) and Geographic Area section below), where the threat from dolphin-directed activities is concentrated and where spinner dolphins engage in daytime behaviors, including resting, socializing, nurturing, and traveling. These additional measures are intended to prevent “take” during important resting periods and allow Hawaiian spinner dolphins to engage in normal fitness-enhancing behaviors, thereby preventing long-term negative impacts to individuals and to the population.

    Development of Proposed Regulations

    In 2005, NMFS convened a Spinner Dolphin Working Group with representatives from the MMC, State and Federal agencies, and scientific researchers who work on spinner dolphin conservation concerns. The group evaluated the best available information at the time to understand the scope of the tourist and recreational activities targeting spinner dolphins. As noted above (Need for Additional Action section), in December 2005, we published an ANPR in the Federal Register (70 FR 73426, December 12, 2005) to solicit input from the public on potential ways to better enhance protections for spinner dolphins and mitigate activities of concern (e.g., close approach and swim-with activities). This was followed by a Notice of Intent (NOI) to Prepare an Environmental Impact Statement (EIS) under the National Environmental Policy Act (NEPA) (71 FR 57923; October 2, 2006), in which we identified a preliminary list of potential regulations for future consideration and comment, which included partial time-area closures in certain spinner dolphin essential daytime habitats, a minimum distance limit for approaching dolphins in the wild, restrictions on certain human behaviors in NMFS-identified spinner dolphin resting areas, and complete closure of all known spinner dolphin resting areas in the MHI.

    During the ANPR and the NOI comment periods, five public scoping meetings were held on the islands of Kauai, Oahu, Maui, and Hawaii, and oral statements were taken at each meeting. NMFS received a total of 4,641 public comments in response to the ANPR and the NOI (this includes all emails, letters, and public testimonies). Comments were submitted by concerned citizens, tour operators, scientific researchers, conservation and education groups, and Federal, State, and other government entities.

    Comments received through both of the public comment periods varied widely and recommended numerous actions to consider, ranging from no regulations to permanent closure of areas used by the dolphins for rest and shelter. Additionally, public comments raised concerns about various topics that should be addressed in the EIS or proposed action. These concerns are grouped into various topics in the final scoping report, and include the following topics: Hawaiian spinner dolphin biology and behavior; cultural issues; cumulative effects; data/data gaps; direct and indirect effects; education/outreach; enforcement; the ESA; guidelines/solutions for other species or from other countries; human-dolphin interaction, medical benefits from swimming with dolphins; MMPA; monitoring; the NEPA; public and stakeholder involvement; regulatory regime; social and economic issues; spiritual and religious issues; take and harassment, traditional Hawaiian knowledge; and welfare of the dolphins. Although comments varied greatly, a consistent theme that stood out under several topics was the need for effective and enforceable regulations.

    As a result of stakeholder concerns expressed through these public comments, and for the preparation of this rule and associated DEIS, we made multiple site visits to areas where concerns have been raised regarding Hawaiian spinner dolphin disturbance in the MHI. During these visits, we met with concerned members of the public to gather information relevant to this analysis. Additionally, we coordinated with State and Federal agencies, and used the public comments generated from the ANPR and NOI to develop a range of actions and mitigation measures that are reflected in numerous alternatives under consideration for the proposed action.

    Presentations made at the public scoping meetings, the April 2007 EIS public scoping summary report, a list of the attendees, the ANPR, public comments, and background materials are provided at http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html.

    We relied on the public comments on the ANPR and the NOI, and on new scientific information to develop a range of regulatory and non-regulatory alternatives, including the alternative of not adopting regulations. We analyzed the environmental effects of these alternatives and considered options for mitigating effects. After a preliminary analysis of alternatives, we developed and analyzed the effects of the swim-with and 50-yard (45.7 m) approach regulations, which we chose as our preferred alternative, which includes no interception (i.e., “leapfrogging” or placing a person or vessel in the path of dolphins for the purpose of interception). As more fully discussed below, we specifically seek public comment on whether these proposed measures alone will provide sufficient protection to spinner dolphins from human interactions.

    Although not currently proposed, we are considering whether other management measures also may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. Accordingly, we have also analyzed the effects of the alternative management measures of promulgating swim-with and approach regulations, while additionally creating either mandatory (see DEIS Alternative 4) or voluntary (see DEIS Alternative 5) time-area closures in five essential daytime habitats. The results of our analyses are contained in a DEIS. The DEIS is available for review and comment in association with this rulemaking (see ADDRESSES). A description of these alternatives is also included in the Additional Measures Under Consideration section of this proposed rule.

    SAPPHIRE Project

    During the initial scoping period for the Spinner Dolphin Human Interaction EIS, we received comments that recommended gathering additional information on Hawaiian spinner dolphins, including monitoring local populations to determine impacts to numbers and overall health of the MHI resident spinner dolphins. In response to this recommendation and to inform this rulemaking effort, NMFS internal grant funding was awarded to the “Spinner Dolphin Acoustics, Population Parameters, and Human Impact Research” (SAPPHIRE) program, conducted jointly by Duke University and Murdoch University. The SAPPHIRE project's objective was to provide baseline data on the local abundance, distribution, and behavior of spinner dolphins in Kealakekua Bay, Honaunau Bay, Kauhako Bay, and Makako Bay off of the island of Hawaii, as well as in nearshore, shallow-water environments near these resting bays. This intensive study integrated a suite of visual and acoustic sampling techniques, using boat-based and land-based surveys, as well as acoustic recording devices, to assess the following: Spinner dolphin daytime habitat use and resting behavior in study areas and surrounding waters; residency and fidelity patterns of spinner dolphins during the day in nearshore habitats in both the study areas and surrounding waters; spinner dolphin exposure to human activities within the studied resting bays and surrounding waters; and spinner dolphin demographic response to human activities within resting bays and surrounding waters.

    Research in the four bays and nearshore waters of the island of Hawaii began in August 2010 and was completed in May 2013. Results from this study provided robust population estimates for the Hawaii Island stock (see Background), as well as additional information about spinner dolphin habitat use and the pressure that this resident stock faces from dolphin-directed human activities. Many of these studies have been published in scientific literature and scientific reports and were used to inform this rulemaking process (Thorne et al. 2012, Johnson et al. 2013, Heenehan et al. 2014, Tyne et al. 2014, Tyne 2015, Tyne et al. 2015). Below we describe information gained from several of these studies.

    Early researchers (Norris and Dohl 1980, Norris et al. 1994) hypothesized that essential daytime habitats have specific environmental characteristics making them more favorable to the dolphins in supporting resting behaviors, such as shallow, calm, flat, protected, sandy-bottomed bays that provide easy access to nearby deep-water foraging areas. Thorne et al. (2012) used dolphin surveys and predictive habitat modeling to test a suite of these environmental factors that may make spinner dolphins favor these areas. The study found that proximity to deep-water foraging areas, depth, the proportion of bays with shallow depths, and low rugosity (indicating low substrate roughness, i.e., sand) were important predictors of spinner dolphin habitat. The strongest predictors of spinner dolphin resting habitat were distance to the 100-m depth contour (foraging habitat) and depth of the resting areas, with spinner dolphin resting habitat generally occurring in the shallow depths (<50 m) within a bay that was close to the 100-m depth contour and thus, their offshore foraging grounds (Thorne et al. 2012). In tests of these characteristics across the MHI, the bays that were predicted by the model to be optimal resting habitats were consistent with spinner dolphin resting habitats that are recognized as preferred from various observations and identified in the DEIS.

    Tyne et al. (2015) further examined key ecological characteristics and spinner dolphin behavior to see which characteristics support resting behavior. The most important factor contributing to the likelihood of rest was the dolphins' presence within a bay, meaning that they were most likely to rest when they were inside a bay (Tyne et al. 2015). Another important factor was the presence of sand substrate. In general, spinner dolphins spent disproportionately more time over sandy substrates in and out of bays; however, outside of bays, spinner dolphins were observed mostly travelling over sandy substrates. This supports the finding that the bays themselves are the most important factor for resting behaviors, because even sandy substrate outside of the bays did not significantly predict resting behavior. This work highlights the role that habitat areas play in supporting important fitness enhancing behaviors, specifically rest.

    Johnson et al. (2013) assessed the influence of human activity on the energy budget of Hawaiian spinner dolphins using a theoretical model and comparing predictions from the model to empirical data collected in Kealakekua Bay on spinner dolphin behavior. Under the model, individual dolphins needed to spend at least 60 percent of their time inshore in a resting state to be in a positive energetic balance. Given this assumption, direct observations of spinner dolphins suggest that these animals are currently spending adequate amounts of time engaged in resting behaviors to meet their energetic requirements; however, researchers cautioned that individuals with high energetic demands could be at a deficit. For example, nursing mothers and juveniles generally have a much higher energetic demand and these individuals could be at risk of an energetic deficit. This study also evaluated the likelihood of spinner dolphins resting, given various human activities occurring at different distances. Researchers found that the presence of swimmers within 150 m significantly decreased the likelihood of resting. Interestingly, the likelihood of dolphins resting was higher when vessels were present between 50 and 150 m, creating the appearance of a positive relationship between resting behavior and vessel presence at this distance. These results may demonstrate a difference in dolphins' perceived risk between swimmers and vessels, or a lack of perceived risk associated with vessels. However, this positive relationship between resting behavior and vessels may also be influenced by the high frequency of observations with vessels present between 50-300 m and few observations with no vessels present (Johnson et al. 2013).

    Tyne (2015) similarly noted that spinner dolphins off the west coast of the island of Hawaii are exposed to a high rate of human activities and that this rate of exposure may obscure researchers' ability to distinguish disturbance effects associated with intense viewing pressures. In his evaluations, Tyne (2015) found that spinner dolphins were exposed to human activities within 100 m over 80 percent of the time that the dolphins were using essential daytime habitat. Evaluations between control conditions, i.e., no vessels or people within 100 m of dolphins, and exposure conditions, i.e., vessels or people within 100 m of dolphins, suggested that human activities did not have a significant effect on the probability of spinner dolphins engaging in resting, socializing, or traveling. However, control conditions did not occur often (less than 18 percent of the time) or for long periods of time (median duration of 10 minutes), preventing a robust comparison for the purposes of measuring effects. With so little control data and with short durations between exposures to human activity, Tyne (2015) questioned whether the observed data were representative of true or deep resting behavior, or whether observed resting behavior may only be “light” rest. In this case, observing behavior alone may not be a reliable indicator for measuring disturbance effects, because observed resting behavior may not represent behavior that provides restorative benefits for these animals. The rate of exposure to human activities off the west coast of the island of Hawaii is 25 percent higher than reported for other dolphins studied for behavioral response to human activities in other areas of the world (Tyne 2015). This rate of exposure may place resident stocks at risk and long-term disturbance could result in habitat displacement or reduced fitness as seen in other dolphin populations (Bejder et al. 2006a, 2006b; Lusseau and Bejder 2007).

    Proposed Rulemaking

    The swim-with and approach prohibitions described in this proposed rule are designed to protect spinner dolphins from take, including harassment and disturbance, caused by dolphin-directed activities that are concentrated in coastal waters (within 2 nm (3.7 km) of shore and in designated waters between Lanai, Maui, and Kahoolawe) and reduce the impact of increased viewing and interaction pressures. Although we stress that unauthorized take of spinner dolphins or any marine mammals already is and continues to be prohibited by the MMPA in any location, we believe that specific regulations aimed at identified human activities that result in take of Hawaiian spinner dolphins is warranted because of the chronic disturbance that is currently taking place in nearshore waters. NMFS is proposing these regulations pursuant to its rulemaking authority under MMPA sections 112(a) (16 U.S.C. 1382(a)) and 102 (16 U.S.C. 1372).

    Although not included in this proposed rule, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. The Additional Measures Under Consideration, Time-Area Closures section below discusses both mandatory and voluntary time-area closures as two alternative management options that may enhance protections for Hawaiian spinner dolphins beyond the proposed swim-with and approach rule.

    Scope and Applicability Applications to All Hawaiian Spinner Dolphins

    The proposed rule's swim-with and approach prohibitions would apply to all Hawaiian spinner dolphins found in the action area (see Geographic Action Area section below).

    Geographic Action Area

    The action area for this rule is limited to waters within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e)). The latter designated waters include all water areas enclosed by three line segments that connect points at the 2-nm boundary between the islands as follows: The rhumb line between (A1) 20°32′51″ N./156°43′50″ W. and (A2) 20°42′4″ N./156°55′34″ W. between Kahoolawe and Lanai; the rhumb line between (B1) 20°51′1″ N./156°54′0″ W. and (B2) 20°59′48″ N./156°42′28″ W. between Lanai and Maui; and the rhumb line between (C1) 20°33′55″ N./156°26′43″ W. and (C2) 20°32′15″ N./156°29′51″ W. between Maui and Kahoolawe. Throughout this rule, all coordinates are referenced to the World Geodetic System of 1984 (WGS84).

    This is inclusive of the majority of the nearshore habitats where MHI resident stocks of spinner dolphins engage in daytime behaviors and where dolphin-directed human activities that may result in take are known to occur (see Rationale section below).

    Applications to All Forms of Swimming and Approach

    The regulations apply to all forms of swim-with and approach activities in water and air. Forms of approaching spinner dolphins include, but are not limited to, operating a manned or unmanned motorized, non-motorized, self-propelled, human-powered, or submersible vessel; operating an unmanned aircraft system (UAS) or drone; and swimming at the water surface or underwater (i.e., SCUBA or free diving).

    Requirements of the Proposed Rule Swim-With and Approach Regulations

    The proposed rule would prohibit people from engaging in the following activities around Hawaiian spinner dolphins:

    (1) Approaching or remaining within 50 yards (45.7 m);

    (2) Swimming or attempting to swim within 50 yards;

    (3) Causing a vessel, person, or object to approach or remain within 50 yards; and

    (4) Intercepting, or placing a vessel, person, or other object on a path of a spinner dolphin so that the dolphin approaches within 50 yards of the vessel, person, or object.

    Exceptions

    NMFS considered specific categories that should be exempt from the regulations, which are proposed below:

    (1) Any person who inadvertently comes within 50 yards (45.7 m) of a Hawaiian spinner dolphin or is approached by a spinner dolphin, provided the person makes no effort to engage or pursue the animal and takes immediate steps to move away from the animal;

    (2) Any vessel that is underway and is approached by a spinner dolphin, provided the vessel continues normal navigation and makes no effort to engage or pursue the animal;

    (3) Any vessel transiting to or from a port, harbor, or in a restricted channel when a 50-yard distance will not allow the vessel to maintain safe navigation;

    (4) Vessel operations necessary to avoid an imminent and serious threat to a person or vessel;

    (5) Activities authorized through a permit or authorization issued by the NMFS to take spinner dolphins; and

    (6) Federal, State, or local government vessels, aircraft, personnel, and assets when necessary in the course of performing official duties.

    The exception for vessels transiting to or from ports, harbors, or restricted channels is necessary to allow continuation of safe navigation when approaching spinner dolphins closer than 50 yards is unavoidable. For these cases, the vessel should continue normal navigation to reduce the likelihood that close interactions result in disturbances for an appreciable period of time. The exception for vessel operations necessary to avoid an imminent and serious threat to a person or vessel is needed for the safety of human life and property, and to allow for compliance with applicable navigation rules. The exception for government vessels, aircraft, personnel, and assets operating in the course of official duties is intended to avoid disruption of essential government missions, including enforcement and national security activities. The exception for vessels or persons engaged in an activity authorized through a permit or other authorization issued by the NMFS to take spinner dolphins is necessary to ensure the continued availability of scientific research and biological data necessary to inform management and conservation decisions related to the dolphins. We anticipate that compliance with relevant permit terms and conditions will help minimize the potential impacts to dolphins.

    Rationale Proposed Action—Swim-With and Approach Regulations

    Hawaiian spinner dolphins resident to the MHI are made up of small, genetically isolated stocks that exhibit a specialized behavioral ecology that makes them easy to access in coastal environments during their daytime resting hours. This leaves these resident stocks vulnerable to human-caused disturbance and its effects such as habitat abandonment or declines in reproductive success (Norris et al. 1994, Andrews et al. 2010, Tyne et al. 2014). In the MHI, dolphin-directed activities have increased in recent years and the public's expectation of close interactions has placed increased pressure on resident stocks of Hawaiian spinner dolphins and the habitats that support these stocks (see Background above). Despite outreach, guidelines, and current prohibitions, observations in the field indicate that MHI resident Hawaiian spinner dolphins' natural behaviors are disrupted by activities that include approach by both swimmers and vessels (Ostman-Lind et al. 2004, Danil et al. 2005, Courbis 2004, Courbis and Timmel 2008), and overarching spinner dolphin group behavioral patterns may be changing in essential daytime habitats as a result of these pressures (Norris et al. 1994, Forest 2001, Courbis 2004, Courbis and Timmel 2008).

    Observed individual dolphin responses to disturbance events when closely approached by people and vessels include charging or threat displays, aerial displays, and avoidance behaviors such as moving around and away from people and vessels, or leaving the bay in response to human pursuit (Norris et al. 1985, Norris et al. 1994, Forest 2001, Ostman-Lind et al. 2004, Courbis 2004, Courbis and Timmel 2008). Additionally, researchers have observed changes to behavioral patterns in essential daytime habitats, including differences in aerial activity (Courbis and Timmel 2008) and changes in dolphin residence time and distribution within essential daytime habitats, that may be linked to the intensity of human activity (Forest 2001; Danil et al. 2005; Courbis 2004, 2007; Courbis and Timmel 2008; Ostman-Lind 2007).

    Chronic disturbance can disrupt natural behavioral patterns associated with feeding, resting, nurturing, and socializing, and diminish the animals' ability to utilize the benefits of important habitat, ultimately resulting in negative impacts to the fitness of individuals and resident populations. For example, disturbance while spinner dolphins are resting detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. If these disturbances happen chronically, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young. In other small cetacean populations, chronic human disturbances have been linked to biologically significant impacts such as reduced female reproductive success (Bejder 2005, Lusseau and Bejder 2007).

    In other locations globally, intense dolphin-directed human activities have resulted in changes to targeted dolphin populations' habitat use and even caused habitat abandonment (Bejder et al. 2006a, 2006b; Gannier and Petiau 2006; Nature Conservation Sector 2006; Lusseau and Bejder 2007; Notarbartolo-di-Sciara et al. 2009). For example, in a bay in Tahiti, spinner dolphin residence times were negatively influenced by boat presence. Spinner dolphins often left the bays earlier when there was an increase in boat presence, and this increased boat disturbance may have deterred dolphins from entering the bay the next day (Gannier and Petiau 2006). Additionally, in Samadai Reef, Egypt, spinner dolphins were reported as noticeably distressed from excessive numbers of visitors and people attempting to interact with the dolphins (Notarbartolo-di-Sciara et al. 2009). The spinner dolphin group abandoned this preferred resting area, presumably to avoid the disturbance from vessels and visitors (Nature Conservation Sector 2006), and did not returned to the site until after management measures were put in place. Management measures included prohibiting human entry into the core resting area, and restricting certain activities in areas surrounding the core resting area to prevent further disturbance (Nature Conservation Sector 2006, Notarbartolo-di-Sciara et al. 2009).

    Chronic disturbance of spinner dolphins in the MHI could negatively affect the habitat use or health of resident populations. Additionally, disturbance effects may be amplified in the MHI's resident stocks, which exhibit high site fidelity and restricted gene flow, because the impacts to multiple individuals' health and fitness are quickly reflected in the overall fitness of these small populations (Bejder 2005).

    The 50-yard (45.7 m) approach regulation, including prohibiting swimming with dolphins, is intended to reduce the degree of behavioral disruption from close approaches by vessels and swimmers, while allowing for meaningful dolphin watching opportunities. Research indicates that spinner dolphins exhibit changes and disruptions to natural behaviors from close approach by swimmers (Danil et al. 2005, Courbis and Timmel 2008) and that swimmer presence within 150 m reduces the likelihood of spinner dolphins being in a resting state (Symons 2013, Johnston et al. 2014). Approach by vessels and watercraft have also been shown to disrupt and alter spinner dolphin behavior (Ross 2001, Forest 2001, Timmel et al. 2008). In the MHI, several studies note that close approach by vessels disrupt dolphin behaviors at various distances ranging from 10 m to 300 m (Forest 2001, Timmel et al. 2008). At Midway Atoll in the Northwestern Hawaiian Islands, Ross (2001) found that spinner dolphins were affected by vessel presence at distances as great as 500 m and that the effects increased as the distance decreased. Although Johnson et al.'s (2013) work in the MHI found the likelihood that dolphins were resting was higher when vessels were present between 50 and 150 m, they noted that these results may be influenced by the fact that vessels were present in proximity to the dolphins most of the time.

    We have considered multiple distances that may provide protections for spinner dolphins from human activities that result in take (such as swimming with and approaching dolphins), including 50 yards, 100 yards (91.4 m), or even greater distances. NMFS believes that 50 yards is the minimum distance that will prevent most forms of take, while also providing the public with sufficient opportunity to tailor their conduct to avoid disruptive encounters with spinner dolphins. We already recommend this distance (50 yards) in our wildlife viewing guidelines and request that people do not swim-with wild dolphins to reduce the risk of behavioral disruption from close encounters. These guidelines are recognized by tour operators and are used by some (e.g., Dolphin SMART operators) to help ensure that spinner dolphins are viewed responsibly.

    A 100-yard approach restriction exists for humpback whales and this distance was also considered for reducing take of spinner dolphins. Spinner dolphins are fast-moving, small cetaceans and groups of dolphins may move through areas changing directions throughout the day. A distance restriction of 100 yards provides more space for these animals to move back and forth, and helps ensure that people and vessels have sufficient opportunity to maintain an appropriate distance to avoid take. A 100-yard approach restriction might also be easier for vessel operators to recognize and achieve, as this distance applies to humpback whales. However, approach regulations at a distance greater than 50 yards may be difficult for recreational swimmers to recognize and achieve in the water. Based on the best scientific information available, it is difficult to determine a precise distance beyond which human activity does not have the potential to cause disturbance by disrupting natural behaviors. However, we recognize that not all approaches within 100 yards result in take, and we are concerned that such a prohibition may unnecessarily burden the public, without necessarily achieving the purposes of this rulemaking. Further, this greater distance may diminish both the experience of dolphin watching and opportunities to participate in dolphin watching, because these animals are small and may be difficult to spot at a distance. NMFS recognizes that the dolphin watching industry is important to Hawaii's economy, and that these tours have the ability to inform the public about dolphins and to foster stewardship. To reduce the threat of take occurring (including harassment and disturbance) when swimmers and vessels closely approach dolphins, to remain consistent with the current recommended approach guideline for the region, and to allow for continued dolphin watching opportunities at safe distances, NMFS is proposing a distance of 50 yards for swim-with and approach restrictions.

    The proposed swim-with and approach regulations prevent a range of human activities that occur in close proximity to Hawaiian spinner dolphins. This includes swimming-with spinner dolphins, touching or attempting to touch spinner dolphins; corralling or herding spinner dolphins into small areas; and leap-frogging, all of which have the potential to disturb the dolphins and result in take. Implementation of these prohibitions would include enforcement by NMFS and DLNR Division of Conservation and Resource Enforcement (DOCARE) personnel, and outreach by NMFS staff and volunteers who would assist with an informational campaign about the new regulation and the scientific information on which it is based. This proposed rule provides new tools for enforcement that are measurable, easy to understand, and based on the best available science regarding human impacts on spinner dolphins. To limit some potential impacts to the public from these regulations, we propose exceptions that are designed to allow for transit into and out of ports, harbors, and restricted channels; public safety measures; avoidance of penalties when the animal has closely approached a boat or person; and continuation of essential government and permitted activities (see Exceptions section above). The DEIS contains a full analysis of a No Action Alternative, other alternatives, and the Preferred Alternative.

    The costs of implementing human and vessel regulations to protect the dolphins are expected to be low. Some will be borne by the commercial dolphin watch and dolphin swim industry, dolphin-associated spiritual retreats, and other generalized nature tours (see the DEIS and the Regulatory Flexibility Act section below for more information). While some dolphin watch companies and community members have suggested that restricting swimming with the dolphins or closely approaching them may affect revenue, surveys of tour participants indicate that close approach of the dolphins may not be the most important aspect for the dolphin watching participants, and that participants will support viewing these animals in a manner that reduces the potential for disruptive encounters with dolphins (Wiener 2015). Other impacts to boaters, swimmers, kayakers, and others who are not engaged in dolphin-directed activities are expected to be minor and include slight changes to operations to comply with the proposed regulations.

    The reduction in disturbance to Hawaiian spinner dolphins, as addressed through each element of the rule as described above, provides a benefit to the dolphins as well as to members of the public who value the dolphins. Reducing threats to the dolphins also supports the long-term sustainability of the responsible dolphin watching industry.

    Geographic Scope (Distance From Shore)

    The proposed regulations are designed to address dolphin-directed activities that are resulting in various forms of take of Hawaiian spinner dolphins. NMFS selected 2 nm (3.7 km) from shore around the MHI as well as designated waters between the islands of Lanai, Maui, and Kahoolawe as the boundary for the proposed prohibitions because this range encompasses the areas where current and best available information indicates that most dolphin-directed activities are likely to be concentrated. NMFS gathered information from scientific literature about Hawaiian spinner dolphin daytime habitat preferences and information from over 400 sightings of spinner dolphins collected around the MHI since 1992 from various members of the Pacific Islands Photo Identification Network (PIPIN) to determine where resident spinner dolphins are likely to occur during the day. Dolphin-directed activities in Hawaii are concentrated in the nearshore portion of the island-associated Hawaiian spinner dolphin stocks' ranges because these stocks are easily accessed in coastal waters during the day when most people seek out marine recreational activities.

    Daytime habitat for Hawaiian spinner dolphins varies across the MHI, because the bathymetry, or depths and shapes of underwater terrain, is different for each island, and spinner dolphins seek out areas with physical and biological characteristics that support their ecological needs (see Background section). On Hawaii Island, Norris et al. (1994) indicate that spinner dolphins generally prefer areas with depths of less than 50 m for engaging in resting activities, and Thorne et al. (2013) note that resting habitats generally occur in close proximity to the 100-m contour (close to the inshore extent of prey species at night). Spinner dolphins are also known to transit along Hawaii Island's coastline, moving between resting areas during the day. Lammers et al. (2004) indicate that Oahu's spinner dolphins show a strong affinity for the 10-fathom isobath (18.3 m), and note that approximately 93 percent of sightings off Waianae and 81 percent of sightings off the south shore of Oahu occurred at depths shallower than 17 fathoms (31.1 m). Lammers et al. (2004) also note that foraging activities begin by evening around the 100-fathom isobath (182.9 m) off Oahu. Information received from PIPIN indicates that approximately 89 percent of spinner sightings across the MHI were in waters within the 100-m depth contour and that 95 percent were in waters within the 200-m depth contour, although spinner dolphins have been observed in waters during the day where depths are as great as 3,000 m (NMFS 2016).

    In reviewing this information, we determined that selecting a boundary based on depth in any particular area may be difficult for people to identify without having access to proper instrumentation (which would be especially difficult for kayakers, standup paddleboarders, and swimmers), and that the distance from shore may provide a more easily discerned boundary. In addition, although spinner dolphin daytime habitat may be located at different distances from the shoreline of different islands, establishing different prohibitions based on the location of these daytime habitats (e.g., having restrictions out to 1 nm (1.9 km) or 2 nm depending on the island) could subject the public to inconsistent and confusing requirements, and complicate both enforcement of and compliance with these regulations. This could be particularly difficult in areas where multiple islands are visible and the restricted distances differ around different islands. Therefore, we evaluated consistent distances from shore across the MHI.

    We reviewed the habitat preferences and sighting information as it relates to distance from shore to identify a boundary that would be easy for people to recognize and would incorporate the best available information about spinner dolphin habitat preferences and sighting information. Along the west coast of Hawaii Island, habitats that are 50 m or less in depth and where dolphin-directed activities are prevalent, are encompassed within 1-1.5 nm (1.9-2.8 km) from shore. Habitats within 100 m depth fall almost entirely within 2 nm of shore, and at 3 nm (5.6 km) these areas are entirely included. Off the west coast of Oahu, where most dolphin-directed activities on this island occur, the 10-fathom (18.3 m) isobath is largely captured within 1 nm of shore, while 17 fathoms (31.1 m) is largely captured within 1.5 nm. Habitats of these depths extend out farther on the south shore where spinner dolphins are also known to rest; these habitats are largely captured within 1.5 and 2 nm from shore respectively. The 100-fathom (182.9 m) contour is largely captured within 1.5 nm on the west side of the island, but extends out past 3 nm on the south shore. Little information is available from the other MHIs regarding specific depth preferences, although there are areas where the 50- and 100-m depth contours extend past 4 nm (7.4 km). Off most of the MHI, a large majority of the PIPIN sighting information is captured within 2 nm from shore.

    A key area for spinner dolphin sightings during the day, where the depth contour extends out past 4 nm, is between the islands of Lanai, Maui, and Kahoolawe. This area is traversed by many recreational and commercial tour vessels in search of marine mammal viewing opportunities throughout the day. Consequently, spinner dolphins also require protections in this area. To ensure that dolphins are protected throughout the day where they may transit between islands and encounter dolphin-directed activities, we delineated an area around all three islands that includes the 2-nm buffer around the outside of each island and the channels and waters between these islands. This delineated area includes 96 percent of all PIPIN sighting information across the MHI.

    We are proposing this action to reduce the threat of take of Hawaiian spinner dolphins (including harassment and disturbance) caused by dolphin-directed activities that are concentrated in coastal waters of the MHI and to reduce the impact of increased viewing and interactions pressures on MHI resident stocks. We do not expect that these same pressures are prevalent in the outer portions of the MHI stocks' ranges, because these spinner dolphins are not easily accessed when they are offshore. Therefore, the proposed rule applies to an area within 2 nm of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe. This area encompasses the majority of the resident stocks' daytime habitat, thereby incorporating the area where spinner dolphins are easily accessed and where take of Hawaiian spinner dolphins is most likely to occur.

    Additional Measures Under Consideration: Time-Area Closures

    Although not currently proposed, we are also considering and seeking public comment on whether additional management measures (beyond swim-with and approach regulations) may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. At this time, we believe that the swim-with and approach regulations alone will provide sufficient protection to Hawaiian spinner dolphins, by reducing close encounters between spinner dolphins and humans that result in take. We also expect that the swim-with and approach regulations will reduce the intensity of activities within essential daytime habitats that are targeted by people for dolphin-directed activities to some degree. However, NMFS recognizes that the intensity of activity in some of these areas is high and that additional measures could be necessary.

    Area closures have been shown to be an effective management tool for addressing the intensity of wildlife viewing and interaction in other areas globally (Notarbartolo-di-Sciara et al. 2009, Nature Conservation Sector 2006). Area closures provide members of the public with precise boundaries so that they may readily tailor their conduct accordingly. However, area closures can also carry undesired costs, such as by imposing a burden on the public when spinner dolphins are not present. We are mindful of this potential and believe a careful approach is warranted. By first implementing swim-with and approach regulations, we expect to reduce take of Hawaiian spinner dolphins resulting from interactions with swimmers and vessels. We also expect to gather additional information about the effectiveness of these measures. Should this action's swim-with and approach regulations provide insufficient protection for Hawaiian spinner dolphins using essential daytime habitats, we would consider additional conservation and management measures, including time-area closures, to reduce take in high intensity areas. Below we discuss two management options that are analyzed in the DEIS. We invite public comment about whether and at what point these management options or others may be necessary and appropriate to protect Hawaiian spinner dolphins from take.

    Two possible management options evaluated in the DEIS would create either mandatory (see Alternative 4 in the DEIS) or voluntary (see Alternative 5 in the DEIS) time-area closures in five essential daytime habitats, in addition to the swim-with and approach regulations. We selected the five areas for potential time-area closures using a step-down process. In this approach, we identified important habitats that might benefit from additional protection, and then considered additional factors that may promote or obstruct the effectiveness of the closure. (See Appendix A of the DEIS for more detail.) The five sites are essential daytime habitats where human activities are largely Hawaiian spinner dolphin-directed, where closures are logistically feasible, and where regulatory measures can be balanced most effectively with human ocean use to protect these dolphins. Once the sites were selected for time-area closures, we delineated core areas within each of the five sites where spinner dolphins are most often engaged in resting activities. The core areas would be subject to closure, while leaving other areas of the bays open in order to minimize impacts on other human activities (e.g., snorkeling, surfing).

    As noted in the SAPPHIRE Project section above, essential daytime habitats are particularly important to island-associated spinner dolphins because the habitats provide environmental characteristics that support the dolphins' ability to minimize travel to offshore food sources and to detect predators (Norris and Dohl 1980, Norris et al. 1994, Thorne et al. 2012). Tyne et al. (2014) reported that spinner dolphins off the island of Hawaii are most likely to rest while inside these habitats that support predator detection and noted that dolphins using these areas off the west coast of Hawaii are experiencing human activities within 100 m over 80 percent of the time. Chronic wildlife disturbance within important habitats may lead to habitat abandonment and/or negatively impact the health of individual dolphins, ultimately leading to population level impacts (Frid and Dill 2002, Bejder 2006). Additional management in these areas may be important to ensure that Hawaiian spinner dolphins are given sufficient space for groups to engage in deep resting behaviors that allow dolphins to recuperate from other energy demanding activities, such as foraging.

    For time-area closures we are considering a closure time of 6 a.m. to 3 p.m. This time-period would allow spinner dolphins to enter essential daytime habitats without disturbance and remain in these areas undisturbed during peak resting hours, while allowing for human activities to occur (at a distance greater than 50 yards (45.7 m) in accordance with the approach regulations) after 3 p.m. Historic spinner dolphin resting times (before human interactions were likely a major factor in the dolphins' resting patterns) were observed to occur between dawn and dusk (Norris and Dohl 1980), and research indicates that Hawaiian spinner dolphin resting behavior still occurs throughout daytime hours (generally 6 a.m. to 6 p.m.) with the highest resting activity occurring between 10 a.m. and 2 p.m. (Tyne et al. 2015). Nevertheless, some Hawaiian spinner dolphin groups have been deterred from entering their essential daytime habitat if human presence in the area was too high early in the day (Danil et al. 2005). Preventing disturbance in these habitats during early morning hours is important to support spinner dolphins' arrival to the essential daytime habitat and their descent into rest. The late afternoon hours are considered a time of transition and described as a time when the dolphins rally together and engage in zig zag movements as they are waking from their deep rest, prior to moving offshore to their foraging grounds (Norris et al. 1994). However, the afternoon hours are also a popular time for human recreational use. Because the swim-with and approach regulations would provide a measure of protection for spinner dolphins as they increase activity toward the end of their resting period, we would end the closure time at 3 p.m. Swim-with and approach regulations would continue to provide a buffer of protection to the dolphins at the end of their peak resting times, while also allowing some of these human activities to occur for a limited time period.

    For either mandatory or voluntary closure options, the closure areas would be marked using buoys, sight-line markers, and landmarks from shore, and explanations of the closure's purpose and effective hours would be provided by signs on land and through other public outreach efforts. The intent of both mandatory and voluntary closures would be to prevent take by eliminating the intense human activity within essential daytime habitats during important resting times. These closures would allow for increased opportunities for spinner dolphins to engage in fitness-enhancing behaviors in the absence of vessels and people.

    The bays identified for the mandatory and voluntary time-area closure options are (1) Makako Bay, (2) Kealakekua Bay, (3) Honaunau Bay, and (4) Kauhako Bay on the island of Hawaii, and (5) La Perouse Bay on the island of Maui. Below we describe the areas delineated for the time-area closures; these areas are also depicted in Figures 1-5 of this preamble.

    Makako Bay. The lines between points A, B, C, and D shown in Figure 1 illustrate the marine boundaries for the time-area closure for Makako Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and D. The following geographic coordinates provide the approximate location for each point in Figure 1: A) 19°44′21.61″ N., 156°3′16.37″ W.; B) 19°44′25.18″ N., 156°3′26.07″ W.; C) 19°44′2.16″ N., 156°3′35.51″ W.; and D) 19°43′57.31″ N., 156°3′23.04″ W. Two buoy markers would be placed at points B and C aligned with site line markers on shore at points A and D to delineate the closure area (Figure 1). The closure encompasses approximately 0.14 mi2 (0.36 km2) of essential daytime habitat used by Hawaiian spinner dolphins. These coordinates, and coordinates for the other time-area closures, are considered approximate because the exact locations would not be specified until the buoy anchoring system is identified and an underwater survey is completed.

    No public access point from shore is identified by the County of Hawaii for Makako Bay. The closest access points are identified south at Wawaloli Beach, with another access point identified North at Keahole Point.

    Kealakekua Bay. The lines between points A, B, C, and D shown in Figure 2 illustrate the time-area closure for Kealakekua Bay. The following geographic coordinates provide the approximate location for each point in Figure 2: A) 19°28′37.82″ N., 155°55′15.03″ W.; B) 19°28′54.23″ N., 155°55′44.90″ W.; C) 19°28′48.42″ N., 155°55′49.04″ W.; and D) 19°28′32.19″ N., 155°55′19.20″ W. The closure area would be delineated by means of six marker buoys—one located at each corner and one located at the middle of each of the lengthwise boundaries. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.08 mi2 (0.21 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

    The County of Hawaii identifies two public access points on Boulder Beach and Napoopoo Landing at Kealakekua Bay; both points would remain open for access. Additionally, the route used by kayakers to access the Captain Cook Monument at Kaawaloa from Napoopoo Pier is located outside of the closure area. A line on the map going across the bay depicts this route.

    Honaunau Bay. The lines between points A, B, and C shown in Figure 3 illustrate the marine boundaries for the time-area closure for Honaunau Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and C. The following geographic coordinates provide the approximate location for each point in Figure 3: (A) 19°25′27.13″ N., 155°54′41.65″ W.; (B) 19°25′21.41″ N., 155°54′58.17″ W.; and (C) 19°25′31.99″ N., 155°54′58.24″ W. The closure site at Honaunau would be delineated by means of a single marker buoy at point B to accommodate local native Hawaiians' requests to honor the sacred nature of this cultural site, and would be aligned with site line markers on shore at points A and C (Figure 3). Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.04 mi2 (0.10 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

    The County of Hawaii identifies Honaunau Bay boat ramp as a public access area for this bay. The boat ramp and the popular access point for swimming and snorkeling known as Two-Step are located outside of the closure area, and would remain open for everyday use.

    Kauhako Bay. The lines between points A, B, and C shown in Figure 4 illustrate the marine boundaries for the time-area closure for Kauhako Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and B. The following geographic coordinates provide the approximate location for each point in Figure 4: (A) 19°37′86.15″ N., 155°89′68.10″ W.; (B) 19°37′91.79″ N., 155°89′95.98″ W.; and (C) 19°37′04.02″ N., 155°89′70.41″ W. A single marker buoy would be placed approximately 35 m from shore to delineate the inner bay closure boundary. Sight line markers at each of the points A, B and C (Figure 4), and two buoys placed along the offshore boundary (line B-C) would delineate the closure area at this bay. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.087 mi2 (0.18 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

    The County of Hawaii identifies Hookena Beach Park as a public access point for this area. The nearshore area located inshore of the line between points A and B would be open for everyday use, including swimming, snorkeling, and freediving.

    La Perouse Bay. The lines between points A, B, C and D shown in Figure 5 illustrate the marine boundaries for the time-area closure for La Perouse Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and C, and between B and D. The following geographic coordinates provide the approximate location for each point in Figure 5: (A) 20°35′56.90″ N., 156°25′17.04″ W.; (B) 20°35′25.68″ N., 156°24′44.72″ W.; (C) 20°35′39.30″ N., 156°25′33.85″ W.; and (D) 20°35′10.98″ N., 156°24′50.90″ W. A single marker buoy would be placed approximately 100 m offshore of the most popular snorkeling entry point to delineate the nearshore boundary line, with three buoys placed along the offshore boundary line (line C-D) to delineate the outer closure boundary. Shore-based markers at points A, B, C, and D would provide a sightline. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.32 mi2 (0.83 km2) of resting habitat used by Hawaiian spinner dolphins.

    Maui County identifies La Perouse as a public access point for this area (coordinates: 20°36′09.66″ N., 156°25′22.48″ W.). The area inshore of the line between A and B, which includes this access point, would remain open for everyday uses such as surfing, snorkeling, and freediving.

    Activities occurring in the intertidal zone (the area that is above water at low tide and under water at high tide), such as shore-based fishing and subsistence gathering, would be able to continue during any time of day in either type of closure.

    BILLING CODE 3510-22-P EP24AU16.123 EP24AU16.124 EP24AU16.125 EP24AU16.126 EP24AU16.127 Mandatory Time-Area Closures and Swim-With and Approach Regulations

    Although not currently proposed, if we were to implement mandatory time-area closures in addition to promulgating swim-with and approach regulations (described under Alternative 4 in the DEIS), we would create the time-area closures (depicted in Figures 1-5 above) and promulgate regulations that prohibit use of waters within the five delineated areas from 6 a.m. to 3 p.m.. All Exceptions (see section above) described for the proposed swim-with and approach regulations would apply to this alternative, and the following three additional exceptions would also apply to the mandatory time-area closures:

    (1) Vessels that transit the time-area closure for the sole purpose of ingress and egress to privately-owned shoreline residential property located immediately adjacent to the time-area closure;

    (2) Vessels participating in organized community-based outrigger canoe races that transit straight through a time-area closure; and

    (3) Vessels that transit straight through the time-area closure for the purpose of traditional subsistence fishing where harvested resources are intended for personal, family, or community consumption or traditional use and not for commercial market sale.

    Entering mandatory time-area closures during closed periods would result in a violation unless an exception to the rule applies.

    Mandatory time-area closures would prevent take within these important areas and ensure that spinner dolphins are provided space to achieve deep rest during the day. Additionally, regulations to impose these closures would provide a strong tool for enforcement that is measurable and easy to understand, promoting both enforcement and compliance. Under this management option, swim-with and approach regulations would reduce disturbance to Hawaiian spinner dolphins from close approach activities throughout nearshore areas, and mandatory time-area closures would provide additional protection by reducing the intensity of viewing pressure in five essential daytime habitats.

    Voluntary Time-Area Closures and Swim-With and Approach Regulations

    Although not currently proposed, if we were to implement voluntary time-area closures in addition to promulgating swim-with and approach regulations (Alternative 5 in the DEIS), we would demarcate the same five areas for voluntary time-area closures as are described for the mandatory closures (see Mandatory Time-Area Closures with Swim-with and Approach Regulation above). Through outreach, we would ask the public to refrain from using waters within the five delineated areas from 6 a.m. to 3 p.m. Participation in the time-area closures would be voluntary, and no penalties would apply to people or vessels that enter the areas during designated spinner dolphin resting times. The voluntary time-area closures would not apply to any activity that falls within the Exceptions (see above) described for the swim-with and approach regulations, or the three additional exceptions described for the mandatory time-area closures option (see three exceptions in the Mandatory Time-Area Closures and Swim-with and Approach Regulations section above). Under this alternative, compliance with the time-area closure would be voluntary.

    Success with voluntary measures requires strong community engagement and support. Ideally, conservation benefits for Hawaiian spinner dolphins would be the same for mandatory and voluntary closures because both management measures demarcate space for Hawaiian spinner dolphins to engage in resting behaviors. However, we expect that compliance with voluntary measures would be generally lower than compliance with regulations that are enforced (May 2005), and within the five bays, resource users are diverse and have varying motivations and beliefs with regard to Hawaiian spinner dolphin conservation. The lack of a common understanding about the value of these conservation measures may make it difficult to achieve voluntary compliance for the closures. Further, inconsistent compliance with voluntary measures could lead to increased tension between resource user groups that have conflicting views about Hawaiian spinner dolphin conservation.

    Additional Measures Eliminated From Consideration

    NMFS did not propose some of the regulatory options suggested in the ANPR and in public comments for several reasons, including the measures' inability to meet the purpose and need for this rulemaking (see the DEIS for more detail), difficulties in enforcing them, changes to infrastructure needed to implement them, lack of effectiveness of the measures, lack of resources available to institute them, and the complexity associated with complying with the measures. For example, a permit certification program for all marine operators that engage in some form of dolphin viewing would be inappropriate for addressing chronic and concentrated viewing practices, would require a large processing infrastructure to implement throughout the Hawaiian Islands, and would not address disturbance caused by vessels that are not conducting dolphin tours (e.g., recreational vessels or kayaks). Another suggestion, implementing full closures of all identified resting habitats throughout the Hawaiian Islands, would create many restrictions on activities that are not dolphin-directed, obstruct some harbors, be costly, and require a larger infrastructure to institute and enforce. We discuss these and other regulatory options suggested in public comments in the DEIS for this action.

    Public Comments

    We are soliciting comments on any aspect of these proposed swim-with and 50-yard (45.7 m) approach regulations. As explained above, NMFS does not propose to implement mandatory or voluntary time-area closures as part of this rulemaking. At this time, NMFS believes that the proposed swim-with and approach regulations will provide adequate protection to spinner dolphins against take, including harassment and disturbances. Should NMFS determine that swim-with and approach regulations provide insufficient protection for Hawaiian spinner dolphins using essential daytime habitats, we would consider additional conservation and management measures, including time-area closures to reduce take in high intensity areas, in a separate rulemaking.

    We are particularly interested in comments concerning the following: (1) Effects of the increasing number of human interactions with Hawaiian spinner dolphins; (2) proposed prohibited and exempted activities; (3) whether 50 yards is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (4) whether 100 yards (91.4 m) or another distance is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (5) research recommendations and priorities for better understanding how human disturbance affects Hawaiian spinner dolphins; (6) information on responsible viewing of marine mammals; (7) additional information on spinner dolphin behaviors; (8) other human activities affected by the proposed rule that were not discussed; (9) the temporal and geographic scope (i.e., 2 nm from shore) of the approach regulation; (10) whether the area where the approach regulation is proposed in the Lanai- Maui-Kahoolawe triangle is adequate and appropriate; (11) whether time-area closures are necessary to address the intensity of Hawaiian spinner dolphin-directed activities in some areas; (12) the effectiveness of mandatory versus voluntary closures; (13) the bays and times of day identified for time-area closures; (14) information about other areas where Hawaiian spinner dolphins may face pressures from human viewing and interaction; and (5) suggestions on other areas that should be considered for time-area closures.

    Please be aware that 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.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    References Cited

    A complete list of all references cited in this proposed rule can be found on our Web site at: http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html, or at www.regulations.gov, and is available upon request from the NMFS office in Honolulu, Hawaii (see ADDRESSES).

    Classification National Environmental Policy Act (NEPA) and Regulatory Impact Review (RIR)

    NMFS has prepared a DEIS and an RIR pursuant to NEPA (42 U.S.C. 4321 et seq.) and Executive Order (E.O.) 12866, to support this proposed rule. The DEIS/RIR contains a full analysis of a No Action Alternative, five action alternatives, and the Preferred Alternative that we are proposing. There are a number of elements that were common to all of the action alternatives analyzed, including the preferred alternative proposed in this notice, and a number of exceptions that would apply to these alternatives. The DEIS/RIR and supporting documents are available for review and comment and can be found on the NMFS Pacific Islands Region Web site at http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html.

    Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, whenever an agency publishes a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a Regulatory Flexibility Analysis describing the effects of the rule on small entities, i.e., small businesses, small organizations, and small government jurisdictions.

    Pursuant to the RFA, NMFS prepared the following Initial Regulatory Flexibility Analysis (IRFA). A description of the action, why it is being considered, and the legal basis for this action are contained in the preamble to this proposed rule. This proposed rule does not duplicate, overlap, or conflict with other Federal rules. The analysis contains a description of and, where feasible, an estimate of the number of, small entities to which the proposed rule will apply. The Small Business Administration (SBA) establishes criteria for defining a “small entity” for purposes of the RFA. This IRFA analyzes the proposed alternatives and other alternatives described in the preamble to the rule, and does not address alternatives previously considered and subsequently dismissed in the DEIS. There are no record-keeping or reporting requirements associated with this proposed rule.

    Description and Estimate of the Number of Small Entities to Which the Proposed Rule Applies

    There are several types of industries directly affected by this proposed rulemaking: Swim-with-wild-dolphins tour operators; dolphin watch tour operators; non-motorized vessel ocean wildlife viewing tour operators; and generalized commercial boat tour operators. This analysis uses size standards prescribed by the SBA. Specifically, for scenic and sightseeing water transportation operators (North American Industry Classification System Code 487210), the SBA size standard for a small business is average annual receipts of $7.5 million or less. Much of the background information for potentially affected entities is based on a 2007 report that summarized surveys and other information collected in 2006 with regard to participants within these industries that potentially interact with Hawaiian spinner dolphins to varying degrees in the MHI (Impact Assessment 2007). The report provides information that suggests that all businesses operating in the swim-with-wild-dolphins tour and the kayak tour industries operating in 2006 could be considered small entities, and all but one of the generalized commercial boat tour operators were assumed to be small entities (Impact Assessment 2007). This is the most recent information available to NMFS regarding revenue information, but NMFS notes that the composition of these vessel-based tour industries, including the number which can be considered small entities and the total number, may have changed since the report was written.

    Swim-with-wild-dolphins tour operators are those that bring clientele into close proximity with spinner dolphins. This includes health and/or spiritual retreat operations as well as dolphin-oriented swim tours. Health and spiritually-linked businesses provide opportunities for persons wishing to interact with spinner dolphins for perceived physical, mental, and/or spiritual well-being enhancement. Spiritually-linked tour operations may charter vessels through other established dolphin-swim companies to transport customers as part of an overall per-person package consisting of lodging, swimming with dolphins, and other activities. For spiritual retreats that offer dolphin swims, the number of businesses is estimated to be as follows: Hawaii (22), Maui (7), Oahu (1), and Kauai (2+).

    Dolphin-oriented swim tours operate by transporting passengers by boat or having them swim from shore to areas in which dolphins are known to be present during daytime hours. Customers may also be provided with facemasks, fins, floatation devices, and snorkels to enhance viewing. Recent information compiled by NMFS suggests that the number of swim-with-dolphins tour companies is as follows: Hawaii (22), Maui (2), Oahu (10), and Kauai (1). All are believed to be small entities.

    Dolphin-watch tour operators involve taking clients out specifically to view wild dolphins. These companies tend to operate smaller boats than the more generalized commercial boat tours described below, and are more likely to view dolphins at a closer range. Revenue information for this specific business category is not available. NMFS estimates the number of dolphin watch tour businesses to be as follows: Hawaii (3), Maui (21), Oahu (3), and Kauai (11).

    More generalized commercial boat tours offer a range of ocean activities, which may include sightseeing, snorkeling, diving, viewing various forms of sea life from a vantage point in and/or above the water, or just generally spending time on the ocean. The majority of the general tour boats derive revenue from whale watching and sightseeing operations, while a number of the dive/snorkel vessels offer snorkeling or diving trips. Based on recent information collected by NMFS, the estimated number of generalized commercial boat tour businesses reportedly involving indirect dolphin interaction is estimated as follows: Hawaii (10), Maui (19), Oahu (36), and Kauai (12). NMFS believes that most, but not all, would be considered small entities.

    Non-motorized vessel ocean wildlife viewing tour operators, specifically kayak tour businesses around the MHI, provide a general wildlife viewing experience, with a very small number of operators advertising direct or intentional interactions with dolphins. The number of kayak tour operators who advertise the opportunity to directly interact with wild dolphins is not available. NMFS estimates the numbers of companies that either operate kayak tours or rent out kayaks to be as follows: Hawaii (6), Maui (9), Oahu (6), and Kauai (13).

    The estimated numbers of small entities directly affected by the proposed rulemaking, by industry, on the MHI are as follows: 67 swim-with-wild-dolphins tour operators (including health and/or spiritual retreats enabling opportunities to swim with wild dolphins), 77 generalized commercial boat tour operators (one or more of which are likely to be considered large entities), and 34 kayak tour and rental companies.

    Economic Impacts to Small Entities Resulting From the Proposed Action (Swim-With and 50-Yard Approach Regulations)

    The preferred alternative would restrict all activities associated with close approach to Hawaiian spinner dolphins, including swimming with dolphins and close approach by vessel. These prohibitions would be applicable within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe.

    The proposed action to ban swimming and approaching within 50 yards (45.7 m) of Hawaiian spinner dolphins, has the potential to eliminate all commercial activities that result in take of spinner dolphins (e.g., swim-with-wild-dolphins) at a close distance. Therefore, implementing this proposed action would require operators that currently offer the opportunity to swim with spinner dolphins to cease this specific activity, although they may choose to continue to provide other services among their menu of options. For example, a spiritual retreat that offers a menu of other activities along with swim-with-wild-dolphins activities may continue to offer the other activities. In addition, swim-with-wild-dolphins tour operators may choose to transition to operate as a dolphin-watching or generalized tour vessel operation. For these businesses, eliminating opportunities to swim with wild spinner dolphins within 50 yards is likely to result in a reduction in revenue in the short term and potentially in the long term. The decrease in revenue could come from the reduction in the number of customers, specifically those who seek the experience of swimming with spinner dolphins, and/or reduced trip or package prices with a reduced menu of options available for each trip. The loss in overall revenue to individual businesses and the industry as a whole that rely on close approach with spinner dolphins by any means for revenue is uncertain. The same is true with regard to the number of businesses that would be still be able to remain in operation if the proposed regulation is implemented.

    Commercial wildlife boat tour operators, including generalized commercial boat tour operators, dolphin watch tour operators, and non-motorized vessel tour operators, would no longer be able to take customers to view Hawaiian spinner dolphins from closer than 50 yards. Restricting operators from approaching within 50 yards of spinner dolphins may reduce demand for vessel-based tours among customers who specifically hope to view dolphins from a vessel at a closer range, although there will be no options other than not taking a tour at all, as no boats in Hawaii would be able to offer tours closer than 50 yards. Some tour operators may be able to offer alternative recreational opportunities or amenities as part of a tour to help offset any loss in demand for tours. For generalized tour boat operators with a clientele base that does not have a specific goal of viewing spinner dolphins, the direct economic impact of the proposed action is likely to be minimal.

    NMFS concludes that there would be disproportionate impacts to the swim-with-wild-dolphin tour operators from implementation of this preferred alternative relative to all other general wildlife viewing tour operators. Similarly, because of the focus of activities, it is also likely that the dolphin watch tour industry will face greater impacts than the generalized wildlife tour companies. As a result, dolphin-watch tour entities may face disproportionate impacts relative to the generalized commercial boat tour companies, which are likely to incur few direct economic impacts from the proposed action. We note that dolphin watch tour entities are all believed to be small entities, and most of the generalized commercial boat tour companies are as well, although a few might be considered large entities with revenues exceeding $7.5 million.

    NMFS considered other alternatives in addition to the swim-with and 50-yard approach regulations in this proposed rule (i.e., Alternative 3a). These include 1) no action; 2) swim-with regulations; 3b) swim-with and 100-yard (91.4 m) approach regulations; 4) mandatory time-area closures and swim-with and approach regulations; and 5) voluntary time-area closures and swim-with and approach regulations. As is the case for this proposed action, Alternatives 2, 3b, 4, and 5 would all be applicable within 2 nm of each MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe. Among the non-selected action alternatives, only Alternative 2 (no swimming with Hawaiian spinner dolphins) would result in a lower direct economic impact to small entities. While the restriction on swimming with dolphins would address one threat to Hawaiian spinner dolphin population, this alternative would not address the remaining documented threats to dolphin populations caused by close approach by vessels and other craft. Section 4.2.2 of the DEIS provides more detail. The remaining non-selected action alternatives would most likely result in a higher economic impact to individual small entities and the dolphin-viewing industry as a whole, relative to the preferred alternative of this proposed action. NMFS has determined that the proposed action meets the goals and objective of reducing human-caused disturbances that Hawaiian spinner dolphins are facing in their natural habitat, and helps protect against declines in the fitness of the population over time.

    No additional reporting, record keeping, and other compliance requirements are anticipated for small businesses. NMFS has identified no Federal rules that may duplicate, overlap, or conflict with the action alternatives.

    Executive Order 12866

    This proposed rule was determined to be not significant for purposes of E.O. 12866.

    Paperwork Reduction Act

    The purpose of the Paperwork Reduction Act is to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, and other persons resulting from the collection of information by or for the Federal government. The preferred alternative includes no new collection of information, so further analysis is not required.

    National Historic Preservation Act (NHPA)

    The goal of the National Historical Preservation Act (NHPA; 16 U.S.C. 470 et seq.) is to have Federal agencies act as responsible stewards of our nation's resources when their actions affect historic properties. Section 106 of the NHPA requires Federal agencies to take into account the effects of undertakings they carry out, assist, fund, or permit on historic properties. Federal agencies meet this requirement by completing the section 106 process set forth in the implementing regulations, “Protection of Historic Properties,” 36 CFR part 800. The goal of the section 106 process is to identify and consider historic properties (or sites eligible for listing) that might be affected by an undertaking, and to attempt to resolve any adverse effects through consultation. The process provides for participation by State Historic Preservation Officers, Tribal Historic Preservation Officers, tribal, state and local governments, Indian tribes and Native Hawaiian organizations, applicants for Federal assistance, permits, or licenses, representatives from interested organizations, private citizens, and other members of the public. Federal agencies and consulting parties strive to reach agreement on measures to avoid, minimize, and mitigate adverse effects on historic properties and to find a balance between project goals and preservation objectives.

    Under the NHPA, an “effect” means an alteration to the characteristics of a historic property qualifying it for inclusion or eligibility for the National Register. The proposed swim-with and approach regulations for Hawaiian spinner dolphins, if finalized, would not have the potential to cause effects on or alterations to the characteristics of historic properties. Therefore, section 106 consultation is not required.

    Coastal Zone Management Act

    Section 307(c)(1) of the Federal Coastal Zone Management Act of 1972 requires that all Federal activities that affect any land or water use or natural resource of the coastal zone be consistent with approved state coastal zone management programs to the maximum extent practicable. We have determined that these proposed swim-with and approach regulations are consistent to the maximum extent practicable with the enforceable policies of the approved Coastal Zone Management Program of Hawaii. This determination, a copy of this document, and the DEIS will be submitted for review by the Hawaii Coastal Zone Management Program.

    Executive Order 13132, Federalism

    E.O. 13132 requires agencies to take into account any federalism impacts of regulations under development. It includes specific consultation directives for situations in which a regulation may preempt state law or impose substantial direct compliance costs on state and local governments (unless required by statute). NMFS has determined that the proposed swim-with and approach regulations do not have federalism implications.

    Information Quality Act (IQA)

    Pursuant to Section 515 of Public Law 106-554 (the Information Quality Act), this information product has undergone a pre-dissemination review by NMFS. The signed Pre-dissemination Review and Documentation Form is on file with the NMFS Pacific Islands Regional Office (see FOR FURTHER INFORMATION CONTACT).

    List of Subjects in 50 CFR Part 216

    Administrative practice and procedure, Marine mammals.

    Dated: August 19, 2016. 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 216 is proposed to be amended as follows:

    PART 216—REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS 1. The authority citation for part 216 continues to read as follows: Authority:

    16 U.S.C. 1361 et seq.

    2. Add § 216.20 to subpart B to read as follows:
    § 216.20 Special restrictions for Hawaiian spinner dolphins.

    (a) Applicability. The following special restrictions designed to protect Hawaiian Spinner Dolphins apply:

    (1) In all waters within 2 nautical miles of the main Hawaiian Islands, and

    (2) In all waters located between the islands of Lanai, Maui, and Kahoolawe enclosed by three line segments that connect points on the 2-nautical mile boundary between the islands as follows: the straight line between 20°32′51″ N./156°43′50″ W. and 20°42′4″ N./156°55′34″ W. between Kahoolawe and Lanai, the straight line between 20°51′1″ N./156°54′0″ W. and 20°59′48″ N./156°42′28″ W. between Lanai and Maui, and the straight line between 20°33′55″ N./156°26′43″ W. and 20°32′15″ N./156°29′51″ W. between Maui and Kahoolawe (all coordinates referenced to The World Geodetic System of 1984 (WGS 84)).

    (b) Prohibitions. Except as noted in paragraph (c) of this section, it is unlawful for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or to cause to be committed any of the following:

    (1) Approach or remain within 50 yards of a Hawaiian spinner dolphin by any means;

    (2) Swim within 50 yards of a Hawaiian spinner dolphin;

    (3) Cause a vessel, person, or other object to approach or remain within 50 yards of a Hawaiian spinner dolphin; or

    (4) Intercept or place a vessel, person, or other object on the path of a Hawaiian spinner dolphin so that the dolphin approaches within 50 yards of the vessel, person, or object.

    (c) Exceptions. The prohibitions of paragraph (b) of this section do not apply to:

    (1) Any person who inadvertently comes within 50 yards of a Hawaiian spinner dolphin or is approached by a spinner dolphin, provided the person makes no effort to engage or pursue the animal and takes immediate steps to move away from the animal;

    (2) Any vessel that is underway and is approached by a Hawaiian spinner dolphin, provided the vessel continues normal navigation and makes no effort to engage or pursue the animal;

    (3) Any vessel transiting to or from a port, harbor, or in a restricted channel when a 50-yard distance will not allow the vessel to maintain safe navigation;

    (4) Vessel operations necessary to avoid an imminent and serious threat to a person or vessel;

    (5) Activities authorized through a permit or authorization issued by the National Marine Fisheries Service to take Hawaiian spinner dolphins; and

    (6) Federal, State, or local government vessels, aircraft, personnel, and assets when necessary in the course of performing official duties.

    (d) Affirmative defense. In connection with any action alleging a violation of this section, any person claiming the benefit of any exemption, exception, or permit listed in paragraph (c) of this section has the burden of proving that the exemption or exception is applicable, or that the permit was granted and was valid and in force at the time of the alleged violation.

    (e) Maps of areas for Hawaiian spinner dolphin special restrictions. The following are overview maps and a table with corresponding coordinate data for the areas for Hawaiian spinner dolphin special restrictions.

    EP24AU16.128 EP24AU16.129 Table 1—Coordinates for the Extent of the Designated Waters Between Lanai, Maui, and Kahoolawe (see Figure 2) [All coordinates referenced to The World Geodetic System of 1984 (WGS 84)] Line segment between islands Figure 2 label Latitude Longitude Kahoolawe and Lanai A1 20°32′51″ N. 156°43′50″ W. A2 20°42′4″ N. 156°55′34″ W. Lanai and Maui B1 20°51′1″ N. 156°54′0″ W. B2 20°59′48″ N. 156°42′28″ W. Maui and Kahoolawe C1 20°33′55″ N. 156°26′43″ W. C2 20°32′15″ N. 156°29′51″ W.
    [FR Doc. 2016-20324 Filed 8-23-16; 8:45 am] BILLING CODE 3510-22-C
    81 164 Wednesday, August 24, 2016 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket No. AMS-LPS-16-0060] United States Standards for Grades of Carcass Beef AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Notice, request for comments.

    SUMMARY:

    The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is seeking public comments on a petition requesting revision to the United States Standards for Grades of Carcass Beef. Specifically, AMS is requesting comments concerning a petition that requests that the beef standards be amended to include dentition and documentation of actual age as an additional determination of maturity grouping for official quality grading. Currently, the standards only include skeletal and muscular evidence as a determination of maturity grouping for the purposes of official quality grading. Official quality grading is used as an indication of meat palatability and is a major determining factor in live cattle and beef value.

    DATES:

    Submit comments on or before October 24, 2016.

    ADDRESSES:

    Comments should be sent to Beef Carcass Revisions, Standardization Branch, Quality Assessment Division; Livestock Poultry and Seed Program, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 3932-S, STOP 0258, Washington, DC 20250-0258. Comments may also be sent by fax to (202) 690-2746 or by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information, please contact Bucky Gwartney, International Marketing Specialist, Quality Assessment Division, at [email protected] or (202) 720-1424.

    SUPPLEMENTARY INFORMATION:

    Section 203(c) of the Agricultural Marketing Act of 1946, as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Carcass Beef do not appear in the Code of Federal Regulations but are maintained by USDA. These standards are located on USDA's Web site at: https://www.ams.usda.gov/sites/default/files/media/Carcass%20Beef%20Standard.pdf. To change the United States Standards for Grades of Carcass Beef, AMS plans to utilize the procedures it published in the August 13, 1997, Federal Register, and that appear in part 36 of title 7 of the Code of Federal Regulations (7 CFR part 36).

    Background

    The Federal beef grade standards and associated voluntary, fee-for-service beef grading service program are authorized under the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.). The primary purpose of Federal grade standards, including the Federal beef grade standards, is to divide the population of a commodity into uniform groups (of similar quality, yield, value, etc.) to facilitate marketing. In concert, the Federal voluntary, fee-for-service grading program is designed to provide an independent, objective determination as to if a given product is in conformance with the applicable official Federal standard. In the case of beef, when it is voluntarily graded to the Federal beef grade standards under the beef grading service, the official grade consists of a quality grade and/or a yield grade.

    The quality grades are intended to identify differences in the palatability or eating satisfaction of cooked beef principally through the characteristics of marbling and physiological maturity groupings. As noted in the standards referenced above, the principal official USDA quality grades for young (maturity groups “A” and “B”) cattle and carcasses are Prime, Choice, and Select, in descending order in terms of historic market value. USDA recognizes that the beef standards must be relevant to be of greatest value to stakeholders and, therefore, recommendations for changes in the standards may be initiated by USDA or by interested parties at any time to achieve that goal.

    For beef, USDA quality grades provide a simple, effective means of describing product that is easily understood by both buyers and sellers. By identifying separate and distinct segments of beef, grades enable buyers to obtain that particular kind of beef that meets their individual needs. For example, certain restaurants may choose to only sell officially graded USDA Prime beef so as to provide their customers with a product that meets a very consistent level of overall palatability. At the same time, grades are important in transmitting information to cattlemen to help ensure informed decisions are made. For example, the market preference and price paid for a particular grade of beef is communicated to cattle producers so they can adjust their production accordingly. In such a case, if the price premium being paid for a grade such as USDA Prime beef merits producers making the investments required in cattle genetics and feeding to produce more USDA Prime beef, such marketing decisions can be made with justification.

    The current beef standards do not utilize dentition or age verification as methods to determine maturity groupings and instead rely solely on skeletal and lean (physiological) maturity. Although never intended to be a definitive method to determine the age of cattle at the time of slaughter and instead utilized to predict beef palatability, the maturity groupings have historically been roughly correlated to different age categories. Maturity grouping A was correlated with beef from cattle between 9 and 30 months of age at time of slaughter, maturity grouping B was correlated with beef from cattle between 30 and 42 months of age at time of slaughter, maturity grouping C was correlated with beef from cattle between 42 and 72 months of age at time of slaughter, maturity grouping D was correlated with beef from cattle between 72 and 96 months of age at time of slaughter, and maturity grouping E was correlated with beef from cattle more than 96 months of age at time of slaughter. However, these are rough approximations that are influenced by other factors including diet, growth promotion administration, calving, breed, and a variety of environmental factors. Therefore, cattle that are younger than 30 months of age (MOA) may have a physiological maturity of B or greater beef quality grade maturity grouping due to other factors listed above.

    The current use of dentition to determine animal age at time of slaughter is done on all slaughtered cattle in order to determine whether their age is less than or greater than 30 MOA due to food safety requirements. Cattle older than 30 MOA must have specific risk materials (e.g., vertebral column) removed from their carcasses before the sale of the resulting beef cuts. Age verification involves providing the paper paperwork or other proof of an animals' actual age (i.e., less than 30 MOA) and is also used for a variety of purposes including meeting foreign market requirements for U.S. beef from cattle under a certain age.

    The official standards have had past revisions made to the maturity grouping requirements, and these revisions resulted in classifications that were designed to reduce the variability of eating quality within the grades. The most recent such change occurred in 1997 when certain carcasses from the B maturity grouping were no longer eligible for the USDA Choice or Select quality grades. However, the official standards have never relied upon any other indicator besides physiological maturity to determine maturity grouping or the resulting USDA quality grade. This was primarily because the use of physiological maturity wasn't intended to be used to predict the age of an animal at time of slaughter but, instead, the resulting palatability of the meat. Many years of research have demonstrated a strong correlation between physiological maturity and beef palatability.

    However, current research has indicated that carcasses from grain-fed steers and heifers that are deemed less than 30 MOA, based on dentition, are similar in palatability to A maturity carcasses determined via physiological maturity and thus could be classified “A” maturity for grading purposes even though the physiological maturity characteristics of “B” or older maturity groupings may be present. Utilizing the recommendations of dentition and age verification would allow for an alternate method of classifying beef carcasses into maturity groupings and thus allow additional carcasses to qualify for the higher USDA grades of Prime, Choice and Select without a significant reduction in the consistency of those grades in predicting palatability.

    AMS was provided a large data set from a recent study of beef packing plant slaughter and has performed a statistical and economic analysis on this data in order to determine the possible impact should the proposed change to the Standards be adopted. That report can be found here: https://www.ams.usda.gov/grades-standards/beef-request-for-comments. The study period ranged from the beginning of May 2014 through the end of April 2015, and the results are summarized below.

    Extrapolating the study data across the total population of cattle graded each year by AMS—approximately 21 million—results in the following:

    • Seventy-two percent were slaughtered in facilities participating in the study,

    • Ninety-seven percent were found to be less than 30 MOA using dentition,

    • Less than 3 percent (2.8) were found to be equal to or greater than 30 MOA,

    • Less than 2 percent (1.68) were deemed to be age-discounted when using skeletal ossification as the measure of maturity grouping, and

    • Less than one-half of 1 percent of the total cattle graded were age-verified.

    According to the study, had there been an allowance to use dentition as a means to override physiological characteristics of advanced maturity grouping, as is proposed, an additional 1.3 percent of those cattle would have been eligible for grading. Of these cattle, 4.5 percent would have been graded Prime, 63.6 percent Choice, and 31.9 percent Select. Within the Choice category, 24.4 percent of all newly graded carcasses, would have been placed in the top two-thirds Choice category (branded Choice programs), and 39.2 percent of all added carcasses would have been placed in the bottom of the Choice category. Currently, many private companies or organizations have established carcass schedules whereby AMS graders evaluate individual carcasses for conformance with those established requirements—things such as breed or breed influence, age, ribeye size, carcass weight. Most of those carcass programs (e.g., Certified Angus BeefTM) currently have requirements for only allowing “A Maturity” carcasses.

    The grade composition of the carcasses being added by using dentition as a measure of age was not much different than the grade composition of carcasses graded using physiological maturity, and overall, these data show an increase of 1.05 percent for Prime beef, 0.91 percent for Choice 1 and 1.29 percent for Select. According to calculations made from wholesale beef elasticity, wholesale beef prices could decline between 1 to 1.5 percent for each of the grade categories as a result of the increased supply of graded beef.

    1 While the volume of Choice carcasses added is large, the existing production of Choice beef is significantly large enough to result is a smaller proportion of Choice added than for Prime and Select.

    According to projections provided by the National Cattlemen's Beef Association (NCBA), producers would yield approximately $59 million in added revenue from removal of discounts for cattle identified as greater than A maturity grouping that dentition would allow to be classified as such. AMS found a net gain to producers of nearly $55 million, primarily due to reduced hard bone discounts for quality grade maturity grouping done by the current physiological maturity approach alone.

    A petition has been submitted by NCBA, the National Association State Departments of Agriculture, the U.S. Meat Export Federation, and the American Farm Bureau Federation and can be found here: https://www.ams.usda.gov/grades-standards/beef-request-for-comments.

    The petitioners cite several research papers, as listed in the reference section at the above link, to support their request. Two of the summary papers that outline the relevant studies can be found here: https://www.ams.usda.gov/grades-standards/beef-request-for-comments. In summary, the studies showed that the use of dentition to determine maturity groupings did not have a significant negative affect on the ability of the official USDA quality grades to group beef into similar palatability categories while at the same time would allow for additional carcasses to qualify for the higher USDA quality grades of Prime, Choice and Select. This would allow for consumers to have access to additional USDA Prime, Choice and Select beef as well as for producers to be paid price premiums for cattle whose carcasses grade USDA Prime, Choice or Select.

    In addition, a recent analysis located at: https://www.ams.usda.gov/grades-standards/beef-request-for-comments, which was done by the American Meat Science Association's Committee on Grading, found that while age at the time of slaughter does influence meat palatability, this becomes less influential within the young U.S. grain-fed cattle population, as the vast majority of cattle presented for grading in U.S. beef processing facilities are less than 30 MOA and USDA “A” or “B” maturity. It is important to note that the population of fed beef cattle in the U.S. has changed significantly over the last several decades. Today, there is greater consistency within the cattle herd, improved genetics, a relatively young slaughter population, more widespread use of growth promoting technologies that are known to effect bone ossification, and much higher carcass weights at slaughter which may also have skeletal implications. These market and production changes, along with recent research, could indicate that physiological maturity is less influential on palatability than in the past.

    Request for Comments

    AMS is soliciting comments from stakeholders about whether changes in the methodology for determining maturity grouping assessment for the purposes of official USDA quality grading should be made. This change would have no effect on the role that maturity groupings have upon USDA quality grade determination, simply how carcasses are placed into those maturity groupings. AMS also invites comments about how those changes would be implemented in the current beef grading system. If, after analyzing the comments, AMS determines that changes are warranted, a notice will be published in the Federal Register proposing specific changes to the United States Standards for Carcass Beef. Interested parties will have an opportunity to comment prior to a final decision adopting any changes.

    Dated: August 19, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-20254 Filed 8-23-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2016-0027] Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products AGENCY:

    Food Safety and Inspection Service, USDA.

    ACTION:

    Notice of availability and opportunity for comment.

    SUMMARY:

    The Food Safety and Inspection Service (FSIS) is announcing the availability of the Agency's compliance guidance on how companies can make label or labeling claims concerning the fact that bioengineered or genetically modified (GM) ingredients or animal feed were not used in the production of meat, poultry, or egg products. For purposes of this guidance document, these claims will be referred to as “negative claims.”

    DATES:

    Comments must be received by October 24, 2016.

    ADDRESSES:

    A downloadable version of the compliance guidance is available to view and print at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/claims-guidance/procedures-nongenetically-engineered-statement. No hard copies of the compliance guidance have been published.

    FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods:

    Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov/. Follow the on-line instructions at that site for submitting comments.

    Mail, including CD-ROMs: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, Washington, DC 20250-3700.

    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.

    Instructions: All items submitted by mail or electronic mail must include the Agency name, docket number FSIS-2016-0027, and the document title: Statements that Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were not Used in the Production of Meat, Poultry, or Egg Products. Comments received in response to this docket will be made available for public insp