Federal Register Vol. 83, No.203,

Federal Register Volume 83, Issue 203 (October 19, 2018)

Page Range52943-53157
FR Document

83_FR_203
Current View
Page and SubjectPDF
83 FR 53157 - Memorandum for the Secretary of Defense [and] the Secretary of CommercePDF
83 FR 53028 - Sunshine Act Meeting NoticePDF
83 FR 53027 - Sunshine Act MeetingPDF
83 FR 52962 - Regulation Crowdfunding and Regulation A Relief and Assistance for Victims of Hurricane MichaelPDF
83 FR 53104 - Notice of Intent To Prepare an Environmental Impact Statement for Deepwater Wind South Fork, LLC's Proposed Wind Energy Facility Offshore Rhode Island and MassachusettsPDF
83 FR 53096 - Commercial Leasing for Wind Power Development on the Outer Continental Shelf (OCS) Offshore California-Call for Information and Nominations (Call)PDF
83 FR 53089 - Atlantic Wind Lease Sale 4A (ATLW-4A) for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore Massachusetts-Final Sale NoticePDF
83 FR 53028 - Notice of Public Meeting of the West Virginia Advisory CommitteePDF
83 FR 53105 - Certain LTE- and 3G-Compliant Cellular Communications Devices Institution of InvestigationPDF
83 FR 52977 - Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks DisplayPDF
83 FR 53141 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of North CarolinaPDF
83 FR 53023 - Safety Zone; NASA Activities, Gulf of Mexico, Galveston, TXPDF
83 FR 53029 - In the Matter of: Luis Antonio Urdaneta Pozo, Inmate Number: 68375-018, FCI Edgefield, P.O. Box 725, Edgefield, SC 29824; Order Denying Export PrivilegesPDF
83 FR 53142 - Presidential Declaration of a Major Disaster for the State of GeorgiaPDF
83 FR 53033 - Proposed Monterey Peninsula Water Supply Project; Notice of Availability of Errata Document for the Final Environmental Impact Report/Environmental Impact StatementPDF
83 FR 52996 - Tetrahydrofurfuryl Alcohol; Exemption From the Requirement of a TolerancePDF
83 FR 53050 - Agency Information Collection Activities; Comment Request; The Department of Education Accrediting Agency, Foreign Medical and Foreign Veterinarian Program Comparability Database ApprovalPDF
83 FR 53054 - Pesticide Registration Maintenance Fee: Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide RegistrationsPDF
83 FR 52950 - Responsibilities of Boards of Directors, Corporate Practices, and Corporate GovernancePDF
83 FR 53111 - Leadership in Equal Access and Diversity Award; New Information Collection Requirements; Comment RequestPDF
83 FR 52986 - Prothioconazole; Pesticide TolerancesPDF
83 FR 53143 - Presidential Declaration Amendment of a Major Disaster for the State of FloridaPDF
83 FR 53072 - Certificate of Alternative Compliance for the Blount Boats Inc., Hull TGI-329PDF
83 FR 52991 - Boscalid; Pesticide TolerancesPDF
83 FR 52954 - Amendment of the Prohibition Against Certain Flights in Specified Areas of the Simferopol and Dnipropetrovsk Flight Information Regions (FIRs) (UKFV and UKDV)PDF
83 FR 53114 - Advisory Committee for Mathematical and Physical Sciences; Notice of MeetingPDF
83 FR 53144 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Mrinalini Mukherjee” ExhibitionPDF
83 FR 53143 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Renaissance Splendor: Catherine de Medici's Valois Tapestries” ExhibitionPDF
83 FR 53114 - Proposal Review Panel for International Science and Engineering; Notice of MeetingPDF
83 FR 53142 - Presidential Declaration of a Major Disaster for the State of FloridaPDF
83 FR 52981 - Safety Zone; Fox River, Brown County Fireworks, Green Bay, WIPDF
83 FR 53118 - Performance Review Boards for Senior Executive ServicePDF
83 FR 53030 - Carbon and Certain Alloy Steel Wire Rod From Mexico: Preliminary Affirmative Determination of Circumvention of the Antidumping Duty OrderPDF
83 FR 52972 - Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for HeadachePDF
83 FR 53032 - Subsidy Programs Provided by Countries Exporting Softwood Lumber and Softwood Lumber Products to the United States; Request for CommentPDF
83 FR 52964 - Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery SystemPDF
83 FR 53143 - Department of State Performance Review Board MembersPDF
83 FR 52966 - Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging DevicePDF
83 FR 53149 - Commercial Driver's License Standards: Application for Exemption; CRST ExpeditedPDF
83 FR 53114 - Membership of National Science Foundation's Senior Executive Service Performance Review BoardPDF
83 FR 53151 - Commercial Driver's License Standards: Application for Exemption; Isuzu North America Corporation (Isuzu)PDF
83 FR 53077 - Final Environmental Impact Statement on American Electric Power's American Burying Beetle Habitat Conservation Plan in Arkansas, Oklahoma, and TexasPDF
83 FR 53107 - Importer of Controlled Substances Application: Noramco Inc.PDF
83 FR 53119 - Oyster Creek Nuclear Generating Station; Consideration of Approval of Transfer of License and Conforming AmendmentPDF
83 FR 53107 - Importer of Controlled Substances RegistrationPDF
83 FR 53106 - Bulk Manufacturer of Controlled Substances RegistrationPDF
83 FR 53108 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.PDF
83 FR 53106 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Consortium for Execution of Rendezvous and Servicing OperationsPDF
83 FR 52979 - Safety Zone; Hornblower Fireworks Display; San Francisco Bay; San Francisco, CAPDF
83 FR 53027 - Information Collection Activity; Comment RequestPDF
83 FR 53029 - Suspension of the Geographically Updated Population Certification Program for Places Incorporating or Annexing Between CensusesPDF
83 FR 53050 - Combined Notice of FilingsPDF
83 FR 53065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship ProgramsPDF
83 FR 53052 - Luminant Energy Company LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 53061 - Notice of Agreements FiledPDF
83 FR 53053 - Combined Notice of Filings #1PDF
83 FR 53052 - Alpine Pacific Utilities Hydro, LLC; Notice of Availability of Environmental AssessmentPDF
83 FR 53081 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Data Elements for Student Enrollment in Bureau-Funded SchoolsPDF
83 FR 53122 - New Postal ProductsPDF
83 FR 53060 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Facility Ground-Water Monitoring Requirements (Renewal)PDF
83 FR 53070 - National Maritime Security Advisory Committee; MeetingPDF
83 FR 53033 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to US 101/Chehalis River Bridge-Scour Repair in Washington StatePDF
83 FR 53059 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of GeorgiaPDF
83 FR 53115 - Interim Storage Partners LLC's Consolidated Interim Storage FacilityPDF
83 FR 53048 - Endangered and Threatened Species; Take of Anadromous FishPDF
83 FR 53059 - Proposed Information Collection Request; Comment Request; Fuel Use Requirements for Great Lake Steamships; RenewalPDF
83 FR 53152 - Proposed Collection; Comment Request for Form 8832PDF
83 FR 53067 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZIPDF
83 FR 53068 - Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug ApplicationsPDF
83 FR 53108 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Comments Requested: 2019 School Crime Supplement (SCS) to the National Crime Victimization Survey (NCVS)PDF
83 FR 53109 - Agency Information Collection Activities: Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection: 2018 Census of Law Enforcement Training Academies (CLETA)PDF
83 FR 53110 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; New Collection: Survey of State Attorneys General Offices (SSAGO): Human TraffickingPDF
83 FR 52976 - Drawbridge Operation Regulation; Willamette River at Portland, ORPDF
83 FR 53113 - Human Exploration and Operations Research Advisory Committee; MeetingPDF
83 FR 53113 - NASA Advisory Council; Aeronautics Committee; MeetingPDF
83 FR 53088 - Notice of Intent To Repatriate Cultural Items: Fowler Museum at the University of California Los Angeles, Los Angeles, CAPDF
83 FR 53087 - Notice of Inventory Completion: The Field Museum, Chicago, ILPDF
83 FR 53084 - Notice of Inventory Completion: Department of Anthropology at Indiana University, Bloomington, INPDF
83 FR 53085 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CAPDF
83 FR 53083 - Notice of Intent To Repatriate Cultural Items: Fowler Museum at the University of California Los Angeles, Los Angeles, CAPDF
83 FR 53086 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CA; CorrectionPDF
83 FR 53082 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CA; CorrectionPDF
83 FR 53049 - Procurement List; DeletionsPDF
83 FR 53049 - Procurement List; Proposed Addition and DeletionsPDF
83 FR 53071 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0095PDF
83 FR 52968 - Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical ApplicationPDF
83 FR 52973 - Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye SymptomsPDF
83 FR 52970 - Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal UsePDF
83 FR 53072 - Agency Information Collection Activities: Allegation of Counterfeiting and Intellectual Piracy, Form No. 73-048PDF
83 FR 53127 - Submission for OMB Review; Comment RequestPDF
83 FR 53128 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment PlanPDF
83 FR 53138 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment PlanPDF
83 FR 53131 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment PlanPDF
83 FR 53134 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Current Rules on Arbitration, Under Chapter 18PDF
83 FR 53136 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to ICC's Stress Testing Framework and ICC's Liquidity Risk Management FrameworkPDF
83 FR 53124 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Relating to the First Trust Senior Loan Fund of First Trust Exchange-Traded Fund IVPDF
83 FR 53123 - Product Change-Priority Mail Negotiated Service AgreementPDF
83 FR 53123 - Product Change-Priority Mail Express and Priority Mail Negotiated Service AgreementPDF
83 FR 53116 - In the Matter of Entergy Nuclear Vermont Yankee, LLC; Entergy Nuclear Operations, Inc.; NorthStar Vermont Yankee LLC; NorthStar Nuclear Decommissioning Company, LLC; Vermont Yankee Nuclear Power StationPDF
83 FR 53144 - Projects Rescinded for Consumptive Uses of WaterPDF
83 FR 53144 - Projects Approved for Consumptive Uses of WaterPDF
83 FR 53073 - Endangered and Threatened Species; Receipt of Recovery Permit ApplicationsPDF
83 FR 53075 - South Bay Salt Pond Restoration Project, Phase 2; Don Edwards National Wildlife Refuge, California; Record of Decision for Final Environmental Impact Statement/Environmental Impact ReportPDF
83 FR 52946 - Hazelnuts Grown in Oregon and Washington; Order Amending Marketing Order No. 982PDF
83 FR 52943 - General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Electronic Mailing of Notice of HearingPDF
83 FR 53069 - National Heart, Lung, and Blood Institute Notice of Closed MeetingsPDF
83 FR 52944 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Changing of Container RequirementsPDF
83 FR 53003 - Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida and Imported Grapefruit; Change in Grade and Size RequirementsPDF
83 FR 53145 - Petition for Exemption; Summary of Petition Received; Anthony Ison, Esq.PDF
83 FR 53078 - Eastern Collier Property Owners, LLC, Multi-Species Habitat Conservation Plan and Draft Environmental Impact Statement, Collier County, FloridaPDF
83 FR 53064 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW)PDF
83 FR 53063 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; the State Plan for Independent Living (SPIL) (0985-0044)PDF
83 FR 53020 - Foreign Criminal and Civil JurisdictionPDF
83 FR 53062 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Independent Living Services Program Performance Report (0985-0043)PDF
83 FR 53074 - Endangered and Threatened Wildlife; Incidental Take Permit Application, Habitat Conservation Plan for the Sand Skink, Lake County, FLPDF
83 FR 53080 - Endangered and Threatened Wildlife and Plants; Availability of Habitat Conservation Plan and Categorical Exclusion for the Mount Hermon June Beetle, Santa Cruz County, CaliforniaPDF
83 FR 53061 - Notice to All Interested Parties of Intent To Terminate ReceivershipPDF
83 FR 52976 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CAPDF
83 FR 53053 - Environmental Impact Statements; Notice of AvailabilityPDF
83 FR 53112 - Petitions for Modification of Application of Existing Mandatory Safety StandardPDF
83 FR 53152 - Advisory Committee on Cemeteries and Memorials, Notice of MeetingPDF
83 FR 53147 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Castignoli EnterprisesPDF
83 FR 53007 - Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-DealersPDF
83 FR 53145 - Notice of Final Federal Agency Actions on Transportation Project in Washington StatePDF
83 FR 53146 - Notice of Final Federal Agency Actions on Transportation Project in Washington StatePDF
83 FR 53026 - Petition for Reconsideration of Action in Rulemaking Proceeding; CorrectionPDF
83 FR 52983 - Determination of Attainment by the Attainment Date and Clean Data Determination for the Logan, UT-ID 2006 24-Hour PM2.5PDF

Issue

83 203 Friday, October 19, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES Changing of Container Requirements: Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas, 52944-52946 2018-22759 Electronic Mailing of Notice of Hearing: General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders, 52943-52944 2018-22761 Marketing Orders: Hazelnuts Grown in Oregon and Washington, 52946-52950 2018-22762 PROPOSED RULES Change in Grade and Size Requirements: Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida and Imported Grapefruit, 53003-53007 2018-22758 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Rural Utilities Service

Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: Consortium for Execution of Rendezvous and Servicing Operations, 53106 2018-22826 Census Bureau Census Bureau NOTICES Suspension of the Geographically Updated Population Certification Program for Places Incorporating or Annexing Between Censuses, 53029 2018-22823 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 53027-53028 2018-22934 Civil Rights Civil Rights Commission NOTICES Meetings: West Virginia Advisory Committee, 53028-53029 2018-22870 Meetings; Sunshine Act, 53028 2018-22963 Coast Guard Coast Guard RULES Drawbridge Operations: Sacramento River, Sacramento, CA, 52976 2018-22746 Willamette River at Portland, OR, 52976-52977 2018-22801 Safety Zones: Delaware River, Penn's Landing, Philadelphia, PA, Fireworks Display, 52977-52979 2018-22868 Fox River, Brown County Fireworks, Green Bay, WI, 52981-52983 2018-22845 Hornblower Fireworks Display; San Francisco Bay; San Francisco, CA, 52979-52981 2018-22825 PROPOSED RULES Safety Zones: NASA Activities, Gulf of Mexico, Galveston, TX, 53023-53026 2018-22866 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53071-53072 2018-22787 Certificates of Alternative Compliance: Blount Boats Inc., Hull TGI-329, 53072 2018-22855 Meetings: National Maritime Security Advisory Committee, 53070-53071 2018-22813 Commerce Commerce Department See

Census Bureau

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 53049-53050 2018-22788 2018-22789 Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Centers for Independent Living Program Performance Report, 53064-53065 2018-22754 Independent Living Services Program Performance Report, 53062-53063 2018-22751 State Plan for Independent Living, 53063-53064 2018-22753 Defense Department Defense Department PROPOSED RULES Foreign Criminal and Civil Jurisdiction, 53020-53023 2018-22752 Drug Drug Enforcement Administration NOTICES Bulk Manufacturer of Controlled Substances Registration, 53106-53107 2018-22829 Importer of Controlled Substances Application: Fisher Clinical Services, Inc., 53108 2018-22828 Noramco Inc., 53107-53108 2018-22832 Importer of Controlled Substances Registration, 53107 2018-22830 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accrediting Agency, Foreign Medical and Foreign Veterinarian Program Comparability Database Approval, 53050 2018-22861 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Determination of Attainment by the Attainment Date and Clean Data Determination for the Logan, UT-ID 2006 24-Hour PM2.5 Nonattainment Area, 52983-52986 2018-22284 Pesticide Tolerances: Boscalid, 52991-52996 2018-22854 Prothioconazole, 52986-52991 2018-22857 Tolerance Exemptions: Tetrahydrofurfuryl Alcohol, 52996-53002 2018-22862 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Facility Ground-Water Monitoring Requirements, 53060-53061 2018-22814 Fuel Use Requirements for Great Lake Steamships, 53059-53060 2018-22808 Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Georgia, 53059 2018-22811 Environmental Impact Statements; Availability, etc.: Weekly Receipts, 53053-53054 2018-22745 Pesticide Registration Maintenance Fee: Voluntarily Cancel Certain Pesticide Registrations, 53054-53059 2018-22860 Federal Aviation Federal Aviation Administration RULES Amendment of the Prohibition Against Certain Flights in Specified Areas of the Simferopol and Dnipropetrovsk Flight Information Regions, 52954-52962 2018-22853 NOTICES Petition for Exemption; Summaries: Anthony Ison, Esq., 53145 2018-22756 Federal Communications Federal Communications Commission PROPOSED RULES Petition for Reconsideration of Action in Rulemaking Proceeding; Correction, 53026 2018-22357 Federal Contract Federal Contract Compliance Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Leadership in Equal Access and Diversity Award, 53111-53112 2018-22858 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: 10142, Madisonville State Bank, Madisonville, TX, 53061 2018-22747 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 53050-53053 2018-22818 2018-22822 Environmental Assessments; Availability, etc.: Alpine Pacific Utilities Hydro, LLC, 53052-53053 2018-22817 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Luminant Energy Co., LLC, 53052 2018-22820 Federal Highway Federal Highway Administration NOTICES Federal Agency Actions: Transportation Project in Washington State, 53145-53147 2018-22471 2018-22503 Federal Housing Finance Agency Federal Housing Finance Agency RULES Responsibilities of Boards of Directors, Corporate Practices, and Corporate Governance, 52950-52954 2018-22859 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 53061-53062 2018-22819 Federal Motor Federal Motor Carrier Safety Administration NOTICES Commercial Driver's License Standards:Exemption Application: CRST Expedited, 53149-53150 2018-22836 Commercial Driver's License Standards Exemption Application: Isuzu North America Corp., 53151-53152 2018-22834 Parts and Accessories Necessary for Safe Operation; Exemption Applications: Castignoli Enterprises, 53147-53149 2018-22704 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Habitat Conservation Plan and Categorical Exclusion for the Mount Hermon June Beetle, Santa Cruz County, CA, 53080-53081 2018-22748 Incidental Take Permit Application, Habitat Conservation Plan for Sand Skink, Lake County, FL, 53074-53075 2018-22749 Recovery Permit Applications, 53073-53074 2018-22764 Environmental Impact Statements; Availability, etc.: American Electric Power American Burying Beetle Habitat Conservation Plan in Arkansas, Oklahoma, and Texas, 53077-53078 2018-22833 Eastern Collier Property Owners, LLC, Multi-species Habitat Conservation Plan, Collier County, FL, 53078-53080 2018-22755 South Bay Salt Pond Restoration Project, Phase 2; Don Edwards National Wildlife Refuge, CA, 53075-53077 2018-22763 Food and Drug Food and Drug Administration RULES Medical Devices: Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System, 52964-52966 2018-22840 General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use, 52970-52972 2018-22784 General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application, 52968-52970 2018-22786 General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device, 52966-52968 2018-22837 Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache, 52972-52973 2018-22842 Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms, 52973-52975 2018-22785 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs, 53065-53067 2018-22821 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMFINZI, 53067-53068 2018-22806 New Drug Applications: Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval, 53068-53069 2018-22805 Health and Human Health and Human Services Department See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

Homeland Homeland Security Department See

Coast Guard

See

U.S. Immigration and Customs Enforcement

Indian Affairs Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data Elements for Student Enrollment in Bureau-funded Schools, 53081-53082 2018-22816 Industry Industry and Security Bureau NOTICES Denial of Export Privileges:, 53029-53030 2018-22865 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

National Park Service

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53152 2018-22807 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Carbon and Certain Alloy Steel Wire Rod from Mexico, 53030-53032 2018-22843 Subsidy Programs Provided by Countries Exporting Softwood Lumber and Softwood Lumber Products to the United States, 53032-53033 2018-22841 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain LTE- and 3G-Compliant Cellular Communications Devices, 53105-53106 2018-22869 Justice Department Justice Department See

Antitrust Division

See

Drug Enforcement Administration

See

Justice Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2019 School Crime Supplement to the National Crime Victimization Survey, 53108-53109 2018-22804
Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2018 Census of Law Enforcement Training Academies, 53109-53110 2018-22803 Survey of State Attorneys General Offices: Human Trafficking, 53110-53111 2018-22802 Labor Department Labor Department See

Federal Contract Compliance Programs Office

See

Mine Safety and Health Administration

Mine Mine Safety and Health Administration NOTICES Petitions for Modification: Application of Existing Mandatory Safety Standard, 53112-53113 2018-22744 NASA National Aeronautics and Space Administration NOTICES Meetings: Aeronautics Committee, 53113 2018-22799 Human Exploration and Operations Research Advisory Committee, 53113-53114 2018-22800 National Institute National Institutes of Health NOTICES Meetings: National Heart, Lung, and Blood Institute, 53069-53070 2018-22760 National Oceanic National Oceanic and Atmospheric Administration NOTICES Endangered and Threatened Species: Takes of Anadromous Fish, 53048-53049 2018-22809 Environmental Impact Statements; Availability, etc.: Proposed Monterey Peninsula Water Supply Project, 53033 2018-22863 Takes of Marine Mammals Incidental to Specified Activities: US 101/Chehalis River Bridge-Scour Repair in Washington State, 53033-53048 2018-22812 National Park National Park Service NOTICES Inventory Completions: Department of Anthropology at Indiana University, Bloomington, IN, 53084-53085 2018-22794 2018-22795 Fowler Museum at the University of California Los Angeles, Los Angeles, CA, 53085-53086 2018-22793 Fowler Museum at the University of California Los Angeles, Los Angeles, CA; Correction, 53082-53083, 53086-53087 2018-22790 2018-22791 The Field Museum, Chicago, IL, 53087-53088 2018-22796 Repatriation of Cultural Items: Fowler Museum at the University of California Los Angeles, Los Angeles, CA, 53083-53084, 53088-53089 2018-22792 2018-22797 National Science National Science Foundation NOTICES Meetings: Advisory Committee for Mathematical and Physical Sciences, 53114 2018-22852 Proposal Review Panel for International Science and Engineering, 53114-53115 2018-22848 Membership of Senior Executive Service Performance Review Board, 53114 2018-22835 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Direct Transfer of Licenses; Applications: Oyster Creek Nuclear Generating Station; Consideration of Approval of Transfer of License and Conforming Amendment, 53119-53122 2018-22831 Environmental Impact Statements; Availability, etc.: Interim Storage Partners LLC's Consolidated Interim Storage Facility, 53115-53116 2018-22810 License Transfers: Entergy Nuclear Vermont Yankee, LLC, Entergy Nuclear Operations, Inc., NorthStar Vermont Yankee, LLC, NorthStar Nuclear Decommissioning Company, LLC, Vermont Yankee Nuclear Power Station, 53116-53118 2018-22768 Performance Review Boards for Senior Executive Service, 53118-53119 2018-22844 Ocean Energy Management Ocean Energy Management Bureau NOTICES Commercial Leasing for Wind Power Development: Outer Continental Shelf Offshore California, 53096-53104 2018-22879 Commercial Leasing for Wind Power on the Outer Continental Shelf: Atlantic Wind Lease Sale 4A Offshore Massachusetts, 53089-53096 2018-22878 Environmental Impact Statements; Availability, etc.: Deepwater Wind South Fork, LLC Proposed Wind Energy Facility Offshore Rhode Island and Massachusetts, 53104-53105 2018-22880 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 53122-53123 2018-22815 Postal Service Postal Service NOTICES Product Changes: Priority Mail Express and Priority Mail Negotiated Service Agreement, 53123-53124 2018-22772 2018-22773 Priority Mail Negotiated Service Agreement, 53123 2018-22769 2018-22770 2018-22771 2018-22774 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Defense and National Security: John S. McCain National Defense Authorization Act for FY 2019; Delegation of Authority (Memorandum of October 16, 2018), 53155-53157 2018-23050 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53027 2018-22824 Securities Securities and Exchange Commission RULES Regulation Crowdfunding and Regulation A Relief and Assistance for Victims of Hurricane Michael, 52962-52964 2018-22930 PROPOSED RULES Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-Dealers, 53007-53020 2018-22531 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53127-53128 2018-22781 Self-Regulatory Organizations; Proposed Rule Changes: Fixed Income Clearing Corp., 53131-53134 2018-22778 ICE Clear Credit, LLC, 53136-53138 2018-22776 Nasdaq GEMX, LLC, 53134-53136 2018-22777 National Securities Clearing Corp., 53128-53131 2018-22780 The Depository Trust Co., 53138-53141 2018-22779 The Nasdaq Stock Market, LLC, 53124-53127 2018-22775 Small Business Small Business Administration NOTICES Major Disaster Declarations: Florida, 53142-53143 2018-22846 2018-22851 Florida; Amendment 2, 53143 2018-22856 Georgia, 53142 2018-22864 North Carolina; Public Assistance Only, 53141-53142 2018-22867 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Mrinalini Mukherjee, 53144 2018-22850 Renaissance Splendor: Catherine de Medici's Valois Tapestries, 53143-53144 2018-22849 Performance Review Board Members, 53143 2018-22839 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved: Consumptive Uses of Water, 53144 2018-22765 Projects Rescinded: Consumptive Uses of Water, 53144-53145 2018-22766 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

Treasury Treasury Department See

Internal Revenue Service

Immigration U.S. Immigration and Customs Enforcement NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Allegation of Counterfeiting and Intellectual Piracy, 53072-53073 2018-22783 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Cemeteries and Memorials, 53152-53153 2018-22743 Separate Parts In This Issue Part II Presidential Documents, 53155-53157 2018-23050 Reader Aids

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83 203 Friday, October 19, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 900 [Doc. No. AMS-SC-18-0066; SC18-900-2 FR] General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Electronic Mailing of Notice of Hearing AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule revises the general regulations for Federal fruit, vegetable, and specialty crop marketing agreements and marketing orders (orders) to allow the use of electronic communication as a method for notifying industry and the public of hearings for proceedings related to proposing new or amending existing orders.

DATES:

Effective October 19, 2018.

FOR FURTHER INFORMATION CONTACT:

Debbie Wray, Senior Marketing Specialist, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 2202 Monterey Street, Suite 102-B, Fresno, CA 93721; Telephone: (559) 487-5901, Fax: (559) 487-5906 or Email: [email protected] or [email protected]

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This final rule is issued under the general regulations for Federal marketing agreements and orders (7 CFR part 900), effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 13175. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See the Office of Management and Budget's (OMB) Memorandum titled, “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule authorizes USDA's Agricultural Marketing Service (AMS) to use either electronic communication or a postal or other delivery service to mail a notice of hearing to industry and the public for proceedings related to proposing new or amending existing orders.

Part 900 provides the procedural requirements that govern proceedings to formulate orders and when necessary, to amend existing orders. These proceedings include holding a public hearing where, among other things, witnesses provide testimony about the proposal and evidence is admitted for consideration by the Secretary of Agriculture.

Section 900.4(b) requires AMS to mail a true copy of a notice of hearing to each of the persons known to the AMS Administrator to be interested in the proceedings. However, the method to be used for mailing the notice is not specified. Historically, AMS has mailed paper copies of the notice using the United States Postal Service or other postal delivery services. These mailings may number in the hundreds, depending on the industry affected by the proposal.

This final rule revises § 900.4 to provide that the mailing of a notice of hearing may be done electronically or by using a postal or other delivery service. By providing that electronic communication may be used for mailing, this action will help strengthen and modernize AMS's outreach process and will reduce costs associated with paper mailings. Eventually, if all notice recipients have access to electronic communication as a delivery method and have adapted to its use, the older, more costly paper delivery methods could be eliminated.

Administrative Procedure Act and Regulatory Flexibility Act

This final rule revises agency rules of practice and procedure. Under the Administrative Procedure Act, prior notice and opportunity for comment are not required for the revision of agency rules of practice and procedure. 5 U.S.C. 553(b)(3)(A). Only substantive rules require publication 30 days prior to their effective date. 5 U.S.C. 553(d). Therefore, this final rule is effective upon publication in the Federal Register.

In addition, because prior notice and opportunity for comment are not required to be provided for this final rule, this rule is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.

Paperwork Reduction Act

This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

List of Subjects in 7 CFR Part 900

Administrative practice and procedure, Freedom of information, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth above, 7 CFR part 900 is amended as follows:

PART 900—GENERAL REGULATIONS 1. The authority citation for part 900 continues to read as follows: Authority:

7 U.S.C. 601-674 and 7 U.S.C. 7401.

2. In § 900.4, revise paragraph (b)(1)(ii) to read as follows:
§ 900.4 Institution of proceeding.

(b) * * *

(1) * * *

(ii) By mailing a true copy of the notice of hearing, using a postal or other delivery service or electronic communication, to each of the persons known to the Administrator to be interested therein;

Dated: October 15, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-22761 Filed 10-18-18; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 906 [Doc. No. AMS-SC-17-0049; SC17-906-2 FR] Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Changing of Container Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation to change the container requirements under the Marketing Order for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. This action removes five containers from the list of authorized containers and adds seven new containers to the list. This change also modifies the descriptions of two authorized containers.

DATES:

Effective November 19, 2018.

FOR FURTHER INFORMATION CONTACT:

Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. Part 906 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Texas Valley Citrus Committee (Committee) locally administers the Order and is comprised of growers and handlers of Texas citrus operating within the production area.

The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule removes five containers from the list of authorized containers under the Order and adds seven new containers to the list. This action also modifies the descriptions of two authorized containers. The Committee recommended these changes to align the Order's container regulations with current industry practices. The Committee unanimously recommended the changes at a meeting on June 8, 2017.

Section 906.40(d) of the Order authorizes the issuance of regulations to fix the size, weight, capacity, dimensions, or pack of the container or containers which may be used in the packaging, transportation, sale, shipment, or other handling of fruit. Section 906.340 provides that no handler shall handle any variety of oranges or grapefruit grown in the production area unless such fruit is packed in one of the containers specified under the Order. This section also specifies a detailed list of the containers currently authorized under the Order. In addition, this section allows the Committee to approve the use of other types and sizes of containers for testing for research purposes.

The Committee reviewed the containers listed in § 906.340 and compared them to the containers being utilized throughout the industry. This process included surveying handlers to determine which containers were being used. As a result, the Committee determined five of the authorized containers were no longer being used to pack Texas oranges or grapefruit.

The Committee also reviewed the list of experimental containers that had been approved for testing purposes. Seven of the experimental containers have been widely accepted throughout the Texas citrus industry and are being used to pack and ship Texas citrus. As a result of the review, the Committee voted to remove the five containers that were no longer being used from the list of authorized containers and add the seven experimental containers to § 906.340.

The Committee also discussed that while the description in § 906.340(a)(1)(ii) of the closed fully telescopic fiberboard carton with approximate inside dimensions of 161/2 by 103/4 by 91/2 inches is correct, this container is commonly known throughout the Texas citrus industry as a standard carton. Consequently, for clarification purposes, the Committee voted to add the words “Standard Carton” to this container description.

Further, the Committee noted that in § 906.340(a)(1)(iv) poly or mesh bags can be used to pack oranges and grapefruit to a capacity of 5, 8, 10, or 18 pounds of fruit, but that only oranges can be packed in the 4-pound bags. During the discussion, Committee members agreed handlers should also be allowed to ship grapefruit in 4-pound bags. Thus, the Committee voted to update the description to allow for the packing of both oranges and grapefruit in poly or mesh bags having a capacity of 4 pounds.

These changes reflect the containers being utilized throughout the industry and aligns the regulations with current industry practices.

Section 8e of the Act provides that when certain domestically produced commodities, including oranges, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements. As this rule changes the container requirements under the domestic handling regulations, no corresponding change to the import regulations is required.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 170 producers of oranges and grapefruit in the production area and 13 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

Based on National Agricultural Statistics Service (NASS) and Committee data, the average price for Texas citrus during the 2016-17 season was approximately $16 per carton, and total shipments were 7.6 million cartons. Using the average price and shipment information, the number of handlers (13), and assuming a normal distribution, the majority of handlers would have average annual receipts of $9.4 million, which is greater than $7,500,000. ($16 per carton times 7.6 million cartons equals $121.6 million, divided by 13 equals $9.4 million per handler.) Thus, the majority of Texas citrus handlers may be classified as large business entities.

In addition, based on NASS information, the weighted grower price for Texas citrus during the 2016-17 season was approximately $9.35 per carton. Using the weighted average price and shipment information, the number of producers (170) and assuming a normal distribution, the majority of producers would have annual receipts of $418,000, which is less than $750,000. ($9.35 per carton times 7.6 million cartons equals $71.06 million, divided by 170 equals $418,000 per producer.) Thus, the majority of Texas citrus producers may be classified as small entities.

This final rule revises the container requirements established under the Order. This rule removes five containers from the list of authorized containers and adds seven new containers to the list. This action also updates one container to allow handlers to use it to pack oranges and grapefruit, and modifies the description of another container to indicate it is the standard container used by the industry. These changes align the list of authorized containers with current industry needs and practices. This rule revises § 906.340. Authority for these changes is provided in § 906.40.

It is not anticipated that this final rule will impose additional costs on handlers or growers, regardless of size. The containers removed from the list of authorized containers are no longer being used by the industry. This rule provides an additional container for packing grapefruit, clarifies the description for one container, and adjusts the container regulations to better reflect current industry practices. The benefits of this rule are expected to be equally available to all fresh orange and grapefruit growers and handlers, regardless of size.

The Committee considered alternatives to this action, including making no changes to the list of authorized containers. However, it was determined that making the recommended changes provides an up-to-date list of containers currently being used by the Texas citrus industry. Therefore, the Committee rejected this alternative.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This final rule does not impose any additional reporting or recordkeeping requirements on either small or large Texas orange and grapefruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

The Committee's meeting was widely publicized throughout the Texas citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 8, 2017, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

A proposed rule concerning this action was published in the Federal Register on July 6, 2018 (83 FR 31471). Copies of the proposed rule were sent via email to all Committee members and Texas citrus handlers. The proposed rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending August 6, 2018, was provided to allow interested persons to respond to the proposal. No comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 906

Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 906 is amended as follows:

PART 906—ORANGES AND GRAPEFRUIT GROWN IN LOWER RIO GRANDE VALLEY IN TEXAS 1. The authority citation for 7 CFR part 906 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Revise § 906.340(a)(1) to read as follows:
§ 906.340 Container, pack, and container marking regulations.

(a) * * *

(1) Containers. (i) Closed fiberboard carton with approximate inside dimensions of 131/4 x 101/2 x 71/4 inches: Provided, That the container has a Mullen or Cady test of at least 200 pounds;

(ii) Closed fully telescopic fiberboard carton with approximate inside dimensions of 161/2 x 103/4 x 91/2 inches (Standard carton);

(iii) Poly or mesh bags having a capacity of 4, 5, 8, 10, or 18 pounds of fruit;

(iv) Rectangular or octagonal bulk fiberboard crib with approximate dimensions of 46 to 471/2 inches in length, 37 to 38 inches in width, and 36 inches in height: Provided, That the container has a Mullen or Cady test of at least 1,300 pounds, and that it is used only once for the shipment of citrus fruit: And Provided further, That the container may be used to pack any poly or mesh bags authorized in this section, or bulk fruit;

(v) Rectangular or octagonal 2/3 fiberboard crib with approximate dimensions of 46 to 471/2 inches in length, 37 to 38 inches in width, and 24 inches in height: Provided, That the crib has a Mullen or Cady test of at least 1,300 pounds, and that it is used only once for the shipment of citrus fruit: And Provided further, That the container may be used to pack any poly or mesh bags authorized in this section, or bulk fruit;

(vi) Octagonal fiberboard crib with approximate dimensions of 46 to 471/2 inches in width, 37 to 38 inches in depth, and 26 to 261/2 inches in height: Provided, That the crib has a Mullen or Cady test of at least 1,300 pounds, and that it is used only once for the shipment of citrus fruit: And Provided further, That the crib may be used to pack any poly or mesh bags authorized in this section, or bulk fruit;

(vii) Fiberboard box holding two layers of fruit, with approximate dimensions of 23 inches in length, 151/2 inches in width, and 7 inches in depth;

(viii) Reusable collapsible plastic container with approximate dimensions of 23 inches in length, 15 inches in width, and 7 to 11 inches in depth;

(ix) Reusable collapsible plastic bin with approximate dimensions of 363/4 x 443/4 x 27 inches;

(x) Octagonal bulk triple wall fiberboard crib with approximate dimensions of 373/4 inches in length, 25 inches in width, and 25 inches in height: Provided, That the container has a Mullen or Cady test of at least 1,100 pounds: And Provided further, That the container may be used to pack any poly or mesh bags authorized in this section, or bulk fruit;

(xi) Bag having the capacity of 15 pounds of fruit, either in a combination 1/2 poly and 1/2 mesh bag or mesh bag;

(xii) Reusable collapsible plastic mini bin with approximate dimensions of 391/2 inches in length, 24 inches in width, and 301/2 inches in height: Provided, That the container may be used to pack any poly or mesh bags authorized in this section, or bulk fruit;

(xiii) Bag having the capacity of three pounds of fruit;

(xiv) Standard carton with approximate inside dimensions of 16.375 x 10.6875 x 10.25 inches;

(xv) 8/5 Body master carton with approximate inside dimensions of 19.5385 x 13.125 x 11.625 inches, one piece;

(xvi) Euro 8/5 (5 Down) with approximate inside dimensions of 22.813 x 14.688 x 7.0 up to 7.936 inches;

(xvii) Fiberboard one piece display container with approximate inside dimensions of 23 inches x 15 inches x 91/2 up to 101/2 inches in depth;

(xviii) Such types and sizes of containers as may be approved by the committee for testing in connection with a research project conducted by or in cooperation with the committee: Provided, That the handling of each lot of fruit in such test containers shall be subject to prior approval and under the supervision of the committee.

Dated: October 15, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-22759 Filed 10-18-18; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 982 [Doc. No. AO-SC-16-0136; AMS-SC-16-0074; SC16-982-1] Hazelnuts Grown in Oregon and Washington; Order Amending Marketing Order No. 982 AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This final rule amends Marketing Order No. 982 (Order), which regulates the handling of hazelnuts grown in Oregon and Washington. The amendments were proposed by the Hazelnut Marketing Board (Board) and add the authority to regulate quality for the purpose of pathogen reduction and to establish different regulations for different markets.

This final rule also makes administrative revisions to subpart headings to bring the language into conformance with the Office of Federal Register requirements.

DATES:

This rule is effective November 19, 2018.

ADDRESSES:

Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237.

FOR FURTHER INFORMATION CONTACT:

Melissa Schmaedick, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, Post Office Box 952, Moab, UT 84532; Telephone: (202) 557-4783, Fax: (435) 259-1502, or Michelle Sharrow, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected] or [email protected]

Small businesses may request information on this proceeding by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

Prior documents in this proceeding: Notice of Hearing issued on September 27, 2016, and published in the September 30, 2016, issue of the Federal Register (81 FR 67217); a Recommended Decision issued on June 5, 2017, and published in the June 12, 2017, issue of the Federal Register (82 FR 26859); and a Secretary's Decision and Referendum Order issued September 14, 2017, and published in the September 28, 2017, issue of the Federal Register (82 FR 45208).

This action is governed by the provisions of sections 556 and 557 of title 5 of the United States Code and, therefore, is excluded from the requirements of Executive Orders 12866, 13563, and 13175. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See the Office of Management and Budget's (OMB) Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

Notice of this rulemaking action was provided to tribal governments through the Department of Agriculture's (USDA) Office of Tribal Relations.

Preliminary Statement

This action finalizes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 982, as amended (7 CFR part 982), regulating the handling of hazelnuts grown in Oregon and Washington. Part 982 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The final rule was formulated on the record of a public hearing held on October 18, 2016, in Wilsonville, Oregon. The hearing was held pursuant to the provisions of the Act, and the applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR part 900). Notice of this hearing was published in the Federal Register September 30, 2016 (81 FR 67217). The notice of hearing contained two proposals submitted by the Board and one submitted by USDA.

Upon the basis of evidence introduced at the hearing and the record thereof, the Administrator of the Agricultural Marketing Service (AMS) on June 5, 2017, filed with the Hearing Clerk, USDA, a Recommended Decision and Opportunity to File Written Exceptions thereto by July 12, 2017. No exceptions were filed.

A Secretary's Decision and Referendum Order was published in the Federal Register on September 28, 2017 (82 FR 45208), directing that a referendum be conducted during the period of October 16 through November 3, 2017, among eligible Oregon and Washington hazelnut growers to determine whether they favored the proposed amendments to the Order. To become effective, the amendments had to be approved by at least two-thirds of those growers voting, or by voters representing at least two-thirds of the volume of hazelnuts represented by voters voting in the referendum. The amendment adding authority to regulate quality was favored by 69.5 percent of the growers voting in the referendum, representing 71.6 percent of the total volume of hazelnuts produced by those voting. The amendment adding authority to establish different regulations for different markets was favored by 67.9 percent of the growers voting in the referendum, representing 69.5 percent of the total volume of hazelnuts produced by those voting.

The amendments favored by voters and included in this final order authorize the regulation of quality for the purpose of pathogen reduction and the establishment of different outgoing quality regulations for different markets.

USDA also made such changes as were necessary to the Order so that all of the Order's provisions conform to the effectuated amendments. USDA recommended one clarifying change to the language in the new paragraph 982.45(c), which adds authority to regulate quality. USDA determined that the language as presented in the Notice of Hearing was redundant and, therefore, confusing. USDA revised the language in the new paragraph § 982.45(c) so that its intent is more clearly stated. This language is included in the regulatory text of this Order.

The amended marketing agreement was subsequently mailed to all hazelnut handlers in the production area for their approval. The marketing agreement was not approved by handlers representing more than 50 percent of the volume of hazelnuts handled by all handlers during the representative period of July 1, 2016, through June 30, 2017. Consequently, no companion handler agreement will be established.

Small Business Consideration

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be unduly or disproportionately burdened. Marketing orders and amendments thereto are unique in that they are normally brought about through group action of essentially small entities for their own benefit.

Hazelnut Industry Background and Overview

According to the hearing transcript, there are currently over 800 hazelnut growers in the production area. According to National Agricultural Statistics Service (NASS) data presented at the hearing, 2015 grower receipts averaged $2,800 per ton. With a total 2015 production of 31,000 tons, the farm gate value for hazelnuts in that year totaled $86.8 million ($2,800 per ton multiplied by 31,000 tons). Taking the total value of production for hazelnuts and dividing it by the total number of hazelnut growers provides a return per grower of $108,500. A small grower as defined by the Small Business Administration (SBA) (13 CFR 121.201) is one having annual receipts of less than $750,000 annually. Therefore, a majority of hazelnut growers are considered small entities under the SBA standards. Record evidence indicates that approximately 98 percent of hazelnut growers are small businesses.

According to the industry, there are 17 hazelnut handlers, four of which handle 80 percent of the crop. While market prices for hazelnuts were not included among the data presented at the hearing, an estimation of handler receipts can be calculated using the 2015 grower receipt value of $86.8 million. Multiplying $86.8 million by 80 percent ($86.8 million multiplied by 80 percent equals $69.4 million) and dividing by four indicates that the largest hazelnut handlers received an estimated $17.3 million each. Dividing the remaining 20 percent of $86.8 million, or $17.4 million, by the remaining 13 handlers, indicates average receipts of $1.3 million each. A small agricultural service firm is defined by the SBA as one having annual receipts of less than $7,500,000. Based on the above calculations, a majority of hazelnut handlers are considered small entities under the SBA's standards.

The production area regulated under the Order covers Oregon and Washington. According to the record, Eastern Filbert Blight has heavily impacted hazelnut production in Washington. One witness stated that there is currently no commercial production in that state. As a result, production data entered into the record pertains almost exclusively to Oregon.

NASS data indicates bearing acres of hazelnuts reached a fifteen-year high during the 2013-2014 crop year at 30,000 acres. Acreage remained steady, at 30,000 bearing acres for the 2015-2016 crop year. By dividing 30,000 acres by 800 growers, NASS data indicate there are approximately 37.5 acres per grower. Industry testimony estimates that due to new plantings, there are potentially 60,000 bearing acres of hazelnuts, or an estimated 75 bearing acres per hazelnut grower.

During the hearing held October 18, 2016, interested parties were invited to present evidence on the probable regulatory impact of the amendments to the Order on small businesses. The evidence presented at the hearing shows that none of the amendments would have a significant economic impact on a substantial number of small agricultural growers or firms.

Material Issues

This action amends the Order to authorize the regulation of quality for the purpose of pathogen reduction and the establishment of different outgoing quality regulations for different markets. These authorities will aid in pathogen reduction in hazelnuts and increase the industry's ability to meet the needs of different market destinations.

During the hearing held on October 18, 2016, interested persons were invited to present evidence on the probable regulatory and informational impact of the amendments to the Order on small businesses. The evidence presented at the hearing shows that the amendments would have no burdensome effects on small agricultural producers or firms.

In discussing the impacts of the amendments on growers and handlers, record evidence indicates that the authority to establish quality regulations that require hazelnuts to be treated prior to shipment to reduce pathogen load would not significantly impact the majority of handlers. Regulations implemented under that authority could impose additional costs on handlers required to comply with them. However, witnesses testified that establishing mandatory treatment regulations could increase the industry's credibility and reduce the risk that shipments of substandard product could jeopardize the entire industry's reputation. Record evidence shows that any additional costs are likely to be offset by the benefits of complying with those requirements.

The record shows that the proposal to add authority to establish different outgoing quality requirements for different markets would, in itself, have no economic impact on growers or handlers of any size. While regulations implemented under that authority could potentially impose additional costs on handlers required to comply with them, the record indicates the benefits of such regulation would outweigh the potential future costs. The record indicates that allowing different regulations for different markets would likely lower the costs to handlers and prevent multiple treatments of hazelnuts while preserving hazelnut quality.

This final rule also makes administrative revisions to subpart headings to bring the language into conformance with the Office of Federal Register requirements.

USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. These amendments are intended to improve the operation and administration of the Order and to assist in the marketing of hazelnuts.

Paperwork Reduction Act

Current information collection requirements for Part 982 are approved by OMB, under 0581-0178 “Vegetable and Specialty Crops.” No changes are anticipated in these requirements as a result of this proceeding. Should any such changes become necessary, they would be submitted to OMB for approval.

As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies.

AMS is committed to complying with the Government Paperwork Elimination Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

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

Civil Justice Reform

The amendments to the Order stated herein have been reviewed under Executive Order 12988, Civil Justice Reform. They are not intended to have retroactive effect. The amendments do not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.

Order Amending the Order Regulating the Handling of Hazelnuts Grown in Oregon and Washington 1

1 This order shall not become effective unless and until the requirements of § 900.14 of the rules of practice and procedure governing proceedings to formulate marketing agreements and marketing orders have been met.

Findings and Determinations

The findings and determinations hereinafter set forth are supplementary to the findings and determinations that were previously made in connection with the issuance of the Marketing Order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.

(a) Findings and Determinations Upon the Basis of the Hearing Record

Pursuant to the provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), and the applicable rules of practice and procedure effective thereunder (7 CFR part 900), a public hearing was held upon further amendment of Marketing Order No. 982, regulating the handling of hazelnuts grown in Oregon and Washington.

Upon the basis of the record, it is found that:

(1) The Order, as amended, and as hereby further amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;

(2) The Order, as amended, and as hereby further amended, regulates the handling of hazelnuts grown in the production area in the same manner as, and is applicable only to, persons in the respective classes of commercial and industrial activity specified in the Order upon which a hearing has been held;

(3) The Order, as amended, and as hereby further amended, is limited in its application to the smallest regional production area that is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;

(4) The Order, as amended, and as hereby further amended, prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of hazelnuts grown in Oregon and Washington; and

(5) All handling of hazelnuts grown in the production area as defined in the Order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.

(b) Determinations. It is hereby determined that:

(1) Handlers (excluding cooperative associations of growers who are not engaged in processing, distributing, or shipping hazelnuts covered by the order as hereby amended) who, during the period July 1, 2016, through June 30, 2017, handled 50 percent or more of the volume of such hazelnuts covered by said order, as hereby amended, have not signed an amended marketing agreement;

(2) The issuance of this amendatory Order, further amending the aforesaid Order, was favored or approved by at least two-thirds of the growers who participated in a referendum on the question of approval and who, during the period of July 1, 2016, through June 30, 2017 (which has been deemed to be a representative period), have been engaged within the production area in the production of such hazelnuts, such growers having also produced for market at least two-thirds of the volume of such commodity represented in the referendum; and

(3) The issuance of this amendatory Order advances the interests of growers of hazelnuts in the production area pursuant to the declared policy of the Act.

Order Relative to Handling

It is therefore ordered, that on and after the effective date hereof, all handling of hazelnuts grown in Oregon and Washington shall be in conformity to, and in compliance with, the terms and conditions of the said Order as hereby amended as follows:

The provisions of the amendments to the Order contained in the Secretary's Decision issued on September 14, 2017, and published in the September 28, 2017, issue of the Federal Register (82 FR 45208) will be and are the terms and provisions of this order amending the Order and are set forth in full herein.

List of Subjects in 7 CFR Part 982

Hazelnuts, Marketing agreements, Nuts, Reporting and recordkeeping requirements.

For the reasons set out in the preamble, 7 CFR part 982 is amended as follows:

PART 982—HAZELNUTS GROWN IN OREGON AND WASHINGTON 1. The authority citation for part 982 continues to read as follows: Authority:

7 U.S.C. 601-674.

[Subpart Redesignated as Subpart A] 2. Redesignate the “Subpart—Order Regulating Handling” as “Subpart A—Order Regulating Handling”. 3. Revise § 982.12 to read as follows:
§ 982.12 Merchantable hazelnuts.

Merchantable hazelnuts means inshell hazelnuts that meet the grade, size, and quality regulations in effect pursuant to § 982.45 and are likely to be available for handling as inshell hazelnuts.

4. Amend § 982.40 by revising paragraph (d) to read as follows:
§ 982.40 Marketing policy and volume regulation.

(d) Grade, size, and quality regulations. Prior to September 20, the Board may consider grade, size, and quality regulations in effect and may recommend modifications thereof to the Secretary.

5. Revise the undesignated center heading prior to § 982.45 to read as follows: Grade, Size, and Quality Regulation 6. In § 982.45, revise the section heading and add paragraphs (c) and (d) to read as follows:
§ 982.45 Establishment of grade, size, and quality regulations.

(c) Quality regulations. For any marketing year, the Board may establish, with the approval of the Secretary, such minimum quality and inspection requirements applicable to hazelnuts to facilitate the reduction of pathogens as will contribute to orderly marketing or will be in the public interest. In such marketing year, no handler shall handle hazelnuts unless they meet applicable minimum quality and inspection requirements as evidenced by certification acceptable to the Board.

(d) Different regulations for different markets. The Board may, with the approval of the Secretary, recommend different outgoing quality requirements for different markets. The Board, with the approval of the Secretary, may establish rules and regulations necessary and incidental to the administration of this provision.

7. Amend § 982.46 by adding paragraph (d) to read as follows:
§ 982.46 Inspection and certification.

(d) Whenever quality regulations are in effect pursuant to § 982.45, each handler shall certify that all product to be handled or credited in satisfaction of a restricted obligation meets the quality regulations as prescribed.

[Subpart Redesignated as Subpart B and Amended] 8. Redesignate “Subpart—Grade and Size Regulation” as subpart B and revise the heading to read as follows: Subpart B—Grade and Size Requirements [Subpart Redesignated as Subpart C] 9. Redesignate “Subpart—Free and Restricted Percentages” as “Subpart C—Free and Restricted Percentages”. [Subpart Redesignated as Subpart D] 10. Redesignate “Subpart—Assessment Rates” as “Subpart D—Assessment Rates”. [Subpart Redesignated as Subpart E and Amended] 11. Redesignate “Subpart—Administrative Rules and Regulations” as subpart E and revise the heading to read as follows: Subpart E—Administrative Requirements

Dated: October 15, 2018.

Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-22762 Filed 10-18-18; 8:45 am] BILLING CODE 3410-02-P
FEDERAL HOUSING FINANCE AGENCY 12 CFR Parts 1239 and 1273 RIN 2590-AA90 Responsibilities of Boards of Directors, Corporate Practices, and Corporate Governance AGENCY:

Federal Housing Finance Agency.

ACTION:

Final rule.

SUMMARY:

The Federal Housing Finance Agency (FHFA) is amending its regulation on the Responsibilities of Boards of Directors, Corporate Practices, and Corporate Governance for its regulated entities. The final rule amends the existing regulation pertaining to Federal Home Loan Bank strategic business plans so that it applies as well to the Enterprises, and makes a number of adjustments and conforming changes to the existing regulation. As amended, the regulation requires that the board of directors of each regulated entity have in effect at all times a strategic business plan that describes its strategy for achieving its mission and public purposes. It extends to the Enterprise boards the existing provision requiring the board of each Federal Home Loan Bank to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan. The final rule adds a new provision regarding current and emerging risks, repeals two outdated provisions of the existing regulation, and makes a conforming change to the Office of Finance Board of Directors regulation.

DATES:

The final rule is effective on December 18, 2018.

FOR FURTHER INFORMATION CONTACT:

Daniel Callis, Principal Risk Analyst, Office of the Chief Accountant, at [email protected] or (202) 649-3448, or Ming-Yuen Meyer-Fong, Office of General Counsel, at [email protected] or (202) 649-3078 (these are not toll-free numbers), Federal Housing Finance Agency, Constitution Center, 400 Seventh Street SW, Washington, DC 20219. The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

SUPPLEMENTARY INFORMATION:

I. Background

On April 6, 2018, FHFA published a proposed rule that would amend the existing FHFA regulation on Responsibilities of Boards of Directors, Corporate Practices and Corporate Governance Matters. The proposed rule would amend, and extend to apply to the board of directors of each Enterprise, the existing provision requiring the board of directors for each Federal Home Loan Bank to have in effect at all times a strategic business plan for the entity. It would also require the strategic business plan to: (1) Articulate measurable operating goals; (2) address credit needs identified through ongoing market research and stakeholder consultations; (3) describe significant activities being planned, including any changes to business strategy; (4) be supported by appropriate and timely research; and (5) identify current and emerging risks, including those associated with the entity's existing activities or new activities. It would also require a board to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan.

The proposed rule would also repeal two outdated provisions, and make a conforming change to the Office of Finance Board of Directors regulation.

II. Summary of Comments and FHFA Responses

FHFA received comments on the proposed rule from Fannie Mae and Freddie Mac (Enterprises) and U.S. Mortgage Insurers (USMI), a trade association comprising various private mortgage insurance companies. The commenters generally agreed with the establishment of a regulatory requirement for a strategic business plan. Two commenters also argued that a regulated board should be permitted to articulate goals, strategies, and risks at a high level, rather than with granular specificity. Other comments included one concerning the effect that the new activities process and conservatorship have on the strategic business plan process.

The comments are summarized below, along with FHFA's responses and discussion of changes, if any, to the final rule text in consideration of the comments.

A. Commenters Agreed on a Requirement for a Board-Approved Strategic Business Plan

The commenters agreed generally with the establishment of a regulatory requirement for a board-approved strategic business plan. The commenters also generally agreed that a strategic business plan should have measurable goals and objectives to hold management accountable.

B. Appropriate Balance Between High-Level View and Granular Detail (§ 1239.14(a) (Opening Provision); § 1239.14(a)(1)(i) and (ii); § 1239.14(a)(3); and § 1239.14(a)(5))

Commenters differed on the appropriate balance between board flexibility to plan from a high-level perspective and at a more detailed level. Two commenters proposed modifying the final rule to permit a board to articulate goals and strategies at a high level, while one commenter supported requirements on the level of individual activities.

The commenters offered specific suggestions to revise the language of the regulation to permit high-level discussion. With respect to proposed § 1239.14(a)(1)(ii), FHFA received suggestions for the plan to articulate goals and objectives for “strategic activities,” not “for each significant activity and all authorized new activities” as proposed. Another commenter suggested that goals and objectives be articulated for “significant business strategy.”

For proposed § 1239.14(a)(3), one commenter suggested that the requirement should be that the plan describe “significant strategic activities” while another suggested “strategies.” Commenters suggested that the final regulation exclude from strategic planning changes in business strategy not determined “significant.”

For proposed § 1239.14(a)(5), commenters suggested excluding less-than-significant risks from being required to be addressed in the strategic business plan. One commenter suggested that the strategic business plan address significant risks associated with significant activities. Another similarly suggested that the rule should not require a strategic business plan to address risks, including significant risks, associated with activities that a board does not determine to be significant.

One commenter expressed concern that requiring the plan to address specific activities could be unworkable due to high numbers of Enterprise activities.

In contrast, another commenter supported strategic planning requirements for individual activities, and questioned a threshold prescribing planning only for “significant” activities, because the metric for “significance” remains too broad, and potentially excludes too much from board scrutiny or oversight. This commenter expressed that strategic planning for individual activities and authorized new activities would facilitate a board's monitoring and review of individual activities and market footprint. The same commenter also suggested the rule apply metrics such as stress testing to Enterprise activities to assess their risks.

FHFA Response: A strategic business plan articulates a regulated entity's long-term vision, and aligns it with the entity's risk management framework, statutory mission, and public purposes. A strategic business plan also articulates a regulated entity's roadmap for achieving its goals.

The management of a regulated entity shall be “by or under the direction” of its board of directors, and the board has “ultimate responsibility” of oversight over the entity, which responsibility may not be delegated to management.1 FHFA recognizes that requirements that are too specific may in some instances involve the board unnecessarily in operational details that it could have otherwise determined to delegate in the absence of such requirements. FHFA also recognizes that granular requirements could mean unwieldy numbers of activities for a strategic business plan to address. Given the interest in avoiding board distraction in its strategic planning by unnecessary or unhelpful operational details, FHFA declines to modify the rule to require strategic goals to be articulated at the level of every existing activity or authorized new activity, regardless of the activity's significance.

1See 12 CFR 1239.4(a).

On the other hand, requirements that are too high-level may not provide a board with a sufficient view of the risks of the goals and of strategies deployed to achieve those goals. To support board planning at a meaningful level of involvement, FHFA also declines to modify the rule to permit strategic goals to be articulated at the highest level of generality. FHFA seeks an appropriate balance in the final rule, necessary to support a board's efforts in setting strategic goals, determining a safe and sound strategy to meet those goals, and overseeing execution. The final rule uses a threshold of “significant” activities.2

2 This approach is consistent with the standards of other regulators of large financial institutions cited by Freddie Mac. See, e.g., 12 CFR part 30, appendix D, III.B. (OCC) (“A covered bank's board of directors should actively oversee the covered bank's risk-taking activities and hold management accountable for adhering to the risk governance framework”); Federal Reserve Board, Consolidated Supervision Framework for Large Financial Institutions (July 2014), 2124.05.3.2 (each firm's board of directors should “maintain a clearly articulated corporate strategy and institutional risk appetite. The board should set direction and oversight for revenue and profit generation, risk management and control functions, and other areas essential to sustaining the consolidated organization . . .”).

Similarly, the Federal Reserve Board's recent proposed supervisory guidance cited by Freddie Mac provides that a “clear strategy includes sufficient detail to enable senior management to identify the firm's strategic objectives; [and] to create an effective management structure, implementation strategies, plans and budgets for each business line”). 82 FR 37219, 37224 (Aug. 9, 2017). The Federal Reserve Board's proposed guidance thus provides that a strategic plan is expected to communicate to senior management the board's priorities, objectives, and strategies in sufficient detail for senior management to allocate resources appropriately to each business line.

A threshold of “significant” activities would avoid requiring a board to engage with activities that the board does not determine are significant. The rule does not require a board to perform, by itself, every task necessary to determine those activities that are significant. Instead, subject to its duties, a board may set parameters for senior management to apply in identifying activities that the board considers to be significant activities. These parameters could relate to the risks posed by an activity, including whether the activity contributes to or deviates from the entity's strategic goals, statutory mission, and public purposes. They could also relate to any increased scaling of the activity, either planned or in execution.

The final rule does not require specific metrics to address expansion or contraction of activities in response to the entity's mission, public purposes and market assessment. Subject to its duties under applicable law in the absence of specific regulatory requirements, a board will determine, or oversee the determination of, any such appropriate metrics.

The final rule in the opening provision of § 1239.14(a), which establishes a general requirement for a strategic business plan, is revised to require a strategic business plan to describe how the “significant” business activities of the regulated entity will achieve a regulated entity's mission and public purposes. Though FHFA did not receive specific comments to the proposed opening provision of § 1239.14(a), FHFA made the final rule revision to the opening provision based on comments it received on this issue.

The final rule is also revised at § 1239.14(a)(1)(i) and (ii) to state that a board's strategic business plan shall articulate measurable goals and objectives. Also, the proposed reference to “operating” is deleted so that a plan is not required, or limited, to articulate “operating” goals and objectives. Section 1239.14(a)(1)(ii) is revised to clarify that a plan articulate measurable goals and objectives also for “significant” authorized new activities. As a result of this revision, a plan would not be required to address authorized new activities that are not determined to be significant activities. A parallel change was not made to § 1239(a)(1)(i), the provision applying to the Banks. The FHFA regulation covering new business activities process for the Banks already contains a determination that the activity “entails material risks . . .” 12 CFR 1272.1. If FHFA were to amend the regulations regarding Enterprise new activities and new products to include a threshold equivalent to the “significant” activities threshold used in the final rule, FHFA may consider taking a similar approach for the Enterprises in § 1239.14(a)(1)(ii) that it does for the Banks in § 1239.14(a)(1)(i).

At § 1239.14(a)(3), the revised final rule requires a plan to describe any “significant” changes to business strategy that are planned, and not just any change to business strategy. As a result of this revision, a board is not required to address changes to business strategy that the entity is planning to undertake that it does not determine to be significant.

At § 1239.14(a)(5), the revised final rule requires a strategic business plan to identify current and emerging risks associated with the regulated entity's “significant” activities, existing or new. The revised final rule also requires that a plan discuss how the entity intends to address such risks, i.e., those risks associated with the entity's significant activities, while furthering its public purposes and mission in a safe and sound manner. The final rule does not require the board to address risks associated with activities that have not been determined to be significant.

C. Differences in Roles Between Board and Management (§ 1239.14(a)(2); § 1239.14(a)(4)(ii))

FHFA received comments that the proposed rule would impose on the board duties more appropriate for management, and that the final rule should preserve the distinct division of roles between board and management.

The comments arose in the context of the proposed requirements that the strategic business plan discuss credit needs and opportunities identified through market research and stakeholder consultation, and be supported by appropriate and timely research and analysis of relevant market developments. Specific comments suggested that any research and analysis supporting the strategic business plan be as Enterprise management deems appropriate.

FHFA Response: The management of a regulated entity shall be “by or under the direction” of its board of directors, and the board has “ultimate responsibility” of oversight over the entity, which responsibility may not be delegated to management.3 Except for a board's ultimate responsibility for oversight of the regulated entity, the board has authority to delegate responsibilities to management and to determine the scope of responsibilities delegated to management.

3See 12 CFR 1239.4(a).

The proposed rule at § 1239.14(a)(2) does not affect a board's authority, require the board to conduct market research and stakeholder consultations, or prescribe the manner in which such research and consultation must be conducted. The proposed rule does not prohibit a board from delegating market research and stakeholder consultations, consistent with the board's duties. The final rule adopts § 1239.14(a)(2) as proposed.

Similarly, the proposed rule at § 1239.14(a)(4)(ii) does not require the board to conduct research and analysis of market developments, or prescribe the type of research and analysis. The proposed rule does not affect the board's authority to determine what research and analysis is appropriate to support the plan. Nor does the proposed rule affect the board's authority to assign research to senior management, while overseeing that it is done to the board's satisfaction.

In addition, while Fannie Mae objected to the reference to timely research in § 1239.14(a)(4)(ii), the purpose of that reference is to specify that the supporting research be suitably timed for the plan, and that the research is not stale or expired.

The final rule adopts § 1239.14(a)(4)(ii) as proposed.

D. Comment Suggested Principles-Based Approach Due to Differences Between the Banks and the Enterprises

FHFA received a comment that the minimum requirements for a strategic business plan adapted from existing requirements applying to the Federal Home Loan Banks are not appropriate for the Enterprises. Specifically, the commenter asserted that, unlike the Banks, the Enterprises are SEC-registered, publicly-traded, and operating under New York Stock Exchange requirements. The commenter further noted that the Enterprises are larger than the Banks and securitize mortgages as their core business model.

FHFA Response: The commenter's point in noting these differences is that the final rule should take a principles-based approach, not a prescriptive approach. The final rule does not prescribe board functions, such as engaging in market research. The revised final rule also does not prohibit the board from delegating functions, other than its ultimate oversight function, to senior management. In fact, the operative requirement in the revised final rule, which is unchanged from the proposed rule, is for a board to “adopt and have in effect at all times a strategic business plan for the regulated entity.” The differences noted by the commenter do not adversely affect the Enterprises. The differences also do not diminish the traditional role that a board plays in setting strategic goals for the entity, and holding management responsible for executing on the plan.

E. The Final Rule Requirements Do Not Apply to Diversity and Inclusion Strategic Plans

FHFA received a comment that the final rule should not apply to diversity and inclusion strategic plans, which are addressed specifically by 12 CFR 1223.21(b), (d), and (e).

FHFA Response: FHFA agrees that the diversity and inclusion strategic plans are subject to separate regulatory requirements. Therefore, this final rule does not apply to such plans. Moreover, the final rule does not prohibit a regulated entity from incorporating its diversity and inclusion strategic plan into its strategic business plan, which is expressly permitted under 12 CFR 1223.21(b)(8).

F. Strategic Business Plan To Address Current and Emerging Risks (§ 1239.14(a)(5))

The commenters also differed on whether the strategic business plan should address current and emerging risks. With respect to proposed § 1239.14(a)(5), FHFA received a comment that, while current risks may be ascertainable, emerging risks may not be knowable at the outset of a multi-year strategic planning process. Another commenter expressed support for a requirement that the strategic business plan address current and emerging risks.

FHFA Response: FHFA acknowledges that while it may be challenging for the board to ascertain emerging risks associated with significant activities at the outset of a multi-year strategic planning process, it should not preclude a board from exercising its duty of care to plan for such risks. A board's goals in strategic planning includes assessing the entity's goals to determine whether they align with the entity's public purposes and mission, and strategies for execution to identify any risks and determine whether the strategies are safe and sound and align with the entity's risk management framework.4 A core part of a board's strategic responsibility for the health and prosperity of a company is to look into the future insofar as it can be done, to assess what risks may be approaching.

4 A similar approach is taken by the OCC in its Guidelines, cited by Freddie Mac, establishing “heightened standards” for certain large insured financial institutions. Specifically, the OCC guidance provides that the strategic plan cover at a minimum a three-year period and contain “a comprehensive assessment of risks that currently have an impact on the covered bank or that could have an impact on the covered bank during the period covered by the strategic plan.” 12 CFR part 30, App. D, sec. D.1.

With the revision discussed above at II.B., the final rule otherwise adopts, as proposed, the provision on emerging risks and furthering the entity's public purposes and mission in a safe and sound manner.

G. The Final Rule During Conservatorship

A commenter asked how conservatorship and 12 CFR part 1253 (Prior Approval for Enterprise Products) affects the final rule, how FHFA views the relationship between its conservatorship and regulatory obligations, and how its processes and decisions regarding activities and products are consistent with FHFA's role as conservator. A commenter suggested that FHFA issue guidance on how the final rule would apply to “significant activities” in light of 12 CFR part 1253.

FHFA Response: As FHFA noted when it most recently adopted its corporate governance regulation, the regulation was not intended to address conservatorship matters. 80 FR 72327, 72328 (Nov. 19, 2015). Rather, the regulation was intended to address matters of corporate practice and governance at the regulated entities, and was adopted consistent with FHFA's regulatory authority under the Safety and Soundness Act.

Separately, pursuant to its conservatorship authority, FHFA has provided for Enterprise boards to exercise the functions of management oversight that exist under applicable law and regulation, including FHFA's corporate governance regulation at 12 CFR part 1239. Although the Enterprises remain in conservatorship, their boards of directors have been operating under FHFA regulations, including most recently 12 CFR part 1239, that govern board members outside of conservatorship, except as modified by the conservator. Therefore, under this final rule, the board of directors at each Enterprise is required to adopt and have in effect a strategic business plan.

The Enterprise new activities process (12 CFR part 1253) and the final rule both reference “new activity.” However, they use the term for different supervisory purposes. Part 1253 defines new activities inclusively to support determination of new products, while the final rule establishes strategic plan requirements involving “significant” new activities, which is a smaller subset of new activities. In addition, the Enterprise new activities process is separate from the strategic business plan process. For example, the Enterprise new activities process may result in the review and authorization of new activities that are not required to be addressed in the strategic business plan because the board does not determine them significant. Similarly, a strategic business plan may address significant activities that are not new activities.

The availability or denial of individual new activities may augment or limit a regulated entity's tools for meeting its chosen strategic goals. A strategic business plan could help identify significant activities on which the regulated entity plans to rely to achieve its strategic goals. It could also help identify alternative strategies that may be safer and more effective, and to explain the role, relevance, and risks of significant activities that the regulated entity is planning to undertake.

However, FHFA decisions relating to new activities do not affect a board's process for developing and adopting a strategic business plan. Given that strategic planning and new activities processes operate separately, guidance explaining the connection between the two rules and processes is inappropriate at this time.

III. Final Rule A. Overview

The final rule retains the general requirement for a strategic business plan to address activities the board determines significant. Clarifying revisions are made to specific provisions.

In addition, the final rule requires a strategic business plan to articulate measurable goals, address credit needs and market opportunities, describe significant activities being planned including significant changes in business strategy, be supported by appropriate and timely research, and identify current and emerging risks. It also requires a board to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan. The final rule also repeals two outdated provisions that required Bank strategic business plans to include quantitative performance goals for Bank products related to multifamily housing and to community financial institution collateral, and that required related reporting. It also makes a conforming change to the Office of Finance Board of Directors regulation.

B. Section-by-Section Analysis

§ 1239.14(a)—opening provision: The final rule is revised to add “significant” to circumscribe the business activities that a strategic business plan is required to describe. Thus, a board of directors is required to adopt and have in effect at all times a strategic business plan that describes how the “significant” business activities of the regulated entity will achieve its mission and public purposes consistent with its authorizing statute, the Safety and Soundness Act, and, in the case of a Bank, 12 CFR part 1265. The focus of the requirement is on those business activities a board determines significant.

§ 1239.14(a)(1)(i): The final rule deletes “operating” to provide that, in the case of a Bank, a strategic business plan is required to articulate measurable goals and objectives for each significant business activity and all authorized new business activities. As a result of the revision, the focus of the requirement is on measurable goals and objectives.

§ 1239.14(a)(1)(ii): The final rule deletes “operating” and replaces “all” with “significant” to provide that, in the case of an Enterprise, a strategic business plan is required to articulate measurable goals and objectives for each significant existing activity and for significant authorized new activities. As a result of the revision, the focus of the requirement is on measurable goals and objectives for significant activities, both existing and new.

§ 1239.14(a)(2): The final rule adopts paragraph 1239.14(a)(2) as proposed.

§ 1239.14(a)(3): The final rule adds “significant” to provide that a strategic business plan is required to describe any significant activities in which the regulated entity is planning to be engaged, including any significant changes to business strategy or approach that the regulated entity is planning to undertake. As a result of the revision, the requirement to describe any significant activities in which the regulated entity is planning to be engaged includes significant changes to business strategy or approach that the entity is planning to undertake.

§ 1239.14(a)(4)(ii): The final rule adopts § 1239.14(a)(4)(ii) as proposed.

§ 1239.14(a)(5): The final rule deletes “including those” and adds “significant” to provide that a strategic business plan is required to identify current and emerging risks associated with the regulated entity's significant existing activities or new activities, and to discuss how it plans to address such risks while furthering its public purposes and mission in a safe and sound manner. As a result of the revision, the focus of the requirement is on risks associated with the entity's significant activities, existing or new.

§ 1239.14(b): The final rule adopts § 1239.14(b)(1) and (2) as proposed and makes a conforming change to § 1239.14(b)(3) by deleting “operating” to provide that each board of directors establish management reporting requirements and monitor implementation of the strategic business plan and the goals and objectives contained therein.

§ 1273.8(d)(2): Section 1273.8(d)(2) of the Office of Finance Board of Directors regulation makes a conforming change to update the reference from “§ 1239.31” to “§ 1239.14.” The amendment is adopted as proposed.

C. Consideration of Differences Between the Banks and the Enterprises

When promulgating regulations that relate to the Banks, section 1313(f) of the Safety and Soundness Act requires FHFA to consider the differences between the Banks and the Enterprises with respect to the Banks' cooperative ownership structure, mission of providing liquidity to members, affordable housing and community development mission, capital structure, and joint and several liability. 12 U.S.C. 4513(f). FHFA has considered these areas of differences between the Banks and the Enterprises, and has determined that the final rule is unlikely to adversely affect the Banks in these areas of differences.

IV. Paperwork Reduction Act

The final rule does not contain any collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Therefore, FHFA has not submitted any information to the Office of Management and Budget for review.

V. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an agency to analyze a regulation's impact on small entities if the regulation is expected to have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605(b). FHFA has considered the impact of this final rule and the General Counsel of FHFA certifies that it is not likely to have a significant economic impact on a substantial number of small entities because it applies only to the regulated entities, which are not small entities for purposes of the Regulatory Flexibility Act.

VI. Congressional Review Act

In accordance with the Congressional Review Act, FHFA has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB). See 5 U.S.C. 804(2).

List of Subjects 12 CFR Part 1239

Administrative practice and procedure, Federal home loan banks, Government-sponsored enterprises, Reporting and recordkeeping requirements.

12 CFR Part 1273

Federal home loan banks, Securities.

Accordingly, for reasons stated in the Supplementary Information, FHFA hereby amends parts 1239 and 1273 of chapter XII of title 12 of the Code of Federal Regulations as follows:

Subchapter B—Regulated Entities PART 1239—[AMENDED] 1. The authority citation for part 1239 continues to read as follows: Authority:

12 U.S.C. 1426, 1427, 1432(a), 1436(a), 1440, 4511(b), 4513(a), 4513(b), 4526, and 15 U.S.C. 78oo(b).

2. Add § 1239.14 to subpart C to read as follows:
§ 1239.14 Strategic business plan.

(a) Adoption of strategic business plan. Each board of directors shall adopt and have in effect at all times a strategic business plan for the regulated entity that describes, at a minimum, how the significant business activities of the regulated entity will achieve its mission and public purposes consistent with its authorizing statute, the Safety and Soundness Act, and, in the case of a Bank, part 1265 of this chapter. Specifically, each regulated entity's strategic business plan shall at a minimum:

(1)(i) In the case of a Bank, articulate measurable goals and objectives for each significant business activity and for all authorized new business activities, which must include plans for maximizing activities that further the Bank's housing finance and community lending mission, consistent with part 1265 of this chapter;

(ii) In the case of an Enterprise, articulate measurable goals and objectives for each significant existing activity and for significant authorized new activities;

(2) Discuss how the regulated entity will address credit needs and market opportunities identified through ongoing market research and stakeholder consultations;

(3) Describe any significant activities in which the regulated entity is planning to be engaged, including any significant changes to business strategy or approach that the regulated entity is planning to undertake, and discuss how such activities would further the regulated entity's mission and public purposes;

(4)(i) In the case of a Bank, be supported by appropriate and timely research and analysis of relevant market developments and member and housing associate demand for Bank products and services;

(ii) In the case of an Enterprise, be supported by appropriate and timely research and analysis of relevant market developments; and

(5) Identify current and emerging risks associated with the regulated entity's significant existing activities or new activities, and discuss how the regulated entity plans to address such risks while furthering its public purposes and mission in a safe and sound manner.

(b) Review and monitoring. Each board of directors shall:

(1) Review the regulated entity's strategic business plan at least annually;

(2) Re-adopt the strategic business plan for the regulated entity at least every three years; and

(3) Establish management reporting requirements and monitor implementation of the strategic business plan and the goals and objectives contained therein.

§ 1239.31 [Removed and reserved]
3. Remove and reserve § 1239.31. Subchapter D—Federal Home Loan Banks PART 1273—[AMENDED] 4. The authority citation for part 1273 continues to read as follows: Authority:

12 U.S.C. 1431, 1440, 4511(b), 4513, 4514(a), 4526(a).

§ 1273.8 [Amended]
5. Section 1273.8(d)(2) is amended by removing the reference to “§ 1239.31” and adding in its place “§ 1239.14.” Dated: October 16, 2018. Melvin L. Watt, Director, Federal Housing Finance Agency.
[FR Doc. 2018-22859 Filed 10-18-18; 8:45 am] BILLING CODE 8070-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 91 [Docket No.: FAA-2014-0225; Amdt. No. 91-331E] RIN 2120-AL39 Amendment of the Prohibition Against Certain Flights in Specified Areas of the Simferopol and Dnipropetrovsk Flight Information Regions (FIRs) (UKFV and UKDV) AGENCY:

Federal Aviation Administration (FAA), Department of Transportation (DOT).

ACTION:

Final rule.

SUMMARY:

This action extends, with modifications to reflect changed conditions in specified areas of Ukraine, the Special Federal Aviation Regulation (SFAR) prohibiting certain flight operations in the Simferopol Flight Information Region (FIR) (UKFV) and Dnipropetrovsk Flight Information Region (FIR) (UKDV) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier. This action extends the prohibition in specified areas of Ukraine to safeguard against continuing hazards to U.S. civil aviation. However, this action also reduces the scope of the prohibition against flights in the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) permitting U.S. civil operations to resume in specified areas due to the stabilization of safety and security conditions in the relevant regions of Ukraine.

DATES:

This final rule is effective on October 19, 2018.

FOR FURTHER INFORMATION CONTACT:

Michael Filippell, Air Transportation Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone 202-267-8166; email [email protected]

SUPPLEMENTARY INFORMATION:

I. Executive Summary

This action extends, with modification to reflect changed conditions in Ukraine, the prohibition against U.S. civil flight operations in specified areas of the Simferopol Flight Information Region (FIR) (UKFV) and Dnipropetrovsk Flight Information Region (FIR) (UKDV) by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier, from October 27, 2018, until October 27, 2020. The FAA assesses that security and safety conditions have sufficiently stabilized in certain regions of Ukraine, thereby reducing the area of hazard to U.S. civil aviation in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). However, the FAA finds an extension of the prohibition is necessary in other specified areas of Ukraine to safeguard against continuing hazards to civil aviation. The new boundaries of the prohibition are described in the preamble to this final rule. In this action, the FAA retains the lateral limits of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), for reference as definitions in new paragraph (f) of the final rule.

II. Legal Authority and Good Cause A. Legal Authority

The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA Administrator's authority to issue rules on aviation safety is found in title 49, U.S. Code, Subtitle I, sections 106(f) and (g). Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise this authority consistently with the obligations of the U.S. Government under international agreements.

This rulemaking is promulgated under the authority described in title 49, U.S. Code, Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security.

This regulation is within the scope of FAA's authority, because it continues to prohibit the persons described in paragraph (a) of SFAR No. 113, 14 CFR 91.1607, from conducting flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) due to the continuing hazards to the safety of U.S. civil flight operations in certain regions of Ukraine, as described in the preamble to this final rule.

The FAA also finds that this action is fully consistent with the obligations under 49 U.S.C. 40105(b)(1)(A) to ensure that the FAA exercises its duties consistently with the obligations of the United States under international agreements.

B. Good Cause for Immediate Adoption

Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d) also authorizes agencies to forgo the delay in the effective date of the final rule for good cause found and published with the rule. In this instance, the FAA finds good cause to forgo notice and comment because notice and comment would be impracticable and contrary to the public interest. In addition, it is contrary to the public interest to delay the effective date of this SFAR.

The FAA has identified an ongoing need to maintain the flight prohibition in certain specified areas of Ukraine due to continued safety of flight hazards associated with both Ukraine and Russia air navigation service providers (ANSPs) claiming control of airspace over portions of the Simferopol FIR (UKFV) and due to the ongoing conflict with localized skirmishes within the eastern portion of the Dnipropetrovsk FIR (UKDV). These hazards are further described in the preamble to this rule. To the extent that the rule is based upon classified information, such information is not permitted to be shared with the general public. Also, threats to U.S. civil aviation can evolve rapidly. As a result, the agency's original proposal could become unsuitable for minimizing the hazards to U.S. civil aviation in the affected airspace during or after the notice and comment process. For these reasons, the FAA finds good cause to forgo notice and comment and any delay in the effective date for this rule.

III. Background

The FAA first published SFAR No. 113, § 91.1607, on April 25, 2014, to prohibit certain flight operations in a portion of the Simferopol FIR (UKFV) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.1 At that time, the FAA viewed the possibility of civil aircraft receiving confusing and conflicting air traffic control instructions from both Ukrainian and Russian air navigation service providers (ANSPs) when operating in the portion of the Simferopol FIR (UKFV) covered by SFAR No. 113, § 91.1607, as an unsafe condition that presented a potential hazard to U.S. civil flight operations.

1 79 FR 22862.

On July 18, 2014, the FAA issued a Notice to Airmen (NOTAM) FDC4/2182, expanding the flight prohibition to the entire Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), primarily as an immediate response to the shoot-down of Malaysia Airlines flight MH17 on July 17, 2014, while flying over Ukraine at 33,000 feet just west of the Russian border. The FAA determined that the ongoing conflict in the region posed a significant threat to U.S. civil aviation operations in these FIRs. The use of weapons capable of targeting and shooting down aircraft flying on civil air routes at cruising altitudes posed a significantly dangerous threat to civil aircraft flying in the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). The FAA published a final rule incorporating the expanded flight prohibition into SFAR No. 113, § 91.1607, on December 29, 2014.2 The FAA extended this flight prohibition on October 27, 2015 3 4 and October 27, 2016 due to continuing flight safety concerns regarding conflicting ANSP guidance in the Simferopol FIR (UKFV) and the ongoing conflict in eastern Ukraine within the Dnipropetrovsk FIR (UKDV).5

2 79 FR 77857.

3 80 FR 65621.

4 The FAA notes that the State Aviation Administration of Ukraine conducted and completed an airspace restructuring that went into effect in the late 2014 timeframe. The new configuration altered both the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) altitude structures. To address the Ukraine airspace restructuring and provide additional clarity, on July 22, 2016, the FAA published a technical amendment to specifically identify the prohibited airspace in which SFAR No. 113, § 91.1607, applies, with inclusive altitudes and lateral limitations (latitude and longitude coordinates). 81 FR 47699.

5 81 FR 74671.

The flight safety concern for the Simferopol FIR (UKFV) at that time was demonstrated by an European Aviation Safety Agency Safety Information Bulletin on February 17, 2016, indicating that ATS routes L851 and M856 could be considered for planning flights in the Simferopol FIR (UKFV), and subsequent Russian Federal Air Transport Agency response in which it asserted that it was responsible for air traffic services in a portion of the Simferopol FIR (UKFV).

Separately, in the Dnipropetrovsk FIR (UKDV), the FAA noted that there was an ongoing risk of skirmishes in the area and a potential for larger-scale fighting in eastern Ukraine involving combined Russian-separatist forces, which could result in civil aircraft being misidentified as a threat and then intercepted or otherwise engaged. In the 2016 final rule, the FAA identified that these combined forces had access to a variety of anti-aircraft weapons, to include man-portable air defense systems (MANPADS) and possibly more advanced surface-to-air missiles (SAMs) that had the capability to engage aircraft at higher altitudes.

IV. Discussion of the Final Rule

Since the 2016 final rule, the FAA assesses that security and safety conditions have sufficiently stabilized in certain regions of Ukraine, thereby reducing the area of impacted airspace in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and is revising the flight prohibition to allow U.S. civil flights to resume in certain areas. However, the FAA finds an extension of the prohibition is necessary in other specified areas of Ukraine to safeguard against continuing hazards to civil aviation.

A. Simferopol Flight Information Region (FIR) (UKFV)

Since 2014, the FAA has prohibited operations within the Simferopol FIR (UKFV) by all U.S. civil operators and airmen, in part, due to continuing flight safety concerns regarding the risk of pilots being given conflicting ANSP guidance within the Simferopol FIR (UKFV). Specifically, in 2014, the Russian Federation annexed the Crimean Peninsula and claimed ANSP authority over the Simferopol FIR (UKFV), including airspace over the Black Sea, and deployed a substantial military force to the Peninsula, including advanced weapon capabilities to enforce their territorial and airspace claims for portions of the Simferopol FIR (UKFV). Since that time, the Russian Federation has claimed authority over the entire Simferopol FIR (UKFV) and continues to assert authority over the Crimean Peninsula and adjacent waters. However, the International Civil Aviation Organization (ICAO) and other countries do not support these assertions by the Russian Federation and recognize the Ukrainian State Air Traffic Service Enterprise as the ANSP with authority over the Simferopol FIR (UKFV).

The previous flight safety concerns for conflicting ANSP guidance for the Black Sea air routes at a distance offshore from the Peninsula within portions of the Simferopol FIR (UKFV) have been addressed by the government of Ukraine. Since the FAA extended the prohibition in SFAR No. 113, § 91.1607, in 2016, the government of Ukraine has established, via its aeronautical information publication (AIP), a restricted airspace area over the Crimean Peninsula and the adjacent territorial sea. In addition, the government of Ukraine has issued flight advisories, prohibitions and other instructions for the safe navigation of civil aircraft, which are published via NOTAMs,6 reclassified Ukrainian airspace in 2014 as discussed earlier, and improved safety incident reporting procedures to mitigate the risks associated with conflicting ANSP guidance from the Russian Federation over the Black Sea routes offshore from the Crimean Peninsula and over the high seas. Since these actions were implemented, there has been a decrease in safety-related hazards demonstrated by over two years of safe flight operations on the Black Sea air routes by non-U.S. civil operators. Therefore, the FAA assesses that these actions have sufficiently mitigated the hazard to civil aviation operating on the Black Sea air routes to allow U.S. civil flights to resume on those routes. Specifically, the FAA is relaxing the prohibition from the surface to unlimited south and southwest of a line drawn direct from SOBLO (431503N 362298E) to DOLOT (434214N 332819E), direct to SOROK (440628N 324260E), then direct to OTPOL (452738N 313064E). This change will allow U.S. operators and codeshare partners the ability to use, among others, the following Black Sea routes; M856, M854, M860 and L851. Ukrainian air traffic control routing dynamically manages the routing of air traffic in the specified airspace to meet changing operational demands and conditions.

6 The advisories and prohibitions, including instructions regarding the closure of certain air routes, which are issued by Ukraine and published via NOTAM can be accessed at https://www.icao.int/safety/iStars/Pages/notams.aspx. See e.g. A1055/18-UKFV (Ukraine): Flight information region Plain language, which requires all aircraft crews flying within the Simferopol FIR to comply only with instructions from Ukraine's air navigation service provider.

Nevertheless, the government of Ukraine has not mitigated the hazards in all of the Simferopol FIR (UKFV) necessitating a continuing, albeit more limited, flight prohibition. An overwhelming Russian military presence and weapon capabilities continue to be located on the Crimean Peninsula, creating a continuing risk for misidentification of aircraft flying over the Peninsula and in the airspace near the Peninsula. Additionally, Ukraine and Russia continue to assert competing claims of the airspace. For those reasons, and their attendant risk to U.S. civil aircraft operations, the FAA is continuing to prohibit operations by U.S. civil operators and airmen in the Simferopol FIR (UKFV) from the surface to unlimited north and northeast of a line drawn direct from SOBLO (431503N 362298E) to DOLOT (434214N 332819E), direct to SOROK (440628N 324260E), then direct to OTPOL (452738N 313064E). The use of airway M747, which partially overlaps with the line of demarcation for the area of prohibition, is also prohibited. The remaining area of prohibition includes a sufficient buffer from the continuing hazard associated with operating over the Crimean Peninsula.

B. Dnipropetrovsk Flight Information Region (FIR) (UKDV)

In the Dnipropetrovsk FIR (UKDV) there continues to be an inadvertent risk to civil aviation associated with the ongoing conflict, which involves localized skirmishes and the potential for larger scale fighting in the eastern portion of the Dnipropetrovsk FIR (UKDV). These skirmishes and a risk for potential larger-scale fighting could lead to the misidentification and/or engagement of civil aviation by separatist air defense forces, as demonstrated by the shoot-down of Malaysia Airlines flight MH17 on July 17, 2014. The majority of military engagements have been in close proximity to the line of conflict in the eastern portion of the Dnipropetrovsk FIR (UKDV). The various military and militia elements in that region have access to a variety of anti-aircraft weapons systems to include MANPADS and possibly more advanced SAMs that have the capability to engage aircraft at higher altitudes. Separatists have demonstrated their ability to use these anti-aircraft weapons by successfully shooting down a number of aircraft during the course of the fighting in eastern Ukraine in 2014. Organization for Security and Cooperation in Europe Special Monitoring Mission to Ukraine unmanned aircraft systems continue to be shot down by SAMs and small arms ground fire, and brought down with GPS jamming in the eastern portion of the Dnipropetrovsk FIR (UKDV).

These threats are concentrated in the eastern portion of the Dnipropetrovsk FIR (UKDV) within the pro-Russian separatist enclave and in close proximity to the line of control that borders the enclave. The anti-aircraft weapons capabilities and deployments of forces associated with the pro-Russian separatists are limited at this time to within the eastern portion of the Dnipropetrovsk FIR (UKDV). While the potential for fluctuating levels of military engagement continues along the line of control in eastern portions of the Dnipropetrovsk FIR (UKDV), the military conflict has begun to stabilize, which reduces the risk of a larger-scale conflict that might extend into the western portion of the Dnipropetrovsk FIR (UKDV). This results in a reduced risk to civil aviation in the western portion of the Dnipropetrovsk FIR (UKDV), and the FAA is relaxing the area of prohibition to account for the reduced risk.

Therefore, due to the continued threats in the eastern portion of the Dnipropetrovsk FIR (UKDV), the FAA is continuing to prohibit operations by U.S. civil operators and airmen in the Dnipropetrovsk FIR (UKDV) from the surface to unlimited east of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E). The use of airways M853 and N604, which partially overlap with the line of demarcation for the prohibition, is also prohibited. This revised area of prohibition includes a sufficient buffer between the conflict region along the Ukraine-Russia border, including known weapons that may be threats to aviation, and the portions of the Dnipropetrovsk FIR (UKDV) where U.S. civil flights are permitted to resume.

Based on the reduced scope of the prohibition, U.S. operators and airmen are permitted to conduct operations in the western portions of the Dnipropetrovsk FIR (UKDV) from the surface to unlimited west of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E), which previously had been prohibited.

In addition, due to the relatively close proximity of the approach and departure routes of three airports to the new boundary of the prohibition flight area, the FAA has added an exception for takeoffs and landings. This exception permits operations within the flight prohibition area of the Dnipropetrovsk FIR (UKDV), to the extent necessary to takeoff and land at three specified airports, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Ukraine: Kharkiv International Airport (UKHH); Dnipropetrovsk International Airport (UKDD); and Zaporizhzhia International Airport (UKDE). The FAA has determined these operations can be conducted with minimal additional risk due to the sufficient distance provided by the specified prohibition boundary line as a buffer from the area of fighting and associated weapons capabilities.

Therefore, as a result of the significant continuing risk to the safety of U.S. civil aviation in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), the FAA extends the expiration date of SFAR No. 113, 14 CFR 91.1607, from October 27, 2018, to October 27, 2020, to maintain the prohibition on flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) by: All U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator is a foreign air carrier. While the FAA's flight prohibition does not apply to foreign air carriers, DOT codeshare authorizations prohibit foreign air carriers from carrying a U.S. codeshare partner's code on a flight segment that operates in airspace for which the FAA has issued a flight prohibition. The FAA is also retaining the lateral limits of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), which are recognized by ICAO, for reference as definitions in new paragraph (f) of the final rule.

The FAA will continue to actively monitor the situation and evaluate the extent to which U.S. civil operators and airmen may be able to operate safely in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). Amendments to SFAR No. 113, § 91.1607, may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind SFAR No. 113, § 91.1607, as necessary, prior to its expiration date.

The FAA is incorporating minor editorial changes for clarifying purposes in § 91.1609, including correcting the title of the FIR and clarifying the procedure for considering approval and exemption requests. These changes are consistent with other recently published SFARs. The FAA is also republishing the details concerning the approval and exemption processes in Sections V and VI of this preamble so that interested persons will be able to refer to this final rule for all relevant information regarding SFAR No. 113.

V. Approval Process Based on a Request From a Department, Agency, or Instrumentality of the United States Government A. Approval Process Based on an Authorization Request From a Department, Agency, or Instrumentality of the United States Government

In some instances, U.S. Government departments, agencies, or instrumentalities may need to engage U.S. civil aviation to support their activities in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). The FAA is revising the approval process for SFAR No. 113, § 91.1607, to make it consistent with the approval process of more recently published flight prohibition SFARs. If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person covered under SFAR No. 113, § 91.1607, including a U.S. air carrier or commercial operator, to conduct a charter to transport civilian or military passengers or cargo, or other operations, in specified areas of the Simferopol FIR (UKFV) or Dnipropetrovsk FIR (UKDV), that department, agency, or instrumentality may request the FAA to approve persons covered under SFAR No. 113, § 91.1607, to conduct such operations.

An approval request must be made directly by the requesting department, agency, or instrumentality of the U.S. Government to the FAA's Associate Administrator for Aviation Safety in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. The FAA will not accept or process requests for approval by anyone other than the requesting department, agency, or instrumentality. In addition, the senior official signing the letter requesting FAA approval on behalf of the requesting department, agency, or instrumentality must be sufficiently highly placed within the organization to demonstrate that the senior leadership of the requesting department, agency, or instrumentality supports the request for approval and is committed to taking all necessary steps to minimize operational risks to the proposed flights. The senior official must also be in a position to: (1) Attest to the accuracy of all representations made to the FAA in the request for approval and (2) ensure that any support from the requesting U.S. Government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless justified by exigent circumstances, requests for approval must be submitted to the FAA no less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the proposed operations to commence.

The letter must be sent to the Associate Administrator for Aviation Safety, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166, to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons covered under SFAR No. 113, § 91.1607, and/or for multiple flight operations. To the extent known, the letter must identify the person(s) expected to be covered under the SFAR on whose behalf the U.S. Government department, agency, or instrumentality is seeking FAA approval, and it must describe—

• The proposed operation(s), including the nature of the mission being supported;

• The service to be provided by the person(s) covered by the SFAR;

• To the extent known, the specific locations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and the airports, airfields and/or landing zones at which the aircraft will take-off and land; and

• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of the proposed operations (i.e., pre-mission planning and briefing, in-flight, and post-flight phases).

The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or its prime contractor has a subcontract(s)) for specific flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). Additional operators may be identified to the FAA at any time after the FAA approval is issued. However, all additional operators must be identified to, and obtain an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, from the FAA for operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), before such operators commence such operations. The approval conditions discussed below apply to any such additional operators. Updated lists should be sent to the email address to be obtained from the Air Transportation Division, by calling (202) 267-8166.

If an approval request includes classified information, requestors may contact Aviation Safety Inspector Michael Filippell for instructions on submitting it to the FAA. His contact information is listed in the For Further Information Contact section of this final rule.

FAA approval of an operation under SFAR No. 113, § 91.1607, does not relieve persons subject to this SFAR of their responsibility to comply with all applicable FAA rules and regulations. Operators of civil aircraft must comply with the conditions of their certificate, OpSpecs, and LOAs, as applicable. Operators must also comply with all rules and regulations of other U.S. Government departments or agencies that may apply to the proposed operation(s), including, but not limited to, regulations issued by the Transportation Security Administration.

B. Approval Conditions

If the FAA approves the request, the FAA's Aviation Safety Organization will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:

(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.

(2) Before any approval takes effect, the operator must submit to the FAA:

(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Simferopol FIR (UKFV) and/or Dnipropetrovsk FIR (UKDV); and

(b) The operator's written agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising from or related to the approved operations in specified areas of the Simferopol FIR (UKFV) and/or Dnipropetrovsk FIR (UKDV).

(3) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs or LOAs, as applicable.

The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443 of title 49, U.S. Code.

If the FAA approves the proposed operation(s), the FAA will issue an OpSpec or LOA, as applicable, to the operator(s) identified in the original request authorizing it to conduct the approved operation(s), and will notify the department, agency, or instrumentality that requested the FAA's approval of any additional conditions beyond those contained in the approval letter.

VI. Information Regarding Petitions for Exemption

Any operations not conducted under an approval issued by the FAA through the approval process set forth previously must be conducted under an exemption from SFAR No. 113, § 91.1607. A petition for exemption must comply with 14 CFR part 11 and requires exceptional circumstances beyond those contemplated by the approval process set forth previously. In addition to the information required by 14 CFR 11.81, at a minimum, the requestor must describe in its submission to the FAA—

• The proposed operation(s), including the nature of the operation;

• The service to be provided by the person(s) covered by the SFAR;

• The specific locations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and the airports, airfields and/or landing zones at which the aircraft will take-off and land;

• The method by which the operator will obtain current threat information, and an explanation of how the operator will integrate this information into all phases of its proposed operations (i.e., the pre-mission planning and briefing, in-flight, and post-flight phases); and

• The plans and procedures that the operator will use to minimize the risks, identified in the preamble of this rule, to the proposed operations, so that granting the exemption would not adversely affect safety or would provide a level of safety at least equal to that provided by this SFAR. The FAA has found comprehensive, organized plans and procedures of this nature to be helpful in facilitating the agency's safety evaluation of petitions for exemption from flight prohibition SFARs.

Additionally, the release and agreement to indemnify, as referred to previously, are required as a condition of any exemption that may be issued under SFAR No. 113, § 91.1607.

The FAA recognizes that operations that may be affected by SFAR No. 113, § 91.1607, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will consider exemption requests for such operations on an expedited basis and prior to any private exemption requests.

VII. Regulatory Notices and Analyses

Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39), as amended, 19 U.S.C. Chapter 13, prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. Chapter 25, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

In conducting these analyses, the FAA has determined that this final rule has benefits that justify its costs. This rule is a significant regulatory action, as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive Order. As notice and comment under 5 U.S.C. 553 are not required for this final rule, the regulatory flexibility analyses described in 5 U.S.C. 603 and 604 regarding impacts on small entities are not required. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector, by exceeding the threshold identified previously.

A. Regulatory Evaluation

On April 25, 2014, the FAA published SFAR No. 113 prohibiting flight operations in part of the Simferopol FIR (UKFV) by U.S. air carriers and airmen because of conflicting airspace claims between Ukraine and the Russian Federation owing to the Russian annexation of the Crimean Peninsula. The FAA expanded this prohibition to the entire Simferopol FIR (UKFV) and also to the Dnipropetrovsk FIR (UKDV), first by NOTAM (July 18, 2014 (UTC)) and then by rule (79 FR 77857, December 29, 2014), owing to conflict between Ukraine military forces and pro-Russian separatists. On October 27, 2015 (80 FR 65621) and October 27, 2016 (81 FR 74671), the FAA further extended this prohibition. The FAA now proposes to extend the prohibition for another two years, but only for portions of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where there is a continuing hazard to civil aviation. The FAA is extending the prohibition against U.S. civil operations over the Crimean peninsula in the Simferopol FIR (UKFV), but is permitting U.S. civil operations over four Black Sea routes, sufficiently offshore from the Crimea Peninsula, and over the high seas, due to a stabilization in the security conditions on these routes. In addition, the FAA is extending the prohibition in the eastern part of the Dnipropetrovsk FIR (UKDV), but is permitting U.S. civil operations from the surface to unlimited in the western portion of the Dnipropetrovsk FIR (UKDV). The FAA is also permitting, by exception, takeoffs and landings at three Ukrainian international airports due to proximity of the arrival and departure routes to the area of prohibition within the Dnipropetrovsk FIR (UKDV).

As was noted in the most recent previous amendment to SFAR No. 113, § 91.1607 (81 FR 74671, October 27, 2016), almost all U.S. operators already had voluntarily ceased their operations in these FIRs prior to the issuance of the FAA NOTAM on July 18, 2014 (UTC), which prohibited U.S. civil flight operations in these two FIRs in their entirety. Owing to the continuing hazards to civil flight operations outlined in the preamble, the FAA believes that few, if any, U.S. operators presently seek to conduct operations in the eastern portion of the Dnipropetrovsk FIR (UKDV), or over the Crimean peninsula within the Simferopol FIR (UKFV) in which the FAA continues to prohibit U.S. operations. The FAA notes that since April 25, 2014, when U.S. operators and airmen were first prohibited from conducting operations in a portion of the Simferopol FIR (UKFV), the FAA has not received any requests for approval or petitions for exemption to conduct operations in either the Simferopol FIR (UKFV) or Dnipropetrovsk FIR (UKDV). Accordingly, where U.S. operations continue to be prohibited the FAA believes incremental costs will be minimal and exceeded by the benefits of avoiding the deaths, injuries, and/or property damage that would result from a U.S. operator's aircraft being shot down (or otherwise damaged) while operating in either the Dnipropetrovsk FIR (UKDV) or the Simferopol FIR (UKFV).

As noted in the sections above, the Ukraine ANSP has implemented risk mitigation measures to address safety hazards over the Black Sea routes and on the high seas. These measures have resulted in a significant decrease in safety-related hazards in that part of the Simferopol FIR (UKFV) as shown by over two years of safe flight operations by non-U.S. civil operators on the Black Sea air routes. In the Dnipropetrovsk FIR (UKDV), the deployments of forces associated with the pro-Russian separatists are at this time limited to the eastern part, reducing the risk of a larger-scale conflict that might extend into the western portion of the Dnipropetrovsk FIR (UKDV) and thereby reducing risk to U.S. civil aviation in the western portion. The FAA believes that lifting the prohibition on U.S. civil operations in those parts of the two FIRs will be socially cost-beneficial because it may result in the resumption of safe U.S. civil operations.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act, in 5 U.S.C. 603, requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever an agency is required by 5 U.S.C. 553, or any other law, to publish a general notice of proposed rulemaking for any proposed rule. Similarly, 5 U.S.C. 604 requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553, after being required by that section or any other law to publish a general notice of proposed rulemaking. The FAA found good cause to forgo notice and comment and any delay in the effective date for this rule. As notice and comment under 5 U.S.C. 553 are not required in this situation, the regulatory flexibility analyses described in 5 U.S.C. 603 and 604 are not required.

C. International Trade Impact Assessment

The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.

The FAA has assessed the potential effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from hazards to their operations in the eastern part of the Dnipropetrovsk FIR (UKDV) and over specified areas of the Crimean Peninsula within the Simferopol FIR (UKFV), locations outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act of 1979.

D. Unfunded Mandates Assessment

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.

This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this immediately adopted final rule.

F. International Compatibility and Cooperation

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA's policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this regulation.

G. Environmental Analysis

The FAA has analyzed this action under Executive Order 12114, Environmental Effects Abroad of Major Federal Actions (44 FR 1957, January 4, 1979), and DOT Order 5610.1C, Paragraph 16. Executive Order 12114 requires the FAA to be informed of environmental considerations and take those considerations into account when making decisions on major Federal actions that could have environmental impacts anywhere beyond the borders of the United States. The FAA has determined that this action is exempt pursuant to Section 2-5(a)(i) of Executive Order 12114 because it does not have the potential for a significant effect on the environment outside the United States.

In accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 8-6(c), FAA has prepared a memorandum for the record stating the reason(s) for this determination; this memorandum has been placed in the docket for this rulemaking.

VIII. Executive Order Determinations A. Executive Order 13132, Federalism

The FAA has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

The FAA analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

C. Executive Order 13609, Promoting International Regulatory Cooperation

Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

D. Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs

This rule is not subject to the requirements of E.O. 13771 (82 FR 9339, Feb. 3, 2017) because it is issued with respect to a national security function of the United States.

IX. Additional Information A. Availability of Rulemaking Documents

An electronic copy of a rulemaking document may be obtained from the internet by—

• Searching the Federal Document Management System (FDMS) Portal (http://www.regulations.gov);

• Visiting the FAA's Regulations and Policies web page at http://www.faa.gov/regulations_policies; or

• Accessing the Government Publishing Office's web page at http://www.fdsys.gov.

Copies may also be obtained by sending a request (identified by amendment or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677.

Except for classified material, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the internet through the Federal Document Management System Portal referenced previously.

B. Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121) (set forth as a note to 5 U.S.C. 601) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the persons listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 91

Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight, Ukraine.

The Amendment

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, part 91, as follows:

PART 91—GENERAL OPERATING AND FLIGHT RULES 1. The authority citation for part 91 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).

2. Revise § 91.1607 to read as follows:
§ 91.1607 Special Federal Aviation Regulation No. 113—Prohibition Against Certain Flights in the Simferopol Flight Information Region (FIR) (UKFV) and the Dnipropetrovsk Flight Information Region (FIR) (UKDV).

(a) Applicability. This Special Federal Aviation Regulation (SFAR) applies to the following persons:

(1) All U.S. air carriers and U.S. commercial operators;

(2) All persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and

(3) All operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.

(b) Flight prohibition. Except as provided in paragraphs (c) and (d) of this section, no person described in paragraph (a) of this section may conduct flight operations in the following specified areas of the Simferopol FIR (UKFV) or the Dnipropetrovsk FIR (UKDV)—

(1) Operations within the Simferopol FIR (UKFV) are prohibited from the surface to unlimited, north and northeast of a line drawn direct from SOBLO (431503N 362298E) to DOLOT (434214N 332819E), direct to SOROK (440628N 324260E), then direct to OTPOL (452738N 313064E). This prohibition applies to airway M747.

(2) Operations within the Dnipropetrovsk FIR (UKDV) are prohibited from the surface to unlimited, east of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E). This prohibition applies to airways M853 and N604.

(c) Permitted operations. This section does not prohibit persons described in paragraph (a) of this section from conducting flight operations within either flight prohibition, as described in paragraph (b) of this section under the following circumstances:

(1) Operations are permitted within the flight prohibition area of the Dnipropetrovsk Flight Information Region (FIR) (UKDV), as described in paragraph (b)(2) of this section, to the extent necessary to takeoff and land at the following three airports, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Ukraine:

(i) Kharkiv International Airport (UKHH);

(ii) Dnipropetrovsk International Airport (UKDD); and

(iii) Zaporizhzhia International Airport (UKDE).

(2) Operations are permitted within the flight prohibition areas described in paragraph (b)(1) or (2) of this section provided that such flight operations are conducted under a contract, grant, or cooperative agreement with a department, agency, or instrumentality of the U.S. Government (or under a subcontract between the prime contractor of the department, agency, or instrumentality and the person described in paragraph (a) of this section) with the approval of the FAA, or under an exemption issued by the FAA. The FAA will consider requests for approval or exemption in a timely manner, with the order of preference being: first, for those operations in support of U.S. Government-sponsored activities; second, for those operations in support of government-sponsored activities of a foreign country with the support of a U.S. Government department, agency, or instrumentality; and third, for all other operations.

(d) Emergency situations. In an emergency that requires immediate decision and action for the safety of the flight, the pilot in command of an aircraft may deviate from this section to the extent required by that emergency. Except for U.S. air carriers and commercial operators that are subject to the requirements of 14 CFR part 119, 121, 125, or 135, each person who deviates from this section must, within 10 days of the deviation, excluding Saturdays, Sundays, and Federal holidays, submit to the responsible Flight Standards office a complete report of the operations of the aircraft involved in the deviation, including a description of the deviation and the reasons for it.

(e) Expiration. This SFAR will remain in effect until October 27, 2020. The FAA may amend, rescind, or extend this SFAR as necessary.

(f) Definitions. (1) The Simferopol FIR (UKFV) is defined as that airspace from the surface to unlimited within the following lateral limits:

465800N 0360000E-463500N 0364200E- 463424N 0372206E-452700N 0364100E- 452242N 0364100E-451824N 0363524E- 451442N 0363542E-451218N 0363200E- 450418N 0363418E-445612N 0363636E- 443100N 0364000E-424400N 0361600E- 424700N 0340000E-424800N 0320000E- 424800N 0310000E-424800N 0304500E- 434100N 0303200E-441000N 0302512E- 441500N 0302400E-444600N 0300900E- 445447N 0300448E-445230N 0302130E- 445848N 0303342E-451530N 0310642E- 452436N 0312500E-453828N 0315311E- 454436N 0320548E-455442N 0322700E- 460730N 0325430E-464600N 0325300E- 474400N 0330300E-472700N 0344800E- 470630N 0355500E-465800N 0360000E

(2) The Dnipropetrovsk FIR (UKDV) is defined as that airspace from the surface to unlimited within the following lateral limits:

511400N 0342700E-504942N 0341300E- 502043N 0335720E-501246N 0335307E- 491848N 0333700E-485700N 0332200E- 484118N 0324431E-483620N 0324010E- 483128N 0323605E-482300N 0323900E- 480730N 0325324E-474600N 0325000E- 474400N 0330300E-472700N 0344800E- 470630N 0355500E-465800N 0360000E- 463500N 0364200E-463424N 0372206E- 463930N 0372518E-464700N 0373000E- 465900N 0382000E-470642N 0381324E- then along state boundary until point/-511400N 0342700.
Issued in Washington, DC, under the authority of 49 U.S.C. 106(f) and (g), 40101(d)(1), 40105(b)(1)(A), and 44701(a)(5), on October 15, 2018. Daniel K. Elwell, Acting Administrator.
[FR Doc. 2018-22853 Filed 10-18-18; 8:45 am] BILLING CODE 4910-13-P
SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 227 and 230 [Release No. 33-10567] Regulation Crowdfunding and Regulation A Relief and Assistance for Victims of Hurricane Michael AGENCY:

Securities and Exchange Commission.

ACTION:

Interim final temporary rule.

SUMMARY:

We are adopting interim final temporary rules for issuers subject to reporting obligations pursuant to Regulation Crowdfunding and Regulation A in order to address the needs of companies directly or indirectly affected by Hurricane Michael. The temporary rules extend the filing deadlines for specified reports and forms due pursuant to Regulation Crowdfunding and Regulation A for certain issuers.

DATES:

These rules are effective from October 19, 2018 through November 23, 2018, except that amendatory instruction 1 revising the authority citation of part 227 is effective October 19, 2018.

FOR FURTHER INFORMATION CONTACT:

Jennifer Zepralka, Office Chief, or Amy Reischauer, Special Counsel, Office of Small Business Policy, Division of Corporation Finance, at (202) 551-3460, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION:

We are adopting amendments to 17 CFR 227.202 (“Rule 202”) of Regulation Crowdfunding 1 under the Securities Act of 1933 (the “Securities Act”) 2 and 17 CFR 230.257 (“Rule 257”) of Regulation A 3 under the Securities Act as interim final temporary rules.

1 17 CFR 227 et seq.

2 15 U.S.C. 77a et seq.

3 17 CFR 230.251 through 230.263.

I. Introduction

On October 10, 2018, Hurricane Michael made landfall on the Florida Panhandle. The storm and subsequent flooding have displaced individuals and businesses and disrupted communications and transportation across the affected region. We are adopting these interim final temporary rules to address the needs of companies directly or indirectly affected by Hurricane Michael or its aftermath that are subject to reporting obligations pursuant to Regulation Crowdfunding or Regulation A.

Section 28 of the Securities Act provides that the Commission may, by rule or regulation, “conditionally or unconditionally exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision or provisions of this title or of any rule or regulation issued under this title, to the extent that such exemption is necessary or appropriate in the public interest, and is consistent with the protection of investors.” 4

4 15 U.S.C. 77z-3.

II. Temporary Relief From Filing Requirements for Issuers Subject to the Reporting Obligations of Regulation Crowdfunding or Regulation A

The lack of communications, transportation, electricity, facilities, and available staff and professional advisors as a result of Hurricane Michael could hamper the efforts of companies with reporting obligations to meet their filing deadlines pursuant to Regulation Crowdfunding or Regulation A. At the same time, investors have an interest in the timely availability of required information about these companies. While the Commission believes that the temporary relief from filing requirements provided by the amendments to Rule 202 of Regulation Crowdfunding 5 and Rule 257 of Regulation A 6 is both necessary in the public interest and consistent with the protection of investors, we remind companies that are the subject of the relief provided in these interim final temporary rules to continue to evaluate their obligations to make materially accurate and complete disclosures in accordance with the anti-fraud provisions of the federal securities laws.

5See Rule 202(c) of Regulation Crowdfunding. 17 CFR 227.202(c).

6See Rule 257(f) of Regulation A. 17 CFR 230.257(f).

Accordingly, pursuant to Section 28 of the Securities Act, we are adopting interim final temporary rules providing that an issuer subject to the reporting requirements of either Regulation Crowdfunding or Regulation A is exempt from any requirement to file specified reports or forms with the Commission where the conditions below are satisfied:

(a) The issuer is not able to meet a filing deadline due to Hurricane Michael or its aftermath;

(b) The issuer files with the Commission, on or before November 23, 2018, the report or form required to be filed pursuant to either Regulation Crowdfunding or Regulation A during the period from and including October 10, 2018 to and including November 21, 2018; and

(c) In any such report or form, the issuer discloses that it is relying on the interim final temporary rules and states the reasons why, in good faith, it could not file such report or form on a timely basis.

For Regulation Crowdfunding, the relief includes annual reports on Form C-AR, progress updates on Form C-U, and termination of reporting on Form C-TR. For Regulation A, the relief includes post-qualification amendments required at least every 12 months after the qualification date to include updated financial statements, annual reports on Form 1-K, semi-annual reports on Form 1-SA, special financial reports on Forms 1-K or 1-SA, current reports on Form 1-U, and exit reports on Form 1-Z.

III. Economic Analysis

Regulation Crowdfunding and Regulation A permit offers and sales of securities without registration under the Securities Act, subject to certain limitations and conditions, including compliance with ongoing reporting requirements. Based on staff analysis, between June 19, 2015 (the effective date of the most recent Regulation A amendments 7 ) and September 30, 2018, approximately 244 filers had Regulation A offering statements qualified by the Commission, excluding withdrawn offerings. Approximately 1,067 issuers initiated Regulation Crowdfunding offerings with Form C filings between May 16, 2016 and September 30, 2018, excluding issuers that have withdrawn offerings.8 Approximately 41 registered intermediaries, including 32 registered funding portals and 9 registered broker-dealers, have participated in Regulation Crowdfunding offerings with Form C filings between May 16, 2016 and September 30, 2018, excluding withdrawn offerings.

7 SEC Rel. No. 33-9741 (Mar. 25, 2015) [80 FR 21806 (Apr. 20, 2015)].

8 These figures overstate the number of issuers with obligations to file annual reports under Regulation Crowdfunding, because they do not exclude issuers that have failed to raise the target amount or have exited the reporting regime.

We lack the data to estimate the number of investors in Regulation A or Regulation Crowdfunding offerings that could be affected if issuers rely on the relief provided by the interim final temporary rules, because information on the number of investors is generally not required to be disclosed in periodic or current reports required under Regulation A or in periodic reports or progress updates required under Regulation Crowdfunding.9

9 Regulation A issuers that file Form 1-Z to suspend reporting are required to disclose the number of shareholders of record.

We are mindful of the costs and benefits of the interim final temporary rules.10 We believe the interim final temporary rules will benefit issuers that have an obligation to file specified reports with the Commission pursuant to either Regulation Crowdfunding or Regulation A and have been adversely affected by Hurricane Michael or its aftermath by permitting them to take additional time to meet their reporting obligations. We expect the relief provided by the interim final temporary rules will benefit issuers that, absent the relief, would not be able to avail themselves of the exemption from registration under Regulation Crowdfunding or Regulation A because the timely filing of required reports is a condition to the exemptions. In the absence of this relief, issuers could incur prohibitively high costs in an attempt to meet filing deadlines given the lack of communications, transportation, electricity, facilities, and available staff and professional advisors.

10 Section 2(b) of the Securities Act [15 U.S.C. 77b(b)] requires the Commission, when engaging in rulemaking where it is required to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation.

The requirement for an issuer to disclose that it is relying on Rule 202(c) of Regulation Crowdfunding or Rule 257(f) of Regulation A and to state the reasons why, in good faith, it could not file a report or form on a timely basis may impose minimal additional costs on issuers availing themselves of this relief. However, we believe that these minimal costs are justified in light of the significant negative implications of not being able to rely on the exemption and the prohibitively high costs an issuer may incur in attempting to file in a timely manner.

We also acknowledge that there may be costs imposed on investors, intermediaries, and other market participants due to delayed access to information about offerings conducted in reliance on Regulation A and Regulation Crowdfunding. Generally, reporting requirements strengthen investor protection and decrease the extent of information asymmetries between issuers and investors. Ongoing reporting provides investors with periodically updated information, allowing them to assess investment opportunities based on the information provided and their level of risk tolerance, resulting in better informed investment decisions and improved allocative efficiency. Given that the interim final temporary rules allow for delayed reporting for a limited time period and only under specified conditions, we do not believe such costs will be significant.

The interim final temporary rules will not substantially affect competition or capital formation. We acknowledge the possibility that the interim final temporary rules may have a minor impact on efficiency. On the one hand, as noted above, the delay in reporting could marginally affect allocative efficiency to the extent that it allows information asymmetries between investors and issuers to persist for the length of time of the delay. On the other hand, we expect efficiency gains to the extent that the interim final temporary rules allow issuers to continue to rely on either of the exemptions from registration that would not be available if one of the required reports that is a condition to the exemptions was not filed in a timely manner, or to the extent the issuers are able to avoid paying a premium to service providers in an attempt to file in a timely manner by delaying reporting during the specified relief period.

As an alternative to the relief specified in the interim final temporary rules, we could have considered a longer or shorter relief period. While a shorter period would have reduced the costs to investors of asymmetric information, it would also reduce the benefits of the interim final temporary rules to issuers. Similarly, a longer period would increase the costs to investors. We believe that the approximately six-week delay in the interim final temporary rules is appropriate given the potential impact Hurricane Michael or its aftermath could have on the efforts of companies to meet filing deadlines pursuant to Regulation Crowdfunding and Regulation A.

IV. Procedural and Other Matters

The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a rulemaking in the Federal Register and provide an opportunity for public comment. This requirement does not apply, however, if the agency “for good cause finds . . . that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.” 11 The APA also generally requires that an agency publish an adopted rule in the Federal Register at least 30 days before it becomes effective. This requirement does not apply, however, if the agency finds good cause for making the rule effective sooner.12

11 5 U.S.C. 553(b)(3)(B).

12 5 U.S.C. 553(d)(3).

Given the temporary nature of the relief contemplated by the interim final temporary rules and the significant and immediate impact of Hurricane Michael and its aftermath on issuers in affected areas, as discussed above, the Commission finds that good cause exists to dispense with notice and comment as impracticable and unnecessary, and to act immediately to amend Rule 202 of Regulation Crowdfunding and Rule 257 of Regulation A.13 Further, the interim final temporary rules will not affect the burden or cost estimates associated with existing collections of information under Regulation Crowdfunding and Regulation A for purposes of the Paperwork Reduction Act of 1995.14

13 This finding also satisfies the requirements of 5 U.S.C. 808(2), allowing the interim final temporary rules to become effective notwithstanding the requirement of 5 U.S.C. 801 (if a federal agency finds that notice and public comment are impractical, unnecessary or contrary to the public interest, a rule shall take effect at such time as the federal agency promulgating the rule determines). The interim final temporary rules also do not require analysis under the Regulatory Flexibility Act. See 5 U.S.C. 604(a) (requiring a final regulatory flexibility analysis only for rules required by the APA or other law to undergo notice and comment).

14 44 U.S.C. 3501 et seq.

V. Statutory Basis and Text of Amendments

We are adopting amendments to Rule 202 of Regulation Crowdfunding and Rule 257 of Regulation A under the authority set forth in the Securities Act (15 U.S.C. 77a et seq.), particularly, Section 28 thereof.

List of Subjects 17 CFR Part 227

Crowdfunding, Funding portals, Intermediaries, Reporting and recordkeeping requirements, Securities.

17 CFR Part 230

Reporting and recordkeeping requirements, Securities.

In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:

PART 227—REGULATION CROWDFUNDING, GENERAL RULES AND REGULATIONS 1. The authority citation for part 227 is revised to read as follows: Authority:

15 U.S.C. 77d, 77d-1, 77s, 77z-3, 78c, 78o, 78q, 78w, 78mm, and Pub. L. 112-106, secs. 301-305, 126 Stat. 306 (2012).

2. Amend § 227.202 by adding paragraph (d) to read as follows:
§ 227.202 Ongoing reporting requirements.

(d) Temporary relief from certain reporting requirements. (1) An issuer that is not able to meet a filing deadline for any report or form required to be filed by this section, 17 CFR 227.203(a)(3)), or 17 CFR 227.203(b) during the period from and including October 10, 2018 to and including November 21, 2018 due to Hurricane Michael and its aftermath shall be deemed to have satisfied the filing deadline for such report or form if the issuer files such report or form with the Commission on or before November 23, 2018.

(2) In any report or form filed pursuant to paragraph (d)(1) of this section, the issuer must disclose that it is relying on this paragraph (d) and state the reasons why, in good faith, it could not file such report or form on a timely basis.

PART 230—GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 3. The authority citation for part 230 continues to read in part as follows: Authority:

15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec. 401, 126 Stat. 313 (2012), unless otherwise noted.

4. Amend § 230.257 by adding paragraph (g) to read as follows:
§ 230.257 Periodic and current reporting; exit report.

(g) Temporary relief from ongoing reporting requirements. (1) An issuer that is not able to meet a filing deadline for any report or form required to be filed by 17 CFR 230.252(f)(2)(i) or this section during the period from and including October 10, 2018 to and including November 21, 2018 due to Hurricane Michael and its aftermath shall be deemed to have satisfied the filing deadline for such report or form if the issuer files such report or form with the Commission on or before November 23, 2018.

(2) In any report or form filed pursuant to paragraph (g)(1) of this section, the issuer must disclose that it is relying on this paragraph (g) and state the reasons why, in good faith, it could not file such report or form on a timely basis.

By the Commission.

Dated: October 16, 2018. Brent J. Fields, Secretary.
[FR Doc. 2018-22930 Filed 10-17-18; 4:15 pm] BILLING CODE 8011-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 868 [Docket No. FDA-2018-N-3684] Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

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

DATES:

This order is effective October 19, 2018. The classification was applicable on June 5, 2018.

FOR FURTHER INFORMATION CONTACT:

Deepika Arora Lakhani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2543, Silver Spring, MD 20993-0002, 301-796-4042, [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

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

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

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

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

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

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

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

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

II. De Novo Classification

On December 14, 2017, FRESCA Medical submitted a request for De Novo classification of the CURVE TM Positive Airway Pressure System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on June 5, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 868.5273. We have named the generic type of device positive airway pressure delivery system, and it is identified as a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.

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

Table 1—Positive Airway Pressure Delivery System Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility evaluation, and Labeling. Electromagnetic interference with other devices Electromagnetic compatibility testing, and Labeling. Infection Reprocessing validation, and Labeling. Device software failure leading to ineffective treatment Software verification, validation, and hazard analysis. Device hardware failure/malfunction leading to high airway pressure, carbon dioxide rebreathing or ineffective treatment Non-clinical performance testing, and Labeling. Electrical shock injury or thermal injury Electrical safety, thermal safety, and mechanical testing; Software verification, validation, and hazard analysis; and Labeling. Use error leading to ineffective therapy or patient injury Labeling.

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

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

III. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 868

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 868 is amended as follows:

PART 868—ANESTHESIOLOGY DEVICES 1. The authority citation for part 868 continues to read as follows: Authority:

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

2. Add § 868.5273 to subpart F to read as follows:
§ 868.5273 Positive airway pressure delivery system.

(a) Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.

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

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:

(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.

(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.

(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.

(iv) Carbon dioxide rebreathing testing must be performed.

(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.

(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.

(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.

(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.

(3) Performance data must validate reprocessing instructions for any reusable components of the device.

(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include the following:

(i) Therapy pressure range;

(ii) Use life and replacement schedule for all components;

(iii) Cleaning instructions; and

(iv) Instructions for assembly and connection of device components.

Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2018-22840 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-3696] Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

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

DATES:

This order is effective October 19, 2018. The classification was applicable on July 31, 2018.

FOR FURTHER INFORMATION CONTACT:

Yasaman Ardeshirpour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G455, Silver Spring, MD, 20993-0002, 240-402-3706, [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

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

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

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

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

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

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

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

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

II. De Novo Classification

On February 16, 2018, MolecuLight, Inc. submitted a request for De Novo classification of the MolecuLight i:X. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on July 31, 2018, FDA issued an order to the requester classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 878.4165. We have named the generic type of device wound autofluorescence imaging device, and it is identified as a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

FDA has identified the following risks to health associated specifically with this type of device: electrical/mechanical/thermal, electromagnetic compatibility (EMC) and optical safety of the device, and the error in fluorescence detection from the wound.

Section 510(l)(1) of the FD&C Act provides that a device within a type that has been classified into class I under section 513 of the FD&C Act is exempt from premarket notification under section 510(k), unless the device is of substantial importance in preventing impairment of human health or presents a potentially unreasonable risk of illness or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt from the premarket notification requirements under section 510(k), subject to the limitations of exemptions in 21 CFR 878.9.

III. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 878

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 878 is amended as follows:

PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for part 878 continues to read as follows: Authority:

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

2. Add § 878.4165 to subpart E to read as follows:
§ 878.4165 Wound autofluorescence imaging device.

(a) Identification. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2018-22837 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-3598] Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

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

DATES:

This order is effective October 19, 2018. The classification was applicable on October 18, 2012.

FOR FURTHER INFORMATION CONTACT:

Neil Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993-0002, 301-796-6397, [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

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

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

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

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

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

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

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

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

II. De Novo Classification

For this device, FDA issued an order on June 10, 2009, finding the ViruLite Cold Sore Machine not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.

On June 30, 2009, Pacer Therapeutics, Ltd. submitted a request for De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on October 18, 2012, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4860. We have named the generic type of device light based energy source device for topical application, and it is identified as a device that emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.

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

Table 1—Light Based Energy Source Device for Topical Application Risks and Mitigation Measures Identified risks Mitigation measures Redness and discomfort Clinical performance testing, Usability testing, and Labeling. Burns and blisters Clinical performance testing, Usability testing, and Labeling. Adverse tissue reaction Biocompatibility evaluation. Infection/transmissibility Labeling, Cleaning and disinfection validation, and Usability testing. Electrical shock Electrical safety testing and Labeling. Electromagnetic incompatibility Electromagnetic compatibility testing and Labeling. User error Usability testing and Labeling. Ocular injury Labeling and Non-clinical performance testing for ocular safety.

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

III. Analysis of Environmental Impact

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 878

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for part 878 continues to read as follows: Authority:

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

2. Add § 878.4860 to subpart E to read as follows:
§ 878.4860 Light based energy source device for topical application.

(a) Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.

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

(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.

(2) The cleaning and disinfection instructions for the device must be validated.

(3) The device must be demonstrated to be biocompatible.

(4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.

(5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.

(6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.

(7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.

(8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.

Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2018-22786 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-3595] Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

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

DATES:

This order is effective October 19, 2018. The classification was applicable on May 7, 2018.

FOR FURTHER INFORMATION CONTACT:

Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301-796-6436, [email protected].

SUPPLEMENTARY INFORMATION: I. Background

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

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

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

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

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

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

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

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

II. De Novo Classification

On March 9, 2017, Wilson-Cook Medical, Inc. submitted a request for De Novo classification of the Hemospray® Endoscopic Hemostat. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on May 7, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4456. We have named the generic type of device hemostatic device for intraluminal gastrointestinal use, and it is identified as a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other means.

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

Table 1—Hemostatic Device for Intraluminal Gastrointestinal Use Risks and Mitigation Measures Identified risks Mitigation measures Bleeding: • Inability to achieve hemostasis
  • • Recurrence of bleeding
  • In vivo performance testing, Non-clinical performance testing, and Labeling.
    Infection Sterilization validation, Shelf life testing, and Labeling. Adverse tissue reaction In vivo performance testing, Non-clinical performance testing, Biocompatibility evaluation, and Labeling. Obstruction of gastrointestinal (GI) tract In vivo performance testing and Labeling. GI distension or perforation In vivo performance testing and Labeling. Vascular obstruction: • Ischemia
  • • Emboli formation
  • In vivo performance testing, Non-clinical performance testing, and Labeling.
    Tissue trauma In vivo performance testing, Non-clinical performance testing, and Labeling. Improper device use In vivo performance testing and Labeling.

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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

    III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

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

    List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

    PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for part 878 continues to read as follows: Authority:

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

    2. Add § 878.4456 to subpart E to read as follows:
    § 878.4456 Hemostatic device for intraluminal gastrointestinal use.

    (a) Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

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

    (1) The device must be demonstrated to be biocompatible.

    (2) Performance data must support the sterility and pyrogenicity of the device.

    (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

    (4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:

    (i) The ability to deliver the hemostatic material to the bleeding site;

    (ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and

    (iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.

    (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:

    (i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.

    (ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.

    (6) Labeling must include:

    (i) Information identifying and explaining how to use the device and its components; and

    (ii) A shelf life.

    Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22784 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2018-N-3690] Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 19, 2018. The classification was applicable on March 26, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240-402-6032, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

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

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

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

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

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

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

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

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

    II. De Novo Classification

    On April 18, 2017, Scion NeuroStim, LLC submitted a request for De Novo classification of the ThermoNeuroModulation Device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

    Therefore, on March 26, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5893. We have named the generic type of device thermal vestibular stimulator for headache, and it is identified as a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.

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

    Table 1—Thermal Vestibular Stimulator for Headache Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility evaluation, Cleaning validation, and Labeling. Thermal injury Labeling, Non-clinical performance testing, Thermal safety testing, Technical specifications, and Software verification, validation, and hazard analysis. Ear tenderness and/or pruritus Labeling, Non-clinical performance testing, and Thermal safety testing. Nausea and/or dizziness Labeling, Non-clinical performance testing, and Software verification, validation, and hazard analysis. Tinnitus Labeling, Non-clinical performance testing, and Software verification, validation, and hazard analysis.

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

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

    III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

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

    List of Subjects in 21 CFR Part 882

    Medical devices.

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

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

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

    2. Add § 882.5893 to subpart F to read as follows:
    § 882.5893 Thermal vestibular stimulator for headache.

    (a) Identification. The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.

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

    (1) The patient-contacting components of the device must be demonstrated to be biocompatible.

    (2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.

    (3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified.

    (4) Cleaning validation of earpieces must be conducted.

    (5) Software verification, validation, and hazard analysis must be performed.

    (6) Labeling must include the following:

    (i) Information on how the device operates and the typical sensations experienced during treatment;

    (ii) A detailed summary of the device's technical parameters; and

    (iii) Instructions for maintenance and cleaning of the device.

    Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22842 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2018-N-3634] Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 19, 2018. The classification was applicable on May 17, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD, 20993-0002, 240-402-4662, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

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

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

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

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

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

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

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

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

    II. De Novo Classification

    On October 23, 2017, Allergan submitted a request for De Novo classification of the TrueTear Intranasal Tear Neurostimulator. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

    Therefore, on May 17, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.5310. We have named the generic type of device intranasal electrostimulation device for dry eye symptoms, and it is identified as a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

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

    Table 1—Intranasal Electrostimulation Device for Dry Eye Symptoms Risks and Mitigation Measures Identified risks Mitigation measures Tissue damage due to overstimulation/understimulation or mechanical injury (ex: tips too long), device breakage Non-clinical performance testing; Software verification, validation, and hazard analysis; Electrical, thermal, and mechanical safety testing; and Labeling. Adverse tissue reaction Biocompatibility evaluation and Labeling. Infection Labeling. Electrical shock or burn Electrical, thermal, and mechanical safety testing; Software verification, validation, and hazard analysis; and Labeling. Interference with other devices Electromagnetic compatibility (EMC) testing; Software verification, validation, and hazard analysis; and Labeling. Pain, headache, or discomfort Clinical performance testing; Non-clinical performance testing; Electrical, thermal, and mechanical safety testing; and Labeling. Failure to mitigate dry eye symptoms Clinical performance testing, Training, and Labeling.

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

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

    III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

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

    List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:

    PART 886—OPHTHALMIC DEVICES 1. The authority citation for part 886 continues to read as follows: Authority:

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

    2. Add § 886.5310 to subpart F to read as follows:
    § 886.5310 Intranasal electrostimulation device for dry eye symptoms.

    (a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

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

    (1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.

    (2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

    (3) Patient-contacting components of the device must be demonstrated to be biocompatible.

    (4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

    (5) Software verification, validation, and hazard analysis must be performed.

    (6) Training for the proper use of the device must be provided.

    (7) Physician and patient labeling must include:

    (i) Summaries of electrical stimulation parameters;

    (ii) Instructions on how to correctly use and maintain the device;

    (iii) Instructions and explanations of all user-interface components;

    (iv) Information related to electromagnetic compatibility classification;

    (v) Instructions on how to clean the device; and

    (vi) Summaries of clinical performance testing demonstrating safety and effectiveness.

    Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22785 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0153] Drawbridge Operation Regulation; Sacramento River, Sacramento, CA 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 Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the bridge owner to conduct mechanical and electrical rehabilitation work on the bridge. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

    DATES:

    This deviation is effective without actual notice from October 19, 2018 through 6 a.m. on December 1, 2018. For the purposes of enforcement, actual notice will be used from 6 a.m. on October 8, 2018 until October 19, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0153, 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 Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email [email protected].

    SUPPLEMENTARY INFORMATION:

    The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over the Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

    The drawspan will be secured in the closed-to-navigation position from 6 a.m. on October 8, 2018 through 6 a.m. on December 1, 2018, to allow the bridge owner to replace the bridge's wire rope and traveler cable and to conduct chain and trunnion bearing inspection and servicing. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

    Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies if at least 72-hour notice is given to the bridge operator. There is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway 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: October 15, 2018. Carl T. Hausner, District Bridge Chief, Eleventh Coast Guard District.
    [FR Doc. 2018-22746 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0300] Drawbridge Operation Regulation; Willamette River at Portland, OR AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation; modification.

    SUMMARY:

    The Coast Guard has modified a temporary deviation from the operating schedule that governs the Burnside Bridge across the Willamette River, mile 12.4, at Portland, OR. The deviation is necessary to accommodate bridge repairs and upgrades. This modified deviation extends the period the Burnside Bridge is authorized to operate in single leaf mode.

    DATES:

    This deviation is effective without actual notice from October 19, 2018 to 4 p.m. on November 30, 2018. For purposes of enforcement, actual notice will be used from 4 p.m. on October 13, 2018, to October 19, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0300 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

    SUPPLEMENTARY INFORMATION:

    On June 7, 2018, we published a temporary deviation entitled Drawbridge Operation Regulation; Willamette River at Portland, OR, in the Federal Register (83 FR 26364). That temporary deviation allowed Multnomah County to operate the subject bridge in single leaf, and reduce the vertical clearance from 7 a.m. on July 1, 2018 to 4 p.m. on October 13, 2018. While performing upgrades and repairs, the contracting company informed Multnomah County more time will be needed to complete the job. This modification is required to extend the authorized time so bridge work crews may complete bridge upgrades and repairs. Multnomah County owns and operates the Burnside Bridge. Multnomah County requested an extension to the current published temporary deviation, and is authorized to operate the Burnside Bridge in single leaf, and maintain the east leaf closed to marine vessels from 4 p.m. on October 13, 2018 to 4 p.m. on November 30, 2018.

    The Burnside Bridge provides a vertical clearance of 41 feet in the closed-to-navigation position referenced to Columbia River Datum 0.0, and the east leaf will be reduced to 31 feet with scaffolding installed. The horizontal clearance for the west leaf opening will be 100 feet. The normal operating schedule is in 33 CFR 117.897. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard contacted all known users of the Willamette River for comment, and we received no objections for this deviation.

    Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open the west side of the span only for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedules 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: October 15, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-22801 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0711] RIN 1625-AA00 Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks Display AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on a portion of the Delaware River in Philadelphia, PA. This action is necessary to protect the surrounding public and vessels on these navigable waters adjacent to Penn's Landing, Philadelphia, PA, during a fireworks display on October 19, 2018. This regulation prohibits persons and vessels from entering, transiting, or remaining within the safety zone unless authorized by the Captain of the Port Delaware Bay or a designated representative.

    DATES:

    This rule is effective from 11 p.m. through 11:59 p.m. on October 19, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0711 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 about this rule, call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division; telephone 215-271-4814, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On June 18, 2018, a wedding party notified the Coast Guard that it will be conducting a fireworks display from 11:15 p.m. to 11:45 p.m. on October 19, 2018. The fireworks are to be launched from a barge in the Delaware River adjacent to Penn's Landing in Philadelphia, PA. In response, on September 28, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks Display; 83 FR 49026. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended October 5, 2018, we received one comment.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the potential safety hazards associated with a fireworks display in this location.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with the fireworks display on October 19, 2018, will be a safety concern for anyone within 500 feet of a fireworks barge in the Delaware River adjacent to Penn's Landing in Philadelphia, PA. The barge will be anchored in approximate position 39°57′05.26″ N Latitude 075°08′10.85″ W Longitude. This rule is needed to protect persons, vessels and the public near the fireworks barge during the fireworks display.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published September 28, 2018. The comment we received was unrelated to the proposed regulation. There is one change in the regulatory text of this rule from the proposed rule in the NPRM. The enforcement period was changed from 11:15 p.m. through 11:45 p.m. to 11 p.m. through 11:59 p.m. on the same date. We made this change to account for movement of the barge into and out of the anchor location.

    This rule establishes a safety zone from 11 p.m. through 11:59 p.m. on October 19, 2018, for the navigable waters in the vicinity of Penn's Landing, Philadelphia, PA, during a fireworks display from a barge. The event is scheduled to take place at approximately 11:15 p.m. on October 19, 2018. The safety zone will extend 500 feet around the barge, which will be anchored at approximate position 39°57′05.26″ N Latitude 075°08′10.85″ W Longitude. Persons or vessels will not be permitted to enter, transit through, or remain within the safety zone without obtaining permission from the COTP or a designated representative.

    If authorization to enter, transit through, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative. The Coast Guard will provide public notice of the safety zone by Broadcast Notice to Mariners and by on-scene actual notice.

    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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which will impact a small designated area of the Delaware River for one hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.

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

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

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

    C. Collection of Information

    This rule would 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.

    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 Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one hour that would prohibit entry within 500 feet of a fireworks barge. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T05-0711 to read as follows:
    § 165.T05-0711 Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks Display.

    (a) Location. The following area is a safety zone: All waters of the Delaware River within a 500-foot radius of the fireworks barge, which will be anchored in approximate position 39°57′05.26″ N Latitude 075°08′10.85″ W Longitude. All coordinates are based on Datum NAD 1983.

    (b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard petty officer, warrant or commissioned officer on board a Coast Guard vessel or on board a federal, state, or local law enforcement vessel assisting the Captain of the Port, Delaware Bay in the enforcement of the safety zone.

    (c) Regulations. (1) Under the general safety zone regulations in subpart C of this part—

    (i) You may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative; and

    (ii) All persons and vessels in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

    (2) To request permission to enter the safety zone, contact the COTP or the COTP's representative on marine band radio VHF-FM channel 16 (156.8 MHz) or 215-271-4807.

    (3) No vessel may take on bunkers or conduct lightering operations within the safety zone during the enforcement period.

    (4) This section applies to all vessels except those engaged in law enforcement, aids to navigation servicing, and emergency response operations.

    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by federal, state, and local agencies.

    (e) Enforcement period. This zone will be enforced from 11 p.m. through 11:59 p.m. on October 19, 2018.

    Dated: October 15, 2018. S.E. Anderson, Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
    [FR Doc. 2018-22868 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2018-0847] RIN 1625-AA00 Safety Zone; Hornblower Fireworks Display; San Francisco Bay; San Francisco, CA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone in the navigable waters of San Francisco Bay in support of the Hornblower Fireworks Display on October 20, 2018. This safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.

    DATES:

    This rule is effective from 11 a.m. to 10:10 p.m. on October 20, 2018.

    ADDRESSES:

    Documents mentioned in this preamble are part of docket USCG-2018-0847. To view documents mentioned in this preamble as being available in the docket, go to 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 rulemaking.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Chief Warrant Officer Mickey Price, U.S. Coast Guard Sector San Francisco; telephone (415) 399-7442 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Acronyms APA Administrative Procedure Act COTP U.S. Coast Guard Captain on the Port DHS Department of Homeland Security FR Federal Register NOAA National Oceanic and Atmospheric Administration NPRM Notice of proposed rulemaking PATCOM U.S. Coast Guard Patrol Commander U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary final 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 notice of proposed rulemaking (NPRM) with respect to this rule. Since the Coast Guard received notice of this event on September 8, 2018, notice and comment procedures would be impracticable in this instance.

    For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) San Francisco has determined that potential hazards associated with the Hornblower Fireworks Display on October 20, 2018, will be a safety concern for anyone within a 100 foot radius of the fireworks barge and anyone within a 420 foot radius of the fireworks firing site. This rule is needed to protect spectators, vessels, and other property from hazards associated with pyrotechnics.

    IV. Discussion of the Rule

    This rule establishes a temporary safety zone during the loading, staging, and transit of the fireworks barge, until after completion of the fireworks display. During the loading and staging of the pyrotechnics onto the fireworks barge, scheduled to take place from 11 a.m. to 8:30 p.m. on October 20, 2018, at Pier 50 in San Francisco, CA, the safety zone will encompass the navigable waters around and under the fireworks barge within a radius of 100 feet.

    The fireworks barge will remain at Pier 50 until the start of its transit to the display location. Towing of the barge from Pier 50 to the display location is scheduled to take place from 8:30 p.m. to 9 p.m. on October 20, 2018, where it will remain until the conclusion of the fireworks display.

    At 9 p.m. on October 20, 2018, 30 minutes prior to the commencement of the 10 minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 420 feet in approximate position 37°48′15″ N, 122°23′27″ W (NAD 83) for the Hornblower Fireworks Display. The safety zone shall terminate at 10:10 p.m. on October 20, 2018.

    The effect of the temporary safety zone is to restrict navigation in the vicinity of the fireworks loading, staging, transit, and firing site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the fireworks firing sites to ensure the safety of participants, spectators, and transiting vessels.

    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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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.

    This rule may affect the following entities, some of which may be small entities: owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Notice to Mariners.

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, 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 of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T11-0847 to read as follows:
    § 165.T11-0847 Safety Zone; Hornblower Fireworks Display, San Francisco Bay, San Francisco, CA.

    (a) Location. The following area is a safety zone: All navigable waters of the San Francisco Bay within 100 feet of the fireworks barge during loading and staging at Pier 50 in San Francisco, as well as transit and arrival to San Francisco, CA. From 11 a.m. on October 20, 2018 until approximately 8:30 p.m. on October 20, 2018, the fireworks barge will be loading and staging at Pier 50. The safety zone will expand to all navigable waters around and under the firework barge within a radius of 420 feet in approximate position 37°48′15″ N, 122°23′27″ W (NAD 83) 30 minutes prior to the start of the 10 minute fireworks display, scheduled to begin at 9:30 p.m. on October 20, 2018.

    (b) Enforcement period. The zone described in paragraph (a) of this section will be enforced from 11 a.m. on October 20, 2018 until approximately 10:10 p.m. on October 20, 2018. The Captain of the Port San Francisco (COTP) will notify the maritime community of periods during which these zones will be enforced via Notice to Mariners in accordance with 33 CFR 165.7.

    (c) Definitions. As used in this section, “designated representative” means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer on a Coast Guard vessel or a Federal, State, or local officer designated by or assisting the COTP in the enforcement of the safety zone.

    (d) Regulations. (1) Under the general regulations in 33 CFR part 165, subpart C, entry into, transiting or anchoring within this safety zone is prohibited unless authorized by the COTP or the COTP's designated representative.

    (2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.

    (3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zones on VHF-23A or through the 24-hour Command Center at telephone (415) 399-3547.

    Dated: October 16, 2018. Anthony J. Ceraolo, Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
    [FR Doc. 2018-22825 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0910] RIN 1625-AA00 Safety Zone; Fox River, Brown County Fireworks, Green Bay, WI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the Fox River in Green Bay, WI, for all navigable waters within a 210-foot radius of the approximate launch position at 44°31.016′ N, 088°01.016′ W (NAD 83). This action is necessary to protect spectators, mariners, vessels, and property from potential hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Lake Michigan or a designated representative.

    DATES:

    This rule is effective from 7 p.m. through 7:30 p.m. on October 26, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0910 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 document, call or email the marine event coordinator, MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § 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 notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public, vessels, mariners, and property from the hazards associated with the fireworks display on October 26, 2018.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register for the same reasons discussed in the preceding paragraph. Waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

    III. Legal Authority and Need for Rule

    The legal basis for this rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    The Coast Guard will enforce a safety zone on October 26, 2018, from 7 p.m. through 7:30 p.m., for a fireworks display on Fox River in Green Bay, WI. The Captain of the Port Lake Michigan has determined that this fireworks display will pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, falling and burning debris, and collisions among spectator vessels.

    IV. Discussion of the Rule

    With the aforementioned hazards in mind, the Captain of the Port Lake Michigan has determined that this temporary safety zone is necessary to protect persons and vessels during the fireworks display in the waters of Fox River, in Green Bay, WI. This zone is effective and will be enforced from 7 p.m. through 7:30 p.m. on October 26, 2018. The safety zone will encompass all navigable waters of Fox River within a 210-foot radius of the approximate launch position at 44°31.016′ N, 088°01.016′ W (NAD 83).

    Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated on-scene representative. The Captain of the Port or a designated on-scene representative may be contacted via VHF Channel 16.

    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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. The safety zone created by this rule will be relatively small and enforced for only 30 minutes. Under certain conditions, vessels may still transit through the safety zone when permitted by the Captain of the Port. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

    B. Impact on Small Entities

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

    This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the affected portion of Fox River, in Green Bay, WI between 7 p.m. through 7:30 p.m. on October 26, 2018. This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons cited in the Regulatory Planning and Review section. Additionally, before the enforcement of the zone, we will issue local Broadcast Notice to Mariners and Public Notice of Safety Zone so vessel owners and operators can plan accordingly.

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such 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 Directive 023-01 and Commandant Instruction M16475.1D, 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 the establishment of a safety zone surrounding a fireworks display on Fox River, in Green Bay, WI. It is categorically excluded from further review under paragraph L[60(a)] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    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.T09-0910 to read as follows:
    § 165.T09-0910 Safety Zone; Fox River, Brown County Fireworks, Green Bay, WI.

    (a) Location. All navigable waters of Fox River within a 210-foot radius of the approximate launch position at 44°31.0167′ N, 088°01.016′ W (NAD 83).

    (b) Effective and enforcement period. This rule is effective and will be enforced from 7 p.m. through 7:30 p.m. on October 26, 2018.

    (c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated on-scene representative.

    (2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Lake Michigan or a designated on-scene representative.

    (3) The “on-scene representative” of the Captain of the Port Lake Michigan is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Lake Michigan to act on his or her behalf.

    (4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Lake Michigan or an on-scene representative to obtain permission to do so. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Lake Michigan or an on-scene representative.

    Dated: October 2, 2018. Thomas J. Stuhlreyer, Captain, U.S. Coast Guard, Captain of the Port.
    [FR Doc. 2018-22845 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2018-0309 and EPA-R10-OAR-2018-0316: FRL-9985-28-Region 8 and Region 10] Determination of Attainment by the Attainment Date and Clean Data Determination for the Logan, UT-ID 2006 24-Hour PM2.5 Nonattainment Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is finalizing a determination of attainment by the attainment date and a clean data determination (CDD) for the 2006 24-hour fine particulate matter (PM2.5) Logan, Utah (UT)-Idaho (ID) nonattainment area. These determinations are based upon quality-assured, quality-controlled and certified ambient air monitoring data for the period 2015-2017, available in the EPA's Air Quality System (AQS) database, showing that the area has attained the 2006 24-hour PM2.5 National Ambient Air Quality Standards (NAAQS). Based on the final determination that the Logan, UT-ID nonattainment area is currently attaining the 24-hour PM2.5 NAAQS, the EPA is also issuing the final determination that the obligation for Utah and Idaho to make submissions to meet certain Clean Air Act (CAA or the Act) requirements related to attainment of the NAAQS for this area is not applicable for as long as the area continues to attain the NAAQS. Additionally, the sanctions and Federal Implementation Plan (FIP) clocks triggered by the partial disapproval of the contingency measure element for the Idaho portion of the Logan, UT-ID PM2.5 State Implementation Plan (SIP) will be suspended.

    DATES:

    This final rule is effective on October 19, 2018.

    ADDRESSES:

    The EPA has established dockets for this action under Docket ID No. EPA-R08-OAR-2018-0309 and/or Docket ID No. EPA-R10-OAR-2018-0316. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Ostigaard, Air Program, EPA, Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6602, [email protected], or Matthew Jentgen, Air Planning Unit, Office of Air and Waste (OAW-150), EPA, Region 10, 1200 Sixth Avenue, Suite 900, Seattle, Washington 98101; (206) 553-0340; [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, wherever “we”, “us” or “our” is used, it is intended to refer to the EPA.

    I. Background

    On October 17, 2006 (71 FR 61144), the EPA revised the level of the 24-hour PM2.5 NAAQS, lowering the primary and secondary standards from the 1997 standard of 65 micrograms per cubic meter (µg/m3) to 35 µg/m3. On November 13, 2009 (74 FR 58688), the EPA designated several areas as nonattainment for the 24-hour PM2.5 NAAQS of 35 µg/m3, including the Logan, Utah UT-ID nonattainment area.

    On July 17, 2018 (83 FR 33886), the EPA proposed to determine, based on the most recent 3 years (2015-2017) of valid data,1 that the Logan, UT-ID nonattainment area has attained the 2006 primary and secondary 24-hour PM2.5 NAAQS by the December 31, 2017 attainment date. In addition, based on the CDD, the EPA also proposed to determine that the obligation to submit any remaining attainment-related SIP revisions arising from classification of the Logan, UT-ID area as a Moderate nonattainment area under subpart 4 of part D (of title I of the Act) for the 2006 24-hour PM2.5 NAAQS is not applicable so long as the area continues to attain the 2006 24-hour PM2.5 NAAQS. Additional detail can be found in the July 17, 2018 (83 FR 33886) proposed action.

    1 Meeting the requirements of 40 CFR part 50, appendix N, and part 58.

    II. Response to Comments

    The EPA received eight public comments on the proposed action. Three of the comments related to forestry practices and wildfire management, primarily in California. One comment related to child labor practices in South America. One comment related to homelessness in California. Another comment discussed water quality issues in Venezuela. Finally, one comment raised issues concerning lead-based paint. None of these seven comments recommended that the EPA take a different action than the EPA proposed on July 17, 2018 (83 FR 33886). The eighth comment was received from the Idaho Conservation League (ICL) and raised issues relevant to this action, which are addressed below. After reviewing the comments received, the EPA has determined that the comments, with the exception of the ICL comment, fall outside the scope of our proposed action or fail to identify any material issue necessitating a response.

    The ICL comment raises concerns regarding monitoring data trends at the Franklin, ID and, to a lesser extent, the Smithfield, UT sites. The comment states that the 3-year average (2015-2017) at the Franklin, ID monitoring site was 30 µg/m3; however, the 98th percentile rose each year (18.8, 33.3, and 38.3 µg/m3, respectively). The commenter briefly mentions the Smithfield, UT monitor and how the 98th percentiles for the three years (2015-2017) rose too, but to a lesser extent. The comment also asserts that if the 2018 monitoring data at the Franklin, ID site yields a 98th percentile measurement of greater than 33.4 µg/m3 (the commenter observes that this measurement is not unreasonable for this site), then the 2016-2018 design value would exceed the standard of 35 µg/m3. The commenter requests that the EPA addresses why the year-to-year increases in PM2.5 is occurring, and what regulatory measures are in place to prevent this area from violating again.

    In accordance with section 188(b)(2) of the CAA, the EPA is required to determine within 6 months of the applicable attainment date whether a nonattainment area attained the standard by that date. On September 8, 2017, the EPA extended the attainment date for the Logan, UT-ID PM2.5 nonattainment area to December 31, 2017, upon which the EPA proposed a determination of attainment. A determination of attainment is not equivalent to a redesignation, and the states must still meet the statutory requirements for redesignation in order for the area to be redesiginated to attainment. The comment may be referring to a redesignation rather than a determination that the area attained by the attainment date and/or a CDD, so the EPA reiterates that the designation status of the area will remain nonattainment for the 2006 PM2.5 NAAQS, until such time as the EPA determines that the area meets the CAA requirements for redesignation to attainment in CAA section 107(d)(3)(E).

    The EPA has established regulations for determining if the 24-hour PM2.5 NAAQS has been met at 40 CFR 50.13 and part 50, appendix N, section 4.2. Specifically, under 40 CFR 50.13 and part 50, appendix N, section 4.2, the 2006 24-hour PM2.5 NAAQS is met when the 24-hour PM2.5 NAAQS design value at each eligible monitoring site is less than or equal to 35 μg/m3. Three years of valid annual PM2.5 98th percentile mass concentrations generally are required to produce a valid design value. The regulations do not require that there be a downward trend over the course of the three years used to calculate the design value. Rather, according to part 50, appendix N, section 4.5, the design value is an average of the three years of valid annual PM2.5 98th percentile mass concentrations. Thus, the process the EPA uses to calculate a design value accounts for the fluctuations in 98th percentiles at the Logan, UT and Smithfield, UT monitoring sites. Following the requirements of 40 CFR 50.13 and part 50, appendix N, the EPA determined that the design values at both the Smithfield, UT and Franklin, ID monitors are below 35 μg/m3, thus the proposed determination of attainment by the attainment date and the proposed CDD are appropriate.

    Also, the 3-year design values are lower for the time period used for this attainment determination compared to the time period when the area was designated nonattainment. The Logan, UT design value used for designations 2 was 36 μg/m3 (2006-2008). The first period when both the Logan, UT and Franklin, ID monitors had valid design values was in 2008-2010, when the Logan, UT monitor recorded a PM2.5 24-hour concentration of 43 μg/m3 and the Franklin, ID monitor was 46 μg/m3. In comparison, the most recent design value (2015-2017) is 33 μg/m3 for the Logan, UT monitor and 30 μg/m3 for the Franklin, ID monitor, which shows attainment. Moreover, since being designated as a Moderate nonattainment area in 2009, Utah and Idaho have adopted and implemented reasonably available control measures (RACM), including reasonably available control technologies (RACT), on sources of direct PM2.5 and PM2.5 precursors. Based on the overall trend towards attainment since the area was designated as nonattainment in 2009, as well as the implementation of RACM on sources in the nonattainment area, it is unlikely the area will re-violate the 24-hour PM2.5 NAAQS. Furthermore, as described in detail in our proposal notice, should the area subsequently violate the 24-hour PM2.5 NAAQS, in accordance with 40 CFR 51.1015(a)(2), the EPA would rescind the CDD, and Utah and Idaho would be obligated to submit a SIP revision to address any deficiencies. Therefore, the EPA is finalizing our action as proposed.

    2 November 13, 2009 (74 FR 58688).

    III. Final Action

    Pursuant to CAA section 188(b)(2), the EPA is finalizing a determination, based on the most recent 3 years (2015-2017) of valid data, that the Logan, UT-ID nonattainment area has attained the 2006 primary and secondary 24-hour PM2.5 NAAQS by the December 31, 2017 attainment date.

    In addition, the EPA is finalizing a determination that the obligation to submit any remaining attainment-related SIP revisions arising from classification of the Logan, UT-ID area as a Moderate nonattainment area under subpart 4 of part D (of title I of the Act) for the 2006 24-hour PM2.5 NAAQS are not applicable under the Clean Data Policy for so long as the area continues to attain the 2006 24-hour PM2.5 NAAQS. See 40 CFR 51.1015(a). In particular, the obligation for Utah and Idaho to submit attainment demonstrations, projected emissions inventories, RACM (including RACT), reasonable further progress (RFP) plans, motor vehicle emissions budgets (MVEB), quantitative milestones, and contingency measures, for the Logan, UT-ID area are suspended until such time as: (1) The area is redesignated to attainment, after which such requirements are permanently discharged; or (2) the EPA determines that the area has re-violated the PM2.5 NAAQS, at which time the state shall submit such attainment plan elements for the Moderate nonattainment area by a future date to be determined by the EPA and announced through publication in the Federal Register at the time the EPA determines the area is violating the PM2.5 NAAQS.

    As discussed in the 2015 PM2.5 SIP Requirements Rule,3 the nonattainment base emissions inventory required by section 172(c)(3) is not suspended by this determination because the base inventory is a requirement independent of planning for an area's attainment. See 81 FR 58009 at 58028 and 58127-8; 80 FR 15340 at 15441-2. Additionally, Nonattainment New Source Review (NNSR) requirements are discussed in the PM2.5 SIP Requirements Rule, and required by CAA sections 110(a)(2)(C); 172(c)(5); 173; 189(a); and 189(e), and are not being suspended by a CDD because this requirement is independent of the area's attainment planning. See 81 FR 58010 at 58107 and 58127.

    3 On August 24, 2016, the EPA finalized the Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements (“PM2.5 SIP Requirements Rule”), 81 FR 58010.

    This determination does not invalidate any prior actions that the EPA has made on any Moderate PM2.5 area attainment plan elements that were submitted by either the State of Utah or the State of Idaho for the Logan, UT-ID Moderate PM2.5 area attainment plans. This action does not preclude either state from submitting, nor the EPA from acting on, the suspended attainment plan elements. As a result of this final action, the sanctions and Federal Implementation Plan (FIP) clocks triggered by the partial disapproval of the contingency measure element of the Idaho portion of the Logan, UT-ID PM2.5 SIP are suspended.

    This final action does not constitute a redesignation of the Logan, UT-ID nonattainment area to attainment for the 2006 24-hour PM2.5 NAAQS under CAA section 107(d)(3) because we have not yet approved a maintenance plan for Logan, UT-ID as meeting the requirements of section 175A of the CAA or determined that the area has met the other CAA requirements for redesignation. The classification and designation status in 40 CFR part 81 remains Moderate nonattainment for this area until such time as the EPA determines that Utah and Idaho have met the CAA requirements for redesignation to attainment for the Logan, UT-ID nonattainment area.

    In accordance with 5 U.S.C. 553(d), the EPA finds there is good cause for these determinations to become effective immediately upon publication in the Federal Register. The expedited effective date for these actions is authorized under both 5 U.S.C. 553(d)(1), which provides that rule actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction,” and 5 U.S.C. 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” As noted above, this determination of attainment will result in a suspension of the requirements for Idaho and Utah to submit attainment demonstrations, projected emissions inventories, RACM (including RACT), RFP plans, MVEB, quantitative milestones, and contingency measures, so long as the Logan, UT-ID area continues to attain the PM2.5 NAAQS. Furthermore, the sanctions and FIP clocks triggered by the partial disapproval of the contingency measure element of the Idaho portion of the Logan, UT-ID PM2.5 SIP are suspended. The suspension of these requirements and the suspension of sanctions is sufficient reason to allow an expedited effective date of this rule under 5 U.S.C. 553(d)(1). In addition, the suspension of the obligations of Idaho and Utah to make submissions for these requirements provides good cause to make this rule effective on the date of publication of this action in the Federal Register, pursuant to 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in 5 U.S.C. 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Where, as here, the final rule suspends requirements rather than imposes obligations, affected parties, such as Idaho and Utah, do not need time to adjust and prepare before the rule takes effect.

    IV. Statutory and Executive Order Reviews

    This action finalizes a determination of attainment based on air quality and suspends certain federal requirements, and thus would not impose additional requirements beyond those imposed by state law. For this reason, this final action:

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

    • Is not expected to be an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 18, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: September 27, 2018. Douglas H. Benevento, Regional Administrator, Region 8. Dated: September 27, 2018. Chris Hladick, Regional Administrator, Region 10.
    [FR Doc. 2018-22284 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0531; FRL-9984-63] Prothioconazole; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of prothioconazole in or on rapeseed subgroup 20A. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0531, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0531 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 18, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0531, by one of the following methods:

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

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

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 27, 2018 (83 FR 8408) (FRL-9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F8596) by Bayer CropScience, LP2, T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be amended by establishing tolerances for residues of the fungicide prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and its desthio metabolite in or on rapeseed subgroup, Crop subgroup 20A at 0.15 parts per million (ppm). That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

    Based upon review of the data supporting the petition, EPA is establishing the tolerance requested by the petitioner as Rapeseed subgroup 20A, to be consistent with the commodity terminology commonly used by the Agency.

    III. Aggregate Risk Assessment and Determination of Safety

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

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

    A. Toxicological Profile

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

    Prothioconazole degrades into different compounds in different matrices, with prothioconazole-desthio (desthio) being the metabolite and degradate of concern. The target organs of prothioconazole and the desthio metabolite include the liver, kidney, bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes, and toxicity to the lymphatic and gastrointestinal systems.

    Developmental studies show that prothioconazole and its metabolites produce adverse effects including malformations in the conceptus at levels equal to or below maternally toxic levels, particularly those studies conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggest that these chemicals do not adversely affect reproductive parameters or the offspring except at parentally toxic dose levels. Acute and subchronic neurotoxicity studies, as well as a developmental neurotoxicity study, raise no neurotoxicity concerns. Immunotoxicity data show that prothioconazole is not an immunotoxicant.

    The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence and EPA has concluded that prothioconazole and its metabolites are not carcinogenic.

    Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Prothioconazole: Human Health Risk Assessment for a Proposed Tolerance on Cottonseed Subgroup 20C, a Tolerance Amendment on Sugar Beet Roots, and New Use Requests for Cotton, Sugar Beet, Soybean, and Dried Shelled Pea and Bean” on page 32 in docket ID number EPA-HQ-OPP-2015-0722.

    B. Toxicological Points of Departure/Levels of Concern

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

    A summary of the toxicological endpoints for prothioconazole used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of November 10, 2016 (81 FR 78917) (FRL-9953-71).

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prothioconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed dietary exposures from prothioconazole in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

    Such effects were identified for prothioconazole for females 13-50 years old. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed tolerance-level values for the proposed new uses and existing tolerances on berries, cucurbit vegetables, cottonseed, sugar beet roots, and sunflower subgroup 20B, average field trial residues for all other commodities, and DEEM default and empirical processing factors. 100 percent crop treated (PCT) was assumed for all proposed and established commodities.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA; 2003-2008. As to residue levels in food, EPA assumed tolerance-level values for the proposed new uses and existing tolerances on berries, cucurbit vegetables, cottonseed, sugar beet roots, and sunflower subgroup 20B, average field trial residues for all other commodities, and DEEM default and empirical processing factors. 100 PCT was assumed for all proposed and established commodities.

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

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

    The Agency did not use percent crop treated estimates for the dietary assessment.

    2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prothioconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of prothioconazole for acute exposures are estimated to be 109 parts per billion (ppb) for surface water and 132 ppb for ground water and for chronic exposures are estimated to be 97 ppb for surface water and 128 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 132 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 128 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Prothioconazole is not registered for any specific use patterns that would result in residential exposure.

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

    Prothioconazole is a member of the conazole class of pesticides containing the 1,2,4-triazole moiety. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events in mammals (EPA, 2002). In the case of conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no conclusive data to indicate that conazoles share common mechanisms of toxicity, and EPA is not following a cumulative risk approach for this the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    Prothioconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including prothioconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL safety factor when the reproduction study was used. In addition, the Agency retained a 10X for the lack of studies including a developmental neurotoxicity (DNT) study. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-0497.

    An updated dietary exposure and risk analysis for the common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was completed on July 18, 2017, in association with registration requests for the triazole fungicides difenoconazole and tetraconazole. That analysis concluded that risk estimates were below the Agency's level of concern for all population groups. The proposed new uses of prothioconazole are not expected to significantly increase the dietary exposure estimates for free triazole or conjugated triazoles; thus, the Agency is relying on the July 18, 2017 analysis to support its conclusion that the exposure to the triazole metabolite, including exposures from the use of prothioconazole on the commodities in subgroup 20A, does not present risks of concern. This assessment may be found on http://www.regulations.gov by searching for the following title and docket number: “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address New Section 3 Registrations for Use of Difenoconazole and Tetraconazole.” (located in docket ID number EPA-HQ-OPP-2016-0254).

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. There are adequate data in the prothioconazole/prothioconazole-desthio toxicological database to characterize the potential for pre-natal or post-natal risks to infants and children: Two-Generation reproduction studies in rats; developmental studies in rats and rabbits; and a DNT study in rats. The effects seen in these studies suggest that offspring are more susceptible. Offspring adverse effects were seen at levels below the LOAELs for maternal toxicity and, in general, were of comparable or greater severity compared to the effects observed in adults. However, clear NOAELs are established for offspring and fetal effects. The most sensitive effects (malformed vertebral body and ribs, anthrogryposis, and other multiple malformations) seen in the fetuses of a rabbit developmental study are established as the toxicity endpoints with a POD of 2 mg/kg/day. This POD is protective all fetal and offspring effects seen in the developmental toxicity and developmental neurotoxicity studies.

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

    i. The toxicity database for prothioconazole is complete.

    ii. No neurotoxicity was seen in acute and subchronic neurotoxicity studies and other studies with prothioconazole or prothioconazole-desthio. Although offspring neurotoxicity was found, characterized by peripheral nerve lesions in the developmental neurotoxicity study on prothioconazole-desthio, the increase was seen only in the highest dose group at 105 mg/kg/day. Further, a NOAEL was established for the peripheral nerve lesions and all of the PODs used in the risk assessment were protective of this finding.

    iii. Evidence of quantitative and qualitative susceptibility of offspring were observed in the developmental studies. However, basing the POD on the offspring in the most sensitive of these studies provides the needed protection of offspring.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues for the proposed new uses and existing tolerances on berries, cucurbit vegetables, cottonseed, sugar beet roots, and sunflower subgroup 20B, average field trial residue levels for the remaining uses, and DEEM default and empirical processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to prothioconazole in drinking water. These assessments will not underestimate the exposure and risks posed by prothioconazole.

    E. Aggregate Risks and Determination of Safety

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

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to prothioconazole will occupy 40% of the aPAD for females 13-49 years old, the population group receiving the greatest exposure.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prothioconazole from food and water will utilize 77% of the cPAD for all infants less than 1-year-old the population group receiving the greatest exposure. There are no residential uses for prothioconazole.

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

    Both short- and intermediate-term adverse effects were identified; however, prothioconazole is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for prothioconazole.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, prothioconazole is not expected to pose a cancer risk to humans.

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

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate liquid chromatography with tandem mass spectrometry (LC/MS/MS) methods are available for enforcing prothioconazole tolerances in crop and livestock commodities.

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

    B. International Residue Limits

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

    The Codex has established MRL for prothioconazole in or on rapeseed at 0.1 ppm. The MRL is different than the tolerance established for prothioconazole in the United States. The residues of concern are not harmonized between the U.S. and Codex, since Codex only includes prothioconazole-desthio, whereas the U.S. includes prothioconazole parent as well as prothioconazole-desthio, and harmonization may result in tolerance exceedances from use in accordance with the label.

    C. Response to Comments

    Two comments were submitted in response to the Notice of Filing for tolerance expansion. One comment (Comment A) requested that EPA deny this tolerance petition based on the radioactivity of prothioconazole and its role as a developmental toxicant. The other comment (Comment B) requested that EPA deny this petition based on the persistence of prothioconazole in the digestive system and effects on the liver, kidney, and thyroid.

    In response to Comment A, prothioconazole is not radioactive. In some studies, the prothioconazole is radio-labeled in order to track how the chemical moves through the body of an organism after consumption, but prothioconazole itself is not radioactive. Although evidence of quantitative and qualitative susceptibility of offspring was observed in the developmental studies in rats and rabbits including the developmental neurotoxicity study; points of departure (PODs) are based on the most sensitive endpoints in the fetuses of the rabbit developmental study; therefore, the risk assessment is protective of any developmental effects of this chemical.

    In response to Comment B, the effect of persistence and/or bioaccumulation on the toxicity of a chemical is evaluated in the repeated dose studies. For example, the severity of adverse effects and the relative dose levels at which they occur can be compared in a subchronic study versus a chronic study. In the case of prothioconazole, a comparison of the subchronic (90-day) study in the rat with the chronic (2-year) studies in the rat, using data on both the parent compound and the desthio metabolite, shows there is no basis for concern for potential persistence, because the PODs are not significantly different in the two time-periods. The same is true among the generations in the reproduction and fertility study where the subsequent generations are not shown to be more sensitive to prothioconazole toxicity than the first generation. The rat studies are referred to here because the metabolism studies which would show persistence and/or bioaccumulation were conducted in the rat. If a basis for concern were demonstrated in the toxicity database the PODs, which are based on the most sensitive endpoints, would be protective of this effect. The target organs of prothioconazole and the desthio metabolite include the liver, kidney, bladder, thyroid and blood. The risk assessment uses the most sensitive endpoints to set PODs, so the assessment is protective of all effects to the liver, kidney, and thyroid.

    V. Conclusion

    Therefore, tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and its desthio metabolite, in or on rapeseed subgroup 20A at 0.15 ppm. In addition, EPA is removing the existing tolerance for “rapeseed, seed” as it is superseded by the new tolerance for subgroup 20A.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: October 11, 2018. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.626, a. Remove the entry for “Rapeseed, seed” from the table in paragraph (a)(1). b. Add alphabetically “Rapeseed subgroup 20A” to the table in paragraph (a)(1).

    The addition reads as follows:

    § 180.626 Prothioconazole; tolerances for residues.

    (a) * * *

    (1) * * *

    Commodity Parts per million *    *    *    *    * Rapeseed subgroup 20A 0.15 *    *    *    *    *
    [FR Doc. 2018-22857 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0310; FRL-9979-17] Boscalid; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of boscalid in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0310, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0310 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 18, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0310, by one of the following methods:

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

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

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

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

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E8564) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.589 be amended by establishing tolerances for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) in or on Brassica leafy greens subgroup 4-16B at 50 parts per million; celtuce at 45 ppm; Florence, fennel at 45 ppm; kohlrabi at 6 ppm; leaf petiole vegetable subgroup 22B at 45 ppm; leafy greens subgroup 4-16A at 70 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 2.5 ppm; pea and bean, succulent shelled, subgroup 6B at 0.6 ppm; vegetable, Brassica head and stem group 5-16 at 6 ppm; vegetable, cucurbit group 9 at 3 ppm; and vegetable root, except sugar beet, subgroup 1B at 2.0 ppm. The petition also requested the removal of the established tolerances of boscalid in or on Brassica, head and stem, subgroup 5A at 3.0 ppm, Brassica, leafy greens, subgroup 5B at 18 ppm, cucumber at 0.5 ppm, leaf petioles subgroup 4B at 45 ppm; leafy greens subgroup 4A, except head lettuce and leaf lettuce at 60 ppm, lettuce, head at 6.5 ppm, lettuce, leaf at 11 ppm, pea and bean, dried shelled, except soybean, subgroup 6C, except cowpea, field pea and grain lupin at 2.5 ppm; pea and bean, succulent shelled, subgroup 6B, except cowpea at 0.6 ppm; turnip, greens at 40 ppm, vegetable, cucurbit group 9, except cucumber at 1.6 ppm, and vegetable, root, subgroup 1A, except sugar beet, garden beet, radish and turnip at 1.0 ppm and the removal of the established tolerances for indirect or inadvertent residues of boscalid, in or on beet, garden, roots at 0.1 ppm; cowpea, seed at 0.1 ppm; lupin, grain, grain at 0.1 ppm; pea, field, seed at 0.1 ppm; radish, roots at 0.1 ppm; and turnip, roots at 0.1 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reasons for these changes are explained in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

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

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

    A. Toxicological Profile

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

    In mammals, the target organs are the liver and the thyroid (indirectly from liver adaptive response). In subchronic and chronic feeding studies in rats, mice and dogs, boscalid generally caused decreased body weights (primarily in mice) and effects on the liver (increase in weights, changes in enzyme levels and histopathological changes) as well as on the thyroid (increase in weights and histopathological changes). Mode of action studies conducted in rats indicated that boscalid has a direct effect upon the liver and that the thyroid effects are secondary. A reversibility study in rats indicated that both liver and thyroid parameters returned to control values after the animals were placed on control diet. Absolute and/or relative thyroid weights were elevated in rats and dogs, but there were no histopathological changes observed in the thyroid in either mice or dogs.

    In a developmental toxicity study in rats, no developmental toxicity was observed in the fetuses at the highest dose tested (limit dose). No effects were noted in the dams in this study. In a developmental toxicity study in rabbits, an increased incidence of abortions or early delivery was observed at the limit dose. There was quantitative evidence of increased susceptibility in the two-generation reproduction study in rats, where decreases in body weights in male offspring were seen at a dose that was lower than the dose that induced parental/systemic toxicity. There was quantitative evidence of increased susceptibility in the developmental neurotoxicity study in rats, where decreases in pup body weights on post-natal day four (PND 4) and body weight gains (PND 1-4) were seen in the absence of any maternal toxicity.

    In a 2-year chronic toxicity study and a 2-year carcinogenicity study in male and female rats, the combined data showed an increased trend in thyroid follicular cell adenomas that appeared to be treatment-related in males. This was supported by thyroid hypertrophy and hyperplasia of follicular cells at the same dose as well as increased thyroid weights plus mechanistic data. Despite these findings, the Agency has determined that quantification of the cancer risk is not necessary because (1) the adenomas occurred at dose levels above the level used to establish the chronic population adjusted dose (cPAD); (2) statistically significant increases were only seen for benign tumors (adenomas) and not for malignant ones (carcinomas); (3) the increase in adenomas in females was slight; and (4) there was no evidence of mutagenicity. Furthermore, the mouse carcinogenicity study was negative.

    There was no evidence of neurotoxicity in rats in the acute, subchronic or developmental studies up to the limit dose. No neurotoxic observations were noted in any of the other studies in any species. Similarly, there was no evidence of immunotoxicity in the available immunotoxicity study in rats, or in any of the other studies in the database.

    Specific information on the studies received and the nature of the adverse effects caused by boscalid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 35-40 of the document titled “Boscalid. Human Health Risk Assessment of Tolerance Requests for Brassica, Leafy Greens, Subgroup 4-16B; Celtuce; Florence Fennel; Kohlrabi; Leaf Petiole Vegetable Subgroup 22B; Leafy Greens Subgroup 4-16A; Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C; Pea and Bean, Succulent Shelled, Subgroup 6B; Vegetable, Brassica, Head and Stem, Group 5-16, Vegetable, Cucurbit, Group 9; and Vegetable, Root, Except Sugar Beet, Subgroup 1B; and Associated Registration Requests on Greenhouse-grown Fruiting Vegetables, Cucurbit Vegetables, and Leafy Vegetables” in docket ID number EPA-HQ-OPP-2017-0310.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for boscalid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 8, 2013 (78 FR 67042) (FRL-9401-5).

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to boscalid, EPA considered exposure under the petitioned-for tolerances as well as all existing boscalid tolerances in 40 CFR 180.589. EPA assessed dietary exposures from boscalid in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for boscalid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used food consumption information from the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT).

    iii. Cancer. EPA has concluded that the chronic endpoint will be protective of potential cancer effects. EPA's estimate of chronic exposure as described above is relied upon to evaluate whether any exposure could exceed the chronic population adjusted doses (cPAD) and thus pose a cancer risk.

    iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for boscalid. Tolerance level residues and 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for boscalid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of boscalid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of boscalid for chronic exposures are estimated to be 26.4 ppb for surface water and 697 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 697 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Boscalid is currently registered for the following uses that could result in residential exposures: Golf course turf, residential fruit and nut trees, and residential ornamentals and landscape gardens. EPA assessed residential exposure using the following assumptions:

    All residential exposures are considered short-term in duration. The residential handler assessment included short-term exposures via the dermal and inhalation routes from treating residential ornamentals, landscape gardens, and trees.

    In terms of post-application exposure, there is the potential for dermal post-application exposure for individuals as a result of being in an environment that has been previously treated with boscalid. Short-term dermal exposures were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. Incidental oral exposure to children 1 to 2 years old is not expected from treated turf because boscalid is registered for use only on golf course turf and residential gardens and trees, and the extent to which young children utilize these areas is low.

    The scenarios used in the aggregate assessment were those that resulted in the highest exposures. The highest exposures for all age groups were associated with only residential post-application dermal exposures, not inhalation exposures, and consist of the following:

    • The residential dermal exposure for use in the adult aggregate assessment reflects dermal exposure from post-application activities on treated gardens.

    • The residential dermal exposure for use in the youth (11-16 years old) aggregate assessment reflects dermal exposure from post-application golfing on treated turf.

    • The residential dermal exposure for use in the child (6-11 years old) aggregate assessment reflects dermal exposure from post-application activities in treated gardens.

    Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

    EPA has not found boscalid to share a common mechanism of toxicity with any other substances, and boscalid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that boscalid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility in the rat developmental study as no developmental toxicity was seen at the highest dose tested (limit dose).

    There was evidence of increased qualitative susceptibility in the rabbit developmental study as characterized by an increased incidence of abortions or early delivery at the limit dose. It could not be ascertained if the abortions were the result of a treatment-related effect on the dams, the fetuses or both. It was concluded that the degree of concern is low because the increased abortions or early delivery was seen only at the limit dose and the abortions may have been due to maternal stress.

    There was evidence of increased quantitative susceptibility seen in the rat 2-generation reproduction study and the developmental neurotoxicity study, in that reduced body weights were seen in the offspring at dose levels where no parental toxicity was observed. However, the degree of concern is low because the dose selected for chronic dietary and non-dietary exposure risk assessments is lower than the dose that caused the body weight effects, and the effect was shown to be reversible in the developmental neurotoxicity study.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x for all scenarios except for inhalation exposures where the 10X FQPA SF was retained. That decision is based on the following findings:

    i. The toxicity database is complete, with the exception of a subchronic inhalation study. EPA is retaining a 10X FQPA SF for assessing residential inhalation risks to adult applicators.

    ii. There is no indication that boscalid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

    iii. For the reasons listed in Unit III.D.2., the Agency has concluded that there are no residual uncertainties concerning the potential for prenatal and post-natal toxicity.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to boscalid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by boscalid.

    E. Aggregate Risks and Determination of Safety

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

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

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to boscalid from food and water will utilize 57% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of boscalid is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Boscalid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to boscalid.

    Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 300 for adults, 660 for youths 11 to 16 years old and 300 for children 6 to 11 years old. Because EPA's level of concern for boscalid is a MOE of 100 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

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

    5. Aggregate cancer risk for U.S. population. Based on the data summarized in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects. Given the results of the chronic risk assessment, cancer risk resulting from exposure to boscalid is not of concern.

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

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass spectrometry (GC/MS)) is available to enforce the tolerance expression.

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

    B. International Residue Limits

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

    The Codex has established MRLs for boscalid in or on several of the commodities that are different than the tolerances established for boscalid in the United States, however, the tolerance expression in the U.S. differs from the Codex MRL expression. Also, the submitted residue data support higher tolerance levels than those set by Codex, indicating that harmonization would cause legal application of pyraclostrobin by U.S. users to result in exceedances of domestic tolerances. Therefore, further harmonization of U.S. tolerances with Codex MRLs is not possible at this time.

    C. Revisions to Petitioned-For Tolerances

    The petitioner proposed a tolerance of 50 ppm for the Brassica, leafy greens, subgroup 4-16B, but the Agency is establishing the tolerance at 60 ppm, based on the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. The Agency has also modified some of the tolerances to be consistent with EPA's policy on significant figures.

    V. Conclusion

    Therefore, tolerances are established for residues of boscalid in or on Brassica, leafy greens subgroup 4-16B, except watercress at 60 ppm; celtuce at 45 ppm; Florence fennel at 45 ppm; kohlrabi at 6.0 ppm; leaf petiole vegetable subgroup 22B at 45 ppm; leafy greens subgroup 4-16A at 70 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 2.5 ppm; pea and bean, succulent shelled, subgroup 6B at 0.60 ppm; vegetable, Brassica, head and stem, group 5-16 at 6.0 ppm; vegetable, cucurbit, group 9 at 3.0 ppm; and vegetable, root, except sugar beet, subgroup 1B at 2.0 ppm.

    Additionally, the following existing tolerances and inadvertent tolerances are removed as unnecessary due to the establishment of the new tolerances. Tolerances: Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; cucumber; leaf petioles, subgroup 4B; leafy greens, subgroup 4A, except head lettuce and leaf lettuce; lettuce, head; lettuce, leaf; pea and bean, dried shelled, except soybean, subgroup 6C, except cowpea, field pea, and grain lupin; pea and bean, succulent shelled, subgroup 6B, except cowpea; turnip, greens; vegetable, cucurbit, group 9, except cucumber; vegetable, root, subgroup 1A, except sugar beet, garden beet, radish, and turnip. Inadvertent tolerances: beet, garden, roots; cowpea, seed; lupin, grain, grain; pea field, seed; radish, roots; turnip, roots.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: October 4, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.589: a. In the table to paragraph (a): i. Add in alphanumeric order entries for “Brassica, leafy greens, subgroup 4-16B, except watercress”; “Celtuce”; “Fennel, Florence”; “Kohlrabi”; “Leaf petiole vegetable subgroup 22B”; “Leafy greens subgroup 4-16A”; “Pea and bean, dried shelled, except soybean, subgroup 6C”; “Pea and bean, succulent shelled, subgroup 6B”; “Vegetable, Brassica, head and stem, group 5-16”; “Vegetable, cucurbit, group 9”; and “Vegetable, root, except sugar beet, subgroup 1B”; and ii. Remove the entries “Brassica, head and stem, subgroup 5A”; “Brassica, leafy greens, subgroup 5B”; “Cucumber”; “Leaf petioles, subgroup 4B”; “Leafy greens, subgroup 4A, except head lettuce and leaf lettuce”; “Lettuce, head”; “Lettuce, leaf”; “Pea and bean, dried shelled, except soybean, subgroup 6C, except cowpea, field pea, and grain lupin”; “Pea and bean, succulent shelled, subgroup 6B, except cowpea”; “Turnip, greens”; “Vegetable, cucurbit, group 9, except cucumber”; “Vegetable, root, subgroup 1A, except sugar beet, garden beet, radish, and turnip”. b. Remove from the table in paragraph (d) the entries “Beet, garden, roots”; “Cowpea, seed”; “Lupin, grain, grain”; “Pea field, seed”; “Radish, roots”; and “Turnip, roots”.

    The additions read as follows:

    § 180.589 Boscalid; tolerances for residues.

    (a) * * *

    (1) * * *

    Commodity Parts per million *    *    *    *    * Brassica, leafy greens, subgroup 4-16B, except watercress 60 *    *    *    *    * Celtuce 45 *    *    *    *    * Fennel, Florence 45 *    *    *    *    * Kohlrabi 6.0 Leaf petiole vegetable subgroup 22B 45 Leafy greens subgroup 4-16A 70 *    *    *    *    * Pea and bean, dried shelled, except soybean, subgroup 6C 2.5 Pea and bean, succulent shelled, subgroup 6B 0.60 *    *    *    *    * Vegetable, Brassica, head and stem, group 5-16 6.0 *    *    *    *    * Vegetable, cucurbit, group 9 3.0 *    *    *    *    * Vegetable, root, except sugar beet, subgroup 1B 2.0 *    *    *    *    *
    [FR Doc. 2018-22854 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2013-0098; FRL-9984-70] Tetrahydrofurfuryl Alcohol; Exemption From the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation amends the exemption from the requirement of a tolerance for residues of tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4) when used as an inert ingredient in pesticide formulations to add one herbicide application prior to the preboot stage on buckwheat, oats, rye, sorghum, triticale, rice and wild rice; extend use on canola to the early bolting stage; extend use on soybeans prior to the bloom growth stage; and allow use in herbicides with two applications to field corn and popcorn prior to 36 inches tall (V8 stage). Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of tetrahydrofurfuryl alcohol.

    DATES:

    This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0098, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0098 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 18, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0098, by one of the following methods:

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

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

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

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

    II. Petition for Exemption

    In the Federal Register of February 27, 2013 (78 FR 13295) (FRL-9380-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 2E8080) by Toxcel, LLC, 7140 Heritage Village Plaza, Gainsville, VA 20156 on behalf of Penn A Kem, LLC, 3324 Chelsea Avenue, Memphis, TN 38108. The petition requested amendment of the exemption from the requirement of a tolerance in 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4) when used as an inert ingredient (solvent/cosolvent) to include allowance of one herbicide application prior to the preboot stage to all small cereal grains; extended use on canola to the early bolting stage; and extended use on soybeans up to the bloom growth stage. That document referenced a summary of the petition prepared by Toxcel, LLC, on behalf of Penn A Kem, LLC, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a revised pesticide petition to supersede the previously submitted petition. EPA issued a document in the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of this revised petition. The revised petition requested that 40 CFR 180.1263 be amended to allow one herbicide application prior to the preboot stage for wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice, and wild rice; extend the use on canola to the early bolting stage; extend the use on soybeans up to the bloom growth stage; and allow two herbicide applications to field corn and popcorn up to 36 inches tall (V8 stage). That document referenced a summary of the petition prepared by Toxcel, LLC, on behalf of Penn A Kem, LLC, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    III. Inert Ingredient Definition

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

    IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. In making this safety finding, EPA is required to take into account the considerations set forth in section 408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

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

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

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by tetrahydrofurfuryl alcohol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Hazard Assessment for the Tolerance Reassessment of Tetrahydrofurfuryl alcohol (THFA)(CAS Reg. No. 97-99-4)” at pp 8-12 in docket ID number EPA-HQ-OPP-2013-0098. A summary of the toxicity of tetrahydrofurfuryl alcohol as given in that document follows.

    Acute toxicity information is available for the oral route with an LD50 for the rat of 1.6-3.2 g/kg. Tetrahydrofurfuryl alcohol was not irritating to the skin of mice but was irritating to the eyes of rabbits. Acute dermal and inhalation toxicity, as well as dermal sensitization information, currently are not available. However, there are reports that suggest tetrahydrofurfuryl alcohol may be moderately irritating via the dermal and inhalation routes of exposure to humans.

    Although data on chronic effects is unavailable, subchronic studies indicate that systemic effects from repeated dermal and oral exposure to tetrahydrofurfuryl alcohol include decreased body weight and body weight gain. Tetrahydrofurfuryl alcohol also exhibits adverse reproductive and developmental effects, and potential effects on the endocrine system.

    Males are not only quantitatively more sensitive to the subchronic effects of tetrahydrofurfuryl alcohol than females, but the male reproductive system appears to be a target for tetrahydrofurfuryl alcohol. Consistent decreases in male reproductive organ weights (testicular, epididymal, and seminal vesicle) were observed in rats in the 90-day dietary (LOAEL 339 mg/kg/day), dermal (LOAEL 300 mg/kg/day), and inhalation (LOAEL <0.21 mg/L/day) toxicity studies. In addition, a 90-day oral (dietary) study in dogs revealed decreased testes weights of males in all treated groups (1,000, 3,000, 6,000 ppm, equivalent to approximately 25, 75, and 150 mg/kg/day), compared to controls, with severe testicular atrophy in all males at the highest dose (6,000 ppm or 150 mg/kg/day). Decreased spermatogenic activity was noted in males of the 3,000 ppm group (75 mg/kg/day) and was interpreted as a prodromal sign of atrophy.

    A 28-day repeated oral (gavage) study in rats revealed significant decreases in absolute testes and epididymal weights after 28 days at a dose level of 600 mg/kg/day which continued through the 14-day recovery period. Necrosis of the seminiferous tubular epithelium of the testes was also observed in males of the 150 and 600 mg/kg/day group at 28 days. Necrosis of the testes was also observed in males of the 600 mg/kg/day group at the end of the 14-day recovery period.

    In the reproduction/developmental toxicity screening test in rats, no reproductive parameters were affected except slightly increased gestation length at the high dose of 150 mg/kg/day.

    The endocrine system may also be a target for tetrahydrofurfuryl alcohol. Alterations in pituitary, thymus, adrenal, and thyroid weights have been reported after subchronic exposure (28 days) to 600 mg/kg/day in male rats and pituitary weights at 150 mg/kg/day in female rats. Decreased absolute and relative adrenal weights were observed in males and females receiving 5,000 ppm (equivalent to 339 mg/kg/day males and 401 mg/kg/day females).

    In one developmental toxicity study in rats a quantitative susceptibility based on decreased fetal body weights and a qualitative susceptibility based on increased incidence of filamentous tail was observed. However, in a more recent reproduction/developmental toxicity screening test (OECD 421 guideline study) in rats, an increased incidence of filamentous tail was not evident nor was there any other evidence of increased qualitative susceptibility. Based on the overall weight of evidence for developmental toxicity, it is determined that there is increased quantitative susceptibility but not increased qualitative susceptibility.

    A neurotoxicity study is not available for tetrahydrofurfuryl alcohol, however no neurotoxic effects were observed in the available subchronic oral, dermal and inhalation toxicity studies.

    Mutagenicity studies indicate tetrahydrofurfuryl alcohol is not mutagenic in Salmonella typhimurium or E. coli with or without metabolic activation. Tetrahydrofurfuryl alcohol was also negative for causing structural chromosomal aberrations or polyploidy with or without metabolic activation in cultured Chinese hamster lung cells.

    There are currently no chronic toxicity or cancer studies available for tetrahydrofurfuryl alcohol. The Agency used a qualitative structure activity relationship (SAR) database, DEREK Nexus, to determine if there were structural alerts for potential carcinogenicity for tetrahydrofurfuryl alcohol. No structural alerts for carcinogenicity were identified for tetrahydrofurfuryl alcohol. In the absence of any structural alerts and lack of mutagenicity concerns, tetrahydrofurfuryl alcohol is not expected to be carcinogenic.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A discussion of the toxicological endpoints for tetrahydrofurfuryl alcohol used for human risk assessment can be found at http://www.regulations.gov in the document “Hazard Assessment for the Tolerance Reassessment of Tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4) at pp. 6-8 in docket ID number EPA-HQ-OPP-2013-0098”. A summary of the toxicological dose and endpoints for THFA follows:

    Table 1—Summary of Toxicological Doses and Endpoints for Tetrahydrofurfuryl Alcohol for Use in Human Risk Assessment Exposure/scenario Point of departure and
  • uncertainty/safety factors
  • RfD, PAD, LOC for risk assessment Study and toxicological effects
    Acute dietary (Females 13-50 years of age) NOAEL = [50] mg/kg/day
  • UFA = [10] x
  • UFH = [10]x
  • FQPA SF = [10]x
  • Acute RfD = [0.5] mg/kg/day
  • aPAD = [0.05] mg/kg/day
  • [Developmental rat].
  • LOAEL = [100] mg/kg/day based on [decreased fetal body weight and increased incidence of filamentous tail, complete resorptions at 500 and 1,000 mg/kg/day].
  • Acute dietary (General population including infants and children) None NA No acute effects relevant to the general population were observed in the available studies. Chronic dietary (All populations) NOAEL= [50] mg/kg/day
  • UFA = [10]x
  • UFH = [10]x
  • FQPA SF = [10]x
  • Chronic RfD = [0.5] mg/kg/day
  • cPAD = [0.05] mg/kg/day
  • [Developmental rat].
  • LOAEL = [100] mg/kg/day based on [decreased fetal body weight and increased incidence of filamentous tail, complete resorptions at 500 and 1,000 mg/kg/day].
  • Incidental oral short-term (1 to 30 days) NOAEL= [50] mg/kg/day
  • UFA = [10]x
  • UFH = [10]x
  • FQPA SF = [10]x
  • LOC for MOE = [1,000] [Developmental, rat].
  • LOAEL = [100] mg/kg/day based on [decreased fetal body weight and increased incidence of filamentous tail, complete resorptions at 500 and 1,000 mg/kg/day].
  • Dermal short-term (1 to 30 days) Dermal study NOAEL = [100] mg/kg/day
  • UFA = [10]x
  • UFH = [10]x
  • FQPA SF = [10]x
  • LOC for MOE = [1,000] [90-day dermal, rat].
  • LOAEL = [300 and 1,000] mg/kg/day M/F respectively based on [decreased sperm count and sperm production rate in males, lower body weight/gains in females].
  • Inhalation short-term (1 to 30 days) Inhalation study LOAEL=0.21 mg/l
  • UFA = [10]x
  • UFH = [10]x
  • FQPA SF = [10]x
  • LOC for MOE = [1000] [90-day inhalation, rat].
  • LOAEL = [0.21] mg/L (50 ppm; approx. 60 mg/kg/day) based on. Decreased body weight of males at 150 and 500 ppm. Multiple effects on sperm number, motility, and morphology at interim and terminal necropsy of males at both 150 and 500 ppm].
  • Cancer (Oral, dermal, inhalation) Classification: No structural alerts for carcinogenicity were identified for tetrahydrofurfuryl alcohol using a qualitative structure activity relationship (SAR) database, DEREK Nexus. In the absence of any structural alerts and lack of mutagenicity concerns, tetrahydrofurfuryl alcohol is not expected to be carcinogenic. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
    C. Exposure Assessment

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

    2. Acute and chronic exposure. In conducting the acute and chronic dietary exposure assessments using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.18, EPA used food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA).

    In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper-bound exposure estimates for the subject inert ingredient. Upper-bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides and fungicides. A complete discussion of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyethoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessment for the Inerts” (D361707, S. Piper 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    In the case of tetrahydrofurfuryl alcohol residues resulting from foliar applications, EPA made specific adjustments to the dietary exposure assessments to account for the use limitations of tetrahydrofurfuryl alcohol as well as some residue chemistry data (plant uptake data) submitted with the petition. The use of the dietary estimated exposure model (DEEM) for upper-bound dietary risk assessments as described above was modified to include only those commodities on which pesticide formulations containing tetrahydrofurfuryl alcohol are being used or are proposed to be used. Specifically, the dietary exposure assessment considered foliar uses of tetrahydrofurfuryl alcohol on wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild rice, canola, cotton, field corn, and popcorn as contained in the existing tolerance exemption expression and that are the subject of the present petitions. A residue chemistry study (a radiolabeled plant uptake study with THFA in corn, tomato, and wheat) suggest that the highest reported detectable level of tetrahydrofurfuryl alcohol residues resulting from foliar application in these crops is 0.5 ppm and this value is used in the dietary exposure assessment for the commodities included in the tolerance exemption.

    For seed treatment use, it was conservatively assumed that all of the following commodities (which represent an agglomeration of all commodities for which seed treatment pesticide products are approved for use) could potentially be treated with a seed treatment pesticide containing tetrahydrofurfuryl alcohol: barley, corn (field, pop, sweet and corn for seed production), legume vegetables (dried shelled peas and beans), brassica and bulb vegetables, alfalfa, cucurbits, rye, wheat, cotton, sugar beets, and sunflowers. For seed treatment use, in the absence of THFA-specific data, residue chemistry data for active ingredients with seed treatment uses were utilized. Residue levels for pesticide active ingredients used for seed treatment are all below the limit of detection, so a highly conservative value of 0.05 ppm is used in the dietary exposure assessment as a residue value for THFA for all seed treatment commodities based on application of Agency policies for assigning values to nondetected/nonquantified pesticide residues.

    3. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for tetrahydrofurfuryl alcohol a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

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

    Tetrahydrofurfuryl alcohol is contained in a pesticide currently registered for uses that could result in residential exposures. The use pattern of the product includes application to dogs. EPA assessed this residential exposure using the Agency's Standard Operating Procedures for Residential Pesticide Exposure Assessment Residential Exposure (Residential SOP). Based on the Treated Pets section of the Residential SOP, the following assumptions are made: for residential handlers, exposure (dermal and inhalation) is expected to be short-term only. Residential post-application dermal exposure (short-term only) was assessed for adults and children. Residential post-application inhalation exposure is generally not assessed for pet treatment product uses as such exposure is typically considered to be negligible. Incidental oral post-application exposure was assessed for children 1 to 2 years old. All post-application exposures are expected to be short-term in duration. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. The data available for evaluation suggest there is evidence of increased quantitative susceptibility of the offspring after in utero exposure to tetrahydrofurfuryl alcohol. No reproductive parameters were affected except slightly increased gestation length at the high dose of 150 mg/kg/day in the OECD 421 study in rats. There is also a concern for the effects of tetrahydrofurfuryl alcohol on the developing male reproductive system. Subchronic and reproductive toxicity studies consistently revealed decreased testicular epididymis and seminal vesicle weights as well as atrophy of the epididymis and seminal vesicles and abnormal morphology and motility of sperm. The level at which tetrahydrofurfuryl alcohol may affect the reproductive system during development is currently not known.

    3. Conclusion. EPA has determined that based on evidence of quantitative and qualitative susceptibility the safety of infants and children would be adequately protected if the FQPA SF was retained at 10x for all scenarios. That decision is based on the following findings:

    i. The toxicity database for tetrahydrofurfuryl alcohol consists of a 28-day and 90-day oral toxicity studies in rats, dogs, 90-day dermal toxicity study in rats, 90-day inhalation toxicity study in rats, several mutagenicity studies, developmental/reproductive toxicity screening study in rats, and a developmental toxicity study and reproductive toxicity study in rats.

    ii. Slight atrophy of thymus was seen in high dose animal groups in the 28-day oral toxicity study, which may be indicative of an immune response, however no guideline immunotoxicity study is available.

    iii. Evidence of increased quantitative susceptibility of offspring is seen in the developmental toxicity study.

    iv. Additionally, alterations in the male reproductive system from subchronic exposure to tetrahydrofurfuryl alcohol does indicate a concern for effects to the developing male reproductive system.

    v. The FQPA factor of 10X is considered adequate to account for potential immunotoxicity and uncertainty regarding the developing reproductive system in males because clear NOAELs are established in the available database.

    vi. There are no residual uncertainties identified in the exposure databases. As described earlier, EPA used highly conservative assumptions for the dietary food exposure assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tetrahydrofurfuryl alcohol in drinking water. EPA used similarly conservative assumptions to assess residential exposures of children to tetrahydrofurfuryl alcohol. These assessments will not underestimate the exposure and risks.

    E. Aggregate Risks and Determination of Safety

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

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, EPA has concluded that acute exposure to tetrahydrofurfuryl alcohol from food and water will utilize 8.88% of the aPAD for females 13-49 years old.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tetrahydrofurfuryl alcohol from food and water will utilize 8.5% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of tetrahydrofurfuryl alcohol is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tetrahydrofurfuryl alcohol is contained in a pesticide currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to tetrahydrofurfuryl alcohol.

    Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined chronic food, water, and short-term residential exposures result in aggregate MOEs of 13,100 for adults and 9,800 for children 1-2 years old. Because EPA's level of concern for tetrahydrofurfuryl alcohol is a MOE of 1,000 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    An intermediate-term adverse effect was identified; however, tetrahydrofurfuryl alcohol is not contained in any pesticide products registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for tetrahydrofurfuryl alcohol.

    5. Cancer. Based on the lack of genotoxicity and a DEREK assessment of tetrahydrofurfuryl alcohol that revealed no structural alerts suggestive of carcinogenicity, tetrahydrofurfuryl alcohol is therefore not expected to pose a cancer risk to humans.

    6. Determination of safety. Taking into consideration all available information on tetrahydrofurfuryl alcohol, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to tetrahydrofurfuryl alcohol resulting from the limited uses contained in 40 CFR 180.1263. Therefore, the amendment of the exemption from requirement of a tolerance at 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol when used as an inert ingredient in pesticide formulations to include allowance of one herbicide application prior to the pre-boot stage to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild rice; extended use on canola to the early bolting stage; extended use on soybeans up to the bloom stage; and allowance of two applications to field corn and popcorn up to 36 inches tall (V8 stage) is safe under FFDCA section 408.

    V. Analytical Enforcement Methodology

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

    VI. Conclusion

    Therefore, the exemption from the requirement of a tolerance under 40 CFR 180.1263 is amended to add exemption from the requirement of a tolerance for residues of tetrahydrofurfuryl alcohol (CAS Reg. No. 97-99-4) when used as an inert ingredient (solvent) in herbicides applied to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild rice prior to the pre-boot stage; use on canola to the early bolting stage; use on soybeans up to the bloom stage; and two applications to field corn and popcorn up to 36 inches tall (V8 stage).

    VII. Statutory and Executive Order Reviews

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

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

    This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

    VIII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: October 9, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.1263, revise paragraphs (d) and (e), and add paragraphs (f) and (g) to read as follows:
    § 180.1263 Tetrahydrofurfuryl alcohol; exemption from the requirement of a tolerance.

    (d) For use in herbicides with one application to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice, and wild rice prior to the pre-boot stage.

    (e) For use in herbicides with two applications to field corn and popcorn up to 36 inches tall (V8 stage).

    (f) For use in herbicides with two applications to canola prior to the early bolting stage.

    (g) For use in herbicides with two applications to soybeans prior to the bloom growth stage.

    [FR Doc. 2018-22862 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    83 203 Friday, October 19, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Parts 905 and 944 [Doc. AMS-SC-18-0046; SC18-905-3 PR] Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida and Imported Grapefruit; Change in Grade and Size Requirements AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule invites comments on a recommendation from the Citrus Administrative Committee (Committee) to relax the minimum grade requirements for oranges and tangerines, remove grade and size requirements for Ambersweet and Temple oranges, and simplify the tables outlining the grade and size requirements for interstate and export shipments currently prescribed under the marketing order for oranges, grapefruit, tangerines, and pummelos grown in Florida. A corresponding change would be made to the grapefruit import regulation as required by section 8e of the Agricultural Marketing Agreement Act of 1937.

    DATES:

    Comments must be received by November 19, 2018.

    ADDRESSES:

    Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

    FOR FURTHER INFORMATION CONTACT:

    Abigail Campos, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

    Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This action, pursuant to 5 U.S.C. 553, proposes amendments to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 905, as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida. Part 905 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of citrus operating within the area of production, and a public member.

    This rule is also issued under section 8e of the Act, which provides that whenever certain specified commodities, including grapefruit, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically produced commodities.

    The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

    The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

    There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 8e of the Act.

    This proposed rule invites comments on changes to the grade and size requirements under the Order. This proposal would relax the minimum grade requirements for oranges and Fall-glo, Sunburst, and Honey tangerines from U.S. No. 1 to U.S. No. 2. This action would also remove grade and size requirements for Ambersweet and Temple oranges and simplify the tables outlining the grade and size requirements for interstate and export shipments. These actions would maximize shipments by allowing more citrus to be shipped to the fresh market and would help increase returns to growers and handlers. These changes were unanimously recommended by the Committee on April 26, 2018.

    Section 905.52 provides authority to establish minimum grade requirements for Florida citrus. Section 905.306 specifies, in part, the minimum grade requirements for citrus. Requirements for domestic shipments are specified in § 905.306 in Table I of paragraph (a) and for export shipments in Table II of paragraph (b). Minimum grade and size requirements for grapefruit imported into the United States are currently in effect pursuant to § 944.106.

    The Committee met on April 26, 2018, and discussed ways to provide additional supplies of Florida citrus to the marketplace and increase grower and handler returns. Committee members recognized that with the ongoing impacts of citrus greening, some adjustments should be made to assist growers and handlers and provide for the utilization of additional volume of Florida citrus in the fresh market.

    Citrus greening has caused the steady decline in Florida citrus production and has spread to all citrus producing counties in Florida. From the 2011-12 to the 2016-17 season, citrus greening has reduced Florida's orange production by 53 percent and tangerine production by 67 percent. During the same period, fresh shipments have declined by 54 percent for oranges and 80 percent for tangerines.

    The industry suffered additional production losses as a result of damage from Hurricane Irma in September 2017. According to USDA`s National Agricultural Statistics Service (NASS), production for the 2016-17 season totaled 68.8 million boxes for oranges and 1.6 million boxes for tangerines. For the 2017-18 season, the forecasted production is expected to decrease by 34 percent for oranges and 53 percent for tangerines. Also, the citrus trees may take several seasons to recover from the hurricane damage, further impacting production and supply.

    Given the decrease in production, the Committee recommended relaxing the minimum grade requirements for oranges and Fallglo, Sunburst, and Honey tangerines from U.S. No. 1 to U.S. No. 2. During the discussion of this change, one Committee member stated the reduction in grade could help address the limited volumes of fruit available in the market. It was also stated that there was a good fresh juice market for the U.S. No. 2 orange and that this change could help promote the sale of more oranges for the fresh juice market.

    For tangerines, it was stated that the very limited volume of tangerines being produced in Florida was causing a supply concern for shippers. Members agreed that lowering the grade for tangerines would promote increased shipments.

    The Committee believes relaxing the grade from U.S. No. 1 to U.S. No. 2 for oranges and Fallglo, Sunburst, and Honey tangerines would allow growers and handlers to utilize a greater percentage of the crop and would make more fruit available for shipment. By implementing this change, the industry would be able to put an additional 300,000 cartons or more into the fresh market, helping to maximize shipments and to increase grower and handler returns.

    The Committee also discussed the limited production of Ambersweet and Temple oranges (also known as Royal tangerines). In the past, the Committee has considered removing the grade and size requirements for varieties with limited commercial value due to the very limited supplies available for shipment. Last season, Ambersweet oranges accounted for 4,280 cartons and Temple oranges accounted for a total of 40,227 cartons sold. Given the decline in production, the Committee recommended removing restrictions on grade and size for Ambersweet and Temple oranges to maximize remaining shipments.

    The Committee also recommended simplifying Table I and Table II in § 905.306, which outline the grade and size requirements for interstate and export shipments, to have them better reflect current industry requirements. Over the past few years, the Committee has made ongoing changes to both grade and size for a number of Florida citrus varieties. These changes have moved grade and size requirements toward greater commonality for both oranges and grapefruit.

    With the grade change considered above, there would be no differences in grade and size requirements for the various types and varieties of oranges listed in the table. Therefore, the Committee recommended that “Early and midseason” oranges be consolidated with “Navel” and “Valencia and other late type” oranges into one “Oranges” classification. For grapefruit, the grade and size requirements for the two listed categories are already the same. “Seedless, red” and “Seedless, except red” would be combined into one “Grapefruit, seedless” classification.

    In addition, the Committee recommended removing the “Regulation Period” column from the two tables. With the exception of the dates listed in Table I for Valencia and other late type oranges, the various dates listed are no longer applicable and are not reflective of the current industry. The grade change proposed for oranges would also negate the need for the current dates listed for Valencia and other late type oranges. The Committee made these recommendations to simplify the tables to reflect changes in the industry.

    Section 8e of the Act provides that when certain domestically produced commodities, including grapefruit, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements. Because this proposed rule would combine “Seedless, red” and “Seedless, except red” into one classification for grapefruit in the two domestic handling regulation tables as well as remove the “Regulation Period” column from those tables, a corresponding change to the table in the grapefruit import regulations would be required.

    Further, two minor administrative changes would be made to § 944.106. In § 944.106(c), the reference to “§ 905.306” would be revised to read “§ 905.306(a) through (d)” so that the requirements specifically applicable to imports are more clearly defined. Additionally, § 944.106(d) would be updated to reflect the revised name of the Agricultural Marketing Service (AMS) program area that oversees federal marketing orders.

    The Committee also recommended establishing new reporting requirements under the Order. That change is being considered under a separate rulemaking action.

    Initial Regulatory Flexibility Analysis

    Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

    The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

    There are approximately 20 handlers of Florida citrus who are subject to regulation under the Order and approximately 500 citrus producers in the regulated area. There are approximately 50 citrus importers. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).

    According to data from NASS, the industry, and the Committee, the weighted average f.o.b. price for Florida citrus for the 2016-17 season was approximately $15.20 per carton with total shipments of 12.6 million cartons. Using the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of more than $7,500,000 ($15.20 times 12.6 million equals $191,520,000 divided by 20 handlers equals $9,576,000 per handler).

    In addition, based on the NASS data, the weighted average grower price for the 2016-17 season was around $8.30 per carton of citrus. Based on grower price, shipment data, and the total number of Florida citrus growers, and assuming a normal distribution, the average annual grower revenue is below $750,000 ($8.30 times 12.6 million cartons equals $104,580,000 divided by 500 growers equals $209,160 per grower).

    South Africa, Peru, and Mexico are the major grapefruit-producing countries exporting grapefruit to the United States. In 2016, shipments of grapefruit imported into the United States totaled approximately 24,000 metric tons. Information from USDA's Foreign Agricultural Service indicates that the dollar value of imported fresh grapefruit was approximately $11.2 million in 2016. Using this value and the number of importers (approximately 50), most importers would have annual receipts of less than $7,500,000 for grapefruit.

    Based on the previously described estimates, the majority of handlers of Florida citrus may be classified as large entities, while the majority of growers and importers may be classified as small entities.

    This proposed rule would relax the minimum grade requirements for oranges and tangerines from U.S. No. 1 to U.S. No. 2, remove grade and size requirements for Ambersweet and Temple oranges, and simplify the tables outlining the grade and size requirements for interstate and export shipments. These changes would help maximize shipments by allowing more citrus to be shipped to the fresh market and would provide some additional fruit to address the losses resulting from citrus greening and the September 2017 hurricane. This proposed rule would revise § 905.306. Authority for this change is provided in § 905.52. This proposed rule would also change § 944.106 in the grapefruit import regulation and is required by section 8e of the Act.

    This action is not expected to increase the costs associated with the Order's requirements or the grapefruit import regulation. Rather, it is anticipated that this action would have a beneficial impact. Reducing the grade requirements would make additional fruit available for shipment to the fresh market, provide an outlet for fruit that may otherwise go unharvested, and afford more opportunity to meet consumer demand. These changes would provide additional fruit to fill the shortage caused by citrus greening and by Hurricane Irma. By maximizing shipments, this action would help provide additional returns to growers and handlers. Further, removing the grade and size requirements for Ambersweet and Temple oranges would also help maximize shipments of these varieties impacted by declining production.

    The benefits of this rule would also be equally available to all growers, handlers, and importers, regardless of their size.

    An alternative to this action would be to maintain the current minimum grade requirements for domestic shipments of oranges and tangerines. However, leaving the requirements unchanged would not make additional fruit available for shipment. Following the significant damage experienced by the industry from citrus greening and the September 2017 hurricane, maximizing shipments would help provide additional returns to growers and handlers. Therefore, this alternative was rejected.

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

    This proposed rule will not impose any additional reporting or recordkeeping requirements on either small or large Florida citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

    In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

    The Committee's meeting was widely publicized throughout the citrus industry, and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the April 26, 2018, meeting was a public meeting, and all entities, both large and small, were able to express their views on this issue. Interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.

    A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

    In accordance with section 8e of the Act, the United States Trade Representative has concurred with the issuance of this proposed rule.

    A 30-day comment period is provided to allow interested persons to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.

    List of Subjects 7 CFR Part 905

    Grapefruit, Marketing agreements, Oranges, Pummelos, Reporting and recordkeeping requirements, Tangelos, Tangerines.

    7 CFR Part 944

    Avocados, Food grades and standards, Grapefruit, Grapes, Imports, Kiwifruit, Limes, Olives, Oranges.

    For the reasons set forth in the preamble, parts 905 and 944 are proposed to be amended as follows:

    PART 905—ORANGES, GRAPEFRUIT, TANGERINES, AND PUMMELOS GROWN IN FLORIDA 1. The authority citation for part 905 and part 944 continues to read as follows: Authority:

    7 U.S.C. 601-674.

    2. Amend § 905.306 by a. Revising paragraph (a), Table I to paragraph (a), paragraph (b), and Table II to paragraph (b); and b. Redesignating Table III as Table III to paragraph (e) and in paragraph (e)(1) adding the words “to paragraph (e)” after “Table III.”:
    § 905.306 Orange, Grapefruit, Tangerine and Tangelo Regulation.

    (a) No handler shall ship between the production area and any point outside thereof, in the 48 contiguous States and the District of Columbia of the United States, any variety of fruit listed in column (1) of Table I to paragraph (a), except for Ambersweet and Temple, unless such variety meets the applicable minimum grade and size (with tolerances for size as specified in paragraph (c) of this section) specified for such variety in columns (2) and (3) of Table I to paragraph (a): Provided, That all grapefruit meet the minimum maturity requirements specified in paragraph (e) of this section.

    Table I to Paragraph (a) Variety Minimum
  • grade
  • Minimum
  • diameter
  • (inches)
  • (1) (2) (3) Oranges U.S. No. 2 2-4/16 Grapefruit, Seedless U.S. No. 1 3 Tangerines: Fallglo U.S. No. 2 2-6/16 Honey U.S. No. 2 2-6/16 Sunburst U.S. No. 2 2-6/16 Tangelos U.S. No. 1 2-8/16

    (b) No handler shall ship to any destination outside the 48 contiguous States and the District of Columbia of the United States any variety of fruit listed in column (1) of Table II to paragraph (b), except for Ambersweet and Temple, unless such variety meets the applicable minimum grade and size (with tolerances for size as specified in paragraph (c) of this section) specified for such variety in columns (2) and (3) of Table II to paragraph (b): Provided, That all grapefruit meet the minimum maturity requirements specified in paragraph (e) of this section.

    Table II to Paragraph (b) Variety Minimum
  • grade
  • Minimum
  • diameter
  • (inches)
  • (1) (2) (3) Oranges U.S. No. 2 2-4/16 Grapefruit, Seedless U.S. No. 1 3 Tangerines: Fallglo U.S. No. 2 2-6/16 Honey U.S. No. 2 2-6/16 Sunburst U.S. No. 2 2-6/16 Tangelos U.S. No. 1 2-8/16
    PART 944—FRUITS; IMPORT REGULATIONS 3. In § 944.106 a. Revise the table in paragraph (a) and designate it as Table 1 to § 944.106; b. Revise paragraph (c) and the first sentence in paragraph (d).

    The revisions to read as follows:

    § 944.106 Grapefruit import regulation.

    (a) * * *

    Table 1 to § 944.106 Grapefruit classification Minimum
  • grade
  • Minimum
  • diameter
  • (inches)
  • (1) (2) (3) Grapefruit, seedless U.S. No. 1 3

    (c) Terms and tolerances pertaining to grade and size requirements, which are defined in the United States Standards for Grades of Florida Grapefruit (7 CFR 51.750-51.784), and in Marketing Order No. 905 (7 CFR 905.18 and 905.306(a) through (d)), shall be applicable herein.

    (d) The Federal or Federal-State Inspection Service, Specialty Crops Program, Agricultural Marketing Service, United States Department of Agriculture, is designated as the governmental inspection service for certifying the grade, size, quality, and maturity of grapefruit imported into the United States. * * *

    Dated: October 15, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
    [FR Doc. 2018-22758 Filed 10-18-18; 8:45 am] BILLING CODE 3410-02-P
    SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 240 [Release No. 34-84409; File No. S7-08-12] RIN 3235-AL12 Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-Dealers AGENCY:

    Securities and Exchange Commission.

    ACTION:

    Proposed rule; reopening of comment period; request for additional comment.

    SUMMARY:

    The Securities and Exchange Commission (“Commission”) is reopening the comment period and requesting additional comment (including potential modifications to proposed rule language) on the following: Proposed amendments and new rules that would establish capital and margin requirements for security-based swap dealers (“SBSDs”) and major security-based swap participants (“MSBSPs”) that do not have a prudential regulator, establish segregation requirements for SBSDs, establish notification requirements for SBSDs and MSBSPs relating to segregation, and raise minimum net capital requirements and establish liquidity requirements for broker-dealers permitted to use internal models when computing net capital (“ANC broker-dealers”). The Commission also is reopening the comment period and requesting additional comment on proposed amendments that would establish the cross-border treatment of security-based swap capital, margin, and segregation requirements; and a proposed amendment that would establish an additional capital requirement for SBSDs that do not have a prudential regulator.

    DATES:

    The comment periods for portions of the proposed rules published Nov. 23, 2012 (77 FR 70213); May 23, 2013 (78 FR 30967); and May 2, 2014 (79 FR 25193), are reopened. Comments should be submitted by November 19, 2018.

    ADDRESSES:

    Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/other.shtml); or

    • Send an email to [email protected] Please include File No. S7-08-12 on the subject line.

    Paper Comments

    • Send paper comments to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number S7-08-12. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method of submission. The Commission will post all comments on the Commission's website (http://www.sec.gov). Comments are also available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make publicly available.

    Studies, memoranda, or other substantive items may be added by the Commission or staff to the comment file during this rulemaking. A notification of the inclusion in the comment file of any such materials will be made available on the Commission's website. To ensure direct electronic receipt of such notifications, sign up through the “Stay Connected” option at www.sec.gov to receive notifications by email.

    FOR FURTHER INFORMATION CONTACT:

    Michael A. Macchiaroli, Associate Director, at (202) 551-5525; Thomas K. McGowan, Associate Director, at (202) 551-5521; Randall W. Roy, Deputy Associate Director, at (202) 551-5522; Sheila Dombal Swartz, Senior Special Counsel, at (202) 551-5545; Timothy C. Fox, Branch Chief, at (202) 551-5687; Valentina Minak Deng, Special Counsel, at (202) 551-5778; or Nina Kostyukovsky, Attorney Advisor, at (202) 551-8833, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In October 2012, the Commission proposed amendments and new rules to: (1) Establish capital and margin requirements for SBSDs and MSBSPs that do not have a prudential regulator 1 (“nonbank SBSDs” and “nonbank MSBSPs”, respectively); (2) establish segregation requirements for SBSDs; (3) establish notification requirements for SBSDs and MSBSPs relating to segregation; and (4) raise minimum net capital requirements and establish liquidity requirements for ANC broker-dealers.2 The Commission published the 2012 Proposals largely pursuant to Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Title VII of the Dodd-Frank Act”). The Commission extended the comment period once,3 and reopened it once.4 The Commission has received a number of comment letters in response to the 2012 Proposals. 5

    1 The term “prudential regulator” is defined in Section 1(a)(39) of the Commodity Exchange Act (7 U.S.C. 1(a)(39)) and that definition is incorporated by reference in Section 3(a)(74) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”). 15 U.S.C. 78c(a)(74). Pursuant to the definition, the Board of Governors of the Federal Reserve System (“FRB”), the Office of the Comptroller of the Currency (“OCC”), the Federal Deposit Insurance Corporation (“FDIC”), the Farm Credit Administration (“FCA”), or the Federal Housing Finance Agency (“FHFA”) (collectively, the “prudential regulators”) is the “prudential regulator” of an SBSD, MSBSP, swap participant, or major swap participant if the entity is directly supervised by that agency.

    2See Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-Dealers, Exchange Act Release No. 68071 (Oct. 18, 2012), 77 FR 70214 (Nov. 23, 2012) (“2012 Proposals”).

    3See Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-Dealers, Exchange Act Release No. 68660 (Jan. 15. 2013), 78 FR 4365 (Jan. 22, 2013).

    4See Reopening of Comment Periods for Certain Rulemaking Releases and Policy Statement Applicable to Security-Based Swaps Proposed Pursuant to the Securities Exchange Act of 1934 and the Dodd-Frank Wall Street Reform and Consumer Protection Act, Exchange Act Release No. 69491 (May 1, 2013), 78 FR 30800 (May 23, 2013).

    5 The comment letters are available at http://www.sec.gov/comments/s7-08-12/s70812.shtml.

    In addition, in May 2013, the Commission proposed provisions to establish the cross-border treatment of security-based swap capital, margin, and segregation requirements.6 The Commission has received a number of comment letters in response to the 2013 Proposals. 7

    6See Cross-Border Security-Based Swap Activities; Re-Proposal of Regulation SBSR and Certain Rules and Forms Relating to the Registration of Security-Based Swap Dealers and Major Security-Based Swap Participants, Exchange Act Release No. 69490 (May 1, 2013), 78 FR 30968 (May 23, 2013) (“2013 Proposals”).

    7 The comment letters are available at http://www.sec.gov/comments/s7-02-13/s70213.shtml.

    Finally, in April 2014, the Commission proposed an additional nonbank SBSD capital requirement.8 The Commission has received one comment letter in response to the 2014 Proposal. 9

    8See Recordkeeping and Reporting Requirements for Security-Based Swap Dealers, Major Security-Based Swap Participants, and Broker-Dealers; Capital Rule for Certain Security-Based Swap Dealers, Exchange Act Release No. 71958 (Apr. 17, 2014), 79 FR 25194, 25254 (May 2, 2014) (the “2014 Proposal” and together with the 2012 Proposals and the 2013 Proposals, the “Proposals”).

    9 The comment letter is available at: https://www.sec.gov/comments/s7-05-14/s70514.shtml.

    In the releases publishing the Proposals, the Commission described the statutory and regulatory background for the proposed amendments and rules, the rationales for each of the proposed amendments and rules, the potential economic consequences, including the baseline against which the proposed amendments and rules may be evaluated, the potential costs and benefits, reasonable alternatives, and the potential effects on efficiency, competition, and capital formation.10

    10See Proposals.

    Since publication of the 2012 Proposals, the Commission has adopted other rules relating to the regulation of the over-the-counter derivatives markets pursuant to Title VII of the Dodd-Frank Act.11 In addition, the prudential regulators and the Commodity Futures Trading Commission (“CFTC”) have adopted or proposed rules under Title VII of the Dodd-Frank Act that are relevant to the Proposals. 12

    11See Clearing Agency Standards, Exchange Act Release No. 68080 (Oct. 22, 2012), 77 FR 66220 (Nov. 11, 2012); Application of “Security-Based Swap Dealer” and “Major Security-Based Swap Participant” Definitions to Cross-Border Security-Based Swap Activities, Exchange Act Release No. 72472 (June 25, 2014), 79 FR 47278 (Aug. 12, 2014); Regulation SBSR—Reporting and Dissemination of Security-Based Swap Information, Exchange Act Release No. 74244 (Feb. 11, 2015), 80 FR 14563 (Mar. 19, 2015); Security-Based Swap Data Repository Registration, Duties, and Core Principles, Exchange Act Release No. 74246 (Feb. 11, 2015), 80 FR 14437 (Mar. 19, 2015); Registration Process for Security-Based Swap Dealers and Major Security-Based Swap Participants, Exchange Act Release No. 75611 (Aug. 5, 2015), 80 FR 48963 (Aug. 14, 2015); Security-Based Swap Transactions Connected with a Non-U.S. Person's Dealing Activity That Are Arranged, Negotiated, or Executed By Personnel Located in a U.S. Branch or Office or in a U.S. Branch or Office of an Agent; Security-Based Swap Dealer De Minimis Exception, Exchange Act Release No. 77104 (Feb. 10, 2016), 81 FR 8597 (Feb. 19, 2016); Business Conduct Standards for Security-Based Swap Dealers and Major Security-Based Swap Participants, Exchange Act Release No. 77617 (Apr. 14, 2016), 81 FR 29960 (May 13, 2016); Trade Acknowledgment and Verification of Security-Based Swap Transactions, Exchange Act Release No. 78011 (June 8, 2016), 81 FR 39808 (June 17, 2016); Regulation SBSR—Reporting and Dissemination of Security-Based Swap Information, Exchange Act Release No. 78321 (July 14, 2016), 81 FR 53545 (Aug. 12, 2016); Access to Data Obtained by Security-Based Swap Data Repositories, Exchange Act Release No. 78716 (Aug. 29, 2016), 81 FR 60585 (Sept. 2, 2016).

    12See FRB, OCC, FDIC, FCA, FHFA, Margin and Capital Requirements for Covered Swap Entities, 80 FR 74840 (Nov. 30, 2015) (adopting capital and margin requirements for bank swap dealers, bank SBSDs, bank swap participants, and bank MSBSPs); CFTC, Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants, 81 FR 636 (Jan. 6, 2016) (adopting margin requirements for nonbank swap dealers and nonbank major swap participants); CFTC, Capital Requirements of Swap Dealers and Major Swap Participants, 81 FR 91252 (Dec. 16, 2016) (proposing capital requirements for nonbank swap dealers and nonbank major swap participants).

    The Commission has carefully considered the comment letters, and the Commission believes it is prudent to reopen the comment period for the Proposals in light of these comments and regulatory developments. In addition, the Commission believes the public should have the opportunity to provide comment on the potential economic effects of the Proposals in light of regulatory and market developments since they were published. Accordingly, the Commission is reopening the public comment period for 30 days and seeking comment on all aspects of the Proposals. The Commission also is seeking specific comment on certain aspects of the Proposals where further information would be particularly helpful to the Commission. In particular, the Commission is seeking comment on potential rule language that would modify rule text that was in the Proposals. This modified rule language would be included in: (1) Existing rules 17 CFR 240.15c3-1 (“Rule 15c3-1”), 17 CFR 240.15c3-1a (“Appendix A to Rule 15c3-1”), 17 CFR 240.15c3-3 (“Rule 15c3-3”), and 17 CFR 240.3a71-6 (“Rule 3a71-6”); (2) new rule 17 CFR 240.15c3-3b (“Exhibit B to Rule 15c3-3”); and (3) in proposed rules 17 CFR 240.18a-1 (“Rule 18a-1”), 17 CFR 240.18a-1a (“Appendix A to Rule 18a-1”), 17 CFR 240.18a-3 (“Rule 18a-3”), 17 CFR 240.18a-4 (“Rule 18a-4”), and 17 CFR 240.18a-4a (“Exhibit A to Rule 18a-4”). Comment letters received by the Commission previously need not be re-submitted as they will continue to be a part of the public comment file for this rulemaking and considered by the Commission.

    II. Request for Comment

    The Commission renews its request for comment on all aspects of the Proposals and on the specific topics identified below. Commenters are requested to provide empirical data in support of any arguments and analyses. The Commission notes that comments are of the greatest assistance to rulemaking initiatives when accompanied by supporting data and analysis, and, if appropriate, accompanied by alternative approaches and suggested language.

    Capital

    1. The 2012 Proposals included a provision that would establish a financial ratio-derived minimum net capital requirement for a nonbank SBSD equal to eight percent (8%) of the firm's risk margin amount. 13 The risk margin amount would be the sum of:

    13See 2012 Proposals, 77 FR at 70223-24. Minimum net capital requirements would be the greater of a fixed-dollar amount and an amount derived by applying a financial ratio. See id. at 70221.

    • The greater of the total margin required to be delivered by the nonbank SBSD with respect to security-based swap transactions cleared for security-based swap customers at a clearing agency or the amount of the deductions (haircuts) that would apply to the cleared security-based swap positions of the security-based swap customers pursuant to the proposed capital requirements; and

    • The total margin amount calculated by the nonbank SBSD with respect to non-cleared security-based swaps pursuant to the proposed margin rule.14

    14 The ratio-based minimum net capital calculation shown as an equation would be: MRNC = [max(IMC, HCC) + IMNC] × 8%. Where MRNC is the ratio-based minimum net capital requirement, IMC is the amount of initial margin for cleared security-based swaps, HCC is the amount of haircuts applied to the same cleared security-based swaps, IMNC is the amount of initial margin calculated for non-cleared security-based swaps, and (max(IMC, HCC) + IMNC) is the risk margin amount. For example, assume that IMC is $10, HCC is $15, and IMNC is $25. In this simple hypothetical example, the risk margin amount would equal $40 [max($10, $15) + $25], and the ratio-based minimum net capital requirement would be $3.20 ($40 × 8%). As proposed, a stand-alone nonbank SBSD would be subject to this ratio-based minimum net capital requirement, whereas a nonbank SBSD dually registered as a broker-dealer would be subject to the sum of this ratio-based minimum net capital requirement plus one of the two existing financial ratio-based minimum net capital requirements in Rule 15c3-1.

    The total of these two amounts would be multiplied by eight percent (8%) to determine the dollar amount of this ratio requirement (and the nonbank SBSD's minimum net capital requirement would be the greater of a fixed-dollar amount and a ratio amount). The proposal for a ratio amount relating to security-based swaps was designed to establish a minimum net capital requirement that increases in tandem with an increase in the risks associated with a nonbank SBSD's security-based swap activities. This scaled ratio amount is separate from the fixed-dollar amount that sets a floor to the minimum net capital requirement.15

    15See id. at 70223-24.

    a. The Commission requests comment and supporting data on the potential minimum net capital amounts that would be required of nonbank SBSDs as a result of the requirement, as proposed. How would those potential minimum net capital amounts compare with the amounts of capital currently maintained by entities that may register as nonbank SBSDs?

    b. One commenter suggested that the Commission modify its proposed definition of the risk margin amount to reflect the lower risk associated with central clearing.16 In light of the comment and the goals of this provision, the Commission requests comment on whether the input to the risk margin amount for cleared security-based swaps should be modified. Should the input to the risk margin amount for cleared security-based swaps be determined solely by the total initial margin required to be delivered by the nonbank SBSD with respect to security-based swap transactions cleared for security-based swap customers at a clearing agency (i.e., not be the greater of that amount or the amount of the deductions (haircuts) that would apply to the cleared security-based swap positions)? 17 The purpose of this potential modification would be to simplify the calculation, align it with the clearing agency margin requirements, and more closely align it with the CFTC's existing rules and proposals.18

    16See Letter from Stuart J. Kaswell, Executive Vice President, Managing Director, and General Counsel, Managed Funds Association (Feb. 22, 2013).

    17 The ratio-based minimum net capital calculation shown as an equation would be: MRNC = (IMC + IMNC) × 8%.

    18 Eliminating the haircut input to the risk margin amount for cleared security-based swaps would more closely align it with the CFTC's existing rules and proposals. For example, currently futures commission merchants (“FCMs”) registered with the CFTC must maintain adjusted net capital in excess of eight percent (8%) of the risk margin on futures, foreign futures, and cleared swaps positions carried in customer and noncustomer accounts. See 17 CFR 1.17. The CFTC has proposed a similar requirement for swap dealers registered as FCMs that also would generally include in the FCM's minimum net capital requirement eight percent (8%) of the total initial margin an FCM is required to post to a clearing agency for cleared security-based swap positions (as well as the initial margin on uncleared swap and security-based swap positions for which the FCM is a counterparty). See Capital Requirements of Swap Dealers and Major Swap Participants, 81 FR at 91266.

    Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing the commenter's concern described above? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (c)(17) of Rule 15c3-1 would provide that the term risk margin amount means the sum of: (i) The total initial margin required to be maintained by the broker or dealer at each clearing agency with respect to security-based swap transactions cleared for security-based swap customers; and (ii) the total margin amount calculated by the broker or dealer with respect to non-cleared security-based swaps pursuant to § 240.18a-3(c)(1)(i)(B).

    Similarly, the potential modifications to paragraph (c)(6) of Rule 18a-1 would provide that the term risk margin amount means the sum of: (i) The total initial margin required to be maintained by the security-based swap dealer at each clearing agency with respect to security-based swap transactions cleared for security-based swap customers; and (ii) the total margin amount calculated by the security-based swap dealer with respect to non-cleared security-based swaps pursuant to § 240.18a-3(c)(1)(i)(B).

    2. The 2012 Proposals included a capital charge that would apply if a nonbank SBSD collects an amount of margin from a counterparty to a cleared security-based swap that is less than the deduction that would apply to the security-based swap if it was a proprietary position of the firm.19 This proposed requirement was designed to account for the risk of the counterparty defaulting by requiring the nonbank SBSD to maintain capital in the place of margin in an amount that is no less than would be required for a proprietary position.20 It also was designed to ensure that there is a standard minimum coverage for exposure to cleared security-based swap counterparties apart from the individual clearing agency margin requirements, which could vary among clearing agencies and over time.21

    19See 2012 Proposals, 77 FR at 70245-46.

    20See id. at 70246.

    21See id.

    One commenter opposed this proposal stating that the requirement would “harm customers because it would provide an incentive for the collection of margin by nonbank SBSDs beyond the amount determined by the clearing agency.” 22 In light of the comment and the goals of this provision, the Commission requests comment on whether this proposed capital charge should be modified to include a risk-based threshold under which the proposed capital charge need not be taken. Should the rule provide that the deduction need not be taken if the difference between the clearing agency margin amount and the haircut is less than one percent (1%) or some other percent of the nonbank SBSD's tentative net capital 23 and less than ten percent (10%) or some other percent of the counterparty's net worth,24 and the aggregate difference across all counterparties is less than twenty-five percent (25%) or some other percent of the nonbank SBSD's tentative net capital? 25 The purpose of these thresholds would be to limit the nonbank SBSD's exposure to a single counterparty as well as to establish a concentration limit across all counterparties. In addition, these thresholds would be scalable and have a more direct relation to the risk to the nonbank SBSD arising from its security-based swap activities.

    22See Letter from Kenneth E. Bentsen, Jr., Executive Vice President, Securities Industry and Financial Markets Association (Feb. 22, 2013) (“SIFMA 2/22/2013 Letter”).

    23See, e.g., Order Granting Conditional Exemption Under the Securities Exchange Act of 1934 in Connection with Portfolio Margining of Swaps and Security-Based Swaps, Exchange Act Release No. 68433 (Dec. 14, 2012), 77 FR 75211 (Dec. 19, 2012). Pursuant to this order, Commission staff granted conditional temporary approval to certain broker-dealers that are also registered as FCMs to participate in a credit default swap (CDS) portfolio margining program, subject to specified conditions. One condition requires a firm to calculate its net credit exposure to a client and if the client's net credit exposure is in excess of one percent (1%) of the firm's tentative net capital, the firm is required to either collect the net credit exposure above the one percent (1%) threshold in the form of margin from its client or take a capital charge equal to that amount. See, e.g., Letter to Keith Bailey, Barclays Capital Inc. from Michael A. Macchiaroli, Division of Trading and Markets, Commission (June 7, 2013).

    24See, e.g., 17 CFR 240.15c3-1(c)(2)(vi)(M)(1) (using a ten percent (10%) of tentative net capital threshold for the calculation of undue concentration charges).

    25See, e.g., 17 CFR 240.15c3-3a, Note E(5) (using a twenty-five percent (25%) of tentative net capital threshold for when a broker-dealer must reduce debits in the customer reserve formula).

    Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing the commenter's concern described above? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (c)(2)(xv)(A) of Rule 15c3-1 would provide the following deduction from net worth in lieu of collecting collateral for cleared security-based swaps and swap transactions: (1) Deducting the amount of the margin difference for each account carried by the broker or dealer for another person that holds cleared security-based swap or swap transactions. The margin difference is the amount of the deductions to the positions in the account calculated pursuant to paragraph (c)(2)(vi) of this section, § 240.15c3-1b, or § 240.15c3-1e (as applicable), less the margin value of collateral held in the account. (2) Exception. The deduction required pursuant to paragraph (c)(2)(xv)(A)(1) of this section need not be taken to the extent that: (i) The amount of the margin difference for the account does not exceed the lesser of 1 percent (1%) of the tentative net capital of the broker or dealer or ten percent (10%) of the net worth of the counterparty; and (ii) The amount of the margin difference for all accounts that hold security-based swaps or swaps does not exceed twenty-five percent (25%) of the tentative net capital of the broker or dealer.

    Similarly, the potential modifications to paragraph (c)(1)(ix)(A) of Rule 18a-1 would provide the following deduction from net worth in lieu of collecting collateral for security-based swaps and swap transactions: (1) Deducting the amount of the margin difference for each account carried by the security-based swap dealer for another person that holds cleared security-based swap or swap transactions. The margin difference is the amount of the deductions to the positions in the account calculated pursuant to paragraph (c)(1)(vi) or (vii) of this section, § 240.18a-1(d), or § 240.18a-1b (as applicable), less the margin value of collateral held in the account. (2) Exception. The deduction required pursuant to paragraph (c)(1)(ix)(A)(1) of this section need not be taken to the extent that: (i) The amount of the margin difference for the account does not exceed the lesser of 1 percent (1%) of the tentative net capital of the security-based swap dealer or ten percent (10%) of the net worth of the counterparty; and (ii) The amount of the margin difference for all accounts that hold security-based swaps or swaps does not exceed twenty-five percent (25%) of the tentative net capital of the security-based swap dealer.

    3. The 2012 Proposals included a provision that a nonbank SBSD would be required to take a 100 percent (100%) capital charge when it does not collect variation or initial margin for non-cleared security-based swaps because of an exception from collecting margin.26 The proposed capital charge was intended to require a nonbank SBSD to set aside net capital to address the risks that would otherwise be mitigated through the collection of variation and initial margin.27 The set aside net capital would serve as an alternative to obtaining margin.28 As an alternative to taking the 100 percent (100%) charge, the Commission proposed that firms using internal models to calculate net capital could take a credit risk charge if the uncollected margin involved a transaction with a commercial end user.29

    26See 2012 Proposals, 77 FR at 70425-27.

    27See id.

    28See id.

    29See id. at 70240-45.

    a. Commenters requested that nonbank SBSDs be permitted to apply the credit risk charge to other types of counterparties.30 In light of the comments and the goals of this provision, the Commission requests comment on whether the use of the credit risk charge should be expanded to other types of counterparties and transactions. Should the rule permit a firm to apply the credit risk charge for uncollected initial margin for security-based swaps and swap transactions with any type of counterparty and for uncollected variation margin for transactions with a commercial end user only? The purpose of limiting the application of the credit risk charge with respect to uncollected variation margin to transactions with commercial end users would be to reduce the types of unsecured receivables that qualify as allowable assets for net capital purposes and, thereby, promote the liquidity of the nonbank SBSD.

    30See, e.g., Letter from Anne-Marie Leroy, Senior Vice President and Group General Counsel, and David Harris, Acting Vice President and General Counsel, The World Bank (Feb. 21, 2013).

    b. The Commission requests comment on whether the rule should establish a threshold for uncollected margin above which the use of the credit risk charge would not be permitted. Should there be a threshold when the aggregate amount of uncollected margin across all counterparties exceeds a level of the nonbank SBSD's tentative net capital? Should the threshold apply to the aggregate amount of uncollected initial and variation margin or just to the aggregate amount of uncollected variation margin? The latter approach would focus the threshold on unsecured receivables that result from not collecting variation margin and, thereby, promote the liquidity of the nonbank SBSD. Should there be a threshold with respect to uncollected variation margin for security-based swap and swap transactions with commercial end users and should that threshold be ten percent (10%) or some other percent of the nonbank SBSD's tentative net capital? 31 This threshold would be designed to limit the nonbank SBSD's aggregate exposure arising from not collecting variation margin from commercial end users and would be scalable to the nonbank SBSD's financial condition.

    31See, e.g., 17 CFR 240.15c3-1(c)(2)(vi)(M)(1) (using a ten percent (10%) of tentative net capital threshold for the calculation of undue concentration charges).

    c. The potential modifications to the rule text in the 2012 Proposals discussed above in 3.a and 3.b would include: (1) Changing the proposed rule to permit a nonbank SBSD to apply the credit risk charge for uncollected initial margin for security-based swaps and swaps from any type of counterparty and for uncollected variation margin from a commercial end user; and (2) establishing a risk-based threshold with respect to uncollected variation margin from commercial end users. Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing commenters' requests to apply the credit risk charge more broadly? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (a)(7) of Rule 15c3-1 would provide: In accordance with Appendix E to this section (§ 240.15c3-1e), the Commission may approve, in whole or in part, an application or an amendment to an application by a broker or dealer to calculate net capital using the market risk standards of appendix E to compute a deduction for market risk on some or all of its positions, instead of the provisions of paragraphs (c)(2)(vi) and (c)(2)(vii) of this section, and § 240.15c3-1b, and using the credit risk standards of Appendix E to compute a deduction for credit risk for certain security-based swap and swap transactions, as specified in this paragraph, instead of the provisions of paragraphs (c)(2)(iv), (c)(2)(xv)(B)(1), and (c)(2)(xv)(B)(2) of this section, subject to any conditions or limitations on the broker or dealer the Commission may require as necessary or appropriate in the public interest or for the protection of investors. A broker or dealer may use the credit risk standards of Appendix E to compute a deduction for credit risk for security-based swap transactions with commercial end users as that term is defined in § 240.18a-3(b)(2), and swap transactions in which a counterparty qualifies for an exception from margin requirements pursuant to Section 4s(e)(4) of the Commodity Exchange Act (7 U.S.C. 6s(e)(4)) instead of the provisions of paragraph (c)(2)(iv) of this section, provided that the deductions, in the aggregate, do not exceed ten percent (10%) of the tentative net capital of the broker or dealer. A broker or dealer also may use the credit risk standards of Appendix E to compute a deduction for credit risk for security-based swap transactions that are subject to an initial margin exception set forth in § 240.18a-3(c)(1)(iii) instead of the provisions of paragraph (c)(2)(xv)(B)(1) of this section, and for swap transactions instead of the provisions of paragraph (c)(2)(xv)(B)(2) of this section.

    Similarly, the potential modifications to paragraph (a)(2) of Rule 18a-1 would provide: In accordance with paragraph (d) of this section, the Commission may approve, in whole or in part, an application or an amendment to an application by a security-based swap dealer to calculate net capital using the market risk standards of paragraph (d) to compute a deduction for market risk on some or all of its positions, instead of the provisions of paragraphs (c)(1)(iv), (vi), and (vii) of this section, and § 240.18a-1b, and using the credit risk standards of paragraph (d) to compute a deduction for certain security-based swap and swap transactions, as specified in this paragraph, instead of the provisions of paragraphs (c)(1)(iii), (c)(1)(ix)(B)(1), and (c)(1)(ix)(B)(2) of this section, subject to any conditions or limitations on the security-based swap dealer the Commission may require as necessary or appropriate in the public interest or for the protection of investors. A security-based swap dealer may use the credit risk standards of paragraph (d) to compute a deduction for credit risk for security-based swap transactions with commercial end users as that term is defined in § 240.18a-3(b)(2), and swap transactions in which a counterparty qualifies for an exception from margin requirements pursuant to Section 4s(e)(4) of the Commodity Exchange Act (7 U.S.C. 6s(e)(4)) instead of the provisions of paragraph (c)(1)(iii) of this section, provided that the deductions, in the aggregate, do not exceed ten percent (10%) of the tentative net capital of security-based swap dealer. A security-based swap dealer also may use the credit risk standards of paragraph (d) to compute a deduction for credit risk for security-based swap transactions that are subject to an initial margin exception set forth in § 240.18a-3(c)(1)(iii) instead of the provisions of paragraph (c)(1)(ix)(B)(1) of this section, and for swap transactions instead of the provisions of paragraph (c)(1)(ix)(B)(2) of this section.

    4. The 2012 Proposals included a capital charge for nonbank SBSDs when a counterparty requires initial margin to be segregated pursuant to Section 3E(f) of the Act, which among other things, provides that the collateral must be carried by an independent third-party custodian.32 Collateral held in this manner would not be in the possession or control of the nonbank SBSD, nor would it would be capable of being liquidated promptly by the nonbank SBSD without the intervention of a third party.

    32See 2012 Proposals, 77 FR at 70246-47; 15 U.S.C. 78c-5(f)(3).

    a. Commenters argued that the charge would discourage the use of segregation under Section 3E(f) of the Act,33 that the charge would create costs to the affected nonbank SBSD (which would be passed on to customers),34 and that the parties could properly structure an agreement to address the Commission's concern about the nonbank SBSD's lack of control over the collateral.35 In light of the comments and the goals of this provision, the Commission requests comment on whether there should be an exception to taking the capital charge (whether 100 percent (100%) or a credit risk charge, as applicable) under conditions that promote the SBSD's ability to promptly access the collateral if needed. Should there be an exception with the following conditions: (1) The custodian is a bank; (2) the nonbank SBSD enters into an agreement with the custodian and the counterparty that provides the nonbank SBSD with the same control over the collateral as would be the case if the nonbank SBSD controlled the collateral directly; and (3) an opinion of counsel deems the agreement enforceable? The purpose of these conditions would be to provide the nonbank SBSD with the unfettered ability to access the collateral in the event the counterparty defaults and, thereby, promote the financial condition of the nonbank SBSD, particularly in a time of market distress. Would this be a practical exception? If not, please explain why.

    33See, e.g., Letter from American Benefits Council, Committee on Investment of Employee Benefit Assets, European Federation for Retirement Provision, the European Association of Paritarian Institutions, the National Coordinating Committee for Multiemployer Plans, and the Pension Investment Association of Canada (May 19, 2014).

    34See, e.g., Letter from Douglas M. Hodge, Managing Director and Chief Operating Officer, Pacific Investment Management Company LLC (Feb. 21, 2013).

    35See, e.g., Letter from Karrie McMillan, General Counsel, Investment Company Institute (Dec. 5, 2013).

    b. The Commission is considering providing guidance on ways a nonbank SBSD could structure the account control agreement to meet a requirement that the nonbank SBSD have the same control over the collateral as would be the case if the nonbank SBSD controlled the collateral directly. In developing the guidance on ways this requirement could be met, the Commission asks commenters to address whether the agreement between the nonbank SBSD, counterparty, and the third-party custodian should: (1) Provide that the collateral will be released promptly and directed in accordance with the instructions of the nonbank SBSD upon the receipt of an effective notice from the nonbank SBSD; (2) provide that when the counterparty provides an effective notice to access the collateral the nonbank SBSD will have sufficient time to challenge the notice in good faith and that the collateral will not be released until a prior agreed-upon condition among the three parties has occurred; and (3) give priority to an effective notice from the nonbank SBSD over an effective notice from the counterparty, as well as priority to the nonbank SBSD's instruction about how to transfer the collateral in the event the custodian terminates the account control agreement? Are there any other provisions regarding the account control agreement that the Commission should address to assist nonbank SBSDs in structuring the agreements to meet a requirement in a rule that the nonbank SBSD have the same control over the collateral as would be the case if the nonbank SBSD controlled the collateral directly?

    c. The potential modification to the rule text in the 2012 Proposals discussed above in 4.a would establish conditions under which a nonbank SBSD could avoid the capital charge that applies when a counterparty requires initial margin to be segregated pursuant to Section 3E(f) of the Act. Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing the commenters' concerns about the impact of the capital charge? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (c)(2)(xv)(B) of Rule 15c3-1 would provide the following deductions from net worth in lieu of collecting collateral for security-based swap and swap transactions: (1) Security-based swaps. Deducting the amounts calculated pursuant to § 240.18a-3(c)(1)(i)(B) for the account of a counterparty at the broker or dealer that is subject to an initial margin exception set forth in § 240.18a-3(c)(1)(iii), less the margin value of collateral held in the account of the counterparty at the broker or dealer. (2) Swaps. Deducting the initial margin calculated pursuant to § 240.18a-3(d)(2) for swaps other than equity swaps, or § 240.15c3-1b, as applicable, in the account of a counterparty at the broker or dealer, less the margin value of collateral held in the account of the counterparty at the broker or dealer. (3) Treatment of collateral held at a third-party custodian. For the purposes of the deductions required pursuant to paragraphs (c)(2)(xv)(B)(1) and (2) of this section, collateral held by an independent third-party custodian as initial margin pursuant to Section 3E(f) of the Act or Section 4s(l) of the Commodity Exchange Act may be treated as collateral held in the account of the counterparty at the broker or dealer if: (a) The independent third-party custodian is a bank as defined in Section 3(a)(6) of the Act that is not affiliated with the counterparty; (b) The broker or dealer, the independent third-party custodian, and the counterparty that delivered the collateral to the custodian have executed an account control agreement governing the terms under which the custodian holds and releases collateral pledged by the counterparty as initial margin that provides the broker or dealer with the same control over the collateral as would be the case if the broker or dealer controlled the collateral directly; and (c) The broker or dealer obtains a written opinion from outside counsel that the account control agreement is legally valid, binding, and enforceable in all material respects, including in the event of bankruptcy, insolvency, or a similar proceeding.

    Similarly, the potential modifications to paragraph (c)(1)(ix) of Rule 18a-1 would provide the following deductions from net worth in lieu of collecting collateral for security-based swap and swap transactions: (1) Security-based swaps. Deducting the amounts calculated pursuant to § 240.18a-3(c)(1)(i)(B) for the account of a counterparty at the security-based swap dealer that is subject to an initial margin exception set forth in § 240.18a-3(c)(1)(iii), less the margin value of collateral held in the account of the counterparty at the security-based swap dealer. (2) Swaps. Deducting the initial margin calculated pursuant to § 240.18a-3(d)(2) for swaps other than equity swaps, or § 240.18a-1b, as applicable, in the account of a counterparty at the security-based swap dealer, less the margin value of collateral held in the account of the counterparty at the security-based swap dealer. (3) Treatment of collateral held at a third-party custodian. For the purposes of the deductions required pursuant to paragraphs (c)(1)(ix)(B)(1) and (2) of this section, collateral held by an independent third-party custodian as initial margin pursuant to Section 3E(f) of the Act or Section 4s(l) of the Commodity Exchange Act may be treated as collateral held in the account of the counterparty at the security-based swap dealer if: (a) The independent third-party custodian is a bank as defined in Section 3(a)(6) of the Act that is not affiliated with the counterparty; (b) The security-based swap dealer, the independent third-party custodian, and the counterparty that delivered the collateral to the custodian have executed an account control agreement governing the terms under which the custodian holds and releases collateral pledged by the counterparty as initial margin that provides the security-based swap dealer with the same control over the collateral as would be the case if the security-based swap dealer controlled the collateral directly; and (c) The security-based swap dealer obtains a written opinion from outside counsel that the account control agreement is legally valid, binding, and enforceable in all material respects, including in the event of bankruptcy, insolvency, or a similar proceeding.

    5. The 2012 Proposals noted that a nonbank SBSD would need to deduct from net worth the value of initial margin delivered to a counterparty when computing net capital.36 A comment letter 37 encouraged the Commission to provide a means for nonbank SBSDs to post initial margin to SBSDs and other types of counterparties without incurring the capital charge. If the Commission adopts capital and margin rules applicable to SBSDs, should the Commission provide a means for a nonbank SBSD to avoid this deduction if the following conditions are met: (1) The initial margin requirement is funded by a fully executed written loan agreement with an affiliate of the broker-dealer; (2) the loan agreement provides that the lender waives re-payment of the loan until the initial margin is returned to the broker-dealer; and (3) the broker-dealer's liability to the lender can be fully satisfied by delivering the collateral serving as initial margin to the lender? 38 A Commission action providing this relief would be styled after the Staff Letter. Would this approach provide a practical solution with respect to avoiding this capital charge? If not, please explain why. Should the Commission by rule permit this approach? Are there alternatives that would more effectively and efficiently achieve this objective? If so, what are they?

    36See 2012 Proposals, 77 FR at 70267.

    37See Letter from Institute of International Bankers and Securities Industry and Financial Markets Association (June 21, 2018).

    38 In this regard, although not binding, the staff of the Division of Trading and Markets issued a no-action letter (in the context of margin collateral posted by a broker-dealer to a swap dealer or other counterparty for a non-cleared swap) that stated that the staff would not recommend enforcement action to the Commission if a broker-dealer did not take this deduction but met certain conditions. The conditions include that: (1) The initial margin requirement is funded by a fully executed written loan agreement with an affiliate of the broker-dealer; (2) the loan agreement provides that the lender waives re-payment of the loan until the initial margin is returned to the broker-dealer; and (3) the broker-dealer's liability to the lender can be fully satisfied by delivering the collateral serving as initial margin to the lender. See Letter from Michael A. Macchiaroli, Associate Director, Division of Trading and Markets, Commission, to Kris Dailey, Vice President, Risk Oversight and Regulation, FINRA (Aug. 19, 2016) (“Staff Letter”).

    Margin

    6. The 2012 Proposals included a provision that would require a nonbank SBSD to calculate a daily initial margin amount for each counterparty.39 The nonbank SBSD could use the standardized or model-based deductions prescribed in the proposed capital rule for nonbank SBSDs to calculate the initial margin amount, except that initial margin for equity security-based swaps would need to be determined exclusively using the standardized deductions.

    39See 2012 Proposals, 77 FR at 70261.

    Some commenters argued that the Commission should approve a uniform initial margin model because it would reduce counterparty disputes and increase efficiency.40 Since the publication of the 2012 Proposals, the prudential regulators and the CFTC adopted final margin rules that permit the use of a model to calculate initial margin subject to the approval of the CFTC or a firm's prudential regulator.41 The Commission understands that the firms subject to these final rules have widely adopted the use of an industry-developed uniform model to compute initial margin.42 In light of the comments and the goals of this provision, the Commission requests comment on whether the margin rule should permit nonbank SBSDs to apply to use models other than proprietary capital models to compute initial margin, including applying to use a standard industry model. The purpose would be to provide flexibility to nonbank SBSDs to apply to the Commission for authorization to use a proprietary or other model to compute initial margin, and, with respect to an industry standard model, to increase transparency and decrease margin disputes among counterparties.

    40See, e.g., Letter from Robert Pickel, Chief Executive Officer, International Swaps and Derivatives Association (Feb. 5, 2014) (“ISDA 2/5/2014 Letter”).

    41See Margin and Capital Requirements for Covered Swap Entities, 80 FR 74840; Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants, 81 FR 636.

    42See, e.g., ISDA, ISDA SIMMTM Deployed Today; New Industry Standard for Calculating Initial Margin Widely Adopted by Market Participants (Sept. 1, 2016), available at: https://www.isda.org/2016/09/01/isda-simm-deployed-today-new-industry-standard-for-calculating-initial-margin-widely-adopted-by-market-participants/.

    Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing commenters' requests for more flexibility? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (d)(2)(i) of Rule 18a-3 would provide: For security-based swaps other than equity security-based swaps, a security-based swap dealer may apply to the Commission for authorization to use a model to compute the margin amount required by paragraph (c)(1)(i)(B) of this section and to compute the deductions required by paragraph § 240.15c3-1(c)(2)(xv) or § 240.18a-1(c)(1)(ix), as applicable, subject to the application process in § 240.15c3-1e or § 240.18a-1(d), as applicable. The model must use a ninety-nine percent (99%), one-tailed confidence level with price changes equivalent to a ten business-day movement in rates and prices, and must use risk factors sufficient to cover all the material price risks inherent in the positions for which the margin amount or deductions are being calculated, including foreign exchange or interest rate risk, credit risk, equity risk, and commodity risk, as appropriate. Empirical correlations may be recognized by the model within each broad risk category, but not across broad risk categories.

    7. The 2012 Proposals included a requirement that a nonbank SBSD would need to collect initial and variation margin from each counterparty unless an exception applies.43 The proposed rule contained four exceptions under which variation and/or initial margin need not be collected: (1) When the counterparty is a commercial end user; (2) when the counterparty is another SBSD; (3) when the counterparty requires segregation pursuant to Section 3E(f) of the Act; and (4) when the counterparty's account holds only legacy transactions.44

    43See 2012 Proposals, 77 FR at 70263-69.

    44See id.

    Some commenters encouraged the Commission to adopt a threshold below which initial margin need not be collected and noted that the prudential regulators and the CFTC established a $50 million threshold (consistent with the recommendation of an international standard setting body).45 In light of the comments and the goals of this provision, the Commission requests comment on whether it would be appropriate to establish a risk-based threshold. A fixed-dollar threshold, depending on the size and activities of the nonbank SBSD, could either be too large and, therefore, not adequately address the risk, or too small and, therefore, overcompensate for the risk. Should a risk-based threshold take into account the financial condition of the SBSD and the counterparty by providing that initial margin need not be collected from a counterparty when the amount is less than one percent (1%) or some other percent of a nonbank SBSD's tentative net capital 46 and is less than ten percent (10%) or some other percent 47 of the counterparty's net worth (in which case, only the amount above the threshold would need to be collected)? The purpose of these financial metrics would be to establish a threshold that is scalable and has a more direct relation to the risk to the nonbank SBSD arising from its security-based swap activities.

    45See, e.g., Letter from Karrie McMillan, General Counsel, Investment Company Institute (Feb. 4, 2013). See also BCBS, IOSCO, Margin Requirements for Non-centrally Cleared Derivatives (Mar. 2015), available at: http://www.bis.org/bcbs/publ/d317.pdf.

    46See, e.g., 17 CFR 240.15c3-3a, Note E(5) (using a twenty-five percent (25%) of tentative net capital threshold for when a broker-dealer must reduce debits in the customer reserve formula).

    47See, e.g., 17 CFR 240.15c3-1(c)(2)(vi)(M)(1) (using a ten percent (10%) of tentative net capital threshold for the calculation of undue concentration charges).

    Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing commenters' requests for a threshold? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (c)(1)(iii)(E) of Rule 18a-3 would provide that an SBSD may elect not to collect the amount required under paragraph (c)(1)(ii)(B) of this section to the extent that the amount does not exceed the lesser of: (1) 1 percent (1%) of the security-based swap dealer's tentative net capital; or (2) ten percent (10%) of the net worth of the counterparty.

    8. As noted above, the 2012 Proposals included an exception from collecting margin when the counterparty is another SBSD.48 In particular, the Commission proposed two alternatives with respect to SBSD counterparties.49 Under the first alternative, a nonbank SBSD would not need to collect initial margin if the counterparty is another SBSD (“Alternative A”). This approach is consistent with the broker-dealer margin rules, which generally do not require a broker-dealer to collect margin from another broker-dealer.50 Under the proposed second alternative, a nonbank SBSD would be required to collect initial margin from another SBSD and the initial margin would need to be segregated pursuant to Section 3E(f) of the Act (“Alternative B”).51

    48See 2012 Proposals, 77 FR at 70267-68.

    49See id.

    50See id.

    51See id.

    A commenter argued that Alternative A was the preferred approach because requiring SBSDs to collect initial margin from other SBSDs would curtail the use of non-cleared security-based swaps for hedging, which would disrupt key financial services, such as those that facilitate the availability of home loans and corporate finance.52 This commenter also argued that the requirement to collect initial margin from another SBSD would have detrimental pro-cyclical effects because it would increase collateral demands in times of market stress.53 Other commenters supported Alternative B stating that Alternative A would permit an inappropriate build-up of systemic risk for transactions within the financial system.54

    52See Letter from Robert Pickel, Chief Executive Officer, International Swaps and Derivatives Association (Jan. 23, 2013) (“ISDA 1/23/2013 Letter”).

    53See id.

    54See, e.g., Letter from Americans for Financial Reform (Feb. 22, 2013).

    a. The Commission requests comment and supporting data that would assist in the quantification of the economic impacts of Alternatives A and B. The 2012 Proposals discussed the potential for increased use of leverage, the potential for a nonbank SBSD to fail, and the potential that a default by a nonbank SBSD could translate to defaults of counterparty SBSDs.55 The 2012 Proposals also noted that the likelihood of these potential events occurring would be smaller under Alternative B than under Alternative A.56 Would the proposed capital requirements complement Alternative A to reduce the potential for increased use of leverage, the potential for a nonbank SBSD to fail, and the potential that a default by a nonbank SBSD could translate to a default of counterparty SBSDs caused by exposure to credit risk in inter-dealer positions? Would there be situations where the proposed capital requirements and Alternative A would not prevent a failure of a nonbank SBSD caused by security-based swap trading losses? Would there be situations where the proposed capital requirements and Alternative A would avoid a failure of a nonbank SBSD by not imposing pro-cyclical collateral demands?

    55See 2012 Proposals, 77 FR at 70267, 70322.

    56See id.

    The 2012 Proposals also noted that in comparison to Alternative A or current practices, Alternative B could have a more significant negative impact on the liquidity of nonbank SBSDs and their ability to trade in security-based swaps.57 If Alternative B is adopted, how much initial margin would be segregated at third-party custodians and how would it impact the liquidity of nonbank SBSDs? If Alternative B is adopted, would the proposed margin requirements limit the ability of nonbank SBSDs to trade in security-based swaps?

    57See id. at 70322.

    Finally, the 2012 Proposals noted that depending on whether Alternative A or B is adopted, the proposed margin requirements may create the potential for regulatory arbitrage.58 In particular, the 2012 Proposals noted that if the Commission does not require nonbank SBSDs to collect initial margin in their inter-dealer transactions (as proposed in Alternative A), while the prudential regulators require the collection of initial margin for the same transactions, intermediaries could have an incentive to conduct business through nonbank entities.59 Would Alternative A create more opportunities for regulatory arbitrage than Alternative B, and would these regulatory arbitrage opportunities have a significant economic impact? If so, please explain how. In addition, Alternative A would differ in some respects from an international policy framework establishing recommended minimum standards for margin requirements for non-centrally cleared derivatives.60 Would these or other differences create opportunities for regulatory arbitrage, impede transactions with other market participants, or have an impact on substituted compliance determinations?

    58See id. at 70305-06.

    59See id.

    60See BCBS, IOSCO, Margin Requirements for Non-centrally Cleared Derivatives (Mar. 2015).

    b. If Alternative A is adopted, should the exception apply to a broader class of entities than just other SBSDs? Should it apply if the nonbank SBSD's counterparty is an SBSD, broker-dealer, bank, futures commission merchant, foreign bank, or foreign dealer? The purpose of adopting Alternative A with a modification to apply the exception to a broader class of counterparties would be to promote the liquidity of nonbank SBSDs and other market participants by reducing the amount of capital they must post as initial margin to counterparties.

    Would rule language as described below effect Alternative A with the potential modification to expand the range of entities from which initial margin need not be collected? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of promoting the liquidity of nonbank SBSDs and other market participants and addressing commenters' concerns about building up systemic risk? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (c)(1)(iii)(B) of Rule 18a-3 would provide that the requirements of paragraph (c)(1)(ii)(B) of this section do not apply to an account of a counterparty that is a security-based swap dealer, swap dealer, broker or dealer, futures commission merchant, bank, foreign bank, or a foreign broker or dealer.

    9. In response to the 2012 Proposals, commenters argued that the requirements adopted pursuant to Title VII of the Dodd-Frank Act should permit the portfolio margining of security-based swaps, swaps, and related positions.61 Portfolio margining of security-based swaps, swaps, and related positions can offer benefits to investors and the markets, including aligning margin requirements more closely with the overall risks of a customer's portfolio. Further, portfolio margining may help to improve cash flows and liquidity, and reduce volatility.

    61See, e.g., Letter from Adam Jacobs, Director of Markets Regulation, Alternative Investment Management Association (Feb. 22, 2013) (“AIMA 2/22/2013 Letter”).

    a. The Commission requests comment on whether swaps should be permitted to be held in a security-based swap account at an entity that is registered as a broker-dealer, nonbank SBSD, and swap dealer to provide a means to portfolio margin security-based swaps with swaps and related cash market and listed options positions. The Commission also requests comment on whether security-based swaps should be permitted to be held in a swap account at an entity that is registered as an FCM, swap dealer, and nonbank SBSD to provide a means to portfolio margin security-based swaps with swaps and related futures positions.

    b. The Commission requests comment on whether swaps should be permitted to be held in a security-based swap account at an entity that is registered as a nonbank SBSD and swap dealer (but not as a broker-dealer or FCM) to provide a means to portfolio margin security-based swaps and swaps in a security-based swap account. The Commission also requests comment on whether security-based swaps should be permitted to be held in a swap account at an entity that is registered as a swap dealer and SBSD (but not as an FCM or broker-dealer) to provide a means to portfolio margin security-based swaps and swaps in a swap account. If so, should such portfolio margining be subject to conditions similar to those set forth in the Commission's exemptive order permitting portfolio margining of credit default swaps (e.g., conditions regarding subordination agreements and disclosures)? 62 In either scenario identified in this paragraph, should the SBSD dually registered as a swap dealer be permitted to use a model to determine portfolio margin requirements for security-based swaps and swaps that reference equity securities, provided the accounts do not hold cash market equity and listed options positions?

    62See Order Granting Conditional Exemptions Under the Securities Exchange Act of 1934 in Connection with Portfolio Margining of Swaps and Security-Based Swaps, Exchange Act Release No. 68433 (Dec. 14, 2012), 77 FR 75211 (Dec. 19, 2012).

    c. The Commission requests comment on how security-based swaps, swaps, cash market and listed options positions, and collateral held in a security-based swap account at an entity registered as a broker-dealer, nonbank SBSD, and swap dealer would be treated in a liquidation proceeding. The Commission requests comment on how security-based swaps, swaps, futures positions, and collateral held in a swap account at an entity registered as an FCM, swap dealer, and nonbank SBSD would be treated in a liquidation proceeding. Would the treatment be different if the entity was also registered as a broker-dealer? The Commission requests comment on how swaps and security-based swaps held in a security-based swap account at an entity registered as an SBSD and swap dealer would be treated in a liquidation proceeding and how security-based swaps and swaps held in a swap account at such an entity would be treated in a liquidation proceeding.

    For each of the four scenarios described above, what steps should be taken to provide protections to the accountholders? What rights (including rights under the bankruptcy laws) might accountholders have to waive? Should there be limits on the types of counterparties that would be permitted to waive these rights? Should the rule require the nonbank SBSD to provide complete and accurate disclosures about the treatment of assets in a liquidation, bankruptcy, or similar proceeding under each of the scenarios described above so that accountholders and prospective accountholders can make informed decisions about the type of portfolio margin account they want to use and about waiving any rights with respect to the account?

    d. The scenarios described above include permitting: (1) An entity registered as a broker-dealer, nonbank SBSD, and swap dealer to hold swaps in a security-based swap account to provide a means to portfolio margin security-based swaps with swaps and related cash market and listed options positions; and (2) an entity that is registered as an SBSD and swap dealer (but not as an FCM or broker-dealer) to hold swaps in a security-based swap account to provide a means to portfolio margin security-based swaps and swaps in a security-based swap account and to use a model to determine portfolio margin requirements for security-based swaps and swaps that reference equity securities, provided the accounts do not hold cash market equity and listed options positions.

    Would rule language as described below effect these approaches to implement portfolio margining of swaps in a security-based swap account? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rules and addressing commenters' requests to permit portfolio margining of swaps and security-based swaps? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (a)(3) of Appendix A to Rule 15c3-1 would provide: The term related instrument within an option class or product group refers to futures contracts, options on futures contracts, and swaps covering the same underlying instrument. In relation to options on foreign currencies a related instrument within an option class also shall include forward contracts on the same underlying currency.

    The potential modifications to paragraph (a)(4) of Appendix A to Rule 15c3-1 would also provide: The term underlying instrument refers to long and short positions, as appropriate, covering the same foreign currency, the same security, security future, security-based swap, or a security which is exchangeable for or convertible into the underlying security within a period of 90 days. If the exchange or conversion requires the payment of money or results in a loss upon conversion at the time when the security is deemed an underlying instrument for purposes of this Appendix A, the broker or dealer will deduct from net worth the full amount of the conversion loss. The term underlying instrument shall not be deemed to include securities options, futures contracts, options on futures contracts, qualified stock baskets, unlisted instruments (other than security-based swaps), or swaps.

    The potential modifications to paragraph (a)(3) of Appendix A to Rule 18a-1 would provide: The term related instrument within an option class or product group refers to futures contracts, options on futures contracts, and swaps covering the same underlying instrument. In relation to options on foreign currencies, a related instrument within an option class also shall include forward contracts on the same underlying currency.

    The potential modifications to paragraph (a)(4) of Appendix A to Rule 18a-1 would provide: The term underlying instrument refers to long and short positions, as appropriate, covering the same foreign currency, the same security, security future, security-based swap, or a security which is exchangeable for or convertible into the underlying security within a period of 90 days. If the exchange or conversion requires the payment of money or results in a loss upon conversion at the time when the security is deemed an underlying instrument for purposes of this Appendix A, the security-based swap dealer will deduct from net worth the full amount of the conversion loss. The term underlying instrument shall not be deemed to include securities options, futures contracts, options on futures contracts, qualified stock baskets, unlisted instruments (other than security-based swaps), or swaps.

    The potential modifications to paragraph (d)(2)(ii) of Rule 18a-3 would provide: Notwithstanding paragraph (d)(2)(i) of this section, a security-based swap dealer that is not registered as a broker or dealer pursuant to Section 15(b) of the Act (15 U.S.C. 78o(b)) may apply to the Commission for authorization to use a model to compute the margin amount required by paragraph (c)(1)(i)(B) of this section and to compute the deductions required by paragraph § 240.18a-1(c)(1)(ix) for equity security-based swaps and equity swaps, subject to the application process and model requirements of paragraph (d)(2)(i) of this section; provided, however, the account of the counterparty subject to the requirements of this paragraph may not hold equity securities or listed options.

    Segregation

    10. Section 3E(f) of the Act provides that a counterparty to a non-cleared security-based swap with an SBSD can require that initial margin be segregated at a third-party custodian or waive segregation.63 The 2012 Proposals included a third alternative under which the initial margin for the non-cleared security-based swap could be held by the SBSD and subject to requirements modeled on the broker-dealer customer protection rule but tailored to security-based swaps (“omnibus segregation requirements”).64 The omnibus segregation requirements would be mandatory for initial margin held by the SBSD for cleared security-based swaps.

    63See 15 U.S.C. 78c-5(f)(3).

    64See 2012 Proposals, 77 FR at 70274-88; 17 CFR 240.15c3-3.

    a. The Commission received a number of comments asking technical questions about how the proposed omnibus segregation requirements would operate in the context of security-based swap transactions, including specific questions about the computation of the reserve formula, and what types of hedging would be permitted under the proposed definition of “excess securities collateral.” 65 The Commission requests comment on whether there are aspects of the proposed omnibus segregation requirements where greater clarity regarding the application of the rule would be helpful. If so, please identify them and suggest appropriate modifications to the proposed rule.

    65See, e.g., SIFMA 2/22/2013 Letter.

    b. The 2013 Proposals would treat segregation as a transaction-level requirement, and the Commission proposed paragraph (e) of Rule 18a-4 to prescribe the scope of application of the segregation requirements in Section 3E(f) of the Act and Rule 18a-4.66 The proposed cross-border application of these segregation requirements to a foreign SBSD or foreign MSBSP depended on whether it is a registered broker-dealer, a U.S. branch or agency of a foreign bank, or neither of the above, and whether the security-based swaps are cleared or non-cleared.67 The Commission requests comment on whether there are aspects of the proposed cross-border application of the segregation requirements where greater clarity regarding the application of the rule would be helpful. If so, please identify them and suggest appropriate modifications to the proposed rule.

    66See 2013 Proposals, 78 FR at 31010-11, 31018-22, 31209-10.

    67See id. at 31018-22.

    c. The 2013 Proposals provided that a foreign SBSD that is a U.S. branch or agency of a foreign bank must comply with segregation requirements with respect to security-based swap transactions with U.S. security-based swap customers, but not with foreign security-based swap customers.68 Should the segregation requirements apply to certain foreign security-based swap customers? In particular, the Commission requests comment on whether a foreign SBSD that is not a broker-dealer and is a foreign bank should be required to comply with the segregation requirements (1) with respect to U.S. security-based swap customers (regardless of which branch or agency the customer's transactions arise out of), and (2) with respect to a foreign security-based swap customer if the foreign SBSD holds funds or other property arising out of a transaction had by such person with a U.S. branch or agency of the foreign SBSD.

    68See id.

    11. The Commission received a comment that the broker-dealer customer protection rule (Rule 15c3-3) should be amended to take into account margin that is posted at a clearing agency by broker-dealers not registered as SBSDs.69 The Commission requests comment on whether Rule 15c3-3 should be amended to add a new paragraph (p) and a new Exhibit B that would contain segregation requirements and a customer reserve formula that parallel those in proposed Rule 18a-4. The security-based swap segregation requirements that would be added to Rule 15c3-3 would be substantially the same as the requirements in each paragraph of proposed Rule 18a-4.70 The purpose would be to permit broker-dealers that are not registered as SBSDs but that engage in security-based swap activities to use segregation requirements that parallel those in proposed Rule 18a-4 and which are tailored to security-based swaps. In addition, the purpose would be to locate in Rule 15c3-3 the security-based swap segregation requirements for entities registered as a broker-dealer and SBSD. Proposed Rule 18a-4 would apply to SBSDs that are not registered as broker-dealers.

    69See Letter from Kathleen M. Cronin, CME Group Inc. (Feb. 22, 2013).

    70 The provisions of paragraph (d) of proposed Rule 18a-4 would not apply to a broker-dealer that is not also registered as either an SBSD or MSBSP because Section 3E(f)(1)(A) of the Act does not apply to broker-dealers. See 2012 Proposals, 77 FR at 70287.

    12. The 2012 Proposals include a definition of “excess securities collateral” to identify securities and money market instruments received from security-based swap customers that must be held in physical possession or control.71 In particular, securities and money market instruments that are not being used to collateralize the SBSD's current exposure to the customer (i.e., exceed the variation margin requirement) would need to be in the physical possession or control of the SBSD unless one of two exceptions applied.72 The exceptions are that the securities and money market instruments are held in a: (1) Qualified clearing agency account but only to the extent they are being used to meet a margin requirement of the clearing agency; or (2) qualified SBSD account but only to the extent they are being used to meet a margin requirement that applies to the other SBSD resulting from entering into a non-cleared security-based swap transaction with the other SBSD to offset the risk of a non-cleared security-based swap transaction between the SBSD and the customer.73 In addition, the 2012 Proposals included a requirement for an SBSD to perform a customer reserve formula calculation.74 Under the proposal, an SBSD could include as a debit item in the formula cash collateral posted to a clearing agency or another SBSD under the same circumstances as the exceptions to the definition of “excess securities collateral.” 75 The prudential regulators require initial margin posted by an SBSD to a bank SBSD to be held at a third-party custodian (rather than being held directly by the bank SBSD).76 This means that if an SBSD enters into a transaction with a bank SBSD to hedge a non-cleared security-based swap transaction with a security-based swap customer, the SBSD may have to post initial margin to the bank SBSD and that initial margin would need to be held by a third-party custodian rather than directly by the bank SBSD.

    71See 2012 Proposals, 77 FR at 70278-70282.

    72See id.

    73See id.

    74See id. at 70282-87.

    75See id.

    76See 12 CFR 45.7; 12 CFR 237.7; 12 CFR 624.7; 12 CFR 1221.7; 12 CFR 349.7.

    The Commission requests comment on how initial margin posted by an SBSD to a bank SBSD to hedge a transaction with a security-based swap customer should be treated for purposes of the possession or control and customer reserve requirements in the proposed SBSD segregation rule. For purposes of the possession or control and customer reserve account requirements, should the initial margin be treated similarly to how initial margin an SBSD posts to a nonbank SBSD is treated if the purpose is to enter into a transaction that hedges a transaction with a security-based swap customer? The purpose would be to accommodate an SBSD that elects to enter into a hedging transaction with a bank SBSD and must post initial margin that is segregated at a third-party custodian.

    Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and accommodating SBSDs that elect to hedge a non-cleared security-based swap transaction by entering into an off-setting transaction with a bank SBSD? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (p)(1)(ii) of Rule 15c3-3 would provide: The term excess securities collateral means securities and money market instruments carried for the account of a security-based swap customer that have a market value in excess of the current exposure of the broker or dealer (after reducing the current exposure by the amount of cash in the account) to the security-based swap customer, excluding: (A) Securities and money market instruments held in a qualified clearing agency account but only to the extent the securities and money market instruments are being used to meet a margin requirement of the clearing agency resulting from a security-based swap transaction of the security-based swap customer; and (B) securities and money market instruments held in a qualified registered security-based swap dealer account or in a third-party custodial account but only to the extent the securities and money market instruments are being used to meet a regulatory margin requirement of a security-based swap dealer resulting from the broker or dealer entering into a non-cleared security-based swap transaction with the security-based swap dealer to offset the risk of a non-cleared security-based swap transaction between the broker or dealer and the security-based swap customer.

    The potential modifications to paragraph (p)(1)(viii) of Rule 15c3-3 would provide: The term third-party custodial account means an account carried by an independent third-party custodian that meets the following conditions: (A) The account is established for the purposes of meeting regulatory margin requirements of another security-based swap dealer; (B) The account is carried by a bank; (C) The account is designated for and on behalf of the broker or dealer for the benefit of its security-based swap customers and the account is subject to a written acknowledgement by the bank provided to and retained by the broker or dealer that the funds and other property held in the account are being held by the bank for the exclusive benefit of the security-based swap customers of the broker or dealer and are being kept separate from any other accounts maintained by the broker or dealer with the bank; and (D) The account is subject to a written contract between the broker or dealer and the bank which provides that the funds and other property in the account shall at no time be used directly or indirectly as security for a loan or other extension of credit to the security-based swap dealer by the bank and, shall be subject to no right, charge, security interest, lien, or claim of any kind in favor of the bank or any person claiming through the bank.

    The potential modifications to Line 16 of Exhibit B to Rule 15c3-3 would provide: Margin related to non-cleared security-based swap transactions in accounts carried for security-based swap customers required and held in a qualified registered security-based swap dealer account at another security-based swap dealer or at a third-party custodial account.

    The potential modifications to paragraph (a)(2) of Rule 18a-4 would provide: The term excess securities collateral means securities and money market instruments carried for the account of a security-based swap customer that have a market value in excess of the current exposure of the security-based swap dealer (after reducing the current exposure by the amount of cash in the account) to the security-based swap customer, excluding (i) securities and money market instruments held in a qualified clearing agency account but only to the extent the securities and money market instruments are being used to meet a margin requirement of the clearing agency resulting from a security-based swap transaction of the security-based swap customer; and (ii) securities and money market instruments held in a qualified registered security-based swap dealer account or in a third-party custodial account but only to the extent the securities and money market instruments are being used to meet a regulatory margin requirement of another security-based swap dealer resulting from the security-based swap dealer entering into a non-cleared security-based swap transaction with the other security-based swap dealer to offset the risk of a non-cleared security-based swap transaction between the security-based swap dealer and the security-based swap customer.

    The potential modifications to paragraph (a)(10) of Rule 18a-4 would also provide: The term third-party custodial account means an account carried by an independent third-party custodian that meets the following conditions: (i) The account is established for the purposes of meeting regulatory margin requirements of another security-based swap dealer; (ii) The account is carried by a bank; (iii) The account is designated for and on behalf of the security-based swap dealer for the benefit of its security-based swap customers and the account is subject to a written acknowledgement by the bank provided to and retained by the security-based swap dealer that the funds and other property held in the account are being held by the bank for the exclusive benefit of the security-based swap customers of the security-based swap dealer and are being kept separate from any other accounts maintained by the security-based swap dealer with the bank; and (iv) The account is subject to a written contract between the security-based swap dealer and the bank which provides that the funds and other property in the account shall at no time be used directly or indirectly as security for a loan or other extension of credit to the security-based swap dealer by the bank and, shall be subject to no right, charge, security interest, lien, or claim of any kind in favor of the bank or any person claiming through the bank.

    The potential modifications to Line 14 of Exhibit A to Rule 18a-4 would provide: Margin related to non-cleared security-based swap transactions in accounts carried for security-based swap customers required and held in a qualified registered security-based swap dealer account at another security-based swap dealer or at a third-party custodial account.

    13. The 2012 Proposals required an SBSD to deduct the amount of funds held in a security-based swap customer reserve account at a single bank to the extent the amount exceeds ten percent (10%) of the equity capital of the bank as reported by the bank in its most recent Consolidated Report of Condition and Income (“Call Report”).77 This proposal was consistent with amendments to Rule 15c3-3 that at that time were still in the proposal stage.78 In 2013, the Commission adopted with modifications the amendments to Rule 15c3-3.79 The modifications increased the threshold applicable to broker-dealer customer reserve accounts held at a bank to fifteen percent (15%) and excluded cash on deposit at an affiliated bank.

    77See 2012 Proposals, 77 FR at 70282-86.

    78See Amendments to Financial Responsibility Rules for Broker-Dealers, Exchange Act Release No. 55431 (Mar. 9, 2007), 72 FR 12862 (Mar. 19, 2007).

    79See Financial Responsibility Rules for Broker-Dealers, Exchange Act Release No. 70072 (Jul. 30, 2013), 78 FR 51824, 51832-35 (Aug. 21, 2013).

    The Commission requests comment on whether, for consistency with broker-dealers, the threshold applicable to SBSD customer reserve accounts held at a bank should be increased to fifteen percent (15%) of the bank's equity capital and whether any cash deposited with an affiliated bank should be excluded. The purpose would be to more closely align the proposed segregation requirements for security-based swaps with the existing customer reserve requirements in Rule 15c3-3, as amended in 2013. Should the fifteen percent (15%) threshold not apply if the SBSD is a bank and maintains the security-based swap customer reserve account itself rather than at an affiliated or non-affiliated bank? The purpose of this exception would be to accommodate a bank SBSD that holds the customer reserve account directly.

    The changes discussed above would modify paragraph (c)(1) of proposed Rule 18a-4 and new paragraph (p)(3) of proposed Rule 15c3-3 to more closely align them with the 2013 amendments to Rule 15c3-3 and, with respect to proposed Rule 18a-4, establish an exception from the fifteen percent (15%) threshold for a bank SBSD that maintains the security-based swap customer reserve account itself. Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and providing sufficient flexibility to SBSDs in terms of locating their reserve account deposits? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    The potential modifications to paragraph (p)(3)(i) of Rule 15c3-3 would provide: In determining the amount maintained in a special reserve account for the exclusive benefit of security-based swap customers, the security-based swap dealer must deduct (A) the amount of cash deposited with a single non-affiliated bank to the extent the amount exceeds fifteen percent (15%) of the equity capital of the bank as reported by the bank in its most recent Call Report or any successor form the bank is required to file by its appropriate federal banking agency (as defined by Section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813)); and (B) the total amount of cash deposited with an affiliated bank.

    Similarly, the potential modifications to paragraph (c)(1)(i) of Rule 18a-4 would provide: In determining the amount maintained in a special reserve account for the exclusive benefit of security-based swap customers, the security-based swap dealer must deduct (A) the amount of cash deposited with a single non-affiliated bank to the extent the amount exceeds fifteen percent (15%) of the equity capital of the bank as reported by the bank in its most recent Call Report or any successor form the bank is required to file by its appropriate federal banking agency (as defined by Section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813)); and (B) for a security-based swap dealer for which there is not a prudential regulator, the total amount of cash deposited with an affiliated bank.

    The potential modifications to paragraph (c)(1)(ii) of Rule 18a-4 would provide the following exception: A security-based swap dealer for which there is a prudential regulator need not take the deduction specified in paragraph (c)(1)(i)(D) of this section if it maintains the special reserve account for the exclusive benefit of security-based swap customers itself rather than at an affiliated or non-affiliated bank.

    Substituted Compliance

    14. The 2013 Proposals would make substituted compliance with respect to capital and margin requirements available to foreign nonbank SBSDs that are not also registered as broker-dealers.80 Upon a Commission substituted compliance determination, this type of SBSD would be able to satisfy relevant capital and margin requirements by complying with corresponding requirements under a foreign regulatory system. The Commission requests comment on whether the potential modifications to the rule text in the 2012 Proposals discussed in this release would have an impact on substituted compliance determinations. If so, please explain how.

    80See 2013 Proposals, 78 FR at 31207-08.

    A number of commenters requested that the Commission consider consistency with the prudential regulators, international standards, and foreign regulators when making substituted compliance determinations with respect to the proposed nonbank SBSD capital requirements.81

    81See, e.g., ISDA 1/23/2013 Letter.

    a. Commenters generally requested additional guidance regarding the criteria the Commission would consider when making substituted compliance determinations.82 In light of the comments and the goals of this provision, the Commission requests comment on the factors it should consider in making a substituted compliance determination with respect to the proposed nonbank SBSD capital requirements of Section 15F(e) of the Act and proposed Rule 18a-1. In making a substituted compliance determination, should the Commission consider whether the capital requirements of the foreign financial regulatory system are designed to help ensure the safety and soundness of registrants in a manner that is comparable to the proposed capital requirements for nonbank SBSDs? 83 In addition, the proposed nonbank SBSD capital rule prescribes a net liquid assets test that requires the firm to have an amount of highly liquid assets that exceeds the amount of the firm's unsubordinated liabilities.84 In terms of the conditions that might be included in an order making an affirmative substituted compliance determination, should the Commission consider a condition that requires foreign nonbank SBSDs relying on the order to maintain liquid assets in excess of their unsubordinated liabilities? 85 Are there reasonable alternatives to a net liquid assets test that could be the basis for a condition that is designed to ensure the foreign nonbank SBSD maintains sufficient liquidity to meet its obligations to security-based swap customers and other creditors? If so, describe them and explain how they would achieve this objective. Would these alternatives be appropriate for a domestic nonbank SBSD that is not registered as a broker-dealer? If so, explain why. Should the Commission consider a condition that the foreign nonbank SBSD not have a disproportionate number of U.S. customers? If not, explain why.

    82See, e.g., Letter from the Coalition for Derivatives End-Users (Agricultural Retailers Association, Business Roundtable, Financial Executives International, National Association of Corporate Treasurers, National Association of Manufacturers, U.S. Chamber of Commerce) (Aug. 21, 2013).

    83See, e.g., 15 U.S.C. 78o-10(e)(3)(A).

    84See 2012 Proposals, 77 FR at 70221-25.

    85See Interpretation Guide to Net Capital Computation for Brokers and Dealers, Exchange Act Release No. 8024 (Jan. 18, 1967), 32 FR 856 (Jan. 25, 1967) (“Rule 15c3-1 (17 CFR 240.15c3-1) was adopted to provide safeguards for public investors by setting standards of financial responsibility to be met by brokers and dealers. The basic concept of the rule is liquidity; its object being to require a broker-dealer to have at all times sufficient liquid assets to cover his current indebtedness.”) (footnotes omitted); Net Capital Requirements for Brokers and Dealers, Exchange Act Release No. 15426 (Dec. 21, 1978), 44 FR 1754 (Jan. 8, 1979) (“The rule requires brokers or dealers to have sufficient cash or liquid assets to protect the cash or securities positions carried in their customers' accounts. The thrust of the rule is to insure that a broker or dealer has sufficient liquid assets to cover current indebtedness.”); Net Capital Requirements for Brokers and Dealers, Exchange Act Release No. 26402 (Dec. 28, 1989), 54 FR 315 (Jan. 5, 1989) (“The rule's design is that broker-dealers maintain liquid assets in sufficient amounts to enable them to satisfy promptly their liabilities. The rule accomplishes this by requiring broker-dealers to maintain liquid assets in excess of their liabilities to protect against potential market and credit risks.”) (footnote omitted). See also Cross-Border Security-Based Swap Activities; Re-Proposal of Regulation SBSR and Certain Rules and Forms Relating to the Registration of Security-Based Swap Dealers and Major Security-Based Swap Participants; Proposed Rule, 78 FR at 31090.

    b. The Commission requests comment on the composition of the balance sheets of entities in foreign jurisdictions that may register as nonbank SBSDs. Are the assets and liabilities of these foreign entities similar to the assets and liabilities of U.S. broker-dealers that are subject to the net liquid assets test? If not, explain the differences.

    c. The approach described in 14.a would modify Rule 3a71-6 (proposed as Exchange Act Rule 3a71-5 at 78 FR 30967, 31207-08) to describe factors that the Commission would consider in making a substituted compliance determination with respect to the proposed nonbank SBSD capital requirements.86 Would rule language as described below effect this potential modification to the rule text in the 2012 Proposals? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rule and addressing the commenters' concerns described above? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.

    86See 17 CFR 240.3a71-6.

    The potential modifications to paragraph (d)(4) of Rule 3a71-6 would provide that substituted compliance is available with respect to: The capital requirements of Section 15F(e) of the Act (15 U.S.C. 78o-10(e)) and § 240.18a-1; provided, however, that prior to making such substituted compliance determination with respect to security-based swap dealers, the Commission intends to consider (in addition to any conditions imposed) whether the capital requirements of the foreign financial regulatory system are designed to help ensure the safety and soundness of registrants in a manner that is comparable to the applicable provisions arising under the Act and its rules and regulations.

    Compliance Date

    15. In the Commission's release establishing the registration process for SBSDs and MSBSPs, the Commission provided that the compliance date for the SBSD and MSBSP registration requirements will be the later of: Six months after the date of publication in the Federal Register of final rules establishing capital, margin, and segregation requirements for SBSDs and MSBSPs; the compliance date of final rules establishing recordkeeping and reporting requirements for SBSDs and MSBSPs; the compliance date of final rules establishing business conduct requirements under Sections 15F(h) and 15F(k) of the Exchange Act; or the compliance date for final rules establishing a process for a registered SBSD or MSBSP to make an application to the Commission to allow an associated person who is subject to a statutory disqualification to effect or be involved in effecting security-based swaps on the SBSD or MSBSP's behalf (the “Registration Compliance Date”).87 Would this provide enough time for registrants to take the necessary steps to come into compliance with applicable requirements? If not, explain why. Would a longer period, such as 18 months after the date of publication of the last of four releases noted above in the Federal Register, be more appropriate? If so, explain why. Would a shorter period be more appropriate? If so, explain why. Should the Commission consider the timing of the phased implementation of initial margin requirements provided for by other regulators in making any changes to the compliance period? 88 If so, explain why.

    87See Registration Process for Security-Based Swap Dealers and Major Security-Based Swap Participants, Exchange Act Release No. 75611 (Aug. 5, 2015), 80 FR 48963 (Aug. 14, 2015).

    88See Margin and Capital Requirements for Covered Swap Entities, 80 FR at 74849-51 (adopting compliance dates phasing-in initial margin requirements beginning September 1, 2016 and ending September 1, 2020 for bank swap dealers, bank SBSDs, bank swap participants, and bank MSBSPs); Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants, 81 FR at 674-677 (adopting compliance dates phasing-in initial margin requirements beginning September 1, 2016 and ending September 1, 2020 for nonbank swap dealers and nonbank major swap participants).

    Additional Requests for Comment—Economic Implications

    16. The Proposals contain economic analyses seeking to identify and consider the benefits and costs—including the effects on efficiency, competition and capital formation—that would result from the proposed capital, margin, and segregation requirements. To assist in the quantification of the economic effects of the proposed requirements, the Commission requests comment and supporting data on the current risk management practices that support the trading activity in security-based swaps. Specifically, what are the main sources of funding available to entities that would be registering as nonbank SBSDs to support their trading activity? How much of the capital available to an entity that would be registering as a nonbank SBSD consists of liquid capital? What are typical risk management procedures for dealing with losses stemming from the market risk of security-based swap positions? What are typical risk management procedures for dealing with losses stemming from the credit risk of uncollateralized security-based swap positions? In the event that losses from trading activities overcome the available liquid capital, how are excess losses dealt with? What are the operational risks and concerns associated with maintaining adequate levels of capital?

    The Commission also requests comment and data on how the baseline of the economic analyses has changed since the publication of the Proposals. For example, in 2015, the U.S. prudential regulators and the CFTC adopted final rules on minimum margin requirements for non-cleared swaps that began to be implemented in September 2016. A June 2017 survey on dealer financing terms noted that some of the survey respondents indicated that their clients' transaction volume or their own transaction volume in non-cleared swaps decreased somewhat over the period of September 2016 to June 2017.89 However, the respondents reported no changes in the prices that they quote to their clients in non-cleared swaps over this period. One-fifth of the survey respondents also reported that they would be less likely to exchange daily variation margin with mutual funds, exchange-traded funds, pension plans, endowments, and separately managed accounts established with investment advisers due primarily to lack of operational readiness (e.g., the need to establish or update the necessary credit support annexes to cover daily exchange of variation margin) over this period. Two-fifths of the survey respondents also reported that the volume of mark and collateral disputes on variation margin has increased somewhat over this period. Furthermore, the survey noted that there is variation among respondents with respect to the number of days it takes to resolve a mark and collateral dispute on variation margin, with one-third reporting less than two days, while three-fifths reporting more than two days but less than a week, on average. This type of data could provide insight regarding how entities that may register as nonbank SBSDs may respond to the Commission's final margin requirements.

    89See Yesol Huh, Division of Research and Statistics, Board of Governors of the Federal Reserve System, The June 2017 Senior Credit Officer Opinion Survey on Dealer Financing Terms, available at https://www.federalreserve.gov/data/scoos/files/scoos_201706.pdf.

    Commenters are asked to describe changes, if applicable, in: (1) The trading volumes in the relevant security-based swap and swap markets; (2) the regulatory structure of these markets; and (3) the number and types of entities that participate in these markets. Commenters also are asked to describe how those changes in the baseline would impact the potential benefits and costs—including the effects on efficiency, competition and capital formation—of the Proposals as well as the potential benefits and costs—including the effects on efficiency, competition and capital formation—that would result from the potential alternatives described in the questions above taking the changes in the baseline into account (if applicable).

    Finally, the Commission requests comment on whether there are economic considerations apart from those discussed in the Proposals that should be considered in the economic analysis of the capital, margin, and segregation requirements as well as the alternatives described in the questions above.

    By the Commission.

    Dated: October 11, 2018. Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-22531 Filed 10-18-18; 8:45 am] BILLING CODE 8011-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 151 [Docket ID: DOD-2012-OS-0069] RIN 0790-AI89 Foreign Criminal and Civil Jurisdiction AGENCY:

    Department of Defense (DoD).

    ACTION:

    Proposed rule.

    SUMMARY:

    This rule describes procedures concerning trial by foreign criminal courts of, treatment in foreign prisons of, and the payment of counsel fees in certain civil cases for individuals referred to collectively in this rule as “dependents of DoD personnel.”

    DATES:

    Comments must be received by December 18, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and or RIN number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN). The general policy for comments and other submissions from members of the public is to make these submissions available at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Bart Wager, 703-571-9355.

    SUPPLEMENTARY INFORMATION:

    Authorities

    Taken together, two statutes authorize the Secretary of Defense to issue legally binding guidelines on the Department of Defense. Under 10 U.S.C. 113, the Secretary has “authority, direction, and control” over the Department of Defense. The Department of Defense is an “executive department,” and the Secretary, as the head of an “executive department,” is empowered under 5 U.S.C. 301 to issue departmental regulations. The General Counsel of the Department of Defense has been delegated authority under Department of Defense Directive 5145.01, “General Counsel of the Department of Defense” (available at http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/514501p.pdf), to issue this policy. Title 10 U.S.C. 1037 authorizes the payment of counsel and other fees in certain cases in foreign judicial tribunals and administrative agencies.

    Revisions Proposed by This Rule

    This rule will update 32 CFR part 151, “Status of Forces Policies and Information” which was last updated on March 28, 1980. In 1985, Section 681 of Public Law 99-145 amended 10 U.S.C. 1037 to authorize the payment of counsel fees for those “not subject to the Uniform Code of Military Justice.” So this rule proposes to update and describe procedures concerning trial by foreign criminal courts of, treatment in foreign prisons of, and the payment of counsel fees in certain civil cases for command-sponsored and non-command sponsored dependents of Armed Forces members, and dependents of nationals and non-nationals of the United States who are serving with or accompanying the Military Services.

    Summary of the Major Provisions

    For dependents of DoD personnel, when those dependents are in a foreign country as a result of accompanying DoD personnel who are assigned duty in that country—it is Department of Defense policy to (a) maximize the exercise of U.S. jurisdiction to the extent permissible under applicable status of forces agreements or other forms of jurisdiction arrangements; (b) protect, to the maximum extent possible, the rights of dependents of DoD personnel who may be subject to criminal trial by foreign courts and imprisonment in foreign prisons; and (c) secure, where possible, the release of an accused to the custody of U.S. authorities pending completion of all foreign judicial proceedings.

    A “designated commanding officer” (DCO) in each geographical area assigned to a Combatant Command is to (1) cooperate with the appropriate U.S. Chief of Mission and to the maximum extent possible, ensure that dependents of DoD personnel receive the same treatment, rights, and support as would be extended to U.S. Armed Forces members in comparable situations; (2) report informally and immediately to the General Counsel of the Department of Defense, the applicable geographic Combatant Commander, and the General Counsel and the Judge Advocate General of the respective Military Department, or, in the case of the Marine Corps, to the General Counsel of the Navy and the Staff Judge Advocate to the Commandant of the Marine Corps, or, in the case of the Coast Guard, the Judge Advocate General of the Coast Guard, about important new cases or important developments in pending cases related to such dependents; and (3) take additional steps that may be authorized under relevant international agreement(s) with the receiving State to implement the policy of this part.

    Expected Impact of the Proposed Rule

    The proposed revisions are expected to cause no change to the burden or cost to dependents of DoD personnel. DoD is not changing the process for dependents to access these services and therefore does not anticipate a change in the population of eligible DoD dependents for these services. The Department will continue to provide relevant free legal services to the dependents of DoD personnel and acceptance of these legal services is entirely voluntary.

    Regulatory Procedures Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”

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

    Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs”

    This proposed rule is not expected to be subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because this proposed rule is expected to be related to agency organization, management, or personnel.

    Section 202, Public Law 104-4, “Unfunded Mandates Reform Act” (2 U.S.C. Chapter 25)

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. This proposed rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. 601)

    The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

    Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)

    It has been determined that 32 CFR part 151 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

    Executive Order 13132, “Federalism”

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This proposed rule will not have a substantial effect on State and local governments.

    List of Subjects in 32 CFR Part 151

    Courts, Foreign relations, Military personnel, Prisons.

    Accordingly, 32 CFR part 151 is proposed to be revised to read as follows:

    PART 151—FOREIGN CRIMINAL AND CIVIL JURISDICTION Sec. 151.1 Purpose. 151.2 Applicability. 151.3 Definitions. 151.4 Policy. 151.5 Responsibilities. 151.6 Procedures. Authority:

    10 U.S.C. chapter 47, 10 U.S.C. 1037.

    § 151.1 Purpose.

    This rule establishes policy, assigns responsibilities, and prescribes procedures, supplemental to those provided in DoD Instruction 5525.01 “Foreign Criminal and Civil Jurisdiction,” which will be made available at http://www.esd.whs.mil/Directives/issuances/dodi/, concerning trial by foreign criminal courts of, treatment in foreign prisons of, and the payment of counsel fees in certain civil cases for the following individuals, referred to collectively in this rule as “dependents of DoD personnel,” when those individuals are in a foreign country as a result of accompanying DoD personnel who are assigned duty in that country:

    (a) Command-sponsored and non-command sponsored dependents of Armed Forces members;

    (b) Dependents of nationals and non-nationals of the United States who are serving with or accompanying the Military Services (referred to in this rule as “non-military DoD personnel”) in an area outside the United States and its territories and possessions, the Commonwealth of the Northern Mariana Islands, and the Commonwealth of Puerto Rico (referred to collectively in this rule as “outside the United States”);

    (c) Dependents of DoD personnel serving under a U.S. Chief of Mission are not considered to be “dependents of DoD personnel” for the purposes of this rule.

    § 151.2 Applicability.

    This part applies to the Office of the Secretary of Defense, the Military Departments (including the Coast Guard at all times, including when it is a Service in the Department of Homeland Security by agreement with that Department), the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD.

    § 151.3 Definitions.

    These terms and their definitions are for the purposes of this part.

    Armed Forces. As set forth in 10 U.S.C. 101(a)(4), the Army, Navy, Air Force, Marine Corps, and Coast Guard.

    Designated commanding officer (DCO). The military officer who is designated by the appropriate geographic Combatant Commander to fulfill the duties outlined in this part.

    Non-military DoD personnel. Nationals and non-nationals of the United States who are serving with or accompanying the Armed Forces in an area outside the United States and its territories and possessions, the northern Mariana Islands, and the Commonwealth of Puerto Rico.

    DoD personnel. Armed Forces members and non-military DoD personnel. Armed Forces members and non-military DoD personnel serving under a U.S. Chief of Mission are not considered to be “DoD personnel” as defined in this part.

    § 151.4 Policy.

    (a) The Department of Defense will, for dependents of DoD personnel when those dependents are in a foreign country accompanying DoD personnel who are assigned duty to that foreign country:

    (1) Maximize the exercise of U.S. jurisdiction to the extent permissible under applicable status of forces agreements or other forms of jurisdiction arrangements.

    (2) Protect, to the maximum extent possible, the rights of dependents of DoD personnel who may be subject to criminal trial by foreign courts and imprisonment in foreign prisons.

    (3) Secure, where possible, the release of an accused to the custody of U.S. authorities pending completion of all foreign judicial proceedings.

    (b) [Reserved]

    § 151.5 Responsibilities.

    (a) The Secretaries of the Military Departments ensure the adequacy of regulations in establishing an information and education policy on the laws and customs of the host country for dependents of DoD personnel assigned to foreign areas.

    (b) For each country in their respective assigned area of responsibility (AOR), the geographic Combatant Commanders:

    (1) Oversee Command implementation of the procedures in this part.

    (2) Oversee DCO responsibilities, as described in paragraphs (c)(1) through (c)(4) of this section.

    (c) DCO responsibilities. The DCOs:

    (1) Are responsible for formal invocation, where applicable, of the Senate resolution procedure in each foreign country where dependents of DoD personnel are present, consistent with the U.S. Senate Resolution of Ratification, with reservations, to the North Atlantic Treaty Organization Status of Forces Agreement, as agreed to by the Senate on July 15, 1953.

    (2) In cooperation with the appropriate U.S. Chief of Mission and to the maximum extent possible, ensure dependents of DoD personnel receive the same treatment, rights, and support as Armed Forces members when in the custody of foreign authorities, or when confined (pre-trial and post-trial) in foreign penal institutions. DCOs will work with the appropriate U.S. Chief of Mission to make appropriate diplomatic contacts for dependents of DoD personnel who are not U.S. nationals.

    (3) Report informally and immediately to the General Counsel of the Department of Defense, the applicable geographic Combatant Commander, and the General Counsel and the Judge Advocate General of the respective Military Department or, in the case of the U.S. Marine Corps (USMC), to the General Counsel of the Navy and the Staff Judge Advocate to the Commandant of the Marine Corps, or, in the case of the Coast Guard, the Judge Advocate General of the Coast Guard, about important new cases or important developments in pending cases. Important cases include, but are not limited to, instances of denial of the procedural safeguards under any applicable agreement; deficiency in the treatment or conditions of confinement in foreign penal institutions; or arbitrary denial of permission to visit dependents of DoD personnel.

    (4) Take additional steps that may be authorized under relevant international agreements with the receiving State to implement the policy of this part.

    § 151.6 Procedures.

    (a) Request to foreign authorities not to exercise their criminal and civil jurisdiction over dependents. The procedures in this section will be followed when it appears that foreign authorities may exercise criminal jurisdiction over dependents of DoD personnel:

    (1) When the DCO determines, after a careful consideration of all the circumstances, including consultation with the Department of Justice where the matter involves possible prosecution in U.S civilian courts, that suitable action can be taken under existing U.S. laws or administrative regulations, the DCO may request the local foreign authorities to waive the exercise of criminal jurisdiction.

    (2) When it appears possible that the accused may not obtain a fair trial, the commander exercising general court-martial jurisdiction over the command to which such persons are attached or with which they are associated will communicate directly with the DCO, reporting the full facts of the case. The DCO will then determine, in the light of legal procedures in effect in that country, if there is a risk that the accused will not receive a fair trial. If the DCO determines that there is a risk that the accused will not receive a fair trial, the DCO will decide, after consultation with the U.S. Chief of Mission, whether a request should be submitted through diplomatic channels to foreign authorities seeking their assurances of a fair trial for the accused or, in appropriate circumstances, that they waive the exercise of jurisdiction over the accused. If the DCO so decides, a recommendation will be submitted through the geographic Combatant Commander and the Chairman of the Joint Chiefs of Staff to the Secretary of Defense. Copies must be provided to the Secretary concerned and the GC DoD.

    (b) Trial observers and trial observers' reports. (1) U.S. observers at trials before courts of the receiving country (referred to in this rule as “trial observers”) must attend and prepare formal reports in all cases of trials by foreign courts or tribunals of dependents of DoD personnel, except for minor offenses. In cases of minor offenses, the observer will attend the trial at the discretion of the DCO, but will not be required to make a formal report.

    (i) Unless directed by the DCO, trial observers are not required to attend all preliminary proceedings, such as scheduling hearings, but will attend the trial on the merits and other pre- and post-trial proceedings where significant procedural or substantive matters are decided.

    (ii) Trial observer reports regarding dependents of DoD personnel will be handled and processed pursuant to DoD Instruction 5525.01(4)(b-c).

    (2) The DCO, upon receipt of a trial observer report, will be responsible for determining whether:

    (i) There was any failure to comply with the procedural safeguards secured by the pertinent status of forces agreement.

    (ii) The accused received a fair trial under all the circumstances. Due regard should be given to those fair trial rights listed in DoD Instruction 5525.01 “Foreign Criminal and Civil Jurisdiction,” Enclosure 5, “Fair Trial Guarantees” that are relevant to the particular facts and circumstances of the trial. A trial will not be determined to be unfair merely because it is not conducted in a manner identical to trials held in the United States.

    (A) If the DCO believes that the procedural safeguards specified in pertinent agreements were denied or that the trial was otherwise unjust, the DCO will submit a recommendation as to appropriate action to rectify the trial deficiencies and otherwise to protect the rights or interests of the accused. This recommendation must include a statement of efforts taken or to be taken at the local level to protect the rights of the accused.

    (B) The DCO will submit the recommendation to the Secretary of Defense, through the Under Secretary of Defense for Policy (with an advance copy to the General Counsel of the Department of Defense); copies must be provided to the geographic Combatant Commander concerned, the General Counsel and the Judge Advocate General of the Military Department concerned or, in the case of the USMC, to the General Counsel of the Navy and the Staff Judge Advocate to the Commandant of the Marine Corps, or, in the case of the Coast Guard, the Judge Advocate General of the Coast Guard, and the Chairman of the Joint Chiefs of Staff.

    (c) Counsel fees and related assistance for U.S. personnel not subject to the UCMJ. In cases of exceptional interest to the Military Department concerned or the Department of Homeland Security involving non-military DoD personnel, the Secretary of that Military Department or the Secretary of Homeland Security may approve, pursuant to 10 U.S.C. 1037, under the following circumstances:

    (1) Criminal cases. Requests for the provision of counsel fees and payment of expenses in criminal cases may be approved in pre-trial, trial, appellate, and post-trial proceedings in any criminal case where:

    (i) The sentence that is normally imposed includes confinement, whether or not such sentence is suspended;

    (ii) Capital punishment might be imposed;

    (iii) An appeal is made from any proceeding in which there appears to have been a denial of the substantial rights of the accused;

    (iv) The case, although not within the criteria established in paragraphs (c)(1)(i) through (c)(1)(iii) of this section, is considered to have significant impact on U.S. interests, including upon the relations of the Armed Forces with the host country.

    (2) Civil cases. Requests for provision of counsel fees and payment of expenses in civil cases may be granted in trial and appellate proceedings in civil cases where the case is considered to have a significant impact on the relations of the Armed Forces with the host country; or in cases brought against eligible non-military DoD personnel (and in exceptional cases, by such personnel) if the case is considered to involve any other U.S. interest.

    (3) Funding restrictions. (i) No funds will be provided under this part in cases where the U.S. Government is—in actuality or in legal effect—the plaintiff or the defendant; all such cases shall be referred to the Department of Justice, Office of Foreign Litigation. No funds will be provided under this part in cases where the non-military DoD personnel member is a plaintiff without prior authorization of the Secretary of the Military Department concerned or the Secretary of Homeland Security. The provisions of this paragraph also are applicable to proceedings with civil aspects that are brought by eligible personnel as criminal cases in accordance with local law. Funds for the posting of bail or bond to secure the release of non-military DoD personnel from confinement will be used as provided by applicable Armed Force regulations.

    (ii) No funds will be provided under paragraph (c)(2) of this section to a plaintiff who, if successful, will receive an award, in whole or in part, from the United States.

    (iii) As provided for in 10 U.S.C. 1037, a person on whose behalf a payment is made under this provision is not liable to reimburse the United States for that payment, unless he or she is responsible for the forfeiture of bail provided for him or her under this provision.

    (d) Treatment of dependents confined in foreign penal institutions. In cooperation with the appropriate U.S. Chief of Mission and to the maximum extent possible, military commanders will ensure that dependents of DoD personnel receive the same treatment, rights, and support as would be extended to Armed Forces members when in the custody of foreign authorities, or when confined (pretrial and post-trial) in foreign penal institutions. Commanders will work with the appropriate U.S. Chief of Mission to make appropriate diplomatic contacts for the categories of dependents described in this section who are not U.S. nationals.

    (e) Information policy. The general public and the Congress must be provided promptly with the maximum information concerning status of forces matters that are consistent with the national interest. Information will be coordinated and provided to the public and the Congress in accordance with established procedures, including those in DoD Directive 5122.05, “Assistant Secretary of Defense for Public Affairs (ASD(PA))” (available at http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/512205_dodd_2017.pdf?ver=2017-08-07-125832-023), 32 CFR part 286, 32 CFR part 310, and DoD Instruction 5400.04, “Provision of Information to Congress” (available at http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/540004p.pdf).

    Dated: October 15, 2018. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-22752 Filed 10-18-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0962] RIN 1625-AA00 Safety Zone; NASA Activities, Gulf of Mexico, Galveston, TX AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard is proposing to establish a temporary, moving safety zone for all navigable waters within a 1000-yard radius of the National Aeronautics and Space Administration's (NASA's) crew module uprighting system test article while it is being tested in the territorial waters of the Gulf of Mexico off the coast of Galveston, TX. The safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards created by vessels and equipment engaged in the crew capsule's at-sea testing. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector Houston-Galveston or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before November 5, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0962 using the Federal eRulemaking Portal at https://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Lieutenant Collin Sykes, Eighth Coast Guard District, Waterways Management Division, U.S. Coast Guard; telephone 504-671-2119, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations CMUS Crew module uprighting system COTP Captain of the Port Sector Houston-Galveston DHS Department of Homeland Security FR Federal Register NASA National Aeronautics and Space Administration NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    The National Aeronautics and Space Administration's (NASA's) Orion program is evaluating an updated design to the crew module uprighting system (CMUS), the system of five airbags on top of the crew capsule that inflate upon splashdown. NASA tested the CMUS at the Neutral Buoyancy Lab at NASA's Johnson Space Center in Houston, and requested Coast Guard support for the at-sea uprighting tests. The at-sea testing will involve numerous surface vessels, divers, and remote-operated submarine vehicles, and features a rapid rotation of the Orion test article in a confined area and partially controlled environment. Due to the complexity of the test and proximity of the participants, unauthorized access by persons or vessels outside the scope of the test present a significant hazard to human life, vessels, and government property. The Captain of the Port Sector Houston-Galveston (COTP) has determined that this rule is needed to protect persons, vessels, and the marine environment on the navigable waters within the safety zone during the test.

    The purpose of this rulemaking is to ensure the safety of persons, vessels, and the marine environment on the navigable waters within a 1000-yard radius of the CMUS test article before, during, and after the scheduled testing activities.

    The Coast Guard is issuing this notice of proposed rulemaking (NPRM) with a 15-day prior notice and opportunity to comment pursuant to section (b)(3) of the Administrative Procedure Act (APA) (5 U.S.C. 553). Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for publishing this NPRM with a 15-day comment period because it is impractical to provide a 30-day comment period. It is impracticable to publish an NPRM with a 30-day comment period because we must establish this temporary safety zone by November 28, 2018. A 15-day comment period would allow the Coast Guard to provide for public notice and comment, but also publish a rule, if adopted, soon enough that the length of the notice and comment period does not compromise public safety.

    III. Discussion of Proposed Rule

    The COTP is proposing to establish a temporary, moving safety zone that would cover all navigable waters within 1000 yards of NASA's CMUS test article, which will be located in the territorial waters of the Gulf of Mexico off the coast of Galveston, TX. NASA anticipates that the testing activities will take place on approximately three days during the effective period, during daylight hours only. The effective period of this proposed rule covers a nine day window from November 28, 2018 through December 6, 2018, to allow for scheduling delays due to inclement weather or technical difficulties. On each of the approximately three days that the proposed rule would be enforced, the enforcement periods would begin approximately 2 hours before testing activities and last until approximately 2 hours after the testing activities. The COTP or a designated representative would inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), and/or other means of public notice, as appropriate, at least 3 hours in advance of each enforcement period. Such notice of enforcement would also include more specific information regarding the location of the CMUS test article.

    The duration of the proposed zone is intended to protect persons, vessels, and the marine environment on these navigable waters during the NASA testing activities. No vessel or person would be permitted to enter or remain in the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel, and a Federal, State, and local officer designated by or assisting the COTP in the enforcement of the safety zone. The Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM”. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times, dates, and locations, for this safety zone through BNMs, LNMs, and/or MSIBs, as appropriate. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

    We developed this proposed 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 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which would affect a small, designated area off the coast of Galveston, TX, outside of the Houston Ship Channel and safety fairway during daylight hours on approximately three days. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed 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. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination 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 proposed rule involves a temporary, moving safety zone that would prohibit entry within 1000 yards of the CMUS test article during daylight hours on approximately three days in the Gulf of Mexico. Normally, such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is 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 proposed 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.

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit https://www.regulations.gov/privacyNotice.

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    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 is proposing to amend 33 CFR part 165 as follows:

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

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

    2. Add § 165.T08-0962 to read as follows:
    § 165.T08-0962 Safety Zone; NASA Activities, Gulf of Mexico, Galveston, TX.

    (a) Location. The following area is a safety zone: All navigable waters within 1,000 yards of the National Aeronautics and Space Administration's (NASA's) crew module uprighting system test article.

    (b) Effective period. This section will be effective from November 28, 2018 through December 6, 2018.

    (c) Enforcement periods. This section will be enforced on approximately 3 days during the effective period, during daylight hours. Each period of enforcement will begin approximately 2 hours before testing activities and end approximately 2 hours after testing activities. The Captain of the Port Sector Houston-Galveston (COTP) or a designated representative will inform the public of the enforcement through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) or other means of public notice at least 3 hours in advance of the enforcement of this safety zone. Such notice of enforcement will also include more specific information regarding the location of the CMUS test article.

    (d) Regulations. (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or a designated representative. A designated representative is a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel, and a Federal, State, and local officer designated by or assisting the COTP) in the enforcement of the safety zone. The Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM”.

    (2) To seek permission to enter, contact the COTP or a designated representative by VHF Channel 16.

    (3) If granted permission to enter, all vessels must transit at their slowest safe speed and comply with all lawful orders or directions of the COTP or a designated representative.

    (e) Informational broadcasts. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) or other means of public notice of the enforcement period for the temporary safety zone as well as any changes in the dates and times of enforcement.

    Dated: October 16, 2018. Kevin D. Oditt, Captain, U.S. Coast Guard, Captain of the Port Sector Houston-Galveston.
    [FR Doc. 2018-22866 Filed 10-18-18; 8:45 am] BILLING CODE 9110-04-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 63 [WC Docket No. 17-84; Report No. 3101] Petition for Reconsideration of Action in Rulemaking Proceeding; Correction AGENCY:

    Federal Communications Commission.

    ACTION:

    Petition for Reconsideration; correction.

    SUMMARY:

    The Federal Communications Commission (Commission) published a document in the Federal Register of September 19, 2018 (83 FR 47325), regarding a Petition for Reconsideration (Petition) filed in the Commission's rulemaking proceeding. The document contained the incorrect deadline for filing replies to an opposition to the Petition. This document corrects the deadline for replies to an opposition to the Petition.

    DATES:

    October 19, 2018.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Michele Berlove, Wireline Competition Bureau, at: (202) 418-1477; email: [email protected]

    SUPPLEMENTARY INFORMATION: Correction

    In the Federal Register of September 19, 2018, in FR Doc. 2018-20238, on page 47325, in the third column, and on page 47326 in the first column, correct the DATES section to read:

    DATES:

    Oppositions to the Petition must be filed on or before October 4, 2018. Replies to an opposition must be filed on or before October 15, 2018.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-22357 Filed 10-18-18; 8:45 am] BILLING CODE 6712-01-P
    83 203 Friday, October 19, 2018 Notices DEPARTMENT OF AGRICULTURE Rural Utilities Service Information Collection Activity; Comment Request AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture's (USDA) Rural Utilities Service (RUS) invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).

    DATES:

    Comments on this notice must be received by December 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB as a revision to an existing collection. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email: [email protected]

    Title: 7 CFR part 1728, Electric Standards and Specifications for Materials and Construction.

    OMB Control Number: 0572-0131.

    Type of Request: Extension of a currently approved collection.

    Abstract: RUS provides loans and loan guarantees in accordance with the Rural Electrification Act of 1936, 7 U.S.C. 901 et seq., as amended, (RE Act). Section 4 of the RE Act requires that the Agency make or guarantee a loan only if there is reasonable assurance that the loan, together with all outstanding loans and obligations of the Borrower, will be repaid in full within the time agreed. In order to facilitate the programmatic interests of the RE Act and, in order to assure that loans made or guaranteed by the Agency are adequately secure, RUS, as a secured lender, has established certain standards and specifications for materials, equipment, and the construction of electric systems. The use of standards and specifications for materials, equipment and construction units helps assure the Agency that: (1) Appropriate standards and specifications are maintained; (2) RUS loan security is not adversely affected, and; (3) Loan and loan guarantee funds are used effectively and for the intended purposes. The regulation, 7 CFR part 1728, establishes Agency policy that materials and equipment purchased by RUS Electric Borrowers or accepted as contractor-furnished material must conform to Agency standards and specifications where established and, if included in RUS Publication IP 202-1, “List of Materials Acceptable for Use on Systems of Agency Electrification Borrowers” (List of Materials), must be selected from that list or must have received technical acceptance from RUS.

    Estimate of Burden: This collection of information is estimated to average 20 hours per response.

    Respondents: Business or other for-profits.

    Estimated Number of Respondents: 38.

    Estimated Number of Responses per Respondent: 2.63.

    Estimated Total Annual Burden on Respondents: 2,000 hours.

    Copies of this information collection can be obtained from Robin M. Jones, Innovation Center, at (202) 772-1172, Email: [email protected]

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Dated: October 15, 2018. Christopher A. McLean, Acting Administrator, Rural Utilities Service.
    [FR Doc. 2018-22824 Filed 10-18-18; 8:45 am] BILLING CODE P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Sunshine Act Meeting TIME AND DATE:

    October 24, 2018, 10:00 a.m. EDT.

    PLACE:

    U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW, Suite 910, Washington, DC 20006.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on Wednesday, October 24, 2018, at 10 a.m. EDT in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW, Suite 910. The Board will discuss open investigations, the status of audits from the Office of the Inspector General, financial and organizational updates. New business will include an overview of items related to a new “Dust Hazards Perception Report,” a factual update on the CSB's ongoing Kuraray investigation, and a discussion and possible vote on a policy regarding employee participation in CSB investigations.

    Additional Information

    The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the CONTACT PERSON FOR FURTHER INFORMATION, at least three business days prior to the meeting.

    A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference:

    Dial In: 1 (630) 691-2748 Audience US Toll.

    Confirmation Number: 47604548.

    The CSB is an independent federal agency charged with investigating incidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

    Public Comment

    The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.

    CONTACT PERSON FOR MORE INFORMATION:

    Hillary Cohen, Communications Manager, at [email protected] or (202) 446-8094. Further information about this public meeting can be found on the CSB website at: www.csb.gov.

    Dated: October 16, 2018. Raymond Porfiri, Deputy General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2018-22934 Filed 10-17-18; 11:15 am] BILLING CODE 6350-01-P
    CIVIL RIGHTS COMMISSION Sunshine Act Meeting Notice AGENCY:

    United States Commission on Civil Rights.

    ACTION:

    Notice of Commission public briefing, Are Rights a Reality? Evaluating Federal Civil Rights Enforcement.

    DATES:

    Friday, November 2, 2018, 9:00 a.m. ET.

    ADDRESSES:

    Place: National Place Building, 1331 Pennsylvania Ave. NW, 11th Floor, Suite 1150, Washington, DC 20245 (Entrance on F Street NW).

    FOR FURTHER INFORMATION CONTACT:

    Brian Walch, (202) 376-8371; TTY: (202) 376-8116; [email protected].

    SUPPLEMENTARY INFORMATION:

    The U.S. Commission on Civil Rights will hold a public briefing to evaluate federal civil rights enforcement, examining in particular Fiscal Years 2016 through 2018. With this assessment, the Commission asks: What are the key elements for effective civil rights enforcement? Do federal agencies have sufficient resources to fulfill their enforcement responsibilities? Most importantly, is the federal government satisfying its obligation to the American people to protect and vindicate their civil rights, including in education, housing, healthcare, employment, policing, the justice system, and other areas?

    Commissioners will hear from current and former senior federal government officials, academic and legal experts, and advocates. We will also offer an open comment session in which members of the public will be able to address the Commission (see below).

    The Commission will issue a report from this investigation in fall 2019, including findings and recommendations.

    This briefing is open to the public. The event will also live-stream at https://www.youtube.com/user/USCCR/videos. (Please note that streaming information is subject to change.) If attending in person, we ask that you RSVP to [email protected]. Persons with disabilities who need accommodation should contact Pamela Dunston at 202-376-8105 or at [email protected] at least seven (7) business days before the date of the meeting.

    We will offer an open comment session in which members of the public will be able to address the Commission. Detailed information on this open comment session will be announced on the Commission's website (www.usccr.gov), Twitter (www.twitter.com/USCCRgov), and Facebook (www.facebook.com/USCCRgov/) in advance of the briefing.

    In addition, the Commission welcomes the submission of additional material for consideration as we prepare our report. Please submit such information to [email protected] no later than December 17, 2018.

    Are Rights a Reality? Evaluating Federal Civil Rights Enforcement Introductory Remarks: Chair Catherine E. Lhamon: 9:00 a.m.-9:10 a.m. Panel One: Current and Former Federal Agency Officials, Larger Civil Rights Offices: 9:10 a.m.-10:40 a.m. Panel Two: Current and Former Federal Agency Officials, Smaller Civil Rights Offices: 10:50 a.m.-12:10 p.m. Panel Three: Advocates and Community Experts in Civil Rights Enforcement: 1:10 p.m.-2:30 p.m. Panel Four: Academics and Legal Experts in Civil Rights Enforcement: 2:40 p.m.-4:00 p.m. Open Public Comment Session: 5:00 p.m.-6:00 p.m. Adjourn: 6:00 p.m. Dated: October 17, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-22963 Filed 10-17-18; 11:15 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the West Virginia Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that a meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12 p.m. (EST) on Friday, November 2, 2018. The purpose of the meeting is to discuss plans for preparing the Committee report on the collateral consequences of a felony record on West Virginians' access to employment, housing, professional licenses and public benefits.

    DATES:

    Friday, November 2, at 12 p.m. EST.

    Public Call-In Information: Conference call-in number: 1-877-604-9665 and conference call ID: 5788080.

    FOR FURTHER INFORMATION CONTACT:

    Ivy Davis at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-604-9665 and conference call ID: 5788080. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call-in number: 1-877-604-9665 and conference call ID: 5788080.

    Members of the public are invited to submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Corrine Sanders at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=279, click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

    Agenda: Friday, November 2, 2018 I. Rollcall II. Welcome III. Planning Discussion IV. Other Business V. Adjourn Dated: October 16, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-22870 Filed 10-18-18; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Bureau of the Census [Docket Number: 180920854-8854-01] Suspension of the Geographically Updated Population Certification Program for Places Incorporating or Annexing Between Censuses AGENCY:

    Bureau of the Census, Department of Commerce.

    ACTION:

    Notice of suspension of program.

    SUMMARY:

    This document serves as notice to state and local governments and to other federal agencies that beginning on January 1, 2019, the Bureau of the Census (Census Bureau) will suspend the Geographically Updated Population Certification Program for three years—the year preceding the decennial census, the decennial census year, and the year following it—to accommodate the 2020 Census operation. During this time, the Census Bureau will not provide the operations necessary to determine the updated April 1, 2010 census population and housing unit counts for entities that: Annex territory; incorporate or organize as counties; or incorporate or organize as boroughs, cities, towns, villages, townships, or other general purpose governments. However, the Census Bureau will consider all requests for population and housing count updates received in writing before January 1, 2019.

    DATES:

    As of January 1, 2019, the Geographically Updated Population Certification Program will be suspended. It will remain suspended until December 31, 2021.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Darryl Cohen, Population Division, U.S. Census Bureau, 4600 Silver Hill Road, Washington, DC 20233, telephone (301) 763-2419, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Census Bureau first began to make updated decennial census count determinations to reflect geographic boundary changes in 1972 in response to the requests of local governments to establish eligibility for participation in the General Revenue Sharing Program, authorized under Public Law 92-512. At that time, the Census Bureau established a fee-for-service program enabling entities with annexations to obtain updated decennial census population counts that reflected the population living in the annexed areas. The Census Bureau also received funding from the U.S. Department of the Treasury to make those determinations for larger annexations that met prescribed criteria and for new incorporations. The General Revenue Sharing Program ended on September 30, 1986, but the certification program continued into 1988 with support for the Census Bureau. The program was suspended to accommodate the 1990 Census operations and resumed in 1992. The Census Bureau supported the program through fiscal year 1995 for cities with large annexations and through fiscal year 1996 for new incorporated places. The program was continued on a fee-for-service basis only until June 1, 1998, at which time it was suspended for the 2000 Census (see the Federal Register, 63 FR 27706, May 20, 1998). In 2002, the program was resumed and has since been referred to as the Geographically Updated Population Certification Program or GUPCP (see the Federal Register, 67 FR 72095, December 4, 2002). As was the case for two previous censuses, the program was suspended to accommodate the 2010 Census operations (see the Federal Register, 72 FR 46602, August 21, 2007). The suspension began on January 1, 2008 and ended on December 31, 2012 (see the Federal Register, 78 FR 54863, September 6, 2013).

    The Census Bureau is suspending the program for the year immediately preceding, the year of, and year following the 2020 Census to permit allocation of necessary resources to the decennial census. However, all requests for population and housing count updates received before January 1, 2019 will be considered. The Census Bureau will announce in a future Federal Register notice the date that the program will resume. The Census Bureau plans to resume the program in the year 2022, after 2020 Census data become available, for those entities that desire the service provided that any and all costs associated with this work are borne by the local governmental entity.

    Authority to continue this program on a fee-for-service basis is contained in Title 13, United States Code, Section 8.

    Dated: October 15, 2018. Ron S. Jarmin, Deputy Director, Performing the Non-Exclusive Functions and Duties of the Director, Bureau of the Census.
    [FR Doc. 2018-22823 Filed 10-18-18; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Luis Antonio Urdaneta Pozo, Inmate Number: 68375-018, FCI Edgefield, P.O. Box 725, Edgefield, SC 29824; Order Denying Export Privileges

    On June 27, 2017, in the U.S. District Court for the Southern District of Florida, Luis Antonio Urdaneta Pozo (“Pozo”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Pozo was convicted of knowingly and willfully exporting from the United States to Venezuela items designated as defense articles on the United States Munitions List, namely, handguns and ammunition of various calibers, without the required U.S. Department of State licenses. Pozo was sentenced to 63 months in prison, three years of supervised release, and a $100 special assessment.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13,222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39,871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Pozo's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Pozo to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Pozo.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Pozo's export privileges under the Regulations for a period of 10 years from the date of Pozo's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Pozo had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until June 27, 2027, Luis Antonio Urdaneta Pozo, with a last known address of Inmate Number: 68375-018, FCI Edgefield, P.O. Box 725, Edgefield, SC 29824, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Pozo by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Pozo may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Pozo and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until June 27, 2027.

    Issued this October 12, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-22865 Filed 10-18-18; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-201-830] Carbon and Certain Alloy Steel Wire Rod From Mexico: Preliminary Affirmative Determination of Circumvention of the Antidumping Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that imports of carbon and certain alloy steel wire rod (wire rod) with actual diameters less than 4.75 mm produced and/or exported by Deacero S.A.P.I. de C.V (Deacero) are circumventing the antidumping duty order on wire rod from Mexico.

    DATES:

    Applicable October 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Samuel Brummitt, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7851.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 31, 2001, Co-Steel Raritan, Inc., GS Industries, Keystone Consolidated, Industries, Inc., and North Star Steel Texas, Inc. filed a petition seeking imposition of antidumping duties on imports of wire rod from Mexico.1 Following the completion of investigations and affirmative final determinations by Commerce and the U.S. International Trade Commission (ITC), Commerce issued an antidumping order on wire rod from Mexico (Order).2 On October 1, 2012, pursuant to section 781(c) of the Tariff Act of 1930, as amended (the Act), Commerce determined that wire rod with an actual diameter of 4.75 mm to 5.00 mm produced and/or exported to the United States by Deacero constituted merchandise altered in form or appearance in such minor respects that it should be included within the scope of the Order. 3 On October 27, 2017, Nucor Corporation (a domestic interested party) (Nucor) filed a circumvention ruling request to determine whether wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero to the United States is circumventing the Order. 4 On February 7, 2018, pursuant to section 781(c) of the Act, Commerce initiated an anti-circumvention inquiry on wire rod with actual diameters that are less than 4.75 mm produced and/or exported by Deacero.5 For a complete description of the events that followed the initiation of this inquiry, see the Preliminary Decision Memorandum.6 A list of topics included in the Preliminary Decision Memorandum is included at the Appendix to this notice. The Preliminary Decision Memorandum is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Commerce building. In addition, a complete public version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Notice of Initiation of Antidumping Duty Investigations: Carbon and Certain Alloy Steel Wire Rod from Brazil, Canada, Egypt, Germany, Indonesia, Mexico, Moldova, South Africa, Trinidad and Tobago, Ukraine, and Venezuela, 66 FR 50164 (October 2, 2001).

    2See Notice of Antidumping Duty Orders: Carbon and Certain Alloy Steel Wire Rod from Brazil, Indonesia, Mexico, Moldova, Trinidad and Tobago, and Ukraine, 67 FR 65945 (October 29, 2002) (Order).

    3See Carbon and Certain Alloy Steel Wire Rod from Mexico: Affirmative Final Determination of Circumvention of the Antidumping Duty Order, 77 FR 59892 (October 1, 2012) (Final Circumvention Determination) and accompanying Issues and Decision Memorandum; see also Deacero S.A. de C.V. v. United States, 817 F.3d 1332 (Fed. Cir. 2016) (affirming the Final Circumvention Determination).

    4See Nucor's Letter, “Carbon and Certain Alloy Steel Wire Rod from Mexico: Request for Circumvention Ruling,” dated October 27, 2018.

    5See Carbon and Certain Alloy Steel Wire Rod from Mexico: Initiation of Anti-Circumvention Inquiry of Antidumping Duty Order, 83 FR 5405 (February 7, 2018).

    6See Affirmative Preliminary Decision Memorandum of Circumvention Concerning Carbon and Certain Alloy Steel Wire Rod from Mexico, dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Order

    The products covered by the Order are wire rod of approximately round cross section, 5.00 mm or more, but less than 19.00 mm, in solid cross-sectional diameter. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

    Scope of the Anti-Circumvention Inquiry

    The products covered by this inquiry are wire rod with an actual diameter less than 4.75 mm and that are produced and/or exported to the United States by Deacero.

    Methodology

    Commerce is conducting this anti-circumvention inquiry in accordance with section 781(c) of the Act. For a full description of the methodology underlying Commerce's preliminary determination, see the Preliminary Decision Memorandum.

    Preliminary Determination

    As detailed in the Preliminary Decision Memorandum, we preliminarily determine, pursuant to section 781(c) of the Act, that wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero, constitutes merchandise “altered in form or appearance in minor respects” that should be considered subject to the Order. Therefore, we preliminarily determine that it is appropriate to include this merchandise within the class or kind of merchandise subject to the Order and to instruct U.S. Customs and Border Protection (CBP) to suspend any entries of wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero.

    Suspension of Liquidation

    As stated above, Commerce has made a preliminary affirmative finding of circumvention of the Order with respect to wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero. In accordance with section 19 CFR 351.225(l)(2), Commerce will direct CBP to suspend liquidation of entries of wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero that were entered, or withdrawn from warehouse, for consumption on or after February 7, 2018, the date of initiation of the anti-circumvention inquiry. Pursuant to 19 CFR 351.225(1)(2), we will also instruct CBP to require a cash deposit of estimated duties equal to 12.56 percent ad valorem for each unliquidated entry of wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero that was entered, or withdrawn from warehouse, for consumption on or after February 7, 2018.7 The suspension of liquidation instructions will remain in effect until further notice.

    7See Carbon and Certain Alloy Steel Wire Rod from Mexico: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016, 83 FR 16832 (April 17, 2018) and accompanying Issues and Decision Memorandum; Carbon and Certain Alloy Steel Wire Rod from Mexico: Notice of Correction to Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016, 83 FR 19223 (May 2, 2018).

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 21 days after the publication of this preliminary determination in the Federal Register, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline date for case briefs.8 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this anti-circumvention inquiry are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

    8See 19 CFR 351.309; see also 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 21 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 781(c) of the Act and 19 CFR 351.225(f).

    Dated: October 15, 2018. Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Statutory and Regulatory Framework V. Prior Anti-Circumvention Determination VI. Parameters of the Anti-Circumvention Inquiry VII. Arguments from Interested Parties VIII. Analysis IX. Recommendation
    [FR Doc. 2018-22843 Filed 10-18-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Subsidy Programs Provided by Countries Exporting Softwood Lumber and Softwood Lumber Products to the United States; Request for Comment AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) seeks public comment on any subsidies, including stumpage subsidies, provided by certain countries exporting softwood lumber or softwood lumber products to the United States during the period January 1, 2018, through June 30, 2018.

    DATES:

    Comments must be submitted within 30 days after publication of this notice.

    ADDRESSES:

    See the Submission of Comments section below.

    FOR FURTHER INFORMATION CONTACT:

    Kristen Johnson or Eric B. Greynolds, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4793 or (202) 482-6071, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On June 18, 2008, section 805 of Title VIII of the Tariff Act of 1930 (the Softwood Lumber Act of 2008) was enacted into law. Under this provision, the Secretary of Commerce is mandated to submit to the appropriate Congressional committees a report every 180 days on any subsidy provided by countries exporting softwood lumber or softwood lumber products to the United States, including stumpage subsidies.

    Commerce submitted its last subsidy report on June 20, 2018. As part of its newest report, Commerce intends to include a list of subsidy programs identified with sufficient clarity by the public in response to this notice.

    Request for Comments

    Given the large number of countries that export softwood lumber and softwood lumber products to the United States, we are soliciting public comment only on subsidies provided by countries whose exports accounted for at least one percent of total U.S. imports of softwood lumber by quantity, as classified under Harmonized Tariff Schedule code 4407.1001 (which accounts for the vast majority of imports), during the period January 1, 2018, through June 30, 2018. Official U.S. import data published by the United States International Trade Commission's Tariff and Trade DataWeb indicate that four countries (Brazil, Canada, Germany, and Sweden) exported softwood lumber to the United States during that time period in amounts sufficient to account for at least one percent of U.S. imports of softwood lumber products. We intend to rely on similar previous six-month periods to identify the countries subject to future reports on softwood lumber subsidies. For example, we will rely on U.S. imports of softwood lumber and softwood lumber products during the period July 1, 2018, through December 31, 2018, to select the countries subject to the next report.

    Under U.S. trade law, a subsidy exists where an authority: (i) Provides a financial contribution; (ii) provides any form of income or price support within the meaning of Article XVI of the GATT 1994; or (iii) makes a payment to a funding mechanism to provide a financial contribution to a person, or entrusts or directs a private entity to make a financial contribution, if providing the contribution would normally be vested in the government and the practice does not differ in substance from practices normally followed by governments, and a benefit is thereby conferred.1

    1See section 771(5)(B) of the Tariff Act of 1930, as amended.

    Parties should include in their comments: (1) The country which provided the subsidy; (2) the name of the subsidy program; (3) a brief description (no more than 3-4 sentences) of the subsidy program; and (4) the government body or authority that provided the subsidy.

    Submission of Comments

    As specified above, to be assured of consideration, comments must be received no later than 30 days after the publication of this notice in the Federal Register. All comments must be submitted through the Federal eRulemaking Portal at http://www.regulations.gov, Docket No. ITA-2018-0002, unless the commenter does not have access to the internet. The materials in the docket will not be edited to remove identifying or contact information, and Commerce cautions against including any information in an electronic submission that the submitter does not want publicly disclosed. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF formats only.

    Commenters who do not have access to the internet may submit the original and one electronic copy of each set of comments by mail or hand delivery/courier.

    All comments should be addressed to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, at U.S. Department of Commerce, Room 18022, 1401 Constitution Avenue NW, Washington, DC 20230.

    Dated: October 15, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-22841 Filed 10-18-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Monterey Peninsula Water Supply Project; Notice of Availability of Errata Document for the Final Environmental Impact Report/Environmental Impact Statement AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice of availability of Errata for the final environmental impact report/environmental impact statement.

    SUMMARY:

    Notice is hereby given that the National Oceanic and Atmospheric Administration (NOAA) has published an errata document for the Final Environmental Impact Report/Environmental Impact Statement (FEIR/EIS) for a permit application to NOAA's Monterey Bay National Marine Sanctuary (MBNMS) submitted by California American Water Company (CalAm) to construct and operate Monterey Peninsula Water Supply Project, a reverse osmosis (RO) desalination facility project (Project) in Monterey County, California. A notice of availability (NOA) of the final EIR/EIS was published in the Federal Register on March 30, 2018 (83 FR 13737).

    DATES:

    This notice is applicable October 19, 2018.

    ADDRESSES:

    Copies of the FEIR/EIS and the Errata document can be downloaded or viewed on the internet at https://montereybay.noaa.gov/resourcepro/resmanissues/desal-projects.html.

    FOR FURTHER INFORMATION CONTACT:

    Karen Grimmer at 99 Pacific Ave., Bldg. 455a, Monterey, CA 93940, or call 831-647-4253, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    NOAA, as the Federal lead agency for purposes of the National Environmental Policy Act (NEPA), and the California Public Utilities Commission (CPUC), the state lead agency for purposes of the California Environmental Quality Act (CEQA), previously released a joint final environmental impact review/environmental impact statement (EIR/EIS) that analyzes the potential effects on the physical and human environment of the proposed Monterey Peninsula Water Supply Project.

    II. Errata Document

    The purpose of this notice is to inform the public that the errata document for the Final Environmental Impact Report/Environmental Impact Statement (FEIR/EIS) for the project is available for public inspection. It is available electronically on the website listed in the ADDRESSES section of this notice. It is also available by email by writing to the addresses identified in the FOR FURTHER INFORMATION CONTACT section of this notice.

    Authority:

    16 U.S.C. 1431 et seq.; 42 U.S.C. 4321 et seq.

    Dated: September 13, 2018. John Armor, Director for the Office of National Marine Sanctuaries.
    [FR Doc. 2018-22863 Filed 10-18-18; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG454 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to US 101/Chehalis River Bridge-Scour Repair in Washington State AGENCY:

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

    ACTION:

    Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.

    SUMMARY:

    NMFS has received a request from the Washington State Department of Transportation (WSDOT) for authorization to take marine mammals incidental to the US 101/Chehalis River Bridge-Scour Repair Project in Washington State. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.

    DATES:

    Comments and information must be received no later than November 19, 2018.

    ADDRESSES:

    Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to [email protected]

    Instructions: NMFS is not responsible for comments sent by any other method, to any other address or individual, or received after the end of the comment period. Comments received electronically, including all attachments, must not exceed a 25-megabyte file size. Attachments to electronic comments will be accepted in Microsoft Word or Excel or Adobe PDF file formats only. All comments received are a part of the public record and will generally be posted online at https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    FOR FURTHER INFORMATION CONTACT:

    Rob Pauline, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents may be obtained online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION:

    Background

    The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed incidental take authorization may be provided to the public for review.

    Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    The National Defense Authorization Act (Pub. L. 108-136) removed the small numbers and specified geographical region limitations indicated above and amended the definition of harassment as it applies to a military readiness activity.

    National Environmental Policy Act

    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (i.e., the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment.

    This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.

    We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.

    Summary of Request

    On July 26, 2018, NMFS received a request from WSDOT for an IHA to take marine mammals incidental to US 101/Chehalis River Bridge-Scour Repair in the State of Washington. The application was deemed adequate and complete on September 21, 2018. WSDOT's request is for take of small numbers of harbor seal (Phoca vitulina); California sea lion (Zalophus californianus); Steller sea lion (Eumetopias jubatus); gray whale (Eschrichtius robustus); and harbor porpoise (Phocoena phocoena) by Level B harassment only. Neither WSDOT nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate. NMFS previously issued an IHA to WSDOT to incidentally take five species of marine mammal by Level B harassment. The IHA was issued on October 10, 2017 (82 FR 50628; November 1, 2017) and is valid from July 1, 2018 through June 30, 2019. However, WSDOT has made minor changes to the project plan and delayed the work by one year. Therefore, WSDOT has requested that NOAA Fisheries re-issue the IHA with the dates changed to accommodate the analyzed work with minor modifications to the number of piles driven and removed as well as the number of animals authorized for take. No work was conducted under the original IHA.

    Description of the Proposed Activity Overview

    The proposed IHA would authorize work for the US 101/Chehalis River Bridge-Scour Repair Project in Washington State between July 15, 2019 and February 15, 2020. Vibratory pile driving will be required to remove and install timber piles, steel sheets and steel H-piles. Sound in the water from vibratory driving may result in behavioral harassment. NMFS previously issued an IHA to WSDOT to incidentally take five species of marine mammal by Level B harassment on October 18, 2017 (82 FR 50628; November 1, 2017). That IHA is valid from July 1, 2018 through June 30, 2019. However, WSDOT has made minor changes to the project plan and delayed the work by one year. Therefore, WSDOT has requested that NMFS re-issue the IHA with the dates changed to accommodate the analyzed work with minor modifications to the number of piles driven and removed as well as the number of animals authorized for take. No work was conducted or is planned to occur under the original IHA.The purpose of the US 101/Chehalis River Bridge-Scour Repair Project is to make the bridge foundation stable and protect the foundation from further scour. Bridge scour is the removal of sediment such as sand and gravel from around bridge abutments or piles. Scour, caused by swiftly moving water, can scoop out scour holes, compromising the integrity of a structure. WSDOT plans to remove debris from the scour area, fill the scour void under Pier 14 with cement (to protect the pilings from marine borers), fill the scour hole, and protect the pier with scour resistant material.

    Note that WSDOT has made revisions to the number and types of piles that would be installed and removed under the proposed 2019 IHA. The first change is the removal of 44 timber piles (some of which may be treated with creosote) from the immediate vicinity of the scour repair project. Additionally, 18 sheet piles will be temporarily installed adjacent to Pier 14, instead of the 44 sheet piles originally proposed.

    Dates and Duration

    Due to NMFS and the U.S. Fish and Wildlife Service (USFWS) in-water work timing restrictions to protect Endangered Species Act (ESA)-listed salmonids, planned WSDOT in-water construction is limited each year to July 15 through February 15. For this project, in-water construction is planned to take place between July 15, 2019 and September 30, 2019. The proposed IHA would be effective from July 15, 2019 to February 15, 2020. The estimated maximum time period for pile installation and removal is 37 hours over 6 days (Table 1).

    Specific Geographic Region

    The US 101/Chehalis River Bridge is located in the City of Aberdeen, Grays Harbor County, Washington (Figure 1-1 in the IHA application). Grays Harbor is an estuarine bay located 45 miles (72 km) north of the mouth of the Columbia River, on the Southwest Pacific coast of Washington state. The bridge is located in Township 17 North, Range 9 West, Section 9, where the Chehalis River enters Grays Harbor. Land use in the Aberdeen area is a mix of residential, commercial, industrial, and open space and/or undeveloped lands (Figure 1-2 in the IHA application).

    Detailed Description of Specific Activity

    Vibratory hammers are commonly used in steel pile driving and removal when appropriate sediments are found at a specific project site. A pile is typically placed into position using a choker and crane, and then vibrated between 1,200 and 2,400 vibrations per minute. The vibrations liquefy the sediment surrounding the pile allowing it to penetrate to the required seating depth, or to be removed.

    Forty-four 14-inch diameter timber piles/stubs located immediately north of Pier 14 will be removed using a vibratory hammer. If necessary, some deteriorated piles may require cutting below the ground level to minimize turbidity. If use of a clamshell bucket is required due to pile breakage, turbidity curtains will be employed.

    A steel template will be located adjacent to or attached to Pier 14. The template will likely be constructed using six steel H piles which will be installed using a vibratory hammer. Using the template as a guide, 18 sheet piles will be driven with a vibratory hammer into the substrate to form a temporary interlocked sheet pile wall shoring system around the scour repair area (Table 1). After the sheet piles have been installed, the template will be removed.

    Table 1—Pile Removal Mitigation and Scour Repair Pile Summary Method Pile type Number
  • of piles
  • Minutes
  • per pile
  • Total
  • minutes
  • Duration
  • (hours)
  • Piles per
  • day
  • Duration
  • (11-hour
  • work days)
  • Vibratory Removal 14-inch diameter timber 44 30 1,320 22 22 2 Vibratory Driving Sheet 18 30 540 9 10 2 Vibratory Driving H pile 6 30 180 3 6 1 Vibratory Removal H pile 6 30 180 3 6 1 Total 2,220 37 6.0

    Once the shoring system is in place, cementitious material will be tremie pumped underwater inside the shoring system to fill the voids between the riverbed and the pier seal. A tremie is a large metal hopper and pipe used to distribute freshly mixed concrete over an underwater site. The foot of the pipe is kept below the concrete level, while the upper level of the concrete in the pipe is kept above the water level to prevent the water diluting the concrete. The concrete falls by gravity and is continuously placed until the shaft is full. This material will protect the untreated wood pier piling from marine borers. Following installation of the cementitious sealing material, the shoring system will be considered a permanent feature of the scour repair. The sheet piles will be cut off and removed to the level of final concrete placement. The final steps will be the placement of scour resistant material, such as rip rap, on and around the pier and in the scour hole to protect the pier from future erosion. The cutting of sheet piles and placement of rip rap is not anticipated to result in take.

    Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).

    Description of Marine Mammals in the Area of Specified Activities

    Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS's website (https://www.fisheries.noaa.gov/find-species).

    Table 2 lists all species with expected potential for occurrence in the project location and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

    Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2017 SARs (https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments) and draft U.S. 2018 SARS (https://www.fisheries.noaa.gov/national/marine-mammal-protection/draft-marine-mammal-stock-assessment-reports). All values presented in Table 2 are the most recent available at the time of publication.

    Table 2—Marine Mammals With Potential Presence Within the Proposed Project Area Common name Scientific name Stock ESA/MMPA status;
  • Strategic
  • (Y/N) 1
  • Stock abundance (CV, Nmin, most
  • recent
  • abundance
  • survey) 2
  • PBR Annual
  • M/SI 3
  • Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family Eschrichtiidae Gray whale Eschrichtius robustus Eastern North Pacific N 20,990 (0.05, 20,125, 2011) 624 132 Family Phocoenidae (porpoises) Harbor porpoise Phocoena phocoena Northern Oregon/Washington Coast N 21,487 (0.44, 15,123, 2011) 151 ≥3.0 Order Carnivora—Superfamily Pinnipedia Family Otariidae (eared seals and sea lions) California sea lion Zalophus californianus U.S. N 296,750 (n/a, 153,337, 2011) 9,200 389 Steller sea lion Eumetopias jubatus Eastern U.S. N 41,638 (n/a, 41,638, 2015) 4 2,498 108 Family Phocidae (earless seals) Harbor seal Phoca vitulina Oregon/Washington Coast N Unk 5 Undet 10.6 1 Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (−) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 NMFS marine mammal stock assessment reports online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments. CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases a CV is not applicable. For certain stocks of pinnipeds, abundance estimates are based upon observations of animals (often pups) ashore multiplied by some correction factor derived from knowledge of the species' (or similar species') life history to arrive at a best abundance estimate; therefore, there is no associated CV. 3 These values, found in NMFS's SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g., commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases. 4 Best estimate of pup and non-pup counts, which have not been corrected to account for animals at sea during abundance surveys. 5 Harbor seal estimate is based on data that are 8 years old, but this is the best available information for use here.

    All species that could potentially occur in the proposed survey areas are included in Table 2.

    Harbor Seals

    Harbor seals haul out on rocks, reefs and beaches, and feed in marine, estuarine and occasionally fresh waters. Harbor seals display strong fidelity for haul out sites (Pitcher and Calkins 1979; Pitcher and McAllister 1981). Harbor seals in Grays Harbor are part of the Oregon/Washington Coast Stock. In Grays Harbor, pups are born from mid-April through July (WDFW 2012). Of the pinniped species that commonly occur within the region of activity, harbor seals are the most common and the only pinniped that breeds and remains in the inland marine waters of Washington year-round (Calambokidis and Baird 1994). Harbor seals are non-migratory; their local movements are associated with such factors as tides, weather, season, food availability and reproduction (Scheffer and Slipp 1944; Fisher 1952; Bigg 1969, 1981). They are not known to make extensive pelagic migrations, although some long-distance movements of tagged animals in Alaska (108 miles) and along the U.S. west coast (up to 342 miles) have been recorded (Pitcher and McAllister 1981).

    In order to estimate abundance, aerial surveys of harbor seals in Oregon and Washington were conducted by the National Marine Mammal Laboratory (NMML) and the Oregon and Washington Departments of Fish and Wildlife (ODFW and WDFW) during the 1999 pupping season. Total numbers of hauled-out seals (including pups) were counted during these surveys. In 1999, the mean count of harbor seals occurring along the Washington coast was 10,430 (CV = 0.14) animals. In 1999, the mean count of harbor seals occurring along the Oregon coast and in the Columbia River was 5,735 (CV = 0.14) animals. Combining these counts results in 16,165 (CV = 0.10) harbor seals in the Oregon/Washington Coast stock. However, because the most recent abundance estimate is >8 years old, there is no current estimate of abundance available for this stock and the current population trend is unknown.

    The nearest documented harbor seal haul out site to the US 101/Chehalis River Bridge is a low-tide haul out located seven miles to the west. According to Jeffries, et al. (2000), all haul outs in Grays Harbor are associated with tidal flats; at high tide it is assumed that these animals are foraging elsewhere in the estuary.

    California Sea Lion

    California sea lions are found along the west coast from the southern tip of Baja California to southeast Alaska. They breed mainly on offshore islands from Southern California's Channel Islands south to Mexico. Non-breeding males often roam north in spring foraging for food (Everitt et al. 1980). Since the mid-1980s, increasing numbers of California sea lions have been documented feeding on fish along the Washington coast and,more recently, in the Columbia River as far upstream as Bonneville Dam, 145 mi (233 km) from the river mouth. All age classes of males are seasonally present in Washington waters (Jeffries, et al. 2000). California sea lions do not avoid areas with heavy or frequent human activity, but rather may approach certain areas to investigate. This species typically does not flush from a buoy or haul out if approached. The nearest documented California sea lion haul out sites to the U.S. 101 Chehalis River Bridge project site are at Split Rock, 35 miles north of the entrance to Grays Harbor; and at the mouth of the Columbia River, 46 miles south of the entrance to Grays Harbor (Jeffries, et al. 2000). A few California sea lions may haul out on docks and buoys in the vicinity of the Westport marina,located 15 miles west of the project site.

    Steller Sea Lion

    The Steller sea lion is a pinniped and the largest of the eared seals. Steller sea lion populations that primarily occur east of 144° W (Cape Suckling, Alaska) comprise the Eastern Distinct Population Segment (DPS), which was de-listed and removed from the Endangered Species List on November 4, 2013 (78 FR 66140). This stock is found in the vicinity of Grays Harbor. Steller sea lions congregate at rookeries in California, Oregon, Washington, and British Columbia for pupping and breeding from late May to early June (Gisiner 1985; NMFS 2016a). Rookeries are usually located on beaches of relatively remote islands, often in areas exposed to wind and waves, where access by humans and other mammalian predators is difficult (WDFW 1993).

    The nearest documented Steller sea lion haul out sites to the U.S. 101 Chehalis River Bridge project site are at Split Rock, 35 miles north of the entrance to Grays Harbor; and at the mouth of the Columbia River, 46 miles south of the entrance to Grays Harbor (Jeffries, et al. 2000). A few Steller sea lions may haul out on buoys in the vicinity of the Westport marina, located 15 miles west of the project site.

    Gray Whale

    During summer and fall, most whales in the Eastern North Pacific population feed in the Chukchi, Beaufort and northwestern Bering Seas. An exception to this is the relatively small number of whales (approximately 200) that summer and feed along the Pacific coast between Kodiak Island, Alaska and northern California (Calambokidis et al. 2012), referred to as the “Pacific Coast Feeding Group” (NMFS 2015a).

    Gray whales are known to use Grays Harbor. For example, during a 1996 survey 27 different whales were recorded in the Harbor. (Calambokidis and Guan 1997). However, between 1998 and 2010, gray whale numbers peaked in the spring followed by slightly lesser numbers in the fall in a study area that included Grays Harbor and coastal waters along the south Washington coast. Note, that much of the in-water pile driving work for the proposed action is likely to occur during summer months. (Calambokidis, et al. 2012)

    Harbor Porpoise

    The harbor porpoise inhabits temporal, subarctic, and arctic waters. Harbor porpoise are known to occur year-round along the Oregon/Washington coast. Aerial survey data from coastal Oregon and Washington, collected during all seasons, suggest that harbor porpoise distribution varies by depth. Although distinct seasonal changes in abundance along the west coast have been noted, and attributed to possible shifts in distribution to deeper offshore waters during late winter, seasonal movement patterns are not fully understood.

    The Northern Oregon/Washington Coast Stock of harbor porpoise may be found near the project site. This stock occurs in waters from Lincoln City, Oregon to Cape Flattery Washington. Little information exists on harbor porpoise movements and stock structure in Grays Harbor, although it is suspected that in some areas harbor porpoises migrate (based on seasonal shifts in distribution).

    Harbor porpoise primarily frequent coastal waters and occur most frequently in waters less than 328 ft (100 m) deep (Hobbs and Waite 2010). They may occasionally be found in deeper offshore waters. Hall (WSDOT 2018) found that the highest numbers were observed at water depths ranging from 61 to 100 m. Harbor porpoises are most often observed in small groups of one to eight animals (Baird 2003).

    Marine Mammal Hearing

    Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes (i.e., low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 dB threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. The functional groups and the associated frequencies are indicated below (note that these frequency ranges correspond to the range for the composite group, with the entire range not necessarily reflecting the capabilities of every species within that group):

    • Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz;

    • Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz;

    • High-frequency cetaceans (porpoises, river dolphins, and members of the genera Kogia and Cephalorhynchus; including two members of the genus Lagenorhynchus, on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz.

    • Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 Hz to 86 kHz;

    • Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz.

    The pinniped functional hearing group was modified from Southall et al. (2007) on the basis of data indicating that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä et al., 2006; Kastelein et al., 2009; Reichmuth and Holt, 2013).

    For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Five marine mammal species (2 cetacean and 3 pinniped (2 otariid and 1 phocid) species) have the reasonable potential to co-occur with the proposed survey activities. Please refer to Table 2. Of the cetacean species that may be present, one is classified as a low-frequency cetacean (i.e., gray whale), and one is classified as a high-frequency cetacean (i.e., harbor porpoise).

    Potential Effects of Specified Activities on Marine Mammals and Their Habitat

    This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The Estimated Take by Incidental Harassment section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take by Incidental Harassment section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks.

    The proposed River Bridge-Scour repair project will utilize in-water vibratory pile driving and pile removal that could adversely affect marine mammal species and stocks by exposing them to elevated noise levels in the vicinity of the activity area.

    Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift (TS)—an increase in the auditory threshold after exposure to noise (Finneran et al. 2005). Factors that influence the amount of threshold shift include the amplitude, duration, frequency content, temporal pattern, and energy distribution of noise exposure. The magnitude of hearing threshold shift normally decreases over time following cessation of the noise exposure. The amount of threshold shift just after exposure is the initial threshold shift. If the threshold shift eventually returns to zero (i.e., the threshold returns to the pre-exposure value), it is a temporary threshold shift (Southall et al. 2007).

    Threshold Shift (noise-induced loss of hearing)—When animals exhibit reduced hearing sensitivity (i.e., sounds must be louder for an animal to detect them) following exposure to an intense sound or sound for long duration, it is referred to as TS. An animal can experience temporary threshold shift (TTS) or permanent threshold shift (PTS). TTS can last from minutes or hours to days (i.e., there is complete recovery), can occur in specific frequency ranges (i.e., an animal might only have a temporary loss of hearing sensitivity between the frequencies of 1 and 10 kHz), and can be of varying amounts (for example, an animal's hearing sensitivity might be reduced initially by only 6 dB or reduced by 30 dB). PTS is permanent, but some recovery is possible. PTS can also occur in a specific frequency range and amount as mentioned above for TTS.

    For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran et al., 2002, 2003, 2005, 2007, 2010a, 2010b; Finneran and Schlundt, 2010; Lucke et al., 2009; Popov et al., 2011a, 2011b; Kastelein et al., 2012a; Schlundt et al., 2000; Nachtigall et al., 2003, 2004). For pinnipeds in water, data are limited to measurements of TTS in harbor seals, an elephant seal, and California sea lions (Kastak et al., 1999, 2005; Kastelein et al., 2012b).

    Lucke et al. (2009) found a TS of a harbor porpoise after exposing it to airgun noise with a received SPL at 200.2 dB (peak-to-peak) re: 1 μPa, which corresponds to a sound exposure level (SEL) of 164.5 dB re: 1 μPa2 s after integrating exposure. Because the airgun noise is a broadband impulse, one cannot directly determine the equivalent of rms SPL from the reported peak-to-peak SPLs. However, applying a conservative conversion factor of 16 dB for broadband signals from seismic surveys (McCauley et al. 2000) to correct for the difference between peak-to-peak levels reported in Lucke et al. (2009) and rms SPLs, the rms SPL for TTS would be approximately 184 dB re: 1 μPa, and the received levels associated with PTS (Level A harassment) would be higher. However, NMFS recognizes that TTS of harbor porpoises is lower than other cetacean species empirically tested (Finneran and Schlundt 2010; Finneran et al. 2002; Kastelein and Jennings 2012).

    Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (i.e., recovery time), and frequency range of TTS, and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to serious (similar to those discussed in auditory masking, below). For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that occurs during a time where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during time when communication is critical for successful mother/calf interactions could have more serious impacts. Also, depending on the degree and frequency range, the effects of PTS on an animal could range in severity, although it is considered generally more serious because it is a permanent condition. Of note, reduced hearing sensitivity as a simple function of aging has been observed in marine mammals, as well as humans and other taxa (Southall et al. 2007), so one can infer that strategies exist for coping with this condition to some degree, though likely not without cost.

    Masking—In addition, chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark et al. 2009). Acoustic masking is when other noises such as from human sources interfere with animal detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction.

    Masking occurs at the frequency band that the animals utilize. Therefore, since noise generated from vibratory pile driving activity is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds by odontocetes (toothed whales). However, lower frequency man-made noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. It may also affect communication signals when they occur near the noise band and thus reduce the communication space of animals (e.g., Clark et al. 2009) and cause increased stress levels (e.g., Foote et al. 2004; Holt and Noren et al. 2009).

    Unlike TS, masking, which can occur over large temporal and spatial scales, can potentially affect the species at population, community, or even ecosystem levels, as well as individual levels. Masking affects both senders and receivers of the signals and could have long-term chronic effects on marine mammal species and populations. Recent science suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of sound pressure level) in the world's ocean from pre-industrial periods, and most of these increases are from distant shipping (Hildebrand 2009).

    Acoustic Effects, Airborne—Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.

    Airborne noise will primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would previously have been `taken' because of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.

    Behavioral disturbance—Finally, marine mammals' exposure to certain sounds could lead to behavioral disturbance (Richardson et al., 1995), such as: changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where noise sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haulouts or rookeries).

    The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography) and is also difficult to predict (Southall et al., 2007). Currently NMFS uses a received level of 160 dB re 1 μPa (rms) to predict the onset of behavioral harassment from impulse noises (such as impact pile driving), and 120 dB re 1 μPa (rms) for continuous noises (such as vibratory pile driving). For the proposed project, only 120 dB re 1 μPa (rms) is considered for effects analysis because only vibratory pile driving and removal will be employed.

    The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be biologically significant if the change affects growth, survival, and/or reproduction, which depends on the severity, duration, and context of the effects.

    Habitat—The primary potential impacts to marine mammal habitat are associated with elevated sound levels produced by pile driving and removal associated with marine mammal prey species. However, other potential impacts to the surrounding habitat from physical disturbance are also possible. Prey species for the various marine mammals include marine invertebrates and fish species. Short-term effects would occur to marine invertebrates during removal of existing piles. This effect is expected to be minor and short-term on the overall population of marine invertebrates in Grays Harbor. Construction will also have temporary effects on salmonids and other fish species in the project area due to disturbance, turbidity, noise, and the potential resuspension of contaminants. All in-water work will occur during the designated in-water work window, to minimize effects on juvenile salmonids.

    SPLs from vibratory driving generally do not have the potential to injure or kill fish in the immediate area. Experiments have shown that fish can sense both the strength and direction of sound (Hawkins and Horner 1981). Primary factors determining whether a fish can sense a sound signal, and potentially react to it, are the frequency of the signal and the strength of the signal in relation to the natural background noise level. The level of sound at which a fish will react or alter its behavior is usually well above the detection level. Fish have been found to react to sounds when the sound level increased to about 20 dB above the detection level of 120 dB; however, the response threshold can depend on the time of year and the fish's physiological condition (Engas et al. 1993). Any disturbance to fish species would be short-term and fish would return to their pre-disturbance behavior once the pile driving activity ceases. The proposed construction would have little, if any, impact on the abilities of marine mammals to feed in the area where construction work is proposed.

    There are no critical habitats or other biologically important areas near the proposed project location, although biologically important feeding and migration areas for gray whales have been established along the coast beyond the mouth of Grays Harbor. However, the project site is upriver to the east of the Harbor, so there will be no impacts to these areas. While harbor seals, California sea lions, and other marine mammals may be present, the area is not an established rookery or breeding ground for local populations. Additionally, during construction activity only a small fraction of the available habitat would be ensonified.

    Short-term turbidity is a water quality effect of most in-water work, including pile driving. Cetaceans are not expected to be close enough to the Chehalis River Bridge to experience turbidity, and any pinnipeds will be transiting the terminal area and could avoid localized areas of turbidity. Therefore, the impact from increased turbidity levels is expected to be discountable to marine mammals.

    For these reasons, any adverse effects to marine mammal habitat in the area from WSDOT's proposed project would be minor.

    Estimated Take

    This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.

    Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to vibratory driving. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (i.e., shutdown, establishment and monitoring of harassment zones) discussed in detail below in Proposed Mitigation section), Level A harassment is neither anticipated nor proposed to be authorized.

    As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.

    Generally speaking, we estimate take by considering: (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the proposed take estimate.

    Acoustic Thresholds

    Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

    Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007, Ellison et al., 2012). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa (rms) for continuous (e.g., vibratory pile-driving, drilling) sources such as those used here.

    WSDOT's proposed activity includes the use of continuous (vibratory driving and removal and, therefore, the 120 dB re 1 μPa (rms) is applicable.

    Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (NMFS, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). WSDOT's proposed activity includes the use non-impulsive (vibratory driving) sources.

    These thresholds are provided in Table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

    Table 3—Thresholds Identifying the Onset of Permanent Threshold Shift Hearing group PTS Onset acoustic thresholds*
  • (received level)
  • Impulsive Non-impulsive
    Low-Frequency (LF) Cetaceans Cell 1
  • L pk,flat: 219 dB
  • L E,LF,24h: 183 dB
  • Cell 2
  • L E,LF,24h: 199 dB.
  • Mid-Frequency (MF) Cetaceans Cell 3
  • L pk,flat: 230 dB
  • L E,MF,24h: 185 dB
  • Cell 4
  • L E,MF,24h: 198 dB.
  • High-Frequency (HF) Cetaceans Cell 5
  • L pk,flat: 202 dB
  • L E,HF,24h: 155 dB
  • Cell 6
  • L E,HF,24h: 173 dB.
  • Phocid Pinnipeds (PW) (Underwater) Cell 7
  • L pk,flat: 218 dB
  • LE,PW,24h: 185 dB
  • Cell 8
  • L E,PW,24h: 201 dB.
  • Otariid Pinnipeds (OW) (Underwater) Cell 9
  • L pk,flat: 232 dB
  • L E,OW,24h: 203 dB
  • Cell 10
  • L E,OW,24h: 219 dB.
  • * Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating PTS onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered. Note: Peak sound pressure (L pk) has a reference value of 1 μPa, and cumulative sound exposure level (L E) has a reference value of 1μPa2s. In this Table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways (i.e., varying exposure levels and durations, duty cycle). When possible, it is valuable for action proponents to indicate the conditions under which these acoustic thresholds will be exceeded.
    Ensonified Area

    Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficient.

    Reference sound source levels used by WSDOT vibratory piling driving and removal activities were derived from several sources. WSDOT utilized in-water measurements generated by the Greenbusch Group (2018) from the WDOT Seattle Pier 62 project (83 FR 39709) to establish proxy sound source levels for vibratory removal of 14-inch timber piles. The results determined unweighted rms ranging from 140 dB to 169 dB. WSDOT used the 75th percentile of these values (161 dB rms measured at 10 meters) as a proxy for vibratory removal of 14-inch timber piles at the Chehalis River Bridge. However, NMFS reviewed the report by the Greenbusch Group (2018) and determined that the findings were derived by pooling together all steel pile and timber pile at various distance measurements data together. The data was not normalized to the standard 10 m distance. NMFS analyzed source measurements at different distances for all 63 individual timber piles that were removed and normalized the values to 10 m. The results showed that the median is 152 dB SPLrms. This value was used as the source level for vibratory removal of 14-inch timber piles.

    The proposed project includes vibratory driving of 18 sheet piles as well as vibratory driving and removal of six steel H piles. Based on in-water measurements at the Elliot Bay Seawall Project, vibratory pile driving of steel sheet piles generated a source level of 165 dB rms measured at 10 m (Greenbush Group 2015). According to CalTrans (2015), 150 dB rms at 10 m is a typical source level for vibratory driving and removal of steel H piles.

    Level B Harassment Zones

    The practical spreading model was used by WSDOT to establish the Level B harassment zones for all vibratory pile installation and removal activities. Practical spreading is described in full detail below.

    Pile driving generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

    TL = B * log10 (R1/R2), Where: R1 = the distance of the modeled SPL from the driven pile, and R2 = the distance from the driven pile of the initial measurement.

    This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20 * log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10 * log[range]). A practical spreading value of 15 is often used under conditions where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions.

    Utilizing the practical spreading loss model, WSDOT determined the distance and area where the noise will fall below the behavioral effects threshold of 120 dB rms. The distances and areas are shown in Table 4. Note that the ensonified area is based on a GIS analysis of the area accounting for structures and landmasses which would block underwater sound transmission.

    Table 4—Level B Harassment Ensonified Area Pile type Level B
  • harassment
  • zone isopleth
  • (meters)
  • Area (km2)
    14-inch timber vibratory removal 1,359 0.93 Steel sheet vibratory driving 10,000 2.04 Steel H-pile vibratory driving and removal 1,000 0.67
    Level A Harassment Zones

    When the NMFS Technical Guidance (2016) was published, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources such as vibratory driving, NMFS User Spreadsheet predicts the closest distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would not incur PTS. User Spreadsheet inputs are shown in Table 5 and outputs are shown in Table 6. Note that since no Level A harassment take is proposed, the areas of Level A harassment zones were not calculated.

    Table 5—Parameters of Pile Driving and Drilling Activity [User spreadsheet input] 14-inch timber Sheet H-Pile Spreadsheet Tab Used A.1) Vibratory driving A.1) Vibratory driving A.1) Vibratory driving Source Level (rms SPL) 152 165 150 Weighting Factor Adjustment (kHz) 2.5 2.5 2.5 Number of piles in 24-h period 22 9 6 Duration to drive a single pile (minutes) 30 30 30 Propagation (xLogR) 15 15 15 Distance of source level measurement (meters) 10 10 10 Table 6—Level A Harassment Zone Isopleths [User spreadsheet output] Source type PTS Isopleth
  • (meters)
  • Low-frequency
  • cetaceans
  • Mid-frequency
  • cetaceans
  • High-
  • frequency
  • cetaceans
  • Phocid pinnipeds Otariid pinnipeds
    14-inch timber 8.5 0.8 12.5 5.2 0.4 Sheet pile 34.4 3 50.9 20.9 1.5 H-pile 2.6 0.2 3.9 1.6 0.1
    Marine Mammal Occurrence

    In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.

    There is little abundance or density data available for marine mammal species that are likely to occur within Grays Harbor and which could potentially be found in the Chehalis River near the project site. In most cases, WSDOT relied on density data from the U.S. Navy Marine Species Density Database (NMSDD) (U.S. Navy 2015). NMFS concurs that this, and the exceptions described below, represent the best available data for use here.

    Harbor Seal

    While the NMSDD (U.S. Navy 2015) estimates the density of harbor seals in the waters offshore of Grays Harbor as 0.279 animals per square kilometer, WSDOT relied on a study which identified 44 harbor seal haul outs in Grays Harbor and provided very rough estimates of the number of seals at each site. Twenty-seven haul outs had less than 100 animals; 16 haul outs had 100-500 animals; and two haul outs were reported to support over 500 animals (Jeffries et al. 2000). These data likely represent the best estimate of harbor seal numbers in Grays Harbor. Using median numbers of each haul out estimate range resulted in an estimated 7,150 harbor seals in Grays Harbor. The area of the estuary during mean higher high water (243 km2) was used to derive a density estimate of 29.4 harbor seals per square kilometer.

    California Sea Lion

    Only 10 California sea lion strandings have been documented between 2006 and 2015 (NMFS 2016c), and no haul outs have been identified. Therefore, it is expected that the density of California sea lions in Grays Harbor is low. The NMSDD (U.S. Navy 2015) estimates the density of California sea lions in the waters offshore of Grays Harbor as ranging from 0.020 to 0.033 animals per square kilometer in summer and fall. The higher estimate is used as a surrogate for Grays Harbor.

    Steller Sea Lion

    According to the NMFS National Stranding Database, there were four confirmed Steller sea lion strandings in Grays Harbor between 2006 and 2015 (NMFS 2016c) and no haul outs have been identified in Grays Harbor. The NMSDD (U.S. Navy 2015) estimates the density of Steller sea lions in the waters offshore of Grays Harbor as 0.0145 animals per square kilometer. This estimate is used as a surrogate for Grays Harbor.

    Gray Whale

    Between 1998 and 2010, gray whale numbers peaked in spring and fall in a study area that included waters inside Grays Harbor and coastal waters along the south Washington coast (Calambokidis, et al. 2012). However, no density estimates are available for Grays Harbor. The NMSDD (U.S. Navy 2015) estimates the density of gray whales in nearshore waters near Grays Harbor as 0.00045 animal per square kilometer in summer and fall. This density is used for Grays Harbor.

    Harbor Porpoise

    The NMSDD (U.S. Navy 2015) estimates the density of harbor porpoises in the waters offshore of Grays Harbor as a range between 0.69 and 1.67 animals per square kilometer. According to Evenson et al. (2016), the maximum harbor porpoise density in the Strait of Juan de Fuca (approximately 105 miles north of Grays Harbor) in 2014 was 0.768 animals per square kilometer. The higher density estimate for waters offshore of Grays Harbor (1.67) is used to estimate take.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate.

    No Level A harassment take is likely because of the small injury zones and relatively low average animal density in the area. Since the largest Level A harassment distance is only 50.9 m from the source for high-frequency cetaceans (harbor porpoise), NMFS considers that WSDOT can effectively monitor such small zones to implement shutdown measures and avoid Level A harassment takes. Therefore, no Level A harassment take of marine mammal is proposed or authorized.

    NMFS used an estimated harbor seal density of 29.4 animals/km2 in the US 101/Chehalis River Bridge-Scour Repair Project area to estimate the following number of Level B harassment exposures that may occur:

    • 14-inch timber pile removal: 29.4. animals/km2 * 0.93 km2 * 2 days = 54.68

    • Sheet pile installation: 29.4 animals/km2 * 2.04 km2 * 2 days= 119.95

    • H-pile installation and removal: 29.4 animals/km2 * 0.67 km2 * 2 days = 39.39

    Based on the sum of the equations above, NMFS proposes to authorize 214 takes of harbor seals by Level B harassment.

    NMFS inserted the California sea lion density of 0.033 animals/km2 into the same equation used above for harbor seals to estimate Level B harassment exposures. Based on the sum of the equations, an estimated 0.24 California sea lions would be taken by Level B harassment. Due to this low value, NMFS conservatively proposes to authorize the take of two California sea lions each day of in-water activities, resulting in 12 takes by Level B harassment.

    NMFS estimated take of Steller sea lions by inserting a density of 0.0145 animals/km2 into the same equation used above for harbor seals resulting in 0.10 takes of sea lions. Given the low value, NMFS conservatively proposes to authorize the take of two Steller sea lions during each day of in-water activities, resulting in 12 takes by Level B harassment.

    NMFS used the same equation that was used for harbor seals to estimate take for gray whales by inserting a density value of 0.00045 animals/km2. Since this resulted in a value less than one, NMFS proposes to authorize Level B harassment take of two gray whales per day based on average group size.

    A density value of 1.67 animal/km2 for harbor porpoises was plugged into the harbor seal equation to arrive at an estimated 12.1 takes. Therefore, NMFS is proposing to authorize 12 harbor porpoise takes by Level B harassment.

    Table 7 shows total number of authorized Level B harassment takes and take as a percentage of population for each of the species.

    Table 7—Take Estimates as a Percentage of Stock Abundance Species Proposed
  • authorized take
  • Level B
  • harassment
  • % population
    Harbor seal 214 1.9 California sea lion 12 <0.01 Steller sea lion 12 <0.01 Gray whale 2 <0.01 Harbor porpoise 12 <0.01
    Proposed Mitigation

    In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:

    (1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned), and;

    (2) the practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

    Mitigation for Marine Mammals and Their Habitat

    Temporal and Seasonal Restrictions—Timing restrictions would be used to avoid in-water work when ESA-listed salmonids are most likely to be present. The combined work window for in-water work for the U.S. 101/Chehalis River Bridge -Scour Project is July 15 through February 15. Furthermore, work may only occur during daylight hours, when visual monitoring of marine mammals can be effectively conducted.

    Establishment of Shutdown Zone—For all pile driving activities, WSDOT will establish a shutdown zone. The purpose of a shutdown zone is generally to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). In this case, shutdown zones are intended to contain areas in which sound pressure levels (SPLs) equal or exceed acoustic injury criteria for authorized species. If a marine mammal is observed at or within the shutdown zone, work must shut down (stop work) until the individual has been observed outside of the zone, or has not been observed for at least 15 minutes for all marine mammals. A determination that the shutdown zone is clear must be made during a period of good visibility (i.e., the entire shutdown zone and surrounding waters must be visible to the naked eye). If a marine mammal approaches or enters the shutdown zone during activities or pre-activity monitoring, all pile driving and removal activities at that location must be halted or delayed, respectively. If pile driving or removal is halted or delayed due to the presence of a marine mammal, the activity may not resume or commence until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal. Pile driving and removal activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes. Shutdown zone sizes are shown in Table 8.

    Table 8—Shutdown Zones for Various Pile Driving Activities and Marine Mammal Hearing Groups [Meters] Source type Low-frequency
  • Cetaceans
  • High-
  • frequency
  • Cetaceans
  • Phocid
  • pinnipeds
  • Otariid
  • pinnipeds
  • 14-inch timber removal 10 15 10 10 Sheet pile installation 35 50 20 10 H-pile installation and removal 10 10 10 10

    For in-water heavy machinery activities other than pile driving, if a marine mammal comes within 10 m, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions. WSDOT must also implement shutdown measures if the cumulative total number of individuals observed within the Level B harassment monitoring zones for any particular species reaches the number authorized under the IHA and if such marine mammals are sighted within the vicinity of the project area and are approaching the Level B Harassment/Monitoring Zone during in-water construction activities.

    Establishment of Level B Harassment/Monitoring Zones—WSDOT must identify and establish Level B harassment zones which are areas where SPLs equal or exceed 120 dB rms. Observation of monitoring zones enables observers to be aware of and communicate the presence of marine mammals in the project area and outside the shutdown zone and thus prepare for potential shutdowns of activity. Monitoring zones are also used to document instances of Level B harassment. Monitoring zone isopleths are shown in Table 4.

    Pre-Activity Monitoring—Prior to the start of daily in-water construction activity, or whenever a break in pile driving of 30 minutes or longer occurs, the observer shall observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone shall be cleared when a marine mammal has not been observed within the zone for that 30-minute period. When a marine mammal permitted for Level B harassment take is present in the Level B harassment zone, piling activities may begin and Level B harassment take shall be recorded. As stated above, if the entire Level B harassment zone is not visible at the start of construction, piling driving activities can begin. If work ceases for more than 30 minutes, the pre-activity monitoring of both the Level B harassment and shutdown zone shall commence.

    Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance

    Proposed Monitoring and Reporting

    In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species or stocks in the area in which take is anticipated (e.g., presence, abundance, distribution, density);

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving or feeding areas);

    • Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

    • Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

    • Mitigation and monitoring effectiveness.

    Proposed Monitoring Measures

    WSDOT shall employ NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its US 101/Chehalis River Bridge-Scour Repair Project. The purposes of marine mammal monitoring are to implement mitigation measures and learn more about impacts to marine mammals from WSDOT's construction activities. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. NMFS-approved PSOs shall meet the following requirements:

    1. Independent observers (i.e., not construction personnel) are required;

    2. At least one observer must have prior experience working as an observer;

    3. Other observers may substitute education (undergraduate degree in biological science or related field) or training for experience;

    4. Where a team of three or more observers are required, one observer should be designated as lead observer or monitoring coordinator. The lead observer must have prior experience working as an observer; and

    5. NMFS will require submission and approval of observer CVs.

    WSDOT must ensure that observers have the following additional qualifications:

    1. Ability to conduct field observations and collect data according to assigned protocols;

    2. Experience or training in the field identification of marine mammals, including the identification of behaviors;

    3. Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

    4. Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and

    5. Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

    Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (e.g., Zeiss, 10 x 42 power). Due to the different sizes of monitoring zones from different pile types, separate zones and monitoring protocols corresponding to each specific pile type will be established.

    For vibratory pile driving and pile removal of sheet piles, a total of four land-based PSOs will monitor the shutdown and Level B harassment zones. For vibratory pile driving and pile removal of H piles and timber piles, a total of three land-based PSOs will monitor the shutdown and Level B harassment zones.

    Reporting Measures

    WSDOT is required to submit a draft monitoring report within 90 days after completion of the construction work or the expiration of the IHA (if issued), whichever comes earlier. This report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the report, and if NMFS has comments, WSDOT would address the comments and submit a final report to NMFS within 30 days. Reports shall contain, at minimum, the following:

    • Date and time that monitored activity begins and ends for each day conducted (monitoring period);

    • Construction activities occurring during each daily observation period, including how many and what type of piles driven;

    • Deviation from initial proposal in pile numbers, pile types, average driving times, etc.

    • Weather parameters in each monitoring period (e.g., wind speed, percent cloud cover, visibility);

    • Water conditions in each monitoring period (e.g., sea state, tide state);

    • For each marine mammal sighting:

    ○ Species, numbers, and, if possible, sex and age class of marine mammals;

    ○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

    ○ Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

    ○ Estimated amount of time that the animals remained in the Level B harassment zone

    • Description of implementation of mitigation measures within each monitoring period (e.g., shutdown or delay);

    • Other human activity in the area within each monitoring period;

    • A summary of the following:

    ○ Total number of individuals of each species detected within the Level B harassment zone;

    ○ Total number of individuals of each species detected within the shutdown zone and the average amount of time that they remained in that zone; and

    ○ Daily average number of individuals of each species (differentiated by month as appropriate) detected within the Level B harassment zone.

    Negligible Impact Analysis and Determination

    NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

    NMFS has identified key qualitative and quantitative factors which may be employed to assess the level of analysis necessary to conclude whether potential impacts associated with a specified activity should be considered negligible. These include (but are not limited to) the type and magnitude of taking, the amount and importance of the available habitat for the species or stock that is affected, the duration of the anticipated effect to the species or stock, and the status of the species or stock. When an evaluation of key factors shows that the anticipated impacts of the specified activity would clearly result in no greater than a negligieble impact on all affected species or stocks, additional evaluation is not required. In this case, the following factors are in place for all affected species or stocks:

    • No takes by Level A harassment are anticipated or authorized;

    • Takes by Level B harassment constitute less than 5% of the best available abundance estimates for all stocks;

    • Take would not occur in places and/or times where take would be more likely to accrue to impacts on reproduction or survival, such as within ESA-designated or proposed critical habitat, biologically important areas (BIA), or other habitats critical to recruitment or survival (e.g., rookery);

    • Take would occur over a short timeframe (less than 30 days of active pile driving required during the IHA effective period);

    • Take would occur over <25% of species/stock range; and

    • Stock is not known to be declining or suffering from known contributors to decline (e.g., unusual mortality event (UME), oil spill effects).

    Based on these factors, and taking into consideration the implementation of the prescribed monitoring and mitigation measures, NMFS preliminarily finds that the total take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.

    Small Numbers

    As noted above, only small numbers of incidental take may be authorized under Sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

    NMFS has estimated that take for all species authorized is less than two percent of their respective stock abundance (Table 7). Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

    Unmitigable Adverse Impact Analysis and Determination

    There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposes to issue an IHA to WSDOT for conducting US 101/Chehalis River Bridge-Scour Repair Project between July 15, 2019, and February 15, 2020, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).

    1. This Authorization is valid from July 15, 2019, through February 15, 2020.

    2. This Authorization is valid only for activities associated with in-water construction work at the US 101/Chehalis River Bridge-Scour Repair Project in the State of Washington.

    3. General Conditions.

    (a) A copy of this IHA must be in the possession of WSDOT, its designees, and work crew personnel operating under the authority of this IHA.

    (b) The species and number of authorized Level B harassment takes are provided in Table 7.

    (c) The taking by serious injury or death of any of the species listed in condition 3(b), or any taking of any other species of marine mammal not listed in condition 3(b) of the Authorization is prohibited and may result in the modification, suspension, or revocation of this IHA.

    (d) WSDOT must conduct briefings between construction supervisors and crews, marine mammal monitoring team, and WSDOT staff prior to the start of all pile driving, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    4. Mitigation Measures.

    The holder of this Authorization is required to implement the following mitigation measures:

    (a) In-water construction work must occur only during daylight hours.

    (b) For in-water heavy machinery activities other than pile driving, if a marine mammal comes within 10 meters (m), operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions.

    (c) Pre-activity marine mammal monitoring must take place from 30 minutes prior to initiation of pile driving and removal. Post-activity marine mammal monitoring must continue through 30 minutes post-completion of pile driving and removal. Pile driving and removal may commence at the end of the 30-minute pre-activity monitoring period, provided observers have determined that the relevant shutdown zone (Table 8) is clear of marine mammals.

    (d) WSDOT must establish and monitor shutdown zone and Level B harassment zones:

    i. Shutdown zone sizes for various pile driving activities and marine mammal hearing groups are shown in Table 8.

    ii. Level B harassment zone sizes are shown in Table 3.

    (e) If a marine mammal approaches or enters the shutdown zone (Table 8) during activities or pre-activity monitoring, all pile driving activities at that location must be halted or delayed, respectively. If pile driving is halted or delayed due to the presence of a marine mammal, the activity may not resume or commence until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.

    (f) WSDOT must establish monitoring locations and protocols as described below. Please also refer to the Marine Species Monitoring Plan (Monitoring Plan; attached).

    i. For vibratory pile driving of sheet piles, a total of four land-based PSOs must monitor the shutdown zone and Level B harassment zone as depicted in the Monitoring Plan.

    ii. For vibratory pile removal of timber piles and vibratory installation and removal of H piles, a total of three land-based PSOs must monitor the shutdown and Level B harassment zones.

    5. Monitoring.

    The holder of this Authorization is required to conduct marine mammal monitoring during pile driving and removal.

    (a) Monitoring during pile driving and removal must be conducted by NMFS-approved PSOs in a manner consistent with the following:

    i. Independent PSOs (i.e., not construction personnel) who have no other assigned tasks during monitoring periods must be used.

    ii. At least one PSO must have prior experience working as a marine mammal observer during construction activities. Other PSOs may substitute education (degree in biological science or related field) or training for experience.

    iii. Where a team of three or more PSOs are required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience working as a marine mammal observer during construction.

    iv. WSDOT must submit PSO CVs for approval by NMFS prior to the onset of pile driving.

    v. WSDOT must ensure that observers have the following additional qualifications:

    a. Ability to conduct field observations and collect data according to assigned protocols.

    b. Experience or training in the field identification of marine mammals, including the identification of behaviors.

    c. Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations.

    d. Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior.

    e. Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

    6. Reporting.

    The holder of this Authorization is required to submit marine mammal monitoring and acoustic reports:

    (a) WSDOT must submit a draft report on all marine mammal monitoring conducted under this Authorization within ninety calendar days following the completion of monitoring. A final report must be submitted within thirty days following resolution of comments on the draft report from NMFS. The marine mammal monitoring report must contain, at minimum, the informational elements described below:

    i. Date and time that monitored activity begins and ends for each day conducted (monitoring period);

    ii. Construction activities occurring during each daily observation period, including how many and what type of piles driven;

    iii. Deviation from initial proposal in pile numbers, pile types, average driving times, etc.

    iv. Weather parameters in each monitoring period (e.g., wind speed, percent cloud cover, visibility);

    v. Water conditions in each monitoring period (e.g., sea state, tide state);

    vi. For each marine mammal sighting:

    a. Species, numbers, and, if possible, sex and age class of marine mammals;

    b. Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

    c. Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

    d. Estimated amount of time that the animals remained in the Level B harassment zone;

    vii. Description of implementation of mitigation measures within each monitoring period (e.g., shutdown or delay);

    viii. Other human activity in the area within each monitoring period

    ix. A summary of the following:

    a. Total number of individuals of each species detected within the Level B harassment zone.

    b. Total number of individuals of each species detected within the Level A harassment zone and the average amount of time that they remained in that zone.

    c. Daily average number of individuals of each species (differentiated by month as appropriate) detected within the Level B Zone, and estimated as taken, if appropriate.

    (b) Reporting injured or dead marine mammals:

    i. In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as serious injury, or mortality, WSDOT must immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Region Stranding Coordinator, NMFS. The report must include the following information:

    1. Time and date of the incident;

    2. Description of the incident;

    3. Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    4. Description of all marine mammal observations and active sound source use in the 24 hours preceding the incident;

    5. Species identification or description of the animal(s) involved;

    6. Fate of the animal(s); and

    7. Photographs or video footage of the animal(s).

    Activities must not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with WSDOT to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. WSDOT may not resume their activities until notified by NMFS.

    ii. In the event WSDOT discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (e.g., in less than a moderate state of decomposition), WSDOT must immediately report the incident to the Office of Protected Resources, NMFS, and the West Coast Region Stranding Coordinator, NMFS. The report must include the same information identified in 6(b)(i) of this IHA. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with WSDOT to determine whether additional mitigation measures or modifications to the activities are appropriate.

    iii. In the event that WSDOT discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), WSDOT must report the incident to the Office of Protected Resources, NMFS, and the West Coast Region Stranding Coordinator, NMFS, within 24 hours of the discovery. WSDOT must provide photographs or video footage or other documentation of the stranded animal sighting to NMFS.

    7. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if NMFS determines the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.

    Request for Public Comments

    We request comment on our analyses, the proposed authorization, and any other aspect of this Notice of Proposed IHA for the proposed project. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.

    On a case-by-case basis, NMFS may issue a second one-year IHA without additional notice when (1) another year of identical or nearly identical activities as described in the Specified Activities section is planned or (2) the activities would not be completed by the time the IHA expires and a second IHA would allow for completion of the activities beyond that described in the Dates and Duration section, provided all of the following conditions are met:

    • A request for renewal is received no later than 60 days prior to expiration of the current IHA;

    • The request for renewal must include the following:

    (1) An explanation that the activities to be conducted beyond the initial dates either are identical to the previously analyzed activities or include changes so minor (e.g., reduction in pile size) that the changes do not affect the previous analyses, take estimates, or mitigation and monitoring requirements; and

    (2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized;

    • Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures remain the same and appropriate, and the original findings remain valid.

    Dated: October 15, 2018. Catherine Marzin, Acting Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-22812 Filed 10-18-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG549 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice of intent to prepare a Draft Supplemental Environmental Impact Statement.

    SUMMARY:

    Pursuant to the National Environmental Policy Act (NEPA), this notice announces that NMFS is preparing a Draft Supplemental Environmental Impact Statement (DSEIS) to supplement information in the 2017 Draft Environmental Impact Statement (DEIS) for 10 Hatchery and Genetic Management Plans (HGMP) for salmon and steelhead hatchery programs jointly submitted by the Washington Department of Fish and Wildlife (WDFW) with the Muckleshoot Indian Tribe and the Suquamish Tribe (referred to as the co-managers), for NMFS's evaluation and determination under Limit 6 of the Endangered Species Act (ESA) 4(d) Rule for threatened salmon and steelhead. The HGMPs specify the propagation of salmon and steelhead in the Duwamish-Green River basin in Washington State. The DSEIS will analyze an additional alternative reflecting an increase in hatchery production of juvenile Chinook salmon.

    DATES:

    Because NMFS has previously requested (81 FR 26776, May 6, 2016) and received information from the public on issues to be addressed in the EIS, and because the Council on Environmental Quality (CEQ) regulations for implementing the National Environmental Policy Act (NEPA) do not require additional scoping for this DSEIS process (40 CFR 1502.9(c)(4)), NMFS is not asking for further public scoping information and comment at this time. Upon release of the DSEIS, NMFS will provide a 45-day public review/comment period.

    ADDRESSES:

    Copies of the 2017 DEIS are available from NMFS, Sustainable Fisheries Division at 510 Desmond Drive SE, Suite 103, Lacey, WA 98503, and on the web at http://www.westcoast.fisheries.noaa.gov/hatcheries/Duwamish-Green/duw-green_hgmps_deis.html.

    FOR FURTHER INFORMATION CONTACT:

    Steve Leider, NMFS, by phone at (360) 753-4650, or email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The WDFW, and the co-managers have jointly submitted to NMFS HGMPs for 10 hatchery programs in the Duwamish-Green River basin in Washington State. The HGMPs reviewed in the DEIS were submitted to NMFS from 2013 to 2015, pursuant to limit 6 of the 4(d) Rule for salmon and steelhead. The hatchery programs include releases of ESA-listed Chinook salmon and winter-run steelhead into the Duwamish-Green River basin. The hatchery programs also release non-listed coho and fall-run chum salmon and summer-run steelhead into the Duwamish-Green River basin. One hatchery program releases coho salmon into marine waters adjacent to the Duwamish-Green River basin. Seven of the programs are currently operating, and three are new.

    NEPA requires Federal agencies to conduct environmental analyses of their proposed major actions to determine if the actions may affect the human environment. NMFS's action of determining that implementation of the co-managers' HGMPs would not appreciably reduce the likelihood of survival and recovery of affected threated ESUs under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the ESA, is a major Federal action subject to environmental review under NEPA.

    On May 4, 2016, NMFS announced its intent to prepare an EIS and the 30-day public scoping period ended on June 3, 2016. On November 3, 2017, NMFS announced the release of a DEIS for public comment. The DEIS includes an analysis of the proposed action identified in the 2016 NOI and the anticipated environmental impacts. Following an extension, the 75-day public comment period ended on January 19, 2018.

    In light of subsequent information, NMFS has determined that the Final EIS would benefit from the analysis of an expanded range of potential alternatives for hatchery production of Chinook salmon. The alternative to be analyzed in the DSEIS is informed by the applicant's interest in increasing hatchery production of juvenile Chinook salmon, and NMFS' analysis of the status of endangered Southern Resident Killer Whales and the importance of Chinook salmon prey to their food base. The DSEIS will analyze an increased level of Chinook salmon hatchery production and provide the public with an opportunity for review and comment. The DSEIS, in conjunction with the 2017 DEIS, will collectively evaluate the proposed action and alternatives.

    Alternatives

    The alternatives analyzed in the 2017 DEIS are summarized in the DEIS Notice of Intent (82 FR 26776, May 4, 2016). The upcoming DSEIS will analyze an alternative in which hatchery production from the Soos Creek Chinook salmon program would produce an additional 2,000,000 juvenile Chinook salmon to be released at Palmer Ponds in the Duwamish-Green River basin.

    Authority

    The environmental review of the 10 salmon and steelhead HGMPs in the Duwamish-Green River basin of Washington State will be conducted in accordance with requirements of the NEPA of 1969 as amended (42 U.S.C. 4321 et seq.), NEPA Regulations (40 CFR parts 1500-1508), other appropriate Federal laws and regulations, and policies and procedures of NMFS for compliance with those regulations.

    Dated: October 15, 2018. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-22809 Filed 10-18-18; 8:45 am] BILLING CODE 3510-22-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Deletions from the Procurement List.

    SUMMARY:

    This action deletes a product and services from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

    DATES:

    Date deleted from the Procurement List: November 18, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Michael R. Jurkowski, Telephone: (703) 603-2117, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Deletions

    On 9/14/2018 (83 FR 179), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the product and services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the product and services to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product and services deleted from the Procurement List.

    End of Certification

    Accordingly, the following product and services are deleted from the Procurement List:

    Product NSN(s)—Product Name(s): 6545-00-853-6309—First Aid Kit, Eye Dressing Mandatory Source of Supply: Suburban Adult Services, Inc., Elma, NY Contracting Activity: Defense Logistics Agency Troop Support Services Service Type: Reproduction and Courier Service Mandatory for: Naval Facilities Engineering Command, Chesapeake Engineering Field Activity Chesapeake, 1314 Harwood Avenue SE, Washington, DC Mandatory Source of Supply: Linden Resources, Inc., Arlington, VA Contracting Activity: DEPT OF THE NAVY, U.S. FLEET FORCES COMMAND Service Type: Janitorial/Custodial Service Mandatory for: Naval & Marine Corps Reserve Center (NMCRC), 1201 N 35th Avenue, Phoenix, AZ Mandatory Source of Supply: The Centers for Habilitation/TCH, Tempe, AZ Contracting Activity: DEPT OF THE NAVY, NAVFAC SOUTHWEST Service Type: Grounds Maintenance Service Mandatory for: Naval Air Warfare Center Weapons Division: Buildings 456 (N97) and 1438 (Main Post Area), White Sands Missile, NM Mandatory Source of Supply: Tresco, Inc., Las Cruces, NM Contracting Activity: DEPT OF THE NAVY, U.S. FLEET FORCES COMMAND Michael R. Jurkowski, Business Management Specialist Business Operations.
    [FR Doc. 2018-22789 Filed 10-18-18; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Addition and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed addition to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

    DATES:

    Comments must be received on or before: November 18, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 603-2117, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Addition

    If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to provide the service listed below from a nonprofit agency employing persons who are blind or have other severe disabilities.

    The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:

    Service Service Type: Custodial Service Mandatory for: U.S. Army, ACC Aberdeen, PEO Facilities, Fort Belvoir, VA Mandatory Source(s) of Supply: Melwood Horticultural Training Center, Inc., Upper Marlboro, MD Contracting Activity: Army Contracting Command—Aberdeen Proving Ground, Natick Contracting Division Deletions

    The following products are proposed for deletion from the Procurement List:

    Products NSN(s)—Product Name(s): 7930-01-517-4178—Cleaner, Industrial, Multi-Purpose, SKILCRAFT Savvy Green, 32 oz 7930-01-517-4171—Cleaner, Industrial, Multi-Purpose, SKILCRAFT Savvy Green, 1 GL 7930-01-517-4172—Cleaner, Industrial, Multi-Purpose, SKILCRAFT Savvy Green, 5 GL 7930-01-517-4177—Cleaner, Industrial, Multi-Purpose, SKILCRAFT Savvy Green, 55 GL 7930-01-517-2726—Cleaner, Heavy Duty, Industrial, Multi-Purpose, SKILCRAFT Savvy Green Plus, 32 oz. 7930-01-517-4185—Cleaner, Industrial, Multi-Purpose, SKILCRAFT Savvy Green, 1 gal 7930-01-517-4186—Cleaner, Heavy Duty, Industrial, Multi-Purpose, SKILCRAFT Savvy Green Plus, 5 GL 7930-01-517-4187—Cleaner, Heavy Duty, Industrial, Multi-Purpose, SKILCRAFT Savvy Green Plus, 55 GL Mandatory Source(s) of Supply: VisionCorps, Lancaster, PA Contracting Activities: General Services Administration, Fort Worth, TX Department of Veterans Affairs, Strategic Acquisition Center Michael R. Jurkowski, Business Management Specialist Business Operations.
    [FR Doc. 2018-22788 Filed 10-18-18; 8:45 am] BILLING CODE 6353-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0107] Agency Information Collection Activities; Comment Request; The Department of Education Accrediting Agency, Foreign Medical and Foreign Veterinarian Program Comparability Database Approval AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 18, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2018-ICCD-0107. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 550 12th Street SW, PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Herman Bounds, 202-453-6128.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: The Department of Education Accrediting Agency, Foreign Medical and Foreign Veterinarian Program Comparability Database Approval.

    OMB Control Number: 1840-0788.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector.

    Total Estimated Number of Annual Responses: 94.

    Total Estimated Number of Annual Burden Hours: 3,988.

    Abstract: The United States Secretary of Education (Secretary) is required by law to publish a list of nationally-recognized accrediting agencies that have been determined to be reliable authorities regarding the quality of education or training offered by the institutions or programs they accredit. In determining whether a specific agency should be recognized, the Secretary evaluates the submission for compliance with the Criteria for Recognition contained in regulations. The collection of information is necessary for the Secretary to evaluate and monitor the continued compliance with the criteria during any period of recognition granted. This collection is submitted due to the approaching end of the 3 year approval period. There is a change in burden hours for the following reasons. The number of accrediting agencies/organizations submitting documentation increased. Two additional accrediting agencies submitted initial petitions for recognition and supporting documentation, one additional foreign veterinary accrediting agency and two additional accrediting organizations communicated their intent to submit an initial application. Department staff consulted with seven accrediting agencies and organizations and determined that a new evaluation of burden hours was necessary.

    Dated: October 16, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-22861 Filed 10-18-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP18-1229-001.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: Tariff Amendment: Volume No. 2—BKV Operating LLC Table of Contents Amend to be effective 11/1/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5101.

    Comments Due: 5 p.m. ET 10/22/18.

    Docket Numbers: RP19-50-000.

    Applicants: White River Hub, LLC.

    Description: eTariff filing per 1430: Form 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5000.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-51-000.

    Applicants: Bear Creek Storage Company, L.L.C.

    Description: eTariff filing per 1430: FERC Form No. 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5023.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-52-000.

    Applicants: Gulfstream Natural Gas System, L.L.C.

    Description: eTariff filing per 1430: GNGS FERC Form 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5024.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-53-000.

    Applicants: Kinetica Deepwater Express, LLC.

    Description: eTariff filing per 1430: Form 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5025.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-54-000.

    Applicants: Kinetica Energy Express, LLC.

    Description: eTariff filing per 1430: Form 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5027.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-55-000.

    Applicants: Kern River Gas Transmission Company.

    Description: eTariff filing per 1430: 20181011 FERC Form No. 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5031.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-56-000.

    Applicants: MIGC LLC.

    Description: eTariff filing per 1430: MIGC FERC Form No. 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5032.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-57-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: eTariff filing per 1430: AGT FERC Form 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5044.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-58-000.

    Applicants: Transcontinental Gas Pipe Line Company, LLC.

    Description: § 4(d) Rate Filing: List of Non-Conforming Service Agreements (ASR In-Svc and Misc.) to be effective 11/11/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5046.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-59-000.

    Applicants: Northern Natural Gas Company.

    Description: eTariff filing per 1430: 20181011 FERC Form No. 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5055.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-60-000.

    Applicants: Vector Pipeline L.P.

    Description: eTariff filing per 1430: FERC Form 501-G Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5070.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-61-000.

    Applicants: Vector Pipeline L.P.

    Description: eTariff filing per 1440: Limited Section 4 Tax Reduction Filing to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5073.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-62-000.

    Applicants: Dominion Energy Transmission, Inc.

    Description: eTariff filing per 1430: DETI—FERC Form No. 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5079.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-63-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: eTariff filing per 1430: ETNG FERC Form No. 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5084.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-64-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: eTariff filing per 1440: ETNG Limited Section 4 to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5088.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-65-000.

    Applicants: Millennium Pipeline Company, LLC.

    Description: eTariff filing per 1430: Form 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5097.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-66-000.

    Applicants: Millennium Pipeline Company, LLC.

    Description: § 4(d) Rate Filing: Limited NGA Section 4 to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5098.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-67-000.

    Applicants: Discovery Gas Transmission LLC.

    Description: eTariff filing per 1430: FERC Form 501-G Submittal.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5101.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-68-000.

    Applicants: Horizon Pipeline Company, L.L.C.

    Description: eTariff filing per 1430: Form No. 501-G Compliance Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5108.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-69-000.

    Applicants: MIGC LLC.

    Description: eTariff filing per 1430: MIGC FERC Form No. 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5114.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-70-000.

    Applicants: Portland Natural Gas Transmission System.

    Description: eTariff filing per 1430: PNGTS 501-G Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5118.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-71-000.

    Applicants: North Baja Pipeline, LLC.

    Description: eTariff filing per 1430: North Baja 501-G.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5121.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-72-000.

    Applicants: North Baja Pipeline, LLC.

    Description: eTariff filing per 1440: North Baja Limited Section 4 Tax Reduction Filing to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5123.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-73-000.

    Applicants: El Paso Natural Gas Company, L.L.C.

    Description: eTariff filing per 1430: El Paso Form No. 501-G Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5124.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-74-000.

    Applicants: Texas Gas Transmission, LLC.

    Description: eTariff filing per 1430: FERC Form No. 501-G Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5129.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-75-000.

    Applicants: Southern Star Central Gas Pipeline, Inc.

    Description: eTariff filing per 1430: Form 501-G in Compliance.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5136.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-76-000.

    Applicants: Kern River Gas Transmission Company.

    Description: Compliance filing 2018 Settlement for Tax Reform Credit to be effective 12/31/9998.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5137.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-77-000.

    Applicants: Trunkline Gas Company, LLC.

    Description: eTariff filing per 1430: FERC Form No. 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5151.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-78-000.

    Applicants: Panhandle Eastern Pipe Line Company, LP.

    Description: eTariff filing per 1430: FERC Form No. 501-G Report.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5152.

    Comments Due: 5 p.m. ET 10/23/18.

    Docket Numbers: RP19-79-000.

    Applicants: Enable Gas Transmission, LLC.

    Description: eTariff filing per 1430: EGT 501-G Filing.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5153.

    Comments Due: 5 p.m. ET 10/23/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 15, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22822 Filed 10-18-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-102-000] Luminant Energy Company LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Luminant Energy Company LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 5, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 15, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22820 Filed 10-18-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14751-002] Alpine Pacific Utilities Hydro, LLC; Notice of Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the original license application for the Fresno Dam Site Water Power Project, located on the Milk River, at the existing U.S. Bureau of Reclamation's (Reclamation) Fresno Dam, in Hill County, Montana, and has prepared an Environmental Assessment (EA) for the project. The project would occupy 0.07 acre of federal land managed by Reclamation.

    The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.

    A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY).

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Any comments should be filed within 30 days from the date of this notice.

    The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-14751-002.

    For further information, please contact John Matkowski at (202) 502-8576 or by email at [email protected]

    Dated: October 15, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22817 Filed 10-18-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC19-11-000.

    Applicants: Liberty Utilities (CalPeco Electric) LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act, et al. of Liberty Utilities (CalPeco Electric) LLC.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5199.

    Comments Due: 5 p.m. ET 11/2/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER18-2029-001.

    Applicants: Southern California Edison Company.

    Description: Tariff Amendment: SCE's Response to Deficiency re GIA & DistribServAgmt AltaGas SA Nos. 1027-1028 to be effective 7/18/2018.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5085.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-104-000.

    Applicants: El Paso Electric Company.

    Description: § 205(d) Rate Filing: Concurrence of EPE to APS Service Agreement No. 367 to be effective 9/7/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5176.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-105-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Periodic Review of Variable Resource Requirement Curve Shape and Key Parameters to be effective 12/12/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5177.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-106-000.

    Applicants: Birdsboro Power LLC.

    Description: Baseline eTariff Filing: Application for Market Based Rate to be effective 12/1/2018.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5048.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-107-000.

    Applicants: ISO New England Inc.

    Description: § 205(d) Rate Filing: 2019 Capital Budget & Revised Tariff Sheets for Recovery of 2019 Admin. Costs to be effective 1/1/2019.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5061.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-108-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to WMPA SA No. 4916; Queue No. AC2-070 to be effective 1/26/2018.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5067.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-109-000.

    Applicants: Duke Energy Ohio, Inc., PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Duke Energy Ohio submits IA SA No. 5186 and Cancellation of IA SA No. 1958 to be effective 6/30/2018.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5068.

    Comments Due: 5 p.m. ET 11/5/18.

    Docket Numbers: ER19-110-000.

    Applicants: ISO New England Inc.

    Description: § 205(d) Rate Filing: Revised Tariff Sheets for Recovery of Costs for the 2019 Operation of NESCOE to be effective 1/1/2019.

    Filed Date: 10/15/18.

    Accession Number: 20181015-5069.

    Comments Due: 5 p.m. ET 11/5/18.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES19-2-000.

    Applicants: KCP&L Greater Missouri Operations Company.

    Description: Application under Section 204 of the Federal Power Act for Authorization to Issue Securities of KCP&L Greater Missouri Operations Company.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5196.

    Comments Due: 5 p.m. ET 11/2/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 15, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22818 Filed 10-18-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9041-8] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-5632 or https://www.epa.gov/ nepa/.

    Weekly receipt of Environmental Impact Statements Filed 10/08/2018 Through 10/12/2018 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

    EIS No. 20180243, Draft Supplement, USFWS, WA, Hanford Reach National Monument Rattlesnake Unit Draft Supplemental Environmental Impact Statement, Comment Period Ends: 12/03/2018, Contact: Trevor Fox 509-546-8311 EIS No. 20180245, Draft, FRA, OR, Oregon Passenger Rail Tier 1 Draft Environmental Impact Statement, Comment Period Ends: 12/18/2018, Contact: Lydia Kachadoorian 781-227-0778 EIS No. 20180246, Draft, FERC, TX, Rio Grande LNG Project, Comment Period Ends: 12/03/2018, Contact: Office of External Affairs 866-208-3372 EIS No. 20180247, Draft, USFWS, FL, Eastern Collier Multiple Species Incidental Take Permit Applications and Habitat Conservation Plan, Comment Period Ends: 12/03/2018, Contact: David Dell 404-679-7313 EIS No. 20180248, Final, USFWS, OK, Proposed Habitat Conservation Plan for the Endangered American Burying Beetle for American Electric Power in Oklahoma, Arkansas, and Texas, Review Period Ends: 11/19/2018, Contact: Seth Willey 505-248-6920 EIS No. 20180249, Draft, USACE, CA, Westminster East Garden Grove Flood Risk Management Study, Comment Period Ends: 12/03/2018, Contact: Michael Padilla 312-846-5427 Amended Notices EIS No. 20180238, Final, UDOT, UT, S.R. 30, S.R. 23 to 1000 West, Contact: Naomi Kisen 801-965-4005 Revision to the FR Notice Published 10/12/2018; Correcting Lead Agency from FHWA to UDOT. Dated: October 15, 2018. Robert Tomiak, Director, Office of Federal Activities.
    [FR Doc. 2018-22745 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2018-0657; FRL-9983-98] Pesticide Registration Maintenance Fee: Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide Registrations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by registrants through Pesticide Registration Maintenance Fee responses to voluntarily cancel certain pesticide registrations. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw its requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled only if such sale, distribution, or use is consistent with the terms as described in the final order.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2018-0657, 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: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Submit written withdrawal request by mail to: Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. ATTN: Michael Yanchulis.

    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:

    Michael Yanchulis, Information Technology and Resources Managements Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-0237; email address: [email protected]

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides.

    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. What action is the Agency taking?

    This notice announces receipt by the Agency of requests from registrants to cancel 200 pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or 24(c) (7 U.S.C. 136v(c)). These registrations are listed in sequence by registration number (or company number and 24(c) number) in Table 1 of this unit.

    Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the Federal Register canceling all of the affected registrations.

    Table 1—Registrations With Pending Requests for Cancellation Registration No. Company No. Product name Chemical name 100-1053 100 Havoc Rodenticide Bait Pack Pellets with Bitrex Brodifacoum. 100-1054 100 Havoc Rodenticide Bait Pack Mini-Pellets with Bitrex Brodifacoum. 100-1065 100 Scimitar WP Insecticide in Water-Soluble Packs lambda-Cyhalothrin. 100-1082 100 Demand Pestab Insecticide lambda-Cyhalothrin. 100-1142 100 Mesotrione/acetochlor 3.5 CS Mesotrione; Acetochlor. 100-1152 100 Lumax Selective Herbicide Mesotrione; Atrazine; S-Metolachlor. 100-1174 100 Impasse Termite Bait Lufenuron. 100-1181 100 Zyrox Plus Termite Baiting Technology Lufenuron. 100-1201 100 Lexar Herbicide Mesotrione; Atrazine; S-Metolachlor. 100-1257 100 Lufenuron Termite Bait Lufenuron. 100-1396 100 Flexstar Gt Manufacturing Use Concentrate Glyphosate; Sodium salt of fomesafen. 100-1436 100 Derby Thiamethoxam; lambda-Cyhalothrin. 100-1542 100 Zyrox SC Cyantraniliprole. 228-689 228 MSM E-Pro 60 EG Herbicide Metsulfuron. 228-702 228 Nufarm Prosedge Selective Herbicide Halosulfuron-methyl. 264-1075 264 Wolverine Herbicide Bromoxynil octanoate; Bromoxynil heptanoate; Fenoxaprop-p-ethyl; Pyrasulfotole Technical. 264-1103 264 Atlantis Herbicide Mesosulfuron-methyl; Iodosulfuron-methyl-sodium. 270-307 270 Farnam Pet Spray 549 MGK 264; Pyrethrins; Pyriproxyfen. 400-583 400 Captan Technical Captan. 400-599 400 Flupro-Technical Flumetralin. 432-1232 432 Chipco 26019 75WDG Brand Fungicide Iprodione. 432-1568 432 Plainview Herbicide Aminocyclopyrachlor; Sulfometuron; Chlorsulfuron. 432-1577 432 Lineage HWC Herbicide Imazapyr; Sulfometuron; Metsulfuron. 432-1579 432 Lineage Prep Herbicide Imazapyr; Sulfometuron; Metsulfuron. 875-41 875 Diversol CX with Arodyne Sodium hypochlorite. 875-95 875 Low Temperature Sanitizer W500l Sodium hypochlorite. 875-182 875 Divosan X-Tend Phosphoric acid. 875-185 875 Pro-Kleen Phosphoric acid; Dodecylbenzenesulfonic acid. 1015-67 1015 Douglas Pyrethrin 5 MGK 264; Piperonyl butoxide; Pyrethrins. 2596-86 2596 Hartz 2 in 1 Flea & Tick Dip for Dogs with Pyrethrin MGK 264; Piperonyl butoxide; Pyrethrins. 2724-640 2724 Speer Neoperm Wasp & Hornet Killer #1 Piperonyl butoxide; Permethrin; Tetramethrin. 2724-646 2724 Speer Neoperm Crawling Insect Killer IV Piperonyl butoxide; Permethrin; Tetramethrin. 3862-135 3862 Drop Dead Propoxur; MGK 264; Piperonyl butoxide; Pyrethrins. 3862-156 3862 Microbiocide LD-5 Potassium dimethyldithiocarbamate. 5383-88 5383 Troysan Polyphase 588 Carbamic acid, butyl-, 3-iodo-2-propynyl ester; Irgarol 1051. 5383-102 5383 Mergal S90 Carbendazim; Octhilinone; Irgarol 1051. 5383-115 5383 Polyphase 3000 Carbamic acid, butyl-, 3-iodo-2-propynyl ester. 5383-167 5383 Nuosept Bit Technical 1,2-Benzisothiazolin-3-one. 5736-102 5736 Super-Bol Quaternary Ammonium Compounds. 5813-52 5813 Ultra Clorox Brand 6.15% Bleach Sodium hypochlorite. 9198-70 9198 The Andersons Weed & Feed 2,4-D, dimethylamine salt. 9198-79 9198 The Andersons Tee Time Fertilizer with 1.15% Team Benfluralin; Trifluralin. 9198-111 9198 The Andersons 1.0% Bayleton(R) Fungicide Triadimefon. 9198-184 9198 Andersons Golf Products Kog Weed Control Dicamba. 9198-201 9198 High K Fertilizer with TGR POA Annual Control Paclobutrazol. 9198-216 9198 The Anderson's 0.058% Granular Bifenthrin Insecticide Bifenthrin. 11556-164 11556 Americare Rabon Flea & Tick Collar for Dogs Gardona (cis-isomer). 11556-165 11556 Americare Rabon Flea & Tick Collar for Cats Gardona (cis-isomer). 28293-146 28293 Unicorn Concentrated Flea and Tick Dip MGK 264; Piperonyl butoxide; Pyrethrins. 28293-158 28293 Unicorn Knockdown Spray MGK 264; Permethrin; Pyrethrins. 28293-161 28293 Unicorn Home Fogger MGK 264; Permethrin; Pyrethrins. 28293-214 28293 Unicorn IGR Total Release Fogger MGK 264; Permethrin; Pyriproxyfen; Pyrethrins. 53883-245 53883 Diuron 4L Algaecide Diuron. 55146-150 55146 NUP-12103 Bulk Product Azoxystrobin; Propiconazole. 60063-27 60063 Sipcam Propiconazole 1.3ME Propiconazole. 66222-96 66222 Diuron 90DF Diuron. 66222-170 66222 Rotary 2 SL Imazapyr, isopropylamine salt. 66330-377 66330 Thifensulfuron + Tribenuron 4:1 Herbicide Tank Mix Thifensulfuron. 66330-378 66330 Thifensulfuron + Tribenuron 2:1 Herbicide Tank Mix Thifensulfuron; Tribenuron-methyl. 66330-405 66330 Raze Herbicide Fluroxypyr 1-methylheptyl ester; Flucarbazone-sodium. 66330-426 66330 Dicamba Technical Dicamba. 66330-427 66330 Dicamba Technical B Dicamba. 67619-7 67619 CPPC Ultra Bleach Sodium hypochlorite. 68156-4 68156 Dintec HFP Trifluralin Trifluralin. 69681-33 69681 Clor Mor Multishock Plus Sodium dichloro-s-triazinetrione. 69681-34 69681 Clor Mor Triple-Action Chlorinating Tabs Trichloro-s-triazinetrione; Boron sodium oxide (B4Na2O7), pentahydrate. 70627-4 70627 Johnson CRS Sodium hypochlorite. 70627-51 70627 Raid Commercial Flying Insect Killer Piperonyl butoxide; Tetramethrin. 70627-61 70627 Multi-Surface Antibacterial L-Lactic acid. 70627-76 70627 Windex Multi-Surface Disinfectant L-Lactic acid. 72155-10 72155 Merit 0.005% PM Plus Fertilizer Imidacloprid. 72155-34 72155 Beta-Cyfluthrin 0.05% Fire Ant Granular Insecticide beta-Cyfluthrin. 72155-44 72155 Merit 0.2 Granular Insecticide Imidacloprid. 72155-61 72155 Tebuconazole 1.0% + Merit 0.2% Concentrate Fungicide/Insecticide Tebuconazole; Imidacloprid. 72155-89 72155 Lawn 3FL Herbicide Concentrate/Ready-To-Spray 2,4-D, dimethylamine salt; Mecoprop-P; Dicamba, potassium salt; Indaziflam. 72155-90 72155 Lawn 3FL Herbicide Ready-To-Use 2,4-D, dimethylamine salt; Mecoprop-P; Dicamba, potassium salt; Indaziflam. 72155-104 72155 Lawn 3FL2 Herbicide Concentrate/Ready-To-Spray 2,4-D, dimethylamine salt; Mecoprop-P; Dicamba, potassium salt; Indaziflam. 72155-105 72155 Lawn 3FL2 Herbicide Ready-To-Use 2,4-D, dimethylamine salt; Mecoprop-P-potassium; Dicamba, potassium salt; Indaziflam. 72304-8 72304 Clortram F-54 Chlorothalonil. 83070-10 83070 Eject 4L Quinclorac. 85588-11 85588 Pysonex Herbicide Pyrithiobac-sodium. AL170004 352 Dupont Fexapan Herbicide Dicamba, diglycolamine salt. AR080014 352 Dupont Firstshot SG Burndown Herbicide Thifensulfuron; Tribenuron-methyl. AR100005 8033 Confirm 2F Agricultural Insecticide Tebufenozide. AR120008 59639 V-10142 AG Herbicide Imazosulfuron. AR130010 352 Dupont Realm Q Herbicide Mesotrione; Rimsulfuron. AR140004 8033 Intruder Brand Insecticide Acetamiprid. AR940002 59639 Valent Bolero 8 EC Thiobencarb. AR940003 59639 Valent Bolero 8 EC Thiobencarb. AR950004 59639 Valent Bolero 8 EC Thiobencarb. AZ110002 7173 Difethialone Paste Place Packs Difethialone. AZ120003 10163 Intruder Brand Insecticide Acetamiprid. AZ170005 8033 Assail 70WP Insecticide Acetamiprid. CA040027 5481 Alco Citrus Fix 2,4-D, isopropyl ester. CA100007 34704 Liqui-Stik Concentrate Ammonium 1-naphthaleneacetate. CA930003 59639 Valent Bolero 8 EC Thiobencarb. CA930013 5481 Tre-Hold Sprout Inhibitor A112 Ethyl 1-naphthaleneacetate. CA990022 352 Dupont Asana XL Insecticide Esfenvalerate. FL030004 100 Fulfill Pymetrozine. FL040006 100 Fulfill Insecticide Pymetrozine. FL930010 59639 Valent Bolero 8 EC Thiobencarb. GA110002 100 Ridomil Gold SL Metalaxyl-M. GA170003 352 Dupont Fexapan Herbicide Dicamba, diglycolamine salt. GA990005 5481 Vapam HL Soil Fumigant Metam-sodium. HI120004 100 Evik 80 WDG Ametryn. ID000010 100 Fulfill Pymetrozine. ID060007 241 Prowl H2O Herbicide Pendimethalin. ID080006 66330 Evito 480 SC Fungicide Fluoxastrobin. ID090016 5481 Orthene 97 Acephate. ID110005 59639 Metconazole 50 WDG Fungicide Metconazole. ID960008 7969 Basagran Herbicide Sodium bentazon. IN110002 100 Ridomil Gold SL Metalaxyl-M. KY140038 100 Ridomil Gold SL Metalaxyl-M. LA010003 59639 Valent Bolero 8 EC Thiobencarb. LA070001 241 Scepter 70 DG Herbicide Imazaquin. LA120001 352 Dupont Dermacor X-100 Seed Treatment Chlorantraniliprole. LA120016 241 Prowl H2O Herbicide Pendimethalin. LA140002 8033 Intruder Brand Insecticide Acetamiprid. LA950005 59639 Valent Bolero 8 EC Thiobencarb. ME100001 50534 Bravo ZN Chlorothalonil. MI040001 50534 Bravo 720 Chlorothalonil. MI040002 50534 Bravo ZN Chlorothalonil. MI100002 50534 Bravo Weather Stik Chlorothalonil. MI120001 50534 Bravo 720 Chlorothalonil. MI130004 100 Cannonball WP Fludioxonil. MN030006 50534 Bravo Weatherstik Chlorothalonil. MN030007 50534 Bravo Ultrex Chlorothalonil. MN030008 50534 Bravo ZN Chlorothalonil. MN080002 66330 Malathion 5 EC Malathion. MO030005 59639 Valent Bolero 8 EC Thiobencarb. MO130001 352 Dupont Realm Q Herbicide Mesotrione; Rimsulfuron. MO930007 59639 Valent Bolero 8 EC Thiobencarb. MO940005 59639 Valent Bolero 8 EC Thiobencarb. MO950002 59639 Valent Bolero 8 EC Thiobencarb. MS120006 352 Dupont Realm Q Herbicide Mesotrione; Rimsulfuron. MS140006 8033 Intruder Brand Insecticide Acetamiprid. MS930009 59639 Valent Bolero 8 EC Thiobencarb. MS930010 59639 Valent Bolero 8 EC Thiobencarb. MS950007 59639 Valent Bolero 8 EC Thiobencarb. MT030008 100 Fulfill Pymetrozine. MT080003 39039 Python Insecticide Cattle Ear Tag Piperonyl butoxide; Zeta-Cypermethrin. MT110001 59639 Metconazole 50 WDG Fungicide Metconazole. MT960001 7969 Basagran Herbicide Sodium bentazon. NC070003 59639 Select Max Herbicide in Inside Technology Clethodim. NC110004 100 Ridomil Gold SL Metalaxyl-M. NC120011 241 Prowl H2O Herbicide Pendimethalin. NC130003 5481 Vapam HL Soil Fumigant Metam-sodium. NC830009 5481 Zeneca Vapam 4-S Soil Fumigant Solution Metam-sodium. ND030007 50534 Bravo Weatherstik Chlorothalonil. ND030008 50534 Bravo ZN Chlorothalonil. ND170007 70506 Super Tin 4L Fentin hydroxide. NE090001 50534 Bravo 720 Chlorothalonil. NE090002 50534 Bravo ZN Chlorothalonil. NJ110011 50534 Bravo 720 Chlorothalonil. NM140002 34704 Malathion 8 Aquamul Malathion. NV000004 100 Fulfill Pymetrozine. NV110002 59639 Valor Herbicide Flumioxazin. NY120011 7969 Headline Fungicide Pyraclostrobin. NY120012 7969 Bas 556 SC Pyraclostrobin; Metconazole. NY120013 7969 Headline SC Pyraclostrobin. NY140004 7969 Merivon Xemium Brand Fungicide Pyraclostrobin; Fluxapyroxad. NY140005 7969 Priaxor Xemium Brand Fungicide Pyraclostrobin; Fluxapyroxad. NY170003 352 Dupont Fexapan Herbicide Dicamba, diglycolamine salt. OH110005 100 Ridomil Gold SL Metalaxyl-M. OK090002 39039 Python Insecticide Cattle Ear Tag Piperonyl butoxide; Zeta-Cypermethrin. OR040004 100 Fulfill Pymetrozine. OR040005 100 Fulfill Pymetrozine. OR070018 66222 Diazinon AG500 Diazinon. OR110004 7969 Basf Poast Herbicide Sethoxydim. OR950033 7969 Basagran Herbicide Sodium bentazon. OR990039 100 Bravo 825 Chlorothalonil. OR990040 100 Bravo 720 Chlorothalonil. SC120001 100 Ridomil Gold SL Metalaxyl-M. SC960006 5481 Vapam HL Soil Fumigant Metam-sodium. SD110003 39039 Python Insecticide Cattle Ear Tag Piperonyl butoxide; Zeta-Cypermethrin. SD120001 7969 Optill Pro Powered by Kixor Herbicide Imazethapyr; Saflufenacil. TN050001 5481 Orthene 97 Acephate. TN110002 100 Ridomil Gold SL Metalaxyl-M. TN130008 34704 Tombstone Cyfluthrin. TX930007 59639 Cobra Herbicide Lactofen. TX930023 59639 Valent Bolero 8 EC Thiobencarb. TX980004 5481 Orthene Turf, Tree & Ornamental Spray B WSP Acephate. UT000010 100 Fulfill Pymetrozine. UT090001 8033 Assail 70WP Insecticide Acetamiprid. UT120030 100 Gramoxone SL 2.0 Paraquat dichloride. UT990004 352 Vydate L Insecticide/Nematicide Oxamyl. UT990005 5481 Dibrom 8 Emulsive Naled. VA050004 70506 Waylay 3.2 AG Permethrin Insecticide Permethrin. VA110002 100 Ridomil Gold SL Metalaxyl-M. WA000016 100 Fulfill Pymetrozine. WA000017 100 Fulfill Pymetrozine. WA110004 66330 ARY 0454-105 Suspension Concentrate Herbicide Flucarbazone-sodium. WA120011 59639 Valor Herbicide Flumioxazin. WA130007 100 Fusilade II Turf and Ornamental Herbicide Fluazifop-P-butyl. WA900005 34704 Clean Crop Simazine 4L Flowable Herbicide Simazine. WA900012 7969 Basagran Sodium bentazon. WI130009 50534 Bravo 825 Agricultural Fungicide Chlorothalonil. WI130010 50534 Bravo 720 Chlorothalonil. WI130011 50534 Bravo ZN Chlorothalonil. WI130013 50534 Bravo 720 Chlorothalonil.

    Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.

    Table 2—Registrants Requesting Voluntary Cancellation EPA Company No. Company name and address 100 Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. 228 Nufarm Americas, Inc., 4020 Aerial Center Parkway, Suite 101, Morrisville, NC 27560. 241 BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. 264 Bayer Cropscience LP, P.O. Box 12014, Research Triangle Park, NC 27709. 270 Farnam Companies, Inc., 1501 E Woodfield Road, Suite 200 West, Shaumburg, IL 60173. 352 E. I. Du Pont de Nemours and Company, Chestnut Run Plaza, 974 Centre Road, Wilmington, DE 19805. 400 MacDermid Agricultural Solutions, Inc., c/o Arysta Lifescience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. 432 Bayer Environmental Science, A Division of Bayer Cropscience LP, P.O. Box 12014, Research Triangle Park, NC 27709. 875 Diversey, Inc., 1410 Newman Road, Racine, WI 53406. 1015 Pyxis Regulatory Consulting, Inc., Agent for Douglas Products and Packaging Co., 4110 136th Street CT NW, Gig Harbor, WA 98332. 2596 The Hartz Mountain Corporation, 400 Plaza Drive, Secaucus, NJ 07094. 2724 Wellmark International, 1501 E Woodfield Road, Suite 200 West, Shaumburg, IL 60173. 3862 ABC Compounding Co., Inc., P.O. Box 80729, Conyers, GA 30013. 5383 Troy Chemical Corp., c/o Troy Corporation, 8 Vreeland Road, Florham Park, NJ 07932. 5481 AMVAC Chemical Corporation, 4695 MacArthur Court, Suite 1200, Newport Beach, CA 92660. 5736 Diversey, Inc., 1410 Newman Road, Racine, WI 53406. 5813 The Clorox Co., c/o PS&RC, P.O. Box 493, Pleasanton, CA 94566. 7173 Liphatech, Inc., 3600 W Elm Street, Milwaukee, WI 53209. 7969 BASF Corporation, Agricultural Products, P.O. Box 13528, Research Triangle Park, NC 27709. 8033 Nisso America Inc., Agent for Nippon Soda Co., Ltd., 88 Pine Street, 14th Floor, New York, NY 10005. 9198 The Andersons, Inc., P.O. Box 119, Maumee, OH 43537. 10163 Gowan Company, P.O. Box 5569, Yuma, AZ 85366. 11556 Bayer Healthcare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 28293 Phaeton Corp., d/b/a Unicorn Laboratories, 1501 E Woodfield Road, Suite 200 West, Schaumburg, IL 60173. 34704 Loveland Products, Inc., P.O. Box 1286, Greeley, CO 80632. 39039 Y-Tex Corporation, 1825 Big Horn Avenue, Cody, WY 82414. 50534 GB Biosciences, LLC, P.O. Box 18300, Greensboro, NC 27419. 53883 Control Solutions, Inc., 5903 Genoa Red Bluff Road, Pasadena, TX 77507. 55146 Nufarm Americas, Inc., 4020 Aerial Center Parkway, Suite 101, Morrisville, NC 27560. 59639 Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. 60063 Sipcam Agro USA, Inc., 2525 Meridian Pkwy., Suite 350, Durham, NC 27713. 66222 Makhteshim Agan of North America, Inc., D/B/A Adama, 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. 66330 Arysta Lifescience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. 67619 Clorox Professional Products Company, c/o PS&RC, P.O. Box 493, Pleasanton, CA 94566. 68156 Dintec Agrichemicals, LLC, 9330 Zionsville Road, Indianapolis, IN 46268. 69681 Allchem Performance Products, 6010 NW First Place, Gainesville, FL 32607. 70506 United Phosphorus, Inc., 630 Freedom Business Center, Suite 402, King of Prussia, PA 19406. 70627 Diversey, Inc., 1410 Newman Road, Racine, WI 53406. 72155 Bayer Advanced, A Business Unit of Bayer CropScience LP, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. 72304 Sostram Corporation, 2525 Meridian Parkway, Suite 350, Durham, NC 27713. 83070 Advan LLC, 2525 Meridian Parkway, Suite 350, Durham, NC 27713. 85588 DuPont Crop Protection, Agent for Agsurf Corporation, Chestnut Run Plaza, 974 Center Road, Newark, DE 19805. III. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. EPA will provide a 30-day comment period on the proposed requests. Thereafter, the EPA Administrator may approve such a request.

    IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling.

    V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Because the Agency has identified no significant potential risk concerns associated with these pesticide products, upon cancellation of the products identified in Table 1 of Unit II., EPA anticipates allowing registrants to sell and distribute existing stocks of these products until January 15, 2019, or the date of that the cancellation notice is published in the Federal Register, whichever is later. Thereafter, registrants will be prohibited from selling or distributing the pesticides identified in Table 1 of Unit II., except for export consistent with FIFRA section 17 or for proper disposal. Persons other than registrants will generally be allowed to sell, distribute, or use existing stocks until such stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: October 1, 2018. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2018-22860 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [9982-45-OEI] Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Georgia AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces EPA's approval of the State of Georgia's request to revise its National Primary Drinking Water Regulations Implementation EPA-authorized program to allow electronic reporting.

    DATES:

    EPA approves the authorized program revision for the State of Georgia's National Primary Drinking Water Regulations Implementation as of November 19, 2018, if no timely request for a public hearing is received and accepted by the Agency.

    FOR FURTHER INFORMATION CONTACT:

    Devon Martin, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2603, [email protected]

    SUPPLEMENTARY INFORMATION:

    On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

    On August 8, 2018, the Georgia Department of Natural Resources (GA DNR) submitted an application titled “Electronic Sample Entry Verify” for revision to its EPA-approved drinking water program under title 40 CFR to allow new electronic reporting. EPA reviewed GA DNR's request to revise its EPA-authorized program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Georgia's request to revise its Part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting under 40 CFR part 141 is being published in the Federal Register.

    GA DNR was notified of EPA's determination to approve its application with respect to the authorized program listed above.

    Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Georgia's request to revise its authorized National Primary Drinking Water Regulations Implementation program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f), to allow for electronic reporting. Requests for a hearing must be submitted to EPA within 30 days of publication of today's Federal Register notice. Such requests should include the following information:

    (1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;

    (2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;

    (3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

    In the event a hearing is requested and granted, EPA will provide notice of the hearing in the Federal Register not less than 15 days prior to the scheduled hearing date. Frivolous or insubstantial requests for hearing may be denied by EPA. Following such a public hearing, EPA will review the record of the hearing and issue an order either affirming today's determination or rescinding such determination. If no timely request for a hearing is received and granted, EPA's approval of the State of Georgia's request to revise its part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting will become effective 30 days after today's notice is published, pursuant to CROMERR section 3.1000(f)(4).

    Matthew Leopard, Director, Office of Information Management.
    [FR Doc. 2018-22811 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2011-0928; FRL-9983-37-OEI] Proposed Information Collection Request; Comment Request; Fuel Use Requirements for Great Lake Steamships; Renewal AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Fuel Use Requirements for Great Lakes Steamships” (EPA ICR No. 2458.03, OMB Control No. 2060-0679) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through October 31, 2018. Public comments were previously requested via the Federal Register on June 15, 2018 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before November 19, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2011-0928, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Alan Stout, Office of Transportation and Air Quality, Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI 48105; 734-214-4805; [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The U.S. Environmental Protection Agency (EPA) adopted requirements for marine vessels operating in and around U.S. territorial waters to use reduced-sulfur diesel fuel. This requirement does not apply for steamships, but it would apply for steamships that are converted to run on diesel engines. A regulatory provision allows vessel owners to qualify for a waiver from the fuel-use requirements for a defined period for such converted vessels. One condition of the exemption from the fuel standard is that engines meet current emission standards. EPA uses the data to oversee compliance with regulatory requirements, including communicating with affected companies and answering questions from the public or other industry participants regarding the waiver in question. Since the IMO Tier III NOX standards apply for Category 3 engines installed on U.S. vessels, we don't expect anyone to use the steamship exemption.

    Form numbers: None.

    Respondents/affected entities: 0.

    Respondent's obligation to respond: Required to obtain a benefit (40 CFR 1043.95).

    Estimated number of respondents: 0.

    Frequency of response: One time for a new notification.

    Total estimated burden: 0 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $0.

    Changes in estimates: The burden estimate decreases from the current estimate of 14 hours per year in the total estimated respondent burden currently approved by OMB. Since the IMO Tier III NOX standards apply for Category 3 engines installed on U.S. vessels, we don't expect anyone to use the steamship exemption.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-22808 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OLEM-2018-0391, FRL-9984-90-OEI] Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Facility Ground-Water Monitoring Requirements (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Facility Ground-Water Monitoring Requirements (EPA ICR Number 0959.16, OMB Control Number 2050-0033), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through October 31, 2018. Public comments were previously requested via the Federal Register on July 3, 2018 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before November 19, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-2018-0391, to (1) EPA, either online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: RCRA Docket (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Peggy Vyas, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-5477; fax number: 703-308-8433; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: Subtitle C of the Resource Conservation and Recovery Act (RCRA) creates a comprehensive program for the safe management of hazardous waste. Section 3004 of RCRA requires owners and operators of facilities that treat, store, or dispose of hazardous waste to comply with standards established by EPA that are to protect the environment. Section 3005 provides for implementation of these standards under permits issued to owners and operators by EPA or authorized States. Section 3005 also allows owners and operators of facilities in existence when the regulations came into effect to comply with applicable notice requirements to operate until a permit is issued or denied. This statutory authorization to operate prior to permit determination is commonly known as “interim status.” Owners and operators of interim status facilities also must comply with standards set under Section 3004.

    This ICR examines the ground-water monitoring standards for permitted and interim status facilities at 40 CFR parts 264 and 265, as specified. The ground-water monitoring requirements for regulated units follow a tiered approach whereby releases of hazardous contaminants are first detected (detection monitoring), then confirmed (compliance monitoring), and if necessary, are required to be cleaned up (corrective action). Each of these tiers requires collection and analysis of ground-water samples. Owners or operators that conduct ground-water monitoring are required to report information to the oversight agencies on releases of contaminants and to maintain records of ground-water monitoring data at their facilities. The goal of the ground-water monitoring program is to prevent and quickly detect releases of hazardous contaminants to groundwater, and to establish a program whereby any contamination is expeditiously cleaned up as necessary to protect human health and environment.

    Form Numbers: None.

    Respondents/affected entities: Business or other for-profit; and State, Local, or Tribal Governments.

    Respondent's obligation to respond: Mandatory (RCRA Sections 3004 and 3005).

    Estimated number of respondents: 813.

    Frequency of response: quarterly, semi-annually, and annually.

    Total estimated burden: 136,258 hours per year. Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $25,524,890 (per year), includes $20,411,396 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is an increase of 19,231 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to an increase in the respondent for permitted facilities.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-22814 Filed 10-18-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of Intent To Terminate Receivership

    Notice is hereby given that the Federal Deposit Insurance Corporation (FDIC or Receiver) as Receiver for the institution listed below intends to terminate its receivership for said institution.

    Notice of Intent To Terminate Receivership Fund Receivership name City State Date of
  • appointment of receiver
  • 10142 Madisonville State Bank Madisonville TX 10/30/2009

    The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated at Washington, DC, on October 15, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-22747 Filed 10-18-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at [email protected], or by mail, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of agreements are available through the Commission's website (www.fmc.gov) or by contacting the Office of Agreements at (202) 523-5793 or [email protected]

    Agreement No.: 201279.

    Agreement Name: Concession Agreement between Diamond State Port Corporation and GT USA Wilmington, LLC.

    Parties: Diamond State Port Corporation and GT USA Wilmington, LLC.

    Filing Party: Elizabeth Lowe; Venable LLP.

    Synopsis: The Agreement is a terminal lease and operating agreement for terminal facilities at the port of Wilmington, DE.

    Proposed Effective Date: 10/10/2018.

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/18301.

    Agreement No.: 012421-001.

    Agreement Name: “K” Line/Hyundai Glovis Co., Ltd. U.S./Mexico Space Charter Agreement.

    Parties: Kawasaki Kisen Kaisha, Ltd. and Hyundai Glovis Co., Ltd.

    Filing Party: Wayne Rohde; Cozen O'Connor.

    Synopsis: The amendment adds the Caribbean Coast of Colombia to the geographic scope of the Agreement.

    Proposed Effective Date: 10/12/2018.

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/1891.

    Agreement No.: 012414-001.

    Agreement Name: LGL/Glovis Space Charter Agreement.

    Parties: Liberty Global Logistics LLC and Hyundai Glovis Co., Ltd.

    Filing Party: Brooke Shapiro; Winston & Strawn LLP.

    Synopsis: The amendment adds The United States Gulf Coast, the United States West Coast, Puerto Rico, and Mexico to the geographic scope of the Agreement.

    Proposed Effective Date: 10/12/2018.

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/1879.

    Agreement No.: 201280.

    Agreement Name: BBC/Seaboard Vessel Sharing Agreement.

    Parties: BBC Chartering & Logistics GmbH & Co. KG, BBC Chartering Carriers GmbH & Co KG, and BBC Project Chartering GmbH Co KG (acting as a single party); and Seaboard Marine Ltd.

    Filing Party: Wayne Rohde; Cozen O'Connor.

    Synopsis: The Agreement authorizes the parties to share vessels in the trade between the U.S. Gulf Coast and ports in Jamaica, the Dominican Republic, Chile, Peru, Ecuador, and on the Gulf Coast of Mexico.

    Proposed Effective Date: 11/29/2018.

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/19300.

    Dated: October 16, 2018. Rachel Dickon, Secretary.
    [FR Doc. 2018-22819 Filed 10-18-18; 8:45 am] BILLING CODE 6731-AA-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Public Comment Request; Independent Living Services Program Performance Report (0985-0043) AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

    This proposed Extension with Changes of a Currently Approved Collection (ICR Rev) solicits comments on the information collection requirements relating to the Independent Living Services (ILS) program under the Rehabilitation Act of 1973, 29 U.S.C. 701, et seq.

    DATES:

    Comments on the information collection request must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.

    ADDRESSES:

    Submit electronic comments on the information collection request to: Peter Nye at [email protected] Submit written comments on the collection of information to Administration for Community Living, Washington, DC 20201, Attention: Peter Nye.

    FOR FURTHER INFORMATION CONTACT:

    Peter Nye, Administration for Community Living, Washington, DC 20201, (202) 795-7606 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

    (1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;

    (2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

    (3) ways to enhance the quality, utility, and clarity of the information to be collected; and

    (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

    In the context of ACL, IL programs are supported through funding authorized by the Rehabilitation Act of 1973, as amended (The Act). Title VII, chapter 1 of the Act states the current purpose of the program is to “promote a philosophy of independent living including a philosophy of consumer control, peer support, self-help, self-determination, equal access, and individual and system advocacy, in order to maximize the leadership, empowerment, independence, and productivity of individuals with disabilities, and the integration and full inclusion of individuals with disabilities into the mainstream of American society.”

    The ILS program provides financial assistance, through formula grants, to states, the District of Columbia, Puerto Rico, and outlying areas for providing, expanding, and improving the provision of IL services. The Designated State Entity (DSE) is the agency that, on behalf of the state, receives, accounts for, and disburses funds received under Subchapter B of the Act. Funds are also made available for the provisions of training and technical assistance to SILCs.

    The Act of 1973 requires three IL program reports: (1) State Plan for Independent Living, (2) ILS PPR, and (3) Centers for Independent Living PPR. The ILS PPR and CIL PPR were previously combined into one submission. However, for the purposes of this data collection, the ILS PPR and CIL PPR are being submitted separately because they are separate collections of different information from different parties. Separating these PRA processes reduces confusion and increases the Independent Living Administration's ability to identify issues specific to DSEs and SILCs. This request is for the ILS PPR, which is submitted annually by the Statewide Independent Living Council and DSE in every state that receives Subchapter B funds. The ILS PPRs are used by ACL to assess grantees' compliance with title VII of the Act, with 45 CFR part 1329 of the Code of Federal Regulations, and with applicable provisions of the HHS Regulations at 45 CFR part 75. The ILS PPR serves as the primary basis for ACL's monitoring activities in fulfillment of its responsibilities under sections 706 and 722 of the Act. The PPR is also used by ACL to design CIL and SILC training and technical assistance programs authorized by section 721 of the Act.

    The current version of the ILS PPR that ILA is requesting an extension for was approved by OMB, but will expire on December 31, 2018. ILA plans to publish a revised ILS program data collection instrument and instructions prior to the expiration of the extension request.

    The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

    Estimated Program Burden

    ACL estimates the burden of this collection of information as follows: Fifty-six jurisdictions—specifically, the fifty states, Puerto Rico, the District of Columbia, and the outlying areas—will each complete ILS PPRs annually, and it will take an estimated 35 hours per jurisdiction per ILS PPR. The 56 jurisdictions combined will take an estimated 1,960 hours per year to complete ILS PPRs. This burden estimate is based on what DSEs and SILCs have told ILA about how long filling out ILS PPRs took in previous reporting years.

    Respondent/data
  • collection activity
  • Number of
  • respondents
  • Responses per
  • respondent
  • Hours per
  • response
  • Annual
  • burden hours
  • SILCs and DSEs 56 1 (for each SILC and DSE combined) 35 1,960 Total 56 1 35 1,960
    Dated: October 9, 2018. Mary Lazare, Principal Deputy Administrator.
    [FR Doc. 2018-22751 Filed 10-18-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Public Comment Request; the State Plan for Independent Living (SPIL) (0985-0044) AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Community Living is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

    This Extension Without Changes (Information Collection Request Ext) solicits comments on the information collection requirements related to the State Plan for Independent Living (SPIL) required under the Rehabilitation Act of 1973, as amended. The Independent Living Administration within ACL is proposing to extend the currently approved forms for one year while we work on a revision. However, we expect to complete the redesign of the proposed information collection forms well before the expiration of the extension.

    DATES:

    Comments on the collection of information must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.

    ADDRESSES:

    Submit electronic comments on the collection of information to: Peter Nye at [email protected]. Submit written comments on the collection of information to Administration for Community Living, Washington, DC 20201, Attention: Peter Nye.

    FOR FURTHER INFORMATION CONTACT:

    Peter Nye, Administration for Community Living, Washington, DC 20201, (202) 795-7606, or [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

    (1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;

    (2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

    (3) ways to enhance the quality, utility, and clarity of the information to be collected; and

    (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

    Legal authority for the State Plan for Independent Living is contained in Chapter 1 of Title VII of the Rehabilitation Act of 1973, as amended by the Workforce Innovation and Opportunity Act ([the Act], Pub. L. 113-128). Section 704 of the Rehabilitation Act requires that, to be eligible to receive financial assistance under Chapter 1, “a State shall submit to the Department, and obtain approval of, a State plan containing such provisions as the Department may require.” The Administration for Community Living's (ACL) approval of the SPIL is required for states to receive federal funding for both the Independent Living Services State grants and Centers for Independent Living programs. Federal statute and regulations require the collection of this information every three years. The current three-year approval period for the SPIL expires April 30, 2019.

    The SPIL is jointly developed by the chairperson of the Statewide Independent Living Council and the directors of the centers for independent living in the State, after receiving public input from individuals throughout the State; and signed by the chairperson of the Statewide Independent Living Council, acting on behalf of—and at the direction of—the Council, the director of the designated State entity, and not less than 51 percent of the directors of the centers for independent living in the State. ACL reviews the SPIL for compliance with the Rehabilitation Act and 45 CFR part 1329 and approves it. The SPIL also serves as a primary planning document for continuous monitoring of, and technical assistance to, the state independent living programs to ensure appropriate planning, financial support and coordination, and other assistance to appropriately address, on a statewide basis, needs for the provision of independent living services in the state.

    The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

    Estimated Program Burden: ACL estimates the burden of this collection of information as follows: 56 Statewide Independent Living Councils will respond to the requirement for a SPIL every three years. It will take approximately 60 hours for each state's Statewide Independent Living Council to jointly complete the development of the SPIL for a total of approximately 3,360 hours. This estimate is based on amounts of time that Statewide Independent Living Councils have reported that they have spent responding to previous requests for this report. ACL is not requesting any change in the data States are required to submit. As such, there is no change to the estimated reporting burden.

    Respondent/data collection activity Number of
  • respondents
  • Responses
  • per
  • respondent
  • Hours per
  • response
  • Annual
  • burden hours
  • Statewide Independent Living Councils 56 1 60 3,360 Total 56 1 60 3,360
    Dated: October 10, 2018. Mary Lazare, Principal Deputy Administrator.
    [FR Doc. 2018-22753 Filed 10-18-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW) AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

    This New Data Collection (ICR New) solicits comments on the information collection requirements relating to the Centers for Independent Living under the Rehabilitation Act of 1973.

    DATES:

    Comments on the collection of information must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.

    ADDRESSES:

    Submit electronic comments on the collection of information to: Peter Nye at [email protected]. Submit written comments on the collection of information to Administration for Community Living, Washington, DC 20201, Attention: Peter Nye.

    FOR FURTHER INFORMATION CONTACT:

    Peter Nye, Administration for Community Living, Washington, DC 20024, (202) 795-7606 or [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

    (1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;

    (2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

    (3) ways to enhance the quality, utility, and clarity of the information to be collected; and

    (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

    In the context of ACL, IL programs are supported through funding authorized by the Rehabilitation Act of 1973, as amended (The Act). Title VII, chapter 1 of the Act states the current purpose of the program is to “promote a philosophy of independent living including a philosophy of consumer control, peer support, self-help, self-determination, equal access, and individual and system advocacy, in order to maximize the leadership, empowerment, independence, and productivity of individuals with disabilities, and the integration and full inclusion of individuals with disabilities into the mainstream of American society.”

    ILS PPR and CIL PPR are being submitted separately because they are separate collections of different information from different parties. Separating these PRA processes reduces confusion and increases the Independent Living Administration's ability to identify issues specific to CILs. This request is for CIL PPR, which is submitted annually by all CILs receiving IL Subchapter C funds. The PPRs are used by ACL to assess grantees' compliance with title VII of the Act, and with 45 CFR 1329 of the Code of Federal Regulations and with applicable provisions of the HHS Regulations at 45 CFR part 75. The PPR serves as the primary basis for ACL's monitoring activities in fulfillment of its responsibilities under sections 706 and 722 of the Act. The PPR also enables ACL to track performance outcomes and efficiency measures of the Centers for Independent Living (CIL) programs with respect to the annual and long-term performance targets established in compliance with GPRA. The PPR is also used by ACL to design CIL and SILC training and technical assistance programs authorized by section 711A and section 721 of the Act.

    ACL published a Federal Register Notice regarding the independent living programs information collection on February 23, 2017. Two-hundred and twenty-one individual comments were received. The responses indicated a need to make substantial changes to the collection. The current version of the ILS PPR that ILA is requesting an extension for was approved by OMB, but will expire on December 31, 2018. Further deliberation is needed to ensure that we appropriately address all of the concerns. ILA is proposing to extend the currently approved forms for three years while we work on a revision that addresses all the suggested changes.

    The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

    Estimated Program Burden: ACL estimates the burden of this collection of information as follows: 353 Centers for Independent Living will each complete one CIL PPR annually, and it will take an estimated 35 hours per CIL for an estimated total of 12,355 hours. This burden estimate is based partly on ILA's estimates of how long CILs probably take to find the information that PPRs ask for and partly on what CILs have told the Independent Living Administration about how long filling out the PPRs took.

    Respondent/data collection activity Number of
  • respondents
  • Responses per
  • respondent
  • Hours per
  • response
  • Annual
  • burden hours
  • Centers for Independent Living 353 1 35 12,355
    Dated: October 9, 2018. Mary Lazare, Principal Deputy Administrator.
    [FR Doc. 2018-22754 Filed 10-18-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1072] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Application for Participation in FDA Fellowship and Traineeship Programs.”

    DATES:

    Submit either electronic or written comments on the collection of information by December 18, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 18, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2014-N-1072 for “Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Application for Participation in FDA Fellowship and Traineeship Programs OMB Control Number 0910-0780—Revision

    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal agencies to rate applicants for Federal jobs. The proposed information collection involves brief online applications completed by applicants applying to FDA's Fellowship and Traineeship programs. These voluntary online applications will allow the Agency to easily and efficiently elicit and review information from students and healthcare professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Recordkeeping Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Commissioner's Fellowship Program 600 1 600 1.33 798 Regulatory Science Internship Program 250 1 250 1 250 Medical Device Fellowship Program 250 1 250 1 250 FDA Traineeship Program 1000 1 1000 1 1000 Reagan-Udall Fellowship at FDA 50 1 50 1 50 Total 2,348 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Because FDA is developing two new training programs, our estimated burden for the information collection reflects an overall increase of 1,050 hours and a corresponding increase of 1,050 responses/records. We attribute this adjustment to an increase in the number of submissions that we will receive with the new training programs.

    Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22821 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-6544 and FDA-2017-E-6542] Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMFINZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 18, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 17, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket Nos. FDA-2017-E-6544 and FDA-2017-E-6542 for “Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product IMFINZI (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for IMFINZI (U.S. Patent Nos. 8,779,108 and 9,493,565) from MedImmune Limited, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated, January 9, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IMFINZI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for IMFINZI is 1,755 days. Of this time, 1,554 days occurred during the testing phase of the regulatory review period, while 201 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 13, 2012. FDA has verified the applicant's claim that the date the initial investigational new drug application became effective was on July 13, 2012.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 13, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for IMFINZI (BLA 761069) was initially submitted on October 13, 2016.

    3. The date the application was approved: May 1, 2017. FDA has verified the applicant's claim that BLA 761069 was approved on May 1, 2017.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 159 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22806 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3761] Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

    DATES:

    Approval is withdrawn as of November 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

    SUPPLEMENTARY INFORMATION:

    The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

    Application No. Drug Applicant NDA 006002 Aralen Hydrochloride (chloroquine hydrochloride (HCl)) Injection, Equivalent to (EQ) 40 milligram (mg) base/milliliter (mL); Aralen (chloroquine phosphate) Tablets, EQ 300 mg base Sanofi-Aventis, U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807. NDA 008107 Leucovorin calcium for Injection USP, EQ 60 mg base/vial for solution, oral; EQ 3 mg base/mL injection; EQ 50 mg base/vial injection; EQ 100 mg base/vial injection; EQ 350 mg base/vial injection Hospira Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. NDA 009321 Cholografin Meglumine (iodipamide meglumine) Injection, 10.3% and 52% (cholografin sodium, 20%) Bracco Diagnostics, Inc., 259 Prospect Plains Rd., Monroe Township, NJ 08831. NDA 017566 Brevicon (ethinyl estradiol; norethindrone) Tablets, 0.035 mg/0.5 mg (21-Day Regimen) Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612. NDA 018181 Mycelex (clotrimazole) Topical Solution, 1% Bayer HealthCare LLC, 100 Bayer Blvd., 100 Bayer Rd., Pittsburgh, PA 15205. NDA 018182 Mycelex-7 (clotrimazole) Tablets, 100 mg Do. NDA 018183 Mycelex (clotrimazole) Topical Cream, 1% Do. NDA 018230 Mycelex-7 (clotrimazole) Topical Vaginal Cream, 1% Do. NDA 018856 D-Xylose (xylose) Powder, 25 grams (g)/bottle Lyne Laboratories, 10 Burke Dr., Brockton, MA 02301. NDA 018874 Calcijex (calcitriol) Injection, 0.001 mg/mL and 0.002 mg/mL AbbVie, Inc., 1 North Waukegan Rd., North Chicago, IL 60064. NDA 020214 Zemuron (rocronium bromide) Injection, 50 mg/5 mL (10 mg/mL); 10 mg/mL (10 mg/mL); 100 mg/10 mL (10 mg/mL) Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 020389 Mycelex-7 Combination Pack (clotrimazole) Topical Vaginal Cream and Tablets, 1%, 100 mg Bayer HealthCare LLC. NDA 020528 Mavik (trandolapril) Tablets, 1 mg, 2 mg, and 4 mg AbbVie, Inc. NDA 020738 Teveten (eprosartan mesylate) Tablets, 300 mg, 400 mg, and 600 mg Do. NDA 020863 Pletal (cilostazol) Tablets, 50 mg and 100 mg Otsuka Pharmaceutical Development and Commercialization, Subsidiary of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rockville, MD 20850. NDA 021268 Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, 600/12.5 mg and 600/25 mg AbbVie, Inc. NDA 021410 Avandamet (rosiglitazone maleate and metformin hydrochloride (HCl)) Tablets, 500 mg EQ 1 mg base; 500 mg EQ 2 mg base; 500 mg EQ 4 mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg base GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426. NDA 021511 Copegus (ribavirin) Tablets, 200 mg and 400 mg Hoffmann La-Roche, Inc., Subsidiary of Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080. NDA 021700 Avandaryl (glimepiride and rosiglitazone maleate) Tablets, 1 mg/4 mg; 2 mg/4 mg; 2 mg/8 mg; 4 mg/4 mg; 4 mg/8 mg SB Pharmco Puerto Rico Inc., Subsidiary of GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426. NDA 205123 Olysio (simeprevir sodium) Capsules, EQ 150 mg base Janssen Pharmaceuticals, Inc., 1000 U.S. Rte. 202 South, Raritan, NJ 08869.

    Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 19, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on November 19, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

    Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22805 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Using Stem Cells to Better Understand Heart Failure.

    Date: November 2, 2018.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Crystal City Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202.

    Contact Person: David A. Wilson, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7204, Bethesda, MD 20892-7924, 301-435-0299, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Bold New Bioengineering Methods and Approaches for Heart, Lung, Blood and Sleep Disorders and Diseases (R21).

    Date: November 2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Westin Grand, 2350 M Street NW, Washington, DC 20037.

    Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: October 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22760 Filed 10-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2018-0877] National Maritime Security Advisory Committee; Meeting AGENCY:

    U.S. Coast Guard, Department of Homeland Security.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The National Maritime Security Advisory Committee will meet in Houston, Texas, to review and discuss various issues relating to national maritime security. All meetings will be open to the public.

    DATES:

    Meetings. The Committee will meet on Tuesday, November 6, 2018, from 12:00 noon to 5 p.m. and on Wednesday, November 7, 2018, from 8 a.m. to 1 p.m. These meetings may close early if all business is finished.

    Comments and supporting documentation. To ensure your comments are reviewed by Committee members before the meetings, submit your written comments no later than November 1, 2018.

    ADDRESSES:

    The meeting will be held at the Double Tree Hilton Hotel by Houston Hobby Airport, 8181 Airport Boulevard, Houston, TX 77061, HoustonHobbyAirport.DoubleTree.com.

    This meeting will be broadcast via a web enabled interactive online format and teleconference line. To participate via teleconference, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section no later than November 1, 2018. Additionally, if you would like to participate in this meeting via the online web format, please log onto https://share.dhs.gov/nmsac/ and follow the online instructions to register for this meeting. If you encounter technical difficulties, contact Mr. Ryan Owens at 202-302-6565.

    For information on facilities or services for individuals with disabilities, or to request special assistance at the meetings, contact the individual listed in FOR FURTHER INFORMATION CONTACT below as soon as possible.

    Written comments must be submitted using the Federal eRulemaking Portal: http://www.regulations.gov. If you encounter technical difficulties, contact the individual in the FOR FURTHER INFORMATION CONTACT section of this document.

    Instructions: You are free to submit comments at any time, including orally at the meetings, but if you want Committee members to review your comment before the meetings, please submit your comments no later than November 1, 2018. We are particularly interested in comments on the issues in the “Agenda” section below. You must include “Department of Homeland Security” and the docket number [USCG-2018-0877]. Comments received will be posted without alteration at http://www.regulations.gov including any personal information provided. For more information about privacy and the docket, review the Privacy and Security Notice for the Federal Docket Management System at https://regulations.gov/privacyNotice.

    Docket Search: For access to the docket or to read documents or comments related to this notice, go to http://www.regulations.gov, and use docket number “USCG-2018-0877” in the “Search” box, press Enter, and then click on the item you wish to view.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Ryan Owens, Alternate Designated Federal Officer of the National Maritime Security Advisory Committee, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593, Stop 7581, Washington, DC 20593-7581; telephone 202-372-1108 or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is in compliance with the Federal Advisory Committee Act, Title 5, United States Code, Appendix. The National Maritime Security Advisory Committee operates under the authority of 46 U.S.C. 70112.

    The National Maritime Security Advisory Committee provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Commandant of the Coast Guard, on matters relating to national maritime security.

    Agenda Day 1

    The Committee will meet to review, discuss and formulate recommendations on the following issues:

    (1) Cyber Security Update. Members will receive an update from the U.S. Coast Guard concerning the draft Cyber Security Navigation and Vessel Inspection Circular and other