Federal Register Vol. 82, No.5,

Federal Register Volume 82, Issue 5 (January 9, 2017)

Page Range2193-2848
FR Document

82_FR_5
Current View
Page and SubjectPDF
82 FR 2217 - Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid SystemsPDF
82 FR 2218 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB-, 5F-AMB, 5F-APINACA, ADB-FUBINACA, NDMB-CHMICA and MDMB-FUBINACA) Into Schedule IPDF
82 FR 2193 - Scope of Sections 202(a) and (b) of the Packers and Stockyards ActPDF
82 FR 2193 - Revisions to Operational Requirements for the Use of Enhanced Flight Vision Systems (EFVS) and to Pilot Compartment View Requirements for Vision SystemsPDF
82 FR 2397 - Sunshine Act MeetingPDF
82 FR 2362 - Sunshine Act MeetingsPDF
82 FR 2218 - 22 CFR Part 241PDF
82 FR 2393 - Sunshine Act MeetingPDF
82 FR 2383 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Advanced Education Nursing Traineeship (AENT) Program Specific Data Collection FormsPDF
82 FR 2280 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule IPDF
82 FR 2326 - Sunshine Act Meetings Notice (Correction)PDF
82 FR 2193 - Hazardous Substances and Articles: Administration and Enforcement RegulationsPDF
82 FR 2335 - Comprehensive Centers Program; CFDA Number: 84.283BPDF
82 FR 2327 - Proposed Collection; Comment RequestPDF
82 FR 2333 - List of Correspondence From January 1, 2015 Through March 31, 2015 and April 1, 2015 Through June 30, 2015PDF
82 FR 2397 - Reno Creek In SituPDF
82 FR 2336 - Applications for New Awards; High School Equivalency ProgramPDF
82 FR 2399 - Category 3 Source Security and AccountabilityPDF
82 FR 2328 - Applications for New Awards; College Assistance Migrant ProgramPDF
82 FR 2390 - 60-Day Notice of Proposed Information Collection: Supportive Services Demonstration Resident Assessment FormPDF
82 FR 2295 - Air Quality Plans; Tennessee; Infrastructure Requirements for the 2012 PM2.5PDF
82 FR 2354 - Granting Petitions To Add n-Propyl Bromide to the List of Hazardous Air PollutantsPDF
82 FR 2395 - Records Management; General Records Schedule (GRS); GRS Transmittal 27PDF
82 FR 2389 - Revision of Agency Information Collection Activity Under OMB Review: Security Threat Assessment for Individuals Applying for a Hazardous Materials Endorsement for a Commercial Driver's LicensePDF
82 FR 2325 - Proposed Information Collection; Comment Request; Computer and Internet Use Supplement to the Census Bureau's Current Population SurveyPDF
82 FR 2323 - Proposed Information Collection; Comment Request; Foreign Fishing Vessel Permits, Vessel, and Gear Identification, and Reporting RequirementsPDF
82 FR 2327 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Formula Grant EASIE (Electronic Application System for Indian Education)PDF
82 FR 2311 - Foreign-Trade Zone (FTZ) 44-Morris County, New Jersey; Notification of Proposed Production Activity; AGFA Corporation (Aluminum Digital Printing Plates); Branchburg, New JerseyPDF
82 FR 2311 - Foreign-Trade Zone (FTZ) 20-Newport News, Virginia; Authorization of Production Activity; Canon Virginia, Inc.; Subzone 20D (Toner Cartridges); Newport News, VirginiaPDF
82 FR 2334 - Agency Information Collection Activities; Comment Request; High School Equivalency Program (HEP) Annual Performance ReportPDF
82 FR 2324 - Proposed Information Collection; Comment Request; Management and Oversight of the National Estuarine Research Reserve SystemPDF
82 FR 2311 - Foreign-Trade Zone (FTZ) 221-Mesa, Arizona; Notification of Proposed Production Activity; Apple Inc. (Data Server Cabinets); Mesa, ArizonaPDF
82 FR 2368 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingPDF
82 FR 2443 - Notice and Request for Public CommentPDF
82 FR 2322 - Stainless Steel Plate in Coils From Belgium, South Africa, and Taiwan: Continuation of Antidumping Duty Orders and Countervailing Duty OrderPDF
82 FR 2319 - Multilayered Wood Flooring From the People's Republic of China: Preliminary Results of Countervailing Duty Administrative Review, Rescission of Review, in Part, and Intent To Rescind the Review in Part; 2014PDF
82 FR 2317 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Preliminary Results of the Countervailing Duty Administrative Review and Preliminary Intent To Rescind, in Part; 2014PDF
82 FR 2309 - Rural Broadband Access Loans and Loan Guarantees ProgramPDF
82 FR 2435 - Rate for Assessment on Direct Payment of Fees to Representatives in 2017PDF
82 FR 2438 - Qualification of Drivers; Exemption Applications; VisionPDF
82 FR 2440 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure DisordersPDF
82 FR 2439 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure DisordersPDF
82 FR 2385 - Modification and Clarification of the National Customs Automation Program Tests Regarding Post-Summary Corrections and Periodic Monthly Statements; Republication With Correction and Further ClarificationPDF
82 FR 2392 - Endangered and Threatened Wildlife and Plants; Notice of Availability of Polar Bear Conservation Management PlanPDF
82 FR 2393 - Hardwood Plywood From ChinaPDF
82 FR 2436 - Motorcyclist Advisory Council to the Federal Highway AdministrationPDF
82 FR 2350 - Viridity Energy Solutions Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 AuthorizationPDF
82 FR 2352 - NEP Energy Services, Ltd.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 2354 - Approved Energy II LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 AuthorizationPDF
82 FR 2345 - Combined Notice of Filings #2PDF
82 FR 2342 - Combined Notice of Filings #1PDF
82 FR 2435 - Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98PDF
82 FR 2323 - Pacific Fishery Management Council; Public MeetingPDF
82 FR 2325 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Data Scoping Webinar for South Atlantic Red Grouper; Public MeetingPDF
82 FR 2436 - Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics PlenaryPDF
82 FR 2366 - Request for InformationPDF
82 FR 2394 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application for Federal Firearms License (ATF F 7(5310.12)/7 CR (5310.16))PDF
82 FR 2291 - Special Local Regulation; Manatee River; Bradenton, FLPDF
82 FR 2380 - Determination of Regulatory Review Period for Purposes of Patent Extension; EMPLICITIPDF
82 FR 2285 - Proximity Detection Systems for Mobile Machines in Underground MinesPDF
82 FR 2284 - Exposure of Underground Miners to Diesel ExhaustPDF
82 FR 2396 - Freedom of Information Act (FOIA) Advisory Committee; MeetingPDF
82 FR 2426 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Relating to the Listing and Trading of Shares of SolidX Bitcoin Trust Under NYSE Arca Equities Rule 8.201PDF
82 FR 2425 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings to Determine Whether to Approve or Disapprove a Proposed Rule Change, as Modified by Amendment No. 1, to BZX Rule 14.11(e)(4), Commodity-Based Trust Shares, to List and Trade Winklevoss Bitcoin Shares Issued by the Winklevoss Bitcoin TrustPDF
82 FR 2418 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing of Proposed Rule Change To Amend Rules 501, 507, 508, 510, and 511PDF
82 FR 2433 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rules To Extend a Pilot ProgramPDF
82 FR 2427 - Self-Regulatory Organizations; NYSE MKT LLC; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Introducing NYSE OptXPDF
82 FR 2417 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Introducing NYSE OptXPDF
82 FR 2428 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Related to the Exchange's Equity Options Platform To Adopt a Price Improvement Auction, the Bats Auction MechanismPDF
82 FR 2378 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATEPDF
82 FR 2367 - Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment PeriodPDF
82 FR 2312 - Order Renewing Order Temporarily Denying Export PrivilegesPDF
82 FR 2402 - Tribal Policy StatementPDF
82 FR 2385 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 2384 - Center for Scientific Review; Notice of Closed MeetingPDF
82 FR 2384 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 2444 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment RequestPDF
82 FR 2369 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; AvailabilityPDF
82 FR 2442 - Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes; Cancellation of Pilot Program Testing Electronic Collection of Import DataPDF
82 FR 2381 - Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and CommentsPDF
82 FR 2362 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
82 FR 2442 - Transfer of Federally Assisted Land or FacilityPDF
82 FR 2351 - American Municipal Power, Inc. v. Midcontinent Independent System Operator, Inc.; Notice of ComplaintPDF
82 FR 2351 - Great River Energy; Notice of FilingPDF
82 FR 2344 - Transcontinental Gas Pipe Line Company, LLC; Notice of Availability of the Final Environmental Impact Statement for the Proposed Atlantic Sunrise ProjectPDF
82 FR 2343 - Records Governing Off-the-Record Communications; Public NoticePDF
82 FR 2345 - WBI Energy Transmission, Inc.; Supplemental Notice of Intent To Prepare an Environmental Assessment for the Planned Valley Expansion Project and Request for Comments on Environmental IssuesPDF
82 FR 2353 - Enel Trading North America, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 2352 - Gulf South Pipeline Company, LP; Notice of Schedule for Environmental Review of the St. Charles Parish Expansion ProjectPDF
82 FR 2348 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Atlantic Coast Pipeline, Supply Header Project, and Capacity Lease ProposalPDF
82 FR 2352 - Old Dominion Electric Cooperative and Direct Energy Business, LLC on Behalf of Itself and Its Affiliate, Direct Energy Business Marketing, LLC and American Municipal Power, Inc. v. PJM Interconnection, L.L.C.; Notice Of ComplaintPDF
82 FR 2343 - Northern Illinois Municipal Power Agency v. PJM Interconnection, L.L.C.; Notice of ComplaintPDF
82 FR 2353 - Nogales Transmission, L.L.C., Nogales Frontier Operations, L.L.C.; Notice of Petition for Declaratory OrderPDF
82 FR 2305 - Approval of Arizona Air Plan Revisions, Arizona Department of Environmental Quality and Pinal County Air Quality Control DistrictPDF
82 FR 2294 - Nondiscrimination in Programs or Activities Receiving Federal Assistance From the Environmental Protection AgencyPDF
82 FR 2251 - Announcement Type: Notice and Request for InformationPDF
82 FR 2293 - Electronic Induction (eInduction®) OptionPDF
82 FR 2363 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsPDF
82 FR 2193 - Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010; Approval of Information Collection RequestPDF
82 FR 2193 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”PDF
82 FR 2249 - General Services Administration Acquisition Regulation (GSAR); Fair Opportunity Complaints on GSA ContractsPDF
82 FR 2248 - Amendments to Regulations Governing Access to Commission Information and Records; Freedom of Information ActPDF
82 FR 2254 - Mallows Bay-Potomac River National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management PlanPDF
82 FR 2269 - Wisconsin-Lake Michigan National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management PlanPDF
82 FR 2230 - Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits; Procedures for DecisionmakingPDF
82 FR 2239 - Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical CorrectionPDF
82 FR 2308 - Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical CorrectionPDF
82 FR 2237 - Approval and Promulgation of Implementation Plans; Rhode Island; Clean Air Act Infrastructure State and Federal Implementation PlansPDF
82 FR 2221 - Updating Regulations Issued Under the Fair Labor Standards Act, Service Contract Act, Davis-Bacon and Related Acts, Contract Work Hours and Safety Standards Act, the Family and Medical Leave Act, Employee Polygraph Protection Act, and the Migrant and Seasonal Agricultural Worker Protection ActPDF
82 FR 2810 - Standards for Accessible Medical Diagnostic EquipmentPDF
82 FR 2760 - Addition of a Subsurface Intrusion Component to the Hazard Ranking SystemPDF
82 FR 2470 - Occupational Exposure to BerylliumPDF

Issue

82 5 Monday, January 9, 2017 Contents Agency Agency for International Development RULES Republic of Iraq Loan Guarantees Issued under the Further Continuing and Security Assistance Appropriations Act—Standard Terms and Conditions, 2218-2220 2017-00294 Agency Toxic Agency for Toxic Substances and Disease Registry NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2362-2363 2017-00080 Agriculture Agriculture Department See

Food and Nutrition Service

See

Grain Inspection, Packers and Stockyards Administration

See

Rural Utilities Service

Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau NOTICES Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes; Cancellation of Pilot Program Testing Electronic Collection of Import Data, 2442-2443 2017-00083 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Federal Firearms License, 2394-2395 2017-00110 Architectural Architectural and Transportation Barriers Compliance Board RULES Standards for Accessible Medical Diagnostic Equipment, 2810-2848 2016-31186 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2327 2017-00173 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicare, Medicaid, and Children's Health Insurance Programs: Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations, 2363-2366 2016-32007 Children Children and Families Administration NOTICES Requests for Information, 2366-2367 2017-00111 Coast Guard Coast Guard PROPOSED RULES Special Local Regulations: Manatee River; Bradenton, FL, 2291-2293 2017-00109 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Community Development Community Development Financial Institutions Fund PROPOSED RULES Community Development Financial Institution Certification; Request for Information, 2251-2254 2017-00013 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2443-2444 2017-00141 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2444-2467 2017-00085 Consumer Product Consumer Product Safety Commission RULES Hazardous Substances and Articles; Administration and Enforcement Regulations; CFR Correction, 2193 2017-00240 NOTICES Meetings; Sunshine Act, 2326 2017-00270 Defense Department Defense Department See

Army Department

Drug Drug Enforcement Administration RULES Schedules of Controlled Substances: Temporary Placement of six synthetic cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) into Schedule I, 2218 C1--2016--30595 PROPOSED RULES Schedules of Controlled Substances: Temporary Placement of six synthetic cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) into Schedule I, 2280-2284 2017-00275 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Formula Grant Electronic Application System for Indian Education, 2327-2328 2017-00149 High School Equivalency Program Annual Performance Report, 2334-2335 2017-00146 Applications for New Awards: College Assistance Migrant Program, 2328-2333 2017-00168 High School Equivalency Program, 2336-2341 2017-00170 Comprehensive Centers Program, 2335-2336 2017-00174 List of Correspondence from January 1, 2015 through March 31, 2015 and April 1, 2015 through June 30, 2015, 2333-2334 2017-00172 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Addition of a Subsurface Intrusion Component to the Hazard Ranking System, 2760-2807 2016-30640 Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits; Procedures for Decisionmaking, 2230-2237 2016-31638 Air Quality State Implementation Plans; Approvals and Promulgations: Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction, 2239-2248 2016-31637 Rhode Island; Clean Air Act Infrastructure State and Federal Implementation Plans, 2237-2239 2016-31444 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona; Air Plan Revisions, Arizona Department of Environmental Quality and Pinal County Air Quality Control District, 2305-2308 2017-00054 Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction, 2308 2016-31636 Tennessee; Infrastructure Requirements for the 2012 PM2.5 National Ambient Air Quality Standard, 2295-2305 2017-00162 Nondiscrimination in Programs or Activities Receiving Federal Assistance; Wthdrawal, 2294-2295 2017-00050 NOTICES Petitions: Add n-Propyl Bromide to the List of Hazardous Air Pollutants, 2354-2362 2017-00158 Federal Aviation Federal Aviation Administration RULES Operational Requirements for Use of Enhanced Flight Vision Systems; Pilot Compartment View Requirements for Vision Systems, 2193 C1--2016--28714 NOTICES Meetings: Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics Plenary, 2436 2017-00112 Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98, 2435-2436 2017-00117 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2444-2467 2017-00085 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 2362 2017-00321 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 2342-2343, 2345 2017-00118 2017-00119 Complaints: American Municipal Power, Inc. v. Midcontinent Independent System Operator, Inc., 2351 2017-00075 Northern Illinois Municipal Power Agency v. PJM Interconnection, LLC, 2343 2017-00066 Old Dominion Electric Cooperative and Direct Energy Business, LLC, et al. v. PJM Interconnection, LLC, 2352 2017-00067 Environmental Assessments; Availability, etc.: Gulf South Pipeline Company, LP, St. Charles Parish Expansion, 2352-2353 2017-00069 WBI Energy Transmission, Inc. Valley Expansion Project, 2345-2347 2017-00071 Environmental Impact Statements; Availability, etc.: Atlantic Coast Pipeline and Supply Header Project, 2348-2350 2017-00068 Transcontinental Gas Pipe Line Company, LLC Atlantic Sunrise Project, 2344-2345 2017-00073 Filings: Great River Energy, 2351 2017-00074 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Approved Energy II LLC, 2354 2017-00120 Enel Trading North America, Inc., 2353 2017-00070 NEP Energy Services, Ltd., 2352 2017-00121 Viridity Energy Solutions Inc., 2350-2351 2017-00122 Petitions for Declaratory Orders: Nogales Transmission, LLC.; Nogales Frontier Operations, LLC, 2353-2354 2017-00065 Records Governing Off-the-Record Communications, 2343-2344 2017-00072 Federal Highway Federal Highway Administration NOTICES Requests for Nominations: Motorcyclist Advisory Council, 2436-2437 2017-00125 Federal Maritime Federal Maritime Commission RULES Amendments to Regulations Governing Access to Commission Information and Records; Freedom of Information Act, 2248-2249 2016-31891 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Epilepsy and Seizure Disorders, 2439-2442 2017-00132 2017-00133 Vision, 2438-2439 2017-00134 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2444-2467 2017-00085 Federal Transit Federal Transit Administration NOTICES Transfers of Federally Assisted Lands or Facilities, 2442 2017-00078 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Polar Bear Conservation Management Plan, 2392-2393 2017-00127 Food and Drug Food and Drug Administration RULES Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”, 2193-2217 2016-31950 Medical Devices: Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth to be known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems, 2217 C1--2016--31670 NOTICES Determinations of Regulatory Review Periods for Purposes of Patent Extensions: ADYNOVATE, 2378-2380 2017-00095 EMPLICITI, 2380-2381 2017-00108 Emergency Use; Authorizations: In Vitro Diagnostic Device for Detection of Zika Virus, 2369-2378 2017-00084 Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers, 2381-2383 2017-00081 Guidance: Submission of Quality Metrics Data; Extension of Comment Period, 2367-2368 2017-00094 Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee, 2368-2369 2017-00143 Food and Nutrition Food and Nutrition Service RULES Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010; Approval of Information Collection Request, 2193 2016-31954 Foreign Trade Foreign-Trade Zones Board NOTICES Authorizations of Production Activity: Canon Virginia, Inc.; Subzone 20D; Newport News, VA, 2311 2017-00147 Production Activities: AGFA Corp.; Foreign-Trade Zone 44; Morris County, NJ, 2311-2312 2017-00148 Apple Inc., Foreign-Trade Zone 221, Mesa, AZ, 2311 2017-00144 General Services General Services Administration RULES General Services Administration Acquisition Regulations: Fair Opportunity Complaints on GSA Contracts, 2249-2250 2016-31932 Grain Inspection Grain Inspection, Packers and Stockyards Administration RULES Scope of Sections 202(a) and (b) of the Packers and Stockyards Act, 2193 C1--2016--30424 Health and Human Health and Human Services Department See

Agency for Toxic Substances and Disease Registry

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Advanced Education Nursing Traineeship Program Specific Data Collection Forms, 2383-2384 2017-00277 Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supportive Services Demonstration Resident Assessment Form, 2390-2392 2017-00163 Industry Industry and Security Bureau NOTICES Denials of Export Privileges: Mahan Airways, et al., 2312-2317 2017-00092 Interior Interior Department See

Fish and Wildlife Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China, 2317-2319 2017-00138 Multilayered Wood Flooring from the People's Republic of China, 2319-2322 2017-00139 Stainless Steel Plate in Coils from Belgium, South Africa, and Taiwan, 2322-2323 2017-00140 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Hardwood Plywood from China, 2393-2394 2017-00126 Meetings; Sunshine Act, 2393 2017-00279 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

See

Drug Enforcement Administration

Labor Department Labor Department See

Mine Safety and Health Administration

See

Occupational Safety and Health Administration

See

Wage and Hour Division

RULES Updating Regulations Issued under the Fair Labor Standards Act, Service Contract Act, Davis-Bacon and Related Acts, etc., 2221-2230 2016-31293
Mine Mine Safety and Health Administration PROPOSED RULES Exposure of Underground Miners to Diesel Exhaust: Request for Information; Reopening of Rulemaking Record; Extension of Comment Period, 2284-2285 2017-00104 Proximity Detection Systems for Mobile Machines in Underground Mines: Reopening Record; Extension of Comment Period, 2285-2291 2017-00105 National Archives National Archives and Records Administration NOTICES Meetings: Freedom of Information Act Advisory Committee, 2396-2397 2017-00103 Records Schedules; Availability, 2395-2396 2017-00157 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 2384-2385 2017-00088 2017-00089 2017-00090 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Mallows Bay-Potomac River National Marine Sanctuary, 2254-2269 2016-31742 Wisconsin-Lake Michigan National Marine Sanctuary, 2269-2280 2016-31741 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Foreign Fishing Vessel Permits, Vessel, and Gear Identification, and Reporting Requirements, 2323-2324 2017-00150 Management and Oversight of the National Estuarine Research Reserve System, 2324-2325 2017-00145 Meetings: Fisheries of the South Atlantic; Southeast Data, Assessment, and Review; Data Scoping Webinar for South Atlantic red grouper, 2325 2017-00113 Pacific Fishery Management Council, 2323 2017-00114 National Telecommunications National Telecommunications and Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Computer and Internet Use Supplement to the Census Bureau's Current Population Survey, 2325-2326 2017-00154 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Category 3 Source Security and Accountability, 2399-2402 2017-00169 Environmental Impact Statements; Availability, etc.: Reno Creek In Situ Uranium Recovery Project in Campbell County, WY, 2397-2398 2017-00171 Meetings; Sunshine Act, 2397 2017-00327 Tribal Policy Statement, 2402-2417 2017-00091 Occupational Safety Health Adm Occupational Safety and Health Administration RULES Occupational Exposure: Beryllium, 2470-2757 2016-30409 Postal Service Postal Service PROPOSED RULES Electronic Induction (eInduction) Option, 2293-2294 2016-32056 Rural Utilities Rural Utilities Service NOTICES Requests for Applications: Rural Broadband Access Loans and Loan Guarantees Program, 2309-2311 2017-00137 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 2425-2426 2017-00101 Bats EDGX Exchange, Inc., 2428-2433 2017-00096 International Securities Exchange, LLC, 2433-2435 2017-00099 NASDAQ PHLX, LLC, 2418-2425 2017-00100 NYSE Arca, Inc., 2417-2418, 2426 2017-00097 2017-00102 NYSE MKT, LLC, 2427-2428 2017-00098 Social Social Security Administration NOTICES Rate for Assessment on Direct Payment of Fees to Representatives in 2017, 2435 2017-00136 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

Federal Transit Administration

Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Security Threat Assessment for Individuals Applying for a Hazardous Materials Endorsement for a Commercial Driver's License, 2389-2390 2017-00155 Treasury Treasury Department See

Alcohol and Tobacco Tax and Trade Bureau

See

Community Development Financial Institutions Fund

See

Comptroller of the Currency

Customs U.S. Customs and Border Protection NOTICES National Customs Automation Program Tests: Post-Summary Corrections and Periodic Monthly Statements; Modifications and Clarifications; Correction and Clarification, 2385-2389 2017-00128 Wage Wage and Hour Division RULES Updating Regulations Issued under the Fair Labor Standards Act, Service Contract Act, Davis-Bacon and Related Acts, etc., 2221-2230 2016-31293 Separate Parts In This Issue Part II Labor Department, Occupational Safety and Health Administration, 2470-2757 2016-30409 Part III Environmental Protection Agency, 2760-2807 2016-30640 Part IV Architectural and Transportation Barriers Compliance Board, 2810-2848 2016-31186 Reader Aids

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

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82 5 Monday, January 9, 2017 Rules and Regulations DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Parts 210 and 220 RIN 0584-AE25 Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010; Approval of Information Collection Request AGENCY:

Food and Nutrition Service, USDA.

ACTION:

Final rule; notice of approval of Information Collection Request (ICR).

SUMMARY:

The final rule titled Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010 was published on July 29, 2016. The Office of Management and Budget (OMB) cleared the associated information collection requirements (ICR) on September 12, 2016. This document announces approval of the ICR.

DATES:

Effective January 9, 2017. The ICR associated with the final rule published in the Federal Register on July 29, 2016, at 81 FR 50151, was approved by OMB on September 12, 2016, under OMB Control Number 0584-0592. The ICR was subsequently merged with 0584-0006.

FOR FURTHER INFORMATION CONTACT:

Tina Namian, School Programs Branch, Policy and Program Development Division, Food and Nutrition Service, at (703) 305-2590.

Dated: December 23, 2016. Richard Lucas, Acting Administrator, Food and Nutrition Service.
[FR Doc. 2016-31954 Filed 1-6-17; 8:45 am] BILLING CODE 3410-30-P
DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 9 CFR Part 201 RIN 0580-AB25 Scope of Sections 202(a) and (b) of the Packers and Stockyards Act Correction

In rule document 2016-30424, appearing on pages 92566 through 92594 in the issue of Tuesday, December 20, 2016, make the following correction:

On page 92566, in the first column, in the DATES section, the first sentence, “This interim final rule is February 21, 2017.” should read, “This interim final rule is effective February 21, 2017.”

[FR Doc. C1-2016-30424 Filed 1-6-17; 8:45 am] BILLING CODE 1301-00-D
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 1, 23, 25, 27, 29, 61, 91, 121, 125, and 135 [Docket No.: FAA-2013-0485; Amdt. Nos. 1-70, 23-63, 25-144, 27-48, 29-56, 61-139, 91-345, 121-376, 125-66, and 135-135] RIN 2120-AJ94 Revisions to Operational Requirements for the Use of Enhanced Flight Vision Systems (EFVS) and to Pilot Compartment View Requirements for Vision Systems Correction

In rule document 2016-28714 appearing on pages 90126-90177 in the issue of Tuesday, December 13, 2016, make the following correction:

On page 90174, in the third column, in the 18th through 22nd line, paragraph (iii) should read
§ 91.176(b)(3)(iii) [Corrected]

“(iii) At 100 feet above the touchdown zone elevation of the runway of intended landing and below that altitude, the flight visibility must be sufficient for one of the following visual references to be distinctly visible and identifiable to the pilot without reliance on the EFVS—”

[FR Doc. C1-2016-28714 Filed 1-6-17; 8:45 am] BILLING CODE 1301-00-D
CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1500 Hazardous Substances and Articles: Administration and Enforcement Regulations CFR Correction In Title 16 of the Code of Federal Regulations, Parts 1000 to End, revised as of January 1, 2016, on page 536, in § 1500.42, paragraph (a)(1), remove the second sentence. [FR Doc. 2017-00240 Filed 1-6-17; 8:45 am] BILLING CODE 1301-00-D DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 801, and 1100 [Docket No. FDA-2015-N-2002] RIN 0910-AH19 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

DATES:

This rule is effective February 8, 2017.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Bryant Godfrey or Darin Achilles, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, [email protected]

SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary I. Background A. Definition of “Tobacco Product” B. Drug/Device/Combination Product Definitions C. Comments and Responses Regarding Definitions D. History of 1996 Rulemaking and Relevant Litigation II. Purpose of Regulatory Action A. Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Disease Prong B. Comments and Responses Regarding Modified Risk Tobacco Products C. Intended Uses For Products Made or Derived From Tobacco That Bring ProductsWithin the Structure/Function Prong D. Comments and Responses Regarding Brown & Williamson and Sottera E. Comments and Responses Regarding Consumer Confusion F. Changes to Existing “Intended Use” Regulations III. Legal Authority IV. Description of the Final Rule A. Exclusion From Tobacco Product Regulation (§ 1100.5) B. Existing “Intended Use” Regulations (§§ 201.128 and 801.4) C. Comments and Responses Regarding Intended Use D. Comments and Responses Regarding Marketing Concerns E. Other Comments and Responses F. Other Changes to the Codified Text G. Effective Date V. Federalism VI. Executive Order 13175: Tribal Consultation VII. Analysis of Environmental Impact VIII. Economic Analysis of Impacts IX. Paperwork Reduction Act of 1995 X. References Executive Summary Purpose of the Rule

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amends the FD&C Act and provides FDA with the authority to regulate tobacco products. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Excluded from the definition of a tobacco product is any article that is a drug, device, or combination product. Any article that is a drug, device, or combination product will be regulated as such rather than as a tobacco product.

Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, FDA is taking this action to provide clarity regarding our interpretation of the drug and device definitions in the FD&C Act with respect to products made or derived from tobacco. This final rule will provide assistance for entities intending to market products made or derived from tobacco. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. The final rule is also intended to increase clarity regarding the intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug, device, or combination product, helping consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses.

In addition, FDA is taking the opportunity to make changes to existing regulations at §§ 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices generally.

Summary of the Major Provisions of the Regulatory Action

Conceptually, the final rule follows the disease prong and the structure/function prong (with certain specified limitations) of the statutory definitions of “drug” and “device” (section 201(g) and (h) of the FD&C Act). Under the final rule, a product made or derived from tobacco and intended for human consumption is regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product.

In addition, FDA is amending its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the final rule to clarify the interplay between these regulations and this final rule. FDA has made further changes to conform §§ 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.

Costs and Benefits

The final rule clarifies the regulatory status of products made or derived from tobacco and our interpretation and application of the existing intended use regulations. This will reduce the ambiguity and may create some efficiency gains associated with submitting an application for approval or marketing authorization of a new tobacco-derived product, or with initiating research for a new tobacco-derived product. In addition, we assume that the regulation will clarify for consumers when products made or derived from tobacco are intended for medical uses rather than for other uses.

We assume that all tobacco-derived product manufacturers would incur one-time costs to learn the rule. There may also be a one-time cost incurred by a small number of manufacturers of tobacco products to review and revise product communications such as labeling and associated promotional materials. The following table reports these one-time costs.

Table 1—One-Time Costs Low Mid-point High Learning costs $117,412 $146,779 $176,147 Review communications, such as labeling and promotional materials 486,024 486,024 486,024 Revisions to communications, such as labeling and promotional materials 283,003 1,092,422 1,901,841 Total 886,439 1,725,225 2,564,012 I. Background

In the Federal Register of September 25, 2015 (80 FR 57756), FDA issued a proposed rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses.' ” We received over 1,900 comments on the proposed rule. Two comments requested that the comment period be extended due to the complexity of the legal issues involved. One of these comments related to the original 60-day comment period. In the Federal Register of November 30, 2015 (80 FR 74737), FDA reopened the comment period for an additional 30 days. The second comment appears to relate to the additional 30-day comment period announced in 80 FR 74737. With respect to the comment requesting an extension beyond the additional 30-day comment period, FDA believes this comment to be misplaced as it generally references “nine questions” that are related to a different rulemaking—the proposed version of the deeming rule.1

1 “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule” (79 FR 23142, April 25, 2014).

A. Definition of “Tobacco Product”

The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-31), amending the FD&C Act and providing FDA with the authority to regulate tobacco products. Section 101(a) of the Tobacco Control Act amends section 201 of the FD&C Act by adding paragraph (rr), which defines the term “tobacco product.” In general, a “tobacco product” is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Section 201(rr)(2) of the FD&C Act excludes from the definition of a tobacco product any article that is defined as a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). Section 201(rr)(3) of the FD&C Act explains that any article that is a drug, device, or combination product shall be subject to chapter V of the FD&C Act (the authorities for drugs and devices) rather than chapter IX (the authorities for tobacco products).2

2 Section 201(rr)(4) of the FD&C Act prohibits a tobacco product from being marketed in combination with any other article or product regulated under the FD&C Act. This rulemaking did not address section 201(rr)(4).

B. Drug/Device/Combination Product Definitions 1. Medical Product Definitions

As noted in section I.A, the definition of “tobacco product” excludes anything that is a “drug,” “device,” or “combination product” under the FD&C Act. The FD&C Act defines “drug” (in relevant part) as an article intended either: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease (referred to as the “disease prong” of the definition) or (2) to affect the structure or any function of the body (the “structure/function prong”) (section 201(g)(1) of the FD&C Act). The FD&C Act defines a “device” (in relevant part) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended either: (1) For use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes (section 201(h) of the FD&C Act).3 Combination products are products that constitute a combination of a drug, device, or biological product (section 503(g) of the FD&C Act). Under the FD&C Act, the Secretary's determination of the primary mode of action of a combination product determines which Center at FDA will have primary jurisdiction over the product (section 503(g) of the FD&C Act).

3 In this final rule, the cited language may be referred to as the “drug/device definitions.”

FDA had previously interpreted the exclusion in the tobacco product definition to mean that if a product made or derived from tobacco is determined to have a drug or device “intended use,” it will be regulated as a medical product, not as a tobacco product. As discussed in greater detail in this document, this interpretation was qualified in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), in which the D.C. Circuit applied the holding of Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), to all tobacco products. Thus, the determination of whether a product is a medical product or a tobacco product is based on the FD&C Act and associated regulations and also takes into account relevant legal precedent (further described in section I.D).

2. How Intended Use Is Determined

In determining a product's intended use, the Agency may look to “any . . . relevant source,” including but not limited to the product's labeling, promotional claims, and advertising (see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985), Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff'd, 540 F.2d 947 (8th Cir. 1976)).

For example, FDA may take into account any claim or statement made by or on behalf of a manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g., § 201.128 (drugs), § 801.4 (devices)).4

4 Under FDA regulations, the term “intended use” relates to the objective intent of the medical product manufacturer, packer, distributor, or seller, including both corporate entities and natural individuals (hereinafter “manufacturers” or “firms”).

To establish a product's intended use, FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (see id.; see also United States v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to pursue firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products. As FDA has previously stated, however, the Agency would not, absent extraordinary circumstances, regard a firm as intending an unapproved new use for an approved drug, or a device that has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (for ease of reference, such a device is referred to as “an approved or cleared device” (or similar terms) throughout this preamble) based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use (Ref. 1).

Thus, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it is regulated as a medical product, subject to the limitations discussed further in this document. Courts have recognized that products made or derived from tobacco marketed with “disease” claims and certain “structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178 F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction)).

C. Comments and Responses Regarding Definitions

Comments were received from tobacco product manufacturers, retailers, academia, medical professionals, advocacy groups, and consumers. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before each comment, and the word “Response,” in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments; the numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment. In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received many general comments expressing support or opposition to the rule. These comments express broad policy views and do not address specific points related to this rulemaking. Therefore, these general comments do not require a response. Other comments outside the scope of this rulemaking also have not been addressed here. Summaries of the remaining comments, as well as FDA's responses, are included in this document.

(Comment 1) At least one comment stated that FDA is not permitted to regulate the nicotine in cigarettes as a drug and should not be permitted to regulate electronic nicotine delivery systems (ENDS) as medical products.

(Response) FDA disagrees. Section 201(g) of the FD&C Act defines “drug” as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or any function of the body of man or other animals. Section 201(h) of the FD&C Act defines “device” (in relevant part) as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory,” that is intended “for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . . to affect the structure or any function of the body,” and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes. As explained in this final rule, FDA has the authority to regulate a product made or derived from tobacco, including cigarettes and ENDS, as a medical product if it is distributed or marketed for an intended use that falls within the drug/device definitions, unless the product is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

(Comment 2) Several comments stated that there is no need to clarify the medical product and tobacco product definitions that govern FDA regulation of these products. One of those comments also went on to state that there is a clear difference between drug product claims and “consumer-oriented marketing statements” about smoking cessation.

(Response) FDA disagrees that there is no need for additional clarity in this area. The Agency frequently receives inquiries regarding jurisdictional distinctions for products made or derived from tobacco, and given the broad range of intended uses for products made or derived from tobacco and the increasing variety of such products on the market, FDA believes that the potential for consumer confusion is increasing. This is especially true when tobacco-derived products that may otherwise appear to be products intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction.

FDA considers claims about smoking cessation to be more than simply “consumer-oriented marketing statements.” As noted in the preamble to the proposed rule, claims related to smoking cessation have long been recognized as evidence of intended use, conferring drug or device jurisdiction, and smoking cessation claims also have long been associated with the intended uses of curing or treating nicotine addiction and its symptoms. For example, smoking cessation claims have appeared on the approved labeling for nicotine replacement therapies since the mid-1990s. FDA believes it is important to clarify and reiterate that smoking cessation claims on any product can render that product subject to FDA's medical products authorities.

(Comment 3) Comments had differing opinions on whether ENDS meet the definition of “tobacco product” as defined in the FD&C Act. Several comments stated that ENDS fall under the definition of “tobacco product” as defined in the FD&C Act if they contain nicotine derived from tobacco and are not intended to be drugs or devices. However, other comments stated that ENDS, including vaping hardware, do not fall within the definition of “tobacco product.”

(Response) FDA agrees that ENDS meet the definition of “tobacco product” if they are not drugs, devices, or combination products. The term “tobacco product” is defined in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to mean any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product), and excluding drugs, devices, and combination products as defined under the FD&C Act. Unless they are marketed for an intended use that falls within the drug/device definitions, ENDS products meet the definition of tobacco product. Additionally, as discussed elsewhere in the preamble, if ENDS products are intended to affect the structure or function of the body in any way related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, they will be regulated as tobacco products. (See section II.C.)

FDA disagrees with comments stating that vaping hardware does not fall within the definition of “tobacco product.” As the Agency explained in the final deeming regulation,5 the definition of tobacco product includes components and parts. Also included in the final deeming regulation is a non-exhaustive list of examples of components and parts used with ENDS products. Examples of components and parts used with ENDS products includes, but are not limited to: E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software. Thus, vaping hardware meets the definition of tobacco product.

5 “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Final Rule” (81 FR 28973, May 10, 2016).

D. History of 1996 Rulemaking and Relevant Litigation

Although the courts have recognized that tobacco-derived products can be regulated as medical products under the FD&C Act in certain circumstances, courts have also held that there are limitations on how the drug and device definitions can be applied to products made or derived from tobacco. This section provides a summary of FDA regulatory action and related litigation relevant to those limitations.

In 1996, FDA issued a regulation restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents (the 1996 rule) (61 FR 44396, August 28, 1996). This rule included FDA's determination that it had jurisdiction over cigarettes and smokeless tobacco under the FD&C Act. The basis for this determination was that cigarettes and smokeless tobacco were intended to affect the structure or function of the body, within the FD&C Act definitions of the terms “drug” and “device,” because nicotine has significant pharmacological effects. In addition, FDA found that cigarettes and smokeless tobacco were combination products consisting of the drug nicotine and device components intended to deliver nicotine to the body. In the 1996 rule, FDA concluded that cigarettes and smokeless tobacco should be regulated under the device authorities of the FD&C Act. The 1996 rule was challenged in court by a group of tobacco manufacturers, retailers, and advertisers on the grounds that FDA lacked jurisdiction to regulate tobacco products “as customarily marketed;” that the regulations exceeded FDA's authority to regulate devices; and that the advertising restrictions violated the First Amendment.

The Supreme Court struck down the 1996 rule in Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), holding that FDA lacked jurisdiction over tobacco products “as customarily marketed.” The Court found that Congress intended to exclude tobacco products from FDA's jurisdiction. In Brown & Williamson, the Court determined that tobacco products could not be made safe and effective for their intended uses, and therefore, if FDA had authority over them, FDA would have to remove them from the market, but that Congress had foreclosed such action (529 U.S. at 135-139). The Court also observed that Congress, in enacting statutes to regulate the labeling and advertising of conventional tobacco products, such as cigarettes and smokeless tobacco, had “effectively ratified FDA's long-held position” that the Agency lacked jurisdiction to regulate tobacco products “absent claims of therapeutic benefit by the manufacturer” (529 U.S. at 144).

In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, two of the importers who were affected by this action sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those products into the United States.6 Between the filing of the lawsuit and a decision on the motion for a preliminary injunction, Congress passed the Tobacco Control Act and the President signed it into law. The District Court subsequently granted a preliminary injunction, relying on Brown & Williamson and the recently enacted Tobacco Control Act (Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010)). FDA appealed the decision and the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) affirmed in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010).7 The D.C. Circuit determined that the decision in Brown & Williamson was not limited to tobacco products that were the subject of the specific federal legislation discussed in that case. The D.C. Circuit found that under the Tobacco Control Act, all products made or derived from tobacco and intended for human consumption that are “marketed for therapeutic purposes” are subject to FDA's drug and/or device provisions, whereas “customarily marketed tobacco products” are subject to regulation as “tobacco products” (Sottera, 627 F.3d at 898-899; see also Brown & Williamson, 529 U.S. at 144-156).

6 The original district court case was filed by Smoking Everywhere, Inc., and the case was joined by Sottera, Inc., which does business as NJOY.

7 On January 24, 2011, the D.C. Circuit denied the government's petitions for rehearing and rehearing en banc (by the full court). See Sottera v. Food & Drug Administration, No. 10-5032 (D.C. Cir. Jan. 24 2011) (per curiam).

The Court in Brown & Williamson frequently referred to “tobacco products as customarily marketed,” but never defined that phrase. The Court contrasted that phrase with “claims of therapeutic benefit” (see, e.g., 529 U.S. at 127, 158), which it also did not define, although it did indicate that tobacco products' purported “therapeutic benefits” included all four of the structure/function intended uses on which FDA had based its 1996 rulemaking: Satisfying addiction, stimulation, sedation, and weight control (529 U.S. at 141). Neither of these terms is used in the FD&C Act. In Sottera, the D.C. Circuit relied on Brown & Williamson and repeated these phrases in describing contrasting types of products. The court in Sottera specifically equated “therapeutic uses” with the disease prong of the drug/device definitions in the FD&C Act and said that customarily marketed tobacco products were sold without therapeutic claims (627 F.3d at 894) and should be regulated as tobacco products under the FD&C Act, as amended by the Tobacco Control Act. As noted, the Brown & Williamson decision indicated that the four intended structure/function effects FDA had identified (satisfying addiction, stimulation, sedation, and weight control) were purported tobacco product “therapeutic benefits” (Brown & Williamson, 529 U.S. at 141). But neither the Brown & Williamson nor the Sottera court defined what might constitute claims of therapeutic benefit, nor did they explain the relationship between “tobacco products as customarily marketed” and the structure/function prong of the drug/device definitions of the FD&C Act. In addition, no court has addressed whether certain structure/function claims for products made or derived from tobacco that generally were not made for “tobacco products as customarily marketed” should be treated as drug or device claims.8

8 In Sottera, there are a few instances where the court's opinion could be read to suggest that all products made or derived from tobacco “marketed without claims of therapeutic effect” are, ipso facto, tobacco products “as customarily marketed” (627 F.3d at 895; see also id. at 898-899). However, because the issue of drug/device jurisdiction over structure/function intended uses that are not related to the commonly understood effects of nicotine was not before the court, this reading—even if it were correct—would be dicta.

II. Purpose of Regulatory Action

Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, we are issuing this final rule to provide clarity regarding our interpretation of the drug/device definitions in the FD&C Act with respect to products made or derived from tobacco. We believe that this final regulation will provide assistance for entities intending to market products made or derived from tobacco and for entities that plan to study these products. For example, the rule is expected to help sponsors determine which FDA Center should be consulted as they develop their products and make appropriate premarket submissions to bring new products to market. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. In addition, we believe it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other uses. The rule is expected to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug or device, which we expect will help consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses. Finally, the rule is intended to provide clarity for drug and device manufacturers generally regarding FDA's interpretation and application of its existing intended use regulations.

In both the Brown & Williamson and Sottera decisions, the courts set forth (but did not define) two poles—“tobacco products as customarily marketed” and “claims of therapeutic benefit”—and found that the “customarily marketed” pole was not within FDA's drug/device jurisdiction, but that the “claims of therapeutic benefit” pole was within FDA's drug/device jurisdiction. As noted in section I.D, the terminology used by the courts in establishing these two poles is not the terminology used by the FD&C Act in defining drugs and devices. Instead, the FD&C Act's drug and device definitions reference, in relevant part, diagnosis, cure, mitigation, treatment, or prevention of disease (disease prong) and effects on the structure or any function of the body (structure/function prong). In addition, while certain products and claims may fall clearly at one pole or the other, a spectrum of products and claims may fall somewhere between the two poles. In the sections that follow, we describe our interpretation of the jurisdictional lines established by the FD&C Act's drug, device, and tobacco product definitions as informed by the decisions in Brown & Williamson and Sottera.

A. Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Disease Prong 1. Intended Uses That Bring Products Within the Disease Prong

As discussed in section I.B, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs, devices, or combination products under the FD&C Act. Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to bring products within FDA's “disease prong” jurisdiction.

FDA has also taken enforcement action against products made or derived from tobacco that were marketed with claims of therapeutic benefit but that did not have approved new drug applications (NDAs). For example, FDA seized cigarettes on the grounds that they were misbranded drugs when the manufacturer represented that the cigarettes were effective in preventing respiratory diseases, common cold, influenza, pneumonia, and various other ailments (United States v. 46 Cartons . . . Containing Fairfax Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953)); see also United States v. 354 Bulk Cartons Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D. N.J. 1959) (similar, where manufacturer made weight-reduction claims for its cigarettes).

The “claims of therapeutic benefit” language used by the Brown & Williamson and Sottera courts has a logical relationship to the disease prong of the drug/device definition, in that “therapeutic” can be defined as “relating to the treatment of disease or disorders by remedial agents or methods” or to “providing or assisting in a cure.” 9 With this rule, FDA is clarifying the categories of claims relevant to products made or derived from tobacco that FDA considers to be evidence of intended use that brings products within the disease prong in light of the Sottera and Brown & Williamson decisions. As discussed previously, claims related to smoking cessation have long been recognized as evidence of intended use conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms. For example, the approved labeling for nicotine replacement therapies includes the following statements: “Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” 10 Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose.

9 See, e.g., Merriam-Webster Online Dictionary, available at http://www.merriam-webster.com/dictionary/therapeutic.

10 See, e.g., approved labeling for Nicoderm CQ, Nicorette, Habitrol.

Given the availability of FDA-approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking. Therefore, FDA considers claims related to smoking cessation to require careful scrutiny. Where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, as discussed in more detail in response to Comment 13, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion due to the product's claimed therapeutic benefit.

FDA will treat several other categories of claims for products made or derived from tobacco as evidence of intended use that brings the products within the disease prong of the drug/device definition. These categories of claims are discussed further in section IV, Description of the Final Rule). We note that sections 911(c) and 918 of the FD&C Act (21 U.S.C. 387k(c) and 387r), as amended by the Tobacco Control Act, contemplate that products intended for the treatment of tobacco dependence and for relapse prevention, among other things, may be subject to FDA's drug/device jurisdiction.

2. Distinction Between Modified Risk Claims and Claims That Are Evidence of Disease-Prong Intended Uses

With this final rule, FDA is also clarifying the relationship between FDA's regulation of a certain category of tobacco products—modified risk tobacco products (MRTPs)—and FDA's regulation of medical products that are intended to mitigate disease. MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). Tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products means a tobacco product:

(1) That represents in its label, labeling, or advertising, either implicitly or explicitly, that:

• The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

• the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

• the tobacco product or its smoke does not contain or is free of a substance;

(2) That uses the descriptors “light,” “mild,” “low,” or similar descriptors in its label, labeling, or advertising; or

(3) For which the tobacco product manufacturer has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

See section 911(b)(2) of the FD&C Act.11

11 No smokeless tobacco product shall be considered to be sold or distributed for use to reduce harm or the risk of tobacco-related disease solely because its label, labeling, or advertising uses the following phrases: “smokeless tobacco,” “smokeless tobacco product,” “not consumed by smoking,” “does not produce smoke,” “smokefree,” “smoke-free,” “without smoke,” “no smoke,” or “not smoke” (section 911(b)(2)(C) of the FD&C Act).

Because MRTPs have the potential to be marketed as less harmful than other tobacco products, including as presenting a lower risk of tobacco-related disease than another tobacco product, FDA recognizes that there might be questions about how these products relate to FDA's medical product jurisdiction over products made or derived from tobacco that are intended for use in disease mitigation and prevention. MRTPs may have the ultimate effect of lowering disease risk for users who would otherwise use another, more harmful tobacco product. However, an important distinction between MRTPs and medical products is that, while medical products approved/cleared for disease mitigation or prevention act affirmatively to combat a disease or health condition, MRTPs present relatively less risk of disease (e.g., by presenting reduced exposure to harmful constituents relative to another tobacco product), but do not affirmatively act to mitigate, prevent, or otherwise treat disease. In addition, while medical products approved for disease mitigation are determined to be both safe and effective for their approved use, MRTPs are reviewed based, in part, on a “benefit the health of the population as a whole” standard, and like other tobacco products, still expose users to inherent (if reduced) harms.

For purposes of illustration, claims of modified risk might include claims like “contains less nicotine than [tobacco product X]”, “using [MRTP] reduces your risk of lung cancer compared to using [tobacco product X]”, and “lower level of nitrosamines than other smokeless tobacco products.” In contrast, a claim that a product “inhibits the progression of disease in adult patients with chronic obstructive pulmonary disease” is evidence of intended uses that would bring the product within drug/device jurisdiction.

B. Comments and Responses Regarding Modified Risk Tobacco Products

(Comment 4) At least one comment remarked that research studies and public opinion may come to reflect that a tobacco product appears to have properties similar to those of a medical drug or MRTP. The comment asserted that acceptance of these properties by the scientific and medical community or by the public should not subject the product to regulation as a medical product or MRTP in the absence of any specific claims by the manufacturer.

(Response) As explained in this final rule, with certain exceptions, products made or derived from tobacco are subject to regulation as medical products if they are distributed for an intended use that falls within the FD&C Act's drug/device definitions, and the Agency may look to any relevant source to determine intended use. To the extent this comment suggests that manufacturer claims are always necessary to establish a medical product's intended use, FDA disagrees. As discussed at various points in this final rule (for example, in response to Comment 18), FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Nevertheless, FDA agrees with the comment that neither the opinions of the scientific and medical communities nor public opinion considered alone should dictate when a product made or derived from tobacco is regulated as a medical product or MRTP. In general, FDA would not regard a manufacturer as intending a medical use for a product made or derived from tobacco based solely on study findings or widespread belief that the product appears to have properties similar to those of a medical product. Similarly, FDA would not regard a manufacturer of a product made or derived from tobacco as selling or distributing a product for use to reduce harm or the risk of tobacco-related disease based solely on study findings or widespread belief that the product appears to have properties similar to those of an MRTP.

C. Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Structure/Function Prong

As discussed in section I.B, the drug/device definitions in the FD&C Act include articles “intended to affect the structure or any function of the body,” and FDA's assertion of jurisdiction over cigarettes and smokeless tobacco in 1996 was predicated on the pharmacological effects of nicotine on the structure or function of the body. In addition, as explained previously, the Court in Brown & Williamson rejected that assertion of jurisdiction, finding that Congress did not intend for FDA to have jurisdiction over cigarettes “as customarily marketed.”

Based on the Brown & Williamson holding and the Sottera court's application of that holding to all tobacco products, it is necessary to determine whether the intended use of a product made or derived from tobacco was the subject of claimed structure or function effects for tobacco products “as customarily marketed”—and therefore outside of FDA's drug/device jurisdiction. FDA believes the appropriate inquiry is whether the intended structure/function effects relate to effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the date of the Supreme Court's decision in Brown & Williamson (March 21, 2000).

For example, as discussed in the 1996 rulemaking, claims related to satisfaction, pleasure, enjoyment, and refreshment are euphemisms for the delivery of a pharmacologically active dose of nicotine and thus relate to effects on the structure or function of the body (61 FR 44396 at 45101 and 45175-45178). Nonetheless, FDA does not consider these tobacco satisfaction and enjoyment claims to bring products within its drug and device regulatory authority because these are structure/function claims related to the effects of nicotine and were commonly and legally made before March 21, 2000. Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to bring a tobacco product within its drug and device authority.

The Brown & Williamson and Sottera decisions do not reach the issue of intended uses that fall outside the disease prong of the drug/device definition and that are outside the area of “customarily marketed” tobacco product claims. FDA believes certain structure/function intended uses for products made or derived from tobacco continue to fall within our drug/device regulatory authority. FDA believes these structure/function intended uses fall into two main categories: (1) Intended uses that are unrelated to the pharmacological effects of nicotine and (2) intended uses that were not the subject of claims that were commonly and legally made for cigarettes and smokeless tobacco products (i.e., the products addressed in the 1996 rule) prior to the Supreme Court's decision in Brown & Williamson. Thus, to the extent manufacturers intend products made or derived from tobacco to be used to affect the structure or function of the body in any way that is not related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, FDA would consider these intended uses to remain within its drug/device jurisdiction under the final rule. For example, FDA's 1996 rulemaking identified “sedation,” “stimulation,” and “weight loss” as intended structure/function effects related to nicotine in cigarettes and smokeless tobacco products (61 FR 44396 at 44667; see also Brown & Williamson, 529 U.S. at 127). These structure/function effects are similar to “relieve tension,” “restore mental alertness,” and “promote weight loss,” which the proposed rule gave as examples of potential intended structure/function effects (80 FR 57756 at 57760; see also Comment 7 in this document). But absent evidence that “sedation,” “stimulation,” or “weight loss” is both a structure/function effect related to nicotine and was commonly and legally claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, whose intended use includes such structure/function effects, to be medical products.

Similarly, “maintain memory”—another example of a potential intended structure/function effect mentioned in the proposed rule (80 FR 57756 at 57760)—was (as FDA's 1996 rulemaking observed) a pharmacological effect that Philip Morris researchers attributed to nicotine and that R.J. Reynolds Tobacco asserted as a “benefit” in court filings (61 FR 44396 at 44857-44858 and 45029). But once again, absent evidence that “maintaining memory” is both a structure/function effect related to nicotine, and was commonly and legally claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to “maintain memory,” to be medical products.

Different facts but a similar analysis apply to the proposed rule's other examples of potential intended structure/function effects, “maintain healthy lung function” and “support the immune system.” (80 FR 57760). In contrast to its findings for “stimulation,” “sedation,” and “weight loss,” (61 FR 44396 at 44667), FDA's 1996 rulemaking did not identify “maintain healthy lung function” or “support the immune system” as intended structure/function effects of cigarettes or smokeless tobacco products. But as with those other potential intended uses, absent evidence that “maintaining healthy lung function” or “supporting the immune system” are both structure/function effects related to nicotine, and were commonly claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to achieve such structure/function effects, to be medical products.

FDA believes that it is important to recognize structure/function intended uses that were not commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the decision in Brown & Williamson. Structure/function intended uses are a longstanding and important aspect of FDA's medical product jurisdiction, grounded in the statutory definitions of “drug” and “device” in the FD&C Act. We recognize that products made or derived from tobacco are unique because of the regulatory regime for tobacco products under the FD&C Act, and that some products made or derived from tobacco making certain structure/function claims are now outside our drug/device jurisdiction. However, we believe it is consistent with the FD&C Act, case law, and our public health mission to determine that medical products include products made or derived from tobacco whose intended use includes effects on the structure or function of the body that are distinct from the pharmacological effects related to nicotine that were commonly and legally claimed before March 21, 2000.

FDA believes this final rule will provide clarity to manufacturers about how products made or derived from tobacco will be regulated if they are marketed or distributed for certain intended uses. This clarification will allow regulated industry to plan accordingly during the product development and postmarketing phases and will help researchers understand the applicable regulatory requirements associated with the investigational use of products made or derived from tobacco.

In addition, we believe this final rule will help to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use (i.e., as a drug/device) versus for a recreational use. Specifically, FDA wishes to avoid situations where products intended to be sold as tobacco products are marketed with the same claims as products sold as drugs or devices.

D. Comments and Responses Regarding Brown & Williamson and Sottera

(Comment 5) At least one comment agreed with FDA that the Brown & Williamson and Sottera rulings did not define the phrases “as customarily marketed” or “claims of therapeutic benefit,” leaving the Agency with some discretion as to what claims fall within each category when the distinction is not clear under existing precedent.

(Response) FDA agrees that the lack of definitions of the terms “customarily marketed” and “claims of therapeutic benefit” as they apply to products made or derived from tobacco in the relevant case law has created ambiguity and resulted in confusion among regulated industry, which has led FDA to promulgate this rule. Specifically, in the absence of clear judicial direction about what might constitute “claims of therapeutic benefit” and the relationship between tobacco products “as customarily marketed” and the structure/function prong of the drug/device definitions, the Agency believes it is important to clarify its statutory interpretations of the drug/device definitions with respect to products made or derived from tobacco in light of these terms used by the courts.

(Comment 6) Several comments supported FDA's proposal to treat satisfaction, smoking alternative, and nicotine fix claims as tobacco product claims. However, these comments assert that all products derived from tobacco that lack express therapeutic claims must be regulated as tobacco products. These comments maintained that FDA's proposed approach—which provides that some structure/function claims will cause products derived from tobacco to be regulated as drugs, devices, or combination products—is inconsistent with the Brown & Williamson and Sottera decisions.

Specifically, the comments argued that neither decision “indicates that `customarily marketed' means anything other than `not marketed with therapeutic claims'.” They maintained that the Sottera court “explicitly concluded that the `better reading' of Brown & Williamson was that it deprives FDA of authority to regulate under the FD&C Act any tobacco products marketed `without claims of therapeutic effect,' viewing such products as `customarily marketed.' ” Accordingly, the comments contended that the courts saw only two categories of tobacco products—products marketed with or without therapeutic claims. The comments asked that FDA clarify that it lacks authority to regulate any product made or derived from tobacco as a drug or device absent express therapeutic claims.

(Response) FDA disagrees with these comments and declines to adopt their overly narrow reading of Brown & Williamson and Sottera. First, Brown & Williamson provides no support for the comments' assertion that therapeutic claims must be express for a product to be subject to FDA's drug/device jurisdiction. The plaintiffs in Brown & Williamson made this very argument, and the dissenting opinion noted that the FD&C Act “does not use the word `claimed'; it uses the word `intended'.” See Brown & Williamson, 529 U.S. 120, 170 (2000) (dissenting opinion). The majority specifically declined to resolve the question. See Brown & Williamson, 529 U.S. 120, 132 (2000).

In addition, as noted in section I.C of the proposed rule, as well as section I.D, neither the Brown & Williamson nor the Sottera decisions defined the term “customarily marketed.” Although the court in Sottera did equate the concept of “therapeutic claims” with the disease prong of the drug and device definitions, there was no such equating of the term “customarily marketed” with the structure/function prong of these definitions. In fact, the term “customarily marketed” itself suggests that the term has some meaning independent of its relationship to the structure/function prong of the drug and device definitions. If the Supreme Court had wanted any structure/function claim to exclude a product made or derived from tobacco from FDA's drug/device jurisdiction, it could have said so. The structure of section 201(rr) of the FD&C Act, added by the Tobacco Control Act, further supports this interpretation. Following the Supreme Court's decision in Brown & Williamson, Congress enacted the Tobacco Control Act to give FDA explicit authority to regulate tobacco products. Under section 201(rr)(2), the term “tobacco product” excludes articles that are drugs under section 201(g)(1) and devices under section 201(h) of the FD&C Act. This statutory carve-out includes the structure/function prong of the drug/device definitions.

Having given FDA regulatory authority over tobacco products, if Congress thought that products made or derived from tobacco should never be regulated as drugs or devices under the structure/function prong of the drug or device definitions in the wake of Brown & Williamson, presumably Congress would have written section 201(rr)(2) of the FD&C Act differently. The better reading is that Congress recognized that products made or derived from tobacco as “customarily marketed” would be regulated as tobacco products under the Tobacco Control Act, but that products made or derived from tobacco meeting the drug/device definitions (including the structure/function prong, to the extent such products were not “customarily marketed”) would continue to be regulated as drugs or devices.

(Comment 7) At least one comment disagreed with some of the examples in the proposed rule of structure/function intended uses that FDA believes remain within its drug/device jurisdiction under the proposal. Specifically, the comment argued that claims about nicotine's stimulant and weight-loss structure/function effects “remain permissible `tobacco product' claims,” because FDA's 1996 rulemaking found that stimulant and weight-loss structure/function effects were among the intended uses of cigarettes and smokeless tobacco products (citing 61 FR 44396 at 44630, 44632).

(Response) FDA disagrees with this comment. In the 1996 rulemaking, FDA found that, in addition to causing and sustaining addiction, nicotine in cigarettes and smokeless tobacco causes other psychoactive (mood-altering) effects, including tranquilization and stimulation; and that nicotine in cigarettes and smokeless tobacco controls weight (61 FR 44396 at 44630). The rulemaking further found that these were intended structure/function effects for cigarettes and smokeless tobacco products (id. at 44632). But the central holding of Brown & Williamson was that “customarily marketed” tobacco products were not subject to FDA's medical product authority, even assuming that such products could be considered to have the intended structure/function effects that FDA attributed to them if their manufacturers and sellers did not claim such effects (529 U.S. at 131-32). As discussed in section I.D, this current rulemaking applies Brown & Williamson, as relevant here, by looking to marketing claims for structure/function effects that were commonly and legally made for “customarily marketed” cigarettes and smokeless tobacco products prior to the date the Brown & Williamson decision was issued. To the extent the comment read the examples “relieve tension” and “restore mental alertness” as stimulant intended uses, FDA does not believe that they are structure/function intended uses relating to effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. Similarly, FDA does not believe that “promotes weight loss” was a “customarily marketed” tobacco product claim within the meaning of Brown & Williamson. Section 1100.5 is written such that, if a particular intended structure/function effect for a product made or derived from tobacco is related to the effects of nicotine commonly and legally claimed prior to March 21, 2000, that product would not be subject to FDA's drug/device jurisdiction. FDA expects that in some cases this would be a fact-specific, case-by-case inquiry.

Sponsors should also keep in mind that, regardless of whether a product is regulated as a tobacco product or a medical product, the claims made for the product would misbrand the product and subject manufacturers to enforcement action if the claims are false or misleading in any particular, including if the claims are unsubstantiated. Thus, if a particular claim related to the effects of nicotine was used in the marketing of a tobacco product prior to March 21, 2000, but that claim is not substantiated by appropriate evidence, the use of such a claim in current labeling or advertising would likely misbrand the product. In addition, both medical products and tobacco products would be subject to enforcement action under section 201(n) of the FD&C Act if their labeling or advertising fails to reveal facts material in the light of the representations made or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates.

(Comment 8) Several comments argued that the proposed rule was an improper attempt to undermine the court's holding in Sottera with respect to the regulation of electronic cigarettes. These comments viewed the proposed rule as an attempt to regulate electronic cigarettes as drugs, and characterized it as an effort to bypass the D.C. Circuit's ruling in Sottera. They also suggested that Sottera made a categorical determination regarding the intended use of electronic cigarettes generally, and maintained that FDA declined to appeal the D.C. Circuit's decision and instead represented that it intended to regulate electronic cigarettes as tobacco products.

(Response) FDA disagrees with these comments. Although the Sottera decision determined that the holding in Brown & Williamson was not limited to cigarettes and smokeless tobacco, the court did not say that electronic cigarettes could never be regulated as drugs or devices. Rather, the court held that FDA can “regulate tobacco products marketed for therapeutic purposes under [the FD&C Act's drug/device provisions],” and observed that “the FDA may establish that NJOY does in fact make therapeutic claims regarding its electronic cigarettes.” See Sottera, 627 F.3d at 899. The rule FDA issues here clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product. Manufacturers are free to choose how they would like to market products made or derived from tobacco, but do so in the context of the regulatory framework set forth in the rule.

Moreover, the comments appear to misunderstand the nature of determinations of intended use with respect to FDA-regulated products. As discussed elsewhere in this document, intended use is a case-by-case, fact-specific inquiry in which the Agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence. See, e.g., Response to Comment 18 in section IV.C. Intended use is not determined on a categorical basis based on product type. Finally, in deciding not to petition for certiorari from the D.C. Circuit's decision in Sottera, FDA did not state or signal that it intended to regulate electronic cigarettes as tobacco products under all circumstances. Rather, in the wake of the Sottera decision, FDA issued a letter to stakeholders,12 noting that the Agency would abide by the jurisdictional lines established by Sottera, and was considering issuing a guidance or rulemaking regarding therapeutic claims. This final rule is the result of FDA's consideration of the issues raised by the Sottera decision and clarifies FDA's interpretation of the statutory definitions of drug and medical device with respect to products made or derived from tobacco.

12 See http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.

(Comment 9) Several comments asserted that claims that use euphemisms for the delivery of a pharmacologically active dose of nicotine, or state that a tobacco product provides an alternative way of obtaining the effects of nicotine or will provide the same effects as another tobacco product, do not fall within FDA's medical product authority. Four comments took the opposite view. Three of these latter comments remarked that excluding such claims from FDA's medical product authority would authorize manufacturers to continue using claims that were found to be fraudulent and deceptive by the U.S. District Court for the District of Columbia in United States v. Philip Morris USA Inc., 449 F. Supp. 2d 1 (D.D.C. 2006). These comments asserted that claims suggesting a product made or derived from tobacco provides “satisfaction,” a “nicotine fix,” or “pleasure” are claims about the pharmacological effects of nicotine, and suggested that products bearing such claims should be regulated as medical products. Another comment suggested that FDA treat such claims as evidence of an article's intended use as a drug.

(Response) The Agency disagrees with any suggestion that FDA is authorizing fraudulent claims. The purpose of this rule is to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a tobacco product versus as a drug, device, or combination product. Regardless of the outcome of that jurisdictional question, the FD&C Act prohibits false and misleading claims in FDA-regulated labeling and advertising (see sections 502(a), 502(n), 502(r), 903(a)(1), and 903(a)(7) (21 U.S.C. 352(a), 352(n), 352(r), 387c(a)(1), and 387c(a)(7)). Similarly, in concluding that certain claims involving “satisfaction,” “pleasure,” “enjoyment,” and “refreshment” are claims about the pharmacological effects of nicotine that were commonly and legally made prior to March 21, 2000, FDA is not authorizing such claims. Rather, the Agency is explaining in more detail its understanding of how the D.C. Circuit's interpretation of the Tobacco Control Act in Sottera affects the jurisdictional determination. As documented in the annex to the 1996 rule, products made or derived from tobacco were customarily marketed at that time for the pharmacological effects of nicotine, using phrases such as “smoking pleasure” and “satisfaction.” 13 Such terms, as discussed in section II.C, are recognized euphemisms for the delivery of a pharmacologically active dose of nicotine to satisfy addiction—an intended structure/function effect—and were commonly and legally made claims for customarily marketed cigarettes and smokeless tobacco products prior to the date of the Brown & Williamson decision. Thus, FDA continues to believe that Brown & Williamson, as extended and applied to the Tobacco Control Act by Sottera, precludes the Agency from regulating products made or derived from tobacco as medical products on the basis of such claims.

13 See 61 FR 44619 at 44648, August 28, 1996.

E. Comments and Responses Regarding Consumer Confusion

(Comment 10) Comments expressed different opinions about the intended uses of products made or derived from tobacco, primarily e-cigarettes, and whether consumers are able to distinguish products that are intended for medical use from products marketed for other uses. Several comments asserted that e-cigarettes are not intended for use as smoking cessation aids, whereas many other comments asserted that e-cigarettes are vital smoking cessation aids. One comment averred that there is no evidence that consumers are confusing e-cigarette products with products that are marketed, labeled, and sold as medical products. Two other comments, however, cited studies that purportedly show many consumers believe e-cigarettes and smokeless tobacco products are effective smoking cessation aids.

(Response) FDA continues to believe that there is consumer confusion about the intended uses of marketed products made or derived from tobacco. Evidence that at least some consumers are confused about the intended uses of products can be found in the comments themselves. We received many comments from individuals who began using e-cigarettes because they believed that e-cigarettes would help them quit smoking. Moreover, as noted in two comments, studies have shown that many consumers are using e-cigarettes to attempt to quit smoking (Ref. 2) despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.

(Comment 11) Several comments expressed concern that this regulation would increase consumer confusion by not allowing ENDS manufacturers to communicate truthful claims to their customers. These comments believed that the regulation would harm, rather than protect public health. Comments also expressed concern that ENDS manufacturers would not be able to state that e-cigarettes could be used for smoking cessation, and ENDS manufacturers would be forced to deceptively market their products. Several comments discussed FDA's authority under section 911 of the FD&C Act to require premarket authorization of modified risk tobacco products. Some commenters urged FDA to implement section 911 in a manner that does not restrict truthful and non-misleading speech.

(Response) FDA disagrees with concerns that ENDS manufacturers will not be able to make claims that accurately represent their products' intended uses. Manufacturers are free to decide how they would like to market their products, but must meet the appropriate statutory and regulatory standards governing the regulatory pathway they choose. Additionally, the proposed rule would not force e-vapor manufacturers to “deceptively” market their products or risk “being categorized as unapproved medical products and forced off the market.” FDA believes that manufacturers of products made or derived from tobacco, including e-vapor manufacturers, could make many types of claims under the rule that would subject them only to tobacco product jurisdiction; the preamble to the proposed rule provides examples of such tobacco product claims, but is not intended to be an exhaustive list. Moreover, section 911 of the FD&C Act allows manufacturers to make truthful and non-misleading modified risk claims with appropriate authorization. Manufacturers that have data to substantiate modified risk claims for a particular product can submit an MRTP application so that FDA can determine whether the product meets the statutory standard and if appropriate, can issue an order authorizing it to be marketed as an MRTP.

FDA continues to believe that smoking cessation claims require close examination. FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction to be evidence of intended uses that confer drug or device jurisdiction. Manufacturers that have data to substantiate cessation claims for a particular product can submit an NDA so that FDA can determine whether the product meets the statutory standard and can approve the application, if appropriate. The rule's treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products. Treating these products as medical products will help assure that such claims are supported by data demonstrating that a product is safe and effective for this intended use. Otherwise, consumers may attempt to quit smoking with unproven products, threatening both individual consumers' health and the public health generally.

(Comment 12) At least one comment suggested that a disclaimer stating that FDA has not approved e-cigarettes for medical use would be sufficient to mitigate any confusion over the intended use of such products. In contrast, several comments argued that disclaimers are insufficient to mitigate any confusion over whether a product made or derived from tobacco is intended for medical use. One of these comments suggested that disclaimers would foster confusion because they often contain statements that conflict with claims that are made elsewhere in the marketing materials and labeling for e-cigarettes and other products.

(Response) FDA does not believe that disclaimers will be sufficient in most cases to mitigate consumer confusion about whether a product made or derived from tobacco is intended for medical use. Studies have shown that disclaimers are frequently ineffective and can actually increase confusion for consumers (Refs. 3 and 4). Thus, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically.

(Comment 13) Several comments suggested that excluding claims that are euphemisms for the delivery of a pharmacologically active dose of nicotine and those that suggest a tobacco product provides an alternative way of obtaining the effects of nicotine from regulation under the Agency's drug/device authorities would create consumer confusion because such claims may not be distinguishable from drug or device claims related to the symptoms of nicotine addiction or could be perceived as modified risk claims.

(Response) As stated previously in this section, FDA has determined that the types of claims described in these comments generally do not bring products made or derived from tobacco within its drug and device authority. We acknowledge that there are circumstances in which consumers might be confused by such claims. A consumer might be confused about a product's intended use, for example, if a “satisfying smoking alternative” claim is accompanied by other text or images indicating that the product can help smokers reduce withdrawal symptoms associated with quitting smoking. In that case, the product may be subject to regulation as a drug or device. But as a general matter, FDA does not expect claims that use euphemisms for the delivery of a pharmacologically active dose of nicotine or suggest that a tobacco product provides an alternative way of obtaining the effects of nicotine to cause much confusion. FDA will continue to monitor consumer perception and will take appropriate regulatory action if evidence accumulates showing that consumers are confused by such claims.

F. Changes to Existing “Intended Use” Regulations

FDA is also making changes to §§ 201.128 and 801.4. First, the final rule inserts a reference to § 1100.5 to clarify the interplay between these regulations and the final rule. Second, as discussed previously, the Agency does not, absent extraordinary circumstances, regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that the product was being prescribed or used by doctors for such use (see Ref. 1). Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA's interpretation and application of these regulations. These changes do not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.

III. Legal Authority

Among the provisions that provide authority for this final rule are sections 201, 503(g), and 701(a) of the FD&C Act (21 U.S.C. 321, 353(g), 371(a)). Section 201 of the FD&C Act defines “drug,” “device,” and “tobacco product” (subsections (g)(1), (h), and (rr)(1) to (rr)(2)), and section 503(g) of the FD&C Act provides that combination products are those “that constitute a combination of a drug, device, or biological product.” Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act. FDA believes this rule will assist the Agency with efficient enforcement of the FD&C Act because it provides increased clarity to stakeholders, particularly regulated entities, regarding FDA's interpretation of which regulatory framework will apply to particular products and will help consumers differentiate between products that are intended for medical use and products marketed for other uses.

FDA regulates the manufacture, sale, and distribution of drugs, devices, combination products, and tobacco products under the authority of the FD&C Act. Although the regulatory pathways for each product category differ, each product category is subject to similar types of regulatory requirements. For example, FDA's regulatory authority for drugs, devices, combination products, and tobacco products includes authority to review and authorize the marketing of new products as well as to oversee product labeling and advertising. Thus, whether a product meets the definition of a drug, device, or tobacco product under the FD&C Act and this final regulation, the manufacture, sale, and distribution of the product are subject to the applicable requirements of the FD&C Act.

(Comment 14) At least one comment stated that the proposed rule exceeds FDA's authority.

(Response) FDA disagrees. As described in the proposed rule, FDA has the authority to regulate as a medical product any product that meets the definition of drug, device, or combination product in the FD&C Act, including cigarettes and other tobacco-derived products unless their intended use was the subject of claimed structure/function effects of nicotine commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. FDA also has tobacco product jurisdiction over all other products made or derived from tobacco intended for human consumption. The final rule seeks to clarify how products containing nicotine derived from tobacco will be regulated.

IV. Description of the Final Rule A. Exclusion From Tobacco Product Regulation (§ 1100.5)

As described in section II, the goal of this final rule is to provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act. In describing these intended uses, the final rule aims to assist regulated entities in the research and development of products made or derived from tobacco by clarifying which regulatory framework (i.e., the drug/device frameworks or the tobacco framework) will apply to particular products based on their intended use. The final rule is also intended to reduce consumer confusion regarding which products are intended for medical use (i.e., as a drug, device, or combination product) and which may be marketed for recreational or other purposes. The final rule reflects the legal and regulatory considerations discussed in sections I and II, including the Brown & Williamson and Sottera holdings. Finally, the final rule amends the existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to § 1100.5 to clarify the interplay among these regulations and this final rule.

The codified language states the circumstances in which a product made or derived from tobacco would be excluded from the definition of “tobacco product” and be subject to regulation as a drug, device, or combination product. Under the final rule, this exclusion could apply in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

Conceptually, the codified language follows the disease prong and the structure/function prong (with certain limitations) of the drug and device definitions.

1. Disease Prong

Section 1100.5(a) follows the disease prong. The paragraph elaborates on the statutory language for the disease prong by describing several categories of intended uses that would cause a product made or derived from tobacco to be regulated as a medical product. The categories identified in § 1100.5(a) are not intended to constitute an exhaustive list; nor are these categories necessarily mutually exclusive. In addition, these categories are intended to capture concepts, rather than to suggest that the use (or omission) of particular words is dispositive with respect to FDA's medical product jurisdiction. These categories are included as examples of types of intended uses that we believe are particularly relevant for products made or derived from tobacco and that fall within the disease prong.

2. Structure/Function Prong

Section 1100.5(b) follows the structure/function prong, but with some changes to reflect the court decisions in Brown & Williamson and Sottera. Specifically, the language in § 1100.5(b) beginning “in any way that is different from . . . .” reflects the fact that, under Brown & Williamson and Sottera, intended structure/function effects related to nicotine will not confer drug/device jurisdiction to the extent they reflect claims that were commonly and legally made for “customarily marketed” tobacco products before the date of the Brown & Williamson decision. This language also references “the marketing of cigarettes and smokeless tobacco products” because these were the product categories considered by the Supreme Court in Brown & Williamson. March 21, 2000, is the date of the Supreme Court's ruling in Brown & Williamson.

FDA believes that it is important to include a date limitation in § 1100.5(b) to provide greater certainty about the universe of historic structure/function claims the Agency intends to consider when determining whether an intended use of a product made or derived from tobacco is different from effects related to nicotine that were commonly and legally claimed for “customarily marketed” cigarettes and smokeless tobacco products. This bright-line limitation also avoids creating a shifting standard that will cause confusion among consumers and regulated industry. FDA intends to look to the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, to determine the types of structure/function claims that constitute customary tobacco product marketing. Cigarettes and smokeless tobacco products provide a reasonable proxy for determining how nicotine-related structure/function claims were conveyed in tobacco product marketing generally. The codified language, however, applies to all products made or derived from tobacco, not just cigarettes and smokeless tobacco.

3. Intended Use

As noted in section I.B.2, intended use may be determined from any relevant source and is not based solely on claims made in a product's labeling or advertising materials. For purposes of illustration, however, claims such as “treatment of tobacco dependence,” “wean yourself off of nicotine,” “for people who wish to quit smoking,” “stop smoking aid,” “prevent relapse,” or “stay quit” generally will bring a product within the intended uses described in § 1100.5(a).14

14 These and other specific claims mentioned in this document are provided solely as examples. Other claims not mentioned in this document could also reflect an intended use described in the codified language. In addition, as discussed elsewhere in this document, FDA intends to consider the full context of claims for products made or derived from tobacco in making jurisdictional determinations.

Claims such as “to reduce withdrawal symptoms,” “helps reduce symptoms including things like [list of withdrawal symptoms]” and “relieve withdrawal symptoms when you are prohibited from smoking” would be associated with an intended use for relief of nicotine withdrawal symptoms, and would also fall within the intended uses described in § 1100.5(a). Withdrawal symptoms that are medically recognized as relevant to nicotine addiction may be determined by reference to standard classification and diagnostic tools such as the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

Certain structure/function claims that were not commonly and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, such as “promotes weight loss,” would fall within the intended uses described in § 1100.5(b).

In contrast to the examples of medical product intended use claims given in the previous paragraphs, certain other claims made about products made or derived from tobacco would not on their own create an intended use that falls within the codified language.15 For example, claims such as “smoke free, spit free tobacco pleasure” or “full taste and satisfaction” may be associated with the marketing of tobacco products for refreshment, satisfaction, or enjoyment (which, as discussed in section II.C, are recognized euphemisms for the delivery of a pharmacologically active dose of nicotine to satisfy addiction—an intended structure/function effect—and were commonly and legally made claims for customarily marketed cigarettes and smokeless tobacco products prior to the date of the Brown & Williamson decision). Claims such as “great tasting tobacco satisfaction when you can't smoke,” “satisfying tobacco alternative,” or “provides the look, feel, and experience of a cigarette” may be associated with the marketing of tobacco products as smoking substitutes. And claims such as “healthier alternative to smoking,” “contains less nicotine than [another product],” or “reduces your risk of lung cancer compared to cigarettes” might be associated with MRTPs, as discussed in section II.A.2.

15 As previously, the specific claims mentioned in this paragraph are provided solely as examples. Other claims not mentioned here could fall outside the intended uses described in § 1100.5.

For products made or derived from tobacco that are intended for investigational use, FDA will consider whether the product is being used in a clinical investigation for an intended use that brings it within the codified language. If it is, the product would meet the definition of “investigational new drug” in § 312.3 (21 CFR 312.3), and the clinical investigation would be subject to the applicable requirements in part 312 (21 CFR part 312).16 Products made or derived from tobacco that are intended for investigational use but that do not meet the definition of “investigational new drug” in § 312.3 may be subject to regulation as investigational tobacco products.

16 Note that studies performed to meet statutory requirements in chapter IX of the FD&C Act relating to the impact of tobacco products on cessation behavior are not required to be designed as clinical investigations subject to the investigational new drug application requirements in part 312. Whether a study is considered a clinical investigation of an “investigational new drug” would depend on the study's design and specific objectives.

B. Existing “Intended Use” Regulations (§§ 201.128 and 801.4)

In the proposed rule, FDA proposed certain changes to FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses (see § 201.128 (drugs), § 801.4 (devices)). These changes were intended to revise the language of the regulations to better reflect how the Agency applies them. As explained in the preamble to the proposed rule, these amendments were intended to clarify FDA's existing position on intended use, not to change it (80 FR 57756 at 57761). Some comments, however, misunderstood FDA's proposal, particularly with respect to the proposed deletion of the last sentence of both regulations (§§ 201.128 and 801.4). FDA has now determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than deleting them.

Accordingly, the last sentence of § 201.128 is amended to provide that if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the FD&C Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for the drug adequate labeling that accords with such other intended uses.

Similarly, the last sentence of § 801.4 is amended to provide that if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the FD&C Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for the device adequate labeling that accords with such other intended uses.

As described in the preamble to the proposed rule, FDA's longstanding position is that, in determining a product's intended use, the Agency may look to any relevant source of evidence. This position has solid support in the case law (see, e.g., United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 (9th Cir. 1985); Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); Nat'l Nutritional Foods Ass'n v. Matthews, 557 F.2d 325, 334 (2d Cir. 1977); United States v. Article of 216 Cartoned Bottles, “Sudden Change,” 409 F.2d 734, 739 (2d Cir. 1969); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957); Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff'd, 540 F.2d 947 (8th Cir. 1976)). This position is unchanged.

In the preamble to the proposed rule, FDA also stated “the Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use” (80 FR 57756 at 57757). Health care providers prescribe or use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients.17 In these limited circumstances, FDA does not consider a firm's knowledge that a health care provider has used or prescribed its approved/cleared medical product for an unapproved use, by itself, as sufficient to establish the intended use element of a prohibited act related to the lack of premarket approval/clearance of that use or the lack of adequate directions for use.18 Instead, FDA examines all relevant evidence, which could include, among other facts, a manufacturer's knowledge that health care providers are prescribing or using its approved/cleared medical product for an unapproved use, to determine whether there is sufficient evidence to establish a new intended use.

17 FDA generally does not seek to interfere with the exercise of the professional judgment of health care providers in prescribing or administering, for unapproved uses for individual patients, most legally marketed medical products. This longstanding position has been codified with respect to devices (see 21 U.S.C. 396). While FDA generally does not seek to interfere with the exercise of the professional judgment of veterinarians, certain unapproved uses of drugs in animals are not permitted and result in the drug being deemed unsafe under section 512 of the FD&C Act (see section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)) and 21 CFR part 530).

18 See 21 U.S.C. 331(d), 351(f), 352(f)(1), 355(a). That position does not apply to products that are not already legally marketed as medical products for at least one use. Similarly, nothing in this regulation or preamble is intended to impact the application of 21 U.S.C. 333(e), which, subject to limited exceptions, penalizes anyone who “knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of disease or other recognized medical conditions, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician.” Further, Congress or the Agency could promulgate other provisions regarding specific products or classes of medical products that recognize knowledge as sufficient evidence of a particular element of a prohibited act.

Before FDA issued the proposed rule, some drug sponsors had expressed concern with the last sentence of § 201.128. That sentence provided, “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses.” (Section 801.4 contains comparable language.) They asserted that, literally read, this sentence would require that, whenever a manufacturer knew that its approved drug was being prescribed for an unapproved use, it would be required to alter the labeling of a drug to provide adequate directions for an off-label use. They further asserted that this addition to FDA-approved labeling would transform the drug into a new drug that cannot be sold without first obtaining approval of a supplemental new drug application pursuant to 21 U.S.C. 321(p) and 355(a). From this they concluded that, under the last sentence of § 201.128, a manufacturer's mere knowledge of an unapproved use of its approved drug automatically triggers requirements for new labeling that in turn render distribution of that approved product unlawful without approval of a supplemental NDA.

In the proposed rule, the proposed deletion of the last sentence of §§ 201.128 and 801.4 was intended to clarify the following: Where a manufacturer is distributing an approved or cleared medical product, evidence that the manufacturer knows that health care providers are prescribing or using that approved or cleared medical product for an unapproved use would not, by itself, automatically trigger obligations for the manufacturer to provide labeling for the uses for which the health care providers are prescribing or using the product.

FDA's clarification of its position and proposed deletion of the last sentence of these regulations in the proposed rule did not suggest that FDA sought to otherwise narrow the scope of evidence of intended use that FDA may consider. However, some of the comments misunderstood the proposal. For example, some comments asserted—incorrectly—that FDA intended to eliminate manufacturer knowledge altogether as a source of evidence of intended use.

FDA has determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than by deleting them. The amended language no longer suggests that a manufacturer's mere knowledge that its approved or cleared product was being prescribed or used for an unapproved use was sufficient to trigger the requirement to provide adequate labeling. In addition, this amended language provides further clarification by reminding manufacturers that, where the totality of evidence is sufficient to establish a new intended use for a medical product, relevant provisions of the FD&C Act and its implementing regulations will be triggered.

In addition, these amendments reflect FDA's longstanding position, upheld by the courts, that FDA may consider a variety of direct and circumstantial evidence to establish intended use. For example, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (see, e.g., United States v. Travia, 180 F. Supp. 2d 115, 119 (D.D.C. 2001)). In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products.

C. Comments and Responses Regarding Intended Use

(Comment 15) Some comments stated that this clarification of the Agency's interpretation and application of the intended use regulations (§§ 201.128 and 801.4) was helpful because it clarifies a point that has been confusing to industry. Another comment stated that the proposed changes to §§ 201.128 and 801.4 provide less information to manufacturers, not more clarity.

(Response) FDA agrees that clarification was warranted because of the apparent confusion over this point. With this final rule, the Agency is making additional changes to the codified language and providing more explanation to further clarify the meaning of the regulations.

(Comment 16) Some comments asserted that FDA should eliminate another reference to “knowledge” in § 201.128. Before the amendments implemented by this rule, both §§ 201.128 and 801.4 contained the following sentence: “[Intended use] may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.” The comments recommended that FDA delete either the phrase “with the knowledge of such person or their representatives” or the entire sentence from the regulation. At least one comment asserted that its recommended change to delete that phrase is consistent with FDA's intent in amending the regulations.

(Response) FDA disagrees with these comments. It was not the Agency's intention to entirely remove manufacturer knowledge from the types of evidence that may be considered in determining a product's intended use. FDA's proposed and final rule not only retained this sentence containing the other reference to “knowledge” in the text of both §§ 201.128 and 801.4, but also added “for example” to emphasize that FDA may rely on any relevant source of evidence of intended use. Accordingly, the amended version of this sentence (in both regulations) now reads that “intended use may be shown, for example, by circumstances in which the article is, with the knowledge of such person or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.”

In the context of medical products, generally, varied types of evidence, including evidence of a manufacturer's knowledge that a product is being used for an unapproved use, often enables FDA to pursue medical product manufacturers who attempt to evade FDA jurisdiction by avoiding express claims with respect to their products. In addition, as courts have recognized, evidence of a manufacturer's knowledge that a product is being used for an unapproved use can also be used to corroborate other evidence of intended use (see, e.g., United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 (7th Cir. 1984) (intended use established in part by witness testimony that device had been used to treat patients, together with other evidence regarding a training program and financial arrangements offered by the defendant).

FDA's intention in proposing to amend §§ 201.128 and 801.4 was more focused than these comments suggest. First, FDA's statement about not relying solely on manufacturer knowledge was limited to approved and cleared products because health care practitioners can generally use and prescribe such products for unapproved uses. That position does not apply to products that are not already legally marketed as medical products for at least one use. Second, manufacturer knowledge may be relevant to intended use, but the Agency would not bring an enforcement action based solely on manufacturer knowledge that an approved/cleared product was being prescribed or used by doctors for an unapproved use. If there is other evidence of intended use, FDA may consider manufacturer knowledge as well as other evidence. Third, FDA proposed deleting, and is now amending, the last sentence of the regulations to avoid the potential misinterpretation that a manufacturer's knowledge of an unapproved use of an approved/cleared medical product, without more, automatically triggers requirements for that manufacturer to provide additional labeling.

(Comment 17) At least one comment suggested that the First Amendment requires the exclusion of knowledge as a category of evidence that may be considered as evidence of intended use.

(Response) FDA disagrees. The First Amendment protects, among other things, freedom of speech, and knowledge and speech are not coextensive. A variety of direct and circumstantial evidence can establish a person's knowledge; a person's speech can be one source—but is not the only source—of evidence of that person's knowledge. Thus, the inclusion of evidence of knowledge within the types of evidence that may be relevant to establishing intended use does not in itself implicate the First Amendment.

(Comment 18) At least one comment asserted that, under relevant statutory text, legislative history, and case law, evidence of intended use is limited to a manufacturer's promotional claims. Another comment similarly proposed that the Agency focus principally on statements in the product labeling to establish intended use (using advertising material only to a lesser extent). In contrast, still another comment urged FDA to consider manufacturer statements in a variety of contexts, including advertising; press statements; official or unofficial statements made by corporate officials; statements made in social media and other online arenas; and statements made in point-of-sale locations (both traditional retail and online).

(Response) FDA disagrees with the comments urging FDA to narrow the scope of evidence it will consider in determining intended use, and FDA agrees with the comment asserting that evidence relevant to intended use should include a manufacturer's statements in a variety of contexts. Under the former set of comments, FDA could not consider, for example, evidence of a manufacturer's marketing plans or directions to its sales force, evidence of the well-known uses and abuses of its products, and circumstantial evidence relating to the sale and distribution of the product. These comments' suggested narrow view of evidence of intended use would not only create a loophole for manufacturers and distributors to evade FDA oversight of the marketing of approved/cleared medical products for unapproved uses but would also open the door to the marketing of wholly unapproved medical products—all to the detriment of the public health.

As courts have recognized, “[s]elf-serving labels cannot be allowed to mask the vendor's true intent as indicated by the overall circumstances” (United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 (9th Cir. 1985)). As one court explained, “[a] disease claim made with a wink and a nudge is still a disease claim. To hold otherwise would create an `obviously wide loophole' that would defeat the `high purpose of the Act to protect consumers.' ” (United States v. Cole, 84 F. Supp. 3d 1159, 1166 (D. Or. 2015) (citation omitted)). Examples of cases where the government has relied on circumstantial evidence to establish intended use include situations where products were labeled as herbal supplements, leather cleaner, incense, potpourri, bath salts, or `for research purposes only,' but in fact contained a pharmacological ingredient such as the active ingredient from approved erectile dysfunction and hair-loss products, albuterol, steroids, or street-drug pharmacological agents (“synthetic marijuana” or “imitation cocaine”). Similar examples for devices include products labeled as laser pointers, massagers, exercise equipment or diving chambers, but actually intended to treat serious conditions such as cancer, HIV, and autism. The government has also considered manufacturers' directions to their sales forces in determining intended use.

Nothing in the statute requires the narrow scope the comments suggest. As four justices of the Supreme Court recognized in rejecting the arguments reflected in these comments, “The [FD&C Act] . . . does not use the word `claimed'; it uses the word `intended' ” (FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 170 (2000) (dissenting opinion) (the majority declined to resolve the issue, id. at 131-32)). The language of the regulations is consistent with the statutory framework. As one court recently explained, “[N]owhere does the regulation state that such statements or claims cannot be used to show objective intent unless they were published to the marketplace. To see the absurdity of defendants' argument, consider a hypothetical in which a medical device manufacturer sells device D, which is approved for use A but frequently prescribed by doctors for off-label use B. If the manufacturer creates a bumper sticker with the words `I intend D to be used for B: Prescribe D for B Today,' by defendants' logic that poster is inadmissible evidence of subjective intent so long as it sits in his briefcase, but admissible evidence of objective intent once he sticks it on his car. The Court is not persuaded that there is a legally relevant distinction here; in either scenario, the defendant has manifested into the physical world `oral or written statements' that may be weighed as evidence of objective intent” (United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 (W.D. Tex. 2016)).

FDA also disagrees that the case law requires that evidence of intended use be limited to marketing representations by firms, to the exclusion of other types of evidence such as internal firm documents and circumstances surrounding the sale of products. Courts have repeatedly held that intended use is determined by looking to all relevant evidence, including statements and circumstances surrounding the manufacture and distribution of a medical product (see, e.g., United States v. Article of 216 Cartoned Bottles, “Sudden Change,” 409 F.2d 734, 739 (2d Cir. 1969) (“It is well settled that the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant source.”) (citations omitted); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957) (observing that a court is “free to look to all relevant sources in order to ascertain what is the `intended use' of a drug”)). As explained by one court: “Whether a product's intended use makes it a device depends, in part, on the manufacturer's objective intent in promoting and selling the product. All of the circumstances surrounding the promotion and sale of the product constitute the `intent'. It is not enough for the manufacturer to merely say that he or she did not `intend' to sell a particular product as a device. Rather, the actual circumstances surrounding the product's sale . . . determine the `intended' use of the product as a device under the Act” (United States v. 789 Cases, More or Less, of Latex Surgeons' Gloves, 799 F. Supp. 1275, 1285 (D. Puerto Rico 1992) (emphasis in original) (internal citations omitted)).

Indeed, courts have rejected the comments' proposition that evidence of intended use is limited to a manufacturer's public claims concerning a device or drug (see Nat'l Nutritional Foods Ass'n v. Matthews, 557 F.2d 325, 334 (2d Cir. 1977) (“In determining whether an article is a `drug' because of an intended therapeutic use, the FDA is not bound by the manufacturer's subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence. Such intent also may be derived or inferred from labeling, promotional material, advertising, and any other relevant source.”) (internal citation and quotations omitted); United States v. Travia, 180 F. Supp. 2d 115, 119 (D.D.C. 2001) (“Labeling is not exclusive evidence of the sellers' intent. Rather, as the very language quoted by the defendants themselves states, `it is well established `that the intended use of a product, within the meaning of the [FD&C Act], is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source' . . . even consumer intent could be relevant, so long as it was pertinent to demonstrating the seller's intent . . . [I]f the government's allegations are true, the sellers did not need to label or advertise their product, as the environment provided the necessary information between buyer and seller. In this context, therefore, the fact that there was no labeling may actually bolster the evidence of an intent to sell a mind-altering article without a prescription—that is, a misbranded drug.”) (citations omitted); United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 (W.D. Tex. 2016) (“Even were this Court at liberty to depart from the Fifth Circuit's position, however, it would still deny defendants' motion; though [21 CFR] § 801.4 indeed says that `objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives,' nowhere does the regulation state that such statements or claims cannot be used to show objective intent unless they were published to the marketplace.”); see also United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 (9th Cir. 1985) (concluding that products innocuously labeled as “incense” and “not for drug use” were in fact drugs where the “overall circumstances” demonstrated vendor's intent that products be used as cocaine substitutes); United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 (7th Cir. 1984) (intended use established in part by witness testimony that device had been used to treat patients, together with other evidence regarding a training program and financial arrangements offered by the defendant); United States v. Undetermined Quantities of an Article of Drug Labeled as “Exachol”, 716 F. Supp. 787, 791 (S.D.N.Y. 1989) (explaining that “FDA is not bound by the vendor's subjective claims of intent” and that “[a]n article intended to be used as a drug will be regulated as a drug . . . even if the products labeling states that it is not a drug”)).

(Comment 19) At least two comments asserted that FDA should significantly contract its proposed definitions of “intended uses” because the First Amendment protects truthful speech. One comment stated that, under Central Hudson Gas and Electric Corp. v. Public Services Commission, 447 U.S. 557, 566 (1980), government regulation of truthful speech concerning a lawful activity violates the First Amendment unless government regulators can establish that: (1) They have identified a substantial government interest; (2) the regulation directly advances that asserted interest; and (3) the regulation is no more extensive than is necessary to serve that interest. The comment then argued that a complete prohibition of truthful speech by manufacturers and their representatives concerning the off-label uses of a drug or device does not satisfy this test.

Similarly, another comment urged FDA to confirm that truthful and non-misleading speech cannot form the basis of a manufacturer's intended use of a medical product. That comment asserted that courts have recently held that enforcement actions based on truthful, non-misleading speech to health care professionals violates core First Amendment values, citing United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) and Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

(Response) FDA is separately examining its rules and policies relating to firm communications regarding unapproved uses of approved/cleared medical products, with the goal of determining how best to integrate the significant and sometimes competing public health and safety interests served by FDA's regulatory approach related to unapproved uses of medical products with ongoing developments in science and technology, medicine, health care delivery, and constitutional law. To that end, FDA held a two-day public hearing on November 9 and 10, 2016, to obtain input on these issues, and created a docket for the submission of written comments (see, e.g., 81 FR 60299, Sept 1, 2016, announcing a public hearing and request for comments on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, available at: http://www.fda.gov/NewsEvents/MeetingsConferences Workshops/ucm489499.htm). That examination is ongoing. In contrast, the purpose of amending §§ 201.128 and 801.4 in this rulemaking is to clarify the scope of these regulations in response to assertions by industry that they did not understand the meaning of the regulations in their previous form.

The broader policy questions and the related First Amendment issues are thus being considered in a separate proceeding. Nevertheless, it is important to note here that we do not agree with the assertion that the current case law allows FDA to consider speech as evidence of intended use only when it is false or misleading. Courts have held that the government's reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment based on Supreme Court precedent establishing that “[t]he First Amendment . . . does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent” (Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993)). The D.C. Circuit applied that precedent in the context of the FD&C Act and held that “th[e] use of speech to infer intent, which in turn renders an otherwise permissible act unlawful, is constitutionally valid” and hence “it is constitutionally permissible for the FDA to use speech [by the manufacturer] . . . to infer intent for purposes of determining that [the manufacturer's] proposed sale . . . would constitute the forbidden sale of an unapproved drug” (Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004); see also Flytenow, Inc. v. FAA, 808 F.3d 882, 894 (D.C. Cir. 2015) (upholding “us[e of] speech (postings on Flytenow.com) as evidence that pilots are offering service that exceeds the limits of their certifications”)). Courts applying that reasoning have found that the government's reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment (see United States v. Lebeau, 654 Fed. App'x 826, 830-31 (7th Cir. 2016) (per curiam), petition for cert. filed, NO. 16-7125 (U.S. Oct. 13, 2016); Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004); United States v. Article of Drug Designated B-Complex Cholinos Capsules, 362 F.2d 923, 927 (3d Cir. 1966); United States v. Cole, 84 F. Supp. 3d 1159, 1166 (D. Or. 2015); United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248, 255-56 (D.D.C. 2012), aff'd, 741 F.3d 1314 (D.C. Cir. 2014); United States v. Livdahl, 459 F. Supp. 2d 1255, 1268 (S.D. Fla. 2005); United States v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547, 579-80 (D.N.J. 2004); United States v. General Nutrition, Inc., 638 F. Supp. 556, 562 (W.D.N.Y. 1986); see also Spectrum Pharms., Inc. v. Burwell, 824 F.3d 1062 (D.C. Cir. 2016) (manufacturer promotion of a generic drug for use approved for the sponsor but not for the generic may lead to enforcement action for misbranding)).

Although the district court in Amarin Pharma, Inc. v. FDA held that the Caronia decision foreclosed reliance (in the Second Circuit) on this doctrine in the context of an FDA enforcement action where the misbranding was based solely on truthful, non-misleading speech regarding the unapproved use of an approved drug, the Second Circuit has more recently confirmed that “Caronia left open the government's ability to prove misbranding on a theory that promotional speech provides evidence that a drug is intended for a use that is not included on the drug's FDA-approved label” (United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 n.2 (2d Cir. 2016)).

In addition, FDA's consideration of speech as evidence of intended use under its statutory and regulatory framework advances substantial public health interests relevant to analyses under Central Hudson Gas & Electric Corp. v. Public Service Comm'n, 447 U.S. 557, 563-64 (1980). The medical products FDA regulates have the potential to adversely impact public health and safety. Congress specifically developed the premarket review frameworks for medical products in response to public health tragedies 19 and after determining that: (1) Exclusive reliance on postmarket remedies, such as enforcement actions for false or misleading labeling, is unacceptable as a public health strategy for medical products because it does not sufficiently prevent harm and injury to patients and (2) safety and effectiveness must be evaluated for each marketed intended use of a medical product to prevent the harm that occurs when patients are prescribed or use ineffective treatments and to ensure that the benefits of an intended use outweigh its risks. The premarket review requirements of the FD&C Act and the Public Health Service Act provide mechanisms to help ensure that protections are in place that will allow the public to obtain the benefits of these products while mitigating the risks. More specifically, FDA's statutory authorities, regulations, and implementation policies advance substantial public health interests including: Motivating the development of robust scientific data on safety and efficacy; 20 maintaining the premarket review process for safety and efficacy of each intended use in order to prevent harm, protect against fraud, misrepresentation, and bias, and prevent the diversion of healthcare resources toward ineffective treatments; 21 ensuring required labeling is accurate and informative; protecting the integrity and reliability of promotional information regarding medical product uses; protecting human subjects receiving experimental treatments; ensuring informed consent; maintaining incentives for clinical trial participation; protecting innovation incentives, including statutory grants of exclusivity; and promoting the development of products for underserved patients.

19 The Federal Food, Drug, and Cosmetic Act of 1938, which introduced the requirement that firms demonstrate a drug product to be safe before being marketed, followed the deaths of approximately 100 people from ingesting “Elixir Sulfanilamide,” in which the lethal substance diethylene glycol was used as a solvent. Prior to 1938, there were no premarket requirements that mandated that the firm test its product's safety. The passage of the 1962 drug amendments was precipitated in part by the distribution of thalidomide, a sleeping pill that caused birth defects when taken by pregnant women. See W.F. Janssen article (Ref. 20). Significant problems with medical devices likewise preceded the Medical Device Amendments of 1976, including significant defects in cardiac pacemakers that led to 34 voluntary recalls involving 23,000 units, and serious side effects following implantation of intraocular lenses, including serious impairment of vision and the need to remove the eyes of some patients (H.R. Rep. No. 94-853, at 8 (1976)).

20 See R. Eisenberg article (Ref. 11) (“By requiring that firms conduct rigorous clinical trials before bringing their products to market and before making promotional claims for their products, the FDA plays an important structural role in promoting a valuable form of biomedical R&D that private firms are undermotivated to perform on their own.”); A. Kesselheim and M. Mello article (Ref. 12) (“There [would] be no need for companies to design these studies to meet the FDA's standards for methodological rigor if the companies have no intention of submitting an application for approval of the new use but rather intend to use the study findings only in marketing communications. Companies [could] design studies in ways that maximize the chances of obtaining a desired result and select which studies to emphasize in promotional communications, ignoring others that do not support their promotional message.”); R. Stafford article (Ref. 13) (Encouraging unapproved uses “undermines the incentives for manufacturers to perform rigorous studies—and instead subtly encourages them to game the system by seeking approval for secondary indications for which clinical trials are less complicated and less expensive. And off-label use may discourage evidence-based practice.”).

21 See, e.g., S. Kesselheim and J. Avorn article (Ref. 5) (“In the pharmaceutical market, determining whether a drug is safe and effective for an intended use can involve dozens of FDA scientists poring over extensive databases of studies in animals, toxicologic evaluations, and clinical trials. In essence, the agency acts as a learned intermediary on behalf of prescribing physicians.”); C. Good and W. Gellad article (Ref. 6) (“Even in situations where an off-label indication has been studied, pharmacokinetics, drug-disease interactions, and other safety considerations are unlikely to have been studied systematically to the level required during the FDA drug approval process. Likewise, few clinicians have the time or the motivation to review evidence for those off-label indications to arrive at a balanced assessment of the risks and benefits to support the appropriate use of that drug”); T. Eguale et al. article (Ref. 7) (summarizing study across cohort of 46,000 patients, and concluding that unapproved use of prescription drugs is associated with adverse drug events, particularly where those uses lack strong scientific evidence in the form of at least one randomized controlled trial).

At the same time, health care providers also prescribe and use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients. Scientific or medical information regarding unapproved uses of products may in some cases help health care providers make better decisions regarding patients, such as where the patient has a disease for which there is no approved/cleared treatment, where the patient is part of a population that has not been studied, or where all approved/cleared treatments have been exhausted. However, in other cases, the use of approved/cleared medical products for unapproved uses has also been associated with significant harm to patients, fraud, and waste of health care resources.22

22 See J. Avorn et al. article (Ref. 8) (“Considerable research shows that marketing can drive prescribing practices, which in turn can lead to adverse patient outcomes if those decisions are not evidence-based.”); A. Kapczynski article (Ref. 9) (“To be effective, a company's marketing must also influence the prescribing patterns of physicians. . . . [T]here is a strong and specific association between pharmaceutical marketing and physician behavior, independent of the evidence supporting the products.”); R. Cardarelli et al. article (Ref. 10) (pharmaceutical industry marketing to prescribing physician creates the potential for prescribing practices that may not benefit the patient, which contribute to escalating health care costs); T. Eguale et al. article (Ref. 7).

FDA's current implementation approach seeks to integrate the complex mix of numerous and sometimes competing interests at play while also taking into account First Amendment issues. For example, FDA has issued guidance documents to describe some of the circumstances when it would not consider a firm's distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved/cleared medical products to be evidence of intended use; and issued a draft guidance on unsolicited requests, confirming FDA's longstanding position that it would not consider a firm's providing truthful, balanced, non-misleading, and non-promotional scientific or medical information (including information about an unapproved use) that is responsive to unsolicited requests for information about FDA-regulated medical products to be evidence of intended use. FDA takes the same view of firms' presenting truthful and non-misleading scientific information about unapproved uses at medical or scientific conferences when done in non-promotional settings and not accompanied by promotional materials.

There are several points worth noting regarding the Central Hudson evaluation conducted by Second Circuit panel majority in United States v. Caronia. First, the panel majority's analysis was limited to addressing the constitutionality of a specific “construction of the FDCA's misbranding provisions to prohibit and criminalize off-label promotion” (see 703 F.3d 149, 161-64, 166-69 (2d Cir. 2012)). The Caronia majority did not conduct a Central Hudson evaluation of FDA's actual approach to manufacturer communications regarding unapproved uses of approved medical products, as described in the preceding paragraph. Second, the panel majority did not consider the multiple facets of public health advanced by FDA's statutory authorities, regulations, and implementation policies, which include motivating the development of reliable scientific evidence that enables the evaluation of the safety and effectiveness of each intended use of a medical product; maintaining the premarket review process for safety and efficacy of each intended use in order to prevent harm, protect against fraud, misrepresentation, and bias, and prevent the diversion of healthcare resources toward ineffective treatments; ensuring required labeling is accurate and informative; protecting the integrity and reliability of promotional information regarding medical product uses; protecting human subjects receiving experimental treatments; ensuring informed consent; maintaining incentives for clinical trial participation; protecting innovation incentives, including statutory grants of exclusivity; and promoting the development of products for underserved patients. The court's limited review of the interests at stake necessarily affected the rest of its Central Hudson analysis. Furthermore, the results of an exceptionally large Canadian study showing an association between unapproved uses and adverse drug events 23 were released more than three years after the Caronia decision. Accordingly, the Caronia court, in conducting its Central Hudson evaluation, did not have the benefit of considering the significant findings of this study.

23 T. Eguale et al. article (Ref. 7) (as noted above, summarizing study across cohort of 46,000 patients, and concluding that unapproved use of prescription drugs is associated with adverse drug events, particularly where those uses lack strong scientific evidence in the form of at least one randomized controlled trial).

(Comment 20) Several comments asserted that FDA should take this opportunity to bring other related regulations and guidance documents into conformance with modern First Amendment case law. These comments suggested, for example, that FDA reconsider its approach to substantial evidence to support manufacturer communications to health care professionals about approved drugs, reconsider its interpretation of the term labeling, and revise its regulations to confirm that FDA will abide by restrictions on FDA authority imposed by federal courts in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and similar First Amendment decisions. At least one comment asserted, citing United States v. Caronia, that FDA's interpretation and implementation of the FD&C Act restricts speech based on the identity of the speaker. The comment further asserted that any restrictions on truthful and non-misleading speech are subject to “heightened judicial scrutiny” and are “presumptively invalid” under Sorrell v. IMS Health Inc., 564 U.S. 552, 565, 571 (2011), Reed v. Town of Gilbert, 135 S. Ct. 2218, 2226 (2015), and Rosenberger v. Rector & Visitors of the Univ. of Va., 515 U.S. 819, 828 (1995). Another comment, quoting Bolger v. Youngs Drug Prods., 463 U.S. 60, 66 (1983), asserted that FDA should recognize that commercial speech is limited to speech that “does no more than propose a commercial transaction.” Another comment urged FDA to open a separate docket related to free speech issues regarding medical products.

(Response) To the extent these comments propose that FDA consider, in this rulemaking, issues that are beyond the scope of this rulemaking, FDA declines the suggestion. FDA agrees with the comment that suggests that broader First Amendment issues should be considered in the context of separate proceedings. FDA notes that there are separate proceedings that are currently ongoing (see, e.g., 81 FR 60299, Sept 1, 2016, announcing a public hearing and request for comments on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, available at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm).

In addition, FDA notes its disagreement with certain characterizations of the existing case law. First, as discussed earlier, the court in Caronia based its analysis on a legal theory that is more proscriptive than the one FDA actually holds. Second, the cited Supreme Court cases did not overrule the Central Hudson test for commercial speech. The Supreme Court in Sorrell confirmed that, where, as here, the speech in question is commercial, the Court applies the “commercial speech inquiry” as outlined in Central Hudson (Sorrell v. IMS Health Inc., 564 U.S. 552, 571-72 (2011); see also 1-800-411-Pain Referral Service, LLC v. Otto, 744 F.3d 1045, 1055 (8th Cir. 2014) (observing that Sorrell held that content- or speaker-based restrictions on commercial speech are subject to “heightened scrutiny,” and using the Central Hudson test to determine the constitutionality of such restrictions)). The Sorrell Court also confirmed that “content-based restrictions on protected expression are sometimes permissible, and that principle applies to commercial speech” (Sorrell, 564 U.S. at 579).

In Reed v. Town of Gilbert, the Court applied strict scrutiny to content-based restrictions on non-commercial speech in public fora. That holding has no bearing on the commercial speech at issue here (see, e.g., Sarver v. Chartier, 813 F.3d 891, 903 n.5 (9th Cir. 2016) (stating that Reed does not apply to laws governing commercial speech); Mass. Ass'n of Private Career Sch. v. Healey, 159 F. Supp. 3d 173, 192-93 (D. Mass. 2016) (same); San Francisco Apt. Ass'n v. City & Cnty. of San Francisco, 142 F. Supp. 3d 910, 922 (N.D. Cal. 2015) (same), appeal docketed, No. 15-17381 (9th Cir. Dec. 3, 2015). The Supreme Court's 1995 decision, Rosenberger v. Rector & Visitors of the Univ. of Va., 515 U.S. 819, likewise did not involve commercial speech.

Third, we disagree with the one comment that asserts, quoting Bolger v. Youngs Drug Prods., 463 U.S. 60, 66 (1983), that the Supreme Court limited the application of the Central Hudson test to speech that literally “does no more than propose a commercial transaction.” Although the Court in Bolger referred to speech that proposes a commercial transaction as “the core notion of commercial speech,” the Court then explained that “informational pamphlets” that “cannot be characterized merely as proposals to engage in commercial transactions” were nevertheless commercial speech based on a combination of relevant circumstances, such as mentioning the seller's product in the pamphlet and the economic motivation of the seller (see Bolger, 463 U.S. at 66-68 (emphasis added); see also Conn. Bar Ass'n v. United States, 620 F.3d 81, 93-94 (2d Cir. 2010)).

(Comment 21) Several comments suggested that FDA replace the phrase “is intended for use” in the first sentence of § 1100.5 with other phrases, such as “is commonly used” or “is primarily used.”

(Response) FDA declines this suggestion. The phrase “is intended for use” is necessary because it reflects the fact that FDA's regulatory authority over a product made or derived from tobacco is, in the context of regulating them as medical products, dependent upon the product's intended use.

(Comment 22) Several comments urged FDA not to consider a manufacturer's knowledge when determining a manufacturer's intent with respect to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The comments also request that the Agency use notice and comment rulemaking instead of guidance to make changes regarding manufacturer intent related to HCT/Ps.

(Response) These comments concern regulations and guidance documents relating specifically to HCT/Ps and are outside the scope of this rulemaking.

D. Comments and Responses Regarding Marketing Concerns

(Comment 23) At least one comment suggested that FDA amend § 1100.5(a) to incorporate the following points: (1) Products intended for use in the cure and treatment of smoking or any other tobacco product use are subject to regulation as medical products; (2) products intended for use for the prevention of relapse into any smoking, tobacco product, or nicotine relapse are subject to regulation as medical products; and (3) relief from nicotine withdrawal symptoms also includes relief from smoking or tobacco use withdrawal symptoms.

(Response) FDA agrees that the three uses identified in the comment appear to be intended uses that would render the products subject to regulation as medical products. Section 1100.5(a) explains that a product made or derived from tobacco is subject to regulation as a medical product if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. For illustrative purposes, the section also provides several examples of intended uses that will subject a product to regulation as a medical product. We believe the list of examples, which is not intended to be exhaustive, adequately illustrates the types of intended uses that will subject a product made or derived from tobacco to regulation as a medical product. Thus, while we agree that the three identified uses appear to be intended uses that would render the products subject to regulation as medical products, we decline to amend the list to incorporate the uses identified by the comment.

(Comment 24) At least one comment objected that the rule would limit e-cigarettes to marketing claims of “smoking pleasure” and “smoking satisfaction” since that is how traditional tobacco products were “customarily marketed” prior to March 21, 2000. The comment asserted that the rule would either force e-cigarettes off the market as unapproved medical products, or require e-cigarettes to be marketed similar to how traditional tobacco products were marketed prior to March 21, 2000, which would be deceptive because e-cigarettes are not intended for smoking pleasure or tobacco satisfaction. The comment argued that FDA should treat e-cigarettes differently from products that both contain tobacco leaf and were commercially available before March 21, 2000, when considering the types of claims that will subject a product made or derived from tobacco to regulation as a medical product.

(Response) FDA disagrees. As explained elsewhere in this document, we believe that the rule gives manufacturers and retailers ample flexibility to market e-cigarettes in a manner that is distinct from how cigarettes were marketed prior to March 21, 2000. The date of March 21, 2000, is relevant only to considering claims about a product's effects related to nicotine on the structure or function of the body as evidence of a product's intended use. E-cigarette manufacturers' and retailers' claims related to customizability, number of puffs per cartridge or charge, and various other differentiating features that do not relate to nicotine structure/function effects, irrespective of whether such claims were customarily and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, should generally not affect the determination of a product's intended use. A manufacturer's making a modified risk claim for a specific tobacco product renders the product an MRTP, which can be marketed only after the manufacturer substantiates any modified risk claims in an MRTP application and after FDA determines that the product meets the statutory standard. Additionally, if a manufacturer intends that its product be used for cessation, it can submit an NDA, Abbreviated New Drug Application (ANDA), Premarket Approval Application (PMA), or premarket notification submission so that FDA can determine whether the product meets the statutory standard and can approve the application or clear the submission, if appropriate.

(Comment 25) At least one comment questioned whether the marketing for tobacco products that are not MRTPs may contain useful contextual information (e.g., ingredient information).

(Response) This comment is outside the scope of this rulemaking because it does not relate to the circumstances in which a product that is made or derived from tobacco will be regulated as a medical product or a tobacco product.

(Comment 26) Several comments stated that ENDS manufacturers need to be able to inform and explain how to properly use vaping devices to help novices to prevent them from having accidents. The comments stated that vape shops need to be able to correctly educate consumers on how to use the products they sell.

(Response) FDA agrees. FDA recognizes that manufacturers may wish to provide instructions to consumers on how to use novel tobacco products, and instructions may be helpful in some cases in preventing consumer injury, such as nicotine poisoning or injuries from exploding batteries. Manufacturers may provide instructions to the consumer in many ways, including verbal instruction. However, if the instructions provided by the manufacturer convey that the product is to be used as a cessation device, then the product will generally be regulated as a medical product. Additionally, if the instructions make a modified risk claim, then the manufacturer must submit an MRTP application so that FDA can determine whether the product meets the statutory standard and can issue an order authorizing it to be marketed as an MRTP.

(Comment 27) Several commenters noted that tobacco products are advertised in a variety of media, including traditional print or mainstream media, blogs, social media, testimonials, and links to studies or media reports on Web sites. One comment observed that manufacturers of ENDS products often use online blogs as a way to make implicit or explicit cessation claims, and in some cases such assertions run counter to disclaimers posted on the same Web site that hosts the blog. Another comment noted that manufacturers used consumer testimonials that make cessation or MRTP claims on their company Web sites. Commenters observed that conflicting claims in advertising caused confusion among consumers regarding whether ENDS products are FDA-approved smoking cessation aids.

(Response) FDA agrees. Tobacco products are advertised in a variety of media, and advertisements may include conflicting information regarding whether the product is a recreational tobacco product or an FDA-approved smoking cessation product. When conflicting claims are made to the consumer, consumers can be confused by those claims. Thus, FDA believes that manufacturers' making smoking cessation claims for any product creates a strong suggestion of therapeutic benefit to the user that would subject the product to regulation under FDA's medical products authority. Such a suggestion generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose. As discussed in response to Comment 12, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion related to the intended therapeutic use of the product.

(Comment 28) Several comments stated that adolescent smokers are especially vulnerable to cessation and therapeutic claims in tobacco product marketing. These comments believe that adolescents misperceive the supposed benefits and underestimate the relative harms, risks, and addictive properties of e-cigarettes and other non-cigarette products.

(Response) FDA agrees that youth and young adults generally “underestimate the tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose” (Ref. 14). For example, one survey found that “nearly 60 percent of adolescents believed that they could smoke for a few years and then quit” (Ref. 15). FDA also believes that unsubstantiated cessation claims that reach adolescents may confuse teens and lead teens to believe that these products are FDA-approved smoking cessation products. For example, a teenager in a recent qualitative study said, “I heard that the only reason they were made is to help people get off from cigarettes for people that want to quit. You would use an e-cigarette to help you quit supposedly. It was on the news” (Ref. 16). FDA believes it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other tobacco product uses among both adolescents and adults, and this rule will help consumers.

(Comment 29) At least one comment stated that users consider ENDS and smokeless tobacco products effective cessation interventions. The comment believed that many people use these products to try to stop smoking because they are influenced by manufacturers' and sellers' marketing messages that make cessation and therapeutic claims about ENDS and other non-cigarette tobacco products.

(Response) FDA agrees that marketing can influence how consumers perceive tobacco products, and products advertised with cessation claims can lead consumers to believe that the product is an FDA-approved smoking cessation device. FDA also agrees that many consumers are using ENDS products for therapeutic purposes. One study concluded that, among State tobacco cessation quitline callers, the most common reported reason for using e-cigarettes was to cut down on, or quit, traditional tobacco use (Ref. 17). Another study concluded that some smokers who were interested in quitting were using ENDS for cessation purposes, possibly discouraging the use of proven smoking cessation treatments, delaying cessation, and thus prolonging exposure to harmful agents in combusted tobacco as an unintended consequence. Additionally, FDA received a large number of comments from individuals using ENDS for therapeutic purposes. One purpose of this regulation is to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use versus for a recreational use.

E. Other Comments and Responses

(Comment 30) At least one comment expressed concern that since the Sottera decision, FDA has not taken action against products made or derived from tobacco and making claims that were “clearly therapeutic.” In order to protect consumers from “false, misleading, and confusing tobacco industry claims,” the comment asks that products made or derived from tobacco making claims without an MRTP order be regulated as drug/device products in the Center for Drug Evaluation and Research.

(Response) FDA disagrees with the comment to the extent that the comment suggests that tobacco products properly regulated as MRTPs be regulated as drugs or devices in the absence of an MRTP order. Tobacco products making modified risk claims are regulated under the tobacco product authorities in the FD&C Act, and an MRTP marketed without an MRTP order would be subject to enforcement as a tobacco product, rather than subject to regulation as a drug or medical device product. With respect to enforcement generally, FDA notes that it is issuing this rule to clarify its interpretation of the drug and device definitions with respect to products made or derived from tobacco, and that it expects this clarification to assist industry in determining the applicable regulatory framework for particular products and help consumers differentiate between products that are intended for medical use and products intended for other uses.

(Comment 31) At least one comment observed that researchers may wish to study the effects that a product made or derived from tobacco has on health outcomes (e.g., withdrawal symptoms, hypertension, etc.) or on the structure and function of the body (e.g., blood pressure, lung function), or the effects of substituting one product made or derived from tobacco for another product. The comment asserted that the methods and measures of such studies are not evidence that the product being investigated is a drug and that FDA should not require an investigational new drug application (IND) for these studies unless they are sponsored by a manufacturer with the intention of supporting a health or medical drug claim.

(Response) The regulations in part 312 set forth the circumstances in which an IND is required for clinical investigations in which a drug is administered to human subjects. The IND requirement applies irrespective of whether the investigation is sponsored by a manufacturer or an academic institution. A study involving a product made or derived from tobacco will generally require an IND if the product, as used in the study, is subject to regulation as a drug. Whether the product, as used in the study, is subject to regulation as a drug depends on whether the product is being investigated for any of the purposes described in § 1100.5(a) or (b) of this rule. To determine if a product made or derived from tobacco is being investigated for one of these purposes, FDA generally would review the protocol for the study, including the proposed methods and measures. In the Agency's experience, the proposed methods and measures for a study can provide insight into the purposes for which a product is being investigated. Ultimately, however, whether a product is being investigated for a therapeutic purpose, and thus whether the study requires an IND, is a fact-specific, case-by-case inquiry. Additional information about the IND requirement can be found in the FDA guidance document entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” We encourage researchers to review this guidance document, which is available on FDA's Web site at http://www.fda.gov/downloads/UCM229175.pdf.

(Comment 32) At least one comment encouraged FDA to coordinate between centers to promote development of safer tobacco products as well as more effective medical products for the treatment of nicotine addiction. This comment also argued that FDA should not allow similar or identical products to be marketed as both tobacco products and medical products, and should consider approving categories of products, rather than individual products, for smoking cessation. This comment also expressed concern about dual use between tobacco product categories.

(Response) FDA agrees with this comment to the extent the comment considers the proposed rule to promote effective coordination between centers by clarifying which center should take the lead in review of premarket applications and postmarketing regulation of particular products. We note that FDA currently interprets the standards in various medical and tobacco product premarket review pathways to refer to individual products rather than product categories, and the question of whether a particular product could obtain marketing authorization as both a tobacco product and as a medical product is beyond the scope of this rule. By clarifying the jurisdictional lines between tobacco and medical products, FDA believes that finalization of this rule will make it less likely that manufacturers will attempt to market products made or derived from tobacco both as tobacco products and as medical products—for example, if a tobacco product manufacturer attempts to add claims to a currently marketed tobacco product that would require the product to be regulated as drug, device, or combination product.

(Comment 33) Several comments recommended that the Center for Tobacco Products (CTP) have sole regulatory jurisdiction over tobacco and nicotine-containing products and provided suggestions for how CTP should structurally reorganize itself to better regulate these products.

(Response) CTP oversees the regulation of products made or derived from tobacco that are intended for human consumption. As stated in this preamble, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it would be regulated as a medical product unless it is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000. In this situation, one of FDA's medical product centers would have regulatory oversight over these products because CTP does not oversee the regulation of medical products. As these comments relate to potentially undertaking a structural re-organization, CTP is not considering a structural reorganization at this time.

(Comment 34) At least one comment suggested that FDA create a separate regulatory category for e-cigarettes that is based on the Agency's medical product regulations, but with less stringent quality standards.

(Response) This recommendation is not consistent with the statutory definitions in the FD&C Act. Under the FD&C Act, a product made or derived from tobacco is subject to regulation as a tobacco product unless it meets the definition of a drug or device or is a combination product, in which case it is subject to regulation as a medical product.

(Comment 35) Several comments stated that the cost and resources required to complete FDA's drug application process would be simply too great and would shut down many small manufacturers.

(Response) This regulation simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product; it does not create new jurisdictional lines or impose new obligations on product manufacturers. Because the jurisdictional lines already exist, tobacco product manufacturers currently making claims that would render their product subject to regulation as a medical product or who wish to make such claims in the future are within FDA's drug and device jurisdiction, absent limited exceptions, and they must follow the applicable statutory and regulatory requirements.

(Comment 36) Many comments believed that the regulation would make e-cigarettes less available to consumers.

(Response) FDA disagrees. This regulation simply clarifies the circumstances under which a product made or derived from tobacco will be regulated as a drug, device, or combination product, and the circumstances under which it will be regulated as a tobacco product. This regulation will not add any additional burden to manufacturers who sell ENDS for recreational use. However, if a manufacturer is selling ENDS and making medical product claims, then the product would be subject to regulation as a drug, device, or combination product if those claims are not structure/function claims related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000.

(Comment 37) At least one comment suggested that the final rule should include a discussion of how the regulation will affect public health.

(Response) The preamble to the proposed rule contained some discussion of this topic, and this preamble to the final rule further expands on various public health protections.

(Comment 38) FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence. One comment asserted that promoting a product as suitable for continued nicotine use after stopping smoking traditional cigarettes is the functional equivalent of a “smoking alternative” claim, which FDA has said does not fall within the Agency's medical product authority, and, therefore, should not subject the product to regulation as a medical product.

(Response) Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons (Ref. 18). Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence may be developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in § 1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction.” FDA intends to closely scrutinize “smoking cessation” claims to ensure that consumers are not misled about the intended use of a product made or derived from tobacco.

(Comment 39) One comment stated that this regulation should not require companies that handle raw materials to determine whether those raw materials would be used in tobacco products or whether those materials would be used in medical products. The comment stated that the intended use of the product is completely within the discretion of the sellers and distributors of the finished products, and the Agency should not extend regulations to cover companies that handle raw materials.

(Response) This comment is beyond the scope of this rule. This regulation does not create new jurisdictional lines or impose new obligations on product manufacturers or companies that handle raw materials. Rather, this rulemaking simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product. If FDA were to consider extending its authority in such a way that would place additional requirements on companies handling raw materials, the Agency would do so through a separate rulemaking.

F. Other Changes to the Codified Text

To eliminate redundancy, we deleted “or prevention or mitigation of disease” from the end of § 1100.5(a), as the opening text already includes similar language. Because of this deletion, we inserted the word “or” in front of “relief of nicotine withdrawal symptoms.”

G. Effective Date

This final rule will become effective 30 days after the date of its publication in the Federal Register. During those 30 days, manufacturers will continue to be under an obligation to comply with all applicable provisions of the FD&C Act and applicable regulations.

V. Federalism

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

VI. Executive Order 13175: Tribal Consultation

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.

VII. Analysis of Environmental Impact

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

VIII. Economic Analysis of Impacts

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

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because, as described in detail in the section entitled “Final Small Entity Analysis” in the full analysis of economic impacts available in the docket for this final rule (Ref. 19) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm, the clarifications in this final rule will not significantly increase costs on manufacturers of products made or derived from tobacco, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

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

The final rule will reduce ambiguity in the market for products made or derived from tobacco and clarify FDA's interpretation and application of its existing intended use regulations. The rule clarifies the intended uses and supporting evidence that would result in these products being regulated as drugs, devices, or combination products rather than tobacco products. Products derived from tobacco that are intended to: (1) Diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation or (2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000, such as an intended use for improving respiratory function, will be subject to regulation as drugs, devices, or combination products. We estimate that there would be one-time costs for tobacco manufacturers to evaluate current product communications such as labeling and associated promotional materials in light of the clarifications in this final rule, and to revise them if needed. We expect that only a small number of product communications such as labeling and associated materials will undergo a one-time change as a result of this rule.

The final rule will provide greater clarity to producers regarding the regulatory requirements for products made or derived from tobacco and to consumers to distinguish products intended for medical uses from those marketed for other uses. The reduction in ambiguity will enhance consumers' understanding of the products they purchase and may increase consumer welfare as a result.

Table 2—Economic Data: Costs and Benefits Statement Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount
  • rate
  • (%)
  • Period
  • covered
  • (years)
  • Notes
    Benefits Annualized 7 Monetized ($millions/year) 3 Annualized 7 Quantified 3 Qualitative Reduce regulatory ambiguity Costs Annualized $0.246 $1.126 $0.365 2014 7 10 Monetized ($millions/year) 0.202 0.202 0.202 0.202 0.104 0.301 2014 3 10 Annualized 7 Quantified 3 Qualitative Transfers Federal 7 Annualized 3 Monetized ($millions/year) From/To From: To: Other 7 Annualized 3 Monetized ($millions/year) From/To From: To: Effects State, Local or Tribal Government: No Effect Small Business: No effect Wages: No estimated effect Growth: No estimated effect

    The full analysis of economic impacts is available in the docket for this final rule (Ref. 19) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    IX. Paperwork Reduction Act of 1995

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

    X. References

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

    1. Defendants' Memorandum of Points and Authorities in Support of Motion to Dismiss or for Summary Judgment. Allergan Inc. v. United States of America, et al., 1:09-cv-01879-JDB (D.D.C. Jan. 11, 2010), 2010 WL 11211158. 2. Etter, J.-F., C. Bullen, “Electronic Cigarette: Users Profile, Utilization, Satisfaction and Perceived Efficacy,” Addiction, 106(11):2017-2028, 2011. 3. Byron, M.J., S.A. Baig, K.E. Moracco, and N.T. Brewer, “Adolescents' and Adults' Perceptions of `Natural', `Organic' and `Additive-Free' Cigarettes, and the Required Disclaimers,” Tobacco Control, Dec 1:tobaccocontrol-2015, 2015. 4. Green, K.C. and J.S. Armstrong, “Evidence on the Effects of Mandatory Disclaimers in Advertising,” Journal of Public Policy & Marketing, 31(2):293-304, 2012. 5. Kesselheim, A.S. and J. Avorn, “Pharmaceutical Promotion to Physicians and First Amendment Rights,” New England Journal of Medicine, 358:1727-1732, 2008. 6. Good, C.B. and W.F. Gellad, “Off-Label Drug Use and Adverse Events: Turning up the Heat on Off-Label Prescribing,” Journal of American Medical Association Internal Medicine, 176(1):63-64, 2016. 7. Eguale, T., D.L. Buckeridge, A. Verma, et al., “Association of Off-Label Drug Use and Adverse Drug Events in an Adult Population,” Journal of American Medical Association Internal Medicine, 176(1):55-63, 2016. 8. Avorn, J., A. Sarpatwari, and A.S. Kessleheim, “Forbidden and Permitted Statements About Medications—Loosening the Rules,” New England Journal of Medicine, 373:967-973, 2015. 9. Kapczynski, A., “Free Speech and Pharmaceutical Regulation—Fishy Business,” Journal of American Medical Association Internal Medicine, 176(3):295-296, 2016. 10. Cardarelli, R., J.C. Licciardone, and L.G. Taylor, “A Cross-Sectional Evidence-Based Review of Pharmaceutical Promotional Marketing Brochures and Their Underlying Studies: Is What They Tell Us Important and True?,” BMC Family Practice, 7(1):13, 2006. 11. Eisenberg, R.S., “The Role of the FDA in Innovation Policy,” Michigan Telecommunications and Technology Law Review, 13:2:345, 370, 2007. 12. Kesselheim, A.S., and M.M. Mello, “Healthcare Decisions in the New Era of Healthcare Reform: Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection,” North Carolina Law Review, 92:1539, 1585, 2014. 13. Stafford, R.S., “Regulating Off-Label Drug Use—Rethinking the Role of the FDA,” New England Journal of Medicine, 358:1427-1429, 2008. 14. President's Cancer Panel, “Promoting Healthy Lifestyles,” 2007, available at http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp07rpt/pcp07rpt.pdf. 15. Institute of Medicine of the National Academies, “Ending the Tobacco Problem: A Blueprint for the Nation,” 2007, available at https://www.nap.edu/read/11795/chapter/1. 16. Roditis, M.L., and B. Halpern-Felsher, “Adolescents' Perceptions of Risks and Benefits of Conventional Cigarettes, E-Cigarettes and Marijuana: A Qualitative Analysis,” Journal of Adolescent Health, 57(2):179-185, 2015. 17. Vickerman, K.A., K.M. Carpenter, T. Altman, et al., “Use of Electronic Cigarettes Among State Tobacco Cessation Quitline Callers,” Nicotine & Tobacco Research, 15(10):1787-1791, 2013. 18. Gallup Consumption Habits poll, July 2013 (see http://www.gallup.com/poll/163763/smokers-quit-tried-multiple-times.aspx). 19. Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination; Amendments to Regulations Regarding “Intended Uses,” Final Rule; Final Regulatory Impact Analysis. 20. Janssen, W.F., “Outline of the History of U.S. Drug Regulation and Labeling,” Food Drug Cosmetic Law Journal, 36: 420, 437-438, 1981. List of Subjects 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

    21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping requirements.

    21 CFR Part 1100

    Combination products, Devices, Drugs, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter 1 is amended as follows:

    PART 201—LABELING 1. The authority citation for part 201 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

    2. Revise § 201.128 to read as follows:
    § 201.128 Meaning of “intended uses”.

    The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. And if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for such drug adequate labeling that accords with such other intended uses.

    PART 801—LABELING 3. The authority citation for part 801 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.

    4. Revise § 801.4 to read as follows:
    § 801.4 Meaning of intended uses.

    The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the device, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. And if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for such device adequate labeling that accords with such other intended uses.

    PART 1100—TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY 5. The authority citation for part 1100 is revised to read as follows: Authority:

    21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d), Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55, 17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321, 353(g), and 371(a); 21 CFR 1.1.

    6. Part 1100 is amended by adding § 1100.5 to read as follows:
    § 1100.5 Exclusion from tobacco regulation.

    If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be subject to regulation as a drug, device, or combination product.

    (a) The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms;

    (b) The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

    Dated: December 29, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-31950 Filed 1-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. FDA-2014-N-1205] Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems Correction

    In rule document 2016-31670 beginning on page 96366 in the issue of Friday, December 30, 2016, make the following correction:

    On page 96372, in the second column, in the 25th, 51st, and 67th lines, and in the third column, in the tenth line, “June 28, 2018” should read “July 1, 2019”.

    [FR Doc. C1-2016-31670 Filed 1-6-17; 8:45 am] BILLING CODE 1301-00-D
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-446] Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB-, 5F-AMB, 5F-APINACA, ADB-FUBINACA, NDMB-CHMICA and MDMB-FUBINACA) Into Schedule I Correction

    Document 2016-30595 was inadvertently classified a rule and published in the Rules and Regulations section in the issue of December 21, 2016, beginning on page 93595. It should have appeared in the Proposed Rules section.

    As a result of the error, an amendment was made to 21 CFR 1308.11 which the DEA did not intend. This classification correction removes added paragraphs (h)(23) through (28) from 21 CFR 1308.11.

    Accordingly, 21 CFR part 1308 is corrected as follows:

    PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: Authority:

    21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    § 1308.11 [Corrected]
    2. In § 1308.11, remove paragraphs (h)(23) through (28).
    [FR Doc. C1-2016-30595 Filed 1-6-17; 8:45 am] BILLING CODE 1301-00-D
    AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 241 Republic of Iraq Loan Guarantees Issued Under the Further Continuing and Security Assistance Appropriations Act of 2017—Standard Terms and Conditions AGENCY:

    Agency for International Development (USAID).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation prescribes the procedures and standard terms and conditions applicable to loan guarantees to be issued for the benefit of the Republic of Iraq pursuant to the Further Continuing and Security Assistance Appropriations Act, 2017.

    DATES:

    Effective January 9, 2017.

    FOR FURTHER INFORMATION CONTACT:

    D. Bruce McPherson, Office of the General Counsel, U.S. Agency for International Development, Washington, DC 20523-6601; tel. 202-712-1611, fax 202-216-3055.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the Further Continuing and Security Assistance Appropriations Act, 2017 (Pub. L. 114-254), the United States of America, acting through the U.S. Agency for International Development, may issue certain loan guarantees applicable to sums borrowed by the Republic of Iraq (the “Borrower”), not exceeding an aggregate total of U.S. $1 billion in principal amount. Upon issuance, the loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings and the full faith and credit of the United States of America shall be pledged for the full payment and performance of such guarantee obligations.

    This rulemaking document is not subject to rulemaking under 5 U.S.C. 553 or to regulatory review under Executive Order 12866 because it involves a foreign affairs function of the United States. The provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) do not apply.

    List of Subjects in 22 CFR Part 241

    Foreign aid, Foreign relations, Guaranteed loans, Loan programs—foreign relations.

    Authority and Issuance Accordingly, part 241 is added to title 22, chapter II, of the Code of Federal Regulations, as follows: PART 241—REPUBLIC OF IRAQ LOAN GUARANTEES ISSUED UNDER THE FURTHER CONTINUING AND SECURITY ASSISTANCE APPROPRIATIONS ACT OF 2017 Sec. 241.1 Purpose. 241.2 Definitions. 241.3 The Guarantee. 241.4 Guarantee eligibility. 241.5 Non-impairment of the Guarantee. 241.6 Transferability of Guarantee; Note Register. 241.7 Fiscal Agent obligations. 241.8 Event of Default; Application for Compensation; payment. 241.9 No acceleration of Eligible Notes. 241.10 Payment to USAID of excess amounts received by a Noteholder. 241.11 Subrogation of USAID. 241.12 Prosecution of claims. 241.13 Change in agreements. 241.14 Arbitration. 241.15 Notice. 241.16 Governing law. Appendix A to Part 241—Application for Compensation Authority:

    Security Assistance Appropriations Act, 2017 (Div. B, Pub. L. 114-254).

    § 241.1 Purpose.

    The purpose of the regulations in this part is to prescribe the procedures and standard terms and conditions applicable to loan guarantees issued for the benefit of the Borrower, pursuant the Further Continuing and Security Assistance Appropriations Act, 2017 (Pub. L. 114-254) (the “Authority”). The loan guarantees will be issued as provided herein pursuant to the Loan Guarantee Agreement, executed in January 2017, between the United States of America and the Republic of Iraq (the “Loan Guarantee Agreement”). The loan guarantee will apply to sums borrowed during a period beginning on the date that the Loan Guarantee Agreement enters into force and ending thirty days after such date, not exceeding an aggregate total of one billion United States Dollars ($1,000,000,000) in principal amount. The loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings. The full faith and credit of the United States of America is pledged for the full payment and performance of such guarantee obligations.

    § 241.2 Definitions.

    Wherever used in the standard terms and conditions set out in this part:

    Applicant means a Noteholder who files an Application for Compensation with USAID, either directly or through the Fiscal Agent acting on behalf of a Noteholder.

    Application for Compensation means an executed application in the form of Appendix A to this part which a Noteholder, or the Fiscal Agent on behalf of a Noteholder, files with USAID pursuant to § 241.8.

    Borrower means the Republic of Iraq.

    Business Day means any day other than a day on which banks in New York, NY are closed or authorized to be closed or a day which is observed as a federal holiday in Washington, DC, by the United States Government.

    Date of Application means the date on which an Application for Compensation is actually received by USAID pursuant to § 241.15.

    Defaulted Payment means, as of any date and in respect of any Eligible Note, any Interest Amount and/or Principal Amount not paid when due, regardless of the reason the Borrower fails to pay, including without limitation withholding taxes.

    Eligible Note(s) means [a] Note[s] meeting the eligibility criteria set out in § 241.4.

    Fiscal Agency Agreement means the agreement among USAID, the Borrower and the Fiscal Agent pursuant to which the Fiscal Agent agrees to provide fiscal agency services in respect of the Note[s], a copy of which Fiscal Agency Agreement shall be made available to Noteholders upon request to the Fiscal Agent.

    Fiscal Agent means the bank or trust company or its duly appointed successor under the Fiscal Agency Agreement which has been appointed by the Borrower with the consent of USAID to perform certain fiscal agency services for specified Eligible Note[s] pursuant to the terms of the Fiscal Agency Agreement.

    Further Guaranteed Payments means the amount of any loss suffered by a Noteholder by reason of the Borrower's failure to comply on a timely basis with any obligation it may have under an Eligible Note to the Noteholders, including late fees under the Eligible Note, but not including any taxes or governmental charges or any expense arising out of taxes or any other governmental charges relating to the Eligible Note in the country of the Borrower.

    Guarantee means the guarantee of USAID pursuant to the Authority.

    Guarantee Payment Date means a Business Day not more than three (3) Business Days after the related Date of Application.

    Interest Amount means for any Eligible Note the amount of interest accrued on the Principal Amount of such Eligible Note at the applicable Interest Rate.

    Interest Rate means the interest rate borne by an Eligible Note.

    Loss of Investment means, in respect of any Eligible Note, an amount in Dollars equal to the total of the:

    (1) Defaulted Payment unpaid as of the Date of Application,

    (2) Further Guaranteed Payments unpaid as of the Date of Application, and

    (3) Interest accrued and unpaid at the Interest Rate(s) specified in the Eligible Note(s) on the Defaulted Payment and Further Guaranteed Payments, in each case from the date of default with respect to such payment to and including the date on which full payment thereof is made to the Noteholder.

    Note[s] means any debt securities issued by the Borrower.

    Noteholder means the owner of an Eligible Note who is registered as such on the Note Register.

    Note Register means the register of Eligible Notes required to be maintained by the Fiscal Agent.

    Person means any legal person, including any individual, corporation, partnership, joint venture, association, joint stock company, trust, unincorporated organization, or government or any agency or political subdivision thereof.

    Principal Amount means the principal amount of the Eligible Notes issued by the Borrower. For purposes of determining the principal amount of the Eligible Notes issued by the Borrower, the principal amount of each Eligible Note shall be the stated principal amount thereof.

    USAID means the United States Agency for International Development or its successor.

    § 241.3 The Guarantee.

    Subject to the terms and conditions set out in this part, the United States of America, acting through USAID, guarantees to Noteholders the Borrower's repayment of 100% of principal and interest due on Eligible Notes. Under this Guarantee, USAID agrees to pay to any Noteholder compensation in Dollars equal to such Noteholder's Loss of Investment under its Eligible Note; provided, however, that no such payment shall be made to any Noteholder for any such loss arising out of fraud or misrepresentation for which such Noteholder is responsible or of which it had knowledge at the time it became such Noteholder. This Guarantee shall apply to each Eligible Note registered on the Note Register required to be maintained by the Fiscal Agent.

    § 241.4 Guarantee eligibility.

    (a) Eligible Notes only are guaranteed hereunder. Notes in order to achieve Eligible Note status:

    (1) Must be signed on behalf of the Borrower, manually or in facsimile, by a duly authorized representative of the Borrower;

    (2) Must contain a certificate of authentication manually executed by the Fiscal Agent whose appointment by the Borrower is consented to by USAID in the Fiscal Agency Agreement; and

    (3) Shall be approved and authenticated by USAID by either:

    (i) The affixing by USAID on the Notes of a guarantee legend incorporating these Standard Terms and Conditions signed on behalf of USAID by either a manual signature or a facsimile signature of an authorized representative of USAID; or

    (ii) The delivery by USAID to the Fiscal Agent of a guarantee certificate incorporating these Standard Terms and Conditions signed on behalf of USAID by either a manual signature or a facsimile signature of an authorized representative of USAID.

    (b) The authorized USAID representatives for purposes of the regulations in this part whose signature(s) shall be binding on USAID shall include the USAID Chief and Deputy Chief Financial Officer, Assistant Administrator and Deputy, Bureau for the Middle East, Mission Director and Acting Mission Director for USAID/Iraq, and such other individual(s) designated in a certificate executed by an authorized USAID Representative and delivered to the Fiscal Agent. The certificate of authentication of the Fiscal Agent issued pursuant to the Fiscal Agency Agreement shall, when manually executed by the Fiscal Agent, be conclusive evidence binding on USAID that an Eligible Note has been duly executed on behalf of the Borrower and delivered.

    § 241.5 Non-impairment of the Guarantee.

    After issuance of a Guarantee, that Guarantee will be an unconditional, full faith and credit obligation of the United States of America, and will not be affected or impaired by any subsequent condition or event. This non-impairment of the guarantee provision shall not, however, be operative with respect to any loss arising out of fraud or misrepresentation for which the claiming Noteholder is responsible or of which it had knowledge at the time it became a Noteholder. Moreover, the Guarantee shall not be affected or impaired by:

    (a) Any defect in the authorization, execution, delivery or enforceability of any agreement or other document executed by a Noteholder, USAID, the Fiscal Agent or the Borrower in connection with the transactions contemplated by this Guarantee; or

    (b) The suspension or termination of the program pursuant to which USAID is authorized to guarantee the Eligible Notes.

    § 241.6 Transferability of Guarantee; Note Register.

    A Noteholder may assign, transfer or pledge an Eligible Note to any Person, provided that such transfer is permitted under applicable law and regulation, including, without limitation, the Office of Foreign Assets Control (OFAC) regulations. Any such assignment, transfer or pledge shall be effective on the date that the name of the new Noteholder is entered on the Note Register required to be maintained by the Fiscal Agent pursuant to the Fiscal Agency Agreement. USAID shall be entitled to treat the Persons in whose names the Eligible Notes are registered as the owners thereof for all purposes of this Guarantee and USAID shall not be affected by notice to the contrary.

    § 241.7 Fiscal Agent obligations.

    Failure of the Fiscal Agent to perform any of its obligations pursuant to the Fiscal Agency Agreement shall not impair any Noteholder's rights under this Guarantee, but may be the subject of action for damages against the Fiscal Agent by USAID as a result of such failure or neglect. A Noteholder may appoint the Fiscal Agent to make demand for payment on its behalf under this Guarantee.

    § 241.8 Event of Default; Application for Compensation; payment.

    At any time after an Event of Default, as this term is defined in an Eligible Note, any Noteholder hereunder, or the Fiscal Agent on behalf of a Noteholder hereunder, may file with USAID an Application for Compensation in the form provided in Appendix A to this part. USAID shall pay or cause to be paid to any such Applicant any compensation specified in such Application for Compensation that is due to the Applicant pursuant to the Guarantee as a Loss of Investment not later than the Guarantee Payment Date. In the event that USAID receives any other notice of an Event of Default, USAID may pay any compensation that is due to any Noteholder pursuant to a Guarantee, whether or not such Noteholder has filed with USAID an Application for Compensation in respect of such amount.

    § 241.9 No acceleration of Eligible Notes.

    Eligible Notes shall not be subject to acceleration, in whole or in part, by USAID, the Noteholder or any other party. USAID shall not have the right to pay any amounts in respect of the Eligible Notes other than in accordance with the original payment terms of such Eligible Notes.

    § 241.10 Payment to USAID of excess amounts received by a Noteholder.

    If a Noteholder shall, as a result of USAID paying compensation under this Guarantee, receive an excess payment, it shall refund the excess to USAID.

    § 241.11 Subrogation of USAID.

    In the event of payment by USAID to a Noteholder under this Guarantee, USAID shall be subrogated to the extent of such payment to all of the rights of such Noteholder against the Borrower under the related Note.

    § 241.12 Prosecution of claims.

    After payment by USAID to an Applicant hereunder, USAID shall have exclusive power to prosecute all claims related to rights to receive payments under the Eligible Notes to which it is thereby subrogated. If a Noteholder continues to have an interest in the outstanding Eligible Notes, such a Noteholder and USAID shall consult with each other with respect to their respective interests in such Eligible Notes and the manner of and responsibility for prosecuting claims.

    § 241.13 Change in agreements.

    No Noteholder will consent to any change or waiver of any provision of any document contemplated by this Guarantee without the prior written consent of USAID.

    § 241.14 Arbitration.

    Any controversy or claim between USAID and any Noteholder arising out of this Guarantee shall be settled by arbitration to be held in Washington, DC in accordance with the then prevailing rules of the American Arbitration Association, and judgment on the award rendered by the arbitrators may be entered in any court of competent jurisdiction.

    § 241.15 Notice.

    Any communication to USAID pursuant to this Guarantee shall be in writing in the English language, shall refer to the Republic of Iraq Loan Guarantee Number inscribed on the Eligible Note and shall be complete on the day it shall be actually received by USAID at the Office of Development Credit, Bureau for Economic Growth, Education and Environment, United States Agency for International Development, Washington, DC 20523-0030. Other addresses may be substituted for the above upon the giving of notice of such substitution to each Noteholder by first class mail at the address set forth in the Note Register.

    § 241.16 Governing law.

    This Guarantee shall be governed by and construed in accordance with the laws of the United States of America governing contracts and commercial transactions of the United States Government.

    Appendix A to Part 241—Application for Compensation United States Agency for International Development Washington, DC 20523 Ref: Guarantee dated as of ____, 20 __:

    To Whom It May Concern: You are hereby advised that payment of $____ (consisting of ____ of principal, ____ of interest and $____ in Further Guaranteed Payments, as defined in § 241.2 of the Standard Terms and Conditions of the above-mentioned Guarantee) was due on ____, 20_, on $____ Principal Amount of Notes issued by the Republic of Iraq (the “Borrower”) held by the undersigned. Of such amount $____ was not received on such date and has not been received by the undersigned at the date hereof. In accordance with the terms and provisions of the above-mentioned Guarantee, the undersigned hereby applies, under § 241.8 of said Guarantee, for payment of $____, representing $____, the Principal Amount of the presently outstanding Note(s) of the Borrower held by the undersigned that was due and payable on ____ and that remains unpaid, and $____, the Interest Amount on such Note(s) that was due and payable by the Borrower on ____ and that remains unpaid, and $____ in Further Guaranteed Payments,1 plus accrued and unpaid interest thereon from the date of default with respect to such payments to and including the date payment in full is made by you pursuant to said Guarantee, at the rate of __% per annum, being the rate for such interest accrual specified in such Note. Such payment is to be made at [state payment instructions of Noteholder or Fiscal Agent, as applicable].

    1 In the event the Application for Compensation relates to Further Guaranteed Payments, such Application must also contain a statement of the nature and circumstances of the related loss.

    All capitalized terms herein that are not otherwise defined shall have the meanings assigned to such terms in the Standard Terms and Conditions of the above-mentioned Guarantee.

    [Name of Applicant] By: Name: Title: Dated:
    Dated: January 5, 2017. D. Bruce McPherson, Attorney Advisor, Office of the General Counsel, U.S. Agency for International Development.
    [FR Doc. 2017-00294 Filed 1-6-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF LABOR Office of the Secretary 29 CFR Parts 1, 3, 4, 5, and 6 Wage and Hour Division 29 CFR Parts 500, 505, 516, 519, 520, 525, 530, 547, 549, 553, 570, 575, 578, 580, 801, and 825 RIN 1235-AA17 Updating Regulations Issued Under the Fair Labor Standards Act, Service Contract Act, Davis-Bacon and Related Acts, Contract Work Hours and Safety Standards Act, the Family and Medical Leave Act, Employee Polygraph Protection Act, and the Migrant and Seasonal Agricultural Worker Protection Act AGENCY:

    Wage and Hour Division, Department of Labor.

    ACTION:

    Final rule; technical corrections.

    SUMMARY:

    In this final rule, the Department of Labor (DOL or Department) revises regulations issued pursuant to the Fair Labor Standards Act of 1938 (FLSA), the Davis-Bacon and Related Acts (DBRA), the Service Contract Act (SCA), Contract Work Hours and Safety Standards Act (CWHSSA), Family and Medical Leave Act (FMLA), Employee Polygraph Protection Act (EPPA), and the Migrant and Seasonal Agricultural Worker Protection Act (MSPA) that include reference to the “Employment Standards Administration” at the DOL. The Employment Standards Administration was eliminated as part of agency reorganization in 2009 and its authorities and responsibilities were devolved into its constituent components, including the Wage and Hour Division (WHD). This action deletes reference to the Employment Standards Administration in the regulations administered by WHD. Additionally, this action updates Office of Management and Budget (OMB) control numbers associated with information collections in the appropriate regulations. WHD was assigned new control numbers by OMB and this action updates those references in the regulations to the current corresponding OMB control number. Further, this action updates cross-references that were not revised in the FMLA Final Rule published February 25, 2015.

    DATES:

    Effective January 9, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Robert Waterman, Compliance Specialist, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW., Washington, DC 20210, telephone: (202) 693-0406 (this is not a toll-free number) or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Department is eliminating references to the Employment Standards Administration at the DOL. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009. In addition, the Department is updating references to OMB information collection control numbers. OMB has assigned different information collection control numbers to WHD information collections and the Department is updating these references in the appropriate regulations so the reader can find the information collection corresponding to a specific regulation.

    The Department is also correcting cross-references to the FMLA's definitions section in two sections of its FMLA regulations, § 825.104(b) and § 825.209(a). A recent rulemaking moved the definitions section of the FMLA regulations from § 825.800 to § 825.102 but did not update the cross-references to the definitions section in § 825.104(b) and § 825.209(a). Additionally, the Department is updating the reference in 29 CFR 3.3 to the Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed. Finally, the Department is replacing the term firefighter with the term employee engaged in fire protection activities in two sections of its regulations, 29 CFR 553.221 and 553.231, to conform to an amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities. The Department published an FLSA Final Rule on April 5, 2011 (76 FR 18832) that incorporated the new definition into the regulations and made several conforming revisions in part 553, subpart C, but did not conform the language of these provisions.

    Administrative Procedure Act

    Section 553(b)(3) of the Administrative Procedure Act (APA) provides that an agency is not required to publish a notice of proposed rulemaking in the Federal Register and solicit public comments when the agency has good cause to find that doing so would be “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3). The Department finds that good cause exists to dispense with the notice and public comment procedures for this technical correction to its regulations, as it concludes that such procedures are unnecessary. This rule merely memorializes the delegation of administrative authority within the Department; updates references to OMB control numbers and WHD's Web site which are now out of date; corrects cross-references to another section of the Department's regulations; and conforms the terminology in the Department's regulations to an amendment to the definitions section of the FLSA. This rule does not impose any new regulatory obligations or information collection requirements on employers or affect the rights of workers. Therefore, the Department is issuing this technical correction as a final rule.

    Section 553(d) of the APA also provides that substantive rules should take effect not less than 30 days after the date they are published in the Federal Register unless “otherwise provided by the agency for good cause found[.]” 5 U.S.C. 553(d)(3). Since this rule is a technical correction that does not change the substance of the Department's regulations, the Department finds that it is unnecessary to delay the effective date of the rule. Accordingly, the Department finds that it has good cause exists to make this technical correction effective on the date of publication.

    Summary of Changes to the Regulations

    In 29 CFR 1.2, 1.5, 4.1a, 4.3, 4.5, 4.6, 4.10, 4.11, 4.12, 4.101, 4.191, 5.2, 5.12, 5.13, 6.2, 500.7, 500.20, 500.41, 500.56, 500.215, 505.2, 520.300, 525.22, 530.1, 530.101, 530.102, 530.403, 570.1, 575.2, 575.3, 578.2, 580.1, 801.2, 801.7, and 825.401, the Department has removed the reference to the Employment Standards Administration and replaced it with the Wage and Hour Division where appropriate. In 29 CFR 519.11, the Department has removed the reference to the Assistant Secretary for Employment Standards. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009. See Secretary's Order No. 09-2009 (Nov. 6, 2009), 74 FR 58836 (Nov. 13, 2009). In 29 CFR 5.5, the Department has removed the reference to the Employment Standards Administration and made two additional technical corrections: Correcting an error made in the instructions to the Final Rule issued under the DBRA in 2000 (65 FR 69674) that resulted in the retention of an editorial note referencing a 1993 suspension of paragraph (a)(1)(ii) that should have been removed at that time; and incorporating the undesignated language that follows paragraph (a)(1)(i) into that paragraph.

    In 29 CFR 3.3, the Department has updated the referenced Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed.

    In 29 CFR 3.4, 5.15, 505.5, 520.403, 520.405, 520.501, 520.502, 525.16, 530.3, 530.4, 547.1, 549.1, 570.6, 570.36, 570.37 and 801.30, the Department has updated the OMB control number where the public may access the relevant information collection approved by OMB under the Paperwork Reduction Act. In 29 CFR 4.6, 5.5 and 516.0, the Department has provided updated information collection requests tables showing the current OMB control numbers associated with the referenced recordkeeping requirements. OMB changed the agency information collection control numbers. The correction will allow the public to access the currently approved information collection.

    In 29 CFR 553.221 and 553.231, the Department has replaced references to firefighters with references to employees engaged in fire protection activities to conform to a recent amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities. See Public Law 106-151, Sec. 1, 113 Stat 1731 (Dec. 9, 1999). The Department published an FLSA Final Rule on April 5, 2011 (76 FR 18832) that incorporated the new definition into the regulations and made several conforming revisions in part 553, subpart C, but did not conform the language of these provisions.

    In 29 CFR 825.104 and 825.209, the Department has corrected cross-references to the definitions section of the FMLA regulations. On February 6, 2013, the Department published a final rule under the FMLA. In that rule, the Department moved the FMLA definitions section from the end of the regulations in § 825.800 to the front of the regulations in § 825.102. However, the Department did not update the cross-references to the definitions section in §§ 825.104 and 825.109. The Department is making this correction so the reader may easily locate the definitions section of the regulations currently located in § 825.102.

    Executive Orders 12866 and 13563; Small Business Regulatory Enforcement Fairness Act; Regulatory Flexibility

    This rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulations. The agency has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, there is no requirement for an assessment of potential costs and benefits under section 6(a)(3) of that order.

    This action is not classified as a “rule” under Chapter 8 of the Small Business Regulatory Enforcement Fairness Act of 1996, because it is pertaining to agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties. See 5 U.S.C. 804(3)(C).

    Because no notice of proposed rulemaking is required for this rule under section 553(b) of the Administrative Procedure Act (APA), the requirements of the Regulatory Flexibility Act (5 U.S.C. 601) pertaining to regulatory flexibility do not apply to this rule. See 5 U.S.C. 601(2).

    Paperwork Reduction Act

    This final rule is not subject to section 350(h) of the Paperwork Reduction Act (44 U.S.C. 3501) since it does not contain any new collection of information requirements. The final rule does, however, update the information collection control numbers assigned by OMB to allow the reader to locate the collections where referenced in the regulations. The information collections referenced herein are not subject to OMB review as they do not amend information collection requirements.

    Unfunded Mandates Reform Act

    This Final Rule has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA). 2 U.S.C. 1501 et seq. For the purposes of the UMRA, this rule does not impose any Federal mandate that may result in increased expenditures by State, local or Tribal governments, or increased expenditures by the private sector, of more than $100 million in any year.

    Executive Order 13132 (Federalism)

    The Department has reviewed this rule in accordance with the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This rule does not have federalism implications as outlined in E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

    Executive Order 13175, Indian Tribal Governments

    The Department has reviewed this rule under the terms of Executive Order 13175 (65 FR 67249, November 6, 2000) and determined it did not have “tribal implications.” The rule does not have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” As a result, no Tribal summary impact statement has been prepared.

    Effects on Families

    The Department certifies that this rule will not adversely affect the well-being of families, as discussed under section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277).

    Executive Order 13045, Protection of Children

    The Department has reviewed this rule under the terms of Executive Order 13045 (62 FR 19885, April 21, 1997, as amended by 68 FR 19931, April 18, 2003) and determined this action is not subject to E.O. 13045 because it is not economically significant as defined in E.O. 12866 and it does not impact the environmental health or safety risks of children.

    Environmental Impact Assessment

    The Department has reviewed this rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq., the regulations of the Council of Environmental Quality, 40 CFR 1500.1 et seq., and the Departmental NEPA procedures, 29 CFR part 11, and determined that this rule will not have a significant impact on the quality of the human environment. There is, therefore, no corresponding environmental assessment or an environmental impact statement.

    Executive Order 13211, Energy Supply

    The Department has determined that this rule is not subject to Executive Order 13211 (66 FR 28355, May 18, 2001). It will not have a significant adverse effect on the supply, distribution, or use of energy.

    Executive Order 12630, Constitutionally Protected Property Rights

    The Department has determined that this rule is not subject to Executive Order 12630 (53 FR 8859, March 15, 1988) because it does not involve implementation of a policy “that has taking implications” or that could impose limitations on private property use.

    Executive Order 12988, Civil Justice Reform Analysis

    The Department drafted and reviewed this Final Rule in accordance with Executive Order 12988 (61 FR 4729, February 5, 1996) and determined that the rule will not unduly burden the Federal court system. The rule was: (1) Reviewed to eliminate drafting errors and ambiguities; (2) written to minimize litigation; and (3) written to provide a clear legal standard for affected conduct and to promote burden reduction.

    List of Subjects 29 CFR Part 1

    Administrative practice and procedure, Construction industry, Government contracts, Minimum wages.

    29 CFR Part 3

    Community facilities, Construction industry, Federal buildings and facilities, Government contracts, Grant programs, Loan programs, Minimum wages, Reporting and recordkeeping requirements.

    29 CFR Part 4

    Administrative practice and procedure, Employee benefit plans, Government contracts, Law enforcement, Minimum wages, Occupational safety and health, Reporting and recordkeeping requirements.

    29 CFR Part 5

    Administrative practice and procedure, Construction industry, Employee benefit plans, Government contracts, Law enforcement, Minimum wages, Reporting and recordkeeping requirements.

    29 CFR Part 6

    Administrative practice and procedure, Construction industry, Employee benefit plans, Government contracts, Minimum wages, Occupational safety and health.

    29 CFR Part 500

    Administrative practice and procedure, Aliens, Housing, Insurance, Intergovernmental relations, Investigations, Migrant labor, Motor vehicle safety, Occupational safety and health, Reporting and recordkeeping requirements, Wages.

    29 CFR Part 505

    Arts and crafts, Grant programs—education, Minimum wages, National Foundation on Arts and Humanities, Occupational safety and health, Reporting and recordkeeping requirements.

    29 CFR Part 516

    Minimum wages, Reporting and recordkeeping requirements, Wages.

    29 CFR Part 519

    Agriculture, Colleges and universities, Minimum wages, Students, Reporting and recordkeeping requirements.

    29 CFR Part 520

    Manpower training programs, Minimum wages, Reporting and recordkeeping requirements, Students.

    29 CFR Part 525

    Administrative practice and procedure, Individuals with disabilities, Minimum wages, Reporting and recordkeeping requirements, Vocational rehabilitation.

    29 CFR Part 530

    Administrative practice and procedure, Clothing, Homeworkers, Indian—arts and crafts, Penalties, Reporting and recordkeeping requirements, Surety bonds, Watches and jewelry.

    29 CFR Part 547

    Employee benefit plans, Reporting and recordkeeping requirements.

    29 CFR Part 549

    Employee benefit plans, Reporting and recordkeeping requirements, Trusts and trustees.

    29 CFR Part 553

    Firefighters, Government employees, Intergovernmental relations, Law enforcement officers, Prisons, Reporting and recordkeeping requirements, Volunteers, Wages.

    29 CFR Part 570

    Administrative practice and procedure, Agriculture, Child labor, Intergovernmental relations, Occupational safety and health, Reporting and recordkeeping requirements.

    29 CFR Part 575

    Agriculture, Child labor, Reporting and recordkeeping requirements.

    29 CFR Part 578

    Penalties, Wages.

    29 CFR Part 580

    Administrative practice and procedure, Child labor, Penalties, Wages.

    29 CFR Part 801

    Administrative practice and procedure, Employment, Lie detector tests, Penalties, Reporting and recordkeeping requirements.

    29 CFR Part 825

    Administrative practice and procedure, Airmen, Employee benefit plans, Health insurance, Health, Labor management relations, Maternal and child health, Penalties, Reporting and recordkeeping requirements, Teachers.

    Dated: December 20, 2016. David Weil, Wage and Hour Administrator. For the reasons set forth above, the Department of Labor amends title 29, parts 1, 3, 4, 5, 6, 500, 505, 516, 519, 520, 525, 530, 547, 549, 553, 570, 575, 578, 580, 801, and 825 of the Code of Federal Regulations as follows: PART 1—PROCEDURES FOR PRE-DETERMINATION OF WAGE RATES 1. The authority citation for part 1 continues to read as follows: Authority:

    5 U.S.C. 301; R.S. 161, 64 Stat. 1267; Reorganization Plan No. 14 of 1950, 5 U.S.C. appendix; 40 U.S.C. 3141 et seq.; 40 U.S.C. 3145; 40 U.S.C. 3148; and the laws listed in appendix A of this part.

    2. In § 1.2, revise paragraph (c) to read as follows:
    § 1.2 Definitions.1

    1 These definitions are not intended to restrict the meaning of the terms as used in the applicable statutes.

    (c) The term Administrator shall mean the Administrator of the Wage and Hour Division, U.S. Department of Labor, or authorized representative.

    3. In § 1.5, revise paragraph (b)(1) to read as follows:
    § 1.5 Procedure for requesting wage determinations.

    (b)(1) If a general wage determination is not available, the Federal agency shall request a wage determination under the Davis-Bacon Act or any of its related prevailing wage statutes by submitting Form SF-308 to the Department of Labor at this address: U.S. Department of Labor, Wage and Hour Division, Branch of Government Construction Contract Wage Determination, Washington, DC 20210. In preparing Form SF-308, the agency shall check only those classifications that will be needed in the performance of the work. Inserting a note such as “entire schedule” or “all applicable classifications” is not sufficient. Additional classifications needed that are not on the form may be typed in the blank spaces or on a separate list and attached to the form.

    PART 3—CONTRACTORS AND SUBCONTRACTORS ON PUBLIC BUILDING OR PUBLIC WORK FINANCED IN WHOLE OR IN PART BY LOANS OR GRANTS FROM THE UNITED STATES 4. The authority citation for part 3 is revised to read as follows: Authority:

    R.S. 161, sec. 2, 48 Stat. 848; Reorg. Plan No. 14 of 1950, 64 Stat. 1267; 5 U.S.C. 301; 40 U.S.C. 3145; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014).

    5. In § 3.3, revise paragraph (b) to read as follows:
    § 3.3 Weekly statement with respect to payment of wages.

    (b) Each contractor or subcontractor engaged in the construction, prosecution, completion, or repair of any public building or public work, or building or work financed in whole or in part by loans or grants from the United States, shall furnish each week a statement with respect to the wages paid each of its employees engaged on work covered by this part 3 and part 5 of this title during the preceding weekly payroll period. This statement shall be executed by the contractor or subcontractor or by an authorized officer or employee of the contractor or subcontractor who supervises the payment of wages, and shall be on the back of Form WH 347, “Payroll (For Contractors Optional Use)” or on any form with identical wording. Copies of WH 347 may be obtained from the Government contracting or sponsoring agency or from the Wage and Hour Division Web site at http://www.dol.gov/whd/forms/index.htm or its successor site.

    6. In § 3.4, revise the parenthetical at the end of section to read as follows:
    § 3.4 Submission of weekly statements and the preservation and inspection of weekly payroll records. (Reporting and recordkeeping requirements in paragraph (b) have been approved by the Office of Management and Budget under control number 1235-0008).
    PART 4—LABOR STANDARDS FOR FEDERAL SERVICE CONTRACTS 7. The authority citation for part 4 is revised to read as follows: Authority:

    41 U.S.C. 351 et seq.; 41 U.S.C. 38 and 39; 5 U.S.C. 301; Pub. L. 104-188, 2105(b); Pub. L. 110-28, 121 Stat. 112; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014).

    8. In § 4.1a, revise paragraphs (b) and (c) to read as follows:
    § 4.1a Definitions and use of terms.

    (b) Secretary includes the Secretary of Labor or their authorized representative.

    (c) Wage and Hour Division means the organizational unit of the Department of Labor to which is assigned the performance of functions of the Secretary under the Service Contract Act of 1965, as amended.

    9. In § 4.3, revise paragraph (e) to read as follows:
    § 4.3 Wage determinations.

    (e) Wage determinations will be available for public inspection during business hours at the Wage and Hour Division, U.S. Department of Labor, Washington, DC, and copies will be made available upon request at Regional Offices of the Wage and Hour Division. In addition, most prevailing wage determinations are available online from WDOL. Archived versions of SCA wage determinations that are no longer current may be accessed in the “Archived SCA WD” database of WDOL for information purposes only. Contracting officers should not use an archived wage determination in a contract action without prior approval of the Department of Labor.

    10. In § 4.5, revise paragraph (a)(1) to read as follows:
    § 4.5 Contract specifications of determined minimum wages and fringe benefits.

    (a) * * *

    (1) Any wage determination from the Wage and Hour Division, Department of Labor, responsive to the contracting agency's submission of an e98 or obtained through WDOL under § 4.4; or

    11. In § 4.6, revise paragraphs (b)(2)(ii) and (b)(3), the first sentence in paragraph (g)(1), and the table in paragraph (r) to read as follows:
    § 4.6 Labor standards clauses for Federal service contracts exceeding $2,500.

    (b) * * *

    (2) * * *

    (ii) Such conforming procedure shall be initiated by the contractor prior to the performance of contract work by such unlisted class of employee. A written report of the proposed conforming action, including information regarding the agreement or disagreement of the authorized representative of the employees involved or, where there is no authorized representative, the employees themselves, shall be submitted by the contractor to the contracting officer no later than 30 days after such unlisted class of employees performs any contract work. The contracting officer shall review the proposed action and promptly submit a report of the action, together with the agency's recommendation and all pertinent information including the position of the contractor and the employees, to the Wage and Hour Division, U.S. Department of Labor, for review. The Wage and Hour Division will approve, modify, or disapprove the action or render a final determination in the event of disagreement within 30 days of receipt or will notify the contracting officer within 30 days of receipt that additional time is necessary.

    (3) If, as authorized pursuant to section 4(d) of the Service Contract Act of 1965 as amended, the term of this contract is more than 1 year, the minimum monetary wages and fringe benefits required to be paid or furnished thereunder to service employees shall be subject to adjustment after 1 year and not less often than once every 2 years, pursuant to wage determinations to be issued by the Wage and Hour Division of the Department of Labor as provided in such Act.

    (g)(1) The contractor and each subcontractor performing work subject to the Act shall make and maintain for 3 years from the completion of the work records containing the information specified in paragraphs (g)(1)(i) through (vi) of this section for each employee subject to the Act and shall make them available for inspection and transcription by authorized representatives of the Wage and Hour Division of the U.S. Department of Labor: * * *

    (r) * * *

    Paragraph OMB
  • Control No.
  • (b)(2)(i)-(iv) 1235-0007 (e) 1235-0007 (g)(1)(i)-(iv) 1235-0007 1235-0018 (g)(1)(v)-(vi) 1235-0007 (l)(1), (2) 1235-0007 (q)(3) 1235-0007
    12. In § 4.10, revise paragraph (b)(1)(i) introductory text to read as follows:
    § 4.10 Substantial variance proceedings under section 4(c) of the Act.

    (b) * * *

    (1)(i) A request for a hearing under this section may be made by the contracting agency or other person affected or interested, including contractors or prospective contractors and associations of contractors, representatives of employees, and other interested Governmental agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and shall include the following:

    13. In § 4.11, revise the second sentence of paragraph (b)(1) introductory text to read as follows:
    § 4.11 Arm's length proceedings.

    (b) * * *

    (1) * * * Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210. * * *

    14. In § 4.12, revise paragraph (c)(1) to read as follows:
    § 4.12 Substantial interest proceedings.

    (c)(1) A request for a determination under this section may be made by any interested party, including contractors or prospective contractors, and associations of contractors, representatives of employees, and interested Government agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.

    15. In § 4.101, revise paragraph (g) to read as follows:
    § 4.101 Official rulings and interpretations in this subpart.

    (g) It should not be assumed that the lack of discussion of a particular subject in this subpart indicates the adoption of any particular position by the Department of Labor with respect to such matter or to constitute an interpretation, practice, or enforcement policy. If doubt arises or a question exists, inquiries with respect to matters other than safety and health standards should be directed to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, or any regional office of the Wage and Hour Division. Safety and health inquiries should be addressed to the Assistant Secretary for Occupational Safety and Health, U.S. Department of Labor, Washington, DC 20210, or to any OSHA regional office. A full description of the facts and any relevant documents should be submitted if an official ruling is desired.

    16. In § 4.191, revise paragraph (d) to read as follows:
    § 4.191 Complaints and compliance assistance.

    (d) In the event that an Assistant Regional Administrator for the Wage and Hour Division, is notified of a breach or violation which also involves safety and health standards, the Regional Administrator of the Wage and Hour Division shall notify the appropriate Regional Administrator of the Occupational Safety and Health Administration who shall with respect to the safety and health violations take action commensurate with his responsibilities pertaining to safety and health standards.

    PART 5—LABOR STANDARDS PROVISIONS APPLICABLE TO CONTRACTS COVERING FEDERALLY FINANCED AND ASSISTED CONSTRUCTION (ALSO LABOR STANDARDS PROVISIONS APPLICABLE TO NONCONSTRUCTION CONTRACTS SUBJECT TO THE CONTRACT WORK HOURS AND SAFETY STANDARDS ACT 17. The authority citation for part 5 continues to read as follows: Authority:

    5 U.S.C. 301; R.S. 161, 64 Stat. 1267; Reorganization Plan No. 14 of 1950, 5 U.S.C. appendix; 40 U.S.C. 3141 et seq.; 40 U.S.C. 3145; 40 U.S.C. 3148; 40 U.S.C. 3701 et seq.; and the laws listed in 5.1(a) of this part; Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at § 701, 129 Stat 584.

    18. In § 5.2, revise paragraph (b) to read as follows:
    § 5.2 Definitions.

    (b) The term Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, or authorized representative.

    19. In § 5.5, lift the suspension and revise paragraphs (a)(1)(i) and (a)(1)(ii)(B) to read as follows:
    § 5.5 Contract provisions and related matters.

    (a) * * *

    (1) * * *

    (i) All laborers and mechanics employed or working upon the site of the work (or under the United States Housing Act of 1937 or under the Housing Act of 1949 in the construction or development of the project), will be paid unconditionally and not less often than once a week, and without subsequent deduction or rebate on any account (except such payroll deductions as are permitted by regulations issued by the Secretary of Labor under the Copeland Act (29 CFR part 3)), the full amount of wages and bona fide fringe benefits (or cash equivalents thereof) due at time of payment computed at rates not less than those contained in the wage determination of the Secretary of Labor which is attached hereto and made a part hereof, regardless of any contractual relationship which may be alleged to exist between the contractor and such laborers and mechanics. Contributions made or costs reasonably anticipated for bona fide fringe benefits under section 1(b)(2) of the Davis-Bacon Act on behalf of laborers or mechanics are considered wages paid to such laborers or mechanics, subject to the provisions of paragraph (a)(1)(iv) of this section; also, regular contributions made or costs incurred for more than a weekly period (but not less often than quarterly) under plans, funds, or programs which cover the particular weekly period, are deemed to be constructively made or incurred during such weekly period. Such laborers and mechanics shall be paid the appropriate wage rate and fringe benefits on the wage determination for the classification of work actually performed, without regard to skill, except as provided in § 5.5(a)(4). Laborers or mechanics performing work in more than one classification may be compensated at the rate specified for each classification for the time actually worked therein: Provided, That the employer's payroll records accurately set forth the time spent in each classification in which work is performed. The wage determination (including any additional classification and wage rates conformed under paragraph (a)(1)(ii) of this section) and the Davis-Bacon poster (WH-1321) shall be posted at all times by the contractor and its subcontractors at the site of the work in a prominent and accessible place where it can be easily seen by the workers.

    (ii) * * *

    (B) If the contractor and the laborers and mechanics to be employed in the classification (if known), or their representatives, and the contracting officer agree on the classification and wage rate (including the amount designated for fringe benefits where appropriate), a report of the action taken shall be sent by the contracting officer to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210. The Administrator, or an authorized representative, will approve, modify, or disapprove every additional classification action within 30 days of receipt and so advise the contracting officer or will notify the contracting officer within the 30-day period that additional time is necessary.

    20. In § 5.5, revise the table following paragraph (c) to read as follows:

    (c) * * *

    Paragraph OMB
  • Control No.
  • (a)(1)(ii)(B) 1235-0023 (a)(1)(ii)(C) 1235-0023 (a)(1)(iv) 1235-0023 (a)(3)(i) 1235-0023 (a)(3)(ii)(A) 1235-0023 1235-0008 (c) 1235-0023
    21. In § 5.12, revise paragraphs (c) and (d)(3)(i) to read as follows:
    § 5.12 Debarment proceedings.

    (c) Any person or firm debarred under paragraph (a)(1) of this section may in writing request removal from the debarment list after six months from the date of publication by the Comptroller General of such person or firm's name on the ineligible list. Such a request should be directed to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and shall contain a full explanation of the reasons why such person or firm should be removed from the ineligible list. In cases where the contractor or subcontractor failed to make full restitution to all underpaid employees, a request for removal will not be considered until such underpayments are made. In all other cases, the Administrator will examine the facts and circumstances surrounding the violative practices which caused the debarment, and issue a decision as to whether or not such person or firm has demonstrated a current responsibility to comply with the labor standards provisions of the statutes listed in § 5.1, and therefore should be removed from the ineligible list. Among the factors to be considered in reaching such a decision are the severity of the violations, the contractor or subcontractor's attitude towards compliance, and the past compliance history of the firm. In no case will such removal be effected unless the Administrator determines after an investigation that such person or firm is in compliance with the labor standards provisions applicable to Federal contracts and Federally assisted construction work subject to any of the applicable statutes listed in § 5.1 and other labor statutes providing wage protection, such as the Service Contract Act, the Walsh-Healey Public Contracts Act, and the Fair Labor Standards Act. If the request for removal is denied, the person or firm may petition for review by the Administrative Review Board pursuant to 29 CFR part 7.

    (d) * * *

    (3)(i) A request for a determination of interest (or substantial interest, as appropriate), may be made by any interested party, including contractors or prospective contractors and associations of contractor's representatives of employees, and interested Government agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.

    22. Revise § 5.13 to read as follows:
    § 5.13 Rulings and interpretations.

    All questions relating to the application and interpretation of wage determinations (including the classifications therein) issued pursuant to part 1 of this subtitle, of the rules contained in this part and in parts 1 and 3, and of the labor standards provisions of any of the statutes listed in § 5.1 shall be referred to the Administrator for appropriate ruling or interpretation. The rulings and interpretations shall be authoritative and those under the Davis-Bacon Act may be relied upon as provided for in section 10 of the Portal-to-Portal Act of 1947 (29 U.S.C. 259). Requests for such rulings and interpretations should be addressed to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.

    23. In § 5.15, revise the parenthetical at the end of the section to read as follows:
    § 5.15 Limitations, variations, tolerances, and exemptions under the Contract Work Hours and Safety Standards Act. (Reporting and recordkeeping requirements in paragraph (d)(2) have been approved by the Office of Management and Budget under control numbers 1235-0023 and 1235-0018. Reporting and recordkeeping requirements in paragraph (d)(3)(ii) have been approved by the Office of Management and Budget under control number 1235-0018).
    PART 6—RULES OF PRACTICE FOR ADMINISTRATIVE PROCEEDINGS ENFORCING LABOR STANDARDS IN FEDERAL AND FEDERALLY ASSISTED CONSTRUCTION CONTRACTS AND FEDERAL SERVICE CONTRACTS 24. The authority citation for part 6 continues to read as follows: Authority:

    Secs. 4 and 5, 79 Stat. 1034, 1035 as amended by 86 Stat. 789, 790, 41 U.S.C. 353 and 354; 5 U.S.C. 301; Reorg. Plan No. 14 of 1950, 64 Stat. 1267, 5 U.S.C. Appendix; 46 Stat. 1494, as amended by 49 Stat. 1011, 78 Stat. 238, 40 U.S.C. 276a-276a-7; 76 Stat. 357-359, 40 U.S.C. 327-332; 48 Stat. 948, as amended by 63 Stat. 108, 72 Stat. 967, 40 U.S.C. 276c.

    25. In § 6.2, revise paragraph (a) to read as follows:
    § 6.2 Definitions.

    (a) Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, or authorized representative.

    PART 500—MIGRANT AND SEASONAL AGRICULTURAL WORKER PROTECTION 26. The authority citation for part 500 continues to read as follows: Authority:

    Pub. L. 97-470, 96 Stat. 2583 (29 U.S.C. 1801-1872); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 28 U.S.C. 2461 Note (Federal Civil Penalties Inflation Adjustment Act of 1990); and Pub. L. 114-74, 129 Stat 584.

    27. In § 500.7, revise paragraph (c) to read as follows:
    § 500.7 Investigation authority of the Secretary.

    (c) Any person may report a violation of the Act or these regulations to the Secretary by advising any local office of the Employment Service of the various States, or any office of the Wage and Hour Division, U.S. Department of Labor, or any other authorized representative of the Administrator. The office or person receiving such a report shall refer it to the appropriate office of the Wage and Hour Division, for the region or area in which the reported violation is alleged to have occurred.

    28. In § 500.20, revise paragraph (a) to read as follows:
    § 500.20 Definitions.

    (a) Administrator means the Administrator of the Wage and Hour Division, United States Department of Labor, and such authorized representatives as may be designated by the Administrator to perform any of the functions of the Administrator under this part.

    29. In § 500.41, revise paragraph (b) to read as follows:
    § 500.41 Farm labor contractor is responsible for actions of his farm labor contractor employee.

    (b) Farm Labor Contractor Employee Certificate of Registration is valid only during the period in which the holder is an employee of the registered farm labor contractor named on the Farm Labor Contractor Employee Certificate. If prior to the expiration of the Employee Certificate, the holder through a change in employment, should become an employee of a different registered farm labor contractor, a replacements Employee Certificate which names the new employer may be obtained by submitting to the regional office that issued the original employee certificate or to any regional office of the Wage and Hour Division, a written statement that includes the date of the change in employment status and the name, the permanent place of residence and certificate registration number of the new employer. Any such change should be reported immediately.

    30. Revise § 500.56 to read as follows:
    § 500.56 Replacement of Certificate of Registration or Farm Labor Contractor Employee Certificate.

    If a Certificate of Registration or a Farm Labor Contractor Employee Certificate is lost or destroyed, a duplicate certificate may be obtained by the submission to the regional office that issued it or to any regional office of the Wage and Hour Division, of a written statement explaining its loss or destruction, indicating where the original application was filed and requesting that a duplicate be issued.

    31. In § 500.215, revise paragraph (b) to read as follows:
    § 500.215 Change of address.

    (b) The notification required in paragraph (a) of this section shall be in writing, by certified mail and addressed to the Administrator, Wage and Hour Division, 200 Constitution Avenue NW, Washington, DC 20210.

    PART 505—LABOR STANDARDS ON PROJECTS OR PRODUCTIONS ASSISTED BY GRANTS FROM THE NATIONAL ENDOWMENT FOR THE ARTS AND HUMANITIES 32. The authority citation for part 505 is revised to read as follows: Authority:

    Sec. 5(j), Pub. L. 89-209, 79 Stat. 848 (20 U.S.C. 954(i)); sec. 7(g), Pub. L. 94-462, 90 Stat. 1971, as amended by sec. 107(4), Pub. L. 99-194, 99 Stat. 1337 (20 U.S.C. 956(g)); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); Secretary's Order 01-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012).

    33. In § 505.2, revise paragraph (c) to read as follows:
    § 505.2 Definitions.

    (c) The term Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, or authorized representative, to whom is assigned the performance of functions of the Secretary pertaining to wages under the National Foundation on the Arts and the Humanities Act of 1965, as amended.

    34. In § 505.5, revise the parenthetical at the end of the section to read as follows:
    § 505.5 Adequate assurances. (The requirements in paragraph (b) were approved by the Office of Management and Budget under control number 1235-0018).
    PART 516—RECORDS TO BE KEPT BY EMPLOYERS 35. The authority citation for part 516 continues to read as follows: Authority:

    Sec. 11, 52 Stat. 1066, as amended, 29 U.S.C. 211. Section 516.28 also issued under Pub. L. 104-188, 2105(b); Pub. L. 110-28, 121 Stat. 112. Section 516.33 also issued under 52 Stat. 1060, as amended; 29 U.S.C. 201 et seq. Section 516.34 also issued under Sec. 7, 103 Stat. 944, 29 U.S.C. 207(q).

    36. Revise § 516.0 to read as follows: Subpart or section where
  • information collection
  • requirement is located
  • Currently
  • assigned
  • OMB Control
  • No.
  • Subpart A 1235-0018 Subpart B 1235-0018 516.31 also discussed in 1235-0001
    PART 519—EMPLOYMENT OF FULL-TIME STUDENTS AT SUBMINIMUM WAGES 37. The authority citation for part 519 continues to read as follows: Authority:

    Secs. 11 and 14, 52 Stat. 1068; sec. 11, 75 Stat. 74; secs. 501 and 602, 80 Stat. 843, 844 (29 U.S.C. 211, 214).

    38. In § 519.11, revise the first sentence of paragraph (a) to read as follows:
    § 519.11 Applicability of the regulations in this subpart.

    (a) Statutory provisions. Under section 14 of the Fair Labor Standards Act of 1938, as amended, and the authority and responsibility delegated to him/her by the Secretary of Labor (36 FR 8755), the Administrator of the Wage and Hour Division is authorized and directed, to the extent necessary in order to prevent curtailment of employment opportunities for employment, to provide by regulation or order for the employment, under certificates, of full-time students in institutions of higher education. * * *

    PART 520—EMPLOYMENT UNDER SPECIAL CERTIFICATE OF MESSENGERS, LEARNERS, (INCLUDING STUDENT-LEARNERS), AND APPRENTICES 39. The authority citation for part 520 continues to read as follows: Authority:

    Sec. 14, 52 Stat. 1062, 1064 (29 U.S.C. 214); secs. 2-12, 60 Stat. 237-244; (5 U.S.C. 1001-1011); 52 Stat. 1068, as amended, 29 U.S.C. 214.

    40. Amend § 520.300 by revising the definitions of “Administrator” and “Wage and Hour Division” to read as follows:
    § 520.300 Definitions.

    Administrator means the Administrator of the Wage and Hour Division, United States Department of Labor, or his/her authorized representative.

    Wage and Hour Division means the Wage and Hour Division, United States Department of Labor.

    41. In § 520.403, revise the parenthetical at end of section to read as follows:
    § 520.403 What information is required when applying for authority to pay less than the minimum wage? (The information collection requirements contained in paragraphs (a), (b), and (c) were approved by the Office of Management and Budget under control number 1235-0001).
    42. In § 520.405, revise the parenthetical at the end of section to read as follows:
    § 520.405 Must I notify my employees that I am applying for a certificate to employ messengers and/or learners at subminimum wages? (The information collection requirements contained herein were approved by the Office of Management and Budget under control number 1235-0001).
    43. In § 520.501, revise the parenthetical at end of section to read as follows:
    § 520.501 How do I obtain authority to employ student-learners at subminimum wages? (The information collection requirements contained in paragraph (b) were approved by the Office of Management and Budget under control number 1235-0001).
    44. In § 520.502, revise parenthetical at end of section to read as follows:
    § 520.502 What information must an application to employ student-learners at subminimum wages contain? (The information collection requirements in paragraphs (a), (b), (c), (d), (e), (f), (g), (h), and (i) were approved by the Office of Management and Budget under control number 1235-0001).
    PART 525—EMPLOYMENT OF WORKERS WITH DISABILITIES UNDER SPECIAL CERTIFICATES 45. The authority citation for part 525 continues to read as follows: Authority:

    52 Stat. 1060, as amended (29 U.S.C. 201-219); Pub. L. 99-486, 100 Stat. 1229 (29 U.S.C. 214).

    46. In § 525.16, revise the parenthetical at the end of section to read as follows:
    § 525.16 Records to be kept by employers. (Approved by the Office of Management and Budget under control number 1235-0001).
    47. In § 525.22, revise paragraph (a) to read as follows:
    § 525.22 Employee's right to petition.

    (a) Any employee receiving a special minimum wage at a rate specified pursuant to subsection 14(c) of FLSA or the parent or guardian of such an employee may petition the Secretary to obtain a review of such special minimum wage rate. No particular form of petition is required, except that a petition must be signed by the individual, or the parent or guardian of the individual, and should contain the name and address of the employee and the name and address of the employee's employer. A petition may be filed in person or by mail with the Administrator of the Wage and Hour Division, U.S. Department of Labor, Room S3502, 200 Constitution Avenue NW., Washington, DC 20210. The petitioner may be represented by counsel in any stage of such proceedings. Upon receipt, the petition shall be forwarded immediately to the Chief Administrative Law Judge.

    PART 530—EMPLOYMENT OF HOMEWORKERS IN CERTAIN INDUSTRIES 48. The authority citation for part 530 continues to read as follows: Authority:

    Sec. 11, 52 Stat. 1066 (29 U.S.C. 211) as amended by sec. 9, 63 Stat. 910 (29 U.S.C. 211(d)); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at § 701, 129 Stat 584.

    49. In § 530.1, revise paragraph (b) to read as follows:
    § 530.1 Definitions.

    (b) Administrator as used in this part means the Administrator of the Wage and Hour Division, U.S. Department of Labor, or an authorized representative of the Administrator.

    50. In § 530.3, revise the parenthetical at end of section to read as follows:
    § 530.3 Application forms for individual homeworker certificates. (Approved by the Office of Management and Budget under control number 1235-0001).
    51. In § 530.4, revise parenthetical at end of section to read as follows:
    § 530.4 Terms and conditions for the issuance of individual homeworker certificates. (Information collection requirements contained in paragraph (a) were approved by the Office of Management and Budget under control number 1235-0001).
    52. In § 530.101, revise paragraph (c) to read as follows:
    § 530.101 General.

    (c) Certificates authorizing such employment may be issued on the following terms and conditions upon written application to the Administrator, Wage and Hour Division, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.

    53. Revise § 530.102 to read as follows:
    § 530.102 Requests for employer certificates.

    The initial request for certification or renewal application shall be signed by the employer and shall contain the name of the firm, its mailing address, the physical location of the firm's principal place of business and a description of the business operations and items produced. In addition, the initial or renewal application shall contain the names, addresses, and languages (if other than English) spoken by the homeworkers that are currently employed (if any) or expected to be employed. The employer shall also provide the Administrator, within thirty (30) days, a notice of each change of address of the principal place of business. The notification shall be in writing and addressed to the Administrator, Wage and Hour Division, 200 Constitution Avenue NW., Washington, DC 20210.

    54. In § 530.403, revise paragraph (a) to read as follows:
    § 530.403 Request for hearing.

    (a) Except in the case of an emergency revocation under § 530.411 of this subpart, a request for an administrative hearing on a determination referred to in § 530.402 of this subpart shall be made in writing to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and must be received no later than thirty (30) days after issuance of the notice referred to in § 530.402 of this subpart.

    PART 547—REQUIREMENTS OF A “BONA FIDE THRIFT OR SAVINGS PLAN” 55. The authority citation for part 547 continues to read as follows: Authority:

    Sec. 7, 52 Stat. 1063, as amended; 29 U.S.C. 207.

    56. In § 547.1, revise parenthetical at end of section to read as follows:
    § 547.1 Essential requirements for qualifications. (Approved by the Office of Management and Budget under control number 1235-0013).
    PART 549—REQUIREMENTS OF A “BONA FIDE PROFIT SHARING PLAN OR TRUST” 57. The authority citation for part 549 continues to read as follows: Authority:

    Sec. 7, 52 Stat. 1063, as amended; 29 U.S.C. 207.

    58. In § 549.1, revise the parenthetical at the end of the section to read as follows:
    § 549.1 Essential requirements for qualifications. (Approved by the Office of Management and Budget under control number 1235-0013).
    PART 553—APPLICATION OF THE FAIR LABOR STANDARDS ACT TO EMPLOYEES OF STATE AND LOCAL GOVERNMENTS 59. The authority citation for part 553 continues to read as follows: Authority:

    Secs. 1-19, 52 Stat. 1060, as amended (29 U.S.C. 201-219); Pub. L. 99-150, 99 Stat. 787 (29 U.S.C. 203, 207, 211). Pub. L. 106-151, 113 Stat. 1731 (29 U.S.C. 203(y)).

    60. In § 553.221, revise paragraph (a) to read as follows:
    § 553.221 Compensable hours of work.

    (a) The general rules on compensable hours of work are set forth in 29 CFR part 785 which is applicable to employees for whom the section 7(k) exemption is claimed. Special rules for sleep time (§ 553.222) apply to both law enforcement and employees in fire protection activities for whom the section 7(k) exemption is claimed. Also, special rules for meal time apply in the case of employees in fire protection activities (§ 553.223). Part 785 does not discuss the special provisions that apply to State and local government workers with respect to the treatment of substitution, special details for a separate and independent employer, early relief, and work performed on an occasional or sporadic and part-time basis, all of which are covered in this subpart.

    61. In § 553.231, revise paragraph (b) to read as follows:
    § 553.231 Compensatory time off.

    (b) Section 7(k) permits public agencies to balance the hours of work over an entire work period for law enforcement and fire protection employees. For example, if an employee engaged in fire protection activities' work period is 28 consecutive days, and he or she works 80 hours in each of the first two weeks, but only 52 hours in the third week, and does not work in the fourth week, no overtime compensation (in cash wages or compensatory time) would be required since the total hours worked do not exceed 212 for the work period. If the same employee in fire protection activities had a work period of only 14 days, overtime compensation or compensatory time off would be due for 54 hours (160 minus 106 hours) in the first 14 day work period.

    PART 570—CHILD LABOR REGULATIONS, ORDERS AND STATEMENTS OF INTERPRETATION Subpart A—General 62. The authority citation for subpart A continues to read as follows: Authority:

    Secs. 3, 11, 12, 52 Stat. 1060, as amended, 1066, as amended, 1067, as amended; 29 U.S.C. 203, 211, 212.

    63. In § 570.1, revise paragraph (g) to read as follows:
    § 570.1 Definitions.

    (g) Wage and Hour Division means the Wage and Hour Division, United States Department of Labor.

    64. The authority citation for subpart B continues to read as follows: Subpart B—Certificates of Age Authority:

    29 U.S.C. 203(l), 211, 212.

    65. In § 570.6, revise the parenthetical at the end of the section to read as follows:
    § 570.6 Contents and disposition of certificates of age. (The information collection requirements contained in paragraph (a) were approved by the Office of Management and Budget under control number 1235-0018.)
    66. The authority citation for subpart C continues to read as follows: Subpart C—Employment of Minors Between 14 and 16 Years of Age (Child Labor Reg. 3) Authority:

    29 U.S.C. 203(l), 212, 213(c).

    67. In § 570.36, revise the parenthetical at the end of the section to read as follows:
    § 570.36 Work experience and career exploration program. (The information collection requirements contained in paragraphs (b)(3)(vi) and (4) were approved by the Office of Management and Budget under control number 1235-0018.)
    68. In § 570.37, revise the parenthetical at the end of section to read as follows:
    § 570.37 Work-study program. (The information collection requirements contained in § 570.37 were approved by the Office of Management and Budget under control number 1235-0018.)
    PART 575—WAIVER OF CHILD LABOR PROVISIONS FOR AGRICULTURAL EMPLOYMENT OF 10 AND 11 YEAR OLD MINORS IN HAND HARVESTING OF SHORT SEASON CROPS 69. The authority citation for part 575 is revised to read as follows: Authority:

    Secs. 11, 12, 13, 18, 52 Stat. 1067, 1069, as amended; 29 U.S.C. 211, 212, 213, 218; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014).

    70. In § 575.2, revise the definition of “Administrator” to read as follows:
    § 575.2 Definitions.

    Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, and includes an authorized representative designated by the Administrator to perform any of the functions of the Administrator under this part.

    71. In § 575.3, revise paragraph (a) to read as follows:
    § 575.3 Application for waiver.

    (a) An application for a waiver shall be filed with the Administrator of the Wage and Hour Division, United States Department of Labor, Washington, DC 20210. To permit adequate time for processing, it is recommended that such applications be filed 6 weeks prior to the period the waiver is to be in effect.

    PART 578—MINIMUM WAGE AND OVERTIME VIOLATIONS—CIVIL MONEY PENALTIES 72. The authority citation for part 578 continues to read as follows: Authority:

    Sec. 9, Pub. L. 101-157, 103 Stat. 938, sec. 3103, Pub. L. 101-508, 104 Stat. 1388-29 (29 U.S.C. 216(e)), Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note), as amended by Pub. L. 104-134, section 31001(s), 110 Stat. 1321-358, 1321-373, and Pub. L. 114-74, 129 Stat. 584.

    73. In § 578.2, revise paragraph (b) to read as follows:
    § 578.2 Definitions.

    (b) Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, and includes any official of the Wage and Hour Division who is authorized by the Administrator to perform any of the functions of the Administrator under this part.

    PART 580—CIVIL MONEY PENALTIES—PROCEDURES FOR ASSESSING AND CONTESTING PENALTIES 74. The authority citation for part 580 is revised to read as follows: Authority:

    29 U.S.C. 9a, 203, 209, 211, 212, 213(c), 216; Reorg. Plan No. 6 of 1950, 64 Stat. 1263, 5 U.S.C. App; secs. 25, 29, 88 Stat. 72, 76; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 5 U.S.C. 500, 503, 551, 559; 103 Stat. 938.

    75. In § 580.1, revise the definition of “Administrator” to read as follows:
    § 580.1 Definitions.

    Administrator means the Administrator of the Wage and Hour Division, U.S. Department of Labor, and includes any official of the Wage and Hour Division authorized by the Administrator to perform any of the functions of the Administrator under this part and parts 578 and 579 of this chapter.

    PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 76. The authority citation for part 801 continues to read as follows: Authority:

    Pub. L. 100-347, 102 Stat. 646, 29 U.S.C. 2001-2009; 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at § 701, 129 Stat. 584.

    77. In § 801.2: a. Remove paragraph (h); b. Redesignate paragraphs (i) and (j) as paragraphs (h) and (i), respectively; and c. Revise newly redesignated paragraph (h).

    The revision reads as follows:

    § 801.2 Definitions.

    (h) Wage and Hour Division means the organizational unit of the Department of Labor to which is assigned primary responsibility for enforcement and administration of the Act.

    78. In § 801.7, revise paragraph (d) to read as follows:
    § 801.7 Authority of the Secretary.

    (d) Any person may report a violation of the Act or these regulations to the Secretary by advising any local office of the Wage and Hour Division, U.S. Department of Labor, or any authorized representative of the Administrator. The office or person receiving such a report shall refer it to the appropriate office of the Wage and Hour Division for the region or area in which the reported violation is alleged to have occurred.

    79. In § 801.30, revise the parenthetical at the end of section to read as follows:
    § 801.30 Records to be preserved for 3 years. (Approved by the Office of Management and Budget under control number 1235-0005.)
    PART 825—THE FAMILY AND MEDICAL LEAVE ACT OF 1993 80. The authority citation for part 525 continues to read as follows: Authority:

    29 U.S.C. 2654; 28 U.S.C. 2461 Note (Federal Civil Penalties Inflation Adjustment Act of 1990); and Pub. L. 114-74 at § 701.

    81. In § 825.104, revise paragraph (b) to read as follows:
    § 825.104 Covered employer.

    (b) The terms commerce and industry affecting commerce are defined in accordance with section 501(1) and (3) of the Labor Management Relations Act of 1947 (LMRA) (29 U.S.C. 142(1) and (3)), as set forth in the definitions at § 825.102 of this part. For purposes of the FMLA, employers who meet the 50-employee coverage test are deemed to be engaged in commerce or in an industry or activity affecting commerce.

    82. In § 825.209, revise paragraph (a) to read as follows:
    § 825.209 Maintenance of employee benefits.

    (a) During any FMLA leave, an employer must maintain the employee's coverage under any group health plan (as defined in the Internal Revenue Code of 1986 at 26 U.S.C. 5000(b)(1) on the same conditions as coverage would have been provided if the employee had been continuously employed during the entire leave period. All employers covered by FMLA, including public agencies, are subject to the Act's requirements to maintain health coverage. The definition of group health plan is set forth in § 825.102. For purposes of FMLA, the term group health plan shall not include an insurance program providing health coverage under which employees purchase individual policies from insurers provided that:

    (1) No contributions are made by the employer;

    (2) Participation in the program is completely voluntary for employees;

    (3) The sole functions of the employer with respect to the program are, without endorsing the program, to permit the insurer to publicize the program to employees, to collect premiums through payroll deductions and to remit them to the insurer;

    (4) The employer receives no consideration in the form of cash or otherwise in connection with the program, other than reasonable compensation, excluding any profit, for administrative services actually rendered in connection with payroll deduction; and,

    (5) The premium charged with respect to such coverage does not increase in the event the employment relationship terminates.

    83. In § 825.401, revise paragraph (a) to read as follows:
    § 825.401 Filing a complaint with the Federal Government.

    (a) A complaint may be filed in person, by mail or by telephone, with the Wage and Hour Division, U.S. Department of Labor. A complaint may be filed at any local office of the Wage and Hour Division; the address and telephone number of local offices may be found in telephone directories or on the Department's Web site.

    [FR Doc. 2016-31293 Filed 1-6-17; 8:45 am] BILLING CODE 4510-27-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 22 and 124 [FRL-9956-53-OARM] Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits; Procedures for Decisionmaking AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This final rule revises the Environmental Protection Agency's (“EPA”) Consolidated Rules of Practice governing the administrative assessment of civil penalties and various other administrative adjudicatory hearings. These revisions simplify the administrative processing of cases by removing inconsistencies, codifying electronic filing and service procedures, and streamlining the procedures in cases initiated at EPA Headquarters. This rule also corrects some punctuation typographical errors found in the Consolidated Rules of Practice. This rule similarly revises EPA's procedures governing decisionmaking in permit appeals. These amendments are procedural in nature and none of these changes are intended to substantively alter the Agency's administrative enforcement actions or review of permit appeals.

    DATES:

    This rule is effective on March 10, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Michael B. Wright, Office of Administrative Law Judges, U.S. Environmental Protection Agency, Ronald Reagan Building, Room M1200, 1300 Pennsylvania Ave. NW., Washington, DC 20004, phone number (202) 564-3247 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Why is the EPA issuing this rule in final form without first issuing a proposal?

    Today's final rule is limited to procedural requirements for administrative adjudicatory hearings and appeals from such hearings and from permit decisions. Under the Administrative Procedure Act, an agency may issue “rules of agency organization, procedure, or practice” without first proposing such rules for public comment. 5 U.S.C. 553(b). Accordingly, public comment is not required.

    II. Does this action apply to me?

    This action affects parties involved in EPA administrative adjudicatory proceedings for the assessment of civil penalties, issuance of various compliance orders, and termination or suspension of certain permits, under part 22 of title 40 of the CFR. See 40 CFR 22.1. This action also affects parties involved in appeal of EPA permits under part 124 of title 40 of the CFR.

    III. Summary of Rule A. Background: The EPA's Consolidated Rules of Practice in Part 22 and the EPA's Rules for Procedures for Decisionmaking on Permits in Part 124

    Part 22 of Title 40 of the CFR establishes procedures governing administrative adjudicatory proceedings to assess administrative civil penalties, to issue various compliance orders, and to terminate or suspend certain permits. 40 CFR 22.1. These proceedings are conducted under a variety of environmental statutes, including the Clean Air Act, the Clean Water Act, the Solid Waste Disposal Act, and the Federal Insecticide, Fungicide, and Rodenticide Act, among others. Such cases are generally heard by the Administrative Law Judges (ALJs) within the EPA's Office of Administrative Law Judges or Regional Judicial Officers. The part 22 regulations are titled the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits” (“Rules of Practice”).

    The EPA promulgated the Rules of Practice to establish uniform procedural rules for administrative proceedings required to be held on the record after opportunity for a hearing in accordance with section 554 of the Administrative Procedure Act, 5 U.S.C. 551 et seq., see 40 CFR part 22, subparts A-G, and administrative enforcement proceedings not governed by section 554, id. part 22, subpart I. Consolidated Rules of Practice, 45 FR 24360 (Apr. 9, 1980). The Rules of Practice also establish supplementary rules that recognize the unique procedural requirements of certain environmental statutes within the EPA's jurisdiction. See 40 CFR part 22, subpart H. Finally, the Rules of Practice establish procedures for appeals from decisions of the ALJs and Regional Judicial Officers to the Environmental Appeals Board. See id. part 22, subpart F.

    Part 124 of Title 40 of the CFR establishes rules governing the EPA's issuance, modification, and revocation of permits under the Resource Conservation and Recovery Act, the Underground Injection Control program of the Safe Drinking Water Act, the Prevention of Significant Deterioration program of the Clean Air Act, and the National Pollutant Discharge Elimination System program of the Clean Water Act. These permit rules include procedures for appealing permit decisions by the EPA's regional offices to the Environmental Appeals Board. See 40 CFR 124.19.

    B. Amendments to Part 22 Procedures

    This action makes several minor changes to part 22 procedures. Many of these changes pertain to the electronic filing and service of documents.

    Filing and service. The EPA has amended the filing and service requirements to clarify how these requirements apply to electronic transmission of documents and to otherwise clarify filing and service requirements and make them more consistent with similar requirements in part 124.

    Section 22.5(a) currently allows a Presiding Officer or the Environmental Appeals Board to “authorize” filing of documents by “facsimile or electronic filing.” 40 CFR 22.5(a). The EPA is amending this section to also allow a Presiding Officer or the Environmental Appeals Board to “require” filing by “facsimile or an electronic filing system.” Both the Office of the Administrative Law Judges and the Environmental Appeals Board have an operational electronic filing system. This section is also being amended to standardize the Environmental Appeals Board filing methods under part 22 with those currently in the EPA's permit regulations in part 124.

    Section 22.5(b)(2) is modified to allow parties to agree with other parties to service by facsimile or other electronic means, including but not necessarily limited to email. A party's consent to such methods of service must be in writing and the party must file acknowledgement of such consent with the Clerk for the Presiding Officer or the Environmental Appeals Board, whichever is appropriate. This section is also modified to allow the Presiding Officer or the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including but not necessarily limited to email. To facilitate electronic service, § 22.5(b)(4) is modified to require that a party include an email address in the first document it files in a proceeding.

    The EPA emphasizes that the rules on electronic delivery of documents differ depending on whether the document is being filed with an EPA adjudicatory tribunal or served on a party to the proceeding. In the case of filing a document in an EPA administrative proceeding, the Presiding Officer or the Environmental Appeals Board has the sole authority to authorize or require electronic filing, and only these entities may authorize or require electronic filing by facsimile or an electronic filing system. As to service of documents between parties, not only may the Presiding Officer or the Environmental Appeals Board authorize or require service by either facsimile or other electronic means, including but not necessarily limited to email, but the parties may agree to such forms of electronic service.

    Additionally, the EPA is revising § 22.5(b) to clarify that in cases before the Environmental Appeals Board, documents a party files with the Board need not also be served on the Board.

    Section 22.6 is amended to allow the Regional Hearing Clerk, the Headquarters Hearing Clerk, or the Clerk of the Environmental Appeals Board to serve rulings, orders, decisions, or other documents by electronic means (including but not necessarily limited to facsimile and email).

    Section 22.7(c) addresses when service is considered complete and includes a provision allowing an additional period of time for response to documents served using certain procedures. Id. § 22.7(c). The EPA has amended this section to specify that when documents are served by facsimile or other electronic means, the service will be complete upon transmission. This approach is similar to that in Rule 5(b) of the Federal Rules of Civil Procedure. Fed. R. Civ. P. 5(b).

    The EPA has also modified the so-called “mailbox rule” in § 22.7(c) providing for additional days to respond to documents served using certain procedures. As modified, the revised mailbox rule in § 22.7(c) allows an additional three days to the time allowed for response to documents served by U.S. mail, the EPA's internal mail,1 or commercial delivery service. Three additional days are not allowed for a response when a document to be responded to is served by personal delivery or electronic means (e.g., facsimile or email). This change allows additional days where needed, but recognizes that extra days for delivery are not needed where same-day delivery is utilized. Further, this change makes part 22 consistent with the Federal Rules of Civil Procedure, including changes made to the Rules effective December 1, 2016. Rule 6(d) of the Federal Rules of Civil Procedure currently grants an additional three days when service is effectuated by U.S. mail, an agreed-to delivery service, or an electronic means. However, an amendment to Rule 6(d) that was effective December 1, 2016, removes electronic service from the types of service to which the additional three-day rule applies. Order (S. Ct. Apr. 28, 2016). This change was based on the conclusion that electronic service has become sufficiently reliable method of providing instantaneous delivery. Fed. R. Civ. P. 6(d) advisory committee's note to 2016 amendment.

    1 EPA has specifically included “EPA internal mail” in this revision to the mailbox rule because the Environmental Appeals Board previously ruled that a prior version of this provision referencing “certified mail” did not cover a document served by EPA internal mail. In re Outboard Marine Corp., 6 E.A.D. 194, 197 (EAB 1995).

    Presiding officer prior to respondent filing answer. Generally, the Presiding Officer in part 22 proceedings is an Administrative Law Judge except for proceedings under subpart I, which are not governed by section 554 of the Administrative Procedure Act. See 40 CFR 22.3 (definition of “Presiding Officer”) & subpart I. Regional Judicial Officers are the Presiding Officer under subpart I proceedings. Id. § 22.51. The Environmental Appeals Board hears appeals from interlocutory orders and initial decisions of a Presiding Officer. Id. § 22.29-22.30.

    However, sections 22.4(a) and 22.16(c) currently specify, among other things, that the Environmental Appeals Board will act as Presiding Officer in proceedings under part 22 commenced at EPA Headquarters until the respondent files an answer. Id. §§ 22.4(a), 22.16(c). In such proceedings, an Administrative Law Judge replaces the Environmental Appeals Board as the Presiding Officer once an answer is filed. Id. § 22.16(c).

    This rule amendment modifies § 22.4(a) and § 22.16(c) to authorize an Administrative Law Judge to serve as the Presiding Officer in part 22 proceedings commenced at EPA Headquarters from the time a complaint is filed. The Environmental Appeals Board will no longer be assigned as a Presiding Officer for the period between the filing of a complaint and the filing of an answer. Rather, an Administrative Law Judge will serve as the Presiding Officer both prior to and after the filing of the answer. Removing the Environmental Appeals Board from the initial stage of enforcement proceedings will enhance the efficiency of proceedings commenced at EPA Headquarters because a single entity will exercise the role of Presiding Officer. This also eliminates the possibility that the Environmental Appeals Board could be asked to review on appeal its own decision on a preliminary motion (filed before an answer is filed).

    Other changes. Section 22.28 addresses motions to reopen a hearing. This rule modifies § 22.28 to clarify the effect of filing such a motion and to expand the section to apply to motions to set aside a default order. The revised language clarifies that the filing of a motion to reopen a hearing tolls not only the time by when an initial decision becomes final or by when an appeal of an initial decision to the Environmental Appeals Board must be filed but also the time by which the Board must decide whether it is going to exercise its authority to hear the case on its own initiative. The revised language also applies similar requirements to a motion to set aside a default order.

    Additionally, the EPA is making a series of changes to § 22.30 to clarify various issues relating to appeals to the Environmental Appeals Board. See id. § 22.30. Section 22.30 is modified to (1) explain how attachments to a notice of appeal, appellate brief, or response brief should be identified (§ 22.30(a)(1)(iii) and (2)); (2) impose word/page limitations for briefs and motions (§ 22.30(a)(3)); (3) provide more consistency between § 22.30(a)(1)(iii) and § 124.19(a)(4)(ii) pertaining to the need for parties' briefs to contain specific citations or other appropriate references (e.g., by including the document name and page number) (§ 22.30(a)(1)(iii) and (2)); (4) clarify that when the Board initiates review of an initial decision, it will identify any issues to be briefed and a schedule for briefing in its initial order of its intent to review or in a subsequent order (§ 22.30(b)); (5) clarify that the Board may request oral argument on its own initiative, how a party must request oral argument, and that the Board may establish additional oral argument procedures by order (§ 22.30(d)); (6) make explicit that the Board may act on a motion without awaiting a response (§ 22.30(e)(2)); and (7) explain the procedure for parties to request an extension of time (§ 22.30(e)(3)).

    C. Amendments to Part 124 Procedures

    Most of the revisions to part 124 also concern filing and service issues. Section 124.19(i) addresses filing and service requirements in permit appeal proceedings before the Environmental Appeals Board. This section has been modified to add language clarifying when service is complete. Specifically, service is complete upon mailing for U.S. mail and EPA internal mail, when placed in the custody of a reliable commercial deliver service, or upon transmission for facsimile or email. This new language is similar to that in Rule 5(b)(2) of the Federal Rules of Civil Procedure and Environmental Appeals Board decisions. Fed. R. Civ. P. 5(b)(2); see In re Beckman Prod. Servs., 5 E.A.D. 10, 15 (EAB 1994) (“When the Region serves a final permit decision by mail, service occurs upon mailing.”). The EPA has revised the language in § 124.19(i)(3) to clarify that parties may agree to electronic service by facsimile, email, or other electronic means. The EPA has also revised § 124.19(i)(3) to require that parties that consent to service by electronic means file acknowledgement of that consent with the Environmental Appeals Board.

    The EPA has also made several changes to part 124 on service and filing that duplicate the changes made to part 22: (1) Requiring that a party's first filing contain an email address (§ 124.19(i)(3)(i)); (2) authorizing the Environmental Appeals Board to require that parties file documents by facsimile or through use of the Board's electronic filing system (§ 124.19(i)(2)); (3) allowing the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including email (§ 124.19(i)(3)(ii)); and (4) authorizing the Board to serve rulings, orders, and decisions on the parties by electronic means (including but not necessarily limited to facsimile and email). (§ 124.19(i)(3)(iii).

    Section 124.19(b)(1) and (2) are modified so that the deadlines for filing a response to a petition for review are based on the date the petition is served, rather than filed. This provides for appropriate notice of the petition for review in advance of the deadline for a response.

    Similar to the changes made in the mailbox rule in § 22.7(c), discussed above, the EPA has modified § 124.20(d) to specify that three days are added to a prescribed period of time to act when service is made by U.S. mail, the EPA's internal mail, or a reliable, commercial delivery service. Three days are not added to the prescribed time to act when service is made by personal delivery or electronic transmission (e.g., facsimile or email).

    The EPA has also added word/page limitations to § 124.19(f) for motions mirroring the word/page limitations added to § 22.30. Finally, the EPA has amended § 124.19(a)(4)(ii) and (b) to further clarify that parties are to provide in their briefs appropriate reference to the administrative record (e.g., by including the document name and page number) as to each issue raised.

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

    This action is exempt from review by the Office of Management and Budget (OMB) because it is limited to agency organization, management, or personnel matters.

    B. Paperwork Reduction Act

    This action does not impose an information collection burden under the PRA. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Specifically, the modifications to the Rules of Practice will codify the electronic service of documents between parties and by EPA adjudicative bodies. In addition, the modifications will facilitate the efficient issuance of rulings on motions by substituting an Administrative Law Judge for the Environmental Appeals Board to serve as the presiding officer in civil penalty cases initiated at EPA Headquarters before an answer is filed.

    C. Regulatory Flexibility Act

    This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule pertains to agency management or personnel, which the APA expressly exempts from notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).

    D. Unfunded Mandates Reform Act

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

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

    This action does not have tribal implications, as specified in Executive Order 13175. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Thus, Executive Order 13175 does not apply to this action.

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

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

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

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

    I. National Technology Transfer Advancement Act

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources.

    K. Congressional Review Act

    This rule is exempt from the CRA because it is a rule relating to agency management or personnel.

    List of Subjects 40 CFR Part 22

    Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Hazardous waste, Penalties, Pesticides and pests, Poison prevention, Water pollution control.

    40 CFR Part 124

    Environmental protection, Administrative practice and procedures.

    Dated: December 20, 2016. Gina McCarthy, Administrator.

    For the reasons set out in the preamble, 40 CFR parts 22 and 124 are amended as follows:

    PART 22—CONSOLIDATED RULES OF PRACTICE GOVERNING THE ADMINISTRATIVE ASSESSMENT OF CIVIL PENALTIES AND THE REVOCATION/TERMINATION OR SUSPENSION OF PERMITS 1. The authority citation for part 22 is revised to read as follows: Authority:

    7 U.S.C. 1361; 15 U.S.C. 2615; 33 U.S.C. 1319, 1342, 1361, 1415 and 1418; 42 U.S.C. 300g-3(g), 6912, 6925, 6928, 6991e and 6992d; 42 U.S.C. 7413(d), 7524(c), 7545(d), 7547, 7601 and 7607(a), 9609, and 11045.

    Subpart A—General 2. In § 22.4, revise the first sentence of paragraph (a)(1) to read as follows:
    § 22.4 Powers and duties of the Environmental Appeals Board, Regional Judicial Officer and Presiding Officer; disqualification, withdrawal, and reassignment.

    (a) Environmental Appeals Board. (1) The Environmental Appeals Board rules on appeals from the initial decisions, rulings and orders of a Presiding Officer in proceedings under these Consolidated Rules of Practice, and approves settlement of proceedings under these Consolidated Rules of Practice commenced at EPA Headquarters. * * *

    3. In § 22.5, revise the section heading and paragraphs (a)(1), (b) introductory text, (b)(2), and (c)(4) to read as follows:
    § 22.5 Filing, service by the parties, and form of all filed documents; business confidentiality claims.

    (a) Filing of documents. (1) The original and one copy of each document intended to be part of the record shall be filed with the Headquarters or Regional Hearing Clerk, as appropriate, when the proceeding is before the Presiding Officer, or filed with the Clerk of the Board when the proceeding is before the Environmental Appeals Board. A document is filed when it is received by the appropriate Clerk. When a document is required to be filed with the Environmental Appeals Board, the document shall be sent to the Clerk of the Board by U.S. Mail, delivered by hand or courier (including delivery by U.S. Express Mail or by a commercial delivery service), or transmitted by the Environmental Appeal Board's electronic filing system, according to the procedures specified in 40 CFR 124.19 (i)(2)(i), (ii), and (iii). The Presiding Officer or the Environmental Appeals Board may by order authorize or require filing by facsimile or an electronic filing system, subject to any appropriate conditions and limitations.

    (b) Service of documents. Unless the proceeding is before the Environmental Appeals Board, a copy of each document filed in the proceeding shall be served on the Presiding Officer and on each party. In a proceeding before the Environmental Appeals Board, a copy of each document filed in the proceeding shall be served on each party.

    (2) Service of filed documents other than the complaint, rulings, orders, and decisions. All documents filed by a party other than the complaint, rulings, orders, and decisions shall be served by the filing party on all other parties. Service may be made personally, by U.S. mail (including certified mail, return receipt requested, Overnight Express and Priority Mail), by any reliable commercial delivery service, or by facsimile or other electronic means, including but not necessarily limited to email, if service by such electronic means is consented to in writing. A party who consents to service by facsimile or email must file an acknowledgement of its consent (identifying the type of electronic means agreed to and the electronic address to be used) with the appropriate Clerk. In addition, the Presiding Officer or the Environmental Appeals Board may by order authorize or require service by facsimile, email, or other electronic means, subject to any appropriate conditions and limitations.

    (c) * * *

    (4) The first document filed by any person shall contain the name, mailing address, telephone number, and email address of an individual authorized to receive service relating to the proceeding on behalf of the person. Parties shall promptly file any changes in this information with the Headquarters or Regional Hearing Clerk or the Clerk of the Board, as appropriate, and serve copies on the Presiding Officer and all parties to the proceeding. If a party fails to furnish such information and any changes thereto, service to the party's last known address shall satisfy the requirements of paragraph (b)(2) of this section and § 22.6.

    4. Revise § 22.6 to read as follows:
    § 22.6 Filing and service of rulings, orders and decisions.

    All rulings, orders, decisions, and other documents issued by the Regional Administrator or Presiding Officer shall be filed with the Headquarters or Regional Hearing Clerk, as appropriate, in any manner allowed for the service of such documents. All rulings, orders, decisions, and other documents issued by the Environmental Appeals Board shall be filed with the Clerk of the Board. The Clerk of the Board, the Headquarters Hearing Clerk, or the Regional Hearing Clerk, as appropriate, must serve copies of such rulings, orders, decisions and other documents on all parties. Service may be made by U.S. mail (including by certified mail or return receipt requested, Overnight Express and Priority Mail), EPA's internal mail, any reliable commercial delivery service, or electronic means (including but not necessarily limited to facsimile and email).

    5. In § 22.7, revise paragraph (c) to read as follows:
    § 22.7 Computation and extension of time.

    (c) Completion of service. Service of the complaint is complete when the return receipt is signed. Service of all other documents is complete upon mailing, when placed in the custody of a reliable commercial delivery service, or for facsimile or other electronic means, including but not necessarily limited to email, upon transmission. Where a document is served by U.S. mail, EPA internal mail, or commercial delivery service, including overnight or same-day delivery, 3 days shall be added to the time allowed by these Consolidated Rules of Practice for the filing of a responsive document. The time allowed for the serving of a responsive document is not expanded by 3 days when the served document is served by personal delivery, facsimile, or other electronic means, including but not necessarily limited to email.

    Subpart C—Prehearing Procedures 6. In § 22.16, revise paragraph (c) to read as follows:
    § 22.16 Motions.

    (c) Decision. The Regional Judicial Officer (or in a proceeding commenced at EPA Headquarters, an Administrative Law Judge) shall rule on all motions filed or made before an answer to the complaint is filed. Except as provided in §§ 22.29(c) and 22.51, an Administrative Law Judge shall rule on all motions filed or made after an answer is filed and before an initial decision becomes final or has been appealed. The Environmental Appeals Board shall rule as provided in § 22.29(c) and on all motions filed or made after an appeal of the initial decision is filed, except as provided pursuant to § 22.28.

    7. Revise the subpart E heading to read as follows: Subpart E—Initial Decision, Motion To Reopen a Hearing, and Motion To Set Aside a Default Order
    8. Revise § 22.28 to read as follows:
    § 22.28 Motion to reopen a hearing or to set aside a default order.

    (a) Motion to reopen a hearing—(1) Filing and content. A motion to reopen a hearing to take further evidence must be filed no later than 20 days after service of the initial decision and shall state the specific grounds upon which relief is sought. Where the movant seeks to introduce new evidence, the motion shall: State briefly the nature and purpose of the evidence to be adduced; show that such evidence is not cumulative; and show good cause why such evidence was not adduced at the hearing. The motion shall be made to the Presiding Officer and filed with the Headquarters or Regional Hearing Clerk, as appropriate. A copy of the motion shall be filed with the Clerk of the Board in the manner prescribed by § 22.5(a)(1).

    (2) Disposition of motion to reopen a hearing. Within 15 days following the service of a motion to reopen a hearing, any other party to the proceeding may file with the Headquarters or Regional Hearing Clerk, as appropriate, and serve on all other parties a response. A reopened hearing shall be governed by the applicable sections of these Consolidated Rules of Practice. The timely filing of a motion to reopen a hearing shall automatically toll the running of the time periods for an initial decision becoming final under § 22.27(c), for appeal under § 22.30, and for the Environmental Appeals Board to elect to review the initial decision on its own initiative pursuant to § 22.30(b). These time periods begin again in full when the Presiding Officer serves an order denying the motion to reopen the hearing or an amended decision. The Presiding Officer may summarily deny subsequent motions to reopen a hearing filed by the same party if the Presiding Officer determines that the motion was filed to delay the finality of the decision.

    (b) Motion to set aside default order—(1) Filing and content. A motion to set aside a default order must be filed no later than 20 days after service of the initial decision and shall state the specific grounds upon which relief is sought. The motion shall be made to the Presiding Officer and filed with the Headquarters or Regional Hearing Clerk, as appropriate. A copy of the motion shall be filed with the Clerk of the Board in the manner prescribed by § 22.5(a)(1).

    (2) Effect of motion to set aside default. The timely filing of a motion to set aside a default order automatically tolls the running of the time periods for an initial decision becoming final under § 22.27(c), for appeal under § 22.30(a), and for the Environmental Appeals Board to elect to review the initial decision on its own initiative pursuant to § 22.30(b). These time periods begin again in full when the Presiding Officer serves an order denying the motion to set aside or an amended decision. The Presiding Officer may summarily deny subsequent motions to set aside a default order filed by the same party if the Presiding Officer determines that the motion was filed to delay the finality of the decision.

    Subpart F—Appeals and Administrative Review 9. In § 22.30, revise paragraphs (a), (b), (c), (d), and (e) to read as follows:
    § 22.30 Appeal from or review of initial decision.

    (a) Notice of appeal and appeal brief—(1) Filing an appeal—(i) Filing deadline and who may appeal. Within 30 days after the initial decision is served, any party may file an appeal from any adverse order or ruling of the Presiding Officer.

    (ii) Filing requirements. Appellant must file a notice of appeal and an accompanying appellate brief with the Environmental Appeals Board as set forth in § 22.5(a). One copy of any document filed with the Clerk of the Board shall also be served on the Headquarters or Regional Hearing Clerk, as appropriate. Appellant also shall serve a copy of the notice of appeal upon the Presiding Officer. Appellant shall simultaneously serve one copy of the notice and brief upon all other parties and non-party participants.

    (iii) Content. The notice of appeal shall summarize the order or ruling, or part thereof, appealed from. The appellant's brief shall contain tables of contents and authorities (with appropriate page references), a statement of the issues presented for review, a statement of the nature of the case and the facts relevant to the issues presented for review (with specific citation or other appropriate reference to the record (e.g., by including the document name and page number)), argument on the issues presented, a short conclusion stating the precise relief sought, alternative findings of fact, and alternative conclusions regarding issues of law or discretion. If any appellant includes attachments to its notice of appeal or appellate brief, the notice of appeal or appellate brief shall contain a table that provides the title of each appended document and assigns a label identifying where it may be found in the record.

    (iv) Multiple appeals. If a timely notice of appeal is filed by a party, any other party may file a notice of appeal and accompanying appellate brief on any issue within 20 days after the date on which the first notice of appeal was served or within the time to appeal in paragraph (a)(1)(i) of this section, whichever period ends later.

    (2) Response brief. Within 20 days of service of notices of appeal and briefs under paragraph (a)(1) of this section, any other party or non-party participant may file with the Environmental Appeals Board an original and one copy of a response brief responding to arguments raised by the appellant, together with specific citation or other appropriate reference to the record, initial decision, and opposing brief (e.g., by including the document name and page number). Appellee shall simultaneously serve one copy of the response brief upon each party, non-party participant, and the Regional Hearing Clerk. Response briefs shall be limited to the scope of the appeal brief. If any responding party or non-party participant includes attachments to its response brief, the response brief shall contain a table that provides the title of each appended document and assigns a label identifying where it may be found in the record. Further briefs may be filed only with leave of the Environmental Appeals Board.

    (3) Length—(i) Briefs. Unless otherwise ordered by the Environmental Appeals Board, appellate and response briefs may not exceed 14,000 words, and all other briefs may not exceed 7000 words. Filers may rely on the word-processing system used to determine the word count. As an alternative to this word limitation, filers may comply with a 30-page limit for appellate and response briefs, or a 15-page limit for replies. Headings, footnotes, and quotations count toward the word limitation. The table of contents, table of authorities, table of attachments (if any), statement requesting oral argument (if any), statement of compliance with the word limitation, and any attachments do not count toward the word or page-length limitation. The Environmental Appeals Board may exclude any appeal, response, or other brief that does not meet word or page-length limitations. Where a party can demonstrate a compelling and documented need to exceed such limitations, such party must seek advance leave of the Environmental Appeals Board to file a longer brief. Such requests are discouraged and will be granted only in unusual circumstances.

    (ii) Motions. Unless otherwise ordered by the Environmental Appeals Board, motions and any responses or replies may not exceed 7000 words. Filers may rely on the word-processing system used to determine the word count. As an alternative to this word limitation, filers may comply with a 15-page limit. Headings, footnotes, and quotations count toward the word or page-length limitation. The Environmental Appeals Board may exclude any motion that does not meet word limitations. Where a party can demonstrate a compelling and documented need to exceed such limitations, such party must seek advance leave of the Environmental Appeals Board. Such requests are discouraged and will be granted only in unusual circumstances.

    (b) Review initiated by the Environmental Appeals Board. Whenever the Environmental Appeals Board determines to review an initial decision on its own initiative, it shall issue an order notifying the parties and the Presiding Officer of its intent to review that decision. The Clerk of the Board shall serve the order upon the Regional Hearing Clerk, the Presiding Officer, and the parties within 45 days after the initial decision was served upon the parties. In that order or in a later order, the Environmental Appeals Board shall identify any issues to be briefed by the parties and establish a time schedule for filing and service of briefs.

    (c) Scope of appeal or review. The parties' rights of appeal shall be limited to those issues raised during the course of the proceeding and by the initial decision, and to issues concerning subject matter jurisdiction. If the Environmental Appeals Board determines that issues raised, but not appealed by the parties, should be argued, it shall give the parties written notice of such determination to allow preparation of adequate argument. The Environmental Appeals Board may remand the case to the Presiding Officer for further proceedings.

    (d) Argument before the Environmental Appeals Board. The Environmental Appeals Board may, at its discretion in response to a request or on its own initiative, order oral argument on any or all issues in a proceeding. To request oral argument, a party must include in its substantive brief a statement explaining why oral argument is necessary. The Environmental Appeals Board may, by order, establish additional procedures governing any oral argument before the Environmental Appeals Board.

    (e) Motions on appeal—(1) General. All motions made during the course of an appeal shall conform to § 22.16 unless otherwise provided. In advance of filing a motion, parties must attempt to ascertain whether the other party(ies) concur(s) or object(s) to the motion and must indicate in the motion the attempt made and the response obtained.

    (2) Disposition of a motion for a procedural order. The Environmental Appeals Board may act on a motion for a procedural order at any time without awaiting a response.

    (3) Timing on motions for extension of time. Parties must file motions for extensions of time sufficiently in advance of the due date to allow other parties to have a reasonable opportunity to respond to the request for more time and to provide the Environmental Appeals Board with a reasonable opportunity to issue an order.

    PART 124—PROCEDURES FOR DECISIONMAKING 10. The authority citation for part 124 continues to read as follows: Authority:

    Resource Conservation and Recovery Act, 42 U.S.C. 6901 et seq.; Safe Drinking Water Act, 42 U.S.C. 300f et seq.; Clean Water Act, 33 U.S.C. 1251 et seq.; Clean Air Act, 42 U.S.C. 7401 et seq.

    Subpart A—General Program Requirements 11. In § 124.19: a. Revise the first sentence of paragraph (a)(4)(ii), and paragraph (b). b. Redesignate paragraph (f)(5) as paragraph (f)(6). c. Add a new paragraph (f)(5). d. Revise paragraphs (i) introductory text, (i)(2) introductory text, and (3).

    The addition and revisions read as follows:

    § 124.19 Appeal of RCRA, UIC, NPDES and PSD Permits.

    (a) * * *

    (4) * * *

    (ii) Petitioners must demonstrate, by providing specific citation or other appropriate reference to the administrative record (e.g., by including the document name and page number), that each issue being raised in the petition was raised during the public comment period (including any public hearing) to the extent required by § 124.13. * * *

    (b) Response(s) to a petition for review. (1) In a PSD or other new source permit appeal, the Regional Administrator must file a response to the petition for review, a certified index of the administrative record, and the relevant portions of the administrative record within 21 days after the service of the petition. The response brief must respond to arguments raised by the appellant, together with specific citation or other appropriate reference to the record (e.g., by including the document name and page number).

    (2) In all other permit appeals under this section, the Regional Administrator must file a response to the petition, a certified index of the administrative record, and the relevant portions of the administrative record within 30 days after the service of a petition.

    (f) * * *

    (5) Length. Unless otherwise ordered by the Environmental Appeals Board, motions and any responses or replies may not exceed 7000 words. Filers may rely on the word-processing system used to determine the word count. In lieu of a word limitation, filers may comply with a 15-page limit. Headings, footnotes, and quotations count toward the word or page-length limitation. The Environmental Appeals Board may exclude any motion that does not meet word limitations. Where a party can demonstrate a compelling and documented need to exceed such limitations, such party must seek advance leave of the Environmental Appeals Board. Such requests are discouraged and will be granted only in unusual circumstances.

    (i) Filing and service requirements. Documents filed under this section, including the petition for review, must be filed with the Clerk of the Environmental Appeals Board. A document is filed when it is received by the Clerk of the Environmental Appeals Board at the address specified for the appropriate method of delivery as provided in paragraph (i)(2) of this section. Service of a document between parties to an appeal or by the Environmental Appeals Board on a party is complete upon mailing for U.S. mail or EPA internal mail, when placed in the custody of a reliable commercial delivery service, or upon transmission for facsimile or email.

    (2) Method of filing. Unless otherwise permitted under these rules, documents must be filed either by using the Environmental Appeals Board's electronic filing system, by U.S. mail, or by hand delivery. In addition, a motion or a response to a motion may be submitted by facsimile if the submission contains no attachments. Upon filing a motion or response to a motion by facsimile, the sender must, within one business day, submit the original copy to the Clerk of the Environmental Appeals Board either electronically, by mail, or by hand-delivery. The Environmental Appeals Board may by order require filing by facsimile or the Board's electronic filing system, subject to any appropriate conditions and limitations.

    (3) Service—(i) Service information. The first document filed by any person shall contain the name, mailing address, telephone number, and email address of an individual authorized to receive service relating to the proceeding. Parties shall promptly file any changes in this information with the Clerk of the Environmental Appeals Board, and serve copies on all parties to the proceeding. If a party fails to furnish such information and any changes thereto, service to the party's last known address shall satisfy the requirements of paragraph (i)(3) of this section.

    (ii) Service requirements for parties. Petitioner must serve the petition for review on the Regional Administrator and the permit applicant (if the applicant is not the petitioner). Once an appeal is docketed, every document filed with the Environmental Appeals Board must be served on all other parties. Service must be by first class U.S. mail, by any reliable commercial delivery service, or, if agreed to by the parties, by facsimile or other electronic means, including but not necessarily limited to or email. A party who consents to service by facsimile or other electronic means must file an acknowledgement of its consent (identifying the type of electronic means agreed to and the electronic address to be used) with the Clerk of the Environmental Appeals Board. The Environmental Appeals Board may by order authorize or require service by facsimile, email, or other electronic means, subject to any appropriate conditions and limitations.

    (iii) Service of rulings, orders, and decisions. The Clerk of the Environmental Appeals Board must serve copies of rulings, orders, and decisions on all parties. Service may be made by U.S. mail (including by certified mail or return receipt requested, Overnight Express and Priority Mail), EPA's internal mail, any reliable commercial delivery service, or electronic means (including but not necessarily limited to facsimile and email).

    12. In § 124.20, revise paragraph (d) to read as follows:
    § 124.20 Computation of time.

    (d) When a party or interested person may or must act within a prescribed period after being served and service is made by U.S. mail, EPA's internal mail, or reliable commercial delivery service, 3 days shall be added to the prescribed time. The prescribed period for acting after being served is not expanded by 3 days when service is made by personal delivery, facsimile, or email.

    [FR Doc. 2016-31638 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2015-0402; FRL-9957-27-Region 1] Approval and Promulgation of Implementation Plans; Rhode Island; Clean Air Act Infrastructure State and Federal Implementation Plans AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is removing several obsolete Federal Implementation Plans (FIPs) for the State of Rhode Island. These FIPs address Clean Air Act (CAA) infrastructure State Implementation Plan (SIP) requirements that have since been addressed by Rhode Island in its SIP. Therefore, EPA is removing from the Code of Federal Regulations (CFR) the corresponding FIPs. This action is being taken in accordance with the CAA.

    DATES:

    This rule is effective on February 8, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2015-0402. All documents in the docket are listed on the http://www.regulations.gov Web site, although some information, such as confidential business information or other information whose disclosure is restricted by statute is not publically available. 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 at http://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square—Suite 100, Boston, MA. EPA requests that, if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Richard P. Burkhart, Air Quality Planning Unit, Air Programs Branch (Mail Code OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston, Massachusetts, 02109-3912; (617) 918-1664; [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

    Organization of this document. The following outline is provided to aid in locating information in this preamble.

    I. Background and Purpose II. Public Comments III. Final Action IV. Statutory and Executive Order Reviews I. Background and Purpose

    This rulemaking addresses infrastructure SIP submissions from the State of Rhode Island for the 1997 fine particle matter (PM2.5), 2006 PM2.5, 2008 lead (Pb), 2008 ozone, 2010 nitrogen dioxide (NO2), and 2010 sulfur dioxide (SO2) National Ambient Air Quality Standards (NAAQS). The state submitted these infrastructure SIPs on the following dates: 1997 PM2.5—September 10, 2008; 2006 PM2.5—November 6, 2009; 2008 Pb—October 26, 2011; 2008 ozone—January 2, 2013; 2010 NO2—January 2, 2013; and 2010 SO2—June 27, 2014. Details of Rhode Island's submittals and EPA evaluation of those submittals can be found in our Notice of Proposed Rulemaking (NPR) (81 FR 10168; February 29, 2016).

    On April 20, 2016, EPA took final action on the vast majority of the elements included in these submittals (see 81 FR 23175). In today's action, EPA is taking final action on its proposal to remove the following sections from the Code of Federal Regulations (CFR): 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). As discussed in detail in the NPR, these sections related to the public availability of emissions data and enforcement procedures are no longer necessary and have become obsolete since EPA has approved the relevant infrastructure SIP elements. Removal of Federal Implementation language is reserved for the Administrator, and has not been delegated to the Regional Administrator, who signed the April 20, 2016 final rulemaking referenced above.

    II. Public Comments

    EPA did not receive any comments in response to the NPR.

    III. Final Action

    EPA is removing the following sections from the CFR: 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). The Federal Implementation Plan requirements in these sections are no longer necessary since EPA has since approved the relevant Clean Air Act infrastructure SIP revisions submitted by Rhode Island (see 81 FR 23175; April 20, 2016). A detailed discussion of the rationale for our action is included in the NPR (see 81 FR 10168; February 29, 2016).

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

    This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under EOs 12866 and 13563 (76 FR 3821, January 21, 2011).

    B. Paperwork Reduction Act

    This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. Entities potentially affected directly by this rule include state, local and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this rule.

    D. Unfunded Mandates Reform Act (UMRA)

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

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in E.O. 13132.

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

    This action does not have tribal implications as specified in E.O. 13175. These regulation revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes.

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

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

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

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

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

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

    K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C section 804(2). This rule will be effective February 8, 2017.

    L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 10, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 15, 2016. Gina McCarthy, Administrator.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart OO—Rhode Island
    § 52.2073 [Removed and Reserved]
    2. Section 52.2073 is removed and reserved.
    § 52.2075 [Removed and Reserved]
    3. Section 52.2075 is removed and reserved.
    § 52.2078 [Removed and Reserved]
    4. Section 52.2078 is removed and reserved.
    [FR Doc. 2016-31444 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R09-OAR-2016-0287; FRL-9957-64-Region 9] Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule and technical correction.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving the second 10-year maintenance plans for the Ajo and Morenci areas in Arizona for the 1971 National Ambient Air Quality Standards (NAAQS or “standards”) for sulfur dioxide (SO2), and correcting an error in the description of the Ajo SO2 maintenance area in the Code of Federal Regulations. Elsewhere in this Federal Register, we are proposing approval and soliciting written comment on these actions. If we receive adverse comments on this direct final rule, resulting in withdrawal of the entire rule or any part(s) of it, we will address those comments when we finalize the proposal. The EPA does not plan to institute a second comment period on this action. Any parties interested in commenting must do so at this time.

    DATES:

    This rule is effective March 10, 2017, without further notice, unless we receive adverse comments by February 8, 2017. If the EPA receives adverse comments, we will publish a timely withdrawal in the Federal Register to notify the public that some or all of the provisions in this direct final rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0287 at http://www.regulations.gov, or via email to Wienke Tax, Air Planning Office at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    You may inspect and copy the rulemaking docket for this notice at the following location during normal business hours: Environmental Protection Agency, Region IX, Air Division, Air Planning Office (AIR-2), 75 Hawthorne Street, San Francisco, CA 94105-3901. Copies of the State Implementation Plan materials are also available for inspection at the address listed here: Arizona Department of Environmental Quality, 1110 W. Washington Street, First Floor, Phoenix, AZ 85007, Phone: (602) 771-4335.

    FOR FURTHER INFORMATION CONTACT:

    Wienke Tax, EPA Region IX, (415) 947-4192, [email protected]

    SUPPLEMENTARY INFORMATION:

    Elsewhere in this Federal Register, we are proposing approval and soliciting written comment on this action. Throughout this document, the words “we,” “us,” or “our” mean EPA.

    Table of Contents I. Summary of Action II. Background A. What National Ambient Air Quality Standards are considered in this rulemaking? B. What is a State Implementation Plan? C. What is the background for this action? D. What are the applicable provisions for second 10-year maintenance plans for SO2? III. The EPA's evaluation of the Arizona State submittals A. Did the State meet the CAA procedural requirements? B. Has the State met the substantive maintenance plan requirements? IV. Technical Correction A. History of the Ajo Nonattainment and Maintenance Area Boundary V. Final Action VI. Statutory and Executive Order Reviews I. Summary of Action

    We are approving the second 10-year maintenance plans for the Ajo and Morenci, Arizona SO2 maintenance areas and correcting an error in the boundary description of the Ajo maintenance area in the Code of Federal Regulations (CFR).1 2

    1 For the definition of the Ajo maintenance area, see 40 CFR 81.303. Ajo is a town located in northwestern Pima County, in the southwestern portion of Arizona. The EPA designated the entire area of Pima County as nonattainment for SO2 on March 3, 1978 for lack of a State recommendation. The EPA approved the State's request that the SO2-affected portion of Pima County be limited to the townships surrounding Ajo on April 10, 1979 (44 FR 21261). Townships T11S, R6W; T11S, R5W; T12S, R6W; T12S, R5W; and T13S, R6W comprised the nonattainment area. Townships T11S, R7W; T12S, R7W; T13S, R5W; and T13S, R7W were designated as “cannot be classified.” At the time of our redesignation, we incorrectly identified the maintenance area as all townships and ranges T11S-13S, R5W-R6W as “better than national standards.” However, T11S, R7W; T12S, R7W; T13S, R7W; and T13S, R5W were originally designated as “cannot be classified” and should have remained such. Today, we are correcting that error.

    2 For the definition of the Morenci maintenance area, see 40 CFR 81.303. Morenci is a town in eastern Greenlee County near the border of Arizona and New Mexico. The EPA designated the entire area of Greenlee County as nonattainment for SO2 on March 3, 1978 for lack of a State recommendation. The EPA approved the State's request that the SO2-affected portion of Greenlee County be limited to the townships surrounding Morenci on April 10, 1979 (44 FR 21261). Within Greenlee County, Townships T3S, R28E; T3S, R29E; T3S, R30E; T4S, R28E; T4S, R29E; T4S, R30E; T5S, R28E; and T5S, R29E comprise the maintenance area. Township T5S, R30E is designated as “cannot be classified.”

    II. Background A. What National Ambient Air Quality Standards are considered in this rulemaking?

    Sulfur dioxide (SO2) is the pollutant that is the subject of this action. The NAAQS are health-based and welfare-based standards for certain ambient air pollutants. SO2 is among the ambient air pollutants for which we have established a health-based standard. SO2 causes adverse health effects by reducing lung function, increasing respiratory illness, altering the lung's defenses and aggravating existing cardiovascular disease. Children, the elderly, and people with asthma are the most vulnerable. SO2 has a variety of additional impacts, including acidic deposition, damage to crops and vegetation, and corrosion of natural and man-made materials.

    In 1971, the EPA established both short- and long-term primary NAAQS for SO2. The short-term (24-hour) standard of 0.14 parts per million (ppm) was not to be exceeded more than once per year. The long-term standard specifies an annual arithmetic mean not to exceed 0.030 ppm.3 See 40 CFR 50.4.

    3 Secondary NAAQS are promulgated to protect welfare. The secondary 1971 SO2 NAAQS (3-hour) of 0.50 ppm is not to be exceeded more than once per year. The Ajo and Morenci areas are not classified nonattainment for the secondary standard, and this action relates only to the primary 1971 SO2 NAAQS.

    In 2010, the EPA revised the primary SO2 NAAQS by establishing a new 1-hour standard of 75 parts per billion (ppb). The EPA revoked the existing 1971 primary standards at that time because they would not provide additional public health protection. See 75 FR 35550 (June 22, 2010). This action relates only to the revoked 1971 NAAQS. The State has requested that we take action on these maintenance plans.4

    4 This action is consistent with the CAA's anti-backsliding provisions. EPA's proposed rule on revocation of the 1971 SO2 NAAQS discussed that maintenance SIPs would continue being implemented by states until such time as they are subsumed by new planning and control requirements associated with the revised NAAQS. See 74 FR 64810, 64863 (December 8, 2009).

    B. What is a State Implementation Plan?

    The Clean Air Act (CAA or “Act”) requires states to attain and maintain ambient air quality equal to or better than the NAAQS. The state's commitments for attaining and maintaining the NAAQS are outlined in the State Implementation Plan (SIP) for that state. The SIP is a planning document that, when implemented, is designed to ensure the achievement of the NAAQS. The Act requires that SIP revisions be made periodically as necessary to provide continued compliance with the standards.

    SIPs include, among other things, the following: (1) An inventory of emission sources; (2) statutes and regulations adopted by the state legislature and executive agencies; (3) air quality analyses that include demonstrations that adequate controls are in place to meet the NAAQS; and (4) contingency measures to be undertaken if an area fails to attain the standard or make reasonable progress toward attainment by the required date, or a contingency plan if the area fails to maintain the NAAQS once redesignated. The state must make the SIP available for public review and comment through a public hearing and the SIP must be adopted by the state and submitted to us by the governor or her/his designee.

    The EPA takes action on the SIP submittal, thus rendering the rules and regulations federally enforceable. The approved SIP serves as the state's commitment to take actions that will reduce or eliminate air quality problems. Any subsequent revisions to the SIP must go through the formal SIP revision process specified in the Act.

    C. What is the background for this action? 1. When were the nonattainment areas established? Ajo

    Ajo is located in northwestern Pima County. On March 3, 1978, at 43 FR 8968, for lack of a State recommendation, we designated Pima County as a primary SO2 nonattainment area based on monitored violations of the primary SO2 NAAQS in the area between 1975 and 1977. At the request of the Arizona Department of Environmental Quality (ADEQ), the nonattainment area was subsequently reduced to five townships in and around Ajo. See 44 FR 21261 (April 10, 1979). As a result, townships T11S, R6W; T11S, R5W; T12S, R6W; T12s, R5W; and T13S, R6W made up the nonattainment area. Townships T11S, R7W; T12S, R7W; T13S, R7W; and T13S, R5W were classified as “cannot be classified” areas.

    Morenci

    Morenci is a town in eastern Greenlee County near the border of Arizona and New Mexico. On March 3, 1978, at 43 FR 8968, for lack of a state recommendation, we designated Greenlee County as a primary SO2 nonattainment area based on monitored violations of the primary SO2 NAAQS in the area between 1975 and 1977. At the request of the ADEQ, the nonattainment area was subsequently reduced to the townships in and around Morenci. See 44 FR 21261 (April 10, 1979). As a result, within Greenlee County townships T3S, R28E; T3S, R29E; T3S, R30E; T4S, R28E; T4S, R29E; T4S, R30E; T5S, R28E; and T5S, R29E made up the nonattainment area. Township T5S, R30E was classified as a “cannot be classified” area.

    On the date of enactment of the 1990 CAA Amendments, SO2 areas meeting the conditions of section 107(d) of the Act were designated nonattainment for the SO2 NAAQS by operation of law. Section 107(d) describes the processes by which nonattainment areas are designated, including the pre-existing SO2 nonattainment areas. Thus, the Ajo and Morenci areas remained nonattainment for the primary SO2 NAAQS following enactment of the 1990 CAA Amendments on November 15, 1990.

    2. When were the Ajo and Morenci areas redesignated for SO2?

    In 2004, we redesignated the Ajo and Morenci areas under the criteria used for areas with shut-down smelters and discontinued monitoring described in a memorandum from John Seitz to Regional Office Air Division Directors titled “Redesignation of Sulfur Dioxide Nonattainment Areas in the Absence of Monitored Data,” dated October 18, 2000 (“Seitz Memo”).5

    5See 68 FR 62239 (November 3, 2003) for Ajo and 69 FR 22447 (April 26, 2004) for Morenci.

    Ajo

    Phelps Dodge Mining Company's Ajo Incorporated (PDAI) operation was the largest point source in the Ajo SO2 nonattainment area. On April 4, 1985, the PDAI smelter was permanently deactivated. Dismantling of the Ajo facility began in 1995. By February 1996, the facility was completely dismantled. On October 15, 1997, ADEQ confirmed that the facility was dismantled and no longer existed at the former site. On November 3, 2003, the EPA finalized approval of the maintenance plan and redesignation request for the Ajo area, effective January 2, 2004 (see 68 FR 62239). At that time, we incorrectly identified the maintenance area as townships and ranges T11S-T13S, R5W-R6W as “better than national standards.” However, T13S, R5W was originally designated as “cannot be classified” and should have remained such. Additionally, townships T13S, R5W; T11S, R7W; T12S, R7W; and T13S, R7W were dropped from the CFR, and should be listed in 40 CFR 81.303 as “cannot be classified,” as they were upon Ajo's original designation in 1979. Today, we are correcting those errors.

    Morenci

    The Phelps Dodge Morenci Incorporated (PDMI) operation was the largest SO2 point source in the Morenci nonattainment area during its operation. PDMI was located next to the Morenci copper mine, one of the largest copper producing operations in North America. PDMI was located close to the community of Morenci, in eastern Greenlee County, near the Arizona/New Mexico border.

    On December 31, 1984, the PDMI smelter was permanently deactivated. Dismantling of the Morenci facility began in 1995 and was complete by December 1996. On October 29, 1997, ADEQ confirmed that the facility was dismantled and no longer existed at the former site. On April 26, 2004, the EPA finalized approval of the maintenance plan and redesignation request for the Morenci area, effective June 25, 2004 (see 69 FR 22447).

    3. What is the current status of the areas?

    The Ajo and Morenci areas remain sparsely settled, and only minor industrial or commercial activities that produce small quantities of SO2 emissions are located in or near the nonattainment areas.

    Ajo

    In Ajo, the only remaining SO2 point sources consist of emergency generators run by Freeport-McMoRan Corporation and Minerals Research and Recovery, which have a potential to emit (PTE) of 0.374 tons per year (tpy) of SO2.6 The 50 kilometer (km) buffer area required to be evaluated by the Seitz Memo includes an Arizona Public Service emergency generator, a paper mill, the Gila Bend Air Force Auxiliary Field, and a cotton gin, with a combined PTE of 7.388 tpy.7

    6 Final Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Planning Area (1971 NAAQS) (2013 Ajo Maintenance Plan), page (p.) 23, Table 4.6.

    7 2013 Ajo Maintenance Plan, p. 24, Table 4.7.

    Currently, no ambient SO2 monitors operate in the Ajo area. However, we do not expect the cumulative impact of the sources in and around Ajo to cause a violation of the NAAQS because the area's emissions are so low. No significant new sources have located in the area since our redesignation of the area to attainment in 2003.

    Morenci

    Minor industrial or commercial activities such as Freeport-McMoRan mining operations and emergency generators for the Morenci wastewater treatment plant operate in the area. The 50 km area around the nonattainment area also contains a construction company, well fields, and several other sources that all still have active permits and together produce about 135 tpy of SO2 emissions.8

    8 Proposed Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Planning Area (1971 NAAQS), p. 20, active permits only.

    Currently, no ambient SO2 monitors operate in the Morenci area. However, we do not expect the cumulative impact of the sources in and around Morenci to cause a violation of the NAAQS. No significant new sources have located in the area, and the smelter was the cause of past violations.

    D. What are the applicable provisions for second 10-year maintenance plans for SO2? 1. What are the statutory provisions?

    Section 175A of the CAA provides the general framework for maintenance plans. The initial 10-year maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, including any additional control measures as may be necessary to ensure such maintenance. In addition, maintenance plans are to contain such contingency provisions as we deem necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the state will implement all control measures contained in the nonattainment SIP prior to redesignation.

    Section 175A(b) of the CAA requires states to submit a subsequent maintenance plan revision (second 10-year maintenance plan) eight years after redesignation. The Act requires only that this second 10-year maintenance plan maintain the applicable NAAQS for ten years after the expiration of the first 10-year maintenance plan. Beyond these provisions, however, section 175A of the CAA does not define the content of a second 10-year maintenance plan.

    2. What general EPA guidance applies to SO2 maintenance plans?

    Our primary general guidance on maintenance plans and redesignation requests is a September 4, 1992 memo from John Calcagni, titled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni Memo”). Specific guidance on SO2 redesignations also appears in a January 26, 1995 memo from Sally L. Shaver, titled “Attainment Determination Policy for Sulfur Dioxide Nonattainment Areas” (“Shaver Memo”).

    Guidance on SO2 maintenance plan requirements for an area lacking monitored ambient data, if the area's historic violations were caused by a major point source that is no longer in operation, is found in the Seitz Memo at section II.C.2 and footnote 4. The Seitz Memo exempts eligible areas from the maintenance plan requirements of continued ambient air quality monitoring.

    While the Seitz Memo primarily addresses redesignations, we find it is appropriate to apply the Seitz Memo to second 10-year maintenance plans for areas that were redesignated in accordance with the memo and continue to experience similar conditions to those at the time of redesignation.

    3. What are the requirements for maintenance plans for single-source SO2 nonattainment areas in the absence of monitored data?

    Our historic redesignation policy for SO2 has called for eight quarters of clean ambient air quality data as a necessary prerequisite to redesignation of any area to attainment. The Seitz Memo provides guidance on SO2 maintenance plan requirements for an area lacking monitored ambient data, if the area's historic violations were caused by a major point source that is no longer in operation. To allow for these areas to qualify for redesignation to attainment, this policy requires that the maintenance plan address otherwise applicable provisions, and include:

    (1) Emissions inventories representing actual emissions when violations occurred; current emissions; and emissions projected to the 10th year after redesignation; all three inventories should include estimates of emissions in a 50 km buffer zone around the nonattainment area;

    (2) dispersion modeling showing that no NAAQS violations will occur over the next 10 years and that the shut-down source was the dominant cause of the high concentrations in the past;

    (3) evidence that if the shut-down source resumes operation, it would be considered a new source and be required to obtain a permit under the Prevention of Significant Deterioration (PSD) provisions of the CAA; and

    (4) a commitment to resume monitoring before any major SO2 source commences operation.

    III. The EPA's Evaluation of the Arizona State Submittals A. Did the State meet the CAA procedural requirements? Ajo

    On February 22, 2013, ADEQ submitted to the EPA the “Final Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Planning Area (1971 NAAQS)” (“2013 Ajo Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2013 Ajo Maintenance Plan, which includes the notice of public hearing, the agenda for the February 7, 2013 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.

    On August 22, 2013, the 2013 Ajo Maintenance Plan was deemed complete by operation of law. See 40 CFR part 51, appendix V, for the EPA's completeness criteria, which must be satisfied before EPA formal review.

    Morenci

    On December 18, 2014, ADEQ submitted to the EPA the “Proposed Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Planning Area (1971 NAAQS)” (“2014 Morenci Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2014 Morenci Maintenance Plan, which includes the notice of public hearing, the agenda for the December 15, 2014 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.

    On May 10, 2015, the 2014 Morenci Maintenance Plan was deemed complete by operation of law. See 40 CFR part 51, appendix V, for the EPA's completeness criteria, which must be satisfied before EPA formal review.

    B. Has the State met the substantive maintenance plan requirements? 1. Were the area's violations caused by a major point source of SO2 emissions that is no longer in operation?

    As discussed above, the only major source of SO2 emissions within the Ajo nonattainment area was the Phelps Dodge Mining Company's PDAI copper smelter, which ceased operation in 1985 and was completely dismantled by February 1996. The last recorded 24-hour or annual average exceedances of the primary NAAQS at PDAI occurred in 1984. During the monitoring network's history, annual average SO2 levels were generally half of the current NAAQS (0.030 ppm). See 2013 Ajo Maintenance Plan, page (p.) 17. ADEQ removed the SO2 monitor in 1985, and the smelter operating permits expired. The smelting equipment was removed over a period of years, and the smelter was completely dismantled by February 1996. No new sources of SO2 of the magnitude of PDAI have located in the area. Thus, Ajo meets this criterion for review under the Seitz Memo.

    As discussed above, the only major source of SO2 emissions within the Morenci nonattainment area was the Phelps Dodge Mining Company's PDMI copper smelter, which was permanently deactivated by December 31, 1984 and was completely dismantled by December 1996. The last recorded 24-hour or annual average exceedances of the primary NAAQS at PDMI occurred in 1984. During the monitoring network's history, annual average SO2 levels were generally half of the current NAAQS (0.030 ppm). See 2014 Morenci Maintenance Plan, p. 15-16. ADEQ removed the SO2 monitors in 1985, and the smelter operating permits expired. The smelting equipment was removed over a period of years, and the smelter was completely dismantled by December 1996. No new sources of SO2 of the magnitude of PDMI have located in the area. Thus, Morenci meets this criterion for review under the Seitz Memo.

    2. Has the state met the requirements for second 10-year maintenance plans?

    The 2013 Ajo Maintenance Plan and 2014 Morenci Maintenance Plan both extend the maintenance period for ten years after the expiration of the first 10-year maintenance plans, as required by Section 175A(b) of the CAA. As discussed below, the State has addressed the requirements in the Seitz Memo for emissions inventories, modeling, permitting of major new sources, and agreement to commence monitoring if a new major source locates in either the Ajo or Morenci areas. Therefore, the State has met the specific criteria in the Seitz Memo for approval of maintenance plans and redesignation requests where a single source was the historic cause of violations and the source is now shut down. We provide more details on each requirement and how the 2013 Ajo Maintenance Plan and the 2014 Morenci Maintenance Plan meet each requirement in the following sections.

    Ajo a. Emissions Inventories

    In addition to reproducing the emissions inventories in the Ajo Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (June 18, 2002) (“2002 Ajo maintenance plan”), the 2013 Ajo Maintenance Plan includes new emissions inventories for 2008, representing an updated “current” emissions inventory (the most recent National Emissions Inventory (NEI) available at the time), 2010, 2015, 2020, and 2025 for the second 10-year maintenance period.9 Continued maintenance of the Ajo area for 10 years following the initial 10-year maintenance period is demonstrated in part by showing that future SO2 emissions in the area are not expected to exceed the level of the attainment emissions inventory.

    9 The State provided the three emissions inventories specified in the Seitz Memo for the sources in, and within 50 kilometers of, the Ajo nonattainment area in the 2002 Ajo maintenance plan. For a representative year when the copper smelter was in operation (1981), direct SO2 emissions from smelting operations were 39,596 tpy. ADEQ's 2002 submittal identified only a single existing point source within the Ajo Area, the Phelps Dodge Generator Station. Phelps Dodge has since shut down the generators and no longer uses them as emergency/back up electric supply. See 2013 Ajo Maintenance Plan, p. 32 and Appendix C-1.

    The emissions inventories in the 2013 Ajo Maintenance Plan include estimates of SO2 from all relevant source categories, which the 2013 Plan divides among stationary, and area and mobile. Point source information was received from the Pima County Department of Environmental Quality (PDEQ) and the Maricopa County Air Quality Division's annual emissions inventory data. The Ajo maintenance area contains two point sources (i.e., Freeport-McMoRan Corporation Childs Well Field Emergency Generator, and Minerals Research and Recovery, Inc.), which together emit less than 1 tpy SO2. The 50 km buffer area contains four point sources, including a cotton gin, a paper mill, an Air Force auxiliary field, and an emergency generator. The 2013 Ajo Maintenance Plan includes a description of current facility types, emitting equipment, permitted emissions limits, operating rates, and emissions calculation methods.

    Area and mobile sources in ADEQ's 2008 and subsequent year inventories were derived from the EPA's NEI and local agency records. Historical and 2008 emissions inventories demonstrate that no significant area or mobile sources existed in the Ajo area prior to or subsequent to the smelter operation, which closed in 1985.

    Based on our review of the emissions inventories in the 2013 Ajo Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.

    b. Dispersion Modeling

    Past EPA policy memoranda on SO2 redesignations all recommend dispersion modeling to show that the NAAQS is met and will be maintained. The Seitz Memo recommends dispersion modeling of all point sources within50 km of the nonattainment area boundary. Screening modeling can be used to conservatively show that non-smelter sources have only an insignificant contribution to average SO2 concentrations in a nonattainment area.

    For the 2002 Ajo Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model run with conservative assumptions about source parameters and meteorology. At the time of the 2002 Ajo Maintenance Plan, the Ajo nonattainment area had one minor point source of SO2 emissions (i.e., Phelps-Dodge Generating Station) and one permitted minor point source in the 50 km buffer (i.e., the proposed Gila Bend Regional Landfill). The model predicted that the impact from these two sources would not exceed 66% of the 1971 SO2 NAAQS, even assuming constant worst-case conditions about high-sulfur content fuel use.

    The Seitz Memo also requires a modeling analysis that shows that the point sources that were shutdown were the dominant sources contributing to high SO2 concentrations in the airshed. Since the emissions of non-smelter sources in the area had changed relatively little since the time that emission controls were placed on the smelter, this same screening modeling was used to show that the non-smelter sources were insignificant in the past, and thus the smelter was the dominant source contributing to past high SO2 concentrations.

    ADEQ did not conduct a new modeling analysis for the 2013 Ajo Maintenance Plan. As described above, the modeling for the 2002 Ajo Maintenance Plan modeled the existing two sources at maximum projected emissions rates from 2004 to 2015 and showed the area would not exceed 66% of the NAAQS. Since that modeling analysis was conducted, the Phelps-Dodge Generating Station has shut down, the Gila Bend Regional Landfill was never constructed, and the permit for the landfill was allowed to expire.

    Currently, only two sources operate within the nonattainment area (i.e., Freeport-McMoRan Incorporated Childs Well Field Emergency Generator, and Minerals Research and Recovery), and they are permitted to emit less than 1% of the emissions modeled in the 2002 Ajo Maintenance Plan. Point sources within the 50 km buffer surrounding the nonattainment area emit about 25% of emissions modeled in the 2002 Ajo Maintenance Plan. 2025 projections show that these low emissions are expected to persist through the second 10-year maintenance period. See 2013 Ajo Maintenance Plan, pp. 33 and 34.

    ADEQ proposes, and we concur, that because current emissions in the maintenance area and the 50 km buffer are a small fraction of modeled emissions from 2002, the ambient SO2 modeling requirement for second 10-year maintenance plans is met by the prior modeling, and the State has demonstrated that the 1971 SO2 NAAQS is adequately protected.

    c. Treatment of New Sources of SO2 Emissions

    In nonattainment areas, section 172(c)(5) of the CAA requires New Source Review (NSR) permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure that projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.

    ADEQ and the PDEQ have PSD permitting programs (i.e., Arizona Administrative Code (A.A.C.) R18-2-406 and Pima County Code 17.16.590) that were established to preserve the air quality in areas where ambient standards have been met. The State's updated PSD program was approved into the SIP on November 2, 2015 (80 FR 67319). PDEQ's PSD program is not SIP-approved, but the federal PSD permitting program at 40 CFR 52.21 was delegated to PDEQ effective April 14, 1994.

    The PSD program has applied to any major source or major modification in the Ajo area since the area was redesignated to attainment for SO2 in 2003, except for coarse particulate (PM10), for which the area is designated nonattainment. Under section 172(c)(5) of the CAA, major sources and major modifications of PM10 in the Ajo area remain subject to the nonattainment NSR program, while all other NSR regulated pollutants are subject to the PSD program. Thus the existing ADEQ and PDEQ PSD and NSR programs satisfy the preconstruction permit provision of the Seitz Memo as one of the prerequisites to redesignation for the Ajo SO2 nonattainment area.

    d. Commitment to Resume Monitoring

    ADEQ commits to resume monitoring before any major source of SO2 commences to operate in the Ajo maintenance area. See 2013 Ajo Maintenance Plan, p. 38. This addresses the monitoring provision of the Seitz Memo.

    Morenci a. Emissions Inventory

    The 2014 Morenci Maintenance Plan includes historical inventories that were submitted as part of the Morenci Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (submitted June 21, 2002) (“2002 Morenci maintenance plan”) as well as a current-year inventory for 2011 (the most recent NEI available at the time), and projected inventories for 2015, 2020, 2025, and 2030 for the second 10-year maintenance period.10

    10 In the 2002 Morenci Maintenance Plan, the State provided the three emissions inventories specified in the Seitz Memo for the sources in, and within 50 kilometers of, the Morenci nonattainment area. For a representative year when the copper smelter was in operation (1984), direct actual SO2 emissions from smelting operations were 82,432 tpy. During its operation, the Morenci primary copper smelter was the only major point source in the area. The 2002 Morenci Maintenance Plan included inventories for 1984 (a year the smelter was in operation), 1999 (a year the area was attaining the SO2 standard), and 2015 (the projected inventory for the horizon year of the maintenance period). Sources in the 50 km buffer around the Morenci area were estimated to emit 186.5 tpy in 1999, based on PTE, but had actual emissions significantly lower, at 1.2 tpy. See 2014 Morenci Maintenance Plan, p. 18.

    The emissions inventories in the 2014 Morenci Maintenance Plan include estimates of SO2 emissions from all relevant source categories, which are divided among stationary, area, and mobile source categories. Additional information on how the inventories were developed, including activity data and emissions calculations, is provided in Appendix C of the 2014 Morenci Maintenance Plan. Point source information was developed by ADEQ from permit information and the NEI. The 2011 inventory identifies two existing point sources within the Morenci maintenance area: The Freeport-McMoRan Morenci mine with 2011 actual emissions of 48.5 tpy SO2, and the Morenci Townsite Wastewater Treatment Plant Emergency Generators with 2011 actual emissions of 0.003 tpy SO2. In 2011, 13 point additional sources with actual emissions of 38.05 tpy SO2 were located within 50 km of the Morenci maintenance area boundary. As of 2014, six of these sources had terminated their permits, resulting in slightly lower emissions.

    Area and mobile source emissions in ADEQ's 2011 and subsequent year inventories were derived from the NEI. The year 2011 was a historically high wildfire year, and included the largest wildfire in Arizona history (i.e., the Wallow fire), which burned in Greenlee County and surrounding areas.11 ADEQ assumed the 2011 wildfire emissions remained constant when projecting emissions into the future.

    11 National Interagency Fire Center's Web site at https://www.nifc.gov/fireInfo/fireInfo_statistics.html, “Historical year-end statistics by state,” and https://en.wikipedia.org/wiki/List_of_Arizona_wildfires. Acres burned in 2011 in Arizona were more than 10 times higher than 2010 acres burned in Arizona due to wildfires, and about five times higher than acres burned in Arizona in 2012 due to wildfires.

    Based on our review of the emissions inventories in the 2014 Morenci Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.

    b. Dispersion Modeling

    The EPA policy memoranda on SO2 redesignations recommend dispersion modeling to show that the NAAQS is met and will be maintained. The Seitz Memo recommends dispersion modeling of all point sources within 50 km of the nonattainment area boundary. For the 2002 Morenci Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model, which was run with conservative assumptions about source parameters and meteorology. The modeling results indicated that the impact of existing sources on concentrations within the nonattainment area would not exceed 25 percent of the 1971 SO2 NAAQS.

    The Seitz Memo also requires a modeling analysis that shows point sources that were shutdown were the dominant sources contributing to high SO2 concentrations in the airshed. The screening modeling described above was used in the 2002 Morenci Maintenance Plan to show that the non-smelter sources have an insignificant contribution, and thus the smelter was the dominant source contributing to past high SO2 concentrations.

    For the 2014 Morenci Maintenance Plan, ADEQ conducted a modeling analysis similar to the analysis in the 2002 Morenci Maintenance Plan. The two largest sources in the maintenance area and within the 50 km buffer area were modeled. The two sources are Freeport-McMoRan Morenci Mine (FMMM) in the maintenance area, with a PTE of 88 tpy SO2, and the Freeport-McMoRan Safford Mine (FMSM) in the 50 km buffer area, with a PTE of 81 tpy SO2. Other point sources were not modeled because of their small or negligible emissions.

    The EPA dispersion model AERSCREEN (version 11126) was used to conservatively estimate the impact of FMMM and FMSM on maintenance in the Morenci planning area.12 The results of the AERSCREEN modeling indicated that the impact of these existing sources would have a cumulative potential impact of 42-53% of the 1971 annual and 24-hour SO2 NAAQS respectively. See 2014 Morenci Maintenance Plan, p. 29. Projections for 2030 show that this low level of emissions is expected to persist through the second maintenance period. See 2014 Morenci Maintenance Plan, p. 32. We therefore conclude that the State has demonstrated that the 1971 SO2 NAAQS is adequately protected.

    12 AERSCREEN has replaced SCREEN3 as the EPA's preferred screening model. See Memorandum dated April 11, 2011, from Tyler Fox to the EPA Regional Modeling Contacts, “AERSCREEN Released as EPA Recommended Screening Model” in the docket for this action. SCREEN3 was used for the 2002 Morenci Maintenance Plan.

    c. Treatment of New Sources of SO2 Emissions

    In nonattainment areas, section 172(c)(5) of the CAA requires NSR permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.

    ADEQ has a PSD permitting program (i.e., A.A.C. R18-2-406) that was established to preserve the air quality in areas where ambient standards have been met. The State's updated PSD program was approved into the SIP on November 2, 2015 (80 FR 67319). The PSD program has applied to any major source or major modification in the Morenci area since the area was redesignated to attainment for SO2 in 2004. Thus the ADEQ's existing PSD program satisfies the preconstruction permit provision of the Seitz Memo as one of the prerequisites to redesignation for the Morenci SO2 nonattainment area.

    d. Commitment To Resume Monitoring

    ADEQ commits to resume monitoring before any major source of SO2 commences to operate. See 2014 Morenci Maintenance Plan, p. 16. This addresses the monitoring provision of the Seitz Memo.

    3. Other CAA Requirements a. Contingency Plan

    As discussed above, section 175A of the CAA sets forth the statutory requirements for maintenance plans, and the Calcagni, Seitz and Shaver Memos cited above contain specific EPA guidance. The only maintenance plan element not covered by the Seitz Memo is the contingency provisions. Section 175A(d) of the CAA requires that maintenance plans contain contingency provisions deemed necessary by the Administrator to assure that the state will promptly correct any violation of the standard which occurs after the redesignation of the area as an attainment area.

    Ajo

    The 2013 Ajo Maintenance Plan includes the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory. Additionally, ADEQ commits to reestablish an appropriate air quality monitoring network before any major source of SO2 begins operations in the Ajo maintenance area. See 2013 Ajo Maintenance Plan, p. 38.

    Since the primary cause of future violations of the 1971 SO2 NAAQS in the area would be from modified or new point sources, ADEQ's current operating permit program places limits on SO2 emissions from existing sources. Should a new facility be constructed in the Ajo area or an existing facility want to upgrade or increase SO2 emissions, the facility would also be subject to PSD as required in the Calcagni Memo.

    The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO2 emissions of the magnitude of the PDAI smelter, and there is no SO2 monitoring in the Ajo area, we agree with the State that the level of specificity recommended in the Calcagni Memo is not necessary, and we conclude that the State's commitment satisfactorily addresses the CAA provisions. We find that the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory and the State's PSD permitting programs are sufficient to assure that the Ajo area will not violate the NAAQS.

    Morenci

    The 2014 Morenci Maintenance Plan includes the State's commitment to continue to demonstrate maintenance of the SO2 NAAQS through updates to the emissions inventory. Additionally, ADEQ commits to reestablish an appropriate air quality monitoring network before any major source of SO2 begins operations in the Morenci maintenance area. See 2014 Morenci Maintenance Plan, p. 32.

    Since the primary cause of future violations of the 1971 SO2 NAAQS in the area would be from modified or new point sources, ADEQ's current operating permit program places limits on SO2 emissions from existing sources. Should a new facility be constructed in the Morenci area or an existing facility want to upgrade or increase SO2 emissions, the facility would also be subject to PSD as required in the Calcagni Memo.

    The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO2 emissions of the magnitude of the PDMI smelter, and there is no SO2 monitoring in the Morenci area, we agree with the State that the level of specificity recommended in the Calcagni Memo is not necessary, and we conclude that the State's commitment satisfactorily addresses the CAA provisions. We find that the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory and the State's PSD permitting programs are sufficient to assure that the Morenci area will not violate the NAAQS.

    b. Transportation and General Conformity

    Conformity is required under section 176(c) of the CAA to ensure that federal actions are consistent with (“conform to”) the purpose of the SIP. Conformity to the purpose of the SIP means that federal activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS or interim reductions and milestones. Conformity applies to areas that are designated nonattainment and to maintenance areas. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded, or approved under Title 23 U.S.C. and the Federal Transit Act (“Transportation conformity”) as well as to other federally supported or funded projects (“general conformity”).

    Transportation conformity applies to projects that require Federal Highway Administration or Federal Transit Administration funding. 40 CFR part 93 describes the requirements for federal actions related to transportation plans, programs, and projects to conform to the purposes of the SIP. Because the EPA does not consider SO2 a transportation-related criteria pollutant,13 only the requirements related to general conformity apply to the Ajo and Morenci areas.

    13 40 CFR 93.102(b)(1).

    Section 176(c)(4) of the CAA establishes the framework for general conformity. Besides ensuring that federal actions not covered by the transportation conformity rule will not interfere with the SIP, the general conformity regulations encourage consultation between the federal agency and the state or local air pollution control agencies before and during the environmental review process, as well as public notification of and access to federal agency conformity determinations, and allows for air quality review of individual federal actions.

    Section 176(c) of the CAA required the states to revise their SIPs to establish criteria and procedures to ensure that federally supported or funded projects in nonattainment and maintenance areas “conform” to the air quality planning goals in the applicable SIP. SIP revisions intended to meet the conformity requirements in section 176(c) are referred to as “conformity SIPs.” In 2005, Congress amended section 176(c), and under the amended conformity provisions, states are no longer required to submit conformity SIPs for general conformity, and the conformity SIP requirements for transportation conformity have been reduced to include only those relating to consultation, enforcement, and enforceability. CAA section 176(c)(4)(E).

    The EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of a redesignation request under section 107(d)(3)(E)(v) because state conformity rules are still required after redesignation and Federal conformity rules apply where state rules have not been approved. See Wall v. EPA, 265 F. 3d 426 (6th Cir. 2001), upholding this interpretation. Because both Ajo and Morenci have already been redesignated for this standard, we believe it is reasonable to apply the interpretation of conformity SIP requirements as not applying for the purposes of redesignation to the approval of second ten-year maintenance plans.

    Criteria for making determinations and provisions for general conformity are contained in Arizona Administrative Code R18-2-1438. Arizona has an approved general conformity SIP.14

    14 64 FR 19916, April 23, 1999.

    Ajo

    ADEQ commits in the 2013 Ajo Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area. See 2013 Ajo Maintenance Plan, p. 13.

    Morenci

    ADEQ commits in the 2014 Morenci Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area. See 2014 Morenci Maintenance Plan, p. 11.

    IV. Technical Correction A. History of the Ajo Nonattainment and Maintenance Area Boundary

    On November 3, 2003, the EPA finalized approval of the maintenance plan and redesignation request for the Ajo area, effective January 2, 2004 (see 68 FR 62239). To codify this rulemaking, we amended 40 CFR 81.303 that lists the designations for air quality planning areas in Arizona, but we incorrectly identified the Ajo maintenance area in the Arizona SO2 table by dropping township T13S, R5W from the maintenance area, and inadvertently deleted other townships and ranges in the “cannot be classified” description. Township T13S, R5W as well as townships T11S, R7W; T12S, R7W; and T13S, R7W should have remained “cannot be classified.”

    Section 110(k)(6) of the CAA provides that when the EPA's action approving any plan or plan revision (or part thereof), area designation, redesignation, classification, or reclassification was in error, the EPA may in the same manner revise such action. Under the EPA's authority under section 110(k)(6) of the Act, we are taking direct final action to amend the Arizona-SO2 table in 40 CFR 81.303 by re-codifying and correcting the previous detailed descriptions of the Ajo maintenance area and townships identified as “cannot be classified.”

    The maintenance area consists of townships T11S, R6W; T11S, R5W; T12S, R6W; T12S, R5W; and T13S, R6W. In addition, townships T13S, R5W; T11S, R7W; T12S, R7W; and T13S, R7W are listed in 40 CFR 81.303 as “cannot be classified,” as they were upon the Ajo area's original designation in 1979.

    V. Final Action

    We are approving the second 10-year SO2 maintenance plans for the Ajo and Morenci areas in Arizona under sections 110 and 175A of the CAA and correcting an error made in the description of the Ajo maintenance area and in the identification of townships as “cannot be classified” in the CFR when we redesignated the area in 2003. As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted SIPs because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted SIPs. If we receive adverse comments by February 8, 2017, we will publish a timely withdrawal in the Federal Register to notify the public that some or all of the provisions of the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on March 10, 2017. This will incorporate these SIPs into the federally enforceable SIP.

    VI. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 10, 2017. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

    List of Subjects 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.

    40 CFR Part 81

    Environmental protection, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.

    Dated: December 15, 2016. Alexis Strauss, Acting Regional Administrator, EPA Region IX.

    Chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart D—Arizona 2. Section 52.120 in paragraph (e), table 1 is amended by: a. Adding an entry for “ `Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Area (1971 NAAQS), (February 2013) excluding Appendix C, “Overview of Point Source Emissions Limits and Potential to Emit” after the heading “Part D Elements and Plans (Other than for the Metropolitan Phoenix and Tucson Areas)' ”; and b. Adding an entry for “Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Area (1971 NAAQS), (December 2014)” after the entry for “Final Miami Sulfur Dioxide Nonattainment Area State Implementation and Maintenance Plan (June 2002)(revised May 26, 2004), excluding appendix A (“SIP Support Information”), sections A.1 (“Pertinent Sections of the Arizona Administrative Code”) and A.2 (“Information Regarding Revisions to AAC R18-2-715 and R18-2-715.01, `Standards of Performance for Primary Copper Smelters: Site Specific Requirements; Compliance and Monitoring'”); and appendix D (“SIP Public Hearing Documentation”)”.

    The additions read as follows:

    § 52.120 Identification of plan.

    (e) * * *

    Table 1—EPA-Approved Non-Regulatory and Quasi-Regulatory Measures [Excluding certain resolutions and statutes, which are listed in tables 2 and 3, respectively] 1 Name of SIP provision Applicable geographic or nonattainment area or title/subject State submittal date EPA approval date Explanation The State of Arizona Air Pollution Control Implementation Plan *         *         *         *         *         *         * Part D Elements and Plans (Other than for the Metropolitan Phoenix or Tucson Areas) Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Area (1971 NAAQS), (February 2013), excluding Appendix C, “Overview of Point Source Emissions Limits and Potential to Emit” Ajo Sulfur Dioxide Air Quality Planning Area February 22, 2013 1/9/2017, [Insert Federal Register citation] Adopted by the Arizona Department of Environmental Quality on February 22, 2013. Fulfills requirements for second ten-year maintenance plans. The SIP includes a request to correct the maintenance area boundary. *         *         *         *         *         *         * Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Area (1971 NAAQS), (December 2014) Morenci Sulfur Dioxide Air Quality Planning Area December 18, 2014 January 9, 2017, [Insert Federal Register citation] Adopted by the Arizona Department of Environmental Quality on December 18, 2014. Fulfills requirements for second ten-year maintenance plans. *         *         *         *         *         *         * 1 Table 1 is divided into three parts: Clean Air Act Section 110(a)(2) State Implementation Plan Elements (excluding Part D Elements and Plans), Part D Elements and Plans (other than for the Metropolitan Phoenix or Tucson Areas), and Part D Elements and Plans for the Metropolitan Phoenix and Tucson Areas.
    PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 3. The authority citation for part 81 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    4. Section 81.303 is amended in the table for “Arizona—1971 Sulfur Dioxide NAAQS (Primary and Secondary)” by revising the entry for “Ajo” to read as follows:
    § 81.303 Arizona. Arizona—1971 Sulfur Dioxide NAAQS [Primary and secondary] Designated area Does not meet primary standards Does not meet secondary
  • standards
  • Cannot be
  • classified
  • Better than
  • national
  • standards
  • Ajo: T11S, R5W X T11S, R6W X T12S, R5W X T12S, R6W X T13S, R6W X T11S, R7W X T12S, R7W X T13S, R5W X T13S, R7W X *         *         *         *         *         *         *
    [FR Doc. 2016-31637 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL MARITIME COMMISSION 46 CFR PART 503 [Docket No. 16-18] RIN 3072-AC66 Amendments to Regulations Governing Access to Commission Information and Records; Freedom of Information Act AGENCY:

    Federal Maritime Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Federal Maritime Commission amends its regulations for processing requests for information and records under the Freedom of Information Act (FOIA). The regulations are being revised to incorporate changes brought by amendments to the FOIA under the FOIA Improvement Act of 2016. The Act requires agencies to review their FOIA regulations and issue regulations implementing the amendments no later than 180 days after enactment.

    DATES:

    This rule is effective January 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mail: Rachel E. Dickon, Assistant Secretary, Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573-0001. Phone: (202) 523-5725. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016. The Act prescribes a range of procedural requirements that affect the Commission's FOIA regulations, and which this final rule implements, including requirements that the Commission:

    • Provide publically available documents and its FOIA Annual Reports in an electronic format;

    • provide FOIA requesters the right to seek dispute resolution services from the Commission's FOIA Public Liaison and/or the Office of Government Information Services during the FOIA process;

    • provide a minimum of 90 days for FOIA requesters to file an administrative appeal; and

    • not apply the deliberative process privilege to records created 25 years or more before the date on which the records were requested.

    Regulatory Analysis and Notices Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities and prepare an initial regulatory flexibility analysis, unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities. This final rule will affect only persons who file FOIA requests, and therefore, the Commission certifies that this final rule will not have a significant or negative economic impacts on a substantial number of small entities.

    Paperwork Reduction Act (PRA)

    The Paperwork Reduction Act of 1995 requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before making most requests for information if the agency is requesting information from more than ten persons. 44 U.S.C. 3507. The agency must submit collections of information in proposed rules to OMB in conjunction with the publication of the proposed rulemaking. 5 CFR 1320.11. This final rule does not impose any collections of information, as defined by 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).

    National Environmental Policy Act (NEPA)

    This final rule will have no physical impact upon the environment, and therefore, will not require any further review under NEPA.

    Regulation Identifier Number

    The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document may be used to find this action in the Unified Agenda, available at http://www.reginfo.gov/public/do/eAgendaMain.

    List of Subjects in 46 CFR Part 503

    Administrative practices and procedures, Archives and records, Classified information, Confidential business information, Freedom of information, Information, Privacy, Records, Reporting and recordkeeping requirements, Sunshine Act.

    For the reasons set forth in the preamble, the Federal Maritime Commission amends 46 CFR part 503 as follows:

    PART 503—PUBLIC INFORMATION 1. The authority citation for part 503 continues to read as follows: Authority:

    5 U.S.C. 552, 552a, 552b, 553; 31 U.S.C. 9701; E.O. 13526, 75 FR 707, 3 CFR, 2010 Comp., p. 298.

    Subpart C—Records, Information and Materials Generally Available to the Public Without Resort to Freedom of Information Act Procedures 2. Amend § 503.21 by revising paragraphs (a) introductory text and (c) introductory text to read as follows:
    § 503.21 Mandatory public records.

    (a) The Commission, as required by the Freedom of Information Act, 5 U.S.C. 552, is responsible for determining which of its records must be made publicly available, for identifying additional records of interest to the public that are appropriate for public disclosure, for posting and indexing such records, and for reviewing and updating posted records and indices on an ongoing basis. The Commission makes the following materials available for public inspection in electronic format on its Web site at www.fmc.gov:

    (c) The Commission maintains and makes available for public inspection in an electronic format, a current log or index providing identifying information for the public as to any matter which is issued, adopted, or promulgated, and which is required by paragraph (a) of this section to be made available or published.

    Subpart D—Requests for Records Under the Freedom of Information Act 3. Amend § 503.32 by revising paragraphs (a)(1) and (2), (a)(3)(i)(B), and (b)(3) to read as follows:
    § 503.32 Procedures for responding to requests made under the Freedom of Information Act.

    (a) * * *

    (1) Such determination shall be made by the Secretary within twenty (20) business days after receipt of such request, except as provided in paragraphs (b) and (e)(4) of this section, and the Secretary shall immediately notify the requester of:

    (i) Such determination and the reasons therefor;

    (ii) The right of such person to seek assistance from the agency's FOIA Public Liaison; and

    (iii) In the case of an adverse determination, the right of such requester to appeal to the Chairman no less than 90 days after the date of such adverse determination, and the right of such requester to seek dispute resolution services from the agency's FOIA Public Liaison or the Office of Government Information Services.

    (2) Upon granting a request, the Secretary shall promptly make records available to the requestor. Upon denial of such a request the Secretary shall promptly notify the requestor of the determination, explain the reason for denial, give an estimate of the volume of matter denied, and set forth the names and titles or positions of each person responsible for the denial of the request.

    (3)(i) * * *

    (B) Be filed not later than 90 days following receipt of notification of full or partial denial of records requested.

    (b) * * *

    (3) If the time limit is extended as prescribed under this section, and the request cannot be processed within the extended time limit, the Secretary shall notify the requestor, and either provide the requestor with an opportunity to limit the scope of the request so that it may be processed within the time limit, or provide the requestor an opportunity to arrange with the Secretary an alternative time frame for processing the request or a modified request. To aid the requester, the Commission will make available its FOIA Public Liaison, who shall assist in the resolution of any dispute between the requester and the Commission, and notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services.

    4. Amend § 503.33 by revising paragraph (a)(5) and adding paragraphs (a)(8) and (9) to read as follows:
    § 503.33 Exceptions to availability of records.

    (a) * * *

    (5) Inter-agency or intra-agency memoranda or letters that would not be available by law to a party other than an agency in litigation with the Commission, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested.

    (8) Contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or

    (9) Geological and geophysical information and data, including maps, concerning wells.

    5. Amend § 503.34 by revising paragraph (b) to read as follows:
    § 503.34 Annual report of public information request activity.

    (b) Each such report shall be made available to the public in electronic format.

    By the Commission.

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-31891 Filed 1-6-17; 8:45 am] BILLING CODE 6731-AA-P
    GENERAL SERVICES ADMINISTRATION 48 CFR Parts 516 and 552 [Change 81; GSAR Case 2015-G513; Docket No. 2016-0021; Sequence No. 1] RIN 3090-AJ79 General Services Administration Acquisition Regulation (GSAR); Fair Opportunity Complaints on GSA Contracts AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Final rule.

    SUMMARY:

    The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) to clarify that the ordering-agency task and delivery order Ombudsman has jurisdiction and responsibility to review and resolve fair opportunity complaints on tasks and delivery orders placed against GSA multiple-award contracts.

    DATES:

    Effective: January 9, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, contact Ms. Dana Davis, General Services Acquisition Policy Division, GSA, by telephone at 202-357-9652 or by email at [email protected] For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite GSAR case 2015-G513.

    SUPPLEMENTARY INFORMATION:

    I. Discussion of Changes

    The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) part 552, Solicitation Provisions and Contract Clauses at 552.216-74 Task and Delivery Orders. The final rule clarifies that the jurisdiction and responsibility to review and resolve fair opportunity complaints placed against GSA multiple-award contracts lies with the ordering-agency task and delivery order Ombudsman. Also, the final rule requires the ordering agency to include contact information for their task and delivery order Ombudsman when placing task or delivery orders against GSA multiple-award contracts. Finally, so that GSA can maintain insight into fair opportunity complaints that arise on orders other agencies place against these contracts, the final rule requires the contractor to provide a copy of its complaint to the GSA Procurement Ombudsman for informational purposes, at the same time the contractor files its complaint to the ordering agency for action.

    II. Public Comments Not Required

    41 U.S.C. 1707, Publication of proposed regulations, applies to the publication of the General Services Administration Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure, or form (including amendment or modification thereof) must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it does not have a significant impact on the public, contractors or offerors. This rule brings internal GSAR policy up-to-date with FAR policy. The change clarifies internal operating procedures by the Government by clarifying GSA's jurisdiction regarding fair opportunity complaints. The proposed rule comment period is impracticable as the FAR has already directed specific regulatory action.

    III. Executive Orders 12866 and 13563

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

    IV. Regulatory Flexibility Act

    The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant GSAR revision and 41 U.S.C. 1707 does not require publication for public comment.

    V. Paperwork Reduction Act

    This final rule does not contain any information collection that requires additional approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    List of Subjects in 48 CFR Parts 516 and 552

    Government procurement.

    Dated: December 29, 2016. Nicholas West, Acting Senior Procurement Executive, Acting Director, Office of Acquisition Policy, Office of Governmentwide Policy.

    Therefore, GSA amends 48 CFR parts 516 and 552 as set forth below:

    1. The authority citation for 48 CFR parts 516 and 552 continues to read as follows: Authority:

    40 U.S.C. 121(c).

    PART 516—TYPES OF CONTRACTS 2. Amend section 516.506 by— a. Revising paragraph (b); b. Redesignate paragraph (d) as paragraph (e); and c. Adding a new paragraph (d).

    The revision and addition reads as follows:

    516.506 Solicitation provisions and contract clauses.

    (b) In solicitations and contracts for multiple-award contracts where GSA is the only ordering activity, or for GSA orders placed against a GSA multiple-award contract, insert clause 552.216-74, GSA Task-Order and Delivery-Order Ombudsman. This clause shall not be included in GSA-awarded contracts available for multiple agency use (i.e., Governmentwide Acquisition Contracts, Multi-Agency Contracts); instead, see paragraph (d) of this section.

    (d) Insert clause 552.216-76, Ordering Agency Task-Order and Delivery-Order Ombudsman in all GSA-awarded contracts available for multiple agency use (i.e., Governmentwide Acquisition Contracts, Multi-Agency Contracts).

    PART 552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 3. Amend section 552.216-74 by revising the date of the clause and paragraph (c) to read as follows:
    552.216-74 GSA Task-Order and Delivery-Order Ombudsman. GSA Task-Order and Delivery-Order Ombudsman JAN 2017)

    (c) The GSA Task-Order and Delivery-Order Ombudsman is located at the General Services Administration (GSA), Office of Government-wide Policy (OGP), Office of Acquisition Policy (MV). Contact information for the GSA Task-Order and Delivery-Order Ombudsman can be found at: http://www.gsa.gov/ombudsman.

    (End of Clause)
    4. Add section 552.216-76 to read as follows:
    552.216-76 Ordering Agency Task-Order and Delivery-Order Ombudsman.

    As prescribed in 516.506(d), insert the following provision:

    Ordering Agency Task-Order and Delivery-Order Ombudsman (JAN 2017)

    (a) Ordering Agency Task-Order and Delivery-Order Ombudsman. The Ordering Agency shall designate a Task-Order and Delivery-Order Ombudsman to review complaints from contractors and ensure that they are afforded a fair opportunity for consideration in the award of task or delivery orders placed against GSA Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts, consistent with the procedures in the contract. The contact information for the Ordering Agency Task-Order and Delivery-Order Ombudsman shall be made available to contractors.

    (b) Submission of Complaints. When a contractor submits a complaint to the Ordering Agency's designated Task-Order and Delivery-Order Ombudsman, the contractor shall also send a copy of the complaint to the GSA Procurement Ombudsman, for informational purposes. The GSA Procurement Ombudsman is located at the General Services Administration, Office of Governmentwide Policy (OGP), Office of Acquisition Policy (MV). Contact information for the GSA Procurement Ombudsman can be found at: http://www.gsa.gov/ombudsman.

    (c) If the contractor is not satisfied with the resolution of its complaint by the Ordering Agency Task-Order and Delivery-Order Ombudsman, the contractor may follow the procedures outlined in FAR subpart 33.1, as applicable (e.g., FAR 16.505(a)(10).

    (End of Clause)
    [FR Doc. 2016-31932 Filed 1-6-17; 8:45 am] BILLING CODE 6820-61-P
    82 5 Monday, January 9, 2017 Proposed Rules DEPARTMENT OF THE TREASURY Community Development Financial Institutions Fund 12 CFR Part 1805 Announcement Type: Notice and Request for Information SUMMARY:

    The Community Development Financial Institutions Fund (CDFI Fund), Department of the Treasury, requests comments from the public regarding the current policies and procedures to certify an organization as a Community Development Financial Institution (CDFI). Capitalized terms found in this notice are defined in the regulations that govern the CDFI Program, in our regulations.

    DATES:

    Written comments must be received on or before March 10, 2017 to be assured of consideration.

    ADDRESSES:

    Submit your comments via email to David Meyer, Certification, Compliance Monitoring and Evaluation (CCME) Manager, CDFI Fund, at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    David Meyer, CCME Manager, CDFI Fund, 1500 Pennsylvania Avenue NW., Washington, DC 20220 or email to [email protected] Information on CDFI Certification may be obtained on the CDFI Fund's Web site at https://www.cdfifund.gov/programs-training/certification/Pages/default.aspx.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the CDFI Fund's authorizing statute (the Community Development and Regulatory Improvement Act of 1994, 12 U.S.C. 4701 et seq.) (the Act) and the regulations that govern the CDFI Program (12 CFR part 1805), a community development financial institution (CDFI) is a legal entity that: (i) Has a primary mission of promoting community development; (ii) serves an investment area or targeted population; (iii) provides development services in conjunction with equity investments or loans, directly or through a subsidiary or affiliate; (iv) maintains, through representation on its governing board or otherwise, accountability to residents of its investment area or targeted population; and (v) is not an agency or instrumentality of the United States, or of any State or political subdivision of a State.

    In accordance with the statutory definition, the CDFI Fund has established seven tests, described below, to certify an Applicant financial entity as a CDFI. Applicants provide legal documentation, narratives and financial data to demonstrate their ability to meet the certification criteria. Applications are accepted on a rolling basis and may be submitted more than once, if declined. Certified CDFIs must complete an annual recertification process to update the financial and organization data contained in the original certification application. CDFI certification application and supplemental information can be found on the CDFI Fund Web site.

    With this Request for Information (RFI), the CDFI Fund is embarking on a review of its CDFI certification tests to ensure that they continue to meet the statutory and regulatory requirements and the evolving nature of an industry that has changed significantly since the CDFI Fund's establishment in 1994. Since the first CDFIs were certified, the universe of certified CDFIs has grown from 196 in 1997 to over a 1,000 in number today, with over $100 billion in total assets and headquarters in all fifty states and several territories. It is a goal of the CDFI Fund to foster a diversity of CDFI types, activities, and geographies, and to enable market-driven solutions to emerge in a constantly changing economic environment.

    In addition, the significance of CDFI certification has increased over the years. While CDFI certification continues to make an entity eligible for various programs at the CDFI Fund (CDFI Program, Native American CDFI Assistance Program, Capital Magnet Fund, and the CDFI Bond Guarantee Program), because it is seen as indicating a strong community development mission, it also has come to serve as a qualifier for other Federal government programs and benefits. These include, among others, the Small Business Administration's Community Advantage program and Federal Home Loan Bank membership, as well as consideration for certain investments under the Community Reinvestment Act and, pursuant to 12 CFR 1026.43(a)(3)(v)(A), an exemption from the Consumer Financial Protection Bureau's “Ability to Repay” rule. The CDFI Fund believes that it is important that certification remain a mark of confidence in an organization's commitment to a community development mission.

    It also is imperative that CDFI certification criteria continue to support, rather than inhibit, the growth and reach of CDFIs, especially as it relates to their ability to take advantage of new technologies. These new technologies create the potential for mission-driven organizations like CDFIs to extend their reach and impact in order to improve access to financial products and services for underserved communities and populations wherever they are. This raises questions, however, of whether CDFI certification—particularly in terms of a CDFI's ability to define a Target Market and demonstrate accountability to that Target Market—is currently designed to enable such scope, which was neither possible nor envisioned when the criteria were first established.

    Through this RFI, the CDFI Fund seeks feedback from the public on certain aspects of the certification criteria and process, as listed in Sections I and II. We also seek any additional information beyond these questions that members of the public believe would assist in updating the CDFI Fund's certification policies. The CDFI Fund intends to consider the feedback received through this RFI as it reexamines its current criteria and proposes any revisions to its CDFI certification policies. In making any changes to the existing criteria, the CDFI Fund will seek to ensure that certification continues to foster a diversity of CDFI types, activities, and geographies; allows for innovation that supports the growth and reach of CDFIs; and signifies confidence in a strong community development mission.

    I. Certification Criteria

    A. Legal Entity: To satisfy the legal entity test, the CDFI Fund requires evidence of an Applicant's incorporation/organization/establishment, such as IRS documentation, establishing documents filed with appropriate authorities, or charter numbers for Insured Depository Institutions and Credit Unions at the time of certification application.

    1. The statute does not indicate how long an organization must be in existence to be considered a “person (other than an individual).” Should there be a minimum period of time an organization should be in existence before applying for CDFI certification? If so, how long? If not, why not?

    2. Is there additional documentation, beyond an organization's establishing documents filed with State jurisdictions, that should be accepted to demonstrate that an organization is a legal entity?

    B. Primary Mission: The statute states that a CDFI must have “a primary mission of promoting community development,” but specifies few criteria for meeting that test. The CDFI Fund currently allows Applicants for certification to meet this test by providing board-approved organizational documents that demonstrate that the Applicant has a primary mission of promoting community development along with a narrative statement describing how the Applicant's mission is consistent with the CDFI Fund's and a brief description of Financial Products offered. Insured Credit Unions that have received a Low Income Designation from the National Credit Union Administration are deemed to have met this criterion by virtue of their designation.

    1. Should the currently required board-approved documentation and narrative statement be sufficient to demonstrate an Applicant's primary mission, or should the CDFI Fund apply a more prescriptive primary mission test? For example, should the CDFI Fund provide a more explicit, possibly quantitative, definition of what it means to “promote community development” that Applicants would be required to meet? If so, what should be the definition and what test should be applied? Are there criteria that the CDFI Fund should not consider and why?

    2. Should there be different standards for meeting the primary mission test for nonprofit versus for-profit organizations, particularly for-profits that are not Insured Depository Institutions? If so, what different standards should be applied?

    3. What evidence can the CDFI Fund use to confirm an Applicant's adherence to a stated community development mission? For example, how can the CDFI Fund distinguish between an organization that is fully committed to a community development mission and one that targets the same communities or populations as a CDFI and claims a community development mission, but whose actions do not demonstrate intent to create community development and/or are predatory in nature?

    4. To what extent should the CDFI Fund evaluate the Financial Products and/or Financial Services offered by an Applicant to determine its ability to meet the primary mission test? What test would the CDFI Fund apply in any such evaluation of Financial Products and/or Financial Services?

    5. Currently, by statute, Depository Institution Holding Companies wishing to be certified as CDFIs must provide documentation that their parent, Subsidiaries, and Affiliate organizations collectively meet the primary mission test. Should the CDFI Fund also make this a requirement for Non-Regulated CDFIs, for example, a Non-Regulated for-profit financial institution? Why or why not?

    C. Financing Entity: Insured Depository Institutions and Credit Unions are deemed to automatically meet this criterion. Non-Regulated CDFIs must demonstrate that they engage in direct financial activity (e.g., the provision of Financial Products, Financial Services, and Development Services) as reflected on financial statements and executed notes, and must dedicate a predominance of their assets to Financial Products, Development Services, and/or similar financing.

    1. The CDFI Fund does not currently define the term “predominance,” but in practice accepts a plurality of assets as meeting this criterion. Should the term “predominance” be defined more specifically, and if so, how?

    2. Should entities that provide less than a plurality of financing activity ever be considered Financing Entities? If so, under what circumstances and is there a minimum level of activity that should be required?

    3. Currently, the amount of assets and staff time dedicated to financing activities are used to measure the level of a CDFI's financing activity. How else could a CDFI's level of financing activity be measured?

    4. For Non-Regulated CDFIs, is the current “predominance of assets” test appropriate, or should alternatives or additional considerations be permitted?

    5. Should Non-Regulated CDFIs be permitted to include the financing or Financial Services activity of a mission-driven Subsidiary as part of the assessment of the parent CDFI's financing activities?

    6. Should Non-Regulated CDFIs be permitted to rely upon the financing or Financial Services activity of a parent CDFI as part of the assessment of the Subsidiary's or Affiliate's financing activities?

    7. Should an organization applying for CDFI certification be required to transact a minimum number or dollar amount of loan or equity investments to be considered a financing entity? Should the Applicant be required to have at least one or more years of loan or equity investment origination? If so, what should those rules be?

    8. Should an organization that only services loans or Equity Investments or has very few transactions be considered a financing entity?

    9. Should certified CDFIs be required to offer loans or Equity Investments each year, in order to maintain certification status?

    10. Currently, non-arms-length transactions do not contribute to meeting the financing entity criteria. For example, transactions made with Subsidiaries and/or Affiliates are not considered to be arms-length transactions. Should some transactions with Affiliates be permissible as evidence of an organization being a financing entity? If so, which ones? How should an “arms-length transaction” be defined?

    11. Should Applicants be required to disclose the expected amount and types of lending that may be made to Affiliates and Insiders in their certification applications? Should such transactions be limited as a condition of certification? Why or why not?

    12. Current CDFI Program regulations use the term “similar financing activities” in its definition of the term “Financial Products.” How should the CDFI Fund determine what is included in “similar financing activities?”

    D. Serves an Investment Area or Targeted Population: Applicants for certification must identify the Investment Area(s) and/or Targeted Population(s) they intend to serve as their Target Market.

    1. Threshold Target Market Test: Although no threshold level of service is indicated in the statute or regulation, current CDFI Fund policy requires that an organization must serve at least one eligible Target Market and must direct at least 60 percent of all of its Financial Product activities to one or more eligible Target Market to qualify for certification. In general, both the number and dollar amount of the organization's Financial Product activities should be at least 60 percent of all of its Financial Product activities in the most recent fiscal year. If an organization does not meet the 60 percent threshold in terms of either number or dollar amount of transactions (but not both), the organization can provide an argument as to why the figure is less than 60 percent and the CDFI Fund reserves the right to accept or reject the explanation.

    a. Is the current standard that 60 percent of a CDFI's Financial Product activities must be in qualified Target Markets the right standard? If not, what percentage of transactions should be in and/or to a qualified Target Market to demonstrate that an organization serves that Target Market and why?

    b. Should there be different thresholds for different institution types (i.e., Insured Depository Institutions and Credit Unions, nonprofit loan funds, and venture capital funds)?

    c. The CDFI Fund currently relies on self-reported summary data submitted by Applicants to demonstrate that they meet the Target Market threshold test. Should statistical sampling of transactions be required to establish a current baseline of activity and document the Target Markets that they are serving?

    d. The August 31, 2015 Interim CDFI Program Regulations added the provision of Financial Services as a means of demonstrating that an applicant serves a Target Market. However, the CDFI Fund does not currently have a method of recognizing or applying the provision of Financial Services toward the current 60 percent threshold test for certification. In addition to the level of Financial Products provided by an Applicant, how should an Applicant receive credit for the provision of Financial Services toward meeting any threshold test? How should this be measured? If an Applicant requests credit for providing Financial Services, should there be a separate minimum level of Financial Products that must be provided by the Applicant?

    e. The CDFI Fund currently first considers an Applicant's financial activity during its most recent fiscal year in determining whether it meets the threshold test. Is this the appropriate time period to consider, or should a longer period of time be considered? If so, should the applicant be required to meet the threshold in each year of the test, for a time period, or should an average be considered? Should the CDFI Fund consider an Applicant's portfolio of loans outstanding?

    2. Investment Areas: The statute requires that an Investment Area must meet at least one of the economic distress criteria (poverty rate greater than 20 percent; Median Family Income (MFI) at 80 percent or below specific MFI benchmarks; unemployment rate 1.5 times the national average) and has significant unmet needs for Financial Products and Services, or is wholly located within an Empowerment Zone or Enterprise Community.

    a. The CDFI Fund's current practice is to define Investment Areas that are composed of one or more units of geography that meet certain distress criteria. Units include but are not limited to counties, census tracts, and Indian Reservations. Should the CDFI Fund change this practice? If so, how?

    b. Currently the CDFI Fund allows Investment Areas to be composed of a set of contiguous geographic units that may include a small portion of units that individually do not qualify as Investment Areas. Should the CDFI Fund continue this practice, or should all units within the Investment Area meet the Investment Area qualifications?

    3. Targeted Populations: Targeted Populations include Low Income Targeted Populations (LITP) and Other Targeted Populations (OTP) for a specific geographic unit. LITP, for a specified geographic unit, by statute includes individuals whose family income (adjusted for family size) is 80 percent of the area MFI (for metropolitan areas). LITP in non-Metropolitan Areas is the greater of 80 percent of the area MFI; or 80 percent of the statewide non-Metropolitan Area MFI. The CDFI Fund currently includes, for a specific geographic unit(s), African-Americans, Hispanics, Native Americans, Native Alaskans, Native Hawaiians, and Other Pacific Islanders among the groups automatically considered eligible for an OTP Target Market. Applicants are permitted to seek OTP recognition for other populations by demonstrating that the group lacks access to capital.

    a. Should the Targeted Populations be expanded to automatically accept more specifically defined Other Targeted Populations that are eligible for other Federal programs that support economic development in Low-Income communities? If so, which ones and why?

    b. CDFIs currently are approved to serve Targeted Populations within a defined geographic unit at below and up to a national level. Should all Applicants proposing to serve Targeted Populations be approved to serve such Target Markets nationally?

    4. National Target Markets: Currently, in order to be certified with a Target Market national in geographic scope, CDFIs need to show that they have conducted their financing activities broadly across the variously defined regions of the country, (e.g. Northeast, West, Midwest, South, Southeast, etc.)

    a. Given that it is unlikely that most CDFIs that work broadly across the nation will complete transactions in every State every year, how can organizations demonstrate that they serve a national Target Market, whether for an Investment Area or for a Targeted Population? Should there be a certain minimum geographic dispersion of actual investments?

    b. Some CDFIs serve multiple markets that are part of a multi-State region or are comprised of geographically unconnected markets. When should the CDFI Fund recognize these practices as constituting a national Target Market?

    E. Development Services: A CDFI directly, through an Affiliate, or through a contract with another provider, must have a track record of providing Development Services in conjunction with its Financial Products and/or Financial Services. Development Services means activities undertaken by a CDFI, its Affiliate or contractor that promote community development and shall prepare or assist current or potential borrowers or investees to use the CDFI's Financial Products or Financial Services. For example, such activities include, but are not limited to, financial or credit counseling; homeownership counseling; and business planning and management assistance.

    1. Should the CDFI Fund more explicitly define Development Services? If so, how should it be defined?

    2. Should the CDFI Fund require CDFIs to provide a corresponding Development Service for each Financial Product and Financial Service?

    3. Should a certified CDFI be required to offer each Development Service each year to maintain certification status?

    F. Accountability: The CDFI Fund currently requires that a CDFI maintain accountability to its Target Market through representation on its governing board and/or advisory boards. Prior to recent changes in the regulation, a CDFI could demonstrate accountability through other mechanisms such as focus groups, community meeting, and/or customer surveys.

    1. What percentage of a CDFI's board members should satisfy accountability rules? Should different percentages apply to different types of boards, i.e. governing vs. advisory boards?

    2. Is representation on an advisory board sufficient to demonstrate accountability?

    3. Should CDFIs be able to demonstrate accountability through means other than board membership? If so, how?

    4. Is a business plan and a stratified, statistically significant random sample of lending by asset class and location sufficient to document accountability? Under what circumstances?

    5. Should accountability requirements differ based on a CDFI's type of Target Market, and if so, how?

    6. How should the CDFI Fund assess accountability if a CDFI's Target Market includes borrowers or investees who are not members of a Targeted Population themselves (e.g., small businesses, micro businesses, and affordable housing developers, charter schools), but whose “end-beneficiaries” are?

    7. How should a CDFI demonstrate accountability to a national Target Market, in particular an Investment Area national in scope? Should there be a requirement to have local accountability to supplement a national governing or advisory board? In this context, how should the term “local” be defined?

    8. How should an Applicant that utilizes a web-based lending platform, especially one that serves a national Target Market, demonstrate accountability?

    G. Non-Governmental Entity: By statute, a CDFI Shall not be an agency or instrumentality of the United States, or any State or political subdivision thereof. An entity that is created by, or that receives substantial assistance from, one or more government entities may be a CDFI provided it is not controlled by such entities and maintains independent decision-making power over its activities. In the CDFI Certification application, the Applicant must respond to a series of questions designed to surface/discover issues or circumstances that may prevent an Applicant from meeting this criteria.

    1. Are the current standards for establishing that an Applicant is not owned or controlled by a governmental entity sufficient?

    2. Are there additional or alternative questions and/or documentation the CDFI Fund should require to determine if an Applicant is an agency or instrumentality of a Federal, State or local government?

    II. Certification Policy and Procedures

    A. Should the CDFI Fund request information on the reason for applying for certification and intended use (e.g., funding requirement, marketing)?

    B. Are there additional sources of data collected by other federal agencies that can be used to meet any of the seven certification tests? If so, please describe.

    III. General Certification Questions for Public Comment: Through This RFI, the CDFI Fund Invites Comments and Responses to the Following Questions Regarding CDFI Certification

    A. “Community-based” is a term often used to describe CDFIs. How should “community-based” be defined and what does it mean for CDFIs to be “community-based?”

    B. Although not defined in statute, the CDFI Fund allows Applicants that serve Native communities to self-designate themselves as Native CDFIs and apply for Financial Assistance and Technical Assistance through the Native CDFI Program. Applicants that self-designate as a Native CDFI must attest to providing 50 percent or more of their products and services to Native lands or Native populations. Should the CDFI Fund continue to allow Applicants to self-designate as Native CDFIs or should there be more defined standards that the CDFI Fund should verify? If so, what should they be?

    C. Should CDFIs be allowed to be composed of multiple legal entities (Subsidiaries and/or Affiliates)? And if so, must a CDFI include all of its Subsidiaries and/or Affiliates for consideration?

    D. Should CDFI certification standards have more “bright-line” tests, i.e. specific thresholds and benchmarks that are, where possible, quantitative in nature, or should the CDFI Fund maintain flexibility to evaluate Applicants on a case by case basis, even at the expense of certainty for applicants?

    E. In addition to earlier questions regarding potentially different Primary Mission or Target Market standards based on institution type, are there other CDFI certification criteria standards that should vary based on institution type or the type of CDFI?

    F. Should “start-up” entities be able to be certified? How should the term “start-up” be defined?

    G. Are there additional areas of CDFI certification policy or the CDFI certification application review process that could use improvement? If so, how?

    Authority:

    12 U.S.C. 4701 et seq.; 12 CFR 1805.

    Mary Ann Donovan, Director, Community Development Financial Institutions Fund.
    [FR Doc. 2017-00013 Filed 1-6-17; 8:45 am] BILLING CODE 4810-70-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 922 [Docket No. 160907827-6827-01] RIN 0648-BG02 Mallows Bay—Potomac River National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management Plan AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Proposed rule.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA) proposes to designate approximately 52 square miles of waters encompassing and surrounding Maryland's Mallows Bay as the Mallows Bay—Potomac River National Marine Sanctuary (MPNMS or sanctuary). NOAA also proposes regulations to implement the sanctuary designation and establish the sanctuary's terms of designation to protect historical, archeological, and cultural resources of national significance. A draft environmental impact statement (DEIS) and draft management plan (DMP) have also been prepared for this proposed action. The purpose of this action is to supplement and complement current Maryland state regulations and resource protection efforts to ensure long term protection of the nationally significant collection of historic shipwrecks and other maritime cultural heritage resources. NOAA is soliciting public comment on the proposed rule, draft environmental impact statement, and draft management plan. NOAA will also begin consultations under Section 106 of the National Historic Preservation Act (NHPA) and solicit public comments specifically related to the identification and assessment of the historic properties within the affected area in compliance with Section 106 review process.

    DATES:

    NOAA will consider all comments received by March 31, 2017. Public meetings will be held on the following dates:

    (1) March 7, 2017, 6:00 p.m. to 9:00 p.m., La Plata, MD, and

    (2) March 9, 2017, 6:00 p.m. to 9:00 p.m., Arnold, MD.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NOS-2016-0149, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NOS-2016-0149, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Paul Orlando, Regional Coordinator, Northeast and Great Lakes Region, 410 Severn Ave., Suite 207-A, Annapolis, MD 21403.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NOAA. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NOAA will accept anonymous comments (enter“N/A” in the required fields if you wish to remain anonymous).

    Copies of the proposed rule, DEIS, and DMP can be downloaded or viewed on the internet at www.regulations.gov (search for docket # NOAA-NOS-2016-0149) or at www.regulations.gov/#!docketDetail;D=NOAA-NOS-2016-0149. Copies can also be obtained by contacting the person identified under FOR FURTHER INFORMATION CONTACT.

    The public meeting locations are:

    (1) La Plata, MD: Charles County Government Building, 200 Baltimore St., La Plata, MD 20646 (March 7, 2017) (2) Arnold, MD: Anne Arundel Community College, Center for Applied Learning and Technology (CALT) Building, Room 100, 101 College Pkwy., Arnold, MD 21012 (March 9, 2017) FOR FURTHER INFORMATION CONTACT:

    Paul Orlando, Regional Coordinator, Northeast and Great Lakes Region at (240) 460-1978, [email protected]

    SUPPLEMENTARY INFORMATION: I. Introduction A. Background

    The National Marine Sanctuaries Act (NMSA; 16 U.S.C. 1431 et seq.) authorizes the Secretary of Commerce (Secretary) to designate and protect as national marine sanctuaries areas of the marine environment that are of special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or esthetic qualities. Day-to-day management of national marine sanctuaries has been delegated by the Secretary to NOAA's Office of National Marine Sanctuaries (ONMS). The primary objective of the NMSA is to protect the sanctuary system's biological and cultural resources, such as coral reefs, marine animals, historical shipwrecks, historic structures, and archaeological sites.

    NOAA is considering the Mallows Bay area of the tidal Potomac River for designation as a national marine sanctuary. The area is 40 miles south of Washington, DC, located off the Nanjemoy Peninsula of Charles County, Maryland. This is an area of national significance featuring unique historical, archaeological, cultural, ecological, and esthetic resources and qualities, which offer opportunities for conservation, education, recreation, and research. Its maritime landscape is home to a diverse collection of historic shipwrecks that date back to the Civil War and potentially date to the American Revolutionary War, totaling nearly 200 known vessels including the remains of the largest “Ghost Fleet” of World War I, wooden steamships built for the U.S. Emergency Fleet. The fleet was constructed at more than 40 shipyards in 17 states as part of the massive national wartime preparation. The area's archaeological and cultural resources cover centuries of history from the earliest American Indian presence in the region about 12,000 years ago to the Revolutionary, Civil and two World Wars, as well as successive regimes of Potomac fishing industries.

    The Maryland Department of Natural Resources (DNR), Maryland Historical Trust, Maryland Department of Tourism, and Charles County, MD, have worked together with community partners to initiate conservation and compatible public access strategies in and around Mallows Bay, consistent with numerous planning and implementation documents. In 2010, DNR purchased a portion of land adjacent to Mallows Bay and made it available to Charles County to create and manage Mallows Bay County Park, the main launch point for access to the historic shipwrecks. Pursuant to the NHPA, Maryland Historical Trust has stewardship and oversight responsibility for the shipwrecks, along with hundreds of other historic sites around the state. DNR manages the waterbody and associated ecosystem resources, including land use, resource conservation and extraction activities. The lands on either side of Mallows Bay County Park are held by the U.S. Department of Interior's Bureau of Land Management and a private citizen.

    On September 16, 2014, pursuant to section 304 of the National Marine Sanctuaries Act and the Sanctuary Nomination Process (SNP; 79 FR 33851), a coalition of community groups submitted a nomination asking NOAA to designate Mallows Bay—Potomac River as a national marine sanctuary. The nomination cited conservation goals to protect and conserve the fragile remains of the Nation's cultural heritage as well as the opportunities to expand public access, recreation, tourism, research, and education to the area. The nomination was endorsed by a diverse coalition of organizations and individuals at local, state, regional, and national levels including elected officials, businesses, Native American, environmental, recreation, conservation, fishing, tourism, museums, historical societies, and education groups. The nomination identified opportunities for NOAA to protect, study, interpret, and manage the area's unique resources, including by building on existing local, county, and State of Maryland efforts to manage the area for the protection of shipwrecks. NOAA's review of the nomination against the criteria and considerations of the SNP, including the requirement for broad-based community support indicated strong merit in proposing this area as a national marine sanctuary. Therefore, NOAA completed its review of the nomination and, on January 12, 2015, added the area to the inventory of nominations that are eligible for designation. All nominations submitted to NOAA can be found at: http://www.nominate.noaa.gov/nominations/.

    NOAA began the sanctuary designation process for Mallows Bay—Potomac River National Marine Sanctuary on October 7, 2015 with the publication of a notice of intent (NOI; 80 FR 60634) to prepare a DEIS and the initiation of a public process, as required under the NMSA and the National Environmental Policy Act (NEPA). The DEIS evaluates alternatives related to the proposed designation of Mallows Bay—Potomac River National Marine Sanctuary, including a no action alternative. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of the NHPA.

    B. Need for Action

    The proposed designation would allow NOAA to complement current state-led efforts to conserve and manage the nationally significant maritime cultural heritage resources while enhancing public awareness and appreciation, and facilitating to the extent compatible with the primary objective of resource protection, all public and private uses including recreation and tourism, as directed by the NMSA. The threats to these resources are related to actions or conditions that result in the damage or loss of the historic resources. Over time direct damage both intentionally and unintentional has occurred from breaking, redistribution of shipwrecks and artifacts, defacing and physical alteration, burning, and removal from the area. Additionally, indirect damage to the resources has occurred from the accumulation and entanglement of trash and marine debris around the resources and from weather-related processes such as wind, flood, and ice events.

    The proposed sanctuary would concentrate on the protection, access and interpretation of the maritime cultural features of the area, including the Ghost Fleet, other vessels of historic significance, and related maritime infrastructure. The State of Maryland currently has a comprehensive set of management measures for the protection of the natural environment, including wildlife, fish, birds, water quality, and habitat. As such, NOAA's proposed sanctuary regulations would focus only on the protection of the shipwrecks and associated maritime cultural heritage resources.

    NOAA's proposed management actions will be primarily non-regulatory in nature with a concise set of regulations focused on protecting the maritime cultural heritage resources. Although the Maryland Submerged Archeological Historic Property Act (Md. Code Ann., State Fin. & Proc. sections 5A-333 et seq.) provides a basic level of protection for maritime cultural heritage resources in Mallows Bay and adjacent areas of the Potomac River, the proposed action would allow NOAA's management under the NMSA to supplement and complement the existing authority and the current management framework in the area. The proposed national marine sanctuary would address ongoing threats to the maritime cultural heritage resources while providing opportunities for research, education, recreation, and tourism through coordinated and comprehensive management and conservation the resources in collaboration with the State of Maryland and Charles County. NOAA is also proposing to carry out education, science, and interpretative programs that describe for visitors and user communities the relationship between the shipwreck structures and their interplay with the natural system.

    C. Designation Process National Marine Sanctuary Designation Process

    The National Marine Sanctuaries Act authorizes NOAA to identify, designate, and protect areas of the marine and Great Lakes environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archaeological, educational, or aesthetic qualities as national marine sanctuaries. NOAA may identify areas to consider for national marine sanctuary designation through the community-based Sanctuary Nomination Process as described in the final rule (79 FR 33851) establishing the process. The NMSA process for designating a new national marine sanctuary has four steps:

    Scoping: NOAA announces its intent to designate a new national marine sanctuary and asks the public for input on potential boundaries, resources that could be protected, issues NOAA should consider and any information that should be included in the detailed resource analysis in a draft environmental impact statement.

    Sanctuary Proposal: NOAA prepares draft designation documents including a DMP, DEIS that analyzes a range of alternatives, proposed regulations, and proposed boundaries.

    Public Review: The public, agency partners, tribes, and other stakeholders provide input on the draft documents. The public review step also includes the formal consultations required under NEPA, the NMSA, the NHPA, and other relevant statutes. NOAA considers all input and determines appropriate changes.

    Sanctuary Designation: NOAA makes a final decision and prepares final documents. Before the designation becomes effective, the Governor reviews the documents. Congress also has the opportunity to review the documents.

    Public Scoping Process

    On October 7, 2015, NOAA initiated the public scoping process with the publication of a NOI in the Federal Register (80 FR 60634) asking for public input on the proposed designation and informing the public that NOAA intended to prepare a DEIS evaluating alternatives related to the proposed designation of Mallows Bay—Potomac River National Marine Sanctuary under the NMSA. That announcement initiated a 90-day public comment period during which NOAA would solicited additional input related to the scale and scope of the proposed sanctuary, including ideas presented in the community nomination. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of the NHPA.

    During the public comment period, NOAA solicited input on the range of issues to be considered in an environmental impact statement to designate this area as a national marine sanctuary. NOAA specifically asked for information that would assist in the development of alternatives including proposed regulations and boundaries. NOAA accepted public comments through a web-based portal and by mail from October 7, 2015 through January 15, 2016, and hosted two public scoping meetings. During the scoping comment period, NOAA received approximately 264 comments from individuals, businesses, organizations, and local, state, and federal agencies. The first scoping meeting was held on November 4, 2015 in La Plata, MD, where approximately 125 people attended and 51 oral and written comments were received. The second meeting was held on November 10, 2015 in Annapolis, MD. Approximately 100 people attended that meeting, and 23 oral and written comments were received.

    The written comments received included 141 from individuals, nine from businesses, 46 from organizations, two from local agencies, two from state agencies, and four from federal agencies. Comments were also submitted by U.S. Representative Steny Hoyer and U.S. Senator Ben Cardin. All comments are available for review online at https://www.regulations.gov/#!docketDetail;D=NOAA-NOS-2015-0111.

    The majority of comments received during the scoping period generally support the proposed sanctuary designation based on the considerable value and significance of the natural, maritime, archaeological, and cultural resources within the area including those related to Native American history and activities, the immense potential for ecological and archaeological research of the area's resources, and the economic and educational benefits of increased tourism and public access and awareness. The public comments also identified several additional potential benefits, including restoration of the Chesapeake watershed, economic revitalization of the local area, and promoting heritage and ecotourism.

    Several comments opposed the nomination predominantly citing opposition to the possibility of increased government intervention, specifically regarding fossil collection and fishing activities that could potentially be impacted by a sanctuary designation.

    The comments also identified boundary alternatives for consideration during the designation process. Several comments supported the boundary proposed in the sanctuary nomination package, intended to align with the boundary of the Mallows Bay—Widewater Archaeological and Historic District submitted by the State of Maryland (National Register Listing Number 15000173, April 24, 2015). However, the majority of comments supported an expanded boundary. Several comments supported a northward expansion to Mattawoman Creek, but most of the comments supported a larger boundary extending from Chapman Park in the North to Chapel point in the South. One comment suggested an even larger northern boundary extending to Piscataway Creek. Most of the support for the expanded boundaries was based on the benefits of the additional protection that the commenters felt a larger boundary would provide to the significant natural and maritime cultural heritage resources in the area.

    Several comments did not support a boundary expansion citing issues related to management, local impact, and government overreach. Some comments expressed concerns regarding how the boundaries would affect the Commonwealth of Virginia's interests and one comment noted that Virginia should be excluded from the sanctuary boundary.

    Additional comments addressed regulatory frameworks, access issues, migratory bird protections, designation timeline goals, intergovernmental collaboration, infrastructure, education and outreach programing, and interpretation plans.

    NOAA used these public comments to inform the preparation of the draft management plan, draft environmental impact statement, and the proposed sanctuary regulations. The proposed designation reflects the general public support for the protection of all nationally significant maritime cultural heritage resources in the area. It also incorporates the need for enhanced recreation and access to the proposed sanctuary to support tourism and the local economy.

    In this proposed rule, NOAA is proposing to regulate damage to the maritime cultural heritage resources in a 52-square mile area of Maryland waters of the Potomac River as described below. The proposed boundaries were expanded beyond the initially nominated area and the National Register Historic District based on public comments, additional research conducted related to the historical and archaeological resources of the area, and input from Maryland Department of Natural Resources, Maryland Historical Trust, and Charles County.

    The environmental effects of this proposed designation and alternatives are analyzed in a DEIS published concurrently with this proposed rule summary statement. NOAA has also developed an associated draft management plan describing comprehensive proposed management framework envisioned for the area, including non-regulatory programs and activities actions and strategies to promote opportunities for research, education, and recreation in the area. NOAA is seeking public comment on the proposed rule, DEIS, and draft management plan, which are available at http://sanctuaries.noaa.gov/mallows-bay/ or may be obtained by contacting the individual listed under the heading FOR FURTHER INFORMATION CONTACT.

    II. Summary of the Proposed Regulations 1. Adding New Subpart S and Reserving Subpart T

    NOAA is proposing to amend 15 CFR part 922 by adding a new subpart (subpart S) that contains site-specific regulations for MPNMS. This subpart would include the proposed boundary, contain definitions of common terms used in the new subpart, provide a framework for co-management of the sanctuary, identify prohibited activities and exceptions, and establish procedures for certification of existing uses, permitting otherwise prohibited activities, and emergency regulation procedures. Several conforming changes would also be made to the national regulations as described detail below.

    NOAA is concurrently working on designating a separate new national marine sanctuary in Wisconsin's Lake Michigan waters as part of a separate rulemaking process, and those regulations would be published in their own new subpart (subpart T). As such, in this rulemaking, NOAA proposes to add and reserve subpart T for any future site-specific regulations that might be issued. NOAA would later harmonize the regulations for the Wisconsin Lake Michigan designation process with any final rule associated with this action.

    2. Proposed Sanctuary Name

    NOAA has proposed to name the sanctuary the “Mallows Bay—Potomac River National Marine Sanctuary (MPNMS)” based on the nomination submitted by the community. The name aptly identifies the area where the proposed sanctuary is located. NOAA has also selected the acronym of “MPNMS” to avoid having a longer acronym, such as “MBPRNMS,” and avoid duplication with an acronym already in use within the national marine sanctuary system, such as “MBNMS” used for Monterey Bay National Marine Sanctuary. NOAA is asking for public input on this proposed name. The public may also suggest an alternative name and state the reasons for suggesting an alternative name.

    3. Proposed Sanctuary Boundary

    NOAA is proposing to designate an area of approximately 52 square miles of the Potomac River as MPNMS. The northern boundary of the area would extend approximately 200 yards upstream of the Dominion Power lines near Ben Doane Road, Maryland to Possum Nose, Virginia. The southern boundary would extend from the end of Owens Drive east of Chotank Creek, Virginia to Benny Gray Point, Maryland. The boundary would encompass all tidal waters within this boundary from mean high tide in Maryland to mean low tide in Virginia, which serves as the boundary between Maryland and Virginia. Areas where the Virginia state line is otherwise delineated, the Quantico exclusion zone, and the area around the Quantico marina would be excluded from the sanctuary. The detailed legal boundary description is included in section 922.200 and the coordinates are located in 15 CFR part 922, subpart S, appendix A. A map of the area is shown in the DEIS.

    The proposed MPNMS would include all of the known WWI-era U.S. Emergency Fleet Corporation vessels in Maryland waters, as well as a number of historically, archaeologically, and recreationally significant shipwrecks not currently included in the National Register Historic District that is located within the proposed area. The area incorporates marine battlescapes such as the land-sea engagements in the Civil War, among the first in that conflict, and one Revolutionary War battlescape; the site of the first military balloon launch from a purpose built “aircraft carrier” in history; the site of two major amphibious invasion operations: Butler's attack from Budd's Ferry to Quantico Creek on March 9, 1861, and the Liverpool Point to Aquia Creek crossings during the Fredericksburg Campaign; several wharves, landings, navigational aids of historic note; Confederate communications and contraband water routes during the Civil War, and the overall scene of the Union's Potomac River blockade, 1861-1865.

    The proposed boundary was developed based on the nomination submitted by the State of Maryland and expanded based on additional information and suggestions received during the public comment period. NOAA's adjustments include moving both the northern and southern boundary lines to incorporate additional maritime culture heritage resources.

    4. Definitions a. Define MPNMS Sanctuary Resources

    NOAA is proposing to narrowly define “sanctuary resources” for MPNMS to include only the maritime cultural heritage resources of the sanctuary area in accordance with the purpose of the proposed designation. The definition would not include biological and ecological resources of the area already managed by the State of Maryland. Creating this new site-specific definition requires NOAA to modify the national definition of “sanctuary resource” in the national regulations at section 922.3 to add an additional sentence that defines the term for MPNMS at section 922.201(a). This is similar to the approach taken for other national marine sanctuaries that do not share the full “sanctuary resource” definition such as Thunder Bay National Marine Sanctuary.

    Additionally NOAA would add a definition in the MPNMS regulations at section 922.201(a) for sanctuary resource that uses the national definition for “historical resources” and expands it to specifically provide examples of the types of resources in this sanctuary that fall within that definition. The national definition of “historical resources” at section 922.3 describes the resource within the definition of “historical resource” to include resources that possess historical, cultural, archaeological or paleontological significance, such as sites, contextual information, structures, districts, and objects significantly associated with or representative of earlier people, cultures, maritime heritage, and human activities and events. These historical resources also include “cultural resources,” “submerged cultural resources,” and also include “historical properties,” as defined in the National Historic Preservation Act.

    The new MPNMS definition of sanctuary resources would then be defined in section 922.201 to include historical resources as defined by section 922.3. This would include any sunken watercraft and any associated rigging, gear, fittings, trappings, and equipment. It would also include personal property of the officers, crew, and passengers, and any cargo, as well as and any submerged or partially submerged prehistoric, historic cultural remains, such as docks, piers, fishing-related remains (e.g. weirs, fish-traps) or other cultural heritage materials. For MPNMS sanctuary resource would also mean any archaeological, historical, and cultural remains associated with or representative of historic or prehistoric American Indians and historic groups or peoples and their activities.

    This proposed rule incorporates and adopts other common terms defined in the existing national regulations at section 922.3; some of those definitions include: “Cultural resources,” which means any historical or cultural feature, including archaeological sites, historic structures, shipwrecks, and artifacts; and “National Marine Sanctuary” or “Sanctuary,” which means an area of the marine environment of special national significance due to its resource or human-use values, which is designated as such to ensure its conservation and management.

    5. Co-Management of the Sanctuary

    In order to further enhance the strong engagement forged by the State of Maryland and Charles County in nominating this area as a proposed national marine sanctuary and in contributing to the development of the draft designation documents, NOAA proposes to manage the sanctuary collaboratively with the state and county. NOAA proposes to establish the framework for co-management of the sanctuary at section 922.202 and intends to work out the operational details of the collaboration in a Memorandum of Understanding (MOU). Details on the execution of sanctuary management such as activities, programs, and permitting programs would be included in the MOU and can be updated to adapt to changing conditions or threats to the sanctuary resources. Any significant changes to the regulations or management plan would not only be jointly coordinated but also subject to public review.

    6. Prohibited and Regulated Activities

    NOAA is proposing to supplement and complement existing management of this area by proposing three regulations to protect the sanctuary resources in section 922.203(a).

    a. Damaging Sanctuary Resources

    As a complement to existing protections under state law and NHPA regulations, NOAA is proposing to prohibit damaging a sanctuary resource. The proposed regulation would prohibit moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource. The sanctuary prohibition on possessing a sanctuary resources would not apply to historical resources removed from the Sanctuary before the designation is complete. However, Maryland state regulations related to the limited removal of historical resources have been in effect since July 1, 1988 currently apply to these resources and will continue to do so. In the case of sanctuary resources that are covered under the Sunken Military Craft Act (SMCA; Pub. L. 108-375, Tit. XIV; 10 U.S.C. 113 note), NOAA and the U.S. Navy would cooperate on protecting those resources using the policy and procedures described in the 2015 Memorandum of Agreement (MOA). NOAA and the Maryland Historical Trust have tentatively identified one shipwreck as covered under the SMCA. A copy of the MOA is available at: http://www.gc.noaa.gov/moa-2014-navy-signed.pdf.

    b. Damaging Sanctuary Signs

    In addition to prohibiting damage to sanctuary resources, NOAA is also proposing to prohibit damage to sanctuary signs, notices, placards, monuments, stakes, posts, buoys, or boundary markers. These materials are part of the management of the sanctuary and may contribute to education and outreach programs. The materials are also federal property and therefore NOAA proposes to prohibit damage from marking, defacing or altering the materials in any way.

    c. Interfering With Investigations

    NOAA is proposing a regulation to prohibit interfering with sanctuary enforcement activities. This regulation will assist in NOAA's enforcement of the sanctuary regulations and strengthen sanctuary management.

    d. Exemption for Emergencies and Law Enforcement

    NOAA is proposing to include an exemption from the three regulations described above for activities the respond to emergencies that threaten lives, property or the environment, or are necessary for law enforcement purposes.

    e. Department of Defense Activities

    NOAA is also proposing that Department of Defense (DOD) activities be carried out in a manner that avoids damage to sanctuary resources to the maximum extent practicable. In the event that DOD activities damage a sanctuary resource, NOAA and DOD would coordinate to work out a mitigation and restoration plan. Given the definition of sanctuary resources is limited to the historical resources and does not include biological or ecological resources NOAA does not anticipate that many, if any, current DOD activities would impact the resources.

    7. Emergency Regulations

    As part of the proposed designation, NOAA is proposing to give the sanctuary authority to issue emergency regulations. Emergency regulations are used in limited cases and under specific conditions when there is an imminent risk to sanctuary resources and a temporary prohibition would prevent the destruction or loss of those resources. Under the NMSA, NOAA only issues emergency regulations that address an imminent risk for a fixed amount of time with a maximum of 6 months that can only be extended a single time. A full rulemaking process must be undertaken, including a public comment period, to consider making an emergency regulation permanent. NOAA would add the authority to issue emergency regulations by modifying the national regulations at section 922.44 to include MPNMS in a list of sanctuaries that have site-specific regulations related to emergency regulations, and adding detailed site-specific emergency regulations to the MPNMS regulations at section 922.204.

    8. General Permits, Certifications, Authorizations, and Special Use Permits a. General Permits

    NOAA is proposing to include the authority to issue permits to allow certain activities that would otherwise violate the prohibition in MPNMS. Similar to other national marine sanctuaries, NOAA is proposing to consider these permits only for education, research, or management.

    To address the above additions to the ONMS general permit authority for MPNMS, NOAA would amend regulatory text in the program-wide regulations in part 922, subpart E, to add references to subpart S, as appropriate. NOAA would also add a new section 922.205 in subpart S titled “Permit procedures and review criteria” that would address site-specific permit procedures for MPNMS.

    b. Certifications

    Because of the possibility that preexisting activities, right of subsistence use or access permitted by other federal, state, local, or tribal agencies might be occurring within the MPNMS area that would otherwise be prohibited by MPNMS regulations, NOAA would add language at section 922.206 describing the process by which it can certify existing activities within the expansion area. In compliance with the NMSA, MPNMS regulations at section 922.206 would state that certification is the process by which permitted activities existing prior to the designation of the sanctuary that violate sanctuary prohibitions may be allowed to continue, provided certain conditions are met. Applications for certifying permitted existing uses would have to be received by NOAA within 180 days of the effective date of the designation.

    c. Authorizations

    NOAA also proposes to provide MPNMS with the authority to consider allowing an otherwise prohibited activity if such activity is specifically authorized by any valid Federal, state, or local lease, permit, license, approval, or other authorization issued after sanctuary designation. Authorization authority is intended to streamline regulatory requirements by reducing the need for multiple permits and would apply to all proposed prohibitions at section 922.203. As such, NOAA proposes to amend the regulatory text at section 922.49 to add reference to subpart S.

    d. Special Use Permits

    NOAA has the authority under the NMSA to issue special use permits (SUPs) at national marine sanctuaries as established by Section 310 of the NMSA. SUPs can be used to authorize specific activities in a sanctuary if such authorization is necessary (1) to establish conditions of access to and use of any sanctuary resource; or (2) to promote public use and understanding of a sanctuary resource. The activities that qualify for a SUP are set forth in the Federal Register (78 FR 25957; May 3, 2013). Categories of SUPs may be changed or added to through public notice and comment. NOAA would not apply the SUP to activities in place at the time of the MPNMS designation.

    SUP applications are reviewed to ensure that the activity is compatible with the purposes for which the sanctuary is designated and that the activities carried out under the SUP be conducted in a manner that do not destroy, cause the loss of, or injure sanctuary resources. NOAA also requires SUP permittees to purchase and maintain comprehensive general liability insurance, or post an equivalent bond, against claims arising out of activities conducted under the permit. The NMSA allows NOAA to assess and collect fees for the conduct of any activity under a SUP. The fees collected could be used to recover the administrative costs of issuing the permit, the cost of implementing the permit, monitoring costs associated with the conduct of the activity, and the fair market value of the use of sanctuary resources.

    9. Other Conforming Amendments

    The general regulations in part 922, subpart A, for general information and part 922, subpart E, for regulations of general applicability would also have to be amended so that the regulations are accurate and up-to-date. The 10 sections that will need to be updated to reflect the increased number of sanctuaries or to add subpart S to the list of sanctuaries. The modified sections to conform to adding a new sanctuary are:

    • Section 922.1  Applicability of regulations • Section 922.40 Purpose • Section 922.41 Boundaries • Section 922.42 Allowed activities • Section 922.43 Prohibited or otherwise regulated activities • Section 922.44 Emergency regulations • Section 922.47 Pre-existing authorizations or rights and certifications of pre-existing authorizations or rights • Section 922.48 National Marine Sanctuary permits—application procedures and issuance criteria • Section 922.49 Notification and review of applications for leases, licenses, permits, approvals, or other authorizations to conduct a prohibited activity • Section 922.50 Appeals of administrative action 10. Terms of Designation

    Section 304(a)(4) of the National Marine Sanctuaries Act (NMSA) requires that the terms of designation include the geographic area included within the sanctuary; the characteristics of the area that give it conservation, recreational, ecological, historical, research, educational, or aesthetic value; and the types of activities that will be subject to regulation by the Secretary of Commerce to protect these characteristics. Section 304(a)(4) also specifies that the terms of designation may be modified only by the same procedures by which the original designation was made. Thus, the terms of designation serve as a constitution for the Sanctuary.

    NOAA is proposing to establish terms to designation that describe the geographic area, resources, and activities as described in details above. NOAA would add the terms of designation language as Appendix B to the MPNMS regulations at 15 CFR part 922, subpart S.

    III. Classification National Marine Sanctuaries Act

    NOAA has determined that the designation of the Mallows Bay—Potomac River National Marine Sanctuary will not have a negative impact on the National Marine Sanctuary System and that sufficient resources exist to effectively implement sanctuary management plans and to update site characterizations. The finding for NMSA section 304(f) is published on the ONMS Web site for the Mallows Bay—Potomac River designation at http://sanctuaries.noaa.gov/mallows-bay/.

    National Environmental Policy Act

    NOAA has prepared a draft environmental impact statement to evaluate the environmental effects of the proposed rulemaking and alternatives as required by NEPA (42 U.S.C. 4321 et seq.) and the NMSA. Copies of the DEIS and related DMP are available at the address and Web site listed in the ADDRESSES section of this proposed rule. NOAA is also soliciting public comments on the DEIS and DMP. Responses to comments received on this proposed rule as well as on the DEIS and draft management plan will be published in the final environmental impact statement and preamble to the final rule.

    Coastal Zone Management Act

    Section 307 of the Coastal Zone Management Act (CZMA; 16 U.S.C. 1456) requires Federal agencies to consult with a state's coastal program on potential Federal regulations having an effect on state waters. Because MPNMS encompasses a portion of the Maryland State waters and is adjacent to the Commonwealth of Virginia lands and waters, NOAA intends to submit a copy of this proposed rule and supporting documents to the Maryland Coastal Zone Management Program and Virginia Coastal Zone Management Program for evaluation of Federal consistency under the CZMA. NOAA will publish the final rule and designation only after completion of the consultation requirements under the CZMA.

    Executive Order 12866: Regulatory Impact

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

    Executive Order 13132: Federalism Assessment

    NOAA has concluded that this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132 because NOAA supplements and complements state and local laws under the NMSA.

    National Historic Preservation Act

    The National Historic Preservation Act (NHPA; 16 U.S.C. 470 et seq.) is intended to preserve historical and archaeological sites in the United States of America. The act created the National Register of Historic Places, the list of National Historic Landmarks, and State Historic Preservation Offices. Section 106 of the NHPA requires Federal agencies to take into account the effects of their undertakings on historic properties, and afford the Advisory Council on Historic Preservation (ACHP) a reasonable opportunity to comment. The historic preservation review process mandated by Section 106 is outlined in regulations issued by ACHP (36 CFR part 800 et seq.). In fulfilling its responsibilities under the NHPA, NOAA is seeking to identify consulting parties in addition to the State Historic Preservation Officer (SHPO), and will complete the identification of historic properties and the assessment of the effects of the undertaking on such properties in scheduled consultations with those identified parties and the SHPO. By this notice NOAA seeks public input, particularly in regard to the identification of historic properties within the proposed areas of potential effect. Pursuant to 36 CFR 800.16(1)(1), historic properties includes: “any prehistoric or historic district, site, building, structure or object included in, or eligible for inclusion in, the National Register of Historic Places maintained by the Secretary of the Interior. The term includes artifacts, records, and remains that are related to and located within such properties. The term includes properties of traditional religious and cultural importance to an Indian tribe or Native Hawaiian organization and that meet the National Register criteria.” If you, your organization(s), or business(es) would like to be considered a “consulting party” under Section 106 please contact the individual listed under the heading FOR FURTHER INFORMATION CONTACT; include contact information for the principal representative for the consultation; and describe you or your party's interest in the proposed designation. In accordance with 36 CFR 800.3(f)(3), NOAA will consider all “consulting party” requests but has ultimate discretion in determining and inviting additional consulting parties.

    Regulatory Flexibility Act

    The Small Business Administration has established thresholds on the designation of businesses as “small entities”. A finfish fishing businesses is considered a small business if it has annual receipts of less than $20.5 million. Scenic and Sightseeing and Recreational industries are considered small businesses if they have annual receipts not in excess of $7.5 million. According to these limits, each of the businesses potentially affected by the proposed rule would most likely be small businesses. However, as further discussed below, these regulations will not have a significant economic impact on the affected small entities, and the Chief Counsel for Regulations for the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have significant economic impact on a substantial number of small entities. Thus, NOAA is not required to and has not prepared an initial regulatory flexibility analysis.

    Methodology. The analysis here is based on limited quantitative information on how much each activity occurs within the proposed sanctuary. Consequently, the result is more qualitative than quantitative.

    Scales Used for Assessing Impacts. For assessing levels of impacts within an alternative, NOAA used three levels; “negligible”, “moderate” and “high” plus “no impacts”. For levels of impacts within the proposed alternatives being analyzed, negligible means very low benefits, costs, or net benefits (less than 1% change). Moderate impacts would be more than 1% but less than or equal to 10%, and high impacts would be more than 10%. For market economic values (revenue, costs, and profits), negligible would mean no likely impact whereas moderate and high could mean some measurable impact on market economic values at the levels noted above. NOAA analyzed the proposed national marine sanctuary described above.

    Small business user groups include commercial fishing operation, recreation-tourism related businesses, and land use and development businesses. Other user groups not included here are research and education, people who receive passive economic use value from stabilization or improvement to the proposed sanctuary resources and the U.S. Navy, none of whom are small businesses.

    NOAA assessed three types of regulations included in the proposed action; (1) moving, removing, recovering, altering, inuring, etc., (2) marking, defacing or damaging etc., and (3) interfering with obstructing, etc. (see section 922.203 for full details).

    Proposed Action.

    Moving, Removing, etc. Regulation. Under the proposed rule, NOAA would not permit moving, removing, recovering, altering, injuring, destroying, possessing or attempting to move, remove, recover, alter, injure, destroy or possess a sanctuary resource (except where removed or possessed prior to sanctuary designation). Small businesses that could potentially be impacted include commercial fishing, recreational for-hire fishing operations, dive operations and other water recreation based operators.

    The expected impact to all these business in the preferred alternative is “no impact”. The gear likely to be used to commercially fish or recreationally fish in the sanctuary will not be impacted by this regulation. Therefore, commercial fishing operations and for-hire operations are not expected to be impacted. Education and outreach will be used to educate user groups about the location of the sanctuary resources to prevent anchor damage. Divers will still be able to use the resource, but not able to take sanctuary resources, therefore the impact for this user group is also “no impact”.

    Marking, defacing or damaging, etc. Regulation. Using the best information, there are no known businesses that rely on damaging or defacing sanctuary resources and no known businesses whose actions damage or deface sanctuary resources. Therefore, this prohibition is expected to have “no impact” on small businesses.

    Interfering with, obstructing, delaying or preventing an investigation Regulation. This prohibition is also expected to have “no impact” on small businesses. There is no evidence that any small businesses in the area would be impacted by this prohibition.

    All Regulations. NOAA expects the combined effects of all the regulations to have “no impact” on small businesses. However, it is possible that some small business may be able to leverage a sanctuary designation to increase awareness and interest in recreational opportunities within the sanctuary and sanctuary community. This could potentially improve the potential for business growth within the area. In which case, recreational operators could potentially see a positive “moderate” improvement. Additionally, these regulations will have no impact on personal property rights, land use and planning.

    Paperwork Reduction Act

    ONMS has a valid Office of Management and Budget (OMB) control number (0648-0141) for the collection of public information related to the processing of ONMS permits across the National Marine Sanctuary System. NOAA's proposal to create MPNMS would likely result in an increase in the number of requests for ONMS general permits, special use permits, certifications, and authorizations because this action proposes to add general permits and special use permits, certifications, appeals, and the authority to authorize other valid federal, state, or local leases, permits, licenses, approvals, or other authorizations. An increase in the number of ONMS permit requests would require a change to the reporting burden certified for OMB control number 0648-0141. An update to this control number for the processing of ONMS permits would be requested as part of the final rule for sanctuary expansion.

    Nationwide, NOAA issues approximately 500 national marine sanctuary permits each year. Of this amount, MPNMS is expected to add 4 to 5 permit requests per year. The public reporting burden for national marine sanctuaries permits is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the collection of information.

    Send comments regarding the burden estimate for this data collection requirement, or any other aspect of this data collection, including suggestions for reducing the burden, to NOAA (see ADDRESSES) and by email to [email protected], or fax to (202) 395-7285.

    Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.

    IV. Request for Comments

    NOAA requests comments on this proposed rule by March 31, 2017. In additional to requesting comments on this proposed rule, NOAA is also soliciting input on the DEIS and DMP. In addition NOAA would like the public comments on the proposed name for the sanctuary.

    List of Subjects in 15 CFR Part 922

    Administrative practice and procedure, Coastal zone, Historic preservation, Intergovernmental relations, Marine resources, Natural resources, Penalties, Recreation and recreation areas, Reporting and recordkeeping requirements, Wildlife.

    Dated: December 22, 2016. W. Russell Callender, Assistant Administrator for Ocean Services and Coastal Zone Management.

    Accordingly, for the reasons discussed in the preamble, the National Oceanic and Atmospheric Administration proposes to amend 15 CFR part 922 as follows:

    PART 922—NATIONAL MARINE SANCTUARY PROGRAM REGULATIONS 1. The authority citation for 15 CFR part 922 continues to read as follows: Authority:

    16 U.S.C. 1431 et seq.

    2. Revise § 922.1 to read as follows:
    § 922.1 Applicability of regulations.

    Unless noted otherwise, the regulations in subparts A, D, and E of this part apply to all National Marine Sanctuaries and related site-specific regulations set forth in this part. Subparts B and C of this part apply to the sanctuary nomination process and to the designation of future Sanctuaries.

    3. Amend § 922.3 by revising the definition of “Sanctuary resource” to read as follows:
    § 922.3 Definitions.

    Sanctuary resource means any living or non-living resource of a National Marine Sanctuary that contributes to the conservation, recreational, ecological, historical, research, educational, or aesthetic value of the Sanctuary, including, but not limited to, the substratum of the area of the Sanctuary, other submerged features and the surrounding seabed, carbonate rock, corals and other bottom formations, coralline algae and other marine plants and algae, marine invertebrates, brine-seep biota, phytoplankton, zooplankton, fish, seabirds, sea turtles and other marine reptiles, marine mammals and historical resources. For Thunder Bay National Marine Sanctuary and Underwater Preserve, Sanctuary resource means an underwater cultural resource as defined at § 922.191. For Mallows Bay—Potomac River National Marine Sanctuary, Sanctuary resource is defined at § 922.201(a).

    4. Revise § 922.40 to read as follows:
    § 922.40 Purpose.

    The purpose of the regulations in this subpart and in the site-specific subparts is to implement the designations of the National Marine Sanctuaries by regulating activities affecting them, consistent with their respective terms of designation in order to protect, preserve and manage and thereby ensure the health, integrity and continued availability of the conservation, ecological, recreational, research, educational, historical and aesthetic resources and qualities of these areas. Additional purposes of the regulations implementing the designation of the Florida Keys and Hawaiian Islands Humpback Whale National Marine Sanctuaries are found at §§ 922.160 and 922.180, respectively.

    5. Revise § 922.41 to read as follows:
    § 922.41 Boundaries.

    The boundary for each of the National Marine Sanctuaries is set forth in the site-specific regulations covered by this part.

    6. Revise § 922.42 to read as follows:
    § 922.42 Allowed activities.

    All activities (e.g., fishing, boating, diving, research, education) may be conducted unless prohibited or otherwise regulated in the site-specific regulations covered by this part, subject to any emergency regulations promulgated under this part, subject to all prohibitions, regulations, restrictions, and conditions validly imposed by any Federal, State, or local authority of competent jurisdiction, including but not limited to, Federal, Tribal, and State fishery management authorities, and subject to the provisions of section 312 of the National Marine Sanctuaries Act (NMSA) (16 U.S.C. 1431 et seq.). The Assistant Administrator may only directly regulate fishing activities pursuant to the procedure set forth in section 304(a)(5) of the NMSA.

    7. Revise § 922.43 to read as follows:
    § 922.43 Prohibited or otherwise regulated activities.

    The site-specific regulations applicable to the activities specified therein are set forth in the subparts covered by this part.

    8. Revise § 922.44 to read as follows:
    § 922.44 Emergency regulations.

    (a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality, or minimize the imminent risk of such destruction, loss, or injury, any and all such activities are subject to immediate temporary regulation, including prohibition.

    (b) The provisions of this section do not apply to the following national marine sanctuaries with site-specific regulations that establish procedures for issuing emergency regulations:

    (1) Cordell Bank National Marine Sanctuary, § 922.112(e).

    (2) Florida Keys National Marine Sanctuary, § 922.165.

    (3) Hawaiian Islands Humpback Whale National Marine Sanctuary, § 922.185.

    (4) Thunder Bay National Marine Sanctuary, § 922.196.

    (5) Mallows Bay—Potomac River National Marine Sanctuary, § 922.204.

    (6) [Reserved]

    9. Amend § 922.47 by revising paragraph (b) to read as follows:
    § 922.47 Pre-existing authorizations or rights and certifications of pre-existing authorizations or rights.

    (b) The prohibitions listed in subparts F through P and R through T of this part do not apply to any activity authorized by a valid lease, permit, license, approval or other authorization in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and issued by any Federal, State or local authority of competent jurisdiction, or by any valid right of subsistence use or access in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, provided that the holder of such authorization or right complies with certification procedures and criteria promulgated at the time of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and with any terms and conditions on the exercise of such authorization or right imposed by the Director as a condition of certification as the Director deems necessary to achieve the purposes for which the Sanctuary was designated.

    10. Revise § 922.48 to read as follows:
    § 922.48 National Marine Sanctuary permits—application procedures and issuance criteria.

    (a) A person may conduct an activity prohibited by subparts F through O and S and T of this part, if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under this section and subparts F through O and S and T, as appropriate. For the Florida Keys National Marine Sanctuary, a person may conduct an activity prohibited by subpart P of this part if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.166. For the Thunder Bay National Marine Sanctuary and Underwater Preserve, a person may conduct an activity prohibited by subpart R of this part in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.195.

    (b) Applications for permits to conduct activities otherwise prohibited by subparts F through O and S and T of this part, should be addressed to the Director and sent to the address specified in subparts F through O of this part, or subparts R through T of this part, as appropriate. An application must include:

    (1) A detailed description of the proposed activity including a timetable for completion;

    (2) The equipment, personnel and methodology to be employed;

    (3) The qualifications and experience of all personnel;

    (4) The potential effects of the activity, if any, on Sanctuary resources and qualities; and

    (5) Copies of all other required licenses, permits, approvals or other authorizations.

    (c) Upon receipt of an application, the Director may request such additional information from the applicant as he or she deems necessary to act on the application and may seek the views of any persons or entity, within or outside the Federal government, and may hold a public hearing, as deemed appropriate.

    (d) The Director, at his or her discretion, may issue a permit, subject to such terms and conditions as he or she deems appropriate, to conduct a prohibited activity, in accordance with the criteria found in subparts F through O of this part, or subparts R through T of this part, as appropriate. The Director shall further impose, at a minimum, the conditions set forth in the relevant subpart.

    (e) A permit granted pursuant to this section is nontransferable.

    (f) The Director may amend, suspend, or revoke a permit issued pursuant to this section for good cause. The Director may deny a permit application pursuant to this section, in whole or in part, if it is determined that the permittee or applicant has acted in violation of the terms and conditions of a permit or of the regulations set forth in this section or subparts F through O of this part, or subparts R through T of this part or for other good cause. Any such action shall be communicated in writing to the permittee or applicant by certified mail and shall set forth the reason(s) for the action taken. Procedures governing permit sanctions and denials for enforcement reasons are set forth in subpart D of 15 CFR part 904.

    11. Revise § 922.49 to read as follows:
    § 922.49 Notification and review of applications for leases, licenses, permits, approvals, or other authorizations to conduct a prohibited activity.

    (a) A person may conduct an activity prohibited by subparts L through P of this part, or subparts R through T of this part, if such activity is specifically authorized by any valid Federal, State, or local lease, permit, license, approval, or other authorization issued after the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary after the effective date of the regulations in subpart P, provided that:

    (1) The applicant notifies the Director, in writing, of the application for such authorization (and of any application for an amendment, renewal, or extension of such authorization) within fifteen (15) days of the date of filing of the application or the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P of this part, whichever is later;

    (2) The applicant complies with the other provisions of this section;

    (3) The Director notifies the applicant and authorizing agency that he or she does not object to issuance of the authorization (or amendment, renewal, or extension); and

    (4) The applicant complies with any terms and conditions the Director deems reasonably necessary to protect Sanctuary resources and qualities.

    (b) Any potential applicant for an authorization described in paragraph (a) of this section may request the Director to issue a finding as to whether the activity for which an application is intended to be made is prohibited by subparts L through P of this part, or subparts R through T of this part, as appropriate.

    (c) Notification of filings of applications should be sent to the Director, Office of National Marine Sanctuaries at the address specified in subparts L through P of this part, or subparts R through T of this part, as appropriate. A copy of the application must accompany the notification.

    (d) The Director may request additional information from the applicant as he or she deems reasonably necessary to determine whether to object to issuance of an authorization described in paragraph (a) of this section, or what terms and conditions are reasonably necessary to protect Sanctuary resources and qualities. The information requested must be received by the Director within 45 days of the postmark date of the request. The Director may seek the views of any persons on the application.

    (e) The Director shall notify, in writing, the agency to which application has been made of his or her pending review of the application and possible objection to issuance. Upon completion of review of the application and information received with respect thereto, the Director shall notify both the agency and applicant, in writing, whether he or she has an objection to issuance and what terms and conditions he or she deems reasonably necessary to protect Sanctuary resources and qualities, and reasons therefor.

    (f) The Director may amend the terms and conditions deemed reasonably necessary to protect Sanctuary resources and qualities whenever additional information becomes available justifying such an amendment.

    (g) Any time limit prescribed in or established under this section may be extended by the Director for good cause.

    (h) The applicant may appeal any objection by, or terms or conditions imposed by, the Director to the Assistant Administrator or designee in accordance with the provisions of § 922.50.

    12. Revise § 922.50 to read as follows:
    § 922.50 Appeals of administrative action.

    (a)(1) Except for permit actions taken for enforcement reasons (see subpart D of 15 CFR part 904 for applicable procedures), an applicant for, or a holder of, a National Marine Sanctuary permit; an applicant for, or a holder of, a Special Use permit issued pursuant to section 310 of the Act; a person requesting certification of an existing lease, permit, license or right of subsistence use or access under § 922.47; or, for those Sanctuaries described in subparts L through P and R through T of this part, an applicant for a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction (hereinafter appellant) may appeal to the Assistant Administrator:

    (i) The granting, denial, conditioning, amendment, suspension or revocation by the Director of a National Marine Sanctuary or Special Use permit;

    (ii) The conditioning, amendment, suspension or revocation of a certification under § 922.47; or

    (iii) For those Sanctuaries described in subparts L through P and R through T of this part, the objection to issuance of or the imposition of terms and conditions on a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction.

    (2) For those National Marine Sanctuaries described in subparts F through K and S and T of this part, any interested person may also appeal the same actions described in paragraphs (a)(1)(i) and (ii) of this section. For appeals arising from actions taken with respect to these National Marine Sanctuaries, the term “appellant” includes any such interested persons.

    (b) An appeal under paragraph (a) of this section must be in writing, state the action(s) by the Director appealed and the reason(s) for the appeal, and be received within 30 days of receipt of notice of the action by the Director. Appeals should be addressed to the Assistant Administrator for Ocean Services and Coastal Zone Management, NOAA 1305 East-West Highway, 13th Floor, Silver Spring, MD 20910.

    (c)(1) The Assistant Administrator may request the appellant to submit such information as the Assistant Administrator deems necessary in order for him or her to decide the appeal. The information requested must be received by the Assistant Administrator within 45 days of the postmark date of the request. The Assistant Administrator may seek the views of any other persons. For the Monitor National Marine Sanctuary, if the appellant has requested a hearing, the Assistant Administrator shall grant an informal hearing. For all other National Marine Sanctuaries, the Assistant Administrator may determine whether to hold an informal hearing on the appeal. If the Assistant Administrator determines that an informal hearing should be held, the Assistant Administrator may designate an officer before whom the hearing shall be held.

    (2) The hearing officer shall give notice in the Federal Register of the time, place and subject matter of the hearing. The appellant and the Director may appear personally or by counsel at the hearing and submit such material and present such arguments as deemed appropriate by the hearing officer. Within 60 days after the record for the hearing closes, the hearing officer shall recommend a decision in writing to the Assistant Administrator.

    (d) The Assistant Administrator shall decide the appeal using the same regulatory criteria as for the initial decision and shall base the appeal decision on the record before the Director and any information submitted regarding the appeal, and, if a hearing has been held, on the record before the hearing officer and the hearing officer's recommended decision. The Assistant Administrator shall notify the appellant of the final decision and the reason(s) therefore in writing. The Assistant Administrator's decision shall constitute final agency action for the purpose of the Administrative Procedure Act.

    (e) Any time limit prescribed in or established under this section other than the 30-day limit for filing an appeal may be extended by the Assistant Administrator or hearing office for good cause.

    13. Add subpart S to read as follows: Subpart S—Mallows Bay—Potomac River National Marine Sanctuary Sec. 922.200 Boundary. 922.201 Definitions. 922.202 Joint management. 922.203 Prohibited or otherwise regulated activities. 922.204 Emergency regulations. 922.205 Permit procedures and review criteria. 922.206 Certification of preexisting leases, licenses, permits, approvals, other authorizations, or rights to conduct a prohibited activity. Appendix A to Subpart S of Part 922—Mallows Bay—Potomac River Marine Sanctuary Boundary Description and Coordinates of the Lateral Boundary Closures and Excluded Areas Appendix B to Subpart S of Part 922—Mallows Bay—Potomac River Marine Sanctuary Terms of Designation
    § 922.200 Boundary.

    The Mallows Bay—Potomac River National Marine Sanctuary consists of an area of approximately 39 square nautical miles (nmi 2) (52 sq. mi) of waters of the state of Maryland in the Potomac River and the submerged lands thereunder, over, around, and under the underwater cultural resources in the Potomac River. The precise boundary coordinates are listed in appendix A to this subpart. The southern and western boundary of the sanctuary approximates the border between the Commonwealth of Virginia and the State of Maryland along the western side of the Potomac River and begins at Point 1 east of Choptank Creek in King George County near Hooes, VA. From this point the boundary continues to the west passing through the points in numerical order until it reaches Point 237 at Bull Bluff on the southern side of the mouth of Potomac Creek. From this point the boundary continues north across the mouth of Potomac Creek to Point 238 near Marlboro Point in Stafford, VA. and once again follows the points in numerical order until it reaches Point 269 at the southern side of the mouth of Aquia Creek. From this point the boundary continues north across the mouth of Aquia Creek to Point 270 near Brent Point in Stafford, VA. The boundary then continues north passing through the points in numerical order until it reaches Point 312 north of Tank Creek near the restricted area in the Potomac River around Marine Base Quantico at the mouth of Chopawamsic Creek. From this point the boundary continues outside of and around the restricted area to the east and then north again passing through the points in numerical order until it reaches Point 343 south of Quantico Marina. From this point the boundary continues to the east, then north and west around the marina and then north again following the points in numerical order until it reaches Point 365 at Shipping Point on the southern side of the mouth of Quantico Creek in Quantico, VA. From this point the boundary moves to the NNE across the mouth of Quantico Creek to Possum Point near Dumfries, VA. From this point the boundary continues north passing through the points in numerical order until it reaches Point 390 SE of Southbridge, VA. From this point the boundary moves SE towards Point 391 in a straight line crossing the Potomac River until it intersects the shoreline of the river at Moss Point on the Maryland side at mean high water near Indian Head, MD just north of Goose Bay. From this intersection the boundary then follows the shoreline initially to the SW cutting across the mouths of creeks and streams along the eastern side of the Potomac River, then south past Sandy Point and around Mallows Bay. The boundary then continues following the shoreline south past Smith Point and Thomas Point where it turns to the SE and then east around Maryland Point. From here the boundary continues to follow the shoreline to the ENE past Riverside, MD until it intersects the line formed between Point 392 and Point 393 at Benny Gray Point on the western side of the mouth of Nanjemoy Creek on Tayloe Neck in Maryland. Finally, from this intersection the boundary crosses the Potomac River to the SE in a straight line and continues to Point 393 east of Choptank Creek on the Virginia side of the Potomac River.

    § 922.201 Definitions.

    (a) The following terms are defined for purposes of this subpart:

    (1) Sanctuary resource means any historical resource with the Sanctuary boundaries, as defined in § 922.3. This includes, but is not limited to, any sunken watercraft and any associated rigging, gear, fittings, trappings, and equipment; the personal property of the officers, crew, and passengers, and any cargo; and any submerged or partially submerged prehistoric, historic cultural remains, such as docks, piers, fishing-related remains (e.g., weirs, fish-traps) or other cultural heritage materials. Sanctuary resource also means any archaeological, historical, and cultural remains associated with or representative of historic or prehistoric American Indians and historic groups or peoples and their activities.

    (2) [Reserved]

    (b) All other terms appearing in the regulations in this subpart are defined at 15 CFR 922.3, and/or in the Marine Protection, Research, and Sanctuaries Act, as amended, 33 U.S.C. 1401 et seq., and 16 U.S.C. 1431 et seq.

    § 922.202 Joint management.

    NOAA has primary responsibility for the management of the Sanctuary pursuant to the Act. However, NOAA shall co-manage the Sanctuary in collaboration with the State of Maryland and Charles County. The Director shall enter into a Memorandum of Understanding regarding this collaboration that shall address, but not be limited to, such aspects as areas of mutual concern, including Sanctuary programs, permitting, activities, development, and threats to Sanctuary resources.

    § 922.203 Prohibited or otherwise regulated activities.

    (a) Except as specified in paragraphs (b) and (c) of this section, the following activities are prohibited and thus are unlawful for any person to conduct or to cause to be conducted:

    (1) Moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a Sanctuary resource. This prohibition does not apply to possessing historical resources removed from the Sanctuary area before the effective date of the Sanctuary designation.

    (2) Marking, defacing, or damaging in any way, or displacing or removing or tampering with any signs, notices, or placards, whether temporary or permanent, or with any monuments, stakes, posts, buoys, or other boundary markers related to the Sanctuary.

    (3) Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation or any permit issued under the Act.

    (b) The prohibitions in paragraphs (a)(1) through (3) of this section do not apply to any activity necessary to respond to an emergency threatening life, property or the environment; or to activities necessary for valid law enforcement purposes.

    (c)(1) Department of Defense activities must be carried out in a manner that avoids to the maximum extent practicable any adverse impacts on Sanctuary resources.

    (2) In the event of destruction of, loss of, or injury to a Sanctuary resource resulting from an incident, including but not limited to discharges, deposits, and groundings, caused by a Department of Defense activity, the Department of Defense, in coordination with the Director, must promptly prevent and mitigate further damage and must restore or replace the Sanctuary resource in a manner approved by the Director.

    § 922.204 Emergency regulations.

    (a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource, or to minimize the imminent risk of such destruction, loss, or injury, any and all activities are subject to immediate temporary regulation, including prohibition. An emergency regulation shall not take effect without the approval of the Governor of Maryland or her/his designee or designated agency.

    (b) Emergency regulations remain in effect until a date fixed in the rule or six months after the effective date, whichever is earlier. The rule may be extended once for not more than six months.

    § 922.205 Permit procedures and review criteria.

    (a) Authority to issue general permits. The Director may allow a person to conduct an activity that would otherwise be prohibited by this subpart, through issuance of a general permit, provided the applicant complies with:

    (1) The provisions of subpart E of this part; and

    (2) The relevant site specific regulations appearing in this subpart.

    (b) Sanctuary general permit categories. The Director may issue a sanctuary general permit under this subpart, subject to such terms and conditions as he or she deems appropriate, if the Director finds that the proposed activity falls within one of the following categories:

    (1) Research—activities that constitute scientific research on or scientific monitoring of national marine sanctuary resources or qualities;

    (2) Education—activities that enhance public awareness, understanding, or appreciation of a national marine sanctuary or national marine sanctuary resources or qualities; or

    (3) Management—activities that assist in managing a national marine sanctuary.

    (c) Review criteria. The Director shall not issue a permit under this subpart, unless he or she also finds that:

    (1) The proposed activity will be conducted in a manner compatible with the primary objective of protection of national marine sanctuary resources and qualities, taking into account the following factors:

    (i) The extent to which the conduct of the activity may diminish or enhance national marine sanctuary resources and qualities; and

    (ii) Any indirect, secondary or cumulative effects of the activity.

    (2) It is necessary to conduct the proposed activity within the national marine sanctuary to achieve its stated purpose.

    (3) The methods and procedures proposed by the applicant are appropriate to achieve the proposed activity's stated purpose and eliminate, minimize, or mitigate adverse effects on sanctuary resources and qualities as much as possible.

    (4) The duration of the proposed activity and its effects are no longer than necessary to achieve the activity's stated purpose.

    (5) The expected end value of the activity to the furtherance of national marine sanctuary goals and purposes outweighs any potential adverse impacts on sanctuary resources and qualities from the conduct of the activity.

    (6) The applicant is professionally qualified to conduct and complete the proposed activity.

    (7) The applicant has adequate financial resources available to conduct and complete the proposed activity and terms and conditions of the permit.

    (8) There are no other factors that would make the issuance of a permit for the activity inappropriate.

    § 922.206 Certification of preexisting leases, licenses, permits, approvals, other authorizations, or rights to conduct a prohibited activity.

    (a) A person may conduct an activity prohibited by § 922.203(a)(1) through (3) if such activity is specifically authorized by a valid Federal, state, or local lease, permit, license, approval, or other authorization, or tribal right of subsistence use or access in existence prior to the effective date of sanctuary designation and within the sanctuary designated area and complies with § 922.49 and provided that the holder of the lease, permit, license, approval, or other authorization complies with the requirements of paragraph (e) of this section.

    (b) In considering whether to make the certifications called for in this section, the Director may seek and consider the views of any other person or entity, within or outside the Federal government, and may hold a public hearing as deemed appropriate.

    (c) The Director may amend, suspend, or revoke any certification made under this section whenever continued operation would otherwise be inconsistent with any terms or conditions of the certification. Any such action shall be forwarded in writing to both the holder of the certified permit, license, or other authorization and the issuing agency and shall set forth reason(s) for the action taken.

    (d) Requests for findings or certifications should be addressed to the Director, Office of National Marine Sanctuaries; ATTN: Sanctuary Superintendent, Mallows Bay—Potomac National Marine Sanctuary, 1305 East West Hwy., 11th Floor, Silver Spring, MD 20910. A copy of the lease, permit, license, approval, or other authorization must accompany the request.

    (e) For an activity described in paragraph (a) of this section, the holder of the authorization or right may conduct the activity prohibited by § 922.203(a)(1) through (3) provided that:

    (1) The holder of such authorization or right notifies the Director, in writing, within 180 days of the effective date of Sanctuary designation, of the existence of such authorization or right and requests certification of such authorization or right;

    (2) The holder complies with the other provisions of this section; and

    (3) The holder complies with any terms and conditions on the exercise of such authorization or right imposed as a condition of certification, by the Director, to achieve the purposes for which the Sanctuary was designated.

    (f) The holder of an authorization or right described in paragraph (a) of this section authorizing an activity prohibited by § 922.203 may conduct the activity without being in violation of applicable provisions of § 922.203, pending final agency action on his or her certification request, provided the holder is otherwise in compliance with this section.

    (g) The Director may request additional information from the certification requester as he or she deems reasonably necessary to condition appropriately the exercise of the certified authorization or right to achieve the purposes for which the Sanctuary was designated. The Director must receive the information requested within 45 days of the postmark date of the request. The Director may seek the views of any persons on the certification request.

    (h) The Director may amend any certification made under this section whenever additional information becomes available that he/she determines justifies such an amendment.

    (i) Upon completion of review of the authorization or right and information received with respect thereto, the Director shall communicate, in writing, any decision on a certification request or any action taken with respect to any certification made under this section, in writing, to both the holder of the certified lease, permit, license, approval, other authorization, or right, and the issuing agency, and shall set forth the reason(s) for the decision or action taken.

    (j) The holder may appeal any action conditioning, amending, suspending, or revoking any certification in accordance with the procedures set forth in § 922.50.

    (k) Any time limit prescribed in or established under this section may be extended by the Director for good cause.

    Appendix A to Subpart S of Part 922—Mallows Bay—Potomac River Marine Sanctuary Boundary Description and Coordinates of the Lateral Boundary Closures and Excluded Areas

    Coordinates listed in this appendix are unprojected (Geographic) and based on the North American Datum of 1983.

    Table A1—Coordinates for Sanctuary Point ID Latitude Longitude 1 38.36739 −77.08823 2 38.36717 −77.08948 3 38.36704 −77.09072 4 38.36699 −77.09216 5 38.36698 −77.09295 6 38.36683 −77.09370 7 38.36674 −77.09433 8 38.36680 −77.09469 9 38.36703 −77.09430 10 38.36735 −77.09456 11 38.36761 −77.09482 12 38.36774 −77.09518 13 38.36808 −77.09629 14 38.36830 −77.09729 15 38.36870 −77.09816 16 38.36879 −77.09873 17 38.36913 −77.10063 18 38.36925 −77.10201 19 38.36947 −77.10402 20 38.36954 −77.10569 21 38.36950 −77.10722 22 38.36936 −77.10863 23 38.36900 −77.11124 24 38.36861 −77.11351 25 38.36845 −77.11467 26 38.36816 −77.11552 27 38.36818 −77.11624 28 38.36810 −77.11658 29 38.36782 −77.11717 30 38.36749 −77.11806 31 38.36709 −77.12039 32 38.36688 −77.12209 33 38.36682 −77.12429 34 38.36681 −77.12705 35 38.36690 −77.12792 36 38.36717 −77.12974 37 38.36742 −77.13146 38 38.36757 −77.13329 39 38.36764 −77.13392 40 38.36774 −77.13577 41 38.36776 −77.13724 42 38.36774 −77.13795 43 38.36753 −77.13850 44 38.36728 −77.13890 45 38.36693 −77.13928 46 38.36577 −77.14035 47 38.36475 −77.14148 48 38.36398 −77.14256 49 38.36280 −77.14402 50 38.36191 −77.14499 51 38.36031 −77.14648 52 38.35891 −77.14763 53 38.35736 −77.14879 54 38.35491 −77.15073 55 38.35391 −77.15170 56 38.35321 −77.15266 57 38.35308 −77.15292 58 38.35282 −77.15334 59 38.35248 −77.15365 60 38.35144 −77.15461 61 38.35025 −77.15589 62 38.34887 −77.15758 63 38.34760 −77.15944 64 38.34669 −77.16101 65 38.34611 −77.16212 66 38.34560 −77.16323 67 38.34525 −77.16412 68 38.34501 −77.16493 69 38.34502 −77.16541 70 38.34491 −77.16578 71 38.34483 −77.16626 72 38.34482 −77.16666 73 38.34460 −77.16748 74 38.34441 −77.16840 75 38.34444 −77.16902 76 38.34429 −77.16950 77 38.34407 −77.17030 78 38.34381 −77.17097 79 38.34350 −77.17163 80 38.34334 −77.17206 81 38.34317 −77.17263 82 38.34287 −77.17360 83 38.34209 −77.17576 84 38.34146 −77.17773 85 38.34128 −77.17854 86 38.34128 −77.17906 87 38.34138 −77.17955 88 38.34137 −77.17966 89 38.34135 −77.17980 90 38.34133 −77.18005 91 38.34131 −77.18017 92 38.34122 −77.18040 93 38.34116 −77.18079 94 38.34119 −77.18150 95 38.34120 −77.18263 96 38.34122 −77.18323 97 38.34115 −77.18430 98 38.34095 −77.18614 99 38.34079 −77.18791 100 38.34064 −77.18962 101 38.34059 −77.19086 102 38.34052 −77.19230 103 38.34053 −77.19403 104 38.34068 −77.19429 105 38.34078 −77.19441 106 38.34064 −77.19511 107 38.34055 −77.19586 108 38.34048 −77.19651 109 38.34040 −77.19799 110 38.34033 −77.19986 111 38.34040 −77.20078 112 38.34052 −77.20213 113 38.34064 −77.20333 114 38.34070 −77.20421 115 38.34043 −77.20531 116 38.34008 −77.20635 117 38.33976 −77.20698 118 38.33959 −77.20767 119 38.33960 −77.20782 120 38.33973 −77.20824 121 38.33977 −77.20867 122 38.33976 −77.20888 123 38.33973 −77.20909 124 38.33964 −77.20958 125 38.33928 −77.21080 126 38.33892 −77.21195 127 38.33854 −77.21310 128 38.33852 −77.21378 129 38.33804 −77.21485 130 38.33792 −77.21523 131 38.33761 −77.21625 132 38.33724 −77.21710 133 38.33692 −77.21799 134 38.33673 −77.21878 135 38.33658 −77.21966 136 38.33647 −77.22072 137 38.33640 −77.22109 138 38.33596 −77.22240 139 38.33567 −77.22315 140 38.33526 −77.22414 141 38.33483 −77.22528 142 38.33444 −77.22657 143 38.33408 −77.22777 144 38.33340 −77.22978 145 38.33291 −77.23116 146 38.33264 −77.23265 147 38.33231 −77.23448 148 38.33227 −77.23495 149 38.33259 −77.23502 150 38.33258 −77.23529 151 38.33209 −77.23529 152 38.33180 −77.23634 153 38.33145 −77.23785 154 38.33130 −77.23898 155 38.33123 −77.23965 156 38.33112 −77.24061 157 38.33110 −77.24127 158 38.33107 −77.24231 159 38.33109 −77.24303 160 38.33109 −77.24356 161 38.33104 −77.24483 162 38.33105 −77.24512 163 38.33107 −77.24533 164 38.33107 −77.24607 165 38.33114 −77.24689 166 38.33144 −77.24694 167 38.33144 −77.24716 168 38.33121 −77.24719 169 38.33109 −77.24770 170 38.33117 −77.24806 171 38.33139 −77.24916 172 38.33133 −77.24978 173 38.33139 −77.25021 174 38.33150 −77.25141 175 38.33159 −77.25294 176 38.33150 −77.25606 177 38.33158 −77.25623 178 38.33177 −77.25646 179 38.33187 −77.25682 180 38.33184 −77.25856 181 38.33196 −77.26076 182 38.33201 −77.26171 183 38.33218 −77.26196 184 38.33233 −77.26254 185 38.33243 −77.26373 186 38.33247 −77.26524 187 38.33264 −77.26545 188 38.33289 −77.26591 189 38.33319 −77.26671 190 38.33340 −77.26757 191 38.33339 −77.26797 192 38.33377 −77.26839 193 38.33391 −77.26862 194 38.33402 −77.26888 195 38.33412 −77.26937 196 38.33416 −77.26960 197 38.33438 −77.27005 198 38.33456 −77.27032 199 38.33482 −77.27065 200 38.33546 −77.27098 201 38.33565 −77.27125 202 38.33558 −77.27149 203 38.33570 −77.27231 204 38.33583 −77.27267 205 38.33592 −77.27292 206 38.33601 −77.27324 207 38.33635 −77.27474 208 38.33656 −77.27539 209 38.33669 −77.27564 210 38.33683 −77.27572 211 38.33694 −77.27583 212 38.33708 −77.27589 213 38.33719 −77.27585 214 38.33728 −77.27637 215 38.33738 −77.27685 216 38.33768 −77.27729 217 38.33803 −77.27741 218 38.33829 −77.27725 219 38.33883 −77.27803 220 38.33888 −77.27829 221 38.33863 −77.27848 222 38.33868 −77.27885 223 38.33899 −77.27960 224 38.33924 −77.28012 225 38.33939 −77.28028 226 38.33954 −77.28022 227 38.33978 −77.27993 228 38.34024 −77.27997 229 38.34082 −77.28058 230 38.34137 −77.28120 231 38.34185 −77.28191 232 38.34227 −77.28244 233 38.34255 −77.28270 234 38.34263 −77.28289 235 38.34276 −77.28333 236 38.34288 −77.28399 237 38.34287 −77.28458 238 38.35169 −77.28785 239 38.35176 −77.28762 240 38.35222 −77.28722 241 38.35296 −77.28696 242 38.35378 −77.28704 243 38.35441 −77.28734 244 38.35475 −77.28746 245 38.35571 −77.28759 246 38.35698 −77.28798 247 38.35753 −77.28814 248 38.35832 −77.28794 249 38.35873 −77.28777 250 38.35909 −77.28772 251 38.35949 −77.28810 252 38.36243 −77.29110 253 38.36281 −77.29123 254 38.36306 −77.29148 255 38.36425 −77.29288 256 38.36685 −77.29439 257 38.36867 −77.29555 258 38.36937 −77.29586 259 38.36998 −77.29646 260 38.37142 −77.29799 261 38.37293 −77.30072 262 38.37327 −77.30098 263 38.37342 −77.30149 264 38.37356 −77.30181 265 38.37371 −77.30200 266 38.37392 −77.30224 267 38.37426 −77.30275 268 38.37482 −77.30401 269 38.37519 −77.30479 270 38.39732 −77.31009 271 38.39823 −77.31030 272 38.39856 −77.31060 273 38.39887 −77.31075 274 38.39917 −77.31067 275 38.40015 −77.31074 276 38.40090 −77.31146 277 38.40139 −77.31216 278 38.40198 −77.31237 279 38.40314 −77.31278 280 38.40658 −77.31377 281 38.40984 −77.31466 282 38.41389 −77.31693 283 38.41832 −77.31913 284 38.41975 −77.31931 285 38.42352 −77.31972 286 38.42549 −77.32030 287 38.42738 −77.32081 288 38.43092 −77.32240 289 38.43163 −77.32242 290 38.43351 −77.32264 291 38.43385 −77.32269 292 38.43430 −77.32265 293 38.43462 −77.32229 294 38.43498 −77.32146 295 38.43526 −77.32057 296 38.43522 −77.32040 297 38.47321 −77.31846 298 38.47434 −77.31874 299 38.47561 −77.31753 300 38.47655 −77.31686 301 38.47748 −77.31667 302 38.47821 −77.31604 303 38.47871 −77.31554 304 38.47885 −77.31564 305 38.47905 −77.31559 306 38.47922 −77.31578 307 38.47943 −77.31592 308 38.47986 −77.31592 309 38.48494 −77.31336 310 38.48878 −77.31142 311 38.49279 −77.30997 312 38.49351 −77.30981 313 38.49257 −77.30624 314 38.49509 −77.30103 315 38.49849 −77.29738 316 38.50281 −77.29424 317 38.50653 −77.29712 318 38.50663 −77.29695 319 38.50755 −77.29621 320 38.50794 −77.29610 321 38.50823 −77.29611 322 38.50858 −77.29613 323 38.50871 −77.29604 324 38.50880 −77.29604 325 38.50896 −77.29612 326 38.51029 −77.29518 327 38.51167 −77.29327 328 38.51204 −77.29382 329 38.51575 −77.29102 330 38.51736 −77.29034 331 38.51778 −77.29023 332 38.51797 −77.29006 333 38.51828 −77.28968 334 38.51867 −77.28916 335 38.51883 −77.28893 336 38.51897 −77.28886 337 38.51905 −77.28874 338 38.51902 −77.28867 339 38.51904 −77.28854 340 38.51909 −77.28843 341 38.51922 −77.28834 342 38.51935 −77.28825 343 38.51945 −77.28816 344 38.51883 −77.28626 345 38.51945 −77.28539 346 38.52021 −77.28482 347 38.52115 −77.28762 348 38.52130 −77.28757 349 38.52175 −77.28728 350 38.52193 −77.28687 351 38.52223 −77.28639 352 38.52282 −77.28636 353 38.52317 −77.28616 354 38.52390 −77.28552 355 38.52434 −77.28500 356 38.52475 −77.28427 357 38.52485 −77.28385 358 38.52498 −77.28362 359 38.52516 −77.28351 360 38.52540 −77.28331 361 38.52558 −77.28310 362 38.52603 −77.28307 363 38.52706 −77.28312 364 38.52767 −77.28309 365 38.52782 −77.28322 366 38.53398 −77.27927 367 38.53458 −77.27946 368 38.53542 −77.27940 369 38.53640 −77.27899 370 38.53725 −77.27822 371 38.53714 −77.27792 372 38.53680 −77.27703 373 38.53820 −77.27624 374 38.53908 −77.27673 375 38.53962 −77.27641 376 38.54088 −77.27604 377 38.54218 −77.27594 378 38.54311 −77.27590 379 38.54345 −77.27604 380 38.54416 −77.27638 381 38.54523 −77.27670 382 38.54603 −77.27677 383 38.54678 −77.27655 384 38.54732 −77.27606 385 38.54806 −77.27536 386 38.54901 −77.27473 387 38.54986 −77.27422 388 38.55036 −77.27373 389 38.55131 −77.27265 390 38.55133 −77.27263 391* 38.52603 −77.25146 392* 38.41053 −77.12394 393 38.36739 −77.08823 Note:

    The coordinates in the table above marked with an asterisk (*) are not a part of the sanctuary boundary. These coordinates are landward reference points used to draw a line segment that intersects with the shoreline.

    Appendix B to Subpart S of Part 922—Mallows Bay—Potomac River Marine Sanctuary Terms of Designation Terms of Designation for the Proposed Mallows Bay—Potomac River National Marine Sanctuary

    Under the authority of the National Marine Sanctuaries Act, as amended (the “Act” or “NMSA”), 16 U.S.C. 1431 et seq., certain waters and submerged lands located off the Nanjemoy Peninsula of Charles County, Maryland and along the tidal Potomac River and its surrounding waters are hereby designated as a National Marine Sanctuary for the purposes of providing long-term protection and management of the historical resources and recreational, research, educational, and aesthetic qualities of the area.

    Article I: Effect of Designation

    The NMSA authorizes the issuance of such regulations as are necessary and reasonable to implement the designation, including managing and protecting the historical resources and recreational, research, and educational qualities of the Mallows Bay—Potomac River National Marine Sanctuary (the “Sanctuary”). Section 1 of Article IV of this Designation Document lists those activities that may have to be regulated on the effective date of designation, or at some later date, in order to protect Sanctuary resources and qualities. Listing an activity does not necessarily mean that it will be regulated; however, if an activity is not listed it may not be regulated, except on an emergency basis, unless Section 1 of Article IV is amended by the same procedures by which the original Sanctuary designation was made.

    Article II: Description of the Area

    The Mallows Bay—Potomac River National Marine Sanctuary consists of an area of approximately 39 square nautical miles (nmi 2) (52 sq. mi) of waters of the state of Maryland in the Potomac River and the submerged lands thereunder, over, around, and under the underwater cultural resources in the Potomac River. The southern and western boundary of the sanctuary approximates the border between the Commonwealth of Virginia and the State of Maryland for roughly 29 miles along the western side of the Potomac River and begins east of Choptank Creek in King George County near Hooes, VA. From this point the boundary approximates the border west and then north cutting across the mouths of Choptank Creek, Potomac Creek, and Aquia Creek. The boundary then continues past Widewater, VA and around the Marine Base Quantico restricted area to the east and then continues north again cutting across the mouth of Quantico Creek. From a point just north of Quantico Creek and Possum Point near Dumfries, VA the boundary crosses the Potomac to the southeast until it intersects the Maryland shoreline at Moss Point near Indian Head, MD. From this point the eastern and northern boundary of the sanctuary, approximately 21 miles in length, follows the Maryland shoreline south past Sandy Point and Mallows Bay cutting across the mouths of streams and creeks. The boundary then continues following the shoreline south past Smith Point and Thomas Point where it turns to the east around Maryland Point. From here the boundary continues to follow the shoreline past Riverside, MD to a location at Benny Gray Point on the western side of the mouth of Nanjemoy Creek on Tayloe Neck in Maryland. From here the boundary crosses the Potomac River again to the south back to its point of origin east of Choptank Creek on the Virginia side of the river. The boundary encompasses all tidal waters within this boundary from mean high tide in Maryland to mean low tide in Virginia. Excluded from the sanctuary are areas where the Virginia state line is otherwise delineated, the Quantico exclusion zone, and the area around the Quantico marina.

    Article III: Special Characteristics of the Area

    Mallows Bay—Potomac River National Marine Sanctuary and its surrounding waters contain a diverse collection of nearly 200 known historic shipwreck vessels dating back to the Civil War and potentially dating back to the Revolutionary War as well as archaeological artifacts dating back 12,000 years indicating the presence of some of the region's earliest American Indian cultures, including the Piscataway Indian Nation and the Piscataway Conoy Tribe of Maryland. The area is most renowned for the remains of over 100 wooden steamships, known as the “Ghost Fleet,” that were built for the U.S. Emergency Fleet between 1917-1919 as part of U.S. engagement in World War I. Their construction at more than 40 shipyards in 17 states reflects the massive national wartime effort that drove the expansion and economic development of communities and related maritime service industries including the present-day Merchant Marines. The area is contiguous to the Captain John Smith Chesapeake National Historic Trail, the Star Spangled Banner National Historic Trail, the Potomac Heritage National Scenic Trail and the Lower Potomac Water Trail which offer meaningful educational and recreational opportunities centered on the region's culture, heritage and history. Additionally, the structure provided by the vessels and related infrastructure serve as important habitat to thriving populations of recreational fisheries, bald eagles, and other aquatic species. The area's listing on the National Historical Register of Places in 2015 codifies the historical, archaeological and recreational significance of the Ghost Fleet and related maritime heritage sites in and around Mallows Bay—Potomac River National Marine Sanctuary.

    Article IV: Scope of Regulations

    Section 1. Activities Subject to Regulation. The following activities are subject to regulation, including prohibition, to the extent necessary and reasonable to ensure the protection and management of the historical resources and recreational, research and educational qualities of the area:

    a. Damaging sanctuary resources.

    b. Damaging sanctuary property.

    c. Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation issued under the Act.

    Section 2. Emergencies. Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource; or minimize the imminent risk of such destruction, loss, or injury, any activity, including those not listed in Section 1, is subject to immediate temporary regulation. An emergency regulation shall not take effect without the approval of the Governor of Maryland or her/his designee or designated agency.

    Article V: Relation to Other Regulatory Program

    Section 1. Fishing Regulations, Licenses, and Permits. Fishing in the Sanctuary shall not be regulated as part of the Sanctuary management regime authorized by the Act. However, fishing in the Sanctuary may be regulated by other Federal, State, Tribal and local authorities of competent jurisdiction, and designation of the Sanctuary shall have no effect on any regulation, permit, or license issued thereunder.

    Section 2. Other Regulations, Licenses, and Permits. If any valid regulation issued by any Federal, state, Tribal, or local authority of competent jurisdiction, regardless of when issued, conflicts with a Sanctuary regulation, the regulation deemed by the Director of the Office of National Marine Sanctuaries, National Oceanic and Atmospheric Administration, or designee, in consultation with the State of Maryland, to be more protective of Sanctuary resources and qualities shall govern. Pursuant to section 304(c)(1) of the Act, 16 U.S.C. 1434(c)(1), no valid lease, permit, license, approval, or other authorization issued by any Federal, State, Tribal, or local authority of competent jurisdiction, or any right of subsistence use or access, may be terminated by the Secretary of Commerce, or designee, as a result of this designation, or as a result of any Sanctuary regulation, if such lease, permit, license, approval, or other authorization, or right of subsistence use or access was issued or in existence as of the effective date of this designation. However, the Secretary of Commerce or designee, in consultation with the State of Maryland, may regulate the exercise of such authorization or right consistent with the purposes for which the Sanctuary is designated.

    Section 3. Defense Activities. Department of Defense activities must be carried out in a manner that avoids to the maximum extent practicable any adverse impacts on Sanctuary resources and qualities.

    Article VI. Alteration of This Designation

    The terms of designation may be modified only by the same procedures by which the original designation is made, including public meetings, consultation according to the NMSA.

    Subpart T—[Added and Reserved] 14. Add and reserve subpart T.
    [FR Doc. 2016-31742 Filed 1-6-17; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 922 [Docket No. 160907828-6828-01] RIN 0648-BG01 Wisconsin—Lake Michigan National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management Plan AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Proposed rule.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA) is proposing to designate an area of 1,075 square miles of Wisconsin state waters as the Wisconsin—Lake Michigan National Marine Sanctuary (WLMNMS or sanctuary). NOAA also proposes regulations to implement the sanctuary designation and establish the sanctuary's terms of designation. A draft environmental impact statement and draft management plan have also been prepared for this proposed action. The purpose of this action is to supplement current Wisconsin state regulations and resource protection efforts in a way that will ensure long term protection of the nationally significant collection of historic shipwrecks and other maritime heritage resources in the area. NOAA is soliciting public comment on the proposed rule, draft environmental impact statement (DEIS), and draft management plan (DMP). NOAA will also begin consultations under Section 106 of the National Historic Preservation Act (NHPA) and solicit public comments specifically related to the identification and assessment of the historic properties within the affected area in compliance with Section 106 review process.

    DATES:

    NOAA will consider all comments received by March 31, 2017. Public meetings will be held on the following dates:

    (1) March 13, 2017, 6:30 p.m. to 8:30 p.m., Algoma, WI;

    (2) March 14, 2017, 6:30 p.m. to 8:30 p.m., Manitowoc, WI;

    (3) March 15, 2017, 6:30 p.m. to 8:30 p.m., Sheboygan, WI; and

    (4) March 16, 2017, 6:30 p.m. to 8:30 p.m., Port Washington, WI.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NOS-2016-0150, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NOS-2016-0150, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Russ Green, Regional Coordinator, Northeast and Great Lakes Region, NOAA Office of National Marine Sanctuaries, University of Wisconsin—Sheboygan, One University Drive, Sheboygan, WI 53081.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NOAA. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NOAA will accept anonymous comments (enter“N/A” in the required fields if you wish to remain anonymous).

    Copies of the proposed rule, DEIS, and DMP can be downloaded or viewed on the internet at www.regulations.gov (search for docket #NOAA-NOS-2016-0150) or at www.regulations.gov/#!docketDetail;D=NOAA-NOS-2016-0150. Copies can also be obtained by contacting the person identified under FOR FURTHER INFORMATION CONTACT.

    The public meeting locations are:

    (1) Algoma, WI: Knudson Hall, 620 Lake Street, Algoma, WI 54201 (March 13, 2017) (2) Manitowoc, WI: Wisconsin Maritime Museum, 75 Maritime Dr., Manitowoc, WI 54220 (March 14, 2017) (3) Sheboygan, WI: University of Wisconsin—Sheboygan, Main Building, Wombat Room (Room 2114), 1 University Drive, Sheboygan, WI 53081 (March 15, 2017) (4) Port Washington, WI: Wilson House, 200 N. Franklin St., Port Washington, WI 53074 (March 16, 2017) FOR FURTHER INFORMATION CONTACT:

    Russ Green, Regional Coordinator, Northeast and Great Lakes Region at (920) 459-4425 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Introduction A. Wisconsin—Lake Michigan National Marine Sanctuary Background

    The National Marine Sanctuaries Act (NMSA; 16 U.S.C. 1431 et seq.) authorizes the Secretary of Commerce (Secretary) to designate and protect as national marine sanctuaries areas of the marine environment that are of special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or esthetic qualities. Day-to-day management of national marine sanctuaries has been delegated by the Secretary to NOAA's Office of National Marine Sanctuaries (ONMS). The primary objective of the NMSA is to protect the sanctuary system's biological and cultural resources, such as coral reefs, marine animals, historic shipwrecks, other historic structures, and archaeological sites.

    The 1,075-square-mile area proposed for designation as the Wisconsin—Lake Michigan National Marine Sanctuary encompasses the waters and bottomlands of Lake Michigan adjacent to Manitowoc, Sheboygan, and Ozaukee Counties. Principal cities in this area include Port Washington, Sheboygan, Manitowoc, Two Rivers, and Mequon. The boundary includes 80 miles of shoreline and extends 7 to 16 miles from the shoreline.

    The area includes a nationally significant collection of maritime heritage resources, including 37 known shipwrecks, about 80 suspected shipwrecks, and numerous other historic maritime-related features such as historic cribs, docks, and piers. The historic shipwrecks in the proposed sanctuary are representative of the vessels that sailed and steamed this corridor, carrying grain and raw materials east as other vessels came west loaded with coal, manufactured goods, and people. Eighteen of the 37 shipwreck sites are listed on the National Register of Historic Places. Many of the shipwrecks in the proposed sanctuary retain an unusual degree of architectural integrity, with 14 vessels nearly intact. Well preserved by Lake Michigan's cold, fresh water, the shipwrecks and related maritime heritage sites in and around the proposed Wisconsin—Lake Michigan National Marine Sanctuary possess exceptional historical, archaeological and recreational value.

    On December 2, 2014, pursuant to section 304 of the NMSA and the Sanctuary Nomination Process (SNP; 79 FR 33851), Wisconsin Governor Scott Walker, on behalf of the State of Wisconsin; the Cities of Two Rivers, Manitowoc, Sheboygan, and Port Washington; the Counties of Ozaukee, Sheboygan, and Manitowoc, submitted a nomination asking NOAA to consider designating this area of Wisconsin's Lake Michigan waters as a national marine sanctuary. The State of Wisconsin's selection of this geographic area for the nomination drew heavily from a 2008 report conducted by the Wisconsin History Society and funded by the Wisconsin Coastal Management Program (Wisconsin's Historic Shipwrecks: An Overview and Analysis of Locations for a State/Federal Partnership with the National Marine Sanctuary Program, 2008, http://www.maritimetrails.org/assets/pages/Wisconsins%20Historic%20Shipwrecks.pdf). The nomination also identified opportunities for NOAA to strengthen and expand on resource protection, education, and research programs by state of Wisconsin agencies and in the four communities along the Lake Michigan coast. NOAA completed its review of the nomination, and on February 5, 2015 added the area to the inventory of nominations that are eligible for designation. All nominations submitted to NOAA can be found at: http://www.nominate.noaa.gov/nominations/.

    NOAA began the sanctuary designation process for Wisconsin—Lake Michigan National Marine Sanctuary on October 7, 2015 with the publication of a notice of intent (NOI; 80 FR 60631) to prepare a DEIS and the initiation of a public process, as required under the NMSA and the National Environmental Policy Act (NEPA). The DEIS evaluates alternatives related to the proposed designation of the area, including a preferred alternative. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of the NHPA.

    A duplicate version of the notice for intent was published in error two days earlier on October 5, 2015 (80 FR 60132). That publication contained the exact same content as the official version made available for public inspection and published on October 7, 2015 (80 FR 60631). Any comments received in connection with the publication in error on October 5, 2015 were accepted and considered by NOAA.

    B. Need for Action

    Establishing a national marine sanctuary in Wisconsin waters would complement and supplement existing state-led preservation efforts, research programs, and public outreach initiatives. Threats to the nationally significant resources in the area include both human activities and natural processes. Natural process include the damaging impacts of wind, waves, storms, and ice, as well as the impact of invasive species such as zebra and quagga mussels that today cover most of Lake Michigan's shipwrecks. Human threats to underwater cultural resources include looting and altering sanctuary shipwreck sites and damaging sites by anchoring. These processes threaten the long term sustainability of historic shipwrecks and other underwater cultural resources, and negatively impact their recreational and archaeological value. Examples of these impacts include: Anchor damage from visiting dive boats, damage due to unpermitted and poorly attached mooring lines, artifacts being looted, artifacts being moved within a shipwreck site, a remotely-operated vehicle tether entangled within a shipwreck, fishing gear entangled within a shipwreck, increased invasive mussel coverage, and the disturbance and natural deterioration of newly uncovered shipwrecks within the boundary's large swaths of shallow, sandy lakebottom.

    The sanctuary would enhance and facilitate broader lake conservation efforts as well as heritage tourism within the many communities that have embraced their centuries-long maritime relationship with Lake Michigan, the Great Lakes region, and the nation. A sanctuary designation would enhance existing comprehensive management programs. The presence of a sanctuary would provide access to NOAA's extended network of scientific expertise and technological resources, enhance ongoing research, and provide an umbrella for the coordination of these activities. It would support and build on existing educational initiatives and provide programming and technology for K-12, post-graduate, and the general public across the state. A sanctuary designation, the local commitment to the sanctuary, the existing state agency interest, and NOAA's existing network of affiliated programs has the potential to create synergies that reach far beyond the proposed sanctuary boundaries.

    C. Designation Process National Marine Sanctuary Designation Process

    NOAA may identify areas to consider for national marine sanctuary designation through the community-based SNP described above. The process for designating a new national marine sanctuary is described in the NMSA and has four steps:

    Scoping: NOAA announces its intent to designate a new national marine sanctuary and asks the public for input on potential boundaries, resources that could be protected, issues NOAA should consider and any information that should be included in the detailed resource analysis in a draft environmental impact statement.

    Sanctuary Proposal: NOAA prepares draft designation documents including a DMP, DEIS that analyzes a range of alternatives, proposed regulations and proposed boundaries.

    Public Review: The public, agency partners, tribes and other stakeholders provide input on the draft documents. The public review step also includes the formal consultations required under NEPA, the NMSA, the NHPA, and other relevant statutes. NOAA considers all input and determines appropriate changes.

    Sanctuary Designation: NOAA makes a final decision and prepares final documents. Before the designation becomes effective, the Governor reviews the documents. Congress also has the opportunity to review the documents.

    Public Scoping Process

    On October 7, 2015 NOAA initiated the public scoping process with the publication of the NOI in the Federal Register (80 FR 60631) asking for public input on the proposed designation and informing the public that NOAA intended to prepare a DEIS evaluating alternatives related to the proposed designation of Wisconsin-Lake Michigan National Marine Sanctuary under NMSA. That announcement initiated a 90-day public comment period during which NOAA solicited additional input related to the scale and scope of the proposed sanctuary, including ideas presented in the community nomination. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of NHPA.

    During the public comment period, NOAA hosted three public meetings in November 2015 and provided additional opportunity for comments through a web-based portal [https://www.regulations.gov/#!docketDetail;D=NOAA-NOS-2015-0112] and by traditional mail until January 15, 2016. All comments received, through any of these formats, were publicly posted on the www.regulations.gov web portal.

    During this period, approximately 135 individuals provided input. Comments were overwhelmingly supportive of the goals of sanctuary designation, including the rationale for conservation of nationally-significant resources, considerations that enhance public use and recreation, considerations that enhance tourism and the local economy, and as a venue for education, science and interpretation as described in the community nomination.

    The comments underscored the need for conservation and interpretation, particularly the importance of educating users about the importance of the Great Lakes and the role that shipbuilding and shipping commerce has played in the history of the region and our nation. There was strong support from local communities, governments, and organizations supporting sanctuary designation and offering opportunities to partner for education, research, outreach and other activities.

    Several commenters who otherwise supported sanctuary designation expressed concern that designation should not in any way disrupt existing lake commerce. Specific concerns focused on the need for continued ability to dredge and maintain ports and the continued ability for ships to ballast in port and in open water.

    The few comments in opposition to sanctuary designation were concerned about the cost of implementation, the possibility that designation would make metal detecting illegal, and that designation would be an unneeded level of government intervention.

    There were several requests that NOAA consider expanding the proposed boundaries. Several comments suggesting expansion north to include shipwrecks in Kewaunee County, and one commenter requested inclusion of Green Bay.

    NOAA used the public comments submitted during the scoping process to inform the preparation of the DMP, DEIS, and the proposed sanctuary regulations. In response to many of these comments, this proposed rule proposes to provide additional protection to maritime heritage resources, particularly the nationally significant collection of historic shipwrecks. The environmental effects of these proposed designations are analyzed in a DEIS published concurrently with this proposed rule. NOAA has also developed an associated DMP describing sanctuary management activities in the area proposed for designation. NOAA is seeking public comment on the proposed rule, DEIS, and DMP, which are available at http://sanctuaries.noaa.gov/wisconsin/ or may be obtained by contacting the individual listed under the heading FOR FURTHER INFORMATION CONTACT.

    II. Summary of the Proposed Regulations 1. Adding New Subpart T and Reserving Subpart S

    NOAA is proposing to amend 15 CFR part 922 by adding a new subpart (subpart T) that contains site-specific regulations for WLMNMS. This subpart would include the proposed boundary, contain definitions of common terms used in the new subpart, provide a framework for co-management of the sanctuary, identify prohibited activities and exceptions, and establish procedures for certification of existing uses, permitting otherwise prohibited activities, and emergency regulation procedures. Several conforming changes would also be made to the national sanctuary regulations as described below.

    NOAA is concurrently working on designating a separate new national marine sanctuary in Mallows Bay—Potomac River waters as part of a separate rulemaking process, and those regulations would be published in their own new subpart (subpart S). As such, in this rulemaking, NOAA proposes to add and reserve subpart S for any future site-specific regulations that might be issued. NOAA would harmonize the regulations for the Mallows Bay-Potomac River designation process with any final rule associated with this action.

    2. Proposed Sanctuary Name

    NOAA has proposed to name the sanctuary the “Wisconsin—Lake Michigan National Marine Sanctuary (WLMNMS)” based on the nomination submitted by the community. This name aptly identifies both the lake and state where the proposed sanctuary is located. NOAA is asking for the public to provide input on this proposed name. The public may also suggest an alternative name and state the reasons for suggesting an alternative name.

    3. Proposed Sanctuary Boundary

    NOAA is proposing to designate a 1,075-square mile area of Lake Michigan waters off Ozaukee, Sheboygan, and Manitowoc Counties as WLMNMS. The sanctuary's shoreward boundary would be defined by the Ordinary High Water Mark as defined by the state of Wisconsin, while the lakeward boundary would be drawn to include all known shipwrecks in each county, extending 16 miles offshore at its greatest extent. The harbors and marinas of Two Rivers, Manitowoc, Sheboygan, and Port Washington would not be included in the sanctuary. The detailed legal boundary description is included in section 922.210 and the coordinates are located in 15 CFR part 922, subpart T, appendix A. A map of the area is shown in the DEIS.

    Within this proposed boundary are 37 known shipwrecks, including 18 on the National Register of Historic Places. The sanctuary would provide comprehensive protection of underwater cultural resources as well as develop partnerships and resources for education, interpretation, personnel, research, and administration. This would provide enhanced management of underwater cultural resources, as well as potential economic benefits to the coastal communities from Mequon to Two Rivers.

    The proposed boundary reflects the boundary the State of Wisconsin submitted to NOAA in the nomination with an adjustment based on discussions with the State of Wisconsin. The State submitted an 875-square-mile boundary in the nomination. NOAA's adjustments result in a 1,075-square-mile boundary, and includes moving the southern and northern boundary lines to the county lines and expanding the southeast corners to include the shipwreck site of the Senator (its location was previously unknown), and excluding ports and harbors.

    4. Definitions

    NOAA is proposing a site-specific definition of “sanctuary resources” for the WLMNMS to be tailored to include only the underwater cultural resources found in this area in accordance with the purpose of the proposed designation. The definition would not include biological and ecological resources of the area. Creating this new site-specific definition requires NOAA to modify the national definition of “sanctuary resource” in the national regulations at section 922.3 to add an additional sentence that defines the term for WLMNMS at section 922.211(a). This is similar to the approach taken for other national marine sanctuaries that do not share the full “sanctuary resource” definition such as Thunder Bay National Marine Sanctuary.

    The new WLMNMS definition of “sanctuary resources” would be all prehistoric, historic, archaeological, and cultural sites and artifacts within the sanctuary boundary, including but not limited to, all shipwrecks and related components.

    Additionally NOAA would add a definition for “shipwreck site” in the WLMNMS regulations at Section 922.211(a) that would define a subset of the “sanctuary resources.” The definition for “shipwreck site” would be more narrowly focused than the broader “sanctuary resource” definition and would be used in one of the prohibited activities regulations. “Shipwreck site” is defined as any sunken watercraft, its components, cargo, contents, and associated debris field.

    This proposed rule incorporates and adopts other common terms defined in the existing national regulations at section 922.3. One of the common terms adopted (without modification) is “National Marine Sanctuary” or “Sanctuary,” which means an area of the marine environment of special national significance due to its resource or human-use values, which is designated as such to ensure its conservation and management.

    5. Co-Management of the Sanctuary

    In order to further enhance the engagement forged by the State of Wisconsin in nominating this area to become a national marine sanctuary, NOAA is proposing to manage the sanctuary collaboratively with the State of Wisconsin. NOAA proposes to establish the framework for co-management of the sanctuary at section 922.212 and intends to work out the operational details of the collaboration in a Memorandum of Understanding (MOU). Details on the execution of sanctuary management such as activities, programs, and permitting programs would be included in the MOU and can be updated to adapt to changing conditions or threats to the sanctuary resources. Any significant changes to the regulations or management plan would not only be jointly coordinated but also subject to public review.

    6. Prohibited and Regulated Activities

    NOAA is proposing to supplement and complement existing management of this area by proposing three regulations to protect the sanctuary resources in section 922.213(a).

    a. Damaging Sanctuary Resources

    As a complement to existing protections under state law and NHPA regulations, NOAA is proposing to prohibit moving, removing, recovering, altering, destroying, possessing or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource. This sanctuary prohibition would supplement the existing Wisconsin regulations that prohibit damaging shipwrecks. Since 1991 Wisconsin has had state regulations related to removing or damaging shipwrecks that currently apply to the proposed area and would continue to apply to these resources after sanctuary designation.

    b. Anchoring or Grappling on a Shipwreck Site

    NOAA is proposing to prohibit the use of grappling hooks and anchoring devices into shipwreck sites to protect fragile shipwrecks within the sanctuary from damage. To provide the public adequate notice of shipwreck sites, NOAA will prepare and make available sanctuary maps with known and suspected shipwreck sites. Shipwreck sites not listed on maps would still be sanctuary resources and the prohibition on anchoring and grappling would still apply. The proposed management plan includes activities related to surveying the sanctuary area and identifying additional shipwreck sites. As appropriate, and in consideration of resource management conflicts, NOAA would update the maps as new shipwreck sites are found by the sanctuary, the Wisconsin Historical Society, or other public or private groups and individuals. Because NOAA seeks to promote public access, while also ensuring sound resource protection, an initial focus of the sanctuary management plan will be the installation of permanent mooring systems at sanctuary shipwreck sites. The moorings will provide a secure and convenient anchoring point for users, eliminating the need for grappling, and providing additional notice of the location of any known shipwreck site. NOAA is proposing to publish guidelines on best practices for anchoring near shipwrecks sites to avoid violating this prohibition. An example of a best practice could include instructions on using a weighted line, with a suggested maximum weight of 15 pounds, and surface float to mark a wreck for divers to descend and ascend. But the line would not use as an anchoring line; it would need to be continuously tended and removed before the dive boat leaves the area.

    c. Interfering With Investigations

    NOAA is proposing a regulation to prohibit interfering with sanctuary enforcement activities. This regulation will assist in NOAA's enforcement of the sanctuary regulations and strengthen sanctuary management.

    d. Exemption for Emergencies and Law Enforcement

    NOAA is proposing to include an exemption from the three regulations described above for activities that respond to emergencies that threaten lives, property or the environment, or are necessary for law enforcement purposes.

    7. Emergency Regulations

    As part of the proposed designation, NOAA is proposing to give the sanctuary authority to issue emergency regulations. Emergency regulations are used in limited cases and under specific conditions when there is an imminent risk to sanctuary resources and a temporary prohibition would prevent the destruction or loss of those resources. Under the NMSA, NOAA only issues emergency regulations that address an imminent risk for a fixed amount of time with a maximum of 6 months that can be extended a single time. A full rulemaking process must be undertaken, including a public comment period, to consider making an emergency regulation permanent. NOAA would add the authority to issue emergency regulations by modifying the national regulations at section 922.44 to include WLMNMS in a list of sanctuaries that have site-specific regulations related to emergency regulations, and adding detailed site-specific emergency regulations to the WLMNMS regulations at section 922.214.

    8. General Permits, Certifications, Authorizations, and Special Use Permits a. General Permits

    NOAA is proposing to include the authority to issue permits to allow certain activities that would otherwise violate the prohibitions in WLMNMS regulations. Similar to other national marine sanctuaries, NOAA is proposing to consider these permits for the purposes of education, research, or management.

    To address the above additions to the ONMS general permit authority for WLMNMS, NOAA would amend regulatory text in the program-wide regulations in part 922, subpart E, to add references to subpart T, as appropriate. NOAA would also add a new section 922.215 in subpart T titled “Permit procedures and review criteria” that would address site-specific permit procedures for WLMNMS.

    b. Certifications

    Because of the possibility that preexisting activities, right of subsistence use or access permitted by other federal, state, local, or tribal agencies might be occurring within the WLMNMS area that would otherwise be prohibited by WLMNMS regulations, NOAA would add language at section 922.216 describing the process by which it can certify existing activities within the WLMNMS area. In compliance with the NMSA, WLMNMS regulations at section 922.216 would state that certification is the process by which permitted activities existing prior to the designation of the sanctuary that violate sanctuary prohibitions may be allowed to continue, provided certain conditions are met. Applications for certifying permitted existing uses would have to be received by NOAA within 180 days of the effective date of the designation.

    c. Authorizations

    NOAA also proposes to provide WLMNMS with the authority to consider allowing an otherwise prohibited activity if such activity is specifically authorized by any valid Federal, state, or local lease, permit, license, approval, or other authorization issued after sanctuary designation. Authorization authority is intended to streamline regulatory requirements by reducing the need for multiple permits and would apply to all proposed prohibitions at section 922.213. As such, NOAA proposes to amend the regulatory text at section 922.49 to add reference to subpart T.

    d. Special Use Permits

    NOAA has the authority under the NMSA to issue special use permits (SUPs) at national marine sanctuaries as established by Section 310 of the NMSA. SUPs can be used to authorize specific activities in a sanctuary if such authorization is necessary (1) to establish conditions of access to and use of any sanctuary resource; or (2) to promote public use and understanding of a sanctuary resource. The activities that qualify for a SUP are set forth in the Federal Register (78 FR 25957; May 3, 2013). Categories of SUPs may be changed or added to through public notice and comment. NOAA would not apply the SUP to activities in place at the time of the WLMNMS designation.

    SUP applications are reviewed to ensure that the activity is compatible with the purposes for which the sanctuary is designated and that the activities carried out under the SUP be conducted in a manner that do not destroy, cause the loss of, or injure sanctuary resources. NOAA also requires SUP permittees to purchase and maintain comprehensive general liability insurance, or post an equivalent bond, against claims arising out of activities conducted under the permit. The NMSA allows NOAA to assess and collect fees for the conduct of any activity under a SUP. The fees collected could be used to recover the administrative costs of issuing the permit, the cost of implementing the permit, monitoring costs associated with the conduct of the activity, and the fair market value of the use of sanctuary resources.

    9. Other Conforming Amendments

    The general regulations in part 922, subpart A, for general information and part 922, subpart E, for regulations of general applicability would also have to be amended so that the regulations are accurate and up-to-date. The 10 sections that will need to be updated to reflect the increased number of sanctuaries or to add subpart T to the list of sanctuaries. The modified sections to conform to adding a new sanctuary are:

    • Section 922.1 Applicability of regulations • Section 922.40 Purpose • Section 922.41 Boundaries • Section 922.42 Allowed activities • Section 922.43 Prohibited or otherwise regulated activities • Section 922.44 Emergency regulations • Section 922.47 Pre-existing authorizations or rights and certifications of pre-existing authorizations or rights • Section 922.48 National Marine Sanctuary permits—application procedures and issuance criteria • Section 922.49 Notification and review of applications for leases, licenses, permits, approvals, or other authorizations to conduct a prohibited activity • Section 922.50 Appeals of administrative action 10. Terms of Designation

    Section 304(a)(4) of the National Marine Sanctuaries Act (NMSA) requires that the terms of designation include the geographic area included within the sanctuary; the characteristics of the area that give it conservation, recreational, ecological, historical, research, educational, or aesthetic value; and the types of activities that will be subject to regulation by the Secretary of Commerce to protect these characteristics. Section 304(a)(4) also specifies that the terms of designation may be modified only by the same procedures by which the original designation was made. Thus, the terms of designation serve as a constitution for the Sanctuary.

    NOAA is proposing to establish terms to designation that describe the geographic area, resources, and activities as described in details above. NOAA would add the terms of designation language as appendix B to the WLMNMS regulations at 15 CFR part 922, subpart T.

    III. Classification National Marine Sanctuaries Act

    NOAA has determined that the designation of the Wisconsin—Lake Michigan National Marine Sanctuary will not have a negative impact on the National Marine Sanctuary System and that sufficient resources exist to effectively implement sanctuary management plans and to update site characterizations. The finding for NMSA section 304(f) is published on the ONMS Web site for Wisconsin-Lake Michigan designation at http://sanctuaries.noaa.gov/wisconsin/.

    National Environmental Policy Act

    NOAA has prepared a draft environmental impact statement to evaluate the environmental effects of the proposed rulemaking and alternatives as required by NEPA (42 U.S.C. 4321 et seq.) and the NMSA. Copies of the DEIS and related DMP are available at the address and Web site listed in the ADDRESSES section of this proposed rule. NOAA is also soliciting public comments on the DEIS and DMP. Responses to comments received on this proposed rule as well as on the DEIS and draft management plan will be published in the final environmental impact statement and preamble to the final rule.

    Coastal Zone Management Act

    Section 307 of the Coastal Zone Management Act (CZMA; 16 U.S.C. 1456) requires Federal agencies to consult with a state's coastal program on potential Federal regulations having an effect on state waters. Because WLMNMS encompasses a portion of the Wisconsin State waters, NOAA intends to submit a copy of this proposed rule and supporting documents to the State of Wisconsin Coastal Zone Management Program for evaluation of Federal consistency under the CZMA. NOAA will publish the final rule and designation only after completion of the consultation requirements under the CZMA.

    Executive Order 12866: Regulatory Impact

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

    Executive Order 13132: Federalism Assessment

    NOAA has concluded that this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132 because NOAA supplements and complements state and local laws under the NMSA.

    National Historic Preservation Act

    The National Historic Preservation Act (NHPA; 16 U.S.C. 470 et seq.) is intended to preserve historical and archaeological sites in the United States of America. The act created the National Register of Historic Places, the list of National Historic Landmarks, and State Historic Preservation Offices. Section 106 of the NHPA requires Federal agencies to take into account the effects of their undertakings on historic properties, and afford the Advisory Council on Historic Preservation (ACHP) a reasonable opportunity to comment. The historic preservation review process mandated by Section 106 is outlined in regulations issued by ACHP (36 CFR part 800 et seq.). In fulfilling its responsibilities under the NHPA, NOAA is seeking to identify consulting parties in addition to the State Historic Preservation Officer (SHPO), and will complete the identification of historic properties and the assessment of the effects of the undertaking on such properties in scheduled consultations with those identified parties and the SHPO. By this notice NOAA seeks public input, particularly in regard to the identification of historic properties within the proposed areas of potential effect. Pursuant to 36 CFR 800.16(l)(1), historic properties includes: “any prehistoric or historic district, site, building, structure or object included in, or eligible for inclusion in, the National Register of Historic Places maintained by the Secretary of the Interior. The term includes artifacts, records, and remains that are related to and located within such properties. The term includes properties of traditional religious and cultural importance to an Indian tribe or Native Hawaiian organization and that meet the National Register criteria.” If you, your organization(s), or business(es) would like to be considered a “consulting party” under Section 106 please contact the individual listed under the heading FOR FURTHER INFORMATION CONTACT; include contact information for the principal representative for the consultation; and describe you or your party's interest in the proposed designation. In accordance with 36 CFR 800.3(f)(3), NOAA will consider all “consulting party” requests but has ultimate discretion in determining and inviting additional consulting parties.

    Regulatory Flexibility Act

    This analysis seeks to fulfill the requirements of Executive Order 12866 and the Regulatory Flexibility Act. The Small Business Administration has established thresholds on the designation of businesses as “small entities”. A finfish fishing businesses is considered a small business if it has annual receipts of less than $20.5 million. Scenic and Sightseeing and Recreational industries are considered small businesses if they have annual receipts not in excess of $7.5 million. According to these limits, each of the businesses potentially affected by the proposed rule would most likely be small businesses. However, as further discussed below, these regulations will not have a significant economic impact on the affected small entities, and the Chief Counsel for Regulations for the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have significant economic impact on a substantial number of small entities. Thus, NOAA is not required to and has not prepared an initial regulatory flexibility analysis.

    Methodology. The analysis here is based on limited quantitative information on how much each activity occurs within the proposed sanctuary. Consequently, the result is more qualitative than quantitative.

    Scales Used for Assessing Impacts. For assessing levels of impacts within an alternative, NOAA used three levels; “negligible”, “moderate” and “high” plus “no impacts”. For levels of impacts within the proposed alternatives being analyzed, negligible means very low benefits, costs, or net benefits (less than 1% change). Moderate impacts would be more than 1% but less than or equal to 10%, and high impacts would be more than 10%. For market economic values (revenue, costs, and profits), negligible would mean no likely impact whereas moderate and high could mean some measurable impact on market economic values at the levels noted above. NOAA analyzed the proposed national marine sanctuary described above.

    Small business user groups include commercial fishing operation, recreation-tourism related businesses, and land use and development businesses. Other user groups not included here are research and education, people who receive passive economic use value from stabilization or improvement to the proposed sanctuary resources, none of whom are small businesses.

    Proposed Action

    Prohibition on damaging a sanctuary resource. Small businesses that could potentially be impacted from the proposed prohibition on damaging a sanctuary resource include commercial fishing, recreational fishing and diving. This regulation is expected to have no to minimal impact on commercial fishermen because it is coextensive with existing state law. The sanctuary will assist the state in notifying the public, including fishermen of the locations of known and suspected shipwreck sites, which will enable them to avoid snagging and damaging their gear on shipwreck sites. Lastly divers and other recreational water users will still be able to use the resource, but will not able to take sanctuary resources. Therefore the impact for this user group from this prohibition is “no impact”.

    Prohibition on anchoring or grappling into a shipwreck site. Commercial fishermen use trap nets or gill nets which are anchored down, but it is unlikely that fishermen would anchor their nets near known shipwrecks due to snagging and the potential to have their gear damaged. Thus, the expected impact to commercial fishermen is negligible. The impact is also expected to be negligible for dive charters who would no longer be able to anchor on or grapple into a shipwreck site. NOAA is planning to add mooring buoys and provide anchoring best practices guidelines to facilitate divers to visit the shipwreck sites without damaging the fragile wrecks.

    Prohibition on interfering with an investigation. There is no evidence that any small business in the area would be affected by this prohibition. Therefore, the prohibition is expected to have no impact on small businesses.

    Thus, the overall expected impact to all these business in the preferred alternative is “no impact,” and the Chief Counsel for Regulations for the Department of Commerce has certified that this rule will not have a significant economic impact on a substantial number of small entities.

    Paperwork Reduction Act

    ONMS has a valid Office of Management and Budget (OMB) control number (0648-0141) for the collection of public information related to the processing of ONMS permits across the National Marine Sanctuary System. NOAA's proposal to create WLMNMS would likely result in an increase in the number of requests for ONMS general permits, special use permits, certifications, and authorizations because this action proposes to add general permits and special use permits, certifications, appeals, and the authority to authorize other valid federal, state, or local leases, permits, licenses, approvals, or other authorizations. An increase in the number of ONMS permit requests would require a change to the reporting burden certified for OMB control number 0648-0141. An update to this control number for the processing of ONMS permits would be requested as part of the final rule for sanctuary expansion.

    Nationwide, NOAA issues approximately 500 national marine sanctuary permits each year. Of this amount, WLMNMS is expected to add 4 to 5 permit requests per year. The public reporting burden for national marine sanctuaries permits is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the collection of information.

    Send comments regarding the burden estimate for this data collection requirement, or any other aspect of this data collection, including suggestions for reducing the burden, to NOAA (see ADDRESSES) and by email to [email protected], or fax to (202) 395-7285. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.

    IV. Request for Comments

    NOAA requests comments on this proposed rule by March 31, 2017. In additional to requesting comments on this proposed rule, NOAA is also soliciting input on the DEIS and DMP. In addition NOAA would like the public comments on the proposed name for the sanctuary.

    List of Subjects in 15 CFR Part 922

    Administrative practice and procedure, Coastal zone, Historic preservation, Intergovernmental relations, Marine resources, Natural resources, Penalties, Recreation and recreation areas, Reporting and recordkeeping requirements, Wildlife.

    Dated: December 22, 2016. W. Russell Callender, Assistant Administrator for Ocean Services and Coastal Zone Management.

    Accordingly, for the reasons discussed in the preamble, the National Oceanic and Atmospheric Administration proposes to amend 15 CFR part 922 as follows:

    PART 922—NATIONAL MARINE SANCTUARY PROGRAM REGULATIONS 1. The authority citation for 15 CFR part 922 continues to read as follows: Authority:

    16 U.S.C. 1431 et seq.

    2. Revise § 922.1 to read as follows:
    § 922.1 Applicability of regulations.

    Unless noted otherwise, the regulations in subparts A, D, and E of this part apply to all National Marine Sanctuaries and related site-specific regulations set forth in this part. Subparts B and C of this part apply to the sanctuary nomination process and to the designation of future Sanctuaries.

    3. Amend § 922.3 by revising the definition of “Sanctuary resource” to read as follows:
    § 922.3 Definitions.

    Sanctuary resource means any living or non-living resource of a National Marine Sanctuary that contributes to the conservation, recreational, ecological, historical, research, educational, or aesthetic value of the Sanctuary, including, but not limited to, the substratum of the area of the Sanctuary, other submerged features and the surrounding seabed, carbonate rock, corals and other bottom formations, coralline algae and other marine plants and algae, marine invertebrates, brine-seep biota, phytoplankton, zooplankton, fish, seabirds, sea turtles and other marine reptiles, marine mammals and historical resources. For Thunder Bay National Marine Sanctuary and Underwater Preserve, Sanctuary resource means an underwater cultural resource as defined at § 922.191. For Wisconsin—Lake Michigan National Marine Sanctuary, sanctuary resource is defined at § 922.211(a).

    4. Revise § 922.40 to read as follows:
    § 922.40 Purpose.

    The purpose of the regulations in this subpart and in the site-specific subparts is to implement the designations of the National Marine Sanctuaries by regulating activities affecting them, consistent with their respective terms of designation in order to protect, preserve and manage and thereby ensure the health, integrity and continued availability of the conservation, ecological, recreational, research, educational, historical and aesthetic resources and qualities of these areas. Additional purposes of the regulations implementing the designation of the Florida Keys and Hawaiian Islands Humpback Whale National Marine Sanctuaries are found at §§ 922.160 and 922.180, respectively.

    5. Revise § 922.41 to read as follows:
    § 922.41 Boundaries.

    The boundary for each of the National Marine Sanctuaries is set forth in the site-specific regulations covered by this part.

    6. Revise § 922.42 to read as follows:
    § 922.42 Allowed activities.

    All activities (e.g., fishing, boating, diving, research, education) may be conducted unless prohibited or otherwise regulated in the site-specific regulations covered by this part, subject to any emergency regulations promulgated under this part, subject to all prohibitions, regulations, restrictions, and conditions validly imposed by any Federal, State, or local authority of competent jurisdiction, including but not limited to, Federal, Tribal, and State fishery management authorities, and subject to the provisions of section 312 of the National Marine Sanctuaries Act (NMSA), (16 U.S.C. 1431 et seq.). The Assistant Administrator may only directly regulate fishing activities pursuant to the procedure set forth in section 304(a)(5) of the NMSA.

    7. Revise § 922.43 to read as follows:
    § 922.43 Prohibited or otherwise regulated activities.

    The site-specific regulations applicable to the activities specified therein are set forth in the subparts covered by this part.

    8. Revise § 922.44 to read as follows:
    § 922.44 Emergency regulations.

    (a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality, or minimize the imminent risk of such destruction, loss, or injury, any and all such activities are subject to immediate temporary regulation, including prohibition.

    (b) The provisions of this section do not apply to the following national marine sanctuaries with site-specific regulations that establish procedures for issuing emergency regulations:

    (1) Cordell Bank National Marine Sanctuary, § 922.112(e).

    (2) Florida Keys National Marine Sanctuary, § 922.165.

    (3) Hawaiian Islands Humpback Whale National Marine Sanctuary, § 922.185.

    (4) Thunder Bay National Marine Sanctuary, § 922.196.

    (5) [Reserved]

    (6) Wisconsin—Lake Michigan National Marine Sanctuary, § 922.214.

    9. Amend § 922.47 by revising paragraph (b) to read as follows:
    § 922.47 Pre-existing authorizations or rights and certifications of pre-existing authorizations or rights.

    (b) The prohibitions listed in subparts F through P and R through T of this part do not apply to any activity authorized by a valid lease, permit, license, approval or other authorization in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and issued by any Federal, State or local authority of competent jurisdiction, or by any valid right of subsistence use or access in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, provided that the holder of such authorization or right complies with certification procedures and criteria promulgated at the time of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and with any terms and conditions on the exercise of such authorization or right imposed by the Director as a condition of certification as the Director deems necessary to achieve the purposes for which the Sanctuary was designated.

    10. Revise § 922.48 to read as follows:
    § 922.48 National Marine Sanctuary permits—application procedures and issuance criteria.

    (a) A person may conduct an activity prohibited by subparts F through O and S and T of this part, if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under this section and subparts F through O and S and T, as appropriate. For the Florida Keys National Marine Sanctuary, a person may conduct an activity prohibited by subpart P of this part if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.166. For the Thunder Bay National Marine Sanctuary and Underwater Preserve, a person may conduct an activity prohibited by subpart R of this part in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.195.

    (b) Applications for permits to conduct activities otherwise prohibited by subparts F through O and S and T of this part, should be addressed to the Director and sent to the address specified in subparts F through O of this part, or subparts R through T of this part, as appropriate. An application must include:

    (1) A detailed description of the proposed activity including a timetable for completion;

    (2) The equipment, personnel and methodology to be employed;

    (3) The qualifications and experience of all personnel;

    (4) The potential effects of the activity, if any, on Sanctuary resources and qualities; and

    (5) Copies of all other required licenses, permits, approvals or other authorizations.

    (c) Upon receipt of an application, the Director may request such additional information from the applicant as he or she deems necessary to act on the application and may seek the views of any persons or entity, within or outside the Federal government, and may hold a public hearing, as deemed appropriate.

    (d) The Director, at his or her discretion, may issue a permit, subject to such terms and conditions as he or she deems appropriate, to conduct a prohibited activity, in accordance with the criteria found in subparts F through O of this part, or subparts R through T of this part, as appropriate. The Director shall further impose, at a minimum, the conditions set forth in the relevant subpart.

    (e) A permit granted pursuant to this section is nontransferable.

    (f) The Director may amend, suspend, or revoke a permit issued pursuant to this section for good cause. The Director may deny a permit application pursuant to this section, in whole or in part, if it is determined that the permittee or applicant has acted in violation of the terms and conditions of a permit or of the regulations set forth in this section or subparts F through O of this part, or subparts R through T of this part or for other good cause. Any such action shall be communicated in writing to the permittee or applicant by certified mail and shall set forth the reason(s) for the action taken. Procedures governing permit sanctions and denials for enforcement reasons are set forth in subpart D of 15 CFR part 904.

    11. Revise § 922.49 to read as follows:
    § 922.49 Notification and review of applications for leases, licenses, permits, approvals, or other authorizations to conduct a prohibited activity.

    (a) A person may conduct an activity prohibited by subparts L through P of this part, or subparts R through T of this part, if such activity is specifically authorized by any valid Federal, State, or local lease, permit, license, approval, or other authorization issued after the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary after the effective date of the regulations in subpart P, provided that:

    (1) The applicant notifies the Director, in writing, of the application for such authorization (and of any application for an amendment, renewal, or extension of such authorization) within fifteen (15) days of the date of filing of the application or the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, whichever is later;

    (2) The applicant complies with the other provisions of this section;

    (3) The Director notifies the applicant and authorizing agency that he or she does not object to issuance of the authorization (or amendment, renewal, or extension); and

    (4) The applicant complies with any terms and conditions the Director deems reasonably necessary to protect Sanctuary resources and qualities.

    (b) Any potential applicant for an authorization described in paragraph (a) of this section may request the Director to issue a finding as to whether the activity for which an application is intended to be made is prohibited by subparts L through P of this part, or subparts R through T of this part, as appropriate.

    (c) Notification of filings of applications should be sent to the Director, Office of National Marine Sanctuaries at the address specified in subparts L through P of this part, or subparts R through T of this part, as appropriate. A copy of the application must accompany the notification.

    (d) The Director may request additional information from the applicant as he or she deems reasonably necessary to determine whether to object to issuance of an authorization described in paragraph (a) of this section, or what terms and conditions are reasonably necessary to protect Sanctuary resources and qualities. The information requested must be received by the Director within 45 days of the postmark date of the request. The Director may seek the views of any persons on the application.

    (e) The Director shall notify, in writing, the agency to which application has been made of his or her pending review of the application and possible objection to issuance. Upon completion of review of the application and information received with respect thereto, the Director shall notify both the agency and applicant, in writing, whether he or she has an objection to issuance and what terms and conditions he or she deems reasonably necessary to protect Sanctuary resources and qualities, and reasons therefor.

    (f) The Director may amend the terms and conditions deemed reasonably necessary to protect Sanctuary resources and qualities whenever additional information becomes available justifying such an amendment.

    (g) Any time limit prescribed in or established under this section may be extended by the Director for good cause.

    (h) The applicant may appeal any objection by, or terms or conditions imposed by, the Director to the Assistant Administrator or designee in accordance with the provisions of § 922.50.

    12. Revise § 922.50 to read as follows:
    § 922.50 Appeals of administrative action.

    (a)(1) Except for permit actions taken for enforcement reasons (see subpart D of 15 CFR part 904 for applicable procedures), an applicant for, or a holder of, a National Marine Sanctuary permit; an applicant for, or a holder of, a Special Use permit issued pursuant to section 310 of the Act; a person requesting certification of an existing lease, permit, license or right of subsistence use or access under § 922.47; or, for those Sanctuaries described in subparts L through P and R through T of this part, an applicant for a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction (hereinafter appellant) may appeal to the Assistant Administrator:

    (i) The granting, denial, conditioning, amendment, suspension or revocation by the Director of a National Marine Sanctuary or Special Use permit;

    (ii) The conditioning, amendment, suspension or revocation of a certification under § 922.47; or

    (iii) For those Sanctuaries described in subparts L through P and subpart R through T, the objection to issuance of or the imposition of terms and conditions on a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction.

    (2) For those National Marine Sanctuaries described in subparts F through K and S and T of this part, any interested person may also appeal the same actions described in paragraphs (a)(1)(i) and (ii) of this section. For appeals arising from actions taken with respect to these National Marine Sanctuaries, the term “appellant” includes any such interested persons.

    (b) An appeal under paragraph (a) of this section must be in writing, state the action(s) by the Director appealed and the reason(s) for the appeal, and be received within 30 days of receipt of notice of the action by the Director. Appeals should be addressed to the Assistant Administrator for Ocean Services and Coastal Zone Management, NOAA 1305 East-West Highway, 13th Floor, Silver Spring, MD 20910.

    (c)(1) The Assistant Administrator may request the appellant to submit such information as the Assistant Administrator deems necessary in order for him or her to decide the appeal. The information requested must be received by the Assistant Administrator within 45 days of the postmark date of the request. The Assistant Administrator may seek the views of any other persons. For the Monitor National Marine Sanctuary, if the appellant has requested a hearing, the Assistant Administrator shall grant an informal hearing. For all other National Marine Sanctuaries, the Assistant Administrator may determine whether to hold an informal hearing on the appeal. If the Assistant Administrator determines that an informal hearing should be held, the Assistant Administrator may designate an officer before whom the hearing shall be held.

    (2) The hearing officer shall give notice in the Federal Register of the time, place and subject matter of the hearing. The appellant and the Director may appear personally or by counsel at the hearing and submit such material and present such arguments as deemed appropriate by the hearing officer. Within 60 days after the record for the hearing closes, the hearing officer shall recommend a decision in writing to the Assistant Administrator.

    (d) The Assistant Administrator shall decide the appeal using the same regulatory criteria as for the initial decision and shall base the appeal decision on the record before the Director and any information submitted regarding the appeal, and, if a hearing has been held, on the record before the hearing officer and the hearing officer's recommended decision. The Assistant Administrator shall notify the appellant of the final decision and the reason(s) therefore in writing. The Assistant Administrator's decision shall constitute final agency action for the purpose of the Administrative Procedure Act.

    (e) Any time limit prescribed in or established under this section other than the 30-day limit for filing an appeal may be extended by the Assistant Administrator or hearing office for good cause.

    Subpart S—[Added and Reserved] 13. Add and reserve subpart S. 14. Add subpart T to read as follows: SUBPART T—WISCONSIN-LAKE MICHIGAN NATIONAL MARINE SANCTUARY Sec. 922.210 Boundary. 922.211 Definitions. 922.212 Co-management. 922.213 Prohibited or otherwise regulated activities. 922.214 Emergency regulations. 922.215 Permit procedures and review criteria. 922.216 Certification of preexisting leases, licenses, permits, approvals, other authorizations, or rights to conduct a prohibited activity. Appendix A to Subpart T of Part 922—Wisconsin-Lake Michigan Marine Sanctuary Boundary Description and Coordinates of the Lateral Boundary Closures and Excluded Areas Appendix B to Subpart T of Part 922—Wisconsin-Lake Michigan Marine Sanctuary Terms of Designation
    § 922.210 Boundary.

    The Wisconsin-Lake Michigan National Marine Sanctuary consists of an area of approximately 812 square nautical miles (nmi2) (1,075 sq. mi) of Lake Michigan waters within the state of Wisconsin and the submerged lands thereunder, over, around, and under the submerged underwater cultural resources in Lake Michigan. The precise boundary coordinates are listed in appendix A to this subpart. The eastern boundary of the sanctuary begins approximately 9.5 miles east of the Wisconsin shoreline in Lake Michigan at Point 1 roughly on the border between Manitowoc and Kewaunee County. From this point the boundary continues SSW in a straight line to Point 2 and then SW to Point 3 at roughly the border between Ozaukee and Milwaukee County. From this point the boundary continues west towards Point 4 until it intersects the shoreline at the ordinary high water mark near Mequon, WI. From this intersection the boundary continues north following the shoreline cutting across the mouths of creeks and streams until it intersects the line segment formed between Point 5 and Point 6 at the end of the southern breakwater at the mouth of Sauk Creek at Port Washington. From this intersection the boundary continues across the river mouth towards Point 6 until it intersects the shoreline at the ordinary high water mark at the end of the northern breakwater. From this intersection the boundary continues north following the shoreline until it intersects the line segment formed between Point 7 and Point 8 at the end of the southern breakwater at the mouth of the Sheboygan River. From this intersection the boundary continues across the river mouth towards Point 8 until it intersects the shoreline at the ordinary high water mark at the end of the northern breakwater. From this intersection the boundary continues north along the shoreline until it intersects the line segment formed between Point 9 and Point 10 at the end of the southern breakwater at the mouth of Manitowoc Harbor. From this intersection the boundary continues across the harbor mouth towards Point until it intersects the shoreline at the ordinary high water mark10 at the end of the northern breakwater. From this intersection the boundary continues north following the shoreline until it intersects the line segment formed between Point 11 and Point 12 at the end of the western breakwater at the mouth of East Twin River. From this intersection the boundary continues across the river mouth towards Point 12 until it intersects the shoreline at the ordinary high water mark at the end of the eastern breakwater. From this intersection the boundary follows the shoreline NE around Rawley Point and then NNW until it intersects the line segment formed between Point 13 and Point 14 along the shoreline at approximately the border between Manitowoc and Kewaunee County near Twin Creeks, WI. Finally, from this intersection the boundary moves east across Lake Michigan to Point 14.

    § 922.211 Definitions.

    (a) The following terms are defined for purposes of this subpart:

    (1) Sanctuary resource means all prehistoric, historic, archaeological, and cultural sites and artifacts within the sanctuary boundary, including but not limited to, all shipwrecks and related components.

    (2) Shipwreck site means any sunken watercraft, its components, cargo, contents, and associated debris field.

    (b) All other terms appearing in the regulations in this subpart are defined at 15 CFR 922.3, and/or in the Marine Protection, Research, and Sanctuaries Act, as amended, 33 U.S.C. 1401 et seq., and 16 U.S.C. 1431 et seq.

    § 922.212 Co-management.

    NOAA has primary responsibility for the management of the Sanctuary pursuant to the Act. However, as the Sanctuary is in state waters, NOAA will co-manage the Sanctuary in collaboration with the State of Wisconsin. The Director may enter into a Memorandum of Understanding regarding this collaboration that may address, but not be limited to, such aspects as areas of mutual concern, including Sanctuary resource protection, programs, permitting, activities, development, and threats to Sanctuary resources.

    § 922.213 Prohibited or otherwise regulated activities.

    (a) Except as specified in paragraph (b) of this section, the following activities are prohibited and thus are unlawful for any person to conduct or to cause to be conducted:

    (1) Moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource.

    (2) Grappling into or anchoring on shipwreck sites.

    (3) Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation or any permit issued under the Act.

    (b) The prohibitions in paragraphs (a)(1) through (3) of this section do not apply to any activity necessary to respond to an emergency threatening life, property or the environment; or to activities necessary for valid law enforcement purposes.

    § 922.214 Emergency regulations.

    (a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource, or to minimize the imminent risk of such destruction, loss, or injury, any and all activities are subject to immediate temporary regulation, including prohibition. An emergency regulation shall not take effect without the approval of the Governor of Wisconsin or her/his designee or designated agency.

    (b) Emergency regulations remain in effect until a date fixed in the rule or six months after the effective date, whichever is earlier. The rule may be extended once for not more than six months.

    § 922.215 Permit procedures and review criteria.

    (a) Authority to issue general permits. The Director may allow a person to conduct an activity that would otherwise be prohibited by this subpart, through issuance of a general permit, provided the applicant complies with:

    (1) The provisions of subpart E of this part; and

    (2) The relevant site specific regulations appearing in this subpart.

    (b) Sanctuary general permit categories. The Director may issue a sanctuary general permit under this subpart, subject to such terms and conditions as he or she deems appropriate, if the Director finds that the proposed activity falls within one of the following categories:

    (1) Research—activities that constitute scientific research on or scientific monitoring of national marine sanctuary resources or qualities;

    (2) Education—activities that enhance public awareness, understanding, or appreciation of a national marine sanctuary or national marine sanctuary resources or qualities; or

    (3) Management—activities that assist in managing a national marine sanctuary.

    (c) Review criteria. The Director shall not issue a permit under this subpart, unless he or she also finds that:

    (1) The proposed activity will be conducted in a manner compatible with the primary objective of protection of national marine sanctuary resources and qualities, taking into account the following factors:

    (i) The extent to which the conduct of the activity may diminish or enhance national marine sanctuary resources and qualities; and

    (ii) Any indirect, secondary or cumulative effects of the activity.

    (2) It is necessary to conduct the proposed activity within the national marine sanctuary to achieve its stated purpose.

    (3) The methods and procedures proposed by the applicant are appropriate to achieve the proposed activity's stated purpose and eliminate, minimize, or mitigate adverse effects on sanctuary resources and qualities as much as possible.

    (4) The duration of the proposed activity and its effects are no longer than necessary to achieve the activity's stated purpose.

    (5) The expected end value of the activity to the furtherance of national marine sanctuary goals and purposes outweighs any potential adverse impacts on sanctuary resources and qualities from the conduct of the activity.

    (6) The applicant is professionally qualified to conduct and complete the proposed activity.

    (7) The applicant has adequate financial resources available to conduct and complete the proposed activity and terms and conditions of the permit.

    (8) There are no other factors that would make the issuance of a permit for the activity inappropriate.

    § 922.216 Certification of preexisting leases, licenses, permits, approvals, other authorizations, or rights to conduct a prohibited activity.

    (a) A person may conduct an activity prohibited by § 922.213(a)(1) through (3) if such activity is specifically authorized by a valid Federal, state, or local lease, permit, license, approval, or other authorization, or tribal right of subsistence use or access in existence prior to the effective date of sanctuary designation and within the sanctuary designated area and complies with § 922.49 and provided that the holder of the lease, permit, license, approval, or other authorization complies with the requirements of paragraph (e) of this section.

    (b) In considering whether to make the certifications called for in this section, the Director may seek and consider the views of any other person or entity, within or outside the Federal government, and may hold a public hearing as deemed appropriate.

    (c) The Director may amend, suspend, or revoke any certification made under this section whenever continued operation would otherwise be inconsistent with any terms or conditions of the certification. Any such action shall be forwarded in writing to both the holder of the certified permit, license, or other authorization and the issuing agency and shall set forth reason(s) for the action taken.

    (d) Requests for findings or certifications should be addressed to the Director, Office of National Marine Sanctuaries; ATTN: Sanctuary Superintendent, Wisconsin-Lake Michigan National Marine Sanctuary, 1305 East-West Hwy, 11th Floor, Silver Spring, MD 20910. A copy of the lease, permit, license, approval, or other authorization must accompany the request.

    (e) For an activity described in paragraph (a) of this section, the holder of the authorization or right may conduct the activity prohibited by § 922.213(a)(1) through (3) provided that:

    (1) The holder of such authorization or right notifies the Director, in writing, within 180 days of the effective date of Sanctuary designation, of the existence of such authorization or right and requests certification of such authorization or right;

    (2) The holder complies with the other provisions of this section; and

    (3) The holder complies with any terms and conditions on the exercise of such authorization or right imposed as a condition of certification, by the Director, to achieve the purposes for which the Sanctuary was designated.

    (f) The holder of an authorization or right described in paragraph (a) of this section authorizing an activity prohibited by § 922.213 may conduct the activity without being in violation of applicable provisions of § 922.213, pending final agency action on his or her certification request, provided the holder is otherwise in compliance with this section.

    (g) The Director may request additional information from the certification requester as he or she deems reasonably necessary to condition appropriately the exercise of the certified authorization or right to achieve the purposes for which the Sanctuary was designated. The Director must receive the information requested within 45 days of the postmark date of the request. The Director may seek the views of any persons on the certification request.

    (h) The Director may amend any certification made under this section whenever additional information becomes available that he/she determines justifies such an amendment.

    (i) Upon completion of review of the authorization or right and information received with respect thereto, the Director shall communicate, in writing, any decision on a certification request or any action taken with respect to any certification made under this section, in writing, to both the holder of the certified lease, permit, license, approval, other authorization, or right, and the issuing agency, and shall set forth the reason(s) for the decision or action taken.

    (j) The holder may appeal any action conditioning, amending, suspending, or revoking any certification in accordance with the procedures set forth in § 922.50.

    (k) Any time limit prescribed in or established under this section may be extended by the Director for good cause.

    Appendix A to Subpart T of Part 922—Wisconsin-Lake Michigan Marine Sanctuary Boundary Description and Coordinates of the Lateral Boundary Closures and Excluded Areas

    Coordinates listed in this appendix are unprojected (Geographic) and based on the North American Datum of 1983.

    Table A1—Coordinates for Sanctuary Point ID Latitude Longitude 1 44.32749 −87.34795 2 43.45716 −87.48817 3 43.19198 −87.62813 4 * 43.19203 −87.89245 5 * 43.38447 −87.86079 6 * 43.38523 −87.85963 7 * 43.74858 −87.69479 8 * 43.74946 −87.69265 9 * 44.09135 −87.64377 10 * 44.09262 −87.64373 11 * 44.14226 −87.56161 12 * 44.14267 −87.56069 13 * 44.32751 −87.54400 14 44.32749 −87.34795 Note:

    The coordinates in the table above marked with an asterisk (*) are not a part of the sanctuary boundary. These coordinates are landward reference points used to draw a line segment that intersects with the shoreline.

    Appendix B to Subpart T of Part 922—Wisconsin-Lake Michigan Marine Sanctuary Terms of Designation

    Terms of Designation for the Proposed Wisconsin-Lake Michigan National Marine Sanctuary Under the authority of the National Marine Sanctuaries Act, as amended (the “Act” or “NMSA”), 16 U.S.C. 1431 et seq., 1,075 square miles of Lake Michigan off the coast of Wisconsin's coastal counties of Ozaukee, Sheboygan and Manitowoc are hereby designated as a National Marine Sanctuary for the purposes of providing long-term protection and management of the historical resources and recreational, research, educational, and aesthetic qualities of the area.

    Article I: Effect of Designation

    The NMSA authorizes the issuance of such regulations as are necessary and reasonable to implement the designation, including managing and protecting the historical resources and recreational, research, and educational qualities of the Wisconsin-Lake Michigan National Marine Sanctuary (the “Sanctuary”). Section 1 of Article IV of this Designation Document lists those activities that may have to be regulated on the effective date of designation, or at some later date, in order to protect Sanctuary resources and qualities. Listing an activity does not necessarily mean that it will be regulated; however, if an activity is not listed it may not be regulated, except on an emergency basis, unless Section 1 of Article IV is amended by the same procedures by which the original Sanctuary designation was made.

    Article II: Description of the Area

    The Wisconsin-Lake Michigan National Marine Sanctuary consists of an area of approximately 812 square nautical miles (nmi2) (1,075 sq. mi) of Lake Michigan waters within the state of Wisconsin and the submerged lands thereunder, over, around, and under the submerged underwater cultural resources in Lake Michigan. The eastern boundary of the sanctuary begins approximately 9.5 miles east of the Wisconsin shoreline in Lake Michigan roughly on the border between Manitowoc and Kewaunee County. From this point the boundary continues in Lake Michigan roughly to the SSW until it intersects the border between Ozaukee and Milwaukee County at a point approximately 13 miles east of the shoreline. The southern boundary continues west approximating the border between these same two counties until it intersects the shoreline near Mequon, WI. The western boundary continues north following the shoreline for approximately 90 miles cutting across the mouths of rivers and streams; specifically those of Sauk Creek at Port Washington, the Sheboygan River at Sheboygan, Manitowoc Harbor as Manitowoc, and East Twin River at Two Rivers as well as any other smaller streams and creeks. The western boundary ends at roughly the border between Manitowoc and Kewaunee County along the shoreline near Twin Creeks, WI. The northern boundary continues from the shoreline east approximating the border between these same two counties back to its point of origin 9.5 miles offshore.

    Article III: Special Characteristics of the Area

    The historic shipwrecks in the Wisconsin-Lake Michigan National Marine Sanctuary are representative of vessels that sailed and steamed the Lake Michigan corridor, carrying grain and raw materials east as other vessels came west loaded with coal, manufactured good, and immigrants. Eighteen of the 37 shipwrecks are listed on the National Register of Historic Places. Many of the shipwrecks in the proposed sanctuary retain an unusual degree of architectural integrity, with 14 vessels virtually intact. Well preserved by Lake Michigan's cold, fresh water, the shipwrecks and related underwater cultural sites in and around the Wisconsin-Lake Michigan National Marine Sanctuary possess exceptional historical, archaeological and recreational value.

    Article IV: Scope of Regulations

    Section 1. Activities Subject to Regulation. The following activities are subject to regulation, including prohibition, to the extent necessary and reasonable to ensure the protection and management of the historical resources and recreational, research and educational qualities of the area:

    a. Damaging sanctuary resources.

    b. Using grappling hooks and anchors at shipwreck sites.

    c. Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation issued under the Act.

    d. Reporting shipwreck discoveries and locations to the sanctuary.

    Section 2. Emergencies. Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality; or minimize the imminent risk of such destruction, loss, or injury, any activity, including those not listed in Section 1, is subject to immediate temporary regulation. An emergency regulation shall not take effect without the approval of the Governor of Wisconsin or her/his designee or designated agency.

    Article V: Relation to Other Regulatory Programs

    Section 1. Fishing Regulations, Licenses, and Permits. Fishing in the Sanctuary shall not be regulated as part of the Sanctuary management regime authorized by the Act. However, fishing in the Sanctuary may be regulated by other Federal, State, Tribal and local authorities of competent jurisdiction, and designation of the Sanctuary shall have no effect on any regulation, permit, or license issued thereunder.

    Section 2. Other Regulations, Licenses, and Permits. If any valid regulation issued by any Federal, state, Tribal, or local authority of competent jurisdiction, regardless of when issued, conflicts with a Sanctuary regulation, the regulation deemed by the Director of the Office of National Marine Sanctuaries, National Oceanic and Atmospheric Administration, or designee, in consultation with the State of Wisconsin, to be more protective of Sanctuary resources and qualities shall govern. Pursuant to section 304(c)(1) of the Act, 16 U.S.C. 1434(c)(1), no valid lease, permit, license, approval, or other authorization issued by any Federal, State, Tribal, or local authority of competent jurisdiction, or any right of subsistence use or access, may be terminated by the Secretary of Commerce, or designee, as a result of this designation, or as a result of any Sanctuary regulation, if such lease, permit, license, approval, or other authorization, or right of subsistence use or access was issued or in existence as of the effective date of this designation. However, the Secretary of Commerce or designee, in consultation with the State of Wisconsin, may regulate the exercise of such authorization or right consistent with the purposes for which the Sanctuary is designated.

    Article VI. Alteration of This Designation

    The terms of designation may be modified only by the same procedures by which the original designation is made, including public meetings, consultation according to the NMSA.

    [FR Doc. 2016-31741 Filed 1-6-17; 8:45 am] BILLING CODE 03510-NK-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-446] Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Notice of intent.

    SUMMARY:

    The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule six synthetic cannabinoids: Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of these synthetic cannabinoids.

    DATES:

    January 9, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

    SUPPLEMENTARY INFORMATION:

    Any final order will be published in the Federal Register and may not be effective prior to February 8, 2017.

    Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

    Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.

    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

    Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

    Background

    Section 201(h)(4) of the CSA 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of any intention to temporarily place a substance into schedule I of the CSA.1 The Acting Administrator transmitted notice of his intent to place 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in schedule I on a temporary basis to the Assistant Secretary by letter dated April 22, 2016. The Assistant Secretary responded to this notice by letter dated May 2, 2016, and advised that based on a review by the Food and Drug Administration (FDA), there were no investigational new drug applications or approved new drug applications for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA. The Assistant Secretary also stated that the HHS had no objection to the temporary placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA into schedule I of the CSA. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA are not currently listed in any schedule under the CSA.

    1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the Department of Health and Human Service (HHS) in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.

    To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

    A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA

    Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these synthetic cannabinoids (SCs) have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.

    Synthetic Cannabinoids

    SCs are substances synthesized in laboratories that mimic the biological effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. It is believed that SCs were first introduced on the designer drug market in several European countries as “herbal incense” before the initial encounter in the United States by U.S. Customs and Border Protection (CBP) in November 2008. From 2009 to the present, misuse and abuse of SCs has increased in the United States with law enforcement encounters describing SCs applied onto plant material and in designer drug products intended for human consumption. It has been demonstrated that the substances and the associated designer drug products are abused for their psychoactive properties. With many generations of SCs having been encountered since 2009, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are some of the latest, and the abuse of these substances is negatively impacting communities.

    As observed by the DEA and CBP, SCs originate from foreign sources, such as China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. According to online discussion boards and law enforcement encounters, applying by spraying or mixing the SCs with plant material provides a vehicle for the most common route of administration—smoking (using a pipe, a water pipe, or rolling the drug-laced plant material in cigarette papers).

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA have no accepted medical use in the United States. Use of these specific SCs has been reported to result in adverse effects in humans including deaths (see 3-Factor document in “Supporting and Related Material” section). Use of other SCs has resulted in signs of addiction and withdrawal, and based on the similar pharmacological profile of these six substances, it is believed that there will be similar observed adverse effects.

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are SCs that have pharmacological effects similar to the schedule I hallucinogen delta-Δ-tetrahydrocannabinol (THC) and temporarily and permanently controlled schedule I synthetic cannabinoid substances. In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have been associated with either overdoses requiring emergency medical intervention or death (see factor 6). With no approved medical use and limited safety or toxicological information, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, and the abuse of these substances for their psychoactive properties is concerning. The DEA's analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at www.regulations.gov under docket number DEA-443.

    Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids have been developed over the last 30 years as tools for investigating the endocannabinoid system (e.g., determining CB1 and CB2 receptor activity). The first encounter of SCs within the United States occurred in November 2008 by CBP. Since then the popularity of SCs and their associated products has increased steadily as evidenced by law enforcement seizures, public health information, and media reports. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are SCs that have been recently encountered (see “Supporting and Related Material,” Factor 5). Multiple overdoses involving emergency medical intervention or deaths have been associated with 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.

    Research and clinical reports have demonstrated that SCs are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and/or psychoactive “high,” believed to be similar to marijuana. Data gathered from published studies, supplemented by discussions on Internet discussion Web sites, demonstrate that these products are being abused mainly by smoking for their psychoactive properties. The adulterated products are marketed as “legal” alternatives to marijuana. In recent overdoses, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been shown to be applied onto plant material, similar to the SCs that have been previously available.

    Law enforcement personnel have encountered various application methods including buckets or cement mixers in which plant material and one or more SCs (including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA) are mixed together, as well as large areas where the plant material is spread out so that a dissolved SC mixture can be applied directly. Once mixed, the SC plant material is then allowed to dry before manufacturers package the product for distribution, ignoring any control mechanisms to prevent contamination or to ensure a consistent, uniform concentration of the substance in each package. Adverse health consequences may also occur from directly ingesting the substance(s) during the manufacturing process. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, similar to other SCs, have been encountered in form of dried leaves or herbal blends.

    The designer drug products laced with SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, are often sold under the guise of “herbal incense” or “potpourri,” use various product names, and are routinely labeled “not for human consumption.” Additionally, these products are marketed as a “legal high” or “legal alternative to marijuana” and are readily available over the Internet, in head shops, or sold in convenience stores. There is an incorrect assumption that these products are safe, that they are a synthetic form of marijuana, and that labeling these products as “not for human consumption” is a legal defense to criminal prosecution.

    A major concern, as reiterated by public health officials and medical professionals, is the targeting and direct marketing of SCs and SC-containing products to adolescents and youth. This is supported by law enforcement encounters and reports from emergency departments; however, all age groups have been reported by media as abusing these substances and related products. Individuals, including minors, are purchasing SCs from Internet Web sites, gas stations, convenience stores, and head shops.

    Factor 5. Scope, Duration and Significance of Abuse

    SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, continue to be encountered on the illicit market regardless of scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Numerous substances are encountered each month, differing only by small modifications intended to avoid prosecution while maintaining the pharmacological effects. Law enforcement and health care professionals continue to report abuse of these substances and their associated products.

    As described by the National Institute on Drug Abuse (NIDA), many substances being encountered in the illicit market, specifically SCs, have been available for years but have reentered the marketplace due to a renewed popularity.

    The threat of serious injury to the individual following the ingestion of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA and other SCs persists. Numerous calls have been received by poison centers regarding the abuse of products potentially laced with SCs that have resulted in visits to emergency departments. Law enforcement continues to encounter novel SCs on the illicit market, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA (see factor 5 in “Supporting and Related Material”).

    The following information details information obtained through NFLIS 2 (queried on November 7, 2016), including dates of first encounter, exhibits/reports, and locations.

    2 The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories in the United States.

    5F-ADB: NFLIS—2,311 reports, first encountered in September 2014, locations include: Arizona, Arkansas, California, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Missouri, New Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, and Wisconsin.

    5F-AMB: NFLIS—3,349 reports, first encountered in January 2014, locations include: Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming.

    5F-APINACA: NFLIS—1,936 reports, first encountered in August 2012, locations include: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin, and Wyoming.

    ADB-FUBINACA: NFLIS—942 reports, first encountered in March 2014, locations include: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Mississippi, Missouri, New Jersey, New Mexico, New York, North Dakota, Ohio, Pennsylvania, Texas, Utah, Virginia, and Wyoming.

    MDMB-CHMICA: NFLIS—227 reports, first encountered in March 2015, locations include: Arkansas, Georgia, Indiana, Kentucky, Louisiana, Nevada, Ohio, Oklahoma, South Carolina, and Texas.

    MDMB-FUBINACA: NFLIS—507 reports, first encountered in July 2015, locations include: Arkansas, California, Colorado, Connecticut, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Missouri, Nevada, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Wisconsin, and West Virginia.

    Factor 6. What, if Any, Risk There Is to the Public Health

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have all been identified in overdose and/or cases involving death attributed to their abuse. Adverse health effects reported from these incidents involving 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have included: nausea, persistent vomiting, agitation, altered mental status, seizures, convulsions, loss of consciousness and/or cardio toxicity. Large clusters of overdoses requiring medical care have been reported involving 5F-AMB, MDMB-FUBINACA, MDMB-CHMICA and 5F-ADB. Reported deaths involving these SCs have included 5F-ADB (8); 5F-AMB (6); 5F-APINACA (1); ADB-FUBINACA (2); MDMB-CHMICA (4), European Monitoring Centre for Drugs and Drug Addiction has reported an additional 12 deaths involving MDMB-CHMICA; and MDMB-FUBINACA (1) (see factor 6 in “Supporting and Related Material”).

    Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these SCs have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 22, 2016, notified the Assistant Secretary of the DEA's intention to temporarily place these six substances in schedule I.

    Conclusion

    This notice of intent initiates a temporary scheduling action and provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h). In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] in schedule I of the CSA, and finds that the placement of these substances into schedule I of the CSA on a temporary basis is necessary to avoid an imminent hazard to the public safety.

    Because the Administrator hereby finds that it is necessary to temporarily place these SCs into schedule I to avoid an imminent hazard to the public safety, any subsequent final order temporarily scheduling these substances will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the intention of the Administrator to issue such a final order as soon as possible after the expiration of 30 days from the date of publication of this notice. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will then be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional activities, and chemical analysis and possession of a schedule I controlled substance.

    The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

    Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).

    Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

    Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator will take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order.

    Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.

    Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget.

    This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

    List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as follows:

    PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: Authority:

    21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. In § 1308.11, add paragraph (h)(23) through (28) to read as follows:
    § 1308.11 Schedule I

    (h) * * *

    (23) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-ADB; 5F-MDMB-PINACA) (7034) (24) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-AMB) (7033) (25) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-APINACA, 5F-AKB48) (7049) (26) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: ADB-FUBINACA) (7010) (27) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB-CHMICA, MMB-CHMINACA) (7042) (28) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB-FUBINACA) (7020)
    Dated: December 13, 2016. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2017-00275 Filed 1-6-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Parts 57, 70, 72, and 75 [Docket No. MSHA-2014-0031] RIN 1219-AB86 Exposure of Underground Miners to Diesel Exhaust AGENCY:

    Mine Safety and Health Administration, Labor.

    ACTION:

    Request for information; reopening of the comment period.

    SUMMARY:

    In response to requests from the public, the Mine Safety and Health Administration (MSHA) is reopening the proposed rulemaking record for public comment on the Agency's request for information on Exposure of Underground Miners to Diesel Exhaust.

    DATES:

    The comment period for the request for information, published on June 8, 2016 (81 FR 36826), and closed on November 30, 2016, (81 FR 58424) is reopened. Comments must be received on or before midnight Eastern Standard Time on January 9, 2018.

    ADDRESSES:

    Submit comments and informational materials for the rulemaking record, identified by RIN 1219-AB86 or Docket No. MSHA-2014-0031, by one of the following methods:

    Federal E-Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    E-Mail: [email protected]

    Mail: MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.

    Hand Delivery or Courier: 201 12th Street South, Suite 4E401, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal holidays. Sign in at the receptionist's desk on the 4th floor East, Suite 4E401.

    Fax: 202-693-9441.

    Instructions: All submissions must include “RIN 1219-AB86” or “Docket No. MSHA-2014-0031.” Do not include personal information that you do not want publicly disclosed; MSHA will post all comments without change to http://www.regulations.gov and http://arlweb.msha.gov/currentcomments.asp, including any personal information provided.

    Docket: For access to the docket to read comments received, go to http://www.regulations.gov or http://arlweb.msha.gov/currentcomments.asp. To read background documents, go to http://www.regulations.gov. Review the docket in person at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal Holidays. Sign in at the receptionist's desk in Suite 4E401.

    E-Mail Notification: To subscribe to receive an email notification when MSHA publishes rules in the Federal Register, go to http://www.msha.gov.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    On June 8, 2016 (81 FR 36826), MSHA published a request for information (RFI) on Exposure of Underground Miners to Diesel Exhaust. The RFI sought input from the public that will help MSHA evaluate the Agency's existing standards and policy guidance on controlling miners' exposures to diesel exhaust to evaluate the effectiveness of the protection now in place to preserve miners' health.

    On June 27, 2016, (81 FR 41486), MSHA published a notice in the Federal Register announcing four public meetings on the RFI. Public meetings were held on July 19, 21, and 26 and August 4, 2016. The comment period was scheduled to close on September 6, 2016; however, in response to requests from the public, MSHA extended the comment period until November 30, 2016 (81 FR 58424).

    During the comment period, MSHA received requests for MSHA and the National Institute for Occupational Safety and Health (NIOSH) to convene a Diesel Exhaust Health Effects Partnership (Partnership) with the mining industry, diesel engine manufacturers, academia and representatives of organized labor to gather information regarding the complex questions contained in the RFI. In response to these requests, MSHA and NIOSH agreed to form a Partnership that includes all relevant stakeholders from the mining community to come together to understand the health effects from underground miners' exposure to diesel exhaust. The Partnership will also provide stakeholders an opportunity to consider best practices and new technologies including engineering controls that enhance control of diesel exhaust exposures to improve protections for miners.

    The first meeting of the Diesel Exhaust Health Effects Partnership was held on December 8, 2016, in Washington, Pennsylvania.

    During the comment period and at the Partnership meeting, MSHA received requests from stakeholders to reopen the rulemaking record for comment on the RFI and allow the comment period to remain open during the Partnership proceedings. In response to these requests, MSHA is reopening the record for comment and extending the comment period to January 9, 2018. The reopening of the record for comment will allow all interested parties an additional opportunity to re-evaluate all issues related to miners' exposure to diesel exhaust and to determine if improvements can be made.

    Joseph A. Main, Assistant Secretary of Labor for Mine Safety and Health.
    [FR Doc. 2017-00104 Filed 1-6-17; 8:45 am] BILLING CODE 4520-43-P
    DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Part 75 [Docket No. MSHA-2014-0019] RIN 1219-AB78 Proximity Detection Systems for Mobile Machines in Underground Mines AGENCY:

    Mine Safety and Health Administration, Labor.

    ACTION:

    Proposed rule; reopening the comment period.

    SUMMARY:

    The Mine Safety and Health Administration (MSHA) is reopening the rulemaking record and requesting additional comments on the Agency's proposed rule on Proximity Detection Systems for Mobile Machines in Underground Mines which was published in the Federal Register on September 2, 2015. The proposed rule would require underground coal mine operators to equip coal hauling machines and scoops with proximity detection systems. Miners working near these machines face pinning, crushing, and striking hazards that result in accidents involving life-threatening injuries and death.

    DATES:

    The comment period for the proposed rule published September 2, 2015 (80 FR 53070) is reopened. Comments must be received by midnight Daylight Saving Time on February 8, 2017.

    ADDRESSES:

    Submit comments and informational materials, identified by RIN 1219-AB78 or Docket No. MSHA-2014-0019 by one of the following methods:

    Federal E-Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    E-Mail: [email protected]

    Mail: MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.

    Hand Delivery or Courier: 201 12th Street South, Suite 4E401, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal holidays. Sign in at the receptionist's desk on the 4th Floor East, Suite 4E401.

    Fax: 202-693-9441.

    Instructions: All submissions must include RIN 1219-AB78 or Docket No. MSHA-2014-0019. Do not include personal information that you do not want publicly disclosed; MSHA will post all comments without change, including any personal information provided.

    Docket: For access to the docket to read comments received, go to http://www.regulations.gov or http://www.msha.gov/currentcomments.asp. To read background documents, go to http://www.regulations.gov. Review the docket in person at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. Sign in at the receptionist's desk on the 4th Floor East, Suite 4E401.

    Email notification: To subscribe to receive email notification when the Agency publishes rulemaking documents in the Federal Register, go to http://www.msha.gov/subscriptions.

    FOR FURTHER INFORMATION CONTACT:

    Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at [email protected] (email), 202-693-9440 (voice), or 202-693-9441 (facsimile).

    SUPPLEMENTARY INFORMATION: I. Introduction

    On September 2, 2015, MSHA published a proposed rule, Proximity Detection Systems for Mobile Machines in Underground mines (80 FR 53070). MSHA is reopening the rulemaking record and requesting comments on issues that were raised by commenters during the comment period and on issues that developed after the record closed.

    MSHA also observed the operation of proximity detection systems on both continuous mining machines and mobile machines (shuttle cars, ram cars and scoops) on working sections in the United States and South Africa after the record closed. There are 106 mobile machines operating on working sections equipped with proximity detection systems in the United States. MSHA visited six mines that operated 79 of these machines. These mines varied by physical, geological, and environmental conditions. MSHA is also including in the rulemaking record MSHA's field-trip report on the use of proximity detection in South Africa's underground coal mines and materials presented at the National Institute for Occupational Safety and Health (NIOSH) Proximity Detection Partnership Meeting held on June 22, 2016.

    II. Request for Comments 1. Requirements for Proximity Detection Systems

    Proposed § 75.1733(b)(1) would require that a proximity detection system cause a machine to stop before contacting a miner except for a miner who is in the on-board operator's compartment. MSHA requested comments on the types of machine movement the proximity detection system should stop. Commenters did not support the total de-energization of all functions of the equipment. One commenter noted that a “stop all machine movement” requirement cannot be applied universally to all mobile equipment covered by this proposed rule. The commenter noted that mine operators need the flexibility to configure proximity detection systems and machine responses based on the individual applications needed underground. In support of this comment, the commenter stated that machines that interact with other equipment, machines that require a ground-standing operator to be in contact with the machine, and machines that lack specific capabilities for motion control may need allowances outside of prescriptive requirements. As an example, the commenter stated that shuttle cars and ram cars do not require a miner to stand on the ground nearby to perform required tasks; however, scoops require a miner to touch or be near the machine to do certain work.

    One commenter also noted that proximity detection systems present significant problems for performing trouble-shooting and maintenance activities. The commenter provided an example of a mechanic trying to identify a leaking hydraulic hose; the mechanic must remove the miner-wearable component for the machine to be started because the mechanic has to be inside a red zone to diagnose the source of the leak.

    The National Institute for Occupational Safety and Health (NIOSH) also commented that requiring all machine movement to stop would potentially limit the development and application of advanced technology for selective shutdown features. NIOSH stated that currently available systems are not capable of providing the level of protection required in the industry while maintaining the operator's freedom to efficiently perform the job. NIOSH further stated that to be acceptable to the miners and to avoid false alarms, a proximity detection system must provide the necessary protection while still allowing normal operation of the machine.

    MSHA observed mobile machines with proximity detection systems operating during coal production on working sections. These proximity detection systems functioned as designed to prevent pinning, crushing, and striking accidents. Four of the six mines that MSHA visited in the United States, after the record closed, had proximity detection systems on mobile machines and continuous mining machines on the working section except for full-face mining machines. The mobile machines included shuttle cars, ram cars, and scoops. These mine operators provided all miners on these working sections with miner-wearable components.

    MSHA solicits additional comments on whether currently available proximity detection systems are capable of preventing coal hauling machines and scoops from pinning, crushing, and striking miners while maintaining the machine operator's freedom to efficiently perform the job.

    Under proposed § 75.1733(b)(1), MSHA would consider stopping a coal hauling machine or scoop to consist of causing it to cease tramming or articulating any part of a machine that could cause the machine to contact a miner. Tramming means to move the machine in a forward or reverse direction. Articulating includes an act of moving or pivoting at a joint, such as when a mobile machine may pivot towards a rib such that the movement could result in pinning, striking, or crushing a miner. Under the proposal, the machine would remain stopped while any miner is within a programmed stop zone. Unexpected tramming and articulation in the direction of a miner may be hazardous. However, MSHA is considering whether it is necessary to stop the movement of all parts of the machine, such as auxiliary movements, as long as the tramming and articulating machine motion that can pin, crush, or strike a miner is stopped. In MSHA's experience, striking, pinning, or crushing hazards are not caused by auxiliary functions such as operation of a pump motor or diesel engine, ram extension, winch movement, vertical bucket movement, or battery lift.

    MSHA is also aware of proximity detection system features that only allow authorized miners to perform maintenance. For example, an authorized miner may swipe an identification card over a card reader mounted on the machine or have a separate miner-wearable component that is programmed to allow a miner to perform maintenance. The proximity detection system records each time maintenance is performed. Miners authorized to perform maintenance on machines equipped with proximity detection systems would continue to observe standard safety procedures, such as removing stored energy and blocking the machine to prevent motion, while maintaining and repairing the machine.

    MSHA is considering a revision to proposed § 75.1733(b)(1) that would require a proximity detection system to stop a machine from tramming or articulating before contacting a miner except for a miner who (i) is in the on-board operator's compartment, or (ii) performing maintenance with the proximity detection system in maintenance mode.

    MSHA observed a miner and a scoop operator perform maintenance by changing the battery on a scoop equipped with a proximity detection system. The miner stayed near the scoop, directed the scoop operator's movement of the machine, and maintained a safe position outside of the proximity detection system's warning zone. MSHA also observed a ram car equipped with a proximity detection system that was installed and programmed to modify its warning and shutdown zone dimensions to allow miners to safely approach the machine to perform maintenance and repairs without causing it to shut down. The warning and shutdown zones extended around the entire machine perimeter during normal operation; however, activating the parking brake reduced these zones to encompass only the pinch point areas around the articulation joint.

    MSHA solicits comments on the types of machine movement a proximity detection system should allow for miners to perform necessary maintenance without exposing them to pinning, crushing, or striking hazards. MSHA also solicits comments on miners' and mine operators' experiences with proximity detection systems that allow a miner to conduct maintenance on a machine without activating the stop movement function.

    Several commenters also noted that sudden stopping of equipment presents hazards for on-board machine operators. A commenter noted that sudden stops and equipment shut downs, like any other unexpected operations, could put the operator of the machine at risk of injury or death based on the size and speed of the machine, and other related factors. One commenter stated concerns that the requirement to stop the machine before contacting a miner could create a hazard for machine operators, especially diesel-powered machine operators since their ground speed is typically faster than electric-powered machines. However, another commenter stated that MSHA should not require that machines slow down before stopping because some machines, such as battery-powered direct current traction drives, do not have this capability; in some cases, it is more important to stop the machine as fast as possible to prevent contact with miners.

    NIOSH commented that field tests of proximity detection systems on continuous mining machines and input from stakeholders found that detection range, environmental effects/limitations, detection accuracy, and system repeatability are considered critical parameters. MSHA observed mobile machines operating in mines in the United States with properly functioning proximity detection systems of various manufacturers with appropriate zone dimensions. These mobile machines worked in a range of seam heights, in dry and wet conditions, on varying grades, with and without wire mesh, with various mine ventilation controls. In MSHA's experience, mine operators work with machine manufacturers and proximity detection system manufacturers to determine the appropriate warning and shutdown zones for the specific mining conditions and practices that the machine encounters. MSHA is aware that proximity detection system manufacturers provide site-specific testing during commissioning of proximity detection systems. MSHA also observed proximity detection system testing used to confirm appropriate zone dimensions for the equipment and the mining conditions at the time of commissioning. MSHA solicits additional comments on appropriate warning and stopping zones for each type of machine movement and various mining conditions including any differences in cost for differing conditions or machines.

    Current NIOSH research is identifying critical parameters that impact the performance of proximity detection systems on mobile machines, such as stopping distances and deceleration rates. MSHA is aware that NIOSH research on proximity detection systems for underground mobile equipment is scheduled to conclude in September, 2018. Several commenters expressed concern that the Agency will require proximity detection systems to be installed on coal haulage machines and scoops before the findings from NIOSH research on proximity detection systems on underground mobile machines are released. MSHA is also aware that some mine operators have installed and are operating proximity detection systems on mobile machines. MSHA observed variations in the installation, maintenance and performance of these systems. MSHA anticipates that a final rule would provide minimum standards for installation, performance, maintenance, and recordkeeping to assure that miners are adequately protected. MSHA observed several dynamic tests of mobile machines equipped with proximity detection systems in which the machine decelerated to a full stop without injury to the on-board operator. MSHA also observed warning and shutdown zone incursions on mobile machines equipped with proximity detection systems that are being used on working sections during normal mine production operations. These proximity detection systems appropriately slowed and/or stopped these mobile machines without injuring the on-board machine operator. MSHA is not aware of any on-board operator injuries resulting from a proximity detection system decelerating and/or stopping a mobile machine.

    MSHA will continue to work with original equipment manufacturers, proximity detection system manufacturers, NIOSH, States, and mine operators to consider the benefits and timing of requiring proximity detection systems on mobile machines in underground coal mines.

    MSHA solicited and received several comments on how the use of proximity detection systems and the overlap of proximity detection system protection zones on multiple types of machines operating on the same working section might affect miners' work positions. One commenter stated that testing, which was conducted in a controlled environment, demonstrated that it was impossible to provide full coverage on the rear section of the coal hauler without creating a shutdown zone in the locations where the continuous mining machine operator was required to stand. A modification to the system allowed the shutdown zone to shrink as the coal hauler backed into the loading position. Due to the shape of the zone, however, the modification removed protective coverage of the rear corners of the coal hauler.

    MSHA observed continuous mining machines and mobile machines equipped with proximity detection systems successfully interact during production on working sections where all of the miners had miner-wearable components. MSHA solicits additional information regarding how coal hauling machines using proximity detection systems work with continuous mining machines equipped with proximity detection systems while allowing continuous mining machine operators to remain in a safe location. MSHA is interested in additional information describing the installation and programming of proximity detection systems and examples of related work practices established to assure that the continuous mining machine operator remains outside of the coal hauling machine warning and shutdown zones.

    Another commenter observed, during tests of proximity detection systems on continuous mining machines and battery haulers, instances in which miners (primarily continuous mining machine operators) could not properly perform necessary tasks without getting closer to the continuous mining machine than the proximity detection system allowed. The commenter noted that without the capability to temporarily bypass proximity detection, these personnel would either be forced to operate equipment without a clear line of sight or they would need to stand in conditions that pose different hazards, such as roof or rib hazards, or in locations that are not permitted under other regulations. The commenter recommended that the proximity detection system regulation for mobile equipment allow for personnel to temporarily bypass proximity detection when such conditions are encountered.

    MSHA may consider such a feature and seeks comment on the availability, use, and appropriateness of a temporary bypass feature. MSHA solicits information regarding how this feature could work with existing proximity detection systems and specific benefits or hazards that could result.

    One commenter noted that coal haulers and scoops would encounter sensors (miner-wearable components) much more frequently during operation than would continuous mining machines. Thus, there is an increased potential for nuisance tripping caused by inadvertent exposure into the detection zones of coal haulers, scoops, and other equipment. The commenter further noted the operation of equipment during the mining process requires multiple machines to operate, often in close proximity and can result in cross zone interference and nuisance tripping. As an example, the commenter noted a mine had to install additional equipment to help alleviate the cross zone interference issue. MSHA is aware that proximity detection system manufacturers must consider the interaction of machines with on-board operators to prevent unnecessary shut downs. MSHA observed a loading machine on which proximity detection equipment was installed to provide a silent zone for the on-board loading machine operator. This silent zone allowed the shuttle car to approach the loading machine without the loading machine operator causing the shuttle car to stop. MSHA is also aware that proximity detection system manufacturers have addressed this situation through programming miner-wearable components with specific permissions.

    In addition, MSHA received a comment from a machine manufacturer stating that its field testing experience with coal customers within the United States demonstrates measurable section production tonnage drops, within five to ten percent of normal production levels, when proximity detection is active on haulage equipment.

    MSHA is aware of mine operators that installed proximity detection systems on all mobile machines on the working section and experienced production decreases. Two of these mine operators reported that production later returned to pre-installation levels. MSHA observed that miners with experience working with mobile machines equipped with proximity detection systems are aware of the warning and shutdown zone locations and position themselves to minimize machine shutdowns. MSHA did observe a proximity detection system provide both a warning and then shut down the machine while the miner-wearable component was physically located outside the established warning and shutdown zones. This mine operator reported working with the proximity detection system manufacturer to resolve this type of occurrence. MSHA is aware of proximity detection system manufacturers that have mitigated nuisance alarms and other issues through engineering solutions. MSHA is also aware that proximity detection system manufacturers continue to improve their technology and develop solutions to minimize unwarranted warnings and shutdowns.

    MSHA solicits definitive data, including cost and time estimates, on delays in production caused by proximity detection system alarms due to cross zone interference and nuisance tripping as well as data on the length of time to return to pre-installation production levels. MSHA also seeks information on how to reduce or eliminate production delays when working with mobile machines equipped with proximity detection systems.

    MSHA solicits comments on how miners can place themselves in a safe work position to avoid causing nuisance alarms when one or more machines with proximity detection systems are on the working section. MSHA also solicits comments on miners' and mine operators' experiences when more than one miner may be in close proximity to one or more machines with proximity detection systems.

    MSHA solicited and received several comments on proposed training for miners who operate or work near machines equipped with proximity detection systems. NIOSH commented that gaining an in-depth view of miners' perspectives and how their job tasks and environment could be or are affected and then incorporating that information into training may help to prevent accidents and injuries that have been labeled as human error in the workplace. NIOSH further commented that studies of continuous mining machine operators have found that unintended consequences, such as a disruption in situational awareness, risks, hazards, and decision-making capabilities, can be avoided if human factors considerations are integrated into each stage of the technology design and implementation process. In addition, NIOSH stated that each piece of equipment needs to have a uniquely prescribed proximity system and the methods and amounts of training for each system should be designed specifically for each system and common platforms established where possible.

    One commenter stated that it has been evaluating and testing proximity detection system technologies since 2011. The commenter further stated that inadequate situational awareness is one of the primary factors in incidents attributed to human error and that the primary purpose of any proximity detection system/collision avoidance technology is to enhance situational awareness.

    Another commenter stated that proximity detection system technology has the potential to dangerously change how miners interact with mobile equipment in underground mines. The commenter further stated that it has witnessed multiple instances where miners have taken higher risks because of a false sense of security and that implementation of proximity detection systems on all mobile machines will lead miners to unsafely rely on the devices and act contrary to their intuition and training. In addition, the commenter stated that the first priority [of the final rule] should be a safe working position for a miner or machine operator, and second a noncontact rule.

    MSHA has observed miners relocate themselves to safer locations because of proximity detection system visible and audible warnings. These warnings increased the miner's situational awareness regarding their location with respect to hazardous areas around the mobile machines.

    MSHA is interested in receiving additional information on miners' and mine operators' experiences with the effect that proximity detection systems have on miners' and machine operators' situational awareness and any examples where reliance on proximity detection technology may cause the miner to develop work practices that introduce additional hazards.

    MSHA observed representatives of mine operators and proximity detection system manufacturers provide instruction and task training to miners on the working section where proximity detection systems have been installed on mobile machines. Miners have demonstrated their knowledge of the installation, maintenance, and use of proximity detection systems to MSHA personnel. For example, MSHA observed one mine operator instruct miners to move into a crosscut adjacent to a coal haulage travelway. This increased their distance from the coal haulage travelway, averted unwanted proximity zone incursions, and ultimately placed the workers in a safer location. MSHA also observed a South African mine operator utilize data reports from the proximity detection systems to reinforce safe work practices specified in company policy. These data reports logged the instances when miner-wearable components entered the established warning and shutdown zones.

    MSHA is also interested in miners', mine operators' and proximity detection system manufacturers' experiences with training that could be done to increase miners' and machine operators' situational awareness around machines with proximity detection systems.

    2. Electromagnetic Interference

    Electrical systems used in the mine, including proximity detection systems, can adversely affect the function of other electrical systems through the generation of electromagnetic interference. Several commenters noted that electromagnetic interference generated from a variety of external sources can adversely affect the performance of proximity detection systems. Several commenters stated that electromagnetic interference prevents proximity detection systems from functioning as designed. Another commenter stated that, because of electromagnetic interference, the proximity detection system failed to locate the miner-wearable component with any level of accuracy or consistency. The commenter further stated that, as a result, it was nearly impossible for the coal hauler to work in close proximity to the continuous miner or operator.

    In addition, on April 6, 2016, MSHA was made aware of concerns from mine operators regarding electromagnetic interferences with proximity detection systems from respirable coal mine dust sampling devices. On April 15 and May 2, 2016, MSHA notified underground coal mine operators who have a proximity detection system installed on any equipment that they should identify sources of any electromagnetic interference that adversely affect the performance of the proximity detection system. The above-referenced notices are included in the rulemaking record.

    Proposed § 75.1733(b)(5) would require a mine operator to install a proximity detection system to prevent interference that adversely affects performance of any electrical system. MSHA clarifies that proposed § 75.1733(b)(5) would require mine operators to prevent electromagnetic interference from affecting the operation of the proximity detection system or any other electrical system. MSHA intends that the system would be installed, maintained and operated in such a way that no electrical systems would be adversely affected due to interference. This would require periodic post-installation evaluation of all new potential sources of electromagnetic interference.

    To clarify this intent, MSHA is considering a revision to proposed § 75.1733(b)(5) that would require proximity detection systems to be both installed and operated in a manner that prevents interferences that adversely affect the performance of any electrical system, including the proximity detection system. The operation of other electrical systems and equipment must not interfere with the performance of the proximity detection system, and the proximity detection system must not interfere with the performance of other electrical systems.

    MSHA has found that one type of common interference can be identified when electrical devices are placed within several inches of the miner-wearable component of the proximity detection system. Electromagnetic interference between these two systems can be mitigated by maintaining a minimum distance between a miner-wearable component and electrical devices. MSHA's technical staff estimated that each mine would require an average of 20 hours for a mining engineer to identify sources of electromagnetic interference and the minimum distance needed to mitigate the interference. Mining engineers will test the compatibility between electrical devices and proximity detection system components. Tests will be based on equipment use and mining conditions. MSHA anticipates that mining engineers will conduct physical tests for compatibility, review equipment user manuals, and consult with the original equipment manufacturers and the proximity detection system manufacturer.

    Based on MSHA's mine visits, the Agency estimated that mine operators are likely, on average, to introduce new electrical equipment twice per year. This would require a mining engineer two hours to identify and mitigate adverse interference from the new electrical equipment.

    Holding all other variables of the preliminary regulatory economic analysis constant, MSHA estimated that, on average, it would cost each mine operator $3,500 over ten years to comply with proposed § 75.1733(b)(5). MSHA seeks comments on the cost drivers for compatibility testing and the Agency's cost estimate for proposed § 75.1733(b)(5).

    MSHA is aware of best practices that mine operators and proximity detection system manufacturers have established to minimize the effects of electromagnetic interference. MSHA is aware that proximity detection system manufacturers have stated that minimum separation distances need to be maintained between miner-wearable components and other electrical equipment. During mine visits, miners have demonstrated the ability to maintain sufficient separation between miner-wearable components and other equipment to ensure proper proximity detection system function. MSHA is also aware of mine operators that have added inline filters on variable frequency drive shuttle cars to reduce electromagnetic emission interference. MSHA is aware of an electrical equipment manufacturer that added material designed to provide electromagnetic shielding to its gas detection equipment which reportedly reduced interference with proximity detection systems.

    MSHA solicits comments on the methods and practices mine operators have used or could use to identify sources of electromagnetic interference. MSHA is also interested in receiving information on the actions an operator has taken or could take to prevent such interference and how electromagnetic interference can be mitigated in instances where a miner needs to wear multiple miner-wearable components because different proximity detection system models are operating on a working section. Please also describe procedures that were successful and those that were not successful in identifying interferences, as well as solutions to prevent adverse interference.

    MSHA has observed that wire mesh and metallic equipment can affect the proximity detection systems' warning and stopping zones. MSHA has also received reports of some pyrite deposits within coal seams affecting the use of the proximity detection system, but has not observed this effect first-hand. MSHA solicits information and data from mine operators and proximity detection system manufacturers on best practices to minimize the effects of these non-electrical interferences.

    Since the record closed, MSHA became aware of a proximity detection system design feature on a miner-wearable component that determines if the magnetic field sensing coils have been affected by electromagnetic interference and can no longer detect the magnetic field generated by the machine-mounted components. This feature provides a distinct audible and visible alarm on the miner-wearable component to alert miners when it is not functioning properly due to electromagnetic interference. MSHA is considering requiring this design feature for all miner-wearable components.

    MSHA solicits comments on the cost and availability of, and experience with, any proximity detection system feature or other technology that automatically alerts the miner or machine operator when the miner-wearable component or proximity detection system is not functioning properly due to electromagnetic interference.

    3. Proximity Detection System Checks

    Proposed § 75.1733(c)(1) would require that a mine operator designate a person to perform a check of machine-mounted components of the proximity detection system to verify that components are intact and the system is functioning properly, and to take action to correct defects. MSHA clarifies that under proposed paragraph (c)(1), the check would include verification that the warning and shutdown zones are set for the established proximity detection field distances and to meet the performance requirements under proposed § 75.1733(b)(1) and (b)(2). Under proposed § 75.1733(c)(1), the person designated to perform the check would verify that the machine-mounted components are intact and correctly mounted and the system is operating properly to identify a miner-wearable component and stop the machine. The check assures that the warning and shutdown zones around the perimeter of the machine are set according to a mine operator's specifications. In MSHA's experience, proximity detection system manufacturers have determined the type of checks that should be conducted to assure that their system is functioning properly. Mine operators are expected to follow the check procedures suggested by the manufacturers. MSHA has observed that a check of the warning and shutdown zones can be made by a miner walking around the machine with a miner-wearable component to confirm proper zone range. MSHA has also observed checking the machine shutdown function of the proximity detection system. This check involves placing a miner wearable component inside the shutdown zone and then attempting to initiate machine movements such as tramming. If the proximity detection system prevents machine movement, the system is functioning properly.

    The check would also include an examination of the machine-mounted components to assure that the field generators, antennas, cabling, and other components are undamaged and correctly mounted. The check would also assure that appropriate audible and visual warning signals are working as required. MSHA solicits comments on how the warning and shutdown zones can be checked, or tested, without putting machine operators at risk.

    With the clarification in this notice, MSHA estimates that the average time required for a check, which includes a verification that the warning and shutdown zones are set to meet the performance requirements under proposed § 75.1733(b)(1) and (b)(2), would increase from 20 seconds to 6 minutes. MSHA's revised estimate of 6 minutes reflects the time needed to: (1) Verify that the machine-mounted components are intact and correctly mounted and the system is operating properly to identify a miner-wearable component and stop the machine, and (2) test and validate that the warning and stopping zones meet performance requirements. MSHA substituted the 6 minutes into the calculations of the proposed rule, held all other variables constant, and calculated that the average 10-year cost per mine increase would be $182,000. Many other assumptions and data values will be updated in a final regulatory analysis. MSHA seeks comments on the Agency's revisions to its proposed time estimate to comply with § 75.1733(c)(1).

    4. South Africa Field-Trip Report and NIOSH Partnership Meeting

    The rulemaking record includes MSHA's Field-Trip Report on Proximity Detection Use in South Africa. On April 2 through April 13, 2016, MSHA and NIOSH representatives visited South Africa to investigate the progress of proximity detection system technology in South Africa. The group visited two proximity detection system manufacturing facilities and observed proximity detection system performance in three underground coal mines. In addition, the group met with a proximity detection system technology developer with experience in proximity detection system development in South Africa and other countries. Among other topics, they discussed the developer's experiences with proximity detection system interference in South Africa.

    MSHA and NIOSH also met with representatives of South Africa's Department of Mineral Resources on the implementation of proximity detection systems on electric-powered, trackless mobile machinery in South Africa's surface and underground mines. MSHA's report and presentation materials from the South Africa trip are included in the rulemaking record and available for comment.

    MSHA has also included in the rulemaking record materials from the NIOSH Proximity Detection Partnership Meeting. On June 22, 2016, NIOSH held a partnership meeting that included representatives from MSHA, industry, labor, and proximity detection system manufacturers. Materials presented during the partnership meeting are included in the rulemaking record and available for comment.

    III. Compliance Cost Revision

    MSHA initially estimated that the proposed rule would cost mine operators, over ten years, approximately $536,000 per mine. MSHA has revised estimates for two provisions to reflect the Agency's clarification on the proposed requirements. Table 1 summarizes the changes to estimated cost for these two provisions.

    Table 1—Average 10-Year Total Cost per Mine Average
  • 10-year
  • per mine cost
  • Total 10-Year Cost as Proposed on 09/02/2015 $536,000 Changes: Proximity Detection System Checks 182,000 Electromagnetic Interference Evaluation 3,500 Total Change 185,500 Total Revised Cost $721,500 Percent increase in average cost per mine 35%

    The rulemaking record and comment period for the proposed rule is reopened until February 8, 2017. MSHA solicits comments on all aspects of the proposed rule. The Agency requests that comments be specific as possible and include any technological and economic feasibility data.

    Joseph A. Main, Assistant Secretary of Labor for Mine Safety and Health.
    [FR Doc. 2017-00105 Filed 1-6-17; 8:45 am] BILLING CODE 4520-43-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0940] RIN 1625-AA08 Special Local Regulation; Manatee River; Bradenton, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a special local regulation for certain waters of the Manatee River during the Bradenton Area River Regatta. This action is necessary to protect the safety of race participants, participant vessels, spectators, and the general public on these navigable waters of the United States during the event. The special local regulation would restrict vessel traffic in the waters of the Manatee River in the vicinity of Bradenton, Florida. It would establish the following three areas: Two spectator areas, where all vessels must be anchored or operate at No Wake Speed; and an enforcement area where designated representatives may control vessel traffic as determined by the prevailing conditions.

    DATES:

    Comments and related material must be received by the Coast Guard on or before February 8, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0940 using the Federal eRulemaking Portal at http://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 Boatswain's Mate First Class Tyrone J. Stafford, Sector St. Petersburg Prevention Department, Coast Guard; telephone 813-228-2191, 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 Pub. L. Public Law § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    The Coast Guard proposes to establish a special local regulation on the waters of the Manatee River, Bradenton, Florida during the Bradenton Area River Regatta. This event is a high speed boat race with approximately 12 Formula 2 Class boats, traveling at speeds in excess of 100 miles per hour. There will also be approximately 14, 1000 cc Hydrocross jet skis participating in scheduled races during this event. Additionally, there will be a jet ski and water ski exhibition located within the regulated area. It is anticipated that 250 spectator vessels will be present along the race course. The race is scheduled to take place annually from approximately 9 a.m. to 9 p.m. during the first Saturday of February.

    This proposed rulemaking is necessary to provide for the safety of race participants, participant vessels, spectators, and the general public on these navigable waters of the United States during the Bradenton Area River Regatta. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233.

    III. Discussion of Proposed Rule

    This proposed rulemaking would encompass certain waters of the Manatee River in Bradenton, Florida. The special local regulation would be enforced from 9 a.m. to 9 p.m. normally occurring during the first Saturday of February. The special local regulation would establish the following three areas: (1) Two spectator areas, where all vessels must be anchored or operate at No Wake Speed; and (2) an enforcement area that encompasses all race courses and demonstrations, where designated representatives may control vessel traffic as determined by the prevailing conditions.

    Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port St. Petersburg by telephone at 727-824-7506, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port St. Petersburg or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port St. Petersburg or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and/or on-scene designated representatives.

    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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. 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.

    The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only twelve hours; (2) although persons and vessels are prohibited to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port St. Petersburg or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the regulated area or anchor in the sponsor's designated spectator area, during the enforcement period if authorized by the Captain of the Port St. Petersburg or a designated representative; and (4) the Coast Guard will provide advance notification of the special local regulations to the local maritime community by Local Notice to Mariners and/or Broadcast Notice to Mariners.

    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.

    This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Manatee River, Bradenton, Florida, encompassed within the special local regulation from 9 a.m. until 9 p.m. annually on the first Saturday of February. For the reasons stated in section IV.A above, this rule will not have a significant economic impact on a substantial number of small entities.

    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 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 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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have 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 special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph (34)(h) of Figure 2-1 of Commandant Instruction M16475.lD. 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 comments 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 http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site'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 100

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

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:

    PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

    33 U.S.C. 1233.

    2. Add § 100.723 to read as follows:
    § 100.723 Special Local Regulation; Bradenton Area River Regatta, Manatee River; Bradenton, FL.

    (a) Regulated Areas. The following regulated areas are established as special local regulations. All coordinates are North American Datum 1983.

    (1) Spectator Area #1. An area marked by the event sponsor encompassed within the following points: 27°30.43′ N., 82°34.55′ W., thence to position 27°30.43′ N., 82°34.43′ W., thence to position 27°30.23′ N., 82°34.43′ W., thence to position 27°30.13′ N., 82°34.30′ W., thence to position 27°30.09′ N., 82°34.30′ W., thence to position 27°30.09′ N., 82°34.55′ W., thence back to the original position 27°30.43′ N., 82°34.55′ W.

    (2) Spectator Area #2. An area marked by the event sponsor east of the CSX Railroad train trestle eastbound of a line connected by the following points: 27°30.73′ N., 82°34.13′ W., thence to position 27°29.99′ N., 82°34.07′ W.

    (3) Enforcement Area. The designated race and demonstration areas that are composed of all waters of the Manatee River encompassed within the following points: 27°30.58′ N., 82°34.62′ W., thence to position 27°30.58′ N., 82°34.13′ W., thence to position 27°29.99′ N., 82°34.06′ W., thence to position 27°29.99′ N., 82°34.62′ W., thence back to the original position 27°30.58′ N., 82°34.62′ W.

    (b) Definition. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port St. Petersburg in the enforcement of the regulated areas.

    (c) Regulations.

    (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the enforcement area unless authorized by the Captain of the Port St. Petersburg or a designated representative.

    (2) Designated representatives may control vessel traffic throughout the enforcement area as determined by the prevailing conditions.

    (3) All vessels are to be anchored and/or operate at a No Wake Speed in the spectator area. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated areas by contacting the Captain of the Port St. Petersburg by telephone at 727-824-7506, or a designated representative via VHF radio on channel 16.

    (d) Enforcement period: This section will be enforced from 9:00 a.m. to 9:00 p.m. annually on the first Saturday during the month of February.

    Dated: December 27, 2016. H.L. Najarian, Captain, U.S. Coast Guard, Captain of the Port Saint Petersburg.
    [FR Doc. 2017-00109 Filed 1-6-17; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 111 Electronic Induction (eInduction®) Option AGENCY:

    Postal ServiceTM.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Postal Service proposes to revise Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®) to add an option to streamline the processing of drop shipments and expedited plant load mailings.

    DATES:

    Submit comments on or before February 8, 2017.

    ADDRESSES:

    Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to [email protected], with a subject line of “eInduction Option.” Faxed comments are not accepted.

    You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.

    FOR FURTHER INFORMATION CONTACT:

    Direct questions or comments to Heather Dyer by email at [email protected] or phone (207) 482-7217, or Jacqueline Erwin by email at [email protected] or phone (202) 268-2158.

    SUPPLEMENTARY INFORMATION:

    The Electronic Induction (eInduction) option is a process that streamlines the preparation and induction (how and where the mail physically enters the Postal Service mailstream) of drop shipments and expedited plant load mailings. eInduction links scans of Intelligent Mail container barcodes (IMcb) to the electronic documentation (eDoc) information, allowing the Postal Service to verify that postage was paid prior to accepting a mailer shipped container. eInduction eliminates the need for paper PS Forms 8125, 8125-CD, and 8017, and manual reconciliation at the entry facility. Correct postage payment is verified both at the entry facility and during post-induction processing in PostalOne!.

    Mailers who would like to use the eInduction option must meet eligibility requirements and request authorization by contacting the Facility Access Shipping Tracking, (FAST)® Helpdesk. Business Mailer Support will provide final authorization. Additional information, including information regarding verification and associated assessments, is provided in Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com/node/581.

    List of Subjects in 39 CFR Part 111

    Administrative practice and procedure, Postal Service.

    Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comments on the following proposed revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

    Accordingly, 39 CFR part 111 is proposed to be amended as follows:

    PART 111—[AMENDED] 1. The authority citation for 39 CFR part 111 continues to read as follows: Authority:

    5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.

    2. Revise the following sections of Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), as follows: Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM) 700 Special Standards 705 Advanced Preparation and Special Postage Payment Systems

    [Add new section 20.0, to read as follows:]

    20.0 eInduction Option 20.1 Description

    Electronic Induction (eInduction) is an electronic alternative to using the following paper PS Forms 8125, 8125C, 8125CD, and 8017 for all containers entered at the dock of a processing facility or claiming a Destination Delivery Unit (DDU) discount. eInduction uses Intelligent Mail container barcode (IMcb) scans to determine container payment and delivery status, and verifies payment and entry location by matching IMcb scan data to electronic documentation (eDoc) information. Containers are eligible for eInduction at certain designated facilities. Additional information, including information regarding verification and associated assessments, is provided in Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, at https://postalpro.usps.com/node/581.

    20.2 Approval

    Mailers must be authorized by the USPS to participate in the eInduction program.

    20.3 General Eligibility Standards

    First-Class Mail, Periodicals, Standard Mail letters and flats, and Bound Printed Matter presorted or carrier route barcoded flats and packages are eligible for eInduction. All containers entered under eInduction must:

    a. Be labeled with a USPS placard and a unique Intelligent Mail container barcode. All required pallets and similar containers (such as all-purpose containers, hampers, and gaylords) and all containers prepared under 8.0 must display container placards that include accurately encoded Intelligent Mail container barcodes (IMcb) as described in 708.6.6. Mailing documentation must indicate each container participating in eInduction. b. Be part of a mailing using an approved electronic method to transmit a postage statement and mailing documentation to the PostalOne! system.

    c. Not include containers included on paper PS Forms 8125/8017.

    d. Be included on a scheduled FAST appointment when entered at a USPS processing facility.

    20.4 Additional Standards 20.4.1 Special Support for Continuous Mailers

    Mailers who cannot generate a finalized postage statement two hours before container entry may request approval for an eInduction Continuous Mailer ID, (MID). Once approved, mailers using an authorized MID in the IMcb may enter any container with the approved MID in the IMcb prior to the receipt of electronic documentation. Mailers are required to submit an eDoc and generate a finalized postage statement for all eInduction MID containers within one calendar day of the unload scan. Mailers may request authorization for an MID through the Business Customer Gateway. The USPS must approve the mailer request before the mailer may participate in the MID process.

    We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes, if our proposal is adopted.

    Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2016-32056 Filed 1-6-17; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 7 and 9 [EPA-HQ-OA-2013-0031; FRL-9958-03-OA] RIN 2090-AA39 Nondiscrimination in Programs or Activities Receiving Federal Assistance From the Environmental Protection Agency AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; withdrawal.

    SUMMARY:

    The Environmental Protection Agency (EPA) is withdrawing a proposed rule for which the EPA no longer intends to issue a final rule. This document identifies the proposed rule and explains the EPA's decision to withdraw the proposal. The withdrawal of this proposed rule does not preclude the EPA from initiating the same or similar rulemaking at a future date. It does, however, close out the entry for this proposed rule in the EPA Semi-Annual Regulatory Agenda, published as part of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). Should the EPA decide at some future date to initiate the same or similar rulemaking, it will add an appropriate new entry to the EPA Semi-Annual Regulatory Agenda to reflect the initiation of the action.

    DATES:

    The EPA is withdrawing the proposed rule as of January 9, 2017.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-HQ-OA-2013-0031. All documents in the docket are listed on the http://www.regulations.gov Web site. 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 electronically through http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Kurt Temple, Environmental Protection Agency, Office of Civil Rights, (Mail Code 1201A), 1200 Pennsylvania Ave. NW., Washington, DC 20460, telephone number: (202) 564-7272 or (202) 564-7299; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. Does this action apply to me?

    This action is directed to the public in general, and may be of particular interest to those persons who follow proposed rules related to the EPA's regulations about Nondiscrimination in Programs or Activities Receiving Federal Assistance from the EPA. Since others may also be interested, the EPA has not attempted to describe all the specific entities potentially interested.

    II. Why is the EPA issuing this withdrawal document?

    This document announces to the public that the EPA is withdrawing a certain proposed rule for which the EPA no longer intends to issue a final rule.

    For the reasons described in this document, the EPA has decided not to finalize this rulemaking at this time. By withdrawing the proposed rule, the EPA is eliminating the pending nature of the regulatory action. Should the EPA determine to pursue anything in these areas in the future, it will issue a new proposed rule and invite public comment through notice in the Federal Register.

    III. Background

    1. What was proposed? On December 14, 2015, the EPA published a proposed rule in the Federal Register (80 FR 77284), to amend its nondiscrimination regulation regarding compliance information requirements for recipients of EPA financial assistance and Agency Compliance Procedures, as well as a technical correction to the reference to the Paperwork Reduction Act.

    2. Why is it being withdrawn? The agency proposed amending its regulation to bring it into conformance with more than 20 other federal agencies. In other words, this proposed regulatory amendment concerned the EPA's internal processes, including the investigation of complaints and compliance reviews, and not obligations imposed on external stakeholders.

    Nonetheless, the EPA received several adverse comments about this proposed amendment; especially regarding the proposal to remove numeric deadlines from the administrative complaint processing regulations. The EPA has considered all comments received. Although the EPA continues to believe that the proposed amendments, including the elimination of the numeric deadlines, are needed in order to better position the EPA to strategically manage and individually tailor resolution approaches to its administrative investigation of complaints and compliance reviews, the EPA has decided to withdraw the proposed amendments.

    Instead of continuing to pursue this rulemaking, the EPA will implement and evaluate the ability of its internal procedural guidance documents and accountability measures that were finalized in December 2016 (including the Case Resolution Manual and the EPA's OCR External Compliance Program Strategic Plan) to achieve prompt effective, and efficient docket management. Based on its evaluation, the EPA may decide at some future date to initiate a new rulemaking to amend its non-discrimination regulation. The EPA is withdrawing the proposed amendments, as opposed to leaving them inactive, to promote transparency and certainty with regard to the status of its non-discrimination regulation.

    3. Where can I get more information about this action? The EPA has established a docket for this action under Docket ID No. EPA-HQ-OA-2013-0031. See the ADDRESSES section above for more detail information about this docket.

    List of Subjects 40 CFR Part 7

    Environmental protection, Administrative practice and procedure, Age discrimination, Civil rights, Equal employment opportunity, Individuals with disabilities, Reporting and recordkeeping requirements, Sex discrimination.

    40 CFR Part 9

    Environmental protection, Control number, Office of Management and Budget, and Paperwork Reduction Act.

    Dated: December 29, 2016. Gina McCarthy, Administrator.
    [FR Doc. 2017-00050 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2014-0430; FRL-9957-91-Region 4] Air Quality Plans; Tennessee; Infrastructure Requirements for the 2012 PM2.5 National Ambient Air Quality Standard AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve the State Implementation Plan (SIP) submission, submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), on December 16, 2015, for inclusion into the Tennessee SIP. This proposal pertains to the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2012 Annual Fine Particulate Matter (PM2.5) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure SIP submission.” TDEC certified that the Tennessee SIP contains provisions that ensure the 2012 Annual PM2.5 NAAQS is implemented, enforced, and maintained in Tennessee. EPA is proposing to determine that portions of Tennessee's infrastructure SIP submission, provided to EPA on December 16, 2015, satisfy certain required infrastructure elements for the 2012 Annual PM2.5 NAAQS.

    DATES:

    Written comments must be received on or before February 8, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2014-0430 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta 30303-8960. Ms. Bell can be reached via electronic mail at [email protected] or via telephone at (404) 562-9088.

    SUPPLEMENTARY INFORMATION:

    I. Background and Overview

    On December 14, 2012 (78 FR 3086, January 15, 2013), EPA promulgated a revised primary annual PM2.5 NAAQS. The standard was strengthened from 15.0 micrograms per cubic meter (μg/m3) to 12.0 μg/m3. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2012 Annual PM2.5 NAAQS to EPA no later than December 14, 2015.1

    1 In these infrastructure SIP submissions States generally certify evidence of compliance with sections 110(a)(1) and (2) of the CAA through a combination of state regulations and statutes, some of which have been incorporated into the federally-approved SIP. In addition, certain federally-approved, non-SIP regulations may also be appropriate for demonstrating compliance with sections 110(a)(1) and (2). Throughout this rulemaking, the cited regulation has either been approved, or submitted for approval into Tennessee's federally-approved SIP.

    This rulemaking is proposing to approve portions of Tennessee's December 16, 2015 PM2.5 infrastructure SIP submission for the applicable requirements of the 2012 Annual PM2.5 NAAQS, with the exception of the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), for which EPA is not proposing any action in this rulemaking regarding these requirements. For the aspects of Tennessee's submittal proposed for approval in this rulemaking, EPA notes that the Agency is not approving any specific rule, but rather proposing that Tennessee's already approved SIP meets certain CAA requirements.

    II. What elements are required under sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains.

    More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The requirements are summarized below and in EPA's September 13, 2013, memorandum entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).” 2

    2 Two elements identified in section 110(a)(2) are not governed by the three-year submission deadline of section 110(a)(1) because SIPs incorporating necessary local nonattainment area controls are not due within three years after promulgation of a new or revised NAAQS, but rather are due at the time the nonattainment area plan requirements are due pursuant to section 172. These requirements are: (1) Submissions required by section 110(a)(2)(C) to the extent that subsection refers to a permit program as required in part D, title I of the CAA; and (2) submissions required by section 110(a)(2)(I) which pertain to the nonattainment planning requirements of part D, title I of the CAA. This proposed rulemaking does not address infrastructure elements related to section 110(a)(2)(I) or the nonattainment planning requirements of 110(a)(2)(C).

    • 110(a)(2)(A): Emission Limits and Other Control Measures • 110(a)(2)(B): Ambient Air Quality Monitoring/Data System • 110(a)(2)(C): Programs for Enforcement of Control Measures and for Construction or Modification of Stationary Sources • 110(a)(2)(D)(i)(I) and (II): Interstate Pollution Transport • 110(a)(2)(D)(ii): Interstate Pollution Abatement and International Air Pollution • 110(a)(2)(E): Adequate Resources and Authority, Conflict of Interest, and Oversight of Local Governments and Regional Agencies • 110(a)(2)(F): Stationary Source Monitoring and Reporting • 110(a)(2)(G): Emergency Powers • 110(a)(2)(H): SIP Revisions • 110(a)(2)(I): Plan Revisions for Nonattainment Areas 3

    3 As mentioned above, this element is not relevant to this proposed rulemaking.

    • 110(a)(2)(J): Consultation with Government Officials, Public Notification, and Prevention of Significant Deterioration (PSD) and Visibility Protection • 110(a)(2)(K): Air Quality Modeling and Submission of Modeling Data • 110(a)(2)(L): Permitting fees • 110(a)(2)(M): Consultation and Participation by Affected Local Entities III. What is EPA's approach to the review of infrastructure SIP submissions?

    EPA is acting upon the SIP submission from Tennessee that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2012 Annual PM2.5 NAAQS. The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

    EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.

    Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.4 EPA therefore believes that while the timing requirement in section 110(a)(1) is unambiguous, some of the other statutory provisions are ambiguous. In particular, EPA believes that the list of required elements for infrastructure SIP submissions provided in section 110(a)(2) contains ambiguities concerning what is required for inclusion in an infrastructure SIP submission.

    4 For example: Section 110(a)(2)(E)(i) provides that states must provide assurances that they have adequate legal authority under state and local law to carry out the SIP; section 110(a)(2)(C) provides that states must have a SIP-approved program to address certain sources as required by part C of title I of the CAA; and section 110(a)(2)(G) provides that states must have legal authority to address emergencies as well as contingency plans that are triggered in the event of such emergencies.

    The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP requirements.5 Section 110(a)(2)(I) pertains to nonattainment SIP requirements and part D addresses when attainment plan SIP submissions to address nonattainment area requirements are due. For example, section 172(b) requires EPA to establish a schedule for submission of such plans for certain pollutants when the Administrator promulgates the designation of an area as nonattainment, and section 107(d)(1)(B) allows up to two years, or in some cases three years, for such designations to be promulgated.6 This ambiguity illustrates that rather than apply all the stated requirements of section 110(a)(2) in a strict literal sense, EPA must determine which provisions of section 110(a)(2) are applicable for a particular infrastructure SIP submission.

    5 See, e.g., “Rule To Reduce Interstate Transport of Fine Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions to Acid Rain Program; Revisions to the NOX SIP Call; Final Rule,” 70 FR 25162, at 25163-65 (May 12, 2005) (explaining relationship between timing requirement of section 110(a)(2)(D) versus section 110(a)(2)(I)).

    6 EPA notes that this ambiguity within section 110(a)(2) is heightened by the fact that various subparts of part D set specific dates for submission of certain types of SIP submissions in designated nonattainment areas for various pollutants. Note, e.g., that section 182(a)(1) provides specific dates for submission of emissions inventories for the ozone NAAQS. Some of these specific dates are necessarily later than three years after promulgation of the new or revised NAAQS.

    Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.7 Similarly, EPA interprets the CAA to allow it to take action on the individual parts of one larger, comprehensive infrastructure SIP submission for a given NAAQS without concurrent action on the entire submission. For example, EPA has sometimes elected to act at different times on various elements and sub-elements of the same infrastructure SIP submission.8

    7 See, e.g., “Approval and Promulgation of Implementation Plans; New Mexico; Revisions to the New Source Review (NSR) State Implementation Plan (SIP); Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR) Permitting,” 78 FR 4339 (January 22, 2013) (EPA's final action approving the structural PSD elements of the New Mexico SIP submitted by the State separately to meet the requirements of EPA's 2008 PM2.5 NSR rule), and “Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Infrastructure and Interstate Transport Requirements for the 2006 PM2.5 NAAQS,” (78 FR 4337) (January 22, 2013) (EPA's final action on the infrastructure SIP for the 2006 PM2.5 NAAQS).

    8 On December 14, 2007, the State of Tennessee, through the Tennessee Department of Environment and Conservation, made a SIP revision to EPA demonstrating that the State meets the requirements of sections 110(a)(1) and (2). EPA proposed action for infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR 3213) and took final action on March 14, 2012 (77 FR 14976). On April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA took separate proposed and final actions on all other section 110(a)(2) infrastructure SIP elements of Tennessee's December 14, 2007, submittal.

    Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.9

    9 For example, implementation of the 1997 PM2.5 NAAQS required the deployment of a system of new monitors to measure ambient levels of that new indicator species for the new NAAQS.

    EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.

    Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.

    Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.10 EPA most recently issued guidance for infrastructure SIPs on September 13, 2013 (2013 Guidance).11 EPA developed this document to provide states with up-to-date guidance for infrastructure SIPs for any new or revised NAAQS. Within this guidance, EPA describes the duty of states to make infrastructure SIP submissions to meet basic structural SIP requirements within three years of promulgation of a new or revised NAAQS. EPA also made recommendations about many specific subsections of section 110(a)(2) that are relevant in the context of infrastructure SIP submissions.12 The guidance also discusses the substantively important issues that are germane to certain subsections of section 110(a)(2). Significantly, EPA interprets sections 110(a)(1) and 110(a)(2) such that infrastructure SIP submissions need to address certain issues and need not address others. Accordingly, EPA reviews each infrastructure SIP submission for compliance with the applicable statutory provisions of section 110(a)(2), as appropriate.

    10 EPA notes, however, that nothing in the CAA requires EPA to provide guidance or to promulgate regulations for infrastructure SIP submissions. The CAA directly applies to states and requires the submission of infrastructure SIP submissions, regardless of whether or not EPA provides guidance or regulations pertaining to such submissions. EPA elects to issue such guidance in order to assist states, as appropriate.

    11 “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act sections 110(a)(1) and 110(a)(2),” Memorandum from Stephen D. Page, September 13, 2013.

    12 EPA's September 13, 2013, guidance did not make recommendations with respect to infrastructure SIP submissions to address section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly after the U.S. Supreme Court agreed to review the D.C. Circuit decision in EME Homer City, 696 F.3d7 (D.C. Cir. 2012) which had interpreted the requirements of section 110(a)(2)(D)(i)(I). In light of the uncertainty created by ongoing litigation, EPA elected not to provide additional guidance on the requirements of section 110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding nor required by statute, whether EPA elects to provide guidance on a particular section has no impact on a state's CAA obligations. On March 17, 2016, EPA released a memorandum titled, “Information on the Interstate Transport `Good Neighbor' Provision for the 2012 Fine Particulate Matter National Ambient Air Quality Standards under Clean Air Act Section 110(a)(2)(D)(i)(I)” to provide guidance to states for interstate transport requirements specific to the PM2.5 NAAQS.

    As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's implementation plan appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (e.g., whether permits and enforcement orders are approved by a multi-member board or by a head of an executive agency). However they are addressed by the state, the substantive requirements of section 128 are necessarily included in EPA's evaluation of infrastructure SIP submissions because section 110(a)(2)(E)(ii) explicitly requires that the state satisfy the provisions of section 128.

    As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in sections 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and new source review (NSR) pollutants, including greenhouse gases (GHG). By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the 2012 PM2.5 NAAQS. Accordingly, the latter optional provisions are types of provisions EPA considers irrelevant in the context of an infrastructure SIP action.

    For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes, inter alia, the requirement that states have a program to regulate minor new sources. Thus, EPA evaluates whether the state has an EPA-approved minor NSR program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.

    With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Thus, EPA believes it may approve an infrastructure SIP submission without scrutinizing the totality of the existing SIP for such potentially deficient provisions and may approve the submission even if it is aware of such existing provisions.13 It is important to note that EPA's approval of a state's infrastructure SIP submission should not be construed as explicit or implicit re-approval of any existing potentially deficient provisions that relate to the three specific issues just described.

    13 By contrast, EPA notes that if a state were to include a new provision in an infrastructure SIP submission that contained a legal deficiency, such as a new exemption for excess emissions during SSM events, then EPA would need to evaluate that provision for compliance against the rubric of applicable CAA requirements in the context of the action on the infrastructure SIP.

    EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.

    For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).

    Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.14 Section 110(k)(6) authorizes EPA to correct errors in past actions, such as past approvals of SIP submissions.15 Significantly, EPA's determination that an action on a state's infrastructure SIP submission is not the appropriate time and place to address all potential existing SIP deficiencies does not preclude EPA's subsequent reliance on provisions in section 110(a)(2) as part of the basis for action to correct those deficiencies at a later time. For example, although it may not be appropriate to require a state to eliminate all existing inappropriate director's discretion provisions in the course of acting on an infrastructure SIP submission, EPA believes that section 110(a)(2)(A) may be among the statutory bases that EPA relies upon in the course of addressing such deficiency in a subsequent action.16

    14 For example, EPA issued a SIP call to Utah to address specific existing SIP deficiencies related to the treatment of excess emissions during SSM events. See “Finding of Substantial Inadequacy of Implementation Plan; Call for Utah State Implementation Plan Revisions,” 74 FR 21639 (April 18, 2011).

    15 EPA has used this authority to correct errors in past actions on SIP submissions related to PSD programs. See “Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources in State Implementation Plans; Final Rule,” 75 FR 82536 (December 30, 2010). EPA has previously used its authority under CAA section 110(k)(6) to remove numerous other SIP provisions that the Agency determined it had approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62 FR 34641 (June 27, 1997) (corrections to American Samoa, Arizona, California, Hawaii, and Nevada SIPs); 69 FR 67062 (November 16, 2004) (corrections to California SIP); and 74 FR 57051 (November 3, 2009) (corrections to Arizona and Nevada SIPs).

    16 See, e.g., EPA's disapproval of a SIP submission from Colorado on the grounds that it would have included a director's discretion provision inconsistent with CAA requirements, including section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21, 2010) (proposed disapproval of director's discretion provisions); 76 FR 4540 (Jan. 26, 2011) (final disapproval of such provisions).

    IV. What is EPA's analysis of how Tennessee addressed the elements of the sections 110(a)(1) and (2) “infrastructure” provisions?

    The Tennessee infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.

    1. 110(a)(2)(A) Emission Limits and Other Control Measures: Section 110(a)(2)(A) requires that each implementation plan include enforceable emission limitations and other control measures, means, or techniques (including economic incentives such as fees, marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements. Several regulations within Tennessee's SIP are relevant to air quality control regulations. The regulations described below include enforceable emission limitations and other control measures. SIP-approved Tennessee Air Pollution Control Regulations (TAPCR) 1200-03-03, Ambient Air Quality Standards, 1200-03-04, Open Burning, 1200-03-06, Non-process Emission Standards, 1200-03-07, Process Emission Standards, 1200-03-09, Construction and Operating Permits, 1200-03-14, Control of Sulfur Dioxide Emission, 1200-03-19, Emission Standards and Monitoring Requirements for Additional Control Areas, 1200-03-21, General Alternate Emission Standards, 1200-03-24, Good Engineering Practice Stack Height Regulations, and 1200-03-27, NO X emissions from designated source categories collectively establish enforceable emissions limitations and other control measures, means or techniques, for activities that contribute to PM2.5 concentrations in the ambient air, and provide authority for TDEC to establish such limits and measures as well as schedules for compliance to meet the applicable requirements of the CAA. Additionally, State statutes established in the Tennessee Air Quality Act and adopted in the Tennessee Code Annotated (TCA) section 68-201-105(a), Powers and duties of board—Notification of vacancy—Termination due to vacancy, provide the Tennessee Air Pollution Control Board and TDEC's Division of Air Pollution Control the authority to take actions in support of this infrastructure element such as issue permits, promulgate regulations, and issue orders to implement the Tennessee Air Quality Act and the CAA, as relevant. EPA has made the preliminary determination that the provisions contained in these State regulations and State statute satisfy Section 110(a)(2)(A) for the 2012 Annual PM2.5 NAAQS in the State.

    In this action, EPA is not proposing to approve or disapprove any existing state provisions with regard to excess emissions during start up, shut down, and malfunction (SSM) operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and the Agency is addressing such state regulations in a separate action.17

    17 On June 12, 2015, EPA published a final action entitled, “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction.” See 80 FR 33840.

    Additionally, in this action, EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.

    2. 110(a)(2)(B) Ambient Air Quality Monitoring/Data System: Section 110(a)(2)(B) requires SIPs to provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to (i) monitor, compile, and analyze data on ambient air quality, and (ii) upon request, make such data available to the Administrator. TCA 68-201-105(b)(4) gives TDEC the authority to provide technical, scientific and other services as may be required to implement the provisions of the Tennessee Air Quality Act. Annually, states develop and submit to EPA for approval statewide ambient monitoring network plans consistent with the requirements of 40 CFR parts 50, 53, and 58. The annual network plan involves an evaluation of any proposed changes to the monitoring network, includes the annual ambient monitoring network design plan, and includes a certified evaluation of the agency's ambient monitors and auxiliary support equipment.18 On June 30, 2015, Tennessee submitted its most recent plan to EPA, which was approved by EPA on October 26, 2015. Tennessee's monitoring network plan can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-2014-0430. EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for the ambient air quality monitoring and data system related to the 2012 Annual PM2.5 NAAQS.

    18 The annual network plans are approved by EPA in accordance with 40 CFR part 58, and, on occasion, proposed changes to the monitoring network are evaluated outside of the network plan approval process in accordance with 40 CFR part 58.

    3. 110(a)(2)(C) Programs for Enforcement of Control Measures and for Construction or Modification of Stationary Sources: This element consists of three sub-elements: Enforcement, state-wide regulation of new and modified minor sources and minor modifications of major sources, and preconstruction permitting of major sources and major modifications in areas designated attainment or unclassifiable for the subject NAAQS as required by CAA title I part C (i.e., the major source PSD program). TDEC's 2012 Annual PM2.5 NAAQS infrastructure SIP submission cites a number of SIP provisions to address these requirements. EPA's rationale for its proposed action regarding each sub-element is described below.

    Enforcement: The following SIP-approved regulation provides TDEC with authority for enforcement of PM2.5 emission limits and control measures. TAPCR 1200-03-13-.01, Violation Statement, states that, “Failure to comply with any of the provisions of these regulations shall constitute a violation thereof and shall subject the person or persons responsible therefore to any and all the penalties provided by law.” Also note, under TCA 68-201-116, Orders and assessments of damages and civil penalty—Appeal, the State's Technical Secretary is authorized to issue orders requiring correction of violations of any part of the Tennessee Air Quality Act, or of any regulation promulgated under this State statute. Violators are subject to civil penalties of up to 25,000 dollars per day for each day of violation and for any damages to the State resulting from the violations.

    Preconstruction PSD Permitting for Major Sources: EPA interprets the PSD sub-element to require that a state's infrastructure SIP submission for a particular NAAQS demonstrate that the state has a complete PSD permitting program in place covering the structural PSD requirements for all regulated NSR pollutants. A state's PSD permitting program is complete for this sub-element (and prong 3 of D(i) and J related to PSD) if EPA has already approved or is simultaneously approving the state's implementation plan with respect to all structural PSD requirements that are due under the EPA regulations or the CAA on or before the date of the EPA's proposed action on the infrastructure SIP submission. For the, 2012 Annual PM2.5 NAAQS, Tennessee's authority to regulate construction of new and modified stationary sources to assist in the protection of air quality in attainment or unclassifiable areas is established in TAPCR 1200-03-09-.01(4), Prevention of Significant Deterioration of Air Quality. Tennessee's infrastructure SIP submission demonstrates that new major sources and major modifications in areas of the State designated attainment or unclassifiable for the specified NAAQS are subject to a federally-approved PSD permitting program meeting all the current structural requirements of part C of title I of the CAA to satisfy the infrastructure SIP PSD elements.19

    19 More information concerning how the Tennessee infrastructure SIP submission currently meets applicable requirements for the PSD elements (110(a)(2)(C); (D)(i)(I), prong 3; and (J)) can be found in the technical support document in the docket for today's rulemaking.

    Regulation of minor sources and modifications: Section 110(a)(2)(C) also requires the SIP to include provisions that govern the minor source program that regulates emissions of the 2012 Annual PM2.5 NAAQS. TAPCR 1200-03-09-.01, Construction Permits, and TAPCR 1200-03-09-.03, General Provisions, collectively govern the preconstruction permitting of modifications and construction of minor stationary sources, and minor modifications of major stationary sources.

    EPA has made the preliminary determination that Tennessee's SIP is adequate for program enforcement of control measures, regulation of minor sources and modifications, and preconstruction permitting of major sources and major modifications related to the 2012 Annual PM2.5 NAAQS.

    4. 110(a)(2)(D)(i)(I) and (II) Interstate Pollution Transport: Section 110(a)(2)(D)(i) has two components: 110(a)(2)(D)(i)(I) and 110(a)(2)(D)(i)(II). Each of these components has two subparts resulting in four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (“prong 1”), and interfering with maintenance of the NAAQS in another state (“prong 2”). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (“prong 3”), or to protect visibility in another state (“prong 4”).

    110(a)(2)(D)(i)(I)—prongs 1 and 2: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states of section 110(a)(2)(D)(i)(I) (prongs 1 and 2). EPA will consider these requirements in relation to Tennessee's 2012 Annual PM2.5 NAAQS infrastructure submission in a separate rulemaking.

    110(a)(2)(D)(i)(II)—prong 3: With regard to section 110(a)(2)(D)(i)(II), the PSD element, referred to as prong 3, may be met by a state's confirmation in an infrastructure SIP submission that new major sources and major modifications in the state are subject to a PSD program meeting all the current structural requirements of part C of title I of the CAA, or (if the state contains a nonattainment area that has the potential to impact PSD in another state), a NNSR program. As discussed in more detail above under section 110(a)(2)(C), Tennessee's SIP contains provisions for the State's PSD program that reflects the required structural PSD requirements to satisfy prong 3 of section 110(a)(2)(D)(i)(II). Tennessee addresses prong 3 through TAPCR 1200-03-09-.01(4), Prevention of Significant Deterioration of Air Quality, and TAPCR 1200-03-09-.01(5), Growth Policy, for the PSD and NNSR programs, respectively. EPA has made the preliminary determination that Tennessee's SIP is adequate for PSD permitting of major sources and major modifications for interstate transport related to the 2012 Annual PM2.5 NAAQS for section 110(a)(2)(D)(i)(II) (prong 3).

    110(a)(2)(D)(i)(II)—prong 4: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to visibility in other states of section 110(a)(2)(D)(i)(II) (prong 4) and will consider these requirements in relation to Tennessee's 2012 Annual PM2.5 NAAQS infrastructure submission in a separate rulemaking.

    5. 110(a)(2)(D)(ii): Interstate Pollution Abatement and International Air Pollution: Section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement. Regulation 1200-03-09 03, General Provisions, requires the permitting authority to notify air agencies whose areas may be affected by emissions from a source. Additionally, Tennessee does not have any pending obligation under sections 115 and 126 of the CAA relating to international or interstate pollution abatement. EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for ensuring compliance with the applicable requirements relating to interstate and international pollution abatement for the 2012 Annual PM2.5 NAAQS.

    6. 110(a)(2)(E) Adequate Resources and Authority, Conflict of Interest, and Oversight of Local Governments and Regional Agencies: Section 110(a)(2)(E) requires that each implementation plan provide: (i) Necessary assurances that the state will have adequate personnel, funding, and authority under state law to carry out its implementation plan, (ii) that the state comply with the requirements respecting state boards pursuant to section 128 of the Act, and (iii) necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any plan provision, the state has responsibility for ensuring adequate implementation of such plan provisions. EPA is proposing to approve Tennessee's infrastructure SIP submission as meeting the requirements of sub-elements 110(a)(2)(E)(i), (ii), and (iii). EPA's rationale for today's proposal respecting each section of 110(a)(2)(E) is described in turn below.

    In support of EPA's proposal to approve sub-elements 110(a)(2)(E)(i) and (iii), TCA 68-201-105, Powers and duties of board—Notification of vacancy—Termination due to vacancy, gives the Tennessee Air Pollution Control Board the power and duty to promulgate rules and regulations to implement the Tennessee Air Quality Act. The Board may define ambient air quality standards, set emission standards, set forth general policies or plans, establish a system of permits, and identify a schedule of fees for review of plans and specifications, issuance or renewal of permits or inspection of air contaminant sources.

    TAPCR 1200-03-26, Administrative Fees Schedule, establishes construction fees, annual emission fees, and permit review fees sufficient to supplement existing State and Federal funding and to cover reasonable costs associated with the administration of Tennessee's air pollution control program. These costs include costs associated with the review of permit applications and reports, issuance of permits, source inspections and emission unit observations, review and evaluation of stack and/or ambient monitoring results, modeling, and costs associated with enforcement actions.

    TCA 68-201-115, Local pollution control programs—Exemption from state supervision—Applicability of part to air contaminant sources burning wood waste—Open burning of wood waste, states that “Any municipality or county in this state may enact, by ordinance or resolution respectively, air pollution control regulations not less stringent than the standards adopted for the state pursuant to this part, or any such municipality or county may also adopt or repeal an ordinance or resolution which incorporates by reference any or all of the regulations of the board, or any federal regulations including any changes in such regulations, when such regulations are properly identified as to date and source.” Before such ordinances or resolutions become effective, the municipality or county must receive a certificate of exemption from the Board to enact local regulations in the State. In granting any certificate of exemption, the State of Tennessee reserves the right to enforce any applicable resolution, ordinance, or regulation of the local program.

    TCA 68-201-115 also directs TDEC to “frequently determine whether or not any exempted municipality or county meets the terms of the exemption granted and continues to comply with this section.” If TDEC determines that the local program does not meet the terms of the exemption or does not otherwise comply with the law, the Board may suspend the exemption in whole or in part until the local program complies with the State standards.

    As evidence of the adequacy of TDEC's resources with respect to sub-elements (i) and (iii), EPA submitted a letter to Tennessee on June 30, 2015, outlining section 105 grant commitments and the current status of these commitments for fiscal year 2015. The letter EPA submitted to Tennessee can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-2014-0430. Annually, states update these grant commitments based on current SIP requirements, air quality planning, and applicable requirements related to the NAAQS. Tennessee satisfactorily met all commitments agreed to in the Air Planning Agreement for fiscal year 2015, therefore Tennessee's grants were finalized and closed out. EPA has made the preliminary determination that Tennessee has adequate resources and authority for implementation of the 2012 Annual PM2.5 NAAQS.

    Section 110(a)(2)(E)(ii) requires that the state comply with section 128 of the CAA. Section 128 requires that the SIP provide: (a)(1) the majority of members of the state board or body which approves permits or enforcement orders represent the public interest and do not derive any significant portion of their income from persons subject to permitting or enforcement orders under the CAA; and (a)(2) any potential conflicts of interest by such board or body, or the head of an executive agency with similar powers be adequately disclosed. Section 110(a)(2)(E)(ii) obligations for the 2012 Annual PM2.5 NAAQS and the requirements of CAA section 128 are met in Regulation 0400-30-17, Conflict of Interest. Under this regulation, the Tennessee board with authority over air permits and enforcement orders is required to determine annually and after receiving a new member that at least a majority of its members represent to public interest and do not derive any significant portion of income from persons subject to such permits and enforcement orders. Further, the board cannot act to hear contested cases until it has determined it can do so consistent with CAA section 128. The regulation also requires TDEC's Technical Secretary and board members to declare any conflict-of-interest in writing prior to the issuance of any permit, variance or enforcement order that requires action on their part.

    EPA has made the preliminary determination that the State has adequately addressed the requirements of section 128, and accordingly has met the requirements of section 110(a)(2)(E)(ii) with respect to infrastructure SIP requirements. Therefore, EPA is proposing to approve Tennessee's infrastructure SIP submission as meeting the requirements of sub-elements 110(a)(2)(E)(i), (ii) and (iii).

    7. 110(a)(2)(F) Stationary Source Monitoring and Reporting: Section 110(a)(2)(F) requires SIPs to meet applicable requirements addressing: (i) The installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources, (ii) periodic reports on the nature and amounts of emissions and emissions related data from such sources, and (iii) correlation of such reports by the state agency with any emission limitations or standards established pursuant to this section, which reports shall be available at reasonable times for public inspection. TDEC's infrastructure SIP submission identifies requirements for compliance testing by emissions sampling and analysis, and for emissions and operation monitoring to ensure the quality of data in the State, and also the collection of source emission data throughout the State and the assurance of the quality of such data. These data are used to compare against current emission limits and to meet requirements of EPA's Air Emissions Reporting Rule (AERR). Specifically, TAPCR 1200-03-10, Required Sampling, Recording, and Reporting, gives the State's Technical Secretary the authority to monitor emissions at stationary sources, and to require these sources to conduct emissions monitoring and to submit periodic emissions reports. This rule requires owners or operators of stationary sources to compute emissions, submit periodic reports of such emissions and maintain records as specified by various regulations and permits, and to evaluate reports and records for consistency with the applicable emission limitation or standard on a continuing basis over time. The monitoring data collected and records of operations serve as the basis for a source to certify compliance, and can be used by Tennessee as direct evidence of an enforceable violation of the underlying emission limitation or standard.

    Additionally, Tennessee is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the AERR on December 5, 2008, which modified the requirements for collecting and reporting air emissions data (73 FR 76539). The AERR shortened the time states had to report emissions data from 17 to 12 months, giving states one calendar year to submit emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through EPA's online Emissions Inventory System. States report emissions data for the six criteria pollutants and the precursors that form them—nitrogen oxides, sulfur dioxides, ammonia, lead, carbon monoxide, particulate matter, and volatile organic compounds. Many states also voluntarily report emissions of hazardous air pollutants. Tennessee made its latest update to the 2011 NEI on April 9, 2014. EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the Web site http://www.epa.gov/ttn/chief/eiinformation.html. EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for the stationary source monitoring systems related to the 2012 Annual PM2.5 NAAQS.

    Regarding credible evidence, TAPCR 1200-3-10-04, Sampling, Recording, and Reporting Required for Major Stationary Sources, states that: “the Technical Secretary is authorized to require by permit condition any periodic or enhanced monitoring, recording and reporting that he deems necessary for the verification of the source's compliance with the applicable requirements as defined in paragraph 1200-03-09-02(11).” EPA is unaware of any provision preventing the use of credible evidence in the Tennessee SIP. EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for the stationary source monitoring systems related to the Annual PM2.5 NAAQS. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(F).

    8. 110(a)(2)(G): Emergency Powers: Section 110(a)(2)(G) of the Act requires that states demonstrate authority comparable with section 303 of the CAA and adequate contingency plans to implement such authority. Tennessee's emergency powers are outlined in TAPCR 1200-03-15, Emergency Episode Plan, which establishes the criteria for declaring an air pollution episode (air pollution alert, air pollution warning, or air pollution emergency), specific emissions reductions for each episode level, and emergency episode plan requirements for major sources located in or significantly impacting a nonattainment area. Additional emergency powers are codified in TCA 68-201-109, Emergency Stop Orders for Air Contaminant Sources. Under TCA 68-201-109, if the Commissioner of TDEC finds that emissions from the operation of one or more sources are causing imminent danger to human health and safety, the Commissioner may, with the approval of the Governor, order the source(s) responsible to reduce or discontinue immediately its (their) air emissions. Additionally, this State law requires a hearing to be held before the Commissioner within 24 hours of any such order.

    Regarding the public welfare and environment, TCA 68-201-106, Matters to be considered in exercising powers, states that “In exercising powers to prevent, abate and control air pollution, the board or department shall give due consideration to all pertinent facts, including, but not necessarily limited to: (1) The character and degree of injury to, or interference with, the protection of the health, generalwelfare and physical property of thepeople. . .” Also, TCA 68-201-116, Orders and assessments of damages and civil penalty Appeal, provides in subsection (a) that if the Tennessee technical secretary discovers that any State air quality regulation has been violated, the Tennessee technical secretary may issue an order to correct the violation, and this order shall be complied with within the time limit specified in the order. EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for emergency powers related to the 2012 Annual PM2.5 NAAQS. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(G).

    9. 110(a)(2)(H) SIP Revisions: Section 110(a)(2)(H), in summary, requires each SIP to provide for revisions of such plan (i) as may be necessary to take account of revisions of such national primary or secondary ambient air quality standard or the availability of improved or more expeditious methods of attaining such standard, and (ii) whenever the Administrator finds that the plan is substantially inadequate to attain the NAAQS or to otherwise comply with any additional applicable requirements. As previously discussed, TDEC is responsible for adopting air quality rules and revising SIPs as needed to attain or maintain the NAAQS in Tennessee.

    Section 68-201-105(a) of the Tennessee Air Quality Act authorizes the Tennessee Air Pollution Control Board to promulgate rules and regulations to implement this State statute, including setting and implementing ambient air quality standards, emission standards, general policies or plans, a permits system, and a schedule of fees for review of plans and specifications, issuance or renewal of permits, and inspection of sources. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate a commitment to provide future SIP revisions related to the 2012 Annual PM2.5 NAAQS when necessary. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(H).

    10. 110(a)(2)(J) Consultation with Government Officials, Public Notification, and PSD and Visibility Protection: EPA is proposing to approve Tennessee's infrastructure SIP submission for the 2012 Annual PM2.5 NAAQS with respect to the general requirement in section 110(a)(2)(J) to include a program in the SIP that complies with the applicable consultation requirements of section 121, the public notification requirements of section 127, PSD and visibility protection. EPA's rationale for each sub-element is described below.

    Consultation with government officials (121 consultation): Section 110(a)(2)(J) of the CAA requires states to provide a process for consultation with local governments, designated organizations and Federal Land Managers (FLMs) carrying out NAAQS implementation requirements pursuant to section 121 relative to consultation. The following State rule, as well as the State's Regional Haze Implementation Plan (which allows for consultation between appropriate state, local, and tribal air pollution control agencies as well as the corresponding FLMs), provide for consultation with government officials whose jurisdictions might be affected by SIP development activities: TAPCR 1200-03-34, Conformity, provides for interagency consultation on transportation and general conformity issues. Tennessee adopted state-wide consultation procedures for the implementation of transportation conformity which includes the development of mobile inventories for SIP development. These consultation procedures were developed in coordination with the transportation partners in the State and are consistent with the approaches used for development of mobile inventories for SIPs. Required partners covered by Tennessee's consultation procedures include Federal, state and local transportation and air quality agency officials. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate consultation with government officials related to the 2012 Annual PM2.5 NAAQS when necessary. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(J) consultation with government officials.

    Public notification: These requirements are met through the State's existing Air Quality Index and Air Quality Forecasting programs, which provide a method to alert the public if any NAAQS is exceeded in an area. Additionally, the State's annual monitoring plan update is sent out each year for public review and comment. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate the State's ability to provide public notification related to the 2012 Annual PM2.5 NAAQS when necessary. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(J) public notification.

    PSD: With regard to the PSD element of section 110(a)(2)(J), this requirement is met by a state's confirmation in an infrastructure SIP submission that it has a PSD program meeting all the current structural requirements of part C of title I of the CAA. As discussed in more detail above under section 110(a)(2)(C), Tennessee's SIP contains a PSD program that includes the required structural PSD requirements to satisfy the requirement of the PSD element of section 110(a)(2)(J). EPA has made the preliminary determination that Tennessee's SIP and practices are adequate for PSD permitting of major sources and major modifications related to the 2012 Annual PM2.5 NAAQS for the PSD element of section 110(a)(2)(J). Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to the PSD element of section 110(a)(2)(J).

    Visibility protection: EPA's 2013 Guidance notes that it does not treat the visibility protection aspects of section 110(a)(2)(J) as applicable for purposes of the infrastructure SIP approval process. EPA recognizes that states are subject to visibility protection and regional haze program requirements under part C of the Act (which includes sections 169A and 169B). However, there are no newly applicable visibility protection obligations after the promulgation of a new or revised NAAQS. Thus, EPA has determined that states do not need to address the visibility component of 110(a)(2)(J) in infrastructure SIP submittals. As such, EPA has made the preliminary determination that it does not need to address the visibility protection element of section 110(a)(2)(J) in Tennessee's infrastructure SIP submission related to the 2012 Annual PM2.5 NAAQS.

    11. 110(a)(2)(K) Air Quality Modeling and Submission of Modeling Data: Section 110(a)(2)(K) of the CAA requires that SIPs provide for performing air quality modeling so that effects on air quality of emissions from NAAQS pollutants can be predicted and submission of such data to the EPA can be made. TAPCR 1200-03-09-.01(4), Prevention of Significant Air Quality Deterioration, specifies when modeling and when monitoring (pre- or post-construction) must be performed and that the resulting data be made available for review to EPA. Tennessee also states that it has personnel with training and experience to conduct dispersion modeling consistent with models approved by EPA protocols. Also note that TCA 68-201-105(b)(7) grants TDEC the power and duty to collect and disseminate information relative to air pollution. Additionally, Tennessee participates in a regional effort to coordinate the development of emissions inventories and conduct regional modeling for several NAAQS, including the 2012 Annual PM2.5 NAAQS, for the Southeastern states. Taken as a whole, Tennessee's air quality regulations and practices demonstrate that TDEC has the authority to provide relevant data for the purpose of predicting the effect on ambient air quality of the Annual PM2.5 NAAQS. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate the State's ability to provide for air quality modeling, along with analysis of the associated data, related to the 2012 Annual PM2.5 NAAQS. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(K).

    12. 110(a)(2)(L) Permitting fees: Section 110(a)(2)(L) requires the owner or operator of each major stationary source to pay to the permitting authority, as a condition of any permit required under the CAA, a fee sufficient to cover: (i) The reasonable costs of reviewing and acting upon any application for such a permit, and (ii) if the owner or operator receives a permit for such source, the reasonable costs of implementing and enforcing the terms and conditions of any such permit (not including any court costs or other costs associated with any enforcement action), until such fee requirement is superseded with respect to such sources by the Administrator's approval of a fee program under title V.

    In Tennessee, funding for review of PSD and NNSR permits comes from permit-specific fees that are charged to new applicants and from annual emission fees charged to existing title V emission sources that are applying for major modifications under PSD or NNSR. The cost of reviewing, approving, implementing, and enforcing PSD and major NNSR permits are covered under the following State regulations: (1) TAPCR 1200-03-26-.02(5) requires each new major stationary source to pay a construction permit application filing/processing fee and (2) TAPCR 1200-03-26-.02(9), Annual Emission Fees for Major Sources, 20 mandates that existing major stationary sources pay annual title V emission fees, which are used to cover the permitting costs for any new construction or modifications at these facilities as well as implementation and enforcement of PSD and NNSR permits after they have been issued. EPA has made the preliminary determination that Tennessee adequately provides for permitting fees related to the 2012 Annual PM2.5 NAAQS when necessary. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(L).

    20 Title V program regulations are federally-approved but not incorporated into the federally-approved SIP.

    13. 110(a)(2)(M) Consultation/participation by affected local entities: Section 110(a)(2)(M) of the Act requires states to provide for consultation and participation in SIP development by local political subdivisions affected by the SIP. TCA 68-201-105, Powers and duties of board Notification of vacancy Termination due to vacancy, authorizes and requires the Tennessee Air Pollution Control Board to promulgate rules and regulations related to consultation under the provisions of the State's Uniform Administrative Procedures Act. TCA 4-5-202, When hearings required, requires agencies to precede all rulemaking with a notice and public hearing, except for exemptions. TCA 4-5-203, Notice of hearing, states that whenever an agency is required by law to hold a public hearing as part of its rulemaking process, the agency shall: “(1) Transmit written notice of the hearings to the secretary of state for publication in the notice section of the administrative register Web site . . . and (2) Take such other steps as it deems necessary to convey effective notice to persons who are likely to have an interest in the proposed rulemaking.” TCA 68-201-105(b)(7) authorizes and requires TDEC to “encourage voluntary cooperation of affected persons or groups in preserving and restoring a reasonable degree of air purity; advise, consult and cooperate with other agencies, persons or groups in matters pertaining to air pollution; and encourage authorized air pollution agencies of political subdivisions to handle air pollution problems within their respective jurisdictions to the greatest extent possible and to provide technical assistance to political subdivisions. . .”. TAPCR 1200-03-34, Conformity, requires interagency consultation on transportation and general conformity issues. Additionally, TDEC has, in practice, consulted with local entities for the development of its transportation conformity SIP and has worked with the FLMs as a requirement of EPA's regional haze rule. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate consultation with affected local entities related to the 2012 Annual PM2.5 NAAQS. Accordingly, EPA is proposing to approve Tennessee's infrastructure SIP submission with respect to section 110(a)(2)(M).

    V. Proposed Action

    With the exception of interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states and visibility protection requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), EPA is proposing to approve Tennessee's infrastructure submission submitted on December 16, 2015, for the 2012 Annual PM2.5 NAAQS for the above described infrastructure SIP requirements. EPA is proposing to approve Tennessee's infrastructure SIP submission for the 2012 Annual PM2.5 NAAQS because the submission is consistent with section 110 of the CAA.

    VI. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: December 20, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2017-00162 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR- 2016-0702; FRL-9957-95-Region 9] Approval of Arizona Air Plan Revisions, Arizona Department of Environmental Quality and Pinal County Air Quality Control District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve revisions to the Arizona State Implementation Plan (SIP). These revisions include a state statute and certain state rules that govern air pollution sources under the Arizona Department of Environmental Quality (ADEQ) and the Pinal County Air Quality Control District (PCAQCD). These revisions concern emissions of particulate matter (PM) from construction sites, agricultural activity and other fugitive dust sources. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by February 8, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0702 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Christine Vineyard, EPA Region IX, (415) 947-4125, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. The State's Submittal A. What statute and rules did the State submit? B. Are there other versions of the statute and rules? C. What is the purpose of the submitted rules and statute revisions? II. The EPA's Evaluation and Action A. How is the EPA evaluating the rules and statute? B. Do the rules and statute meet the evaluation criteria? C. EPA Recommendations To Further Improve the Rules D. Public Comment and Proposed Action III. Incorporation by Reference IV. Statutory and Executive Order Reviews I. The State's Submittal A. What statute and rules did the State submit?

    Table 1 lists the statute and rules addressed by this proposal with the dates that they were adopted by the state or local air agency and submitted by the ADEQ.

    Table 1—Submitted Statute and Rules Local agency Rule No. Rule title Adopted Submitted PCAQCD Chapter 4—Article 1 Fugitive Dust 10/28/15 12/21/15 PCAQCD Chapter 4—Article 3 Construction Sites—Fugitive Dust 10/28/15 12/21/15 Arizona Revised Statutes (ARS) Statute No. Statute title Effective date Submitted ARS § 49-424 Duties of Department 4/18/14 12/21/15 Arizona Administrative Code (AAC) Rule No. AAC No. AAC title Amended/
  • effective date
  • Submitted
    AAC R18-2-210 Attainment, Nonattainment, and Unclassifiable Area Designations 07/01/14 12/21/15 AAC R18-2-610 Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03 07/02/15 12/21/15 AAC R18-2-610.03 Agricultural PM General Permit for Crop Operations; Pinal County PM Nonattainment Area 07/02/15 12/21/15 AAC R18-2-612 Definitions for R18-2-612.01 07/02/15 12/21/15 AAC R18-2-612.01 Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009 07/02/15 12/21/15 AAC Appendix 2 Test Methods and Protocols 07/02/15 12/21/15

    On March 21, 2016, the EPA determined that the submitted revisions from ADEQ and PCAQCD listed in Table 1 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

    B. Are there other versions of the statute and rules?

    There are no previous versions of PCAQCD Chapter 4, Articles 1 and 3 in the SIP. Table 2 lists versions of the statute and rules EPA has previously approved into the SIP.

    Table 2—SIP-Approved Rules ARS Title Existing SIP-approved rule superseded by this action Previous approval § 49-424 Duties of Department 49-424 (2011) Duties of Department 77 FR 66398 11/05/12 AAC Title Existing SIP superseded by this action Previous Approval R18-2-210 Attainment, Nonattainment, and Unclassifiable Area Designations Attainment, Nonattainment, and Unclassifiable Area Designations 79 FR 56656
  • 09/23/14
  • Appendix 2 Test Methods and Protocols Test Methods and Protocols 79 FR 56655
  • 09/23/15
  • In addition, we note that SIP-approved rule R18-2-610, “Definitions for R18-2-611,” has the same AAC number as new rule R18-2-610, “Definitions for R18-2-610.01 R18-2-610.02, and R18-2-610.03,” but is not superseded by the new rule. See 66 FR 51869 (October 11, 2001). Both versions of R18-2-610 will be in the SIP, but can be differentiated by their different titles and dates.

    C. What is the purpose of the submitted rule and statute revisions?

    Particulate matter, including PM equal to or less than 2.5 microns in diameter (PM2.5) and PM equal to or less than 10 microns in diameter (PM10), contributes to effects that are harmful to human health and the environment, including premature mortality, aggravation of respiratory and cardiovascular disease, decreased lung function, visibility impairment, and damage to vegetation and ecosystems. Section 110(a) of the CAA requires states to submit regulations that control PM emissions.

    PCAQCD Chapter 4, Article 1—Fugitive Dust

    • New rule applies to open areas/vacant lots, unpaved roads, unpaved lots and paved public roadways.

    • Establishes a 20 percent opacity limit.

    • Requires no trespassing signs, physical barriers or other effective control measures upon evidence of trespass.

    • Limits silt content on unpaved lots and roads to eight percent and six percent respectively.

    PCAQCD Chapter 4, Article 3—Construction Sites—Fugitive Dust

    • New rule designed to regulate PM10 emissions attributed to construction activities under both stagnation and windy conditions.

    • Limits opacity to 20 percent.

    ARS § 49-424—Duties of Department

    • Revised rule extends the requirement to develop and disseminate air quality dust forecasts to the Maricopa County PM10 maintenance area and any other PM10 nonattainment or maintenance areas designated on or after December 31, 2011.

    AAC R18-2-210—Attainment, Nonattainment, and Unclassifiable Area Designations

    • Revised rule reflects updated 40 CFR 81.303 as amended July 1, 2014.

    AAC R18-2-610—Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03

    • New rule provides definitions for commercial farms general permit rule and applies to general permit rules in other specified nonattainment areas.

    AAC R18-2-610.03—Agricultural PM General Permit for Crop Operations; Pinal County PM Attainment Area

    • New menu-based rule requires a general permit for commercial farms in the Pinal County PM Nonattainment Area.

    • Requires implementation of at least one (best management practice) BMP in the following five categories: Tillage, ground operations and harvest, noncropland, commercial farm roads, and cropland. Beginning in calendar year 2017, and no more than once every subsequent three years, requires facility response to an ADEQ survey on BMP implementation.

    AAC R18-2-612—Definitions for R18-2-612.01

    • New rule provides definitions for R18-2-612.01.

    AAC R18-2-612.01—Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009

    • New menu-based rule requires a general permit for irrigation districts in nonattainment areas designated after June 1, 2009.

    • Requires implementation of at least one BMP in the following three categories: unpaved operation and maintenance roads, canals, and unpaved utility access roads.

    • Beginning in calendar year 2017, and no more than once every subsequent three years, requires irrigation district response to an ADEQ survey on BMP implementation.

    AAC Appendix 2—Test Methods and Protocol

    • Revised rule adds section L: 40 CFR 51.128 Appendix A (1)(B) and section M: Silt Content Test Method.

    The EPA's technical support documents (TSDs) have more information about these rules.

    II. The EPA's Evaluation and Action A. How is the EPA evaluating the statute and rules?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and are limited in how they can modify certain SIP control requirements in nonattainment areas (see CAA section 193).

    In addition, generally, SIP rules must implement Reasonably Available Control Measures (RACM), including Reasonably Available Control Technology (RACT), in moderate PM2.5/PM10 nonattainment areas (see CAA sections 172(c)(1) and 189(a)(1)(C)). The PCAQCD regulates a PM10 nonattainment area classified as moderate for the 1987 24-hour PM10 National Ambient Air Quality Standard (NAAQS) (40 CFR 81. 303).1 A RACM evaluation is generally performed in context of a broader plan, so we are not proposing to determine whether ADEQ has demonstrated RACM for the Pinal area as part of this notice.

    1 The 1997 PM10 24-hour National Ambient Air Quality Standard (primary and secondary) is 150 micrograms per cubic meter. See https://www.epa.gov/criteria-air-pollutants/naaqs-table.

    Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:

    1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

    2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).

    3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

    4. “PM-10 Guideline Document,” EPA 452/R-93-008, April 1993.

    5. “Fugitive Dust Background Document and Technical Information Document for Best Available Control Measures,” EPA 450/2-92-004, September 1992.

    B. Do the rules and statute meet the evaluation criteria?

    We believe these rules and statute are consistent with CAA requirements and relevant guidance and fulfill the evaluation criteria. The statute and rules are clear and contain adequate testing, recordkeeping and reporting requirements to be sufficiently enforceable. The statute and rules strengthen effective requirements (e.g., by strengthening/adding general permit rules and BMPs for agricultural operations) and are consistent with CAA section 193. The statute and rules generally impose RACT-level requirements (e.g., the revisions limit silt content on unpaved lots and roads to eight percent and six percent respectively) for the affected categories.

    The TSDs have more information on our evaluation.

    C. EPA recommendations To Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for the next time the state and local agency modifies the rules.

    D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rules and statute because we believe they fulfill all relevant requirements. We will accept comments from the public on this proposal until February 8, 2017. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate these rules and statute into the federally-enforceable SIP.

    III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the PCAQCD/ADEQ rules/statute as described in Table 1 of this notice. The EPA has made, and will continue to make, these documents available electronically through www.regulations.gov and in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: December 20, 2016. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-00054 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R09-OAR-2016-0287; FRL-9957-63-Region 9] Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve the second ten-year maintenance plans for the Ajo and Morenci areas in Arizona for the 1971 National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO2), and to correct an error in the description of the Ajo, Arizona SO2 maintenance area in the Code of Federal Regulations.

    DATES:

    Any comments on this proposal must arrive by February 8, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0287 at http://www.regulations.gov, or via email to Wienke Tax, at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Wienke Tax, EPA Region IX, (415) 947-4192, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses the second ten-year maintenance plans submitted by the Arizona Department of Environmental Quality to address the 1971 SO2 NAAQS in the Ajo and Morenci maintenance areas, AZ. In the Rules and Regulations section of this Federal Register, we are approving these second ten-year maintenance plans in a direct final action without prior proposal because we believe these SIP revisions are not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. If we receive adverse comment on a distinct provision of this rulemaking, i.e., our action regarding only one maintenance plan, we will publish a timely withdrawal in the Federal Register indicating which provisions we are withdrawing. The provisions that are not withdrawn, i.e., our approval of the other maintenance plan that is not the subject of an adverse comment, will become effective on the date set out above, notwithstanding adverse comment on the other maintenance plan.

    We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.

    Dated: December 15, 2016. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2016-31636 Filed 1-6-17; 8:45 am] BILLING CODE 6560-50-P
    82 5 Monday, January 9, 2017 Notices DEPARTMENT OF AGRICULTURE Rural Utilities Service Rural Broadband Access Loans and Loan Guarantees Program AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice of Solicitation of Applications (NOSA).

    SUMMARY:

    The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), announces that it is accepting applications for fiscal year (FY) 2017 for the Rural Broadband Access Loan and Loan Guarantee program (the Broadband Program). There will be two application windows for FY 2017.

    In addition to announcing the application windows, RUS announces the minimum and maximum amounts for broadband loans for FY 2017.

    DATES:

    Unless otherwise extended by a notice of funds availability, applications for the first application window under this NOSA must be submitted from March 1, 2017, through March 31, 2017, and for the second application window from September 1, 2017, through September 30, 2017. Applications can only be submitted through the Agency's online application system during the periods specified above; however, applicants may begin working on their applications in the online system as outlined below.

    FOR FURTHER INFORMATION CONTACT:

    For further information contact Shawn Arner, Deputy Assistant Administrator, Loan Originations and Approval Division, Rural Utilities Service, Room 2844, STOP 1597, 1400 Independence Avenue SW., Washington, DC 20250-1597, Telephone: (202) 720-0800, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    General Information

    The Rural Broadband Access Loan and Loan Guarantee Program (the “Broadband Program”) is authorized by the Rural Electrification Act (7 U.S.C. 901 et seq.), as amended by the Agricultural Act of 2014 (Pub. L. 113-79) also referred to as the 2014 Farm Bill.

    During FY 2017, loans will be made available for the construction, improvement, and acquisition of facilities and equipment to provide service at the broadband lending speed for eligible rural areas. Applications are subject to the requirements of 7 CFR 1738.

    Application Assistance

    Since the implementation of the requirements of the 2014 Farm Bill, RUS has held two application windows. After reviewing the applications for eligibility, RUS has determined that there is considerable misunderstanding of the revised requirements for the Broadband Program. Under the two previous windows, once an application was submitted, RUS could not contact an applicant for additional information and the application had to be evaluated on the information that was submitted. If incorrect or inadequate information was submitted or a regulatory requirement was not met, an applicant did not have the ability to adjust its application and RUS was forced to reject it as incomplete or inadequate. In order to break with the pattern of wide scale applications that do not meet the regulation's requirements, RUS will place additional emphasis on providing assistance to applicants with submitting complete applications. As a result, RUS will open pre-application periods, in which National Office staff as well as the General Field Representative assigned to the project will be able to review the draft application, provide detailed comments, and identify when an application is not meeting eligibility requirements for funding. The online application system will allow RUS staff to assist an applicant with completing every part of an application as it is being developed.

    The first pre-application window will open on January 9, 2017, and application assistance will be available until the application is formally submitted for consideration by the applicant, but no later than midnight, Eastern Time, on March 24, 2017. Once the application is formally submitted, RUS will be unable to provide additional assistance with completing the application and will begin reviewing the application for conformance with the broadband regulation with respect to eligibility and technical and financial feasibility. In addition, once an application is formally submitted through the online system, the applicant can no longer submit supporting information. For assistance with an application, please contact Shawn Arner, Deputy Assistant Administrator, Loan Originations and Approval Division, Rural Utilities Service, Room 2844, STOP 1597, 1400 Independence Avenue SW., Washington, DC 20250-1597, Telephone: (202) 720-0800, or email: [email protected] If an application is ultimately found to be incomplete or inadequate for funding after it is formally submitted, a detailed explanation will be provided to the applicant at least thirty days prior to the opening of the second window of FY 2017 for formally submitting applications.

    The second pre-application window will open on July 1, 2017, and application assistance will be available until the application is formally submitted for consideration by the applicant, but not later than midnight, Eastern Time, on September 22, 2017. As with the first pre-application window, once an application is formally submitted, RUS will be unable to provide additional assistance with completing the application and will begin reviewing the application for conformance with the broadband regulation with respect to eligibility and technical and financial feasibility. In addition, once an application is formally submitted through the online system, the applicant can no longer submit supporting information. Please contact Shawn Arner at the above contact information if you would like assistance with your application. If an application is ultimately found to be incomplete or inadequate, a detailed explanation will be provided to the applicant.

    To further assist in the preparation of applications, an application guide is available online at: http://www.rd.usda.gov/programs-services/farm-bill-broadband-loans-loan-guarantees. Application guides may also be requested from the RUS contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

    Application requirements: All requirements for submission of an application under the Broadband Program are subject to 7 CFR 1738.

    Application Materials/Submission: Applications must be submitted through the Agency's online application system located at http://www.rd.usda.gov/programs-services/rd-apply. All materials required for completing an application are included in the online system.

    Items of Special Emphasis: The following items have been overlooked or inadequately addressed in a number of applications received in the last two application cycles. They are highlighted below to help ensure that future applications do not have the same deficiencies.

    Calculation of Additional Cash Requirement 7 CFR 1738.208: Certain applications may need to satisfy an additional cash requirement even though they have addressed the equity requirement covered in 7 CFR 1738.207 (an element of a complete application in accordance with 7 CFR 1738.202(c)). If an applicant is either a start-up operation or has not demonstrated positive cash flow from operations for the two years prior to the submission date of the application, then the applicant must submit adjusted financial projections in which projected revenues are decreased by 50 percent for each year of the five-year forecast period, unless revenues are based on documented binding commitments which would preclude such a drop. If the adjusted financial projections show an inadequate cash balance at the end of any year during the five-year forecast period, the amount of cash necessary to eliminate that cash insufficiency is the Additional Cash Requirement for the application.

    Equity requirement 7 CFR 1738.207: If an applicant has equity at the time of application equal to less than 10 percent of the requested loan amount, then the applicant must submit either an investor commitment or a commitment to issue a general obligation bond, along with a legal opinion demonstrating that the applicant has the authority to issue such a bond in an amount sufficient to meet the equity requirement (this second option is available to State, Tribal and local government applicants only). If an applicant submits more than one application, then the equity requirement will be calculated based on the sum of the requested loan amounts, as if all applications will be successful.

    Market survey (7 CFR 1738.209): If a market survey is required, the survey must have been completed within 6 months of the application submission date.

    Methodology and Assumptions included with Financial Information (7 CFR 1738.211): The narrative explaining the methodology and assumptions used to develop the financial projections for the five-year forecast period (7 CFR 1738.211(b)(2)) and the adjusted financial projections, if applicable (7 CFR 1738.208(a)(2)), must adequately address every category in the pro-forma financial statements. This narrative should include a discussion of any historical trends or anomalies and their impact on the forecast(s). The applicant should not only include any calculations or percentage changes in the assumptions but also discuss the reasons for choosing any multipliers or percentage increases/decreases for the forecast.

    Audited Financial Statements vs. Unaudited Financial Statements plus Tax Returns (7 CFR 1738.211(a)(1)-(3)): Audited financial statements submitted in compliance with 7 CFR 1738.211(a)(1)-(3) must be audited and certified by an independent certified public accountant (CPA) and include an opinion, balance sheet, income statement, statement of changes in financial position, and notes to the financial statements. Compilations or reviews are considered unaudited financial statements, even if a CPA was involved in their preparation or presentation. If an applicant submits unaudited statements, tax returns for the relevant years are also required. Start-up entities must provide, at a minimum, an opening balance sheet dated within 30 days of the final submission of all application material.

    Minimum and Maximum Loan Amounts

    Loans under this authority will not be made for less than $100,000. The maximum loan amount that will be considered for FY 2017 is $10,000,000.

    Required Definitions for Broadband Program Regulation

    The regulation for the Broadband Program requires that certain definitions affecting eligibility be revised and published from time to time by the agency in the Federal Register. For the purposes of this NOSA, the agency is revising the definition of Broadband Service, such that for applications submitted under these two windows, existing Broadband Service shall mean the minimum rate-of-data transmission of ten megabits downstream and one megabit upstream for both mobile and fixed service. With respect to the Broadband Lending Speed, the rate at which applicants must propose to offer new broadband service is a minimum bandwidth of ten megabits downstream and one megabit upstream for mobile service and twenty-five megabits downstream and three megabits upstream for fixed service to the customer.

    Priority for Approving Loan Applications

    Applications for FY 2017 will be accepted from March 1, 2017, through March 30, 2017, for the first application window and from September 1, 2017, through September 30, 2017, for the second application window. Although review of applications will start when they are submitted for each window, all applications submitted for the first application period will be evaluated and ranked together based on the percentage of unserved households in the proposed funded service area. Likewise, all applications submitted for the second window will be evaluated and ranked together based on the percentage of unserved households in the proposed funded service area. Subject to available funding, eligible applications that propose to serve the highest percentage of unserved households will receive funding offers before other eligible applications that have been submitted. The amount available for each window will be published on the Agency Web page once the annual appropriation process has been completed.

    Applications will not be accepted after September 30, 2017, until a new funding window has been opened with the publication of an additional NOSA in the Federal Register.

    Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with Broadband loans, as covered in this NOSA, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0572-0130.

    USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

    Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at http://www.ascr.usda.gov/complaint_filing_cust.html and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

    (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410;

    (2) Fax: (202) 690-7442; or

    (3) Email: [email protected]

    USDA is an equal opportunity provider, employer, and lender.

    Dated: November 21, 2016. Brandon McBride, Administrator, Rural Utilities Service.
    [FR Doc. 2017-00137 Filed 1-6-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-1-2017] Foreign-Trade Zone (FTZ) 221—Mesa, Arizona; Notification of Proposed Production Activity; Apple Inc. (Data Server Cabinets); Mesa, Arizona

    The City of Mesa Office of Economic Development, grantee of FTZ 221, submitted a notification of proposed production activity to the FTZ Board on behalf of Apple Inc. (Apple), located in Mesa, Arizona. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on December 27, 2016.

    Apple already has authority to produce certain components for consumer electronics within Subzone 221A. The current request would add finished products and foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt Apple from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, Apple would be able to choose the duty rate during customs entry procedures that applies to finished server assembly cabinets (duty-free) for the foreign-status materials/components noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The materials/components sourced from abroad include: Tape; plastic boxes; polyethylene bags; plastic bags; plastic packing; plastic washers; rubber washers; rubber spacers; steel screw hooks; steel screws; steel nuts; steel standoff; steel spring washers; steel washers, not spring/lock type; steel rivets; steel cotter pins; steel springs; steel springs, of wire; steel baffles; copper washers; copper boss; copper nuts; nickel fasteners; aluminum screws; aluminum hooks; metal hinges; metal brackets; fans; fan blades, fan unit housings; servers; input/output units; storage units; smart cables; card readers; server housing/enclosures; printed circuit board assemblies; electric motors; transformers; static converters; inductors; magnets; lithium batteries; lithium polymer batteries; routers and network switches; microphones; CDs, software; solid state drives; semiconductor media; monitors; capacitors; fuses; circuit breakers; power strips; relays; switches; electrical connectors; optical fiber cable connectors; terminals; power strips with rack mounts; diodes; transistors; thyristors; LEDs; electronic integrated circuits; infrared LED strips; data server cables; copper and power cables; cables; optical fiber cables; metal furniture; and, server rack rails (duty rate ranges from duty-free to 8.6%).

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is February 21, 2017.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: January 3, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-00144 Filed 1-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-62-2016] Foreign-Trade Zone (FTZ) 20—Newport News, Virginia; Authorization of Production Activity; Canon Virginia, Inc.; Subzone 20D (Toner Cartridges); Newport News, Virginia

    On September 2, 2016, Canon Virgina, Inc., submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility within Subzone 20D, in Newport News, Virginia.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (81 FR 64870, September 21, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: January 3, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-00147 Filed 1-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-02-2017] Foreign-Trade Zone (FTZ) 44—Morris County, New Jersey; Notification of Proposed Production Activity; AGFA Corporation (Aluminum Digital Printing Plates); Branchburg, New Jersey

    AGFA Corporation (AGFA) submitted a notification of proposed production activity to the FTZ Board for its facility in Branchburg, New Jersey, within FTZ 44. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on December 19, 2016.

    A separate application for subzone designation at the AGFA facility has been submitted and is being processed under Section 400.31 of the FTZ Board's regulations (S-152-2016). The facility is used for the production of aluminum digital printing plates used in the commercial printing industry. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status component and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt AGFA from customs duty payments on the foreign-status components used in export production. On its domestic sales, AGFA would be able to choose the duty rate during customs entry procedures that applies to aluminum digital printing plates (duty free) for foreign-status aluminum coils (duty rate 3%). Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is February 21, 2017.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Diane Finver at [email protected] or (202) 482-1367.

    Dated: January 3, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-00148 Filed 1-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Order Renewing Order Temporarily Denying Export Privileges Mahan Airway, Mahan Tower, No. 21, Azadegan St., M.A. Jenah Exp. Way, Tehran, Iran; Pejman Mahmood Kosarayanifard, a/k/a Kosarian Fard, P.O. Box 52404, Dubai, United Arab Emirates; Mahmoud Amini, G#22 Dubai Airport Free Zone, P.O. Box 393754, Dubai, United Arab Emirates and P.O. Box 52404, Dubai, United Arab Emirates and Mohamed Abdulla Alqaz Building, Al Maktoum Street, Al Rigga, Dubai, United Arab Emirates; Kerman Aviation, a/k/a GIE Kerman Aviation, 42 Avenue Montaigne 75008, Paris, France; Sirjanco Trading LLC, P.O. Box 8709, Dubai, United Arab Emirates; Ali Eslamian, 33 Cavendish Square, 4th Floor, London, W1G0PW, United Kingdom and 2 Bentinck Close, Prince Albert Road St. Johns Wood, London NW87RY, United Kingdom; Mahan Air General Trading LLC, 19th Floor Al Moosa Tower One, Sheik Zayed Road; Dubai 40594, United Arab Emirates; Skyco (UK Ltd., 33 Cavendish Square, 4th Floor, London, W1G 0PV, United Kingdom; Equipco (UK Ltd., 2 Bentinck Close, Prince Albert Road, London, NW8 7RY, United Kingdom; Mehdi Bahrami, Mahan Airways—Istanbul Office, Cumhuriye Cad. Sibil Apt No: 101 D:6, 34374 Emadad, Sisli Istanbul, Turkey; Al Naser Airlines, a/k/a al-Naser Airlines,a/k/a Alnaser Airlines and Air Freight Ltd., Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside Al Jadirya Private Hospital, Baghdad, Iraq and Al Amirat Street, Section 309, St. 3/H.20, Al Mansour Baghdad, Iraq and P.O. Box 28360, Dubai, United Arab Emirates and P.O. Box 911399, Amman 11191, Jordan; Ali Abdullah Alhay, a/k/a Ali Alhay, a/k/a Ali Abdullah Ahmed Alhay, Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside Al Jadirya Private Hospital, Baghdad, Iraq and Anak Street, Qatif, Saudi Arabia 61177; Bahar Safwa General Trading, P.O. Box 113212, Citadel Tower, Floor-5, Office #504, Business Bay, Dubai, United Arab Emirates and P.O. Box 8709, Citadel Tower, Business Bay, Dubai, United Arab Emirates; Sky Blue Bird Group, a/k/a Sky Blue Bird Aviation,a/k/a Sky Blue Bird Ltd, a/k/a Sky Blue Bird FZC, P.O. Box 16111, Ras Al Khaimah Trade Zone, United Arab Emirates; Issam Shammout, a/k/a Muhammad Isam Muhammad Anwar Nur Shammout,a/k/a Issam Anwar, Philips Building, 4th Floor, Al Fardous Street, Damascus, Syria and Al Kolaa, Beirut, Lebanon 151515 and 17-18 Margaret Street, 4th Floor, London, W1W 8RP, United Kingdom and Cumhuriyet Mah. Kavakli San St. Fulya, Cad. Hazar Sok. No.14/A Silivri, Istanbul, Turkey;

    Pursuant to Section 766.24 of the Export Administration Regulations, 15 CFR parts 730-774 (2016) (“EAR” or the “Regulations”),1 I hereby grant the request of the Office of Export Enforcement (“OEE”) to renew the July 7, 2016 Temporary Denial Order (the “TDO”). The July 7, 2016 Order denied the export privileges of Mahan Airways, Pejman Mahmood Kosarayanifard, Mahmoud Amini, Kerman Aviation, Sirjanco Trading LLC, Ali Eslamian, Mahan Air General Trading LLC, Skyco (UK) Ltd., Equipco (UK) Ltd., Mehdi Bahrami, Al Naser Airlines, Ali Abdullah Alhay, Bahar Safwa General Trading, Sky Blue Bird Group, and Issam Shammout.2 I find that renewal of the TDO is necessary in the public interest to prevent an imminent violation of the EAR.

    1 The Regulations, currently codified at 15 CFR parts 730-774 (2016), originally issued pursuant to the Export Administration Act of 1979. Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13222 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 4, 2016 (81 FR 52,58748,223 (Aug. 8, 2016)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2006 & Supp. IV 2010)).

    2 See note 3, infra.

    I. Procedural History

    On March 17, 2008, Darryl W. Jackson, the then-Assistant Secretary of Commerce for Export Enforcement (“Assistant Secretary”), signed a TDO denying Mahan Airways' export privileges for a period of 180 days on the grounds that its issuance was necessary in the public interest to prevent an imminent violation of the Regulations. The TDO also named as denied persons Blue Airways, of Yerevan, Armenia (“Blue Airways of Armenia”), as well as the “Balli Group Respondents,” namely, Balli Group PLC, Balli Aviation, Balli Holdings, Vahid Alaghband, Hassan Alaghband, Blue Sky One Ltd., Blue Sky Two Ltd., Blue Sky Three Ltd., Blue Sky Four Ltd., Blue Sky Five Ltd., and Blue Sky Six Ltd., all of the United Kingdom. The TDO was issued ex parte pursuant to Section 766.24(a), and went into effect on March 21, 2008, the date it was published in the Federal Register.

    The TDO subsequently has been renewed in accordance with Section 766.24(d), including most recently on July 7, 2016.3 As of March 9, 2010, the Balli Group Respondents and Blue Airways were no longer subject to the TDO. As part of the February 25, 2011 TDO renewal, Gatewick LLC (a/k/a Gatewick Freight and Cargo Services,a/k/a Gatewick Aviation Services), Mahmoud Amini, and Pejman Mahmood Kosarayanifard (“Kosarian Fard”) were added as related persons in accordance with Section 766.23 of the Regulations.4 On July 1, 2011, the TDO was modified by adding Zarand Aviation as a respondent in order to prevent an imminent violation.5 As part of the August 24, 2011 renewal, Kerman Aviation, Sirjanco Trading LLC, and Ali Eslamian were added to the TDO as related persons. Mahan Air General Trading LLC, Skyco (UK) Ltd., and Equipco (UK) Ltd. were added as related persons on April 9, 2012. Mehdi Bahrami was added to the TDO as a related person as part of the February 4, 2013 renewal order.

    3 The July 7, 2016 Order was published in the Federal Register on July 13, 2016 (81 Fed Reg. 45276). The TDO previously had been renewed on September 17, 2008, March 16, 2009, September 11, 2009, March 9, 2010, September 3, 2010, February 25, 2011, August 24, 2011, February 15, 2012, August 9, 2012, February 4, 2013, July 31, 2013, January 24, 2014, July 22, 2014, January 16, 2015, July 13, 2015, and January 7, 2016. The August 24, 2011 renewal followed the modification of the TDO on July 1, 2011, which added Zarand Aviation as a respondent. The July 13, 2015 renewal followed the modification of the TDO on May 21, 2015, which added Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading as respondents. Each renewal or modification order was published in the Federal Register.

    4 On August 13, 2014, BIS and Gatewick LLC resolved administrative charges against Gatewick, including a charge for acting contrary to the terms of a BIS denial order (15 CFR 764.2(k)). In addition to the payment of a civil penalty, the settlement includes a seven-year denial order. The first two years of the denial period are active, with the remaining five years suspended on condition that Gatewick LLC pays the civil penalty in full and timely fashion and commits no further violation of the Regulations during the seven-year denial period. The Gatewick LLC Final Order was published in the Federal Register on August 20, 2014. See 79 FR 49283 (Aug. 20, 2014).

    5 As of July 22, 2014, Zarand Aviation was no longer subject to the TDO.

    On May 21, 2015, the TDO was modified to add Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading as respondents. Sky Blue Bird Group and its chief executive officer Issam Shammout were added to the TDO as related persons as part of the July 13, 2015 renewal order.6

    6 The U.S. Department of the Treasury's Office of Foreign Assets Control (“OFAC”) designated Sky Blue Bird and Issam Shammout as Specially Designated Global Terrorists (“SDGTs”) on May 21, 2015, pursuant to Executive Order 13324, for “providing support to Iran's Mahan Air.” See 80 FR 30762 (May 29, 2015).

    On December 13, 2016, BIS, through its Office of Export Enforcement (“OEE”), submitted a written request for renewal of the TDO. The written request was made more than 20 days before the scheduled expiration of the current TDO, which issued on July 7, 2016. Notice of the renewal request also was provided to Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading in accordance with Sections 766.5 and 766.24(d) of the Regulations. No opposition to the renewal of the TDO has been received. Furthermore, no appeal of the related person determinations made as part of the September 3, 2010, February 25, 2011, August 24, 2011, April 9, 2012, February 4, 2013, and July 13, 2015 renewal or modification orders has been made by Kosarian Fard, Mahmoud Amini, Kerman Aviation, Sirjanco Trading LLC, Ali Eslamian, Mahan Air General Trading LLC, Skyco (UK) Ltd., Equipco (UK) Ltd., Mehdi Bahrami, Sky Blue Bird Group, or Issam Shammout.7

    7 A party named or added as a related person may not oppose the issuance or renewal of the underlying temporary denial order, but may file an appeal of the related person determination in accordance with Section 766.23(c).

    II. Renewal of the TDO A. Legal Standard

    Pursuant to Section 766.24, BIS may issue or renew an order temporarily denying a respondent's export privileges upon a showing that the order is necessary in the public interest to prevent an “imminent violation” of the Regulations. 15 CFR 766.24(b)(1) and 766.24(d). “A violation may be `imminent' either in time or degree of likelihood.” 15 CFR 766.24(b)(3). BIS may show “either that a violation is about to occur, or that the general circumstances of the matter under investigation or case under criminal or administrative charges demonstrate a likelihood of future violations.” Id. As to the likelihood of future violations, BIS may show that the violation under investigation or charge “is significant, deliberate, covert and/or likely to occur again, rather than technical or negligent [.]” Id. A “lack of information establishing the precise time a violation may occur does not preclude a finding that a violation is imminent, so long as there is sufficient reason to believe the likelihood of a violation.” Id.

    B. The TDO and BIS's Request for Renewal

    OEE's request for renewal is based upon the facts underlying the issuance of the initial TDO and the TDO renewals in this matter and the evidence developed over the course of this investigation indicating a blatant disregard of U.S. export controls and the TDO. The initial TDO was issued as a result of evidence that showed that Mahan Airways and other parties engaged in conduct prohibited by the EAR by knowingly re-exporting to Iran three U.S.-origin aircraft, specifically Boeing 747s (“Aircraft 1-3”), items subject to the EAR and classified under Export Control Classification Number (“ECCN”) 9A991.b, without the required U.S. Government authorization. Further evidence submitted by BIS indicated that Mahan Airways was involved in the attempted re-export of three additional U.S.-origin Boeing 747s (“Aircraft 4-6”) to Iran.

    As discussed in the September 17, 2008 renewal order, evidence presented by BIS indicated that Aircraft 1-3 continued to be flown on Mahan Airways' routes after issuance of the TDO, in violation of the Regulations and the TDO itself.8 It also showed that Aircraft 1-3 had been flown in further violation of the Regulations and the TDO on the routes of Iran Air, an Iranian Government airline. Moreover, as discussed in the March 16, 2009, September 11, 2009 and March 9, 2010 Renewal Orders, Mahan Airways registered Aircraft 1-3 in Iran, obtained Iranian tail numbers for them (EP-MNA, EP-MNB, and EP-MNE, respectively), and continued to operate at least two of them in violation of the Regulations and the TDO,9 while also committing an additional knowing and willful violation when it negotiated for and acquired an additional U.S.-origin aircraft. The additional acquired aircraft was an MD-82 aircraft, which subsequently was painted in Mahan Airways' livery and flown on multiple Mahan Airways' routes under tail number TC-TUA.

    8 Engaging in conduct prohibited by a denial order violates the Regulations. 15 CFR 764.2(a) and (k).

    9 The third Boeing 747 appeared to have undergone significant service maintenance and may not have been operational at the time of the March 9, 2010 renewal order.

    The March 9, 2010 Renewal Order also noted that a court in the United Kingdom (“U.K.”) had found Mahan Airways in contempt of court on February 1, 2010, for failing to comply with that court's December 21, 2009 and January 12, 2010 orders compelling Mahan Airways to remove the Boeing 747s from Iran and ground them in the Netherlands. Mahan Airways and the Balli Group Respondents had been litigating before the U.K. court concerning ownership and control of Aircraft 1-3. In a letter to the U.K. court dated January 12, 2010, Mahan Airways' Chairman indicated, inter alia, that Mahan Airways opposes U.S. Government actions against Iran, that it continued to operate the aircraft on its routes in and out of Tehran (and had 158,000 “forward bookings” for these aircraft), and that it wished to continue to do so and would pay damages if required by that court, rather than ground the aircraft.

    The September 3, 2010 renewal order discussed the fact that Mahan Airways' violations of the TDO extended beyond operating U.S.-origin aircraft and attempting to acquire additional U.S.-origin aircraft. In February 2009, while subject to the TDO, Mahan Airways participated in the export of computer motherboards, items subject to the Regulations and designated as EAR99, from the United States to Iran, via the United Arab Emirates (“UAE”), in violation of both the TDO and the Regulations, by transporting and/or forwarding the computer motherboards from the UAE to Iran. Mahan Airways' violations were facilitated by Gatewick LLC, which not only participated in the transaction, but also has stated to BIS that it acted as Mahan Airways' sole booking agent for cargo and freight forwarding services in the UAE.

    Moreover, in a January 24, 2011 filing in the U.K. court, Mahan Airways asserted that Aircraft 1-3 were not being used, but stated in pertinent part that the aircraft were being maintained in Iran especially “in an airworthy condition” and that, depending on the outcome of its U.K. court appeal, the aircraft “could immediately go back into service . . . on international routes into and out of Iran.” Mahan Airways' January 24, 2011 submission to U.K. Court of Appeal, at p. 25, ¶¶ 108, 110. This clearly stated intent, both on its own and in conjunction with Mahan Airways' prior misconduct and statements, demonstrated the need to renew the TDO in order to prevent imminent future violations. Two of these three 747s subsequently were removed from Iran and are no longer in Mahan Airways' possession. The third of these 747s, with Manufacturer's Serial Number (“MSN”) 23480 and Iranian tail number EP-MNE, remained in Iran under Mahan's control. Pursuant to Executive Order 13324, it was designated a Specially Designated Global Terrorist (“SDGT”) by the U.S. Department of the Treasury's Office of Foreign Assets Control (“OFAC”) on September 19, 2012.10 Furthermore, as discussed in the February 4, 2013 Order, open source information indicated that this 747, painted in the livery and logo of Mahan Airways, had been flown between Iran and Syria, and was suspected of ferrying weapons and/or other equipment to the Syrian Government from Iran's Islamic Revolutionary Guard Corps. Open source information showed that this aircraft had flown from Iran to Syria as recently as June 30, 2013, and continues to show that it remains in active operation in Mahan Airways' fleet.

    10See http://www.treasury.gov/resource-center/sanctions/OFAC-Enforcement/pages/20120919.aspx.

    In addition, as first detailed in the July 1, 2011 and August 24, 2011 orders, and discussed in subsequent renewal orders in this matter, Mahan Airways also continued to evade U.S. export control laws by operating two Airbus A310 aircraft, bearing Mahan Airways' livery and logo, on flights into and out of Iran.11 At the time of the July 1, 2011 and August 24, 2011 Orders, these Airbus A310s were registered in France, with tail numbers F-OJHH and F-OJHI, respectively.12

    11 The Airbus A310s are powered with U.S.-origin engines. The engines are subject to the EAR and classified under Export Control Classification (“ECCN”) 9A991.d. The Airbus A310s contain controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result are subject to the EAR. They are classified under ECCN 9A991.b. The export or reexport of these aircraft to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    12 OEE subsequently presented evidence that after the August 24, 2011 renewal, Mahan Airways worked along with Kerman Aviation and others to de-register the two Airbus A310 aircraft in France and to register both aircraft in Iran (with, respectively, Iranian tail numbers EP-MHH and EP-MHI). It was determined subsequent to the February 15, 2012 renewal order that the registration switch for these A310s was cancelled and that Mahan Airways then continued to fly the aircraft under the original French tail numbers (F-OJHH and F-OJHI, respectively). Both aircraft apparently remain in Mahan Airways' possession.

    The August 2012 renewal order also found that Mahan Airways had acquired another Airbus A310 aircraft subject to the Regulations, with MSN 499 and Iranian tail number EP-VIP, in violation of the TDO and the Regulations.13 On September 19, 2012, all three Airbus A310 aircraft (tail numbers F-OJHH, F-OJHI, and EP-VIP) were designated as SDGTs.14

    13 See note 12, supra.

    14See http://www.treasury.gov/resource-center/sanctions/OFAC-Enforcement/pages/20120919.aspx. Mahan Airways was previously designated by OFAC as a SDGT on October 18, 2011. 77 FR 64,427 (October 18, 2011).

    The February 4, 2013 Order laid out further evidence of continued and additional efforts by Mahan Airways and other persons acting in concert with Mahan, including Kral Aviation and another Turkish company, to procure U.S.-origin engines—two GE CF6-50C2 engines, with MSNs 517621 and 517738, respectively—and other aircraft parts in violation of the TDO and the Regulations.15 The February 4, 2013 renewal order also added Mehdi Bahrami as a related person in accordance with Section 766.23 of the Regulations. Bahrami, a Mahan Vice-President and the head of Mahan's Istanbul Office, also was involved in Mahan's acquisition of the original three Boeing 747s (Aircraft 1-3) that resulted in the original TDO, and has had a business relationship with Mahan dating back to 1997.

    15 Kral Aviation was referenced in the February 4, 2013 Order as “Turkish Company No. 1.” Kral Aviation purchased a GE CF6-50C2 aircraft engine (MSN 517621) from the United States in July 2012, on behalf of Mahan Airways. OEE was able to prevent this engine from reaching Mahan by issuing a redelivery order to the freight forwarder in accordance with Section 758.8 of the Regulations. OEE also issued Kral Aviation a redelivery order for the second CF6-50C2 engine (MSN 517738) on July 30, 2012. The owner of the second engine subsequently cancelled the item's sale to Kral Aviation. In September 2012, OEE was alerted by a U.S. exporter that another Turkish company (“Turkish Company No. 2”) was attempting to purchase aircraft spare parts intended for re-export by Turkish Company No. 2 to Mahan Airways. See February 4, 2013 Order.

    On December 31, 2013, Kral Aviation was added to BIS's Entity List, Supplement No. 4 to Part 744 of the Regulations. See 78 FR75458 (Dec. 12, 2013). Companies and individuals are added to the Entity List for engaging in activities contrary to the national security or foreign policy interests of the United States. See 15 CFR 744.11.

    The July 31, 2013 Order detailed additional evidence obtained by OEE showing efforts by Mahan Airways to obtain another GE CF6-50C2 aircraft engine (MSN 528350) from the United States via Turkey. Multiple Mahan employees, including Mehdi Bahrami, were involved in or aware of matters related to the engine's arrival in Turkey from the United States, plans to visually inspect the engine, and prepare it for shipment from Turkey.

    Mahan sought to obtain this U.S.-origin engine through Pioneer Logistics Havacilik Turizm Yonetim Danismanlik (“Pioneer Logistics”), an aircraft parts supplier located in Turkey, and its director/operator, Gulnihal Yegane, a Turkish national who previously had conducted Mahan related business with Mehdi Bahrami and Ali Eslamian. Moreover, as referenced in the July 31, 2013 Order, a sworn affidavit by Kosol Surinanda, also known as Kosol Surinandha, Managing Director of Mahan's General Sales Agent in Thailand, stated that the shares of Pioneer Logistics for which he was the listed owner were “actually the property of and owned by Mahan.” He further stated that he held “legal title to the shares until otherwise required by Mahan” but would “exercise the rights granted to [him] exactly and only as instructed by Mahan and [his] vote and/or decisions [would] only and exclusively reflect the wills and demands of Mahan[.]” 16

    16 Pioneer Logistics, Gulnihal Yegane, and Kosol Surinanda also were added to the Entity List on December 12, 2013. See 78 FR 75458 (Dec. 12, 2013).

    The January 24, 2014 Order outlined OEE's continued investigation of Mahan Airways' activities and detailed an attempt by Mahan, which OEE thwarted, to obtain, via an Indonesian aircraft parts supplier, two U.S.-origin Honeywell ALF-502R-5 aircraft engines (MSNs LF5660 and LF5325), items subject to the Regulations, from a U.S. company located in Texas. An invoice of the Indonesian aircraft parts supplier dated March 27, 2013, listed Mahan Airways as the purchaser of the engines and included a Mahan ship-to address. OEE also obtained a Mahan air waybill dated March 12, 2013, listing numerous U.S.-origin aircraft parts subject to the Regulations—including, among other items, a vertical navigation gyroscope, a transmitter, and a power control unit—being transported by Mahan from Turkey to Iran in violation of the TDO.

    The July 22, 2014 Order discussed open source evidence from the March-June 2014 time period regarding two BAE regional jets, items subject to the Regulations, that were painted in the livery and logo of Mahan Airways and operating under Iranian tail numbers EP-MOK and EP-MOI, respectively.17 In addition, aviation industry resources indicated that these aircraft were obtained by Mahan Airways in late November 2013 and June 2014, from Ukrainian Mediterranean Airline, a Ukrainian airline that was added to BIS's Entity List (Supplement No. 4 to Part 744 of the Regulations) on August 15, 2011, for acting contrary to the national security and foreign policy interests of the United States.18 OEE's on-going investigation indicates that both BAE regional jets remain active in Mahan's fleet, with open source information showing EP-MOI being used on flights into and out of Iran as recently as January 12, 2015. The continued operation of these aircraft by Mahan Airways violates the TDO.

    17 The BAE regional jets are powered with U.S.-origin engines. The engines are subject to the EAR and classified under ECCN 9A991.d. These aircraft contain controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result are subject to the EAR. They are classified under ECCN 9A991.b. The export or reexport of these aircraft to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    18See 76 FR 50407 (Aug. 15, 2011). The July 22, 2014 TDO renewal order also referenced two Airbus A320 aircraft painted in the livery and logo of Mahan Airways and operating under Iranian tail numbers EP-MMK and EP-MML, respectively. OEE's investigation also showed that Mahan obtained these aircraft in November 2013, from Khors Air Company, another Ukrainian airline that, like Ukrainian Mediterranean Airlines, was added to BIS's Entity List on August 15, 2011. Open source evidence indicates the two Airbus A320 aircraft may be been transferred by Mahan Airways to another Iranian airline in October 2014, and issued Iranian tail numbers EP-APE and EP-APF, respectively.

    The January 16, 2015 Order detailed evidence of additional attempts by Mahan Airways to acquire items subject the Regulations in further violation of the TDO. Specifically, in March 2014, OEE became aware of an inertial reference unit bearing serial number 1231 (“the IRU”) that had been sent to the United States for repair. The IRU is subject to the Regulations, classified under ECCN 7A103, and controlled for missile technology reasons. Upon closer inspection, it was determined that IRU came from or had been installed on an Airbus A340 aircraft bearing MSN 056. Further investigation revealed that as of approximately February 2014, this aircraft was registered under Iranian tail number EP-MMB and had been painted in the livery and logo of Mahan Airways.

    The January 16, 2015 Order also described related efforts by the Departments of Justice and Treasury to further thwart Mahan's illicit procurement efforts. Specifically, on August 14, 2014, the United States Attorney's Office for the District of Maryland filed a civil forfeiture complaint for the IRU pursuant to 22 U.S.C. 401(b) that resulted in the court issuing an Order of Forfeiture on December 2, 2014. EP-MMB remains listed as active in Mahan Airways' fleet.

    Additionally, on August 29, 2014, OFAC blocked the property and interests in property of Asian Aviation Logistics of Thailand, a Mahan Airways affiliate or front company, pursuant to Executive Order 13224. In doing so, OFAC described Mahan Airways' use of Asian Aviation Logistics to evade sanctions by making payments on behalf of Mahan for the purchase of engines and other equipment.19

    19 See http://www.treasury.gov/resource-center/sanctions/OFAC-Enforcement/Pages/20140829.aspx. See 79 FR 55073 (Sep. 15, 2014). OFAC also blocked the property and property interests of Pioneer Logistics of Turkey on August 29, 2014. Id. Mahan Airways' use of Pioneer Logistics in an effort to evade the TDO and the Regulations was discussed in a prior renewal order, as summarized, supra, at 13-14. BIS added both Asian Aviation Logistics and Pioneer Logistics to the Entity List on December 12, 2013. See 78 FR 75458 (Dec. 12, 2013).

    The May 21, 2015 modification order detailed the acquisition of two aircraft, specifically an Airbus A340 bearing MSN 164 and an Airbus A321 bearing MSN 550, that were purchased by Al Naser Airlines in late 2014/early 2015 and are currently located in Iran under the possession, control, and/or ownership of Mahan Airways.20 The sales agreements for these two aircraft were signed by Ali Abdullah Alhay for Al Naser Airlines.21 Payment information reveals that multiple electronic funds transfers (“EFT”) were made by Ali Abdullah Alhay and Bahar Safwa General Trading in order to acquire MSNs 164 and 550.

    20 Both of these aircraft are powered by U.S.-origin engines that are subject to the Regulations and classified under ECCN 9A991.d. Both aircraft contain controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result are subject to the EAR regardless of their location. The aircraft are classified under ECCN 9A991.b. The export or re-export of these aircraft to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    21 Ali Abdullah Alhay is a 25% owner of Al Naser Airlines.

    The May 21, 2015 modification order also laid out evidence showing the respondents' attempts to obtain other controlled aircraft, including aircraft physically located in the United States in similarly-patterned transactions during the same recent time period. Transactional documents involving two Airbus A320s bearing MSNs 82 and 99, respectively, again showed Ali Abdullah Alhay signing sales agreements for Al Naser Airlines.22 A review of the payment information for these aircraft similarly revealed EFTs from Ali Abdullah Alhay and Bahar Safwa General Trading that follow the pattern described for MSNs 164 and 550, supra. MSNs 82 and 99 were detained by OEE Special Agents prior to their planned export from the United States.

    22 Both aircraft were physically located in the United States and therefore are subject to the Regulations pursuant to Section 734.3(a)(1). Moreover, these Airbus A320s are powered by U.S.-origin engines that are subject to the Regulations and classified under Export Control Classification Number ECCN 9A991.d. The Airbus A320s contain controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result are subject to the EAR regardless of their location. The aircraft are classified under ECCN 9A991.b. The export or re-export of these aircraft to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    The July 13, 2015 Order outlined evidence showing that Al Naser Airlines' attempts to acquire aircraft on behalf of Mahan Airways extended beyond MSNs 164 and 550 to include a total of nine aircraft.23 Four of the aircraft, all of which are subject to the Regulations and were obtained by Mahan from Al Naser Airlines, had been issued the following Iranian tail numbers: EP-MMD (MSN 164), EP-MMG (MSN 383), EP-MMH (MSN 391) and EP-MMR (MSN 416), respectively.24 Publicly available flight tracking information provided evidence that at the time of the July 13, 2015 renewal, both EP-MMH and EP-MMR were being actively flown on routes into and out of Iran in violation of the TDO and Regulations.25

    The January 7, 2016 Order discussed evidence that Mahan Airways had begun actively flying EP-MMD, another of the aircraft Mahan had obtained from Al Naser Airlines (as discussed in the July 13, 2015 renewal order), on international routes into and out of Iran, including from/to Bangkok, Thailand. Additionally, the January 7, 2016 Order described publicly available aviation database and flight tracking information indicating that Mahan Airways was continuing its efforts to acquire Iranian tail numbers and press into active service under Mahan's livery and logo at least two more of the Airbus A340 aircraft it had obtained from or through Al Naser Airlines: EP-MME (MSN 371) and EP-MMF (MSN 376), respectively. Since January 2016, EP-MME has logged flights to and from Tehran, Iran involving various destinations, including Guangzhou, China and Dubai, United Arab Emirates in further violation of the TDO and the Regulations.

    23 This evidence included a press release dated May 9, 2015, that appeared on Mahan Airways' Web site and stated that Mahan “added 9 modern aircraft to its air fleet [,]” and that the newly acquired aircraft included eight Airbus A340s and one Airbus A321. See http://www.mahan.aero/en/mahan-air/press-room/44. The press release was subsequently removed from Mahan Airways' Web site. Publicly available aviation databases similarly showed that Mahan had obtained nine additional aircraft from Al Naser Airlines in May 2015, including MSNs 164 and 550. As also discussed in the July 13, 2015 renewal order, Sky Blue Bird Group, via Issam Shammout, was actively involved in Al Naser Airlines' acquisition of MSNs 164 and 550, and the attempted acquisition of MSNs 82 and 99 (which were detained by OEE).

    24 The Airbus A340s are powered by U.S.-origin engines that are subject to the Regulations and classified under ECCN 9A991.d. The Airbus A340s contain controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result are subject to the EAR regardless of their location. The aircraft are classified under ECCN 9A991.b. The export or re-export of these aircraft to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    25 There is some publicly available information indicating that the aircraft Mahan Airways is flying under Iranian tail number EP-MMR is now MSN 615, rather than MSN 416. Both aircraft are Airbus A340 aircraft that Mahan acquired from Al Naser Airlines in violation of the TDO and the Regulations. Moreover, both aircraft were designated as SDGTs by OFAC on May 21, 2015, pursuant to Executive Order 13324. See 80 FR 30762 (May 29, 2015).

    The July 7, 2016 Order described Mahan Airways' acquisition of a BAE Avro RJ-85 aircraft (MSN E2392) in violation of the TDO and its subsequent registration under Iranian tail number EP-MOR.26 This information was corroborated by publicly available information on the Web site of Iran's civil aviation authority. The July 7, 2016 Order also outlined Mahan's continued operation of EP-MMF in violation of the TDO on routes from Tehran Iran to Beijing, China and Shanghai, China, respectively.

    26 The BAE Avro RJ-85 is powered by U.S.-origin engines that are subject to the Regulations and classified under ECCN 9A991.d. The BAE Avro RJ-85 contains controlled U.S.-origin items valued at more than 10 percent of the total value of the aircraft and as a result is subject to the EAR regardless of its location. The aircraft is classified under ECCN 9A991.b, and its export or re-export to Iran requires U.S. Government authorization pursuant to Sections 742.8 and 746.7 of the Regulations.

    The December 13, 2016 renewal request discusses OEE's on-going concerns that Mahan Airways has continued to utilize aircraft, engines, and other aircraft parts that it previously acquired in violation of the TDO. This conduct includes, but is not limited to, operating aircraft originally obtained from or through Al Naser Airlines on international flights into and out of Iran. Publicly available flight tracking information shows that since December 20, 2016, EP-MMD (MSN 164), EP-MMF (MSN 376), and EP-MMH (MSN 391) has each been flown on routes into or out of Tehran, Iran, including from/to Beijing, China, Kuala Lumpur, Malaysia, and Istanbul, Turkey.27 These flights into or out of Iran by Mahan Airways constitute additional violations of the TDO and the Regulations.28

    27 Publicly available flight tracking information shows that on December 22, 2016, EP-MMD (MSN 164) flew from Dubai, UAE to Tehran, Iran. Additionally, between December 20, 2016, and December 22, 2016, EP-MMF (MSN 376) flew on routes from Tehran, Iran to Beijing, China and Istanbul, Turkey, respectively. Similar flight tracking information shows that between December 26, 2016 and December 28, 2016, EP-MMH (MSN 391) flew on routes from Tehran, Iran to Kuala Lumpur, Malaysia.

    28 OEE's December 13, 2016 request also raised its concerns about an Airbus A340 previously registered in the United States. The aircraft was recently exported from the United States to Indonesia contrary to filings made with the U.S. Federal Aviation Administration indicating, first that the aircraft was being flown to Almaty, Kazakhstan, and then indicating that the aircraft should be de-registered in the U.S. because it was being exported to and going to be registered in Ukraine, neither of which has occurred.

    Mahan's acquisition of these aircraft from or through Al Naser Airlines and their subsequent registration in Iran were detailed in the July 13, 2015 and January 7, 2016 renewal orders, respectively. Both Mahan Airways and Al Naser Airways remain subject to an on-going investigation by OEE.

    C. Findings

    Under the applicable standard set forth in Section 766.24 of the Regulations and my review of the entire record, I find that the evidence presented by BIS convincingly demonstrates that the denied persons have acted in violation of the Regulations and the TDO; that such violations have been significant, deliberate and covert; and that given the foregoing and the nature of the matters under investigation, there is a likelihood of future violations. Therefore, renewal of the TDO is necessary to prevent imminent violation of the Regulations and to give notice to companies and individuals in the United States and abroad that they should continue to cease dealing with Mahan Airways, Al Naser Airlines, and the other denied persons under the TDO in connection with export and reexport transactions involving items subject to the Regulations.

    IV. Order

    IT IS THEREFORE ORDERED:

    FIRST, that MAHAN AIRWAYS, Mahan Tower, No. 21, Azadegan St., M.A. Jenah Exp. Way, Tehran, Iran; PEJMAN MAHMOOD KOSARAYANIFARD A/K/A KOSARIAN FARD, P.O. Box 52404, Dubai, United Arab Emirates; MAHMOUD AMINI, G#22 Dubai Airport Free Zone, P.O. Box 393754, Dubai, United Arab Emirates, and P.O. Box 52404, Dubai, United Arab Emirates, and Mohamed Abdulla Alqaz Building, Al Maktoum Street, Al Rigga, Dubai, United Arab Emirates; KERMAN AVIATION A/K/A GIE KERMAN AVIATION, 42 Avenue Montaigne 75008, Paris, France; SIRJANCO TRADING LLC, P.O. Box 8709, Dubai, United Arab Emirates; ALI ESLAMIAN, 33 Cavendish Square, 4th Floor, London W1G0PW, United Kingdom, and 2 Bentinck Close, Prince Albert Road St. Johns Wood, London NW87RY, United Kingdom; MAHAN AIR GENERAL TRADING LLC, 19th Floor Al Moosa Tower One, Sheik Zayed Road, Dubai 40594, United Arab Emirates; SKYCO (UK) LTD., 33 Cavendish Square, 4th Floor, London, W1G 0PV, United Kingdom; EQUIPCO (UK) LTD., 2 Bentinck Close, Prince Albert Road, London, NW8 7RY, United Kingdom; and MEHDI BAHRAMI, Mahan Airways- Istanbul Office, Cumhuriye Cad. Sibil Apt No: 101 D:6, 34374 Emadad, Sisli Istanbul, Turkey; AL NASER AIRLINES A/K/A AL-NASER AIRLINES A/K/A ALNASER AIRLINES AND AIR FREIGHT LTD., Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside Al Jadirya Private Hospital, Baghdad, Iraq, and Al Amirat Street, Section 309, St. 3/H.20, Al Mansour, Baghdad, Iraq, and P.O. Box 28360, Dubai, United Arab Emirates, and P.O. Box 911399, Amman 11191, Jordan; ALI ABDULLAH ALHAY A/K/A ALI ALHAY A/K/A ALI ABDULLAH AHMED ALHAY, Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside Al Jadirya Private Hospital, Baghdad, Iraq, and Anak Street, Qatif, Saudi Arabia 61177; BAHAR SAFWA GENERAL TRADING, P.O. Box 113212, Citadel Tower, Floor-5, Office #504, Business Bay, Dubai, United Arab Emirates, and P.O. Box 8709, Citadel Tower, Business Bay, Dubai, United Arab Emirates; SKY BLUE BIRD GROUP A/K/A SKY BLUE BIRD AVIATION A/K/A SKY BLUE BIRD LTD A/K/A SKY BLUE BIRD FZC, P.O. Box 16111, Ras Al Khaimah Trade Zone, United Arab Emirates; and ISSAM SHAMMOUT A/K/A MUHAMMAD ISAM MUHAMMAD ANWAR NUR SHAMMOUT A/K/A ISSAM ANWAR, Philips Building, 4th Floor, Al Fardous Street, Damascus, Syria, and Al Kolaa, Beirut, Lebanon 151515, and 17-18 Margaret Street, 4th Floor, London, W1W 8RP, United Kingdom, and Cumhuriyet Mah. Kavakli San St. Fulya, Cad. Hazar Sok. No.14/A Silivri, Istanbul, Turkey, and when acting for or on their behalf, any successors or assigns, agents, or employees (each a “Denied Person” and collectively the “Denied Persons”) 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 Export Administration Regulations (“EAR”), or in any other activity subject to the EAR 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 EAR, or in any other activity subject to the EAR; 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 EAR, or in any other activity subject to the EAR.

    SECOND, that no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of a Denied Person any item subject to the EAR;

    B. Take any action that facilitates the acquisition or attempted acquisition by a Denied Person of the ownership, possession, or control of any item subject to the EAR that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby a 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 a Denied Person of any item subject to the EAR that has been exported from the United States;

    D. Obtain from a Denied Person in the United States any item subject to the EAR 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 EAR that has been or will be exported from the United States and which is owned, possessed or controlled by a Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by a Denied Person if such service involves the use of any item subject to the EAR 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, that, after notice and opportunity for comment as provided in section 766.23 of the EAR, any other person, firm, corporation, or business organization related to a Denied Person by affiliation, ownership, control, or position of responsibility in the conduct of trade or related services may also be made subject to the provisions of this Order.

    FOURTH, that this Order does not prohibit any export, reexport, or other transaction subject to the EAR where the only items involved that are subject to the EAR are the foreign-produced direct product of U.S.-origin technology.

    In accordance with the provisions of Sections 766.24(e) of the EAR, Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and/or Bahar Safwa General Trading may, at any time, appeal this Order by filing a full written statement in support of the appeal with the Offic