Federal Register Vol. 82, No.9,

Federal Register Volume 82, Issue 9 (January 13, 2017)

Page Range4149-4768
FR Document

82_FR_9
Current View
Page and SubjectPDF
82 FR 4422 - Sunshine Act Meeting NoticePDF
82 FR 4317 - Sunshine Act Meeting NoticePDF
82 FR 4151 - Cardiovascular DevicesPDF
82 FR 4410 - Notice of Availability of the Record of Decision for the Dominguez-Escalante National Conservation Area Resource Management Plan and Final Environmental Impact Statement, ColoradoPDF
82 FR 4411 - Notice of Temporary Closures and Restrictions of Public Lands in La Paz County, AZPDF
82 FR 4415 - Public Land Order No. 7859; Withdrawal of National Forest System and Bureau of Land Management Public Lands in Southwestern Oregon; OregonPDF
82 FR 4365 - Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)PDF
82 FR 4232 - National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology ReviewPDF
82 FR 4414 - Renewal of Approved Information Collection; OMB Control No. 1004-0196PDF
82 FR 4406 - Renewal of Approved Information Collection; OMB Control No. 1004-0042PDF
82 FR 4287 - Foreign-Trade Zone (FTZ) 21-Dorchester County, South Carolina, Authorization of Limited Production Activity, Volvo Car US Operations, Inc., (Motor Vehicles and Related Parts), Ridgeville, South CarolinaPDF
82 FR 4286 - Foreign-Trade Zone (FTZ) 122-Corpus Christi, Texas, Notification of Proposed Production Activity, Superior Weighting Products LLC, (Barite/Calcium Carbonate/Bentonite), Corpus Christi, TexasPDF
82 FR 4322 - Application for New Awards; Expanding Opportunity Through Quality Charter Schools Program (CSP)-Grants to Charter Management Organizations for the Replication and Expansion of High-Quality Charter SchoolsPDF
82 FR 4317 - Applications for New Awards; Fulbright-Hays Doctoral Dissertation Research Abroad Fellowship ProgramPDF
82 FR 4279 - Notice of Intent to Grant Exclusive LicensePDF
82 FR 4335 - Environmental Laboratory Advisory Board (ELAB) Meeting Dates and AgendaPDF
82 FR 4287 - Approval of Expansion of Subzone 100D; Thor Industries, Inc.; Jackson Center, OhioPDF
82 FR 4286 - Foreign-Trade Zone (FTZ) 79-Tampa, Florida; Authorization of Production Activity; Givaudan Flavors Corporation (Flavor Products); Lakeland, FloridaPDF
82 FR 4301 - Caribbean Fishery Management Council; Public MeetingsPDF
82 FR 4305 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingsPDF
82 FR 4291 - Granular Polytetrafluoroethylene Resin From Italy: Rescission of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 4366 - Government-Owned Inventions; Availability for LicensingPDF
82 FR 4367 - National Institute of Allergy and Infectious Diseases Notice of Closed MeetingsPDF
82 FR 4365 - National Institute on Aging; Notice of Closed MeetingsPDF
82 FR 4368 - National Human Genome Research Institute; Notice of Closed MeetingsPDF
82 FR 4368 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 4370 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 4455 - Award Management Requirements: Availability of Final CircularPDF
82 FR 4348 - Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment PeriodPDF
82 FR 4225 - Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment PeriodPDF
82 FR 4343 - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; AvailabilityPDF
82 FR 4358 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; AvailabilityPDF
82 FR 4362 - Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; AvailabilityPDF
82 FR 4313 - The Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of ThingsPDF
82 FR 4420 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability ActPDF
82 FR 4336 - Environmental Impact Statements; Notice of AvailabilityPDF
82 FR 4388 - Affirmatively Furthering Fair Housing: Announcement of Renewal of Approval of the Assessment Tool for Local GovernmentsPDF
82 FR 4373 - Affirmatively Furthering Fair Housing Assessment Tool for Public Housing Agencies: Announcement of Final Approved DocumentPDF
82 FR 4420 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability ActPDF
82 FR 4336 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 4449 - In the Matter of the Designation of Jamaah Ansharut Daulah also known as Jemaah Anshorut Daulahalso known as Jamaah Ansharut Daulatalso Known as JAD as a Specially Designated Global Terrorist Pursuant to Section 1(b) of E.O. 13224, as AmendedPDF
82 FR 4421 - Committee on Equal Opportunities in Science and Engineering; Notice of MeetingPDF
82 FR 4449 - North Carolina Disaster Number NC-00086PDF
82 FR 4405 - Reservation ProclamationsPDF
82 FR 4286 - Submission for OMB Review; Comment Request; Report of Requests for Restrictive Trade Practice or BoycottPDF
82 FR 4450 - Tenth RTCA SC-229 406 MHz ELT Plenary Joint With WG-98; CorrectionPDF
82 FR 4334 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information Collection for Importation of On-Highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and EquipmentPDF
82 FR 4335 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Performance Evaluation Studies on Wastewater Laboratories (Renewal)PDF
82 FR 4229 - Safety zone; Tennessee River, Mile 446.0 to 454.5PDF
82 FR 4353 - Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; AvailabilityPDF
82 FR 4345 - Nonproprietary Naming of Biological Products; Guidance for Industry; AvailabilityPDF
82 FR 4454 - Petition for Waiver of CompliancePDF
82 FR 4453 - Petition for Waiver of CompliancePDF
82 FR 4453 - Establishment of an Emergency Relief Docket for Calendar Year 2017PDF
82 FR 4300 - Certain Magnesia Carbon Bricks From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014PDF
82 FR 4316 - Procurement List; Additions and DeletionsPDF
82 FR 4337 - General Services Administration Acquisition Regulation; Information Collection; Industrial Funding Fee and Sales ReportingPDF
82 FR 4423 - Duke Energy Progress; Combined License Applications for Shearon Harris Nuclear Plant Units 2 and 3PDF
82 FR 4282 - Notice of Initiating the Assessment Phase of the Forest Plan Revision for the Salmon-Challis National ForestPDF
82 FR 4425 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Debris Screen Related DimensionsPDF
82 FR 4299 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Rescission, in Part, of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 4315 - Procurement List; Proposed Additions and DeletionsPDF
82 FR 4294 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
82 FR 4372 - Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Claims FormsPDF
82 FR 4314 - Reopening of the Period for Comments on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at The Hague Conference on Private International LawPDF
82 FR 4333 - Request for Public Comment on Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive WastesPDF
82 FR 4301 - Circular Welded Carbon Quality Steel Pipe From the People's Republic of China: Rescission of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 4290 - Steel Wire Garment Hangers From the People's Republic of China; 2015-2016; Partial Rescission of the Eighth Antidumping Duty Administrative ReviewPDF
82 FR 4332 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19PDF
82 FR 4449 - 30-Day Notice of Proposed Information Collection: Request for Determination of Possible Loss of United States CitizenshipPDF
82 FR 4333 - Innovative Pathways Funding Opportunity AnnouncementPDF
82 FR 4403 - Endangered and Threatened Wildlife and Plants; Permit ApplicationsPDF
82 FR 4451 - Notice of Statute of Limitations on Claims; Final Federal Agency Actions on Proposed Highway in CaliforniaPDF
82 FR 4413 - Notice of Public Meetings for the John Day-Snake Resource Advisory CouncilPDF
82 FR 4413 - Notice of Public Meeting For the Southeast Oregon Resource Advisory CouncilPDF
82 FR 4412 - Notice of Grand Staircase-Escalante National Monument Advisory Committee MeetingPDF
82 FR 4404 - Endangered and Threatened Wildlife and Plants; Status Review of the Northern Rocky Mountain Distinct Population Segment of the FisherPDF
82 FR 4341 - Statement of Organization, Functions, and Delegations of AuthorityPDF
82 FR 4291 - Certain Pasta From Italy: Final Results of Antidumping and Countervailing Duty Changed Circumstances ReviewsPDF
82 FR 4287 - Increase of Controls: Infrared Detection ItemsPDF
82 FR 4226 - Notice of Inquiry; Request for Comments Regarding United States Munitions List Category XIIPDF
82 FR 4281 - Information Collection Request; General Program AdministrationPDF
82 FR 4459 - Community Development Advisory Board MeetingPDF
82 FR 4371 - Chemical Transportation Advisory CommitteePDF
82 FR 4460 - Sanctions Actions Pursuant To The Cuban Assets Control RegulationsPDF
82 FR 4349 - Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a DocketPDF
82 FR 4419 - Agency Information Collection Activities; Proposed eCollection eComments Requested; [Notice of Firearms Manufactured or Imported (ATF Form 2 (5320.2)]PDF
82 FR 4279 - Submission for OMB Review; Comment RequestPDF
82 FR 4418 - Certain Liquid Crystal Ewriters and Components Thereof; Institution of InvestigationPDF
82 FR 4418 - Softwood Lumber Products From Canada; DeterminationsPDF
82 FR 4417 - Solid Urea From Russia and Ukraine; Termination of Five-Year ReviewsPDF
82 FR 4422 - Advisory Committee for Cyberinfrastructure; Notice of MeetingPDF
82 FR 4421 - Alan T. Waterman Award Committee; Notice of MeetingPDF
82 FR 4422 - Advisory Committee for Mathematical and Physical Sciences; Notice of MeetingPDF
82 FR 4354 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)PDF
82 FR 4361 - 180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; AvailabilityPDF
82 FR 4351 - How To Prepare a Pre-Request for Designation; Draft Guidance for Industry; AvailabilityPDF
82 FR 4441 - Guardian Variable Products Trust and Park Avenue Institutional Advisers LLC; Notice of ApplicationPDF
82 FR 4434 - Self-Regulatory Organizations; The Depository Trust Company; Order Granting Approval of Proposed Rule Change Relating To Processing of Transactions in Money Market InstrumentsPDF
82 FR 4426 - Self-Regulatory Organizations; The Depository Trust Company; Notice of No Objection To Advance Notice Filing Relating To Processing of Transactions in Money Market InstrumentsPDF
82 FR 4461 - Agency Information Collection Activity: (Non-Degenerative Arthritis (Including Inflammatory, Autoimmune, Crystalline and Infectious Arthritis) and Dysbaric Osteonecrosis Disability Benefits Questionnaire (VA Form 21-0960M-3)PDF
82 FR 4421 - Notice of Lodging of Proposed Consent Decree Under The Comprehensive Environmental Response, Compensation, and Liability ActPDF
82 FR 4416 - Draft Environmental Impact Statement/Grizzly Bear Restoration Plan, North Cascades Ecosystem, WashingtonPDF
82 FR 4437 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Fees for Connectivity and Its Communication and Routing Service Known as Bats ConnectPDF
82 FR 4442 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Fees for Connectivity and Its Communication and Routing Service Known as Bats ConnectPDF
82 FR 4445 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Fees for Connectivity and Its Communication and Routing Service Known as Bats ConnectPDF
82 FR 4430 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 1, To Amend NYSE Arca Rule 6.91PDF
82 FR 4430 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Fees for Connectivity and Its Communication and Routing Service Known as Bats ConnectPDF
82 FR 4364 - Advisory Council on Alzheimer's Research, Care, and Services; MeetingPDF
82 FR 4356 - Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; AvailabilityPDF
82 FR 4460 - Sanctions Actions Pursuant to the Sergei Magnitsky Rule of Law Accountability Act of 2012PDF
82 FR 4275 - Connect America FundPDF
82 FR 4269 - 1998 Biennial Regulatory Review-Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio ServicesPDF
82 FR 4280 - Privacy Act of 1974: Notice of Computer Matching Agreement Between Food Nutrition Service (FNS) and State Agencies Administering the Supplemental Nutrition Assistance Program (SNAP)PDF
82 FR 4461 - Notification of Citizens Coinage Advisory Committee January 17, 2017, Public Meeting Pursuant to United States Code, Title 31, Section 5135(b)(8)(C), the United States Mint Announces the Citizens Coinage Advisory Committee (CCAC) Public Meeting Scheduled for January 17, 2017PDF
82 FR 4339 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
82 FR 4198 - Addition of Mandatory Country of Origin Labeling Requirements for VenisonPDF
82 FR 4203 - Beef Promotion and Research; ReapportionmentPDF
82 FR 4284 - Generic Clearance for Proposed Information Collection; Comment Request; Generic Clearance for Internet Nonprobability Panel Pretesting and Qualitative Survey Methods TestingPDF
82 FR 4341 - Proposed Information Collection Activity; Comment RequestPDF
82 FR 4367 - National Institute of General Medical Sciences Notice of Closed MeetingPDF
82 FR 4366 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
82 FR 4368 - National Institute on Aging; Notice of Closed MeetingPDF
82 FR 4365 - National Cancer Institute; Notice of MeetingPDF
82 FR 4369 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 4407 - Identifying Lands Subject to Secretarial Order of Restoration of February 22, 1945PDF
82 FR 4452 - Notice of Final Federal Agency Actions on Proposed Highway in North CarolinaPDF
82 FR 4306 - National Environmental Policy Act Implementing Procedures and Executive Order 12114 Categorical ExclusionsPDF
82 FR 4450 - Notice of Final Federal Agency Action on Proposed Transportation Project in IllinoisPDF
82 FR 4303 - Addition of Species to the Annexes of the Protocol Concerning Specially Protected Areas and Wildlife in the Wider Caribbean RegionPDF
82 FR 4282 - Superior National Forest; Minnesota; Application for WithdrawalPDF
82 FR 4302 - Proposed Monterey Peninsula Water Supply Project; Notice of Availability of a Draft Environmental Impact Report/Environmental Impact StatementPDF
82 FR 4173 - Diseases Associated With Exposure to Contaminants in the Water Supply at Camp LejeunePDF
82 FR 4738 - EB-5 Immigrant Investor Program ModernizationPDF
82 FR 4276 - Endangered and Threatened Species; Petition for Rulemaking To Establish a Whale Protection Zone for Southern Resident Killer WhalesPDF
82 FR 4278 - Confidentiality of Information; Magnuson-Stevens Fishery Conservation and Management Reauthorization ActPDF
82 FR 4149 - Amendment of Class E Airspace for the Following Wisconsin Towns; Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI; Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI; and Revocation of Class E Airspace; Wausau, WIPDF
82 FR 4222 - Proposed Amendment of Class D and E Airspace for the Following North Dakota Towns; Wahpeton, ND; Hettinger, ND; Fargo, ND; Grand Fork, ND; Carrington, ND; Cooperstown, ND; Pembina, ND; Rugby, ND; Devils Lake, ND; Bottineau, ND; Valley City, ND and Gwinner, NDPDF
82 FR 4221 - Proposed Amendment of Class E Airspace; Kyle-Oakley Field Airport, Murray, KYPDF
82 FR 4504 - Medicare and Medicaid Program: Conditions of Participation for Home Health AgenciesPDF
82 FR 4151 - Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance; Response to Elevated Blood Lead LevelsPDF
82 FR 4403 - Federal Property Suitable as Facilities To Assist the HomelessPDF
82 FR 4231 - Seamless Acceptance ProgramPDF
82 FR 4172 - Civil PenaltiesPDF
82 FR 4281 - Administrative Reviews in the School Nutrition Programs; Approval of Information Collection RequestPDF
82 FR 4255 - TSCA Inventory Notification (Active-Inactive) RequirementsPDF
82 FR 4233 - Public Notification Requirements for Combined Sewer Overflows to the Great Lakes BasinPDF
82 FR 4185 - Freedom of Information Act Improvement Act Implementation OrderPDF
82 FR 4734 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-95; Small Entity Compliance GuidePDF
82 FR 4732 - Federal Acquisition Regulation; Prohibition on Reimbursement for Congressional Investigations and InquiriesPDF
82 FR 4724 - Federal Acquisition Regulation; Contracts Under the Small Business Administration 8(a) ProgramPDF
82 FR 4717 - Federal Acquisition Regulation; Contractor Employee Internal Confidentiality Agreements or StatementsPDF
82 FR 4716 - Federal Acquisition Regulation; Acquisition Threshold for Special Emergency Procurement AuthorityPDF
82 FR 4709 - Federal Acquisition Regulation; Uniform Use of Line ItemsPDF
82 FR 4708 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-95; IntroductionPDF
82 FR 4594 - Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air ActPDF
82 FR 4206 - Designation of Product Categories for Federal ProcurementPDF
82 FR 4464 - Reform of Generator Interconnection Procedures and AgreementsPDF

Issue

82 9 Friday, January 13, 2017 Contents Agricultural Marketing Agricultural Marketing Service PROPOSED RULES Beef Promotion and Research; Reapportionment, 4203-4206 2017-00587 Mandatory Country of Origin Labeling Requirements for Venison, 4198-4203 2017-00588 Agricultural Research Agricultural Research Service NOTICES Exclusive License Approvals, 4279 2017-00746 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Agricultural Research Service

See

Farm Service Agency

See

Food and Nutrition Service

See

Forest Service

See

Procurement and Property Management Office, Agriculture Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 4279 2017-00641 Privacy Act; Computer Matching Program, 4280 2017-00596
Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Internet Nonprobability Panel Pretesting and Qualitative Survey Methods Testing, 4284-4286 2017-00584 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 4339-4341 2017-00590 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies, 4504-4591 2017-00283 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pathways for Advancing Careers and Education: Third Follow-Up Data Collection, 4341 2017-00583 Statements of Organization, Functions, and Delegations of Authority, 4341-4343 2017-00655 Coast Guard Coast Guard PROPOSED RULES Safety Zones: Tennessee River, Mile 446.0 to 454.5, 4229-4231 2017-00696 NOTICES Meetings: Chemical Transportation Advisory Committee, 4371-4372 2017-00648 Commerce Commerce Department See

Census Bureau

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

See

Patent and Trademark Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Requests for Restrictive Trade Practice or Boycott, 4286 2017-00702
Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 4315-4317 2017-00675 2017-00688 Community Development Community Development Financial Institutions Fund NOTICES Meetings: Community Development Advisory Board, 4459-4460 2017-00649 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 4317 2017-00799 Defense Department Defense Department RULES Federal Acquisition Regulation: Acquisition Threshold for Special Emergency Procurement Authority, 4716-4717 2016-31496 Contractor Employee Internal Confidentiality Agreements or Statements, 4717-4724 2016-31497 Contracts Under the Small Business Administration 8(a) Program, 4724-4731 2016-31498 Federal Acquisition Circular 2005-95; Introduction, 4708-4709 2016-31494 Federal Acquisition Circular 2005-95; Small Entity Compliance Guide, 4734-4735 2016-31500 Prohibition on Reimbursement for Congressional Investigations and Inquiries, 4732-4734 2016-31499 Uniform Use of Line Items, 4709-4716 2016-31495 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19, 4332-4333 2017-00666 Applications for New Awards: Expanding Opportunity Through Quality Charter Schools Program—Grants to Charter Management Organizations for the Replication and Expansion of High-Quality Charter Schools, 4322-4332 2017-00748 Fulbright-Hays Doctoral Dissertation Research Abroad Fellowship Program, 4317-4322 2017-00747 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

NOTICES Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive Wastes: Extension of Comment Period, 4333 2017-00670
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Funding Opportunity: Innovative Pathways, 4333-4334 2017-00664 Environmental Protection Environmental Protection Agency RULES Accidental Release Prevention Requirements: Risk Management Programs under the Clean Air Act, 4594-4705 2016-31426 PROPOSED RULES National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology Review, 4232-4233 2017-00762 Public Notification Requirements for Combined Sewer Overflows to the Great Lakes Basin, 4233-4255 2016-31745 TSCA Inventory Notification (Active-Inactive) Requirements, 4255-4269 2016-31923 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of On-highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment, 4334-4335 2017-00698 Performance Evaluation Studies on Wastewater Laboratories, 4335 2017-00697 Environmental Impact Statements; Availability, etc., 4336 2017-00716 Meetings: Environmental Laboratory Advisory Board, 4335-4336 2017-00745 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: General Program Administration, 4281 2017-00650 Federal Aviation Federal Aviation Administration RULES Class E Airspace; Amendments: Wisconsin Towns; Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI; Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI; and Revocation of Class E Airspace; Wausau, WI, 4149-4151 2017-00287 PROPOSED RULES Class D and E Airspace; Amendments: North Dakota Towns; Wahpeton, ND; Hettinger, ND; Fargo, ND; Grand Fork, ND; Carrington, ND; Cooperstown, ND; Pembina, ND; Rugby, ND; Devils Lake, ND; Bottineau, ND; Valley City, ND and Gwinner, ND, 4222-4225 2017-00286 Class E Airspace; Amendments: Kyle-Oakley Field Airport, Murray, KY, 4221-4222 2017-00284 NOTICES Meetings: Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98; Correction, 4450 2017-00699 Federal Communications Federal Communications Commission RULES Freedom of Information Act Improvement Act Implementation Order, 4185-4197 2016-31703 PROPOSED RULES 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services, 4269-4275 2017-00597 Connect America Fund, 4275-4276 2017-00598 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Flood Insurance Program Claims Forms, 4372-4373 2017-00673 Federal Energy Federal Energy Regulatory Commission PROPOSED RULES Reform of Generator Interconnection Procedures and Agreements, 4464-4501 2016-30972 Federal Highway Federal Highway Administration NOTICES Federal Agency Actions: Illinois; Proposed Transportation Project, 4450-4451 2017-00551 North Carolina; Proposed Highway, 4452-4453 2017-00554 Proposed Highway in California, 4451-4452 2017-00662 Federal Railroad Federal Railroad Administration NOTICES Emergency Relief Docket for Calendar Year 2017, 4453 2017-00691 Petitions for Waivers of Compliance: Long Island Railroad Co., 4454-4455 2017-00693 Norfolk Southern Corp., 4453-4454 2017-00692 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 4336-4337 2017-00711 Federal Transit Federal Transit Administration NOTICES Circulars: Award Management Requirements, 4455-4459 2017-00728 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species Permit Applications, 4403-4404 2017-00663 Endangered and Threatened Species: Status Review of the Northern Rocky Mountain Distinct Population Segment of the Fisher, 4404-4405 2017-00656 Environmental Impact Statements; Availability, etc.: Grizzly Bear Restoration Plan, North Cascades Ecosystem, Washington, 4416-4417 2017-00616 Food and Drug Food and Drug Administration RULES Cardiovascular Devices; CFR Correction, 4151 2017-00796 PROPOSED RULES Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition, 4225-4226 2017-00724 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food and Drug Administration Rapid Response Surveys (Generic Clearance), 4354-4356 2017-00632 Combination Product Policy Council; Establishment of Docket, 4349-4351 2017-00646 Guidance: 180-Day Exclusivity—Questions and Answers, 4361-4362 2017-00631 Emergency Use Authorization of Medical Products and Related Authorities, 4362-4364 2017-00721 Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions, 4356-4358 2017-00604 How to Prepare a Pre-Request for Designation, 4351-4353 2017-00629 Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application, 4358-4361 2017-00722 Multiple Endpoints in Clinical Trials, 4353-4354 2017-00695 Nonproprietary Naming of Biological Products, 4345-4348 2017-00694 Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities, 4343-4345 2017-00723 Requests for Information: Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates, 4348-4349 2017-00725 Food and Nutrition Food and Nutrition Service NOTICES Administrative Reviews in the School Nutrition Programs; Approval of Information Collection Request, 4281 2016-31955 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 4460-4461 2017-00603 2017-00647 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Givaudan Flavors Corp., Foreign-Trade Zone 79, Tampa, FL, 4286-4287 2017-00739 Superior Weighting Products LLC, Foreign-Trade Zone 122, Corpus Christi, TX, 4286 2017-00750 Volvo Car US Operations, Inc., Foreign-Trade Zone 21, Dorchester County, SC, 4287 2017-00751 Subzone Expansions; Approvals: Thor Industries, Inc., Subzone 100D, Jackson Center, OH, 4287 2017-00741 Forest Forest Service NOTICES Environmental Assessments; Availability, etc.: Salmon-Challis National Forest, 4282 2017-00684 Environmental Impact Statements; Availability, etc.: Withdrawl of Public Lands, Superior National Forest, MN, 4282-4284 2017-00506 General Services General Services Administration RULES Federal Acquisition Regulation: Acquisition Threshold for Special Emergency Procurement Authority, 4716-4717 2016-31496 Contractor Employee Internal Confidentiality Agreements or Statements, 4717-4724 2016-31497 Contracts Under the Small Business Administration 8(a) Program, 4724-4731 2016-31498 Federal Acquisition Circular 2005-95; Introduction, 4708-4709 2016-31494 Federal Acquisition Circular 2005-95; Small Entity Compliance Guide, 4734-4735 2016-31500 Prohibition on Reimbursement for Congressional Investigations and Inquiries, 4732-4734 2016-31499 Uniform Use of Line Items, 4709-4716 2016-31495 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Industrial Funding Fee and Sales Reporting, 4337-4339 2017-00687 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Meetings: Advisory Council on Alzheimer's Research, Care, and Services, 4364-4365 2017-00606
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

PROPOSED RULES EB-5 Immigrant Investor Program Modernization, 4738-4768 2017-00447
Housing Housing and Urban Development Department RULES Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance: Response to Elevated Blood Lead Levels, 4151-4172 2017-00261 NOTICES Affirmatively Furthering Fair Housing: Approval of the Assessment Tool for Local Governments, 4388-4403 2017-00714 Assessment Tool for Public Housing Agencies, 4373-4388 2017-00713 Federal Properties Suitable as Facilities to Assist the Homeless, 4403 2017-00256 Indian Affairs Indian Affairs Bureau NOTICES Identifying Lands Subject to Secretarial Order of Restoration, 4407-4410 2017-00556 Reservation Proclamations, 4405-4406 2017-00703 Industry Industry and Security Bureau NOTICES Increase of Controls: Infrared Detection Items, 4287-4289 2017-00652 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews, 4294-4299 2017-00674 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Magnesia Carbon Bricks from the People's Republic of China; Rescission of Administrative Review; 2014, 4300 2017-00689 Certain Pasta from Italy; Final Results of Changed Circumstances Reviews, 4291-4294 2017-00654 Circular Welded Carbon Quality Steel Pipe from the People's Republic of China, 4301 2017-00668 Granular Polytetrafluoroethylene Resin from Italy, 4291 2017-00736 Steel Wire Garment Hangers from the People's Republic of China, 4290-4291 2017-00667 Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China, 4299-4300 2017-00682 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Liquid Crystal Ewriters and Components Thereof, 4418 2017-00640 Softwood Lumber Products from Canada, 4418-4419 2017-00639 Solid Urea from Russia and Ukraine; Termination of Five-Year Reviews, 4417 2017-00638 Justice Department Justice Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notice of Firearms Manufactured or Imported, 4419-4420 2017-00642 Proposed Consent Decrees under CERCLA, 4420-4421 2017-00618 2017-00712 2017-00718 Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Oil and Gas Leasing; National Petroleum Reserve, Alaska, 4414-4415 2017-00759 Protection, Management, and Control of Wild Horses and Burros, 4406-4407 2017-00757 Environmental Impact Statements; Availability, etc.: Dominguez-Escalante National Conservation Area Resource Management Plan, Colorado, 4410-4411 2017-00772 Identifying Lands Subject to Secretarial Order of Restoration, 4407-4410 2017-00556 Meetings: Grand Staircase-Escalante National Monument Advisory Committee, 4412-4413 2017-00657 John Day-Snake Resource Advisory Council, 4413 2017-00661 Southeast Oregon Resource Advisory Council, 4413-4414 2017-00659 Public Land Orders: Oregon; Withdrawal of National Forest System and Bureau of Land Management Public Lands in Southwestern Oregon, 4415-4416 2017-00770 Temporary Closures and Restrictions of Public Lands: La Paz County, AZ, 4411-4412 2017-00771 NASA National Aeronautics and Space Administration RULES Federal Acquisition Regulation: Acquisition Threshold for Special Emergency Procurement Authority, 4716-4717 2016-31496 Contractor Employee Internal Confidentiality Agreements or Statements, 4717-4724 2016-31497 Contracts Under the Small Business Administration 8(a) Program, 4724-4731 2016-31498 Federal Acquisition Circular 2005-95; Introduction, 4708-4709 2016-31494 Federal Acquisition Circular 2005-95; Small Entity Compliance Guide, 4734-4735 2016-31500 Prohibition on Reimbursement for Congressional Investigations and Inquiries, 4732-4734 2016-31499 Uniform Use of Line Items, 4709-4716 2016-31495 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 4366 2017-00735 Meetings: Center for Scientific Review, 4368-4371 2017-00578 2017-00730 2017-00731 National Cancer Advisory Board, 4365 2017-00579 National Human Genome Research Institute, 4368-4369 2017-00732 National Institute of Allergy and Infectious Diseases, 4367-4368 2017-00734 National Institute of Diabetes and Digestive and Kidney Diseases, 4366-4367 2017-00581 National Institute of General Medical Sciences, 4367 2017-00582 National Institute on Aging, 4365, 4368 2017-00580 2017-00733 NIH Guidelines: Research Involving Recombinant or Synthetic Nucleic Acid Molecules, 4365-4366 2017-00766 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Confidentiality of Information; Magnuson-Stevens Fishery Conservation and Management Reauthorization Act; Withdrawal, 4278 2017-00307 Endangered and Threatened Species: Petition for Rulemaking To Establish a Whale Protection Zone for Southern Resident Killer Whales, 4276-4277 2017-00437 NOTICES Addition of Species to the Annexes of the Protocol Concerning Specially Protected Areas and Wildlife: Wider Caribbean Region, 4303-4305 2017-00541 Environmental Impact Statements; Availability, etc.: Monterey Peninsula Water Supply Project, 4302-4303 2017-00505 Meetings: Caribbean Fishery Management Council, 4301-4302 2017-00738 Mid-Atlantic Fishery Management Council, 4305-4306 2017-00737 National Environmental Policy Act Implementing Procedures and Categorical Exclusions, 4306-4313 2017-00553 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Grizzly Bear Restoration Plan, North Cascades Ecosystem, Washington, 4416-4417 2017-00616 National Science National Science Foundation NOTICES Meetings: Advisory Committee for Cyberinfrastructure, 4422 2017-00635 Advisory Committee for Mathematical and Physical Sciences, 4422 2017-00633 Alan T. Waterman Award Committee, 4421 2017-00634 Committee on Equal Opportunities in Science and Engineering, 4421-4422 2017-00705 National Telecommunications National Telecommunications and Information Administration NOTICES Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things, 4313-4314 2017-00720 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemptions and Combined License Amendments: Duke Energy Progress; Shearon Harris Nuclear Plant Units 2 and 3, 4423-4425 2017-00685 Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Debris Screen Related Dimensions, 4425-4426 2017-00683 Meetings; Sunshine Act, 4422-4423 2017-00875 Patent Patent and Trademark Office NOTICES Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at The Hague Conference on Private International Law, 4314-4315 2017-00671 Postal Service Postal Service PROPOSED RULES Seamless Acceptance Program, 4231-4232 2016-32057 Procurement Procurement and Property Management Office, Agriculture Department PROPOSED RULES Designation of Product Categories for Federal Procurement, 4206-4221 2016-31128 Saint Lawrence Saint Lawrence Seaway Development Corporation RULES Civil Penalties, 4172-4173 2016-32050 Securities Securities and Exchange Commission NOTICES Applications: Guardian Variable Products Trust and Park Avenue Institutional Advisers LLC, 4441-4442 2017-00628 Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 4445-4449 2017-00609 Bats BZX Exchange, Inc., 4430-4434, 4437-4441 2017-00607 2017-00611 Bats EDGX Exchange, Inc., 4442-4445 2017-00610 NYSE Arca, Inc., 4430 2017-00608 The Depository Trust Co., 4426-4430, 4434-4437 2017-00625 2017-00626 Small Business Small Business Administration NOTICES Major Disaster Declarations: North Carolina; Amendment 3, 4449 2017-00704 State Department State Department PROPOSED RULES U.S. Munitions List Category XII, 4226-4229 2017-00651 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Determination of Possible Loss of United States Citizenship, 4449-4450 2017-00665 Designations as Global Terrorists: Jamaah Ansharut Daulah also known as Jemaah Anshorut Daulahalso known as Jamaah Ansharut Daulatalso known as JAD, 4449 2017-00708 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

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Federal Railroad Administration

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Federal Transit Administration

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Saint Lawrence Seaway Development Corporation

Treasury Treasury Department See

Community Development Financial Institutions Fund

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Foreign Assets Control Office

See

United States Mint

U.S. Mint United States Mint NOTICES Meetings: Citizens Coinage Advisory Committee, 4461 2017-00594 Veteran Affairs Veterans Affairs Department RULES Diseases Associated with Exposure to Contaminants in the Water Supply at Camp Lejeune, 4173-4185 2017-00499 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Non-Degenerative Arthritis (including inflammatory, autoimmune, crystalline and infectious arthritis) and Dysbaric Osteonecrosis Disability Benefits Questionnaire, 4461-4462 2017-00624 Separate Parts In This Issue Part II Energy Department, Federal Energy Regulatory Commission, 4464-4501 2016-30972 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 4504-4591 2017-00283 Part IV Environmental Protection Agency, 4594-4705 2016-31426 Part V Defense Department, 4708-4735 2016-31496 2016-31497 2016-31498 2016-31494 2016-31500 2016-31499 2016-31495 General Services Administration, 4708-4735 2016-31500 2016-31499 2016-31495 2016-31496 2016-31497 2016-31498 2016-31494 National Aeronautics and Space Administration, 4708-4735 2016-31496 2016-31497 2016-31498 2016-31494 2016-31500 2016-31499 2016-31495 Part VI Homeland Security Department, 4738-4768 2017-00447 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 9 Friday, January 13, 2017 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-8557; Airspace Docket No. 16-AGL-17] Amendment of Class E Airspace for the Following Wisconsin Towns; Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI; Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI; and Revocation of Class E Airspace; Wausau, WI AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action modifies Class E airspace extending upward from 700 feet above the surface at Langlade County Airport, Antigo, WI; John F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown Airport, Wausau, WI. Decommissioning of non-directional radio beacon (NDB), cancellation of NDB approaches, and implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at the above airports. This action also removes Class E surface area airspace at Wausau Municipal Airport (Wausau Downtown Airport), Wausau, WI, as a review has determined that the airport no longer meets the requirements for this airspace. Additionally, the geographic coordinates at Langlade County Airport, John F. Kennedy Memorial Airport, Cumberland Municipal Airport, Eagle River Union Airport, and Wausau Downtown Airport (formerly Wausau Municipal Airport) are adjusted to coincide with the FAA's aeronautical database.

DATES:

Effective 0901 UTC, April 27, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Langlade County Airport, Antigo, WI; John F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown Airport, Wausau, WI; and removes Class E surface area airspace at Wausau Downtown Airport (formerly Wausau Municipal Airport), Wausau, WI.

History

On August 11, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM), (81 FR 53093) Docket No. FAA-2016-8557, to modify Class E airspace extending upward from 700 feet above the surface at Langlade County Airport, Antigo, WI; John F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown Airport, Wausau, WI, and to remove Class E surface area airspace at Wausau Municipal Airport (Wausau Downtown Airport), Wausau, WI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

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

Within a 6.5-mile radius (increasing from the previous 6.4-mile radius) of Langlade County Airport, Antigo, WI, removing the extension to the north of the airport, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 7.0-mile radius (increasing from the previous 6.5-mile radius) of John F. Kennedy Memorial Airport, Ashland, WI, with an extension southwest of the airport from the 7.0-mile radius to 8.2 miles, removing extensions to the southwest and southeast of the airport, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 7.1-mile radius (increasing from the previous 6.4-mile radius) of Black River Falls Area Airport, Black River Falls, WI, with an extension southwest of the airport from the 7.1-mile radius to 11.7 miles, with an extension northeast of the airport from the 7.1-mile radius to 11.4 miles;

Within a 6.9-mile radius (increasing from the previous 6.4-mile radius) of Cable Union Airport, Cable Union, WI, and removing the extension to the southwest of the airport;

Within a 6.4-mile radius of Cumberland Municipal Airport, Cumberland, WI, with extensions from the 6.4-mile radius to 10.2 miles west and east; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 6.5-mile radius (reducing from the previous 6.6-mile radius) of Eagle River Union Airport, Eagle River, WI, with an extension southwest of the airport from the 6.5-mile radius to 9.2 miles, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 6.6-mile radius (increasing from the previous 6.5-mile radius) of Sawyer County Airport, Hayward, WI, with an extension northeast of the airport from the 6.6-mile radius to 8.5 miles;

And within a 6.8-mile radius (increasing from the previous 6.5-mile radius) of Wausau Downtown Airport, Wausau, WI, and updating the name and geographic coordinates of the airport to coincide with the FAA's aeronautical database.

The Class E airspace designated as a surface area at Wausau Municipal Airport, Wausau, WI, is removed as the airport no longer meets the requirements for this airspace.

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

Regulatory Notices and Analyses

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

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 6002 Class E Airspace Designated as Surface Areas. AGL WI E2 Wausau, WI [Removed] Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL WI E5 Antigo, WI [Amended] Langlade County Airport, WI (Lat. 45°09′14″ N., long. 89°06′38″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Langlade County Airport.

AGL WI E5 Ashland, WI [Amended] John F. Kennedy Memorial Airport, WI (Lat. 46°32′55″ N., long. 90°55′08″ W.)

That airspace extending upward from 700 feet above the surface within a 7.0-mile radius of John F. Kennedy Memorial Airport, and within 2.9 miles each side of the 201° bearing from the airport extending from the 7.0-mile radius to 8.2 miles southwest of the airport.

AGL WI E5 Black River Falls, WI [Amended] Black River Falls Area Airport, WI (Lat. 44°15′03″ N., long. 90°51′19″ W.)

That airspace extending upward from 700 feet above the surface within a 7.1-mile radius of Black River Falls Area Airport, and within 2 miles each side of the 081° bearing from the airport extending from the 7.1-mile radius to 11.4 miles east of the airport, and within 2 miles each side of the 260° bearing from the airport extending from the 7.1-mile radius to 11.7 miles west of the airport.

AGL WI E5 Cable Union, WI [Amended] Cable Union Airport, WI (Lat. 46°11′42″ N., long. 91°14′54″ W.)

That airspace extending upward from 700 feet above the surface within a 6.9-mile radius of Cable Union Airport.

AGL WI E5 Cumberland, WI [Amended] Cumberland Municipal Airport, WI (Lat. 45°30′22″ N., long. 91°58′51″ W.)

That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Cumberland Municipal Airport, and within 2 miles each side of the 091° bearing from the airport extending from the 6.4-mile radius to 10.2 miles east of the airport, and within 2 miles each side of the 270° bearing from the airport extending from the 6.4-mile radius to 10.2 miles west of the airport.

AGL WI E5 Eagle River, WI [Amended] Eagle River Union Airport, WI (Lat. 45°55′56″ N., long. 89°16′06″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Eagle River Union Airport, and within 2 miles each side of the 225° bearing from the airport extending from the 6.5-mile radius to 9.2 miles southwest of the airport.

AGL WI E5 Hayward, WI [Amended] Sawyer County Airport, WI (Lat. 46°01′31″ N., long. 91°26′39″ W.)

That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Sawyer County Airport, and within 2 miles each side of the 025° bearing from the airport extending from the 6.6-mile radius to 8.5 miles northeast of the airport.

AGL WI E5 Wausau, WI [Amended] Wausau Downtown Airport, WI (Lat. 44°55′35″ N., long. 89°37′37″ W.)

That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Wausau Downtown Airport.

Issued in Fort Worth, Texas, on December 28, 2016. Thomas L. Lattimer, Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-00287 Filed 1-12-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 Cardiovascular Devices CFR Correction In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2016, on page 371, § 870.5800 is reinstated to read as follows:
§ 870.5800 Compressible limb sleeve.

(a) Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

(b) Classification. Class I (performance standards).

[FR Doc. 2017-00796 Filed 1-12-17; 8:45 am] BILLING CODE 1301-00-D
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 35 [Docket No. FR-5816-F-02] RIN 2501-AD77 Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance; Response to Elevated Blood Lead Levels AGENCY:

Office of the Secretary, HUD.

ACTION:

Final rule.

SUMMARY:

This final rule amends HUD's lead-based paint regulations to reduce blood lead levels in children under age six (6) who reside in federally-owned or -assisted pre-1978 housing, formally adopting a revised definition of “elevated blood lead level” (EBLL) in children under the age of six (6), in accordance with Centers for Disease Control and Prevention (CDC) guidance. It also establishes more comprehensive testing and evaluation procedures for the housing where such children reside. This final rule also addresses certain additional elements of the CDC guidance pertaining to assisted housing and makes technical corrections and clarifications. This final rule, which follows HUD's September 1, 2016, proposed rule, takes into consideration public comments submitted in response to the proposed rule.

DATES:

Effective Date: February 13, 2017.

Compliance Date: July 13, 2017.

FOR FURTHER INFORMATION CONTACT:

Warren Friedman, Office of Lead Hazard Control and Healthy Homes, Department of Housing and Urban Development, 451 7th Street SW., Room 8236, Washington, DC 20410; telephone number 202-402-7698 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service, toll-free at 800-877-8339.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Background A. HUD's Long-Term and Ongoing Efforts To Reduce Lead Poisoning in Children B. Authority for HUD's Lead-Based Paint Regulation II. Regulatory Approach A. Overview B. Changes Made at the Final Rule Stage C. Applicability of Civil Rights Laws III. Public Comments Submitted on Proposed Rule and HUD's Responses A. Overview of Public Comments B. Significant Public Comments and HUD's Responses 1. Primary Prevention 2. Resources Available 3. Tenant Protections 4. Coordination Between the Involved Parties 5. Technical Concerns 6. Landlord Exemptions 7. Time Available To Complete Work 8. Penalties for Noncompliance 9. Future Changes in CDC Recommendations 10. Timing of Implementation 11. Other Issues C. Public Comments in Response to HUD's Questions III. Findings and Certifications A. Regulatory Review—Executive Orders 12866 and 13563 B. Regulatory Impact Assessment C. Paperwork Reduction Act Statement D. Regulatory Flexibility Act E. Environmental Impact F. Executive Order 13132, Federalism G. Unfunded Mandates Reform Act I. Background A. HUD's Long-Term and Ongoing Efforts To Reduce Lead Poisoning in Children

Childhood lead poisoning has long been documented as causing reduced intelligence, low attention span, and reading and learning disabilities; it has additionally been linked to juvenile delinquency, behavioral problems, and many other adverse health effects.1 Despite public health efforts successfully reducing toxic lead exposure in children nationwide, blood lead monitoring continues to reveal children with elevated blood lead levels due to exposure in their specific housing environments. The Centers for Disease Control and Prevention (CDC) has consistently affirmed its position that lead-based paint and lead-contaminated dust are the most hazardous sources of lead for U.S. children.2 Over the past decade, HUD has dramatically reduced housing-based lead exposure among children through lead paint abatement and interim controls.3 Nevertheless, a considerable number of children under age six (6) currently reside in HUD-assisted housing units that contain lead-based paint.

1See HUD's proposed rule and the accompanying regulatory impact assessment, available at www.regulations.gov/document?D=HUD-2016-0096.

2See CDC, Lead: Prevention Tips, http://www.cdc.gov/nceh/lead/tips.htm.

3See, e.g. , HUD's lead hazard control grant programs and the lead hazard control work required of landlords under settlements HUD has reached in enforcing the Lead Disclosure Statute and related regulations at 42 U.S.C. 4852d and 24 CFR part 35, subpart A.

To address this issue, HUD issued a proposed rule on September 1, 2016, at 81 FR 60304, to revise HUD's Lead Safe Housing Rule (LSHR) by adopting the CDC's guidance on when an environmental intervention should be conducted in response to a child's blood lead level, thereby establishing HUD's definition of elevated blood lead level (EBLL) as the level for which environmental intervention is required in certain federally-owned and federally-assisted housing, among other changes. This final rule considers public comments submitted on the September 1, 2016, proposed rule and defines “elevated blood lead level” (EBLL) as the level at which the CDC recommends environmental intervention.

B. Authority for HUD's Lead-Based Paint Regulation

HUD's LSHR is codified in Title 24 of the Code of Federal Regulations (CFR) part 35, subparts B through R. The LSHR implements sections 1012 and 1013 of the Residential Lead-Based Paint Hazard Reduction Act of 1992, which is Title X of the Housing and Community Development Act of 1992 (Pub. L. 102-550, approved October 28, 1992); sections 1012 and 1013 are codified at 42 U.S.C. 4822.

Under Title X, HUD has specific authority to control lead-based paint and lead-based paint hazards in HUD-assisted housing that may have lead-based paint, called “target housing.” 4 The LSHR aims in part to ensure that federally-owned or federally-assisted target housing is free of lead-based paint hazards. Lead-based paint hazards are lead-based paint and all residential lead-containing dusts and soils, regardless of the source of the lead, which, due to their condition and location, would result in adverse human health effects.

4 HUD's regulation at 24 CFR 35.110, based on the Title X definition at 42 U.S.C. 4851b(27), defines “target housing” as any housing constructed prior to 1978, but not including housing for the elderly or persons with disabilities where no child less than 6 years of age resides or is expected to reside, or any zero-bedroom dwelling.

HUD recognizes that there is no safe level of lead exposure. Consistent with Title X and the LSHR, HUD's primary focus is on minimizing childhood lead exposures, rather than on waiting until children have elevated blood lead levels to undertake actions to eliminate lead-based paint hazards. HUD's Office of Lead Hazard Control and Healthy Homes (OLHCHH) has spearheaded major efforts to that end by taking actions feasible and authorized by law to reduce lead exposure in children.5

5 These actions include administering a successful Lead Hazard Control program of grants, enforcement, research, and outreach, and providing conditions of funding through the office's notices of funding availability, updating guidelines and best practices, and working collaboratively with other Federal agencies such as the U.S. Department of Health and Human Services (HHS), particularly its CDC, and the U.S. Environmental Protection Agency (EPA). See Advancing Healthy Housing, a Strategy for Action, http://portal.hud.gov/hudportal/documents/huddoc?id=stratplan_final_11_13.pdf.

II. Regulatory Approach A. Overview

This final rule revises HUD's criteria under the LSHR for responding to the identification of children under age six (6) with high blood lead levels residing in covered federally-assisted and federally-owned target housing. The final rule also addresses lead hazard evaluation and control for additional assisted housing units in the same properties as those in which children under age six (6) with high blood lead levels have been discovered. The final rule adopts an approach based on the previously codified LSHR, the CDC's reference range value for blood lead levels in children under age six (6),6 the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (HUD Guidelines), HUD's experience implementing the LSHR since its 1999 promulgation, and public comments received on the September 1, 2016, proposed rule.

6 CDC's “reference range value” method for defining EBLLs is based on the blood lead level equaled or exceeded by 2.5 percent of U.S. children aged 1-5 years as determined by CDC's most recent National Health and Nutritional Examination Survey. Currently, CDC's reference range value is 5 μg/dL (5 micrograms of lead per deciliter of blood).

Specifically, under this final rule, when a child under age six (6) with an EBLL is identified, the “designated party” and/or the housing owner shall undertake certain actions.7 This protocol is the same for each of the four applicable HUD subparts (H, I, L, M), and slightly narrower for the subpart covering other agencies (D), under which those agencies must decide how to treat housing units in multi-unit properties other than the unit in which the child with an EBLL resides. Figure 1 provides an overview of the protocol for addressing EBLL cases in housing covered by the LSHR.

7 The designated party is the owner or other entity (e.g., federal agency, state, local government, public housing agency, tribally designated housing entity, sponsor, etc.) designated under the LSHR as responsible for complying with applicable requirements of the LSHR for the residential property or dwelling unit, as applicable. See 24 CFR 35.110.

ER13JA17.000 B. Changes Made at the Final Rule Stage

8 “Index Unit” refers to the housing unit in which the child who has an EBLL resides, with the terminology adapted from the traditional epidemiology term, “index case, the case that is first reported to public health authorities.” CDC, Guidelines for the Control of Pertussis Outbreaks. Centers for Disease Control and Prevention: Atlanta, GA, 2000. Chapter 11, Definitions. www.cdc.gov/pertussis/outbreaks/guide/downloads/chapter-11.pdf.

This final rule follows publication of, and takes into consideration, public comments received on the September 1, 2016, proposed rule. Based on that review, HUD makes the following changes to the proposed rule at the final rule stage. For some of those changes, the wording changes in multiple instances.

1. In §§ 35.325(b)(2)(i), 35.730(f)(4)(i), 35.830(f)(3)(i), 35.1130(f)(4)(i), and 35.1225(f)(3)(i), HUD changes the requirements for other assisted dwelling units covered by §§ 35.325(b)(1), 35.730(f)(1), 35.830(f)(1), 35.1130(f)(1), and 35.1225(f)(1), respectively, by clarifying that they do not apply if the owner both conducted a risk assessment of those units and the common areas servicing them and conducted interim controls of identified lead-based paint hazards after the date the child's blood was last sampled.

2. In § 35.730(f)(1), regarding assisted units, other than the index unit, with a child or children under age six (6), in a project-based assisted property with a child or children under age six (6) with an EBLL in a household for which the project-based rental assistance is up to $5,000 per year, and in § 35.1225(f), regarding units, other than the index unit, with a child or children under age six (6), occupied by households receiving tenant-based rental assistance, in a property with a child or children under age six (6) with an EBLL in a household receiving tenant-based rental assistance, HUD revises the proposed rule to require the designated party, i.e., the owner or, as discussed in section III.B.10.h of this preamble, the public housing agency, HOME grantee or subrecipient, or HOPWA grantee or sponsor, as applicable, to conduct a risk assessment,9 in accordance with methods and standards established either by a state or tribal program authorized by the EPA, or by the EPA at 40 CFR 745.227(d) with procedures defined by the EPA—rather than a visual assessment—of the other units for which the household receives tenant-based rental assistance in the property, and interim controls of the lead-based paint hazards identified by the risk assessment, using the proposed rule's schedule for completion of lead-based paint hazard reduction activities.

9 Throughout this Final Rule, “risk assessment” has the meaning of the term as used in the LSHR (at 24 CFR 35.110, Definitions), which is derived from the Title X definition (42 U.S.C. 4851b(25) (for HUD rules) and 15 U.S.C. 2681(16) (for EPA rules); it does not have the meaning of the same term under Superfund (the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA)), or other statutes, regulations or policies. See, e.g., https://www.epa.gov/risk/risk-assessment-guidelines.

3. In § 35.730(f)(2), HUD replaces the provision regarding paint stabilization following a visual assessment with a provision regarding interim controls following a risk assessment.

4. HUD is not including in this final rule proposed §§ 35.730(g), 35.1130(g) and 35.1225(g), which contained language encouraging owners to evaluate and control for sources of lead exposure other than those covered by this subpart.

5. In § 35.1225(f)(1), HUD changes the reference to a “visual assessment” to “risk assessment” and changes the cross-reference to the section that describes procedures for such an assessment.

6. In § 35.1225(f)(2), HUD clarifies that the discussion concerns “lead-based paint hazards” rather than “deteriorated paint” to emphasize reduction of lead-based paint hazards rather than paint stabilization.

7. In § 35.1225(f)(3), HUD removes reference to visual assessment and amends and adds language to clarify that the discussion is of “interim controls” of “lead-based paint” rather than “deteriorated paint” and to emphasize reduction of lead-based paint hazards rather than paint stabilization.

Additionally, HUD takes this opportunity to make the following technical corrections and conforming changes.

1. In § 35.105, HUD removes past effective dates and reserves the section.

2. In § 35.110, HUD makes a technical correction to indicate the correct section number for the Definitions section, and revises the definition of “Certified”.

3. In § 35.155(a), on minimum requirements for lead-based paint hazard evaluation or reduction, HUD makes a technical correction by changing both instances of “designated party or occupant” to “designated party or owner,” in order to identify correctly who may be required to conduct additional lead-based paint hazard evaluation or reduction, beyond the minimum under the LSHR.

4. In §§ 35.325(b)(1), 35.830(f)(3)(i), 35.1225(f)(1), and 35.1225(f)(3)(i), HUD makes a technical correction to grammar by replacing the verb “serving” with the verb “servicing” in the first sentence.

5. In § 35.325(b)(1), HUD replaces the auxiliary verb “would” with the auxiliary verb “shall,” in the second sentence.

6. In § 35.325(b)(1), HUD adds language to clarify that the hazards referenced in the third sentence are those identified in accordance with § 35.1325 or § 35.1330. In § 35.325(d), HUD clarifies that the timetable referenced therein shall include provision of documentation on the lead hazard evaluation and control activities to the agency.

7. In §§ 35.730(a), 35.830(a), 35.1130(a), and 35.1225(a), the rule discusses the requirements that apply if a public health department has already conducted an evaluation of the dwelling unit. HUD revises the proposed rule to state explicitly that in order to exempt the designated party from conducting an environmental investigation, the public health department's evaluation must have been conducted in response to the current case.

8. In §§ 35.730(f)(2), 35.830(f)(2), 35.1130(f)(2), and 35.1225(f)(2), HUD clarifies when lead-based paint hazard reduction is considered complete.

9. In § 35.730(f)(4), HUD clarifies when the requirements of paragraph (f) do not apply.

10. In § 35.830(h), HUD clarifies that “clearance” is among the deadline-driven activities covered by this section.

11. In § 35.1330(a)(4)(iii) on training requirements for interim control workers and supervisors, which are applicable to some of the work conducted under this rule, HUD makes a technical correction by replacing all references to the defunct HUD course approval process, with references to the current EPA and EPA-authorized state renovator course accreditation process.

C. Applicability of Civil Rights Laws

HUD notes that housing-based lead exposure has a disproportionate impact on children of some racial and ethnic groups and those living in older housing.10 Lead hazard evaluation and control activities in federally-assisted and federally-owned target housing are subject to the requirements of the applicable civil rights laws, including the Fair Housing Act, as amended (and its prohibition of discrimination on several bases, including, but not limited to, race, disability, and familial status, including the presence of a child under age of 18, or of a pregnant woman), Title VI of the Civil Rights Act of 1964 (prohibiting discrimination on the basis of race, color, and national origin), Title IX of the Education Amendments of 1972 (prohibiting discrimination on the basis of sex), and section 504 of the Rehabilitation Act of 1973 (prohibiting discrimination on the basis of disability). Under this final rule, these and other applicable Federal laws, and their associated HUD regulations and guidance, which were incorporated into the current LSHR, continue to apply to these activities without change.

10See CDC, Lead: Prevention Tips, http://www.cdc.gov/nceh/lead/tips.htm; CDC, Recommendations for Blood Lead Screening of Medicaid-Eligible Children Aged 1-5 Years: an Updated Approach to Targeting a Group at High Risk (Aug. 2009), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5809a1.htm.

III. Public Comments Submitted on Proposed Rule and HUD's Responses A. Overview of Public Comments

The public comment period for the September 1, 2016, proposed rule closed on October 31, 2016. As of the close of the comment period, HUD received 62 public comments, including one mass mailing. Comments and HUD's responses are summarized below. All comments can be accessed at http://www.regulations.gov.

The overwhelming majority of comments were supportive of the rule. Some commenters, while supporting the rule, suggested ways that it could be improved. In the comments received, the Department identified 378 distinct recommendations. The Department thanks the commenters for their thoughtful insights, and their efforts to improve the current LSHR. The commenters' recommendations fell into 11 broad categories, discussed below. Many comments addressed the four specific questions for comments HUD requested. Most commenters (53) also had concerns about one or more technical issues in applying and administering the LSHR.

Although they presented a range of foci and approaches, commenters were nearly unanimous in expressing their support for increasing the protection of America's children from lead hazards, and the importance of aligning HUD's regulations with the current science from the CDC. These sentiments are best summed up by a comment submitted on behalf of the 13,765 individuals who signed a letter circulated by the commenter that stated that they, “fully support [HUD's] proposal to update the Lead Safe Housing Rule by lowering the threshold of lead exposure to align with the Centers for Disease Control and Prevention's recommendations and allow for HUD to move more quickly to protect children's health. Given the risks, anything your agency can do to reduce lead exposure is appreciated.”

B. Significant Public Comments and HUD's Responses 1. Primary Prevention

Comment: Almost half of the commenters (32) identified the importance of primary prevention. Many recommended conducting a risk assessment in a unit before a family with a child occupied the unit. Other commenters noted that recent CDC-HUD research shows children in HUD-assisted housing already have lower blood lead levels than children in comparable low-income housing.11 However, as the article notes, while the result provides a favorable assessment of the benefits of HUD's assistance requirements and assistance monitoring programs, the size of the study's filtered sample was not sufficiently large to identify patterns within particular types of housing assistance.

11See Ahrens KA, Haley BA, Rossen LM, Lloyd PC, Aoki Y, Housing Assistance and Blood Lead Levels: Children in the United States, 2005-2012, American Journal of Public Health: November 2016, Vol. 106, No. 11: 2049-2056, abstract available at https://www.regulations.gov/document?D=HUD-2016-0096-0027 (as part of comment docket for this final rule); full text available with subscription at http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2016.303432.

HUD Response: HUD has adopted the position of CDC and other federal agencies that no amount of lead in a child's blood can be considered safe,12 and that primary prevention is critical to protecting America's children. However, it must be noted that the primary purposes of this rulemaking are adopting the revised definition of “elevated blood lead level” (EBLL) in children under the age of six (6), and strengthening designated parties' or owners' responses in cases where children with high blood lead levels reside in federally-assisted and federally-owned target housing. Therefore, the currently codified LSHR's primary prevention requirements associated with pre-occupancy activities and ongoing lead-based maintenance programs not associated with EBLL cases in federally-assisted and federally-owned target housing are outside the scope of this rulemaking. The Department will consider addressing pre-occupancy activities and ongoing lead-based maintenance programs in future rulemaking.

12See President's Task Force on Environmental Health Risks and Safety Risks to Children, Key Federal Programs to Reduce Childhood Lead Exposures and Eliminate Associated Health Impacts, 2 (Nov. 30, 2016), https://ptfceh.niehs.nih.gov/.

2. Resources Available

Comment: Almost half of the commenters (30) expressed a need for appropriate resources for grantees to implement this rule correctly. Resources mentioned included additional funding for environmental investigation and appropriate training and technical assistance. Some commenters stated that, without these additional resources, the rule could not be properly implemented, and encouraged HUD to wait until such resources were available before implementing the rule.

HUD Response: HUD is sensitive to the cost of implementation, especially in an era of tightened budgets among grantees, state, local, and tribal governments, and other federal assistance recipients-and in the face of competing priorities, including those related to health of vulnerable populations, such as young children. However, a delay in implementation to wait for potential additionally appropriated resources could result in avoidable long-term harm to children in federally-assisted and federally-owned target housing. Furthermore, as calculated in the Regulatory Impact Assessment accompanying this rule, the benefits of the rule outweigh the costs. One commenter said, regarding, “the Regulatory Impact Assessment [that they] believe that it is a reasonable estimate. If anything, we believe (as discussed in the RIA) that the benefits of the proposed regulation are underestimated, because some benefits cannot be quantified or monetized, such as avoided stress on parents and children. We also believe that some costs are likely to be lower than those estimated by HUD,” because, for example, HUD assumes the presence of only one child with EBLL in each unit, when some units may have more.

HUD will work with grantees and owners to identify ways in which this rule can be implemented with as little burden as feasible, and how existing resources can be directed to implementation, particularly in rural and underserved areas. HUD will also provide training opportunities to assist in implementing the rule.

Comment: Two commenters requested that public housing agencies be allowed to compete for lead hazard control grants from HUD's Office of Healthy Homes and Lead Hazard Control.

HUD Response: Eligibility for that grant program is outside the scope of this rulemaking However, HUD wishes to advise that public housing agencies, per Title X, are eligible for those grants only if they are an agency of a unit of state or local government. Similarly, housing units are eligible for enrollment under a grant (and, thus for lead-based paint inspection and risk assessment, and, if lead-based paint hazards are found, lead hazard control) only if they are target housing and meet certain other qualifications, e.g., the housing does not receive any federal housing assistance, or the family is receiving tenant-based rental assistance, such as a housing choice voucher. The housing is ineligible for enrollment in a lead hazard control grant if it is “federally assisted housing, federally owned housing, or public housing.” 13 The first of these includes housing receiving project-based rental assistance, the second, housing for which the mortgagee has defaulted on a federally-insured mortgage, and the third, housing owned by a public housing agency.

13 42 U.S.C. 4852(a), regarding housing unit eligibility, and (b), regarding grant applicant eligibility.

HUD has been reaching out to public housing agencies to encourage owners of housing units in which the families receive a Housing Choice Voucher to enroll those units in the lead hazard control grant (funded by the OLHCHH), whose target area includes the location of the units. Because most families eligible for this type of voucher have incomes which make them eligible for enrolling in a lead hazard control grant, HUD has expedited the process for the grantees to enroll them. HUD will continue to promote lead hazard control grantee-public housing agency partnerships.

3. Tenant Protections a. Anti-Retaliation Protections

Comment: Many commenters (36) remarked on the need for protections for tenants. Generally, these commenters were worried about possible “retaliation” or “reprisal” against tenants and “blame shifting.” Retaliation or reprisal meant, as described by one commenter, the “loss of benefits, lease violations, termination of assistance, or reporting to a child-welfare agency.” Several of these commenters suggested specifying in the rule that this type of retaliation would be prohibited. They also suggested that HUD revise the rule to include an anti-retaliation clause that would prohibit penalties if a child with an EBLL is identified who is not included on the occupant list of the rental or assistance agreement or contract. In addition, commenters proposed several family interview methods to provide further protection to households.

HUD Response: HUD already has regulations and policies in place that protect families against retaliation by landlords and has determined that these policies should be sufficient to protect tenants from discrimination and retaliation. Under existing fair housing regulations, interviewers will be required to abide by policies about limited English proficiency, which require HUD, its grantees, and sub-grantees to make reasonable efforts to provide language assistance to ensure meaningful access for persons with limited English proficiency to the recipient's programs and activities.

However, HUD cannot establish a policy that would negate regulations requiring that every individual living in the household be listed on the lease. These regulations are in place to prevent overcrowding, which is associated with its own negative effects on children's well-being, including their health.14 They are also in place to ensure proper subsidy calculations and enforce lease provisions. Ensuring these regulations and policies are appropriately integrated with the implementation of the LSHR amendments will be addressed through program management. Thus, in this rulemaking, HUD declines to adopt a provision specifically prohibiting penalties if a child with an EBLL is identified who is not included on the occupant list of the rental or assistance agreement or contract.

14See Solari CD, Mare RD, Housing Crowding Effects on Children's Wellbeing, Social Science Research (Mar. 2012), 41(2): 464-476, available at www.sciencedirect.com/science/article/pii/S0049089X11001694.

b. Relocation Protections

Comment: Many commenters (18) offered recommendations about tenant relocation, either permanently or while work was being done in their unit.

HUD Response: HUD understands that relocation may be necessary in some circumstances but it can also be very expensive for the designated party or owner. Existing HUD regulations, policies and guidance on when relocation is appropriate, including those in the currently codified LSHR, have already considered these issues, and HUD was not presented with any evidence that requires reopening those discussions. Thus, in this rulemaking, HUD declines to adopt a provision specifically pertaining to tenant relocation.

4. Coordination Between the Involved Parties a. Coordination Between HUD and Grantees

Comment: Many commenters (36) addressed the proposed rule's reporting requirements for property owners—specifically their requirements for reporting EBLL discovery and responsive activities to their HUD field office and the OLHCHH—from a variety of viewpoints. Some expressed concerns that reporting would impose difficult burdens on public housing agencies and assisted private owners. Many of these commenters provided helpful suggestions on methods to reduce that burden. Some asked for increases in reporting. Others provided helpful suggestions on mandates, penalties for noncompliance, and the importance of public data profiles. One commenter asked HUD to clarify why public housing authorities must contact both the field office and OLHCHH, instead of having the field office contact OLHCHH.

HUD Response: HUD is mindful of the need to minimize burdens on owners and public housing authorities, the necessity of having appropriate information received timely in order to ensure efficient and effective program administration and monitoring, and the public's interest in open and transparent government information and operation. HUD is also mindful that public health authorities, HUD Field Offices, and the OLHCHH each have distinct roles in addressing an EBLL case, and that time is often of the essence in fulfilling those roles.

The concurrent notification is necessary to ensure that the OLHCHH is aware of the EBLL case timely and knows, upon receiving the notification, the same information that has been provided to the Field Office without having to conduct a verification, which would delay its ability to respond effectively to requests for assistance from the Field Office and monitor the case. HUD also notes that the concurrent notification was proposed for all LSHR subparts in the proposed rule, a scope retained in this final rule, so that public housing authorities are not being subjected to a different requirement than are owners who have this case notification responsibility under certain LSHR subparts.

Considering the necessary balancing of interests, potential future changes in federal and local laws, and the rapid pace of technological advances in sharing and reporting on data, HUD does not believe it is appropriate to be prescriptive in codifying a particular notification process in regulation. Instead, HUD retains the requirement as drafted in the proposed rule. Specific processes for reporting EBLLs and actions taken will be developed, including an electronic submission pathway. In developing pathways for reporting, HUD will continue to carefully balance these interests.

b. Coordination With Parents, Guardians, and Other Non-Medical Professional Sources

Comment: Several commenters (5) recommended that designated parties and owners accept notification of EBLLs from parents, guardians, and other non-professional sources when notification is accompanied by sufficient documentation such as a doctor's letter.

HUD Response: A letter or report from a medical health care provider, such as a physician or nurse, or the public health department, has always been acceptable notification under the LSHR (because HUD has never required or expected that the provider would come to the office of the designated party personally to deliver the notification). This will continue to be the case under this final rule. Similarly, in the absence of a medically reliable notification that a child under age six (6) has an EBLL, it would be imprudent for HUD to require the designated party and/or the owner to undertake an environmental intervention. When presented with notification of an EBLL from a non-medical-professional source, the designated party is required to contact the local health department or another medical health care provider to verify the notification. This rule details the procedure (including contacting HUD) to be used when a public health department or provider declines to verify a report from a non-medical professional source.

c. Coordination With HIPAA and Local Data Privacy Laws

Comment: Several commenters (8) requested clarification of the protocols for reporting, including the interaction with other federal laws such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), and state and local privacy laws.

HUD Response: For the purpose of preventing or controlling childhood lead poisoning, in regard to lead hazard evaluation and control activities, the OLHCHH and its lead hazard control grantees acting on its behalf, are considered public health authorities under HIPAA; thus, they may receive related private health information that is minimally necessary to accomplish the intended purpose of the disclosure, including the addresses of housing units and vital information about the children and their families, and must protect that information.

5. Technical Concerns a. Environmental Investigations of Lead Hazards That Are Not Lead-Based Paint Hazards

Comment: Many comments (18) expressed concerns about whether federally-assisted housing providers should look for sources of lead exposure that are not lead-based paint hazards, or would be responsible for such sources of lead exposure if they were identified in the environmental investigation. Some commenters raised concerns about the responsibility for controlling lead exposure if the source of lead was a non-lead-based paint hazard or at another property outside of the control of the designated party or owner, as applicable. Additionally, some commenters requested that HUD add safeguards to ensure that owners are not penalized for missing other sources of exposure if a public health department decides not to, or is unable to work with a designated party or owner on the child's case.

HUD Response: This final rule requires that the owner or designated party, as applicable, ensure that an environmental investigation of the child's lead exposure is completed, which includes investigating sources that are or are not lead-based paint hazards. Environmental investigations must be performed by EPA, state, or tribally certified risk assessors, and the contents of their report must meet EPA, state or tribal requirements, as applicable. The rule also provides that, if a public health department has already conducted an evaluation of the dwelling unit in response to the case, the owner or designated party does not need to conduct another one. HUD has clarified applicable sections of the proposed rule 15 to provide that the evaluation be in response to the current case. This clarification eliminates the potential confusion that a previous case in the same housing unit, whether for an EBLL or other reason, that had prompted a public health department evaluation, however long before the current EBLL case, might allow an environmental investigation or public health department evaluation not to be conducted for the current case. HUD is not aware of this having occurred, but the technical clarification provides transparency on this issue.

15 24 CFR 35.730(a), 35.830(a), 35.1130(a), and 35.1225(a) have been revised to read: “If a public health department has already conducted an evaluation of the dwelling unit in regard to the child's elevated blood lead level case, the requirements of this paragraph shall not apply” (emphasis added).

Because children can be exposed to lead by toys, dishes, homeopathic remedies, certain cultural practices, and other non-paint-related sources, the family interview portion of the environmental investigation will include questions on these sources. The designated party or owner is responsible for ensuring that an environmental investigation in accordance with federal, state, and local requirements is conducted timely, regardless of whether it is done by staff or through contract, or that the public health department has conducted an evaluation in response to the case.

In some areas of the country, the public health department will perform the environmental investigation or a comparable evaluation, as may be required by a public health department initiative or state, tribal, or local law, the latter of which may also specify how the environmental investigation is performed and what follow-up actions must be taken by the designated party. In these cases, the most stringent of the federal, State, tribal, or local requirements must be followed.

Regardless of who performs the environmental investigation, HUD is not establishing a requirement that the designated party or owner address sources of exposure that are not lead-based paint hazards, or sources from housing not controlled by the designated party or owner, such as a relative's home, because HUD does not have authority to require that those sources be addressed. As discussed elsewhere in this preamble, risk assessments of certain other housing units in the property may be conducted; as with the environmental investigation of the index unit,16 these risk assessments may identify non-paint-related sources of lead exposure. Indeed, the HUD Guidelines encourage risk assessors to note other obvious sources of lead exposure, and many risk assessors routinely test items other than paint for lead. The Guidelines also explicitly include such testing as a part of environmental investigations. Nevertheless, HUD does not believe that such activities would subject property owners to expanded legal vulnerability under this rule. In both the index unit and other units, the designated party or owner is not responsible for controlling these sources. In the 22 years since the Guidelines were first published, this has not created a legal liability problem for risk assessors or building owners and managers.

16 Here, this refers to the housing unit in which the child who has an EBLL resides, with the terminology adapted from the traditional epidemiology term, “index case, the case that is first reported to public health authorities.” CDC, Guidelines for the Control of Pertussis Outbreaks. Centers for Disease Control and Prevention: Atlanta, GA, 2000. Chapter 11, Definitions. www.cdc.gov/pertussis/outbreaks/guide/downloads/chapter-11.pdf.

HUD, such as through its OLHCHH, will continue to encourage designated parties and owners to address such lead hazards as part of its broader effort to ensure the safety and health of residents of its assisted housing, but, for regulatory clarity, not do so through this rulemaking.

Additionally, the EPA regulations at 40 CFR 745.235, 745.237, and 745.327 (or the equivalent regulations of an EPA authorized state or tribal lead-based paint program as applicable) prescribe the training and certification requirements for risk assessors as well as the work practice standards for conduct of a risk assessment and the reporting of the assessment results. This rule does not hold the designated party or owner responsible for a certified risk assessor performing the environmental investigation missing a source of exposure (except, of course, in the case of collusion).

b. Lead in Water

Comment: Several comments (7) specifically addressed the issue of lead-contaminated water, the desirability of testing and controlling lead levels in water, and the responsibilities of owners if high lead levels are found in the water supply.

HUD Response: Controlling exposures to lead from water is outside of HUD's authority for this rulemaking, because Title X, which the LSHR implements, does not authorize HUD to regulate lead in water. The HUD Guidelines' chapter 16 on environmental investigations, discussed in the preamble to the proposed rule, indicates when water testing as part of the investigation is appropriate and provides guidance on how to conduct such testing. Further information on lead in water testing is available from EPA.17 Requiring control of drinking water lead levels is outside the scope of this rule. Thus, HUD declines to specifically address the issue of lead-contaminated water in this rulemaking.

17See, e.g., EPA, Protect Your Family from Exposures to Lead (Drinking Water), www.epa.gov/lead/protect-your-family-exposures-lead#testdw; EPA, Basic Information about Lead in Drinking Water, https://www.epa.gov/ground-water-and-drinking-water/basic-information-about-lead-drinking-water.

c. Visual Assessment of Housing Units in the Tenant-Based Rental Assistance Program

Comment: Many commenters (28) claimed that the visual assessment protocol in the Housing Choice Voucher (HCV) Program, which provides tenant-based rental assistance, was insufficient to protect children from lead, and that a more rigorous assessment protocol was needed when children under age six (6) will be moving into a unit of target housing with the family receiving assistance through an HCV. Several commenters also recommended that evaluations should be conducted on every unit in a building, regardless of subsidy.

HUD Response: As noted in this preamble, the primary purpose of this rule is adopting the revised definition of “elevated blood lead level” in children under the age of six (6), and the response in cases of children with such a level who reside in federally-assisted target housing. Therefore, pre-occupancy activities are outside the scope of this rule, as are activities in non-federally-assisted units.

Comment: Many commenters (20) addressed the need for assessment of other assisted units in the same property as that of a child under age six (6) with an EBLL in which a child under age six (6) resides or is expected to reside (“other units”), which is within the scope of this rule, as part of the response to the child with an EBLL. Most commenters (18) recommended that HUD strengthen the assessment in the units of other households receiving tenant-based rental assistance to a risk assessment, or, in the alternative, a lead hazard screen.18 Commenters noted both that the CDC strongly recommends a more stringent risk assessment, and that lead hazards do not discriminate among victims by the type of subsidy they receive.

18 The EPA's work practice standards for conducting lead hazard screens and lead risk assessments are provided at 40 CFR 745.227(c) and (d), respectively; both may be conducted only by a person certified by EPA or an EPA-authorized state or tribal lead-based activities program as a risk assessor.

HUD Response: Under this final rule, risk assessments will be required in other HUD-assisted units in which a child under age six (6) resides or is expected to reside, and the common areas servicing those units. HUD has always distinguished between pre-occupancy and post-occupancy activities in assisted housing. Prior to this final rule, the LSHR distinguished between general, pre-occupancy activities in tenant-based rental assistance housing units and specific responses to the identification of a child under age six (6) with an environmental intervention blood lead level (EIBLL) 19 who had a housing-related lead exposure. It did so by going beyond the visual assessment and paint stabilization requirement of pre-occupancy activities to requiring risk assessments and interim controls for EIBLL cases.20 These measures are being extended by this final rule to the other housing choice voucher units in properties where children under age six (6) reside or are expected to reside.

19 A confirmed concentration of lead in whole blood equal to or greater than 20 μg/dL (micrograms of lead per deciliter) for a single test or 15-19 μg/dL in two tests taken at least 3 months apart, per 24 CFR 35.110.

20See 24 CFR 35.730(a).

HUD is basing this approach on the CDC guidance that other housing units should receive the same evaluation and controls as the index unit, while narrowing the application of that guidance by not requiring action where statutory authority clearly does not support HUD require action (e.g., in unassisted units), and reducing the overall costs and increasing the effectiveness of the controls by requiring a risk assessment to identify with specificity the lead-based paint hazards in the other units before the controls are undertaken.

The increased burden on a landlord of a family receiving tenant-based rental assistance is expected to be modest, because a certified risk assessor will already be at the property to conduct the environmental investigation in the index unit, and the cost of the risk assessment will be borne by the designated party, i.e., the public housing agency, or the HOME or HOPWA grantee, as applicable. Giving that risk assessor an expanded scope of work to conduct a risk assessment in other units will be an additional cost to the designated party, as will the cost to the owner for control of any lead-based paint hazards that would not have been detected by visual assessments conducted as part of the initial and periodic inspections of the units, but were detected by the risk assessment. These other units of an owner who has been properly implementing the required ongoing lead-based paint maintenance program are more likely not to have hazards and, if they are present, for them to be fewer in number and less extensive. This risk assessment, and the interim control of any lead-based paint hazards found will provide substantial additional protection to the other children under age six (6) residing or expected to reside in the property, and increased liability protection for the owner as a result of the more comprehensive evaluation of the housing and resulting lead hazard control, in comparison to the otherwise routine use of the visual assessment and paint stabilization process.

Similarly to how HUD considered commenters' arguments related to other tenant-based rental assisted units and is responding by requiring risk assessments and interim controls for such units in this final rule—instead of visual assessment and paint stabilization, as proposed—HUD is applying the commenters' logic to housing receiving project-based assistance of up to $5,000 per unit per year by requiring risk assessments and interim controls in this final rule, instead of visual assessment and paint stabilization, as proposed.

The Regulatory Impact Assessment has been revised accordingly and continues to show that the benefits of this regulation substantially outweigh the costs.

d. Sampling of Other Units in Large Properties

Comment: Two commenters inquired if the sampling protocols for larger properties (with over 20 housing units in properties built before 1960, or over 10 units in properties build between 1960-1977) in the existing HUD Guidelines' Chapter 7 would apply to buildings where a child under age six (6) has developed an EBLL, and the child's unit was found to have lead-based paint hazards, so that examinations of other housing units in the property were required.

HUD Response: As noted in the preamble to the proposed rule, the existing housing unit random sampling protocols for multi-family housing would apply, because, procedurally, they are not being amended by this rule, and substantively, because the statistical foundation for the protocols applies to the EBLL situation just as it does to lead-based paint inspections and risk assessments in general.

e. Interim Controls

Comment: Four commenters recommended that, for at least the types of housing affected under this rule, if not all housing under the LSHR, HUD require abatement, as opposed to mere interim controls, in a unit in which lead-based paint hazards (or, for a visual assessment, deteriorated painted surfaces) were found.

HUD Response: HUD is aware from its experience with its lead hazard control grant program that there can be a substantial cost difference between interim controls of lead-based paint hazards and abatement of them. As noted in the RIA for the proposed rule, the interim controls used under HUD's lead hazard control grant programs were found to be effective for at least 6 years following the intervention, with window replacement and lead hazard control effective after 12 years. Thus, even if an owner did not implement an ongoing lead-based paint management program after the interim control work (such a program is not required under the grants), the duration of the protection of the children's environment regarding lead in the housing would extend beyond the child's sixth birthday. If the owner did implement the management program, as the LSHR requires, the duration of the protection would be at least as long as the period found for protection resulting from work under the grants, and, HUD believes, longer.

HUD also notes that, as described above, the evaluation activity in the other assisted units with a child under age six (6) is being changed from a visual assessment, as proposed, to a risk assessment.

Therefore, HUD declines to modify the proposed rule. However, the designated party or owner may choose to require abatement in circumstances when they do not believe interim controls will sufficiently protect their resident children under age six (6).

f. Update the Standards for Lead Based Paint, Lead Based Paint Hazards and Various Lead Hazard Control Protocols

Comment: Eight commenters requested that HUD, either alone or in partnership with EPA, update various other lead regulations, standards and protocols.

HUD Response: Such changes are beyond the scope of this rulemaking. HUD will collaborate with EPA, as it considers any updates to revise those standards. In the interim, HUD will continue to use existing protocols, including paint-testing requirements,21 and lead-safe work practices requirements that were of specific interest to some commenters.

21E.g., by requiring the paint testing before interim controls involving RRP work in assisted target housing covered by the LSHR be conducted by a certified lead-based paint inspector or risk assessor (24 CFR 35.110), versus a renovation contractor's using a spot-test kit (40 CFR 745.82(a)(2)).

HUD declines a commenter's request to further define the responsibilities of particular owners of a building with multiple owners as related to notices of lead-based paint hazard evaluation and reduction, because its interest is in having the designated party provide notices to occupants as required, not in establishing criteria for which of the ownership partners within the designated party, which is as a whole, responsible for complying with applicable requirements (see § 35.110), should carry out that responsibility. That is an internal matter for the partners to decide.

g. Pregnant Women Under the LSHR

Comment: Two commenters requested that HUD extend the protections of the LSHR in child-occupied units to units where a pregnant woman resides.

HUD Response: The LSHR has always defined units occupied by pregnant women as units where a child is expected to reside. The Title X and LSHR definitions of “target housing” encompass units where a child under age six (6) “resides or is expected to reside,” and, in the LSHR, HUD further clarified the phrase “expected to reside” to mean that “there is actual knowledge that a child will reside in a dwelling unit . . . If a resident is known to be pregnant, there is actual knowledge that a child will reside in the dwelling unit.” (See, § 35.110) That definition remains unchanged by the current rule.

h. Landlord Exemptions

Comment: Multiple commenters (16) made recommendations about the provisions that would exempt landlords in certain cases from performing additional risk assessments in their building once a child with an EBLL had been identified. Some of these commenters (5) felt the exemptions were too broad and would not sufficiently protect the other residents of a building that had exposed at least one child to a lead hazard. Most of these commenters (11) felt that the exemptions should be expanded, either for work done in the last 24 months, for work done while the same family occupied the unit, or until such time as the CDC updated its EBLL guidance, or if a unit is scheduled to undergo redevelopment.

HUD Response: HUD's rule provides that a lead risk assessment remains applicable for 12 months. HUD will continue to use this period (vs. the longer 24 months, or the indefinite period of a family's continued occupancy in a unit, for which there is no reason to believe that hazards would not form) in the exemption criteria for when the owner has documentation, “throughout the 12 months preceding the date the owner received the environmental investigation report, of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements.” Given that the LSHR requires retention of documentation of the owner's compliance with these operational LSHR requirements for the period when ongoing lead-based paint maintenance is required, and for at least 3 years beyond that period, the absence of such documentation for just the past 12 months allows for a reasonable inference that the owner has not complied with the operational requirements of the LSHR, so that a risk assessment is required in the other units. Thus, HUD declines to change this implementation period.

HUD also declines to exempt units that are scheduled for redevelopment. Redevelopment timelines are often uncertain by many months, and it would violate the intent of the LSHR to leave a child exposed to potential lead hazards for such an uncertain length of time. If preliminary work on the redevelopment is sufficiently far advanced that building occupant vacating and/or relocating is under way with completion of vacating and/or relocating and the start of construction both scheduled to be within 45 days (i.e., the sum of the 15-day period for conducting the environmental investigation of the index child's unit and common areas servicing that unit and the 30-day period for conducting lead hazard control there) after the designated party was notified of a child under age six (6) with EBLL, the lead activities need not be conducted in one or more of the other assisted units with a child under age six (6) by that due date if the family in each of those un-assessed or uncontrolled units is relocated within 15 days after the designated party received the environmental investigation report, with the lead safety of the family's destination housing meeting the criteria of the preface to § 35.1345(a)(2), and with the family continuing to receive housing assistance without interruption and having their relocation costs covered. Making the original housing lead safe is required by the LSHR (subparts H, J, and/or L, as applicable) to be part of the redevelopment.

At the same time, HUD understands that evaluating additional units poses a burden for owners, and there are some circumstances where documented past performance makes the possibility of future lead hazards substantially less likely. Therefore, HUD also declines to make the exemptions more stringent.

6. Time Available To Complete Work

Comment: Multiple commenters (15) made recommendations about timelines for investigating lead hazards, completing hazard control work, and relocating families if necessary. Most of these commenters (11) felt that the timelines were aggressive and may be unrealistic for owners, particularly owners who operate under complex procurement rules, or owners in communities without adequate numbers of certified risk assessors, lead hazard control workers, and firms who employ them. Other commenters (4) felt that the timelines were too lax, and left families exposed to lead hazards in their home longer than necessary.

HUD Response: None of the commenters provided data on lead hazard control activity durations, temporary relocation costs, or the health effects of lead exposure for the number of days they recommended versus the number of days proposed to support their recommendations. Accordingly, HUD determined that it would retain the timelines in the currently codified LSHR, as proposed. If a designated party or owner believes they will be unable to meet the timelines in a specific circumstance, they should discuss their concerns with HUD when they report the EBLL.

HUD also declines to apply a business day schedule instead of a calendar day schedule to these evaluation and hazard control timelines. The primary victims of lead poisoning are children, who are most likely to be exposed to hazards in their home on non-business days, and many risk assessors and lead hazard control contractors are available to work on weekends for high priority projects, such as responding to the case of a child under age six (6) with an EBLL. With respect to providing notifications to HUD, for which the rule uses business day schedules, HUD will adopt the practice already used by HUD for hearings before hearing officers, that when the due date is a Saturday, Sunday, national holiday, or other day on which the relevant HUD office is closed, the due date is extended until the end of the next following business day. (See, 24 CFR 26.11(a).)

7. Penalties for Noncompliance

Comment: Several commenters (11) recommended that this rule include enforcement remedies and civil money penalties for non-compliance.

HUD Response: The Lead Disclosure Rule, also issued under Title X, allows for violators to be subject to civil money penalties. (See, 24 CFR 35.96, implementing 42 U.S.C. 4852d(b)(1).) In contrast, as the preamble to the original LSHR states (at 64 FR 50168), “The Lead-Based Paint Poisoning Prevention Act does not provide any independent enforcement provisions. Remedies will vary based on which [assistance] program's requirements have been violated.” For example, a designated party or owner not in compliance with the LSHR, including this rule, may be considered in default of its regulatory agreement or annual contributions contract, as applicable, with the Department. Noncompliance may also result in the designated party or owner being debarred from receiving assistance from the Department or denied future participation in HUD or federal programs. A designated party or owner in noncompliance may be forced to surrender grant funds, or may be otherwise subject to civil money penalties or other sanctions. HUD plans to enhance its monitoring for LSHR compliance, but does not have the authority to create penalties under this rule or the currently codified LSHR.

8. Future Changes in CDC Recommendations

Comment: Multiple commenters (20) recommended keeping the LSHR synchronized with expected future CDC guidance that may further change the blood lead level that triggers an investigation. A majority (10) of these commenters recommended that future updates to CDC guidance automatically cause HUD's guidance to change. The remainder recommended variations on using CDC's current definition, including allowing the level to decrease, but not increase; creating local levels based on the data from a given geography; changing the terminology from CDC's current usage; or simply waiting for the CDC to update their guidance again before amending the LSHR.

HUD Response: The purpose of this rulemaking is to bring HUD's requirements into alignment with CDC guidance in regard to environmental investigations for cases of elevated blood lead levels in children under age six (6), while placing the minimum necessary burden on assisted property owners and other designated parties. To do so, while also maximizing the effectiveness of environmental investigations and remedial actions taken as a result of those investigations, HUD proposed that the EBLL under this rule would be a confirmed blood lead level at least that for which U.S. Department of Health and Human Services recommends that an environmental intervention be conducted. This level may be the CDC's reference range value, as it is at the publication of this rule, or it could be higher, if CDC found recommending environmental interventions to be appropriate only at a higher level than the reference range value. Accordingly, HUD declines to apply any of the recommended variations.

To respect the potential burden placed on assisted property owners before adjusting its EBLL standard in the LSHR, and to provide transparency in its decision-making, HUD will provide for public notice and comment as described in the proposed rule so that potentially affected parties, including designated parties, their property management firms, risk assessment firms, renovation firms, and tenants, and advocates for all of these parties will have the opportunity to provide comments on proposed EBLL changes. Therefore, HUD declines to modify the proposed process for revising the blood lead level in children under age six (6).

9. Timing of Implementation

Comment: Half of the commenters (29) addressed the issue of the rule's effective date or implementation date. Of these, some recommended a longer implementation time to adequately prepare, and some recommended a shorter implementation time to begin increasing the protection of children's health more rapidly. A few commenters felt that the initially proposed 6 months was appropriate.

HUD Response: HUD is mindful of the need to update policies and procedures for planning purposes, and that, as one commenter noted, “it is doubly important that the rule is implemented in such a way that Housing Authorities will be able to comply.” That commenter, and others, noted that CDC has not yet revised its 2012 reference range value, and recommended waiting until some period after CDC's update. HUD believes it likely that CDC will issue its update in 2017, but it does not want to delay for an indeterminate period the additional protections for children with blood lead levels in the range between the currently codified LSHR's EIBLL threshold and this rule's proposed EBLL threshold. Therefore, HUD cannot agree with either the majority or minority of commenters and declines to implement the rule faster than 6 months, nor after a longer period. Instead, the compliance date of the rule will be 6 months from publication, as proposed.

10. Other Issues a. Low Income Communities, Communities of Color, and Affirmatively Furthering Fair Housing

Comment: Five commenters requested that HUD consider that lead poisoning occurs more frequently in low-income communities and communities of color, and that, furthermore, this may have implications under its fair housing rules.

HUD Response: HUD agrees that research clearly shows higher incidence of EBLLs in low-income communities and in communities of color.22 However, the fair housing implications of this information are governed by fair housing statutes and regulations, and are therefore beyond the scope of this rulemaking; this rule needs to be issued with nationwide applicability. Nevertheless, such comments will be considered as HUD develops future outreach and enforcement strategies for implementing this rule.

22 See, e.g., CDC, Lead: Prevention Tips, http://www.cdc.gov/nceh/lead/tips.htm; CDC, Recommendations for Blood Lead Screening of Medicaid-Eligible Children Aged 1-5 Years: an Updated Approach to Targeting a Group at High Risk (Aug. 2009), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5809a1.htm.

b. EPA's Renovation, Repair, and Painting Rule

Comment: Five commenters recommended clarifying and making more explicit the relationship between the LSHR and the EPA's Renovation, Repair and Painting Rule (RRP Rule, 40 CFR part 745, especially subparts E and Q; implementing 15 U.S.C. 2682(c), Renovation and remodeling).

HUD Response: The original LSHR predated the RRP Rule, and therefore could not reference it explicitly. The RRP Rule defines “renovation” broadly in the context of lead-based paint, saying in essence that the term “means the modification of any existing structure, or portion thereof, that results in the disturbance of painted surfaces, unless that activity is performed as part of an abatement . . . [but not] minor repair and maintenance activities,” (40 CFR 745.83) where “abatement” and “minor repair and maintenance activities” are defined for purposes of that rule at 40 CFR 745.223 and 745.83, respectively. Accordingly, most of the lead-based paint hazard reduction activities to be conducted as a result of the environmental investigation of the index unit and the risk assessment in other units, will be renovations covered by the RRP Rule, and must be conducted by contractors and individual renovators who are certified renovation firms or certified renovators. The relationship between this rule and the RRP Rule needs to be made explicit for the sake of transparency; doing so will have the additional benefit of making the other portions of the LSHR that require the use of certified renovation firms and certified renovators more transparent. Because this requirement has been operationally in effect for the LSHR since the RRP Rule went into full effect, clarifying this creates no change in the burden or benefits of implementing the LSHR.

Accordingly, the relationship between the RRP rule and the LSHR is being made explicit through this rulemaking.

First, for the sake of transparency, HUD is adding “renovation” to the list of “activities” within the scope of the definition of “certified” in 24 CFR 35.110, along with the current listing of “risk assessment, lead-based paint inspection, or abatement supervision.” HUD notes that the scope of activities in its definition of “certified” is broader than EPA's scope of “Lead-based paint activities,” which they define at 40 CFR 745.223, because HUD's definition uses the unmodified term “activities” and includes, in the definition, the phrase “such as” the listed activities of “risk assessment, lead-based paint inspection, or abatement supervision,” while the EPA definition is limited to the specific listed activities of “inspection, risk assessment, and abatement.” Because HUD's definition is broader, this clarification in the definition will have no effect on the operations of HUD, owners, contractors or employees.

Second, the current LSHR language on interim controls training requirements in § 35.1330(a)(4)(iii), which allowed for approval of certain lead-safe work practices courses by HUD after consultation with the EPA, will be replaced with wording that recognizes renovator courses accredited under the EPA's or by an EPA-authorized state or tribe's renovation program.

HUD also notes that “abatement” of lead-based paint or lead-based paint hazards as defined by EPA at 40 CFR 745.223, and by HUD in the LSHR at 24 CFR 35.110, may be conducted under the LSHR when interim controls are required, because the LSHR already allows conducting additional lead-based paint hazard evaluation or reduction beyond the minimum under the rule. Abatements must be conducted, in accordance with the work practice standards developed by EPA at 40 CFR 745.227(e) or by an EPA authorized state or tribal lead-based paint activities program by certified abatement supervisors and certified abatement workers. HUD encourages the use of abatement as a permanent (at least 20-year-long, or eternally, in the case of paint removal abatement) method of addressing exposures from lead-based paint, dust, and soil in a home, particularly where it may be cost-effective, such as during a major rehabilitation (e.g., a “gut rehab”).

c. Other Partnerships

Comment: Five commenters suggested partnerships, or approaches to partnerships that would aid in the implementation of the LSHR.

HUD Response: HUD welcomes these suggestions and fully expects to engage in numerous partnerships to fully implement the LSHR and protect America's children from lead poisoning. However, codifying these partnerships in regulation is unnecessary, so HUD declines to do so.

d. Other Sections of the LSHR Not Amended

Comment: Two commenters recommended that HUD amend the LSHR's subparts C (Disposition of Residential Property Owned by a Federal Agency Other Than HUD), E (which had been proposed in the original LSHR to cover Single Family Insured Property,23 but was reserved in the final LSHR rulemaking, with 24 CFR part 200, subpart O, being revised at that time) and F (HUD-Owned Single Family Property).

23 Proposed 24 CFR part 36, subpart E; 61 FR 29170-29232, at 29210 (see also 29180), June 7, 1996.

HUD Response: HUD appreciates these suggestions and, while noting that they are outside of the scope of the current rulemaking, will consider future rulemaking to amend these subparts.

e. Accessibility of Inspection Reports

Comment: One commenter recommended protecting a renter's ability to access inspection reports.

HUD Response: This issue is governed by the Lead Disclosure Rule (24 CFR part 35, subpart A) and is therefore outside the scope of this rule.

f. Uniform Physical Condition Standards for the Voucher Program (UPCS-V) Demonstration

Comment: One commenter requested clarifying language on the relationship between the LSHR and the UPCS-V pilot program.

HUD Response: As noted on HUD's Web site (http://portal.hud.gov/hudportal/HUD?src=/program_offices/public_indian_housing/reac/oed/upcs-v), to help improve tenant safety and HUD's oversight of the HCV program, HUD is introducing the UPCS-V inspection protocol with new measures to enhance the consistency and objectivity of the inspection process, and provide more information about the condition of individual housing units. The UPCS-V Demonstration is HUD's formal mechanism to test the protocol with up to 250 public housing agencies (www.regulations.gov/document?D=HUD-2016-0044-0001).

Participation in the UPCS-V pilot program does not affect whether or how a housing unit or property is covered under the LSHR or this rule amending the LSHR, nor an owner's or designated party's responsibilities under the LSHR. Questions on specific interactions between the LSHR and the UPCS-V pilot, such as one commenter's question, “If a PHA does not complete the hazard reduction on a voucher unit, would that dwelling be in violation of UPCS-V?”, are outside the scope of this rulemaking, and should be directed to HUD's Office of Public and Indian Housing.

g. Liability Safeguards

Comment: One commenter expressed concern that because of the lapse in time between CDC issuing guidance and HUD issuing a proposed rule on EBLLs, tenants of HUD-assisted housing may decide to take legal action against PHAs once they learn that the PHA was not in compliance with CDC guidelines. The commenter requested that the LSHR include, “Safeguards that protect PHAs from any litigious behavior that may result from HUD's delayed rulemaking process.”

HUD Response: HUD cannot speculate on the merits or costs of any potential litigation, nor to address PHAs' compliance with other federal agencies' guidance, as both are outside the scope of this rulemaking.

h. Determining the Responsible Party

Comment: One commenter requested that, “HUD clarify that there is a single responsible party in areas of the proposed rule where there is an option for one of two entities to assume responsibility. As currently written, sections of the rule would assign responsibility to either the PHA (the designated party) or the property owner.”

HUD Response: As defined by the LSHR, a designated party is an entity responsible for complying with applicable requirements of the rule.

This commenter does not identify which LSHR subparts are of concern to it, but an examination of subpart H, L, and M, with which public housing agencies may be involved, shows that subparts H and L each specify only one such entity; so the concern must be for subpart M (Tenant-Based Rental Assistance). Within that subpart, §§ 35.1200(b)(2) through (6) identify the designated party for the assistance programs covered by each of those regulatory paragraphs. In the example of the HCV program, paragraph (2) has identified the public housing agency as the designated party, with responsibilities under certain provisions of that subpart (e.g., engaging an inspector on its behalf to conduct the pre-occupancy visual assessment (see, § 35.1215(a)(1))) and the owner has had certain responsibilities under other provisions of that subpart (e.g., stabilizing the deteriorated paint surfaces identified by the visual assessment (see, § 35.1215(b))). Regarding EBLL cases under the HCV program, this rule as proposed and made final here uses the same approach: The designated party, i.e., the PHA, is responsible for the environmental investigation and, if needed, verification of the case (see, §§ 35.1225(a) and (b)), while the owner is, for the lead-based paint hazard reduction (see, § 35.1225(c)).

Similarly, in the example of tenant-based rental assistance under the HOME Investment Partnerships Program (HOME) (see, § 92.209), under which HUD's Office of Community Planning and Development (CPD) awards grants to state and local governments (“participating jurisdictions”) that provide rental assistance to households and contract with owners of the units they rent, the designated party for the unit occupied by a household receiving tenant-based rental assistance is the participating jurisdiction, or if the tenant-based rental assistance program is administered by a subrecipient, that entity.

Also, the Housing Opportunities for Persons with AIDS (HOPWA) Program provides tenant-based rental assistance to households as an eligible activity (see, § 574.300(b)(5)). HUD's CPD office awards HOPWA entitlement formula grant funds to state and local government grantees (“eligible states and qualifying cities”) and HOPWA competitive grant funds to state, local government and non-profit grantees. In this example, if a grantee provides rental assistance to households and contracts directly with owners of the units they rent, the designated party for a unit in which the assisted household occupies is the grantee. In another example, if the tenant-based rental assistance program is administered by a project sponsor, the designated party for a unit in which the assisted household occupies is the project sponsor.

i. Ongoing Lead-Based Paint Maintenance Program

Comment: One commenter recommended that the written notice provided to each dwelling unit asking occupants to report deteriorated paint and, if applicable, failure of encapsulation or enclosure, along with contact information, be provided to each individual tenant (see, § 35.1355(a)(7)). The same commenter recommended adding “and reporting deteriorated paint” to the heading of § 35.130, Lead hazard information pamphlet, because the reporting notification required by § 35.1355(a)(7) as discussed above, goes to the recipients of the lead hazard information pamphlet provided under § 35.130. The same commenter suggested adding a paragraph (8) to § 35.1355(a), to require that each property covered by the ongoing lead-based paint maintenance requirement must have a written maintenance plan on how to address lead-based activities and who will be able to conduct the activities.

HUD Response: As to the first suggestion, typical notification practice is to provide one notification on a housing operations topic to the dwelling unit, rather than multiple copies for each adult in the unit. HUD will consider the effectiveness and burden of a change for this notification as it develops future rulemaking. As to the second suggestion, while § 35.130 pertains to providing a pamphlet rather than property-specific information, this comment raises the idea of having the Lead Disclosure Rule disclosure form, for at least housing covered by the LSHR, include a confirmation that the reporting notification was provided. HUD will consider the feasibility of such an addition in its implementation of the LSHR.

As to the third suggestion, this would implement the HUD Guidelines Chapter 6, Ongoing Lead-Based Paint Maintenance, Step-by-Step Summary, item 1, that “owners should develop a written program [regarding] lead-safe maintenance that apply to each pre-1978 property and should assign responsibilities,” and similarly at unit III.B, Assignment of Responsibilities, of that chapter. HUD will consider this suggestion in further rulemaking.

j. Technical Corrections

Comment: One commenter noted that the grammar of subpart D might be incorrect.

HUD Response: The commenter's insight was accurate, and a technical correction is necessary. The second sentence of proposed § 35.325, Child with an elevated blood lead level, paragraph (b), begins by stating that, “The risk assessments would be conducted within” a certain period, while the other requirements of the paragraph are specified by using “shall” instead of the conditional “would;” in addition, “shall” is used in the corresponding provisions of other sections. HUD is replacing “would” in this instance with “shall.”

Comment: One commenter noted that § 35.155 implies that occupants would conduct lead-based paint hazard evaluation or reduction, a requirement which would not be supported by Title X.

HUD Response: HUD is also making a technical correction to § 35.155 by changing both instances of “designated party or occupant” to “designated party or owner,” to correct the language regarding who may be required to conduct additional lead-based paint hazard evaluation or reduction beyond the minimum under the LSHR. While occupants are mentioned in the LSHR many times, the LSHR does not establish any requirements for them to conduct lead-based paint hazard evaluations or reductions. (An assisted-property owner who resides in one of the units of a property covered by the LSHR is subject to that rule's requirements as the owner, not as an occupant.) This correction is particularly timely because of the requirements being amended by this rule for owners who are not designated parties.

C. Public Comments in Response to HUD's Questions

HUD is particularly grateful for the comments responding to specific questions:

1. To facilitate effective HUD monitoring of responses to a case of an elevated blood lead level, the proposed rule would have designated parties provide documentation to HUD that the response actions have been conducted in the child's unit and in all other assisted units with a child under age six (6), or if there are such other units, that the designated party has been complying with the LSHR for the past 12 months, and need not evaluate those other units.

a. Is this approach sufficient for HUD to effectively monitor response actions in these cases, and why? Are there areas in which reporting and oversight could be strengthened?

b. Can the approach to monitoring response actions in these cases be streamlined while maintaining its effectiveness, and if so, how?

Comment: Many commenters provided input regarding the information that needed to be shared to effectively monitor the responses to a case of an elevated blood lead level.

HUD Response: Commenters took a wide variety of positions, which are primarily summarized under comments section III.B.4 of this preamble entitled, Coordination Between the Involved Parties. The sub-issue of when a designated party need not evaluate other units was discussed in comments and responses in section III.B.6 of this preamble entitled, Landlord Exemptions.

2. Regarding the definition of elevated blood lead level in the proposed rule, is the definition appropriately protective of the health of children in assisted housing covered by the rule? Too protective? Not protective enough? Why?

Comment: Commenters were nearly unanimous in expressing their support for aligning HUD's regulations with the current definition of elevated blood lead level from the CDC. Commenters did have concerns that the LSHR as proposed was not protective enough, as discussed in comments and responses provided in section III.B.1, Primary Prevention, and section III.B.5, Technical Concerns. No commenters felt that the rule was too protective of America's children, however, some commenters worried that they would not have sufficient resources available to meet their obligations under the rule.

HUD Response: HUD responds to these concerns in section III.B.2, Resources Available.

3. Regarding the set of types of housing assistance covered by the proposed rule (i.e., in the covered subparts D, H, I, L, and M), is this set appropriately protective of the health of children in assisted housing?

a. If it is too protective, why, and which types of housing assistance should be removed from the proposed rule?

b. If it is not protective enough, why, which additional type or types of housing assistance should be included, and how would sufficient resources be provided to ensure implementation and monitoring of the rule in that additional assisted housing?

Comment: No commenters felt that certain types of housing assistance should be removed from the proposed rule, although several commenters recommended that Public Housing's history of superior performance entitled it to a lower standard of monitoring. (As discussed in commenting subsection 1, Primary Prevention, the study did not have the capacity to address the performance of particular housing assistance programs.) A few commenters felt that additional HUD programs should be included in the rule.

HUD Response: HUD response to these comments are provided in section III.B.11.d of this preamble entitled, Other Sections of the LSHR Not Amended.

Comment: Two commenters also suggested the LSHR should be extended to the Low-Income Housing Credit program administered by the United States Treasury.

HUD Response: According to the Low Income Housing Credit regulations, 26 CFR 1.42-5(d), the state allocating agency may opt to use HUD's Uniform Physical Condition Standards as the compliance standard, in which case the LSHR applies.

4. If interim controls or abatement in a housing unit takes longer than 5 calendar days, or if other occupant protection requirements of 24 CFR 35.1345(a)(2) are not met, the occupants of the unit shall be temporarily relocated before and during lead-based paint hazard reduction activities.

a. HUD is seeking data on the fraction of lead hazard control activities that take longer than 5 calendar days, including the type of activity (e.g., interim control or abatement; the hazard control method used (e.g., if abatement, component removal, paint stripping, enclosure, encapsulation, etc.), the extent of the work, the reason that the activities cannot be completed within 5 calendar days, whether the housing is a single family, duplex, triplex, quad, or multifamily housing, whether it is located in an urban, suburban, or rural area, whether the EPA has authorized the state to administer the applicable lead certification program (i.e., renovation or abatement), and other factors that are causing temporary relocation to be required under the rule.

b. HUD is seeking information on the costs of temporary relocation, on a per day basis (average amount or day-specific amounts, as is available), including breakouts of expenses for such categories as lodging, transportation, meals, and incidental expense amounts, if the information is available that way, or as lump sum per-day or per relocation period amounts.

Comment: HUD did not receive any data (let alone data supported by robust quality assurance) on either the time work took, or the costs of relocation. A few anecdotal comments were provided, e.g., that it can be hard to find good lead professionals and contractors in rural portions of the country, and that the costs of temporary stays in Manhattan can be quite high.

HUD Response: In the absence of actionable data, HUD left the current standards unchanged. As HUD stated in responding to comments in subsection 2, Resources Available, of this preamble, HUD is encouraging designated parties and owners in remote rural areas to contact HUD if they encounter difficulty in finding lead professionals and contractors, to see if the Department can help find them, and will keep these comments in mind as it implements this rule.

III. Findings and Certifications A. Regulatory Review—Executive Orders 12866 and 13563

Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. OMB reviewed this final rule under Executive Order 12866 (entitled “Regulatory Planning and Review”). This rule was determined to be a “significant regulatory action,” (but not economically significant) as defined in 3(f) of the order. The docket file is available for public inspection electronically at Federal eRulemaking Portal at http://www.regulations.gov under the title and docket number of this rule, HUD-2016-0096.

B. Regulatory Impact Assessment

HUD is publishing, concurrently with this final rule, its final Regulatory Impact Analysis (RIA) that examines the costs and benefits of the final regulatory action in conjunction with this final rule, organized into three sections: Cost-Benefit Analysis; Sensitivity Analysis; and Economic Impacts. The RIA is available on-line at: http://www.regulations.gov. The major findings in the RIA are presented in this summary.

The analysis of net benefits reflects costs and benefits associated with the first year of hazard evaluation and reduction activities under the final rule. These costs and benefits, however, include the present value of future costs and benefits associated with first year lead-based paint hazard reduction activities. Similarly, the benefits of first year activities include the present value of lifetime earnings benefits for children living in the affected unit during that first year, and for children living in that unit during the second and subsequent years after lead-based paint hazard reduction activities.

In regard to the discount rate used for this regulatory analysis, HUD is using both the 3 percent, and the 7 percent discount rates in accordance with OMB guidance in OMB Circulars A-4, Regulatory Analysis (https://www.whitehouse.gov/omb/circulars_a004_a-4/), and A-94, Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs (https://www.whitehouse.gov/omb/circulars_a094). By presenting results using both 3 and 7 percent discount rates, HUD is providing a broad view of costs and benefits.

Employing a 3 percent discount rate of the lifetime earnings estimates, the RIA concludes that monetized benefits of activities have a present value of $98.96 million; while first-year costs are $29.04 million. Thus the estimated net benefit is $69.92 million using a 3 percent discount rate. If a 7 percent discount rate is used for lifetime earnings benefits, the monetized present value of the benefits of the final rule are estimated to be $32.15 million, with estimated first year costs remaining at $29.04 million. The final rule would therefore be seen as having a net benefit of $3.11 million using the 7 percent discount rate.

Further, the monetized benefit estimates represent a lower bound on benefits, as they only account for lifetime earnings resulting from cognitive impacts on children under age six. Reductions in lead exposure would be expected to result in additional health benefits for these children, as well as older children and adults living in or visiting the housing units addressed by the rule. Such additional benefits include avoidance of harmful symptoms of lead poisoning such as: Decreased attention, increased impulsivity, hyperactivity, impaired hearing, slowed growth, and delayed menarche.24

24See, e.g., CDC, Educational Interventions for Children Affected by Lead (Apr. 2015), available at https://www.cdc.gov/nceh/lead/publications/educational_interventions_children_affected_by_lead.pdf; Selevan SG, Rice DC, Hogan KA, Euling SY, Pfahles-Hutchens A, Bethel J, Blood lead concentration and delayed puberty in girls, N Engl J Med. 17;348(16):1527-36, (Apr. 17, 2003), available at www.nejm.org/doi/full/10.1056/NEJMoa020880; Mayo Clinic, Lead Poisoning: Symptoms and Causes, http://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/dxc-20275054.

Costs are overestimated, such as by assuming that only one environmental investigation is conducted in a property at a time, that that each housing unit has at most one child with an EBLL. The analysis also assumes that no designated parties are eligible for (nor take, if they are eligible) the exemptions from conducting a risk assessment of other housing units covered by this rule, and that each index unit has lead-based paint hazards, whether or not the environmental investigation identifies non-lead-based paint lead hazards. These assumptions would tend to overestimate both the costs and benefits of the regulation.

That the benefit-cost calculation giving lower weight to future generations shows a smaller net benefit is not surprising, given that the monetized benefits of the rule pertain to the future earnings of children under age six (6), while the costs pertain to the designated parties of the housing in which the young children currently reside. As noted above, the calculation included monetized benefits but not non-monetized quality of life factors associated with children's lower intelligence, fewer skills, and reduced education and job potential, and adults' cognitive function decrements, psychopathological effects (self-reported symptoms of depression and anxiety), hypertension, coronary heart disease, blood system effects (decreased red blood cell survival and function, and altered heme synthesis), male reproductive function decrements, among other effects.25

25See, e.g., CDC, Educational Interventions for Children Affected by Lead (Apr. 2015), available at https://www.cdc.gov/nceh/lead/publications/educational_interventions_children_affected_by_lead.pdf; Mayo Clinic, Lead Poisoning: Symptoms and Causes, http://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/dxc-20275054.

C. Paperwork Reduction Act Statement

The information collection requirements contained in this rule have been approved by or are pending with the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2539-0009. In accordance with the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.

D. Regulatory Flexibility Act

In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), HUD has reviewed this final rule before publication and by approving it for publication, certifies that the regulatory requirements would not have a significant economic impact on a substantial number of small entities, other than those impacts specifically required to be applied universally by the statute. As discussed below, the requirements of the final rule are applicable only to a limited and specifically defined portion of the nation's housing stock. To the extent that the requirements affect small entities, the impact is generally discussed in the economic analysis that accompanies this final rule. Specifically, the economic analysis estimated the number of small entities and voucher owners that would be impacted by the rule, as well as the number of index units and other assisted units to be evaluated and, possibly, based on the evaluation, having lead hazard control work done.

HUD has estimated that this final rule affects two types of small entities, Public Housing Agencies (PHAs) and private lessors and owners. There are 2,334 small PHAs, defined as PHAs with fewer than 250 units, which make up for 75 percent of the public housing stock across the country. HUD has estimated that there are approximately 42,618 private landlords/lessors of residential real estate, or approximately 99 percent of the 42,911 lessors of residential real estate counted in the 2012 Economic Census, where SBA defines a “small” business as one that earns annual revenues (sales receipts) of less than $27.5 million. Finally, HUD has estimated the number of owners who participate in the housing choice voucher program. It is noted that based on HUD data, the overwhelming proportion of owners rent to very few voucher tenants. Approximately two-thirds of owners who rent to voucher tenants rent to only one voucher tenant household. Many of these are likely owners of single-family homes for whom the rental income is not the primary source of income. Approximately 90 percent rent to no more than 4 voucher tenant households, which could be housed in a large two-story building. Very few owners rent to enough voucher tenants to occupy multiple buildings. Fewer than 0.6 percent of voucher tenant owners will be affected by this rule (out of the 647,956 owners with voucher tenant households, at most, an estimated 3,383 such owners, assuming that each EBLL case occurs in a housing unit owned by an owner none of whose other properties with voucher tenant households have children with an EBLL.

HUD has determined, for each type of assistance and for all types of assistance together, the economic analysis also estimated:

• The cost per unit of the evaluation (environmental investigation for index units, and risk assessments for other units that are assisted and have a child under age six (6) residing, as per the current LSHR);

• The total cost of the evaluation and hazard control (for index units, other units, and both); and

• The percentage of units evaluated and possibly, based on the evaluation results, hazard controlled (again, for index units, other units, and both).

The annual estimates are summarized in the table below.

Table 1—Regulatory Flexibility Analysis Unit cost activity Public housing HUD
  • project-based
  • assistance
  • Tenant-based assistance USDA
  • project-based
  • assistance
  • Total
    Unit cost of evaluation, and weighted hazard control and temporary relocation for index units $2,890.33 $2,890.33 $2,890.33 $2,890.33 Est. no. buildings/complexes with child having EBLL 1,899 1,494 3,383 112 6,887 Presume LBP hazard prevalence in index units 100% 100% 100% 100% Cost of evaluation, hazard control and temporary relocation in index units $5,488,724 $4,318,158 $9,776,541 $323,720 $19,907,143 Unit cost of evaluation, and weighted hazard control and temporary relocation for other units $611.37 $611.37 $611.37 $611.37 Est. no. other units with assisted rental units having child under age 6 8,014 3,783 2,855 284 14,936 Total number of units evaluated 9,913 5,277 6,238 396 21,823 Estimated LBP hazard prevalence in other units, per the American Healthy Homes Survey 12.30% 12.30% 12.30% 12.30% Estimated no. other units with LBP hazards identified and controlled 986 465 351 35 1,837 Cost for other assisted rental units having child under age 6 $4,899,521 $2,312,806 $1,745,456 $173,629 $9,131,412 Total cost $10,388,245 $6,630,964 $11,521,998 $497,349 $29,038,556 Total number of units evaluated and having hazards controlled 2,885 1,959 3,734 147 8,725 Program assistance per unit $5,849.09 $9,013.33 $9,329.09 $4,911.00 Total number of assisted units 1,100,000 1,200,000 2,200,000 286,108 $4,786,108 Percent of assisted units evaluated 0.90% 0.44% 0.28% 0.14% 0.46% Percent of assisted units evaluated and having hazards controlled 0.26% 0.16% 0.17% 0.05% 0.18% # assisted units that would be forgone if funding were from funding agency with no appropriation increase 1,776 736 1,235 101 3,848 % assisted units that would be forgone if funding were from funding agency with no appropriation increase 0.161% 0.061% 0.056% 0.035% 0.080%

    Among the key results are that, in each year:

    • About 6,887 housing units are estimated to have a child under age six (6) with a blood lead level that is elevated but not an environmental intervention blood lead level; these units would be required to have an environmental investigation and have any lead-based paint hazards controlled. An additional 152 housing units would have a child under age six (6) with a blood lead level that is an environmental intervention blood lead level; these units would be required to have an environmental investigation, rather than a risk assessment, as under the current rule, and have any lead-based paint hazards controlled.

    • About 14,936 other housing units would have a risk assessment, of which about 1,837 are estimated to have lead-based paint hazards, and to have these hazards controlled by certified firms and workers using lead-safe work practices and clearance (i.e., conservatively, all of the lead-based paint hazards are assumed to be significant, that is, above the de minimis levels of § 35.1350(d)).

    • About 0.46 percent of the assisted housing stock covered by this rulemaking would be evaluated (i.e., have an environmental investigation or a risk assessment), specifically, 0.90 percent of the public housing stock, 0.44 percent of the HUD project-based rental assisted housing stock, 0.28 percent of the tenant-based rental assisted housing stock, and 0.14 percent of the U.S. Department of Agriculture (USDA) project-based rental assisted housing stock.

    • About 0.18 percent of the assisted housing stock covered by this rulemaking would have lead-based paint hazards controlled, specifically, 0.26 percent of the public housing stock, 0.16 percent of the HUD project-based rental assisted housing stock, 0.17 percent of the tenant-based rental assisted housing stock, and 0.05 percent of the USDA project-based rental assisted housing stock.

    • The total cost of evaluation and control (and the small amount of temporary relocation of occupants) would be $29.04 million, including $10.39 million for public housing, $6.63 million for HUD project-based rental assisted housing, $11.52 million for tenant-based rental assisted housing, and $497 thousand for USDA project-based rental assisted housing.

    • Using the 3 percent discount rate, benefits are estimated at $98.96 million, with net benefits (i.e., benefits less the $29.04 million in costs) estimated at $69.92 million. Using the OMB's 7 percent discount rate, benefits are estimated at $32.15 million, with costs remaining at $29.04 million, so the net benefits would be $3.11 million.

    • Regarding index units, for FY 2017, an estimated 1,899 units of public housing, 1,494 units of HUD project-based rental assisted housing, 3,383 units of tenant-based rental assisted housing, and 112 units of USDA project-based rental assisted housing have children under age 6 with EBLLs that are not EIBLLs, that is, children for whom an environmental investigation and possible (i.e., if hazards are found) interim control of their housing unit and common area servicing it would be newly required under the final rule.

    • Regarding other units in the same property to have risk assessments conducted because they have children under age six (6) residing, there would be an estimated 8,014 units of public housing, 3,783 units of HUD project-based rental assisted housing, 2,855 units of tenant-based rental assisted housing, and 284 units of USDA project-based rental assisted housing.

    • Regarding these other units having interim controls conducted based on the risk assessments finding lead-based paint hazards, there would be an estimated 986 units of public housing, 465 units of HUD project-based rental assisted housing, 351 units of tenant-based rental assisted housing, and 35 units of USDA project-based rental assisted housing that would have such controls.

    • The conservative (i.e., intentionally high, in this instance) assumption about the properties in which these children reside is that each of them is a different property (vs. there being more than one such child in a property); a similarly conservative assumption about the private entities (i.e., the ones that lease units receiving project-based rental assistance to the families of these children, or that lease units occupied by households receiving tenant-based rental assistance to their families) is that all of them are small entities and all have just one such child (vs. an entity having more than one property with such a child), and that all index units in such properties have lead-based paint hazards. The economic analysis used the FY 2017 Congressional Justifications of the estimated number of housing units assisted by the several programs, recognizing that the actual numbers assisted vary over time: 1,100,000 public housing units, 1,200,000 HUD project-based rental assistance units, 2,200,000 tenant-based rental assistance units, and 286,108 USDA project-based rental assistance units.

    E. Environmental Impact

    A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implements section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection electronically at Federal eRulemaking Portal at http://www.regulations.gov under the title and docket number of this rule.

    F. Executive Order 13132, Federalism

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

    G. Unfunded Mandates Reform Act

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

    List of Subjects in 24 CFR Part 35

    Grant programs—housing and community development, Lead poisoning, Mortgage insurance, Rent subsidies, Reporting and recordkeeping requirements.

    Accordingly, for the reasons stated in the preamble, HUD amends 24 CFR part 35 to read as follows:

    PART 35—LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES 1. The authority citation for 24 CFR part 35 continues to read as follows: Authority:

    42 U.S.C. 3535(d), 4821, and 4851.

    § 35.105 [Removed and Reserved]
    2. Remove and reserve § 35.105. 3. In § 35.110, add, in alphabetical order the definitions of “Elevated blood lead level” and “Environmental investigation”, revise the definitions of “Certified”, “Evaluation” and “Expected to reside” and remove the definition of “Environmental intervention blood lead level”, to read as follows:
    § 35.110 Definitions.

    Certified means certified to perform such activities as risk assessment, lead-based paint inspection, abatement supervision, or renovation, either by a State or Indian tribe with a lead-based paint certification program authorized by the Environmental Protection Agency (EPA), in accordance with 40 CFR part 745, subpart Q, or by the EPA, in accordance with 40 CFR part 745, subparts E or L.

    Elevated blood lead level means a confirmed concentration of lead in whole blood of a child under age 6 equal to or greater than the concentration in the most recent guidance published by the U.S. Department of Health and Human Services (HHS) on recommending that an environmental intervention be conducted. (When HHS changes the value, HUD will publish a notice in the Federal Register, with the opportunity for public comment, on its intent to apply the changed value to this part, and, after considering comments, publish a notice on its applying the changed value to this part.)

    Environmental investigation means the process of determining the source of lead exposure for a child under age 6 with an elevated blood lead level, consisting of administration of a questionnaire, comprehensive environmental sampling, case management, and other measures, in accordance with chapter 16 of the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (“Guidelines”).

    Evaluation means a risk assessment, a lead hazard screen, a lead-based paint inspection, paint testing, or a combination of these to determine the presence of lead-based paint hazards or lead-based paint, or an environmental investigation.

    Expected to reside means there is actual knowledge that a child will reside in a dwelling unit reserved or designated exclusively for the elderly or reserved or designated exclusively for persons with disabilities. If a resident woman is known to be pregnant, there is actual knowledge that a child will reside in the dwelling unit.

    4. Amend § 35.125 by adding paragraph (c)(4)(iii) to read as follows:
    § 35.125 Notice of evaluation and hazard reduction activities.

    (c) * * *

    (4) * * *

    (iii) However, for the protection of the privacy of the child and the child's family or guardians, no notice of environmental investigation shall be posted to any centrally located common area.

    § 35.155 [Amended]
    5. Amend § 35.155(a) by removing the phrase “designated party or occupant” wherever it appears and adding in its place the phrase “designated party or owner”.
    § 35.165 [Amended]
    6. Amend § 35.165(b)(4) by removing the term “environmental intervention blood lead level” wherever it appears and adding its place the term “elevated blood lead level”. 7. Revise § 35.325 to read as follows:
    § 35.325 Child with an elevated blood lead level.

    (a) If a child less than 6 years of age living in a federally assisted dwelling unit has an elevated blood lead level, the owner shall immediately conduct an environmental investigation. Interim controls of identified lead-based paint hazards shall be conducted in accordance with § 35.1330.

    (b) Other assisted dwelling units in the property. (1) If the environmental investigation conducted under paragraph (a) of this section identifies lead-based paint hazards, the owner shall conduct a risk assessment for other assisted dwelling units covered by this subpart in which a child under age 6 resides or is expected to reside on the date interim controls are complete, and for the common areas servicing those units. The risk assessments shall be conducted within 30 calendar days after receipt of the environmental investigation report on the index unit if there are 20 or fewer such units, or 60 calendar days for risk assessments if there are more than 20 such units. If the risk assessment identifies lead-based paint hazards, the owner shall control identified hazards in accordance with § 35.1325 or § 35.1330 in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d).

    (2) The requirements for other assisted dwelling units covered by paragraph (b)(1) of this section do not apply if:

    (i) The owner both conducted a risk assessment of the other assisted dwelling units covered by paragraph (b)(1), and the common areas servicing those units, and conducted reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level; or

    (ii) The owner provides the Federal agency documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report.

    (c) Interim controls are complete when clearance is achieved in accordance with § 35.1340.

    (d) The Federal agency shall establish a timetable for completing, and providing documentation to the agency on the environmental investigation, risk assessments, and lead-based paint hazard reduction when a child is identified as having an elevated blood lead level.

    § 35.715 [Amended]
    8. Amend § 35.715 by: a. Redesignating paragraph (d)(4) as paragraph (e); and b. In newly redesignated paragraph (e), remove the term “environmental intervention blood lead level” wherever it appears and adding in its place “elevated blood lead level”.
    § 35.720 [Amended]
    9. Amend § 35.720(c) by removing the term “environmental intervention blood lead level” wherever it appears and adding in its place “elevated blood lead level”. 10. Revise § 35.730 to read as follows:
    § 35.730 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the owner shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when the owner receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if the owner conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the owner received the notification of the elevated blood lead level. If the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the owner need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit in regard to the child's elevated blood lead level case, the requirements of this paragraph shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the owner shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the owner shall send documentation of the denial to the HUD rental assistance program manager, who shall make an effort to verify the information. If the public health department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the owner shall take the action required in paragraphs (a) and (c) of this section.

    (c) Lead-based paint hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the owner, between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the owner is not required to conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment.

    (d) If an environmental investigation or lead-based paint hazard evaluation or reduction is undertaken, each owner shall provide notice to occupants in accordance with § 35.125.

    (e) Reporting requirement. (1) The owner shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The owner shall also report each confirmed case of a child with an elevated blood lead level to the HUD field office and HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The owner shall provide to the HUD field office documentation that the designated party has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the owner shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date lead-based paint hazard reduction under paragraph (c) of this section is complete, and for the common areas servicing those units, conduct a risk assessment within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more than 20 such other units.

    (2) Control measures. If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the risk assessment have been treated with interim controls or abatement.

    (3) The owner shall provide to the HUD field office documentation that the designated party has conducted the activities of paragraph (f)(1) and (f)(2) of this section, within 10 business days of the deadline for each activity.

    (4) The requirements of this paragraph (f) do not apply if:

    (i) The owner both conducted a risk assessment of the other assisted dwelling units covered by paragraph (f)(1) of this section and the common areas servicing those units, and conducted reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level; or

    (ii) The owner has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report pursuant to paragraph (a) of this section; and

    (iii) In either case, the owner provides to the HUD field office documentation that it has conducted the activities of paragraphs (f)(4)(i) and (ii) of this section, within 10 business days of the deadline for each activity.

    11. Revise § 35.830 to read as follows:
    § 35.830 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit owned by HUD (or where HUD is mortgagee-in-possession) has been identified as having an elevated blood lead level, HUD shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when HUD receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if HUD conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when HUD received the notification of the elevated blood lead level. If HUD conducted a risk assessment of the unit and common areas servicing the unit during that period, HUD is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit in regard to the child's elevated blood lead level case, the requirements of this paragraph shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, HUD shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the HUD Realty Specialist assigned to that property shall send documentation of the denial to the HUD Office of Lead Hazard Control and Healthy Homes, which shall make an effort to verify the information. If the public health department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and HUD shall take the action required in paragraphs (a) and (c) of this section.

    (c) Lead-based paint hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, HUD shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if HUD, between the date the child's blood was last sampled and the date HUD received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If HUD conducted a risk assessment of the unit and common areas servicing the unit during that period, it is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment.

    (d) Notice. If lead-based paint hazard evaluation or reduction is undertaken, each owner shall provide a notice to occupants in accordance with § 35.125.

    (e) Reporting requirement. (1) HUD shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) HUD shall also report each confirmed case of a child with an elevated blood lead level to the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) HUD shall provide to the HUD Office of Lead Hazard Control and Healthy Homes documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, HUD shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date lead-based paint hazard reduction under paragraph (c) of this section, and the common areas servicing those units, is complete, conduct a risk assessment in accordance with § 35.815 within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more than 20 such other units.

    (2) If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, HUD shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330 in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the risk assessment have been treated with interim controls or abatement.

    (3) The requirements of this paragraph (f) do not apply if:

    (i) HUD, between the date the child's blood was last sampled and the date HUD received the notification of the elevated blood lead level, both conducted a risk assessment in the other assisted dwelling units covered by paragraph (f)(1) of this section and the common areas servicing those units, and conducted interim controls of identified lead-based paint hazards in accordance with § 35.820; or

    (ii) HUD has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date HUD received the environmental investigation report pursuant to paragraph (a) of this section.

    (4) HUD shall provide to the HUD Office of Lead Hazard Control and Healthy Homes documentation that it has conducted the activities of paragraph (f)(1) through (2) of this section, or that it has complied with the requirements in paragraph (f)(3) of this section, within 10 business days of the deadline for each activity.

    (g) Closing. If the closing of a sale is scheduled during the period when HUD is responding to a case of a child with an elevated blood lead level, HUD may arrange for the completion of the procedures required by paragraphs (a) through (d) of this section by the purchaser within a reasonable period of time.

    (h) Extensions. The Assistant Secretary for Housing-Federal Housing Commissioner or designee may consider and approve a request for an extension of deadlines established by this section for lead-based paint inspection, risk assessment, environmental investigation, lead-based paint hazard reduction, clearance, and reporting. Such a request may be considered, however, only during the first six months during which HUD is owner or mortgagee-in-possession of a multifamily property.

    12. Revise § 35.1130 to read as follows:
    § 35.1130 Child with an elevated blood lead level.

    (a) Environmental investigation. Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the PHA shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. The environmental investigation is considered complete when the PHA receives the environmental investigation report. The requirements of this paragraph apply regardless of whether the child is or is not still living in the unit when the PHA receives the notification of the elevated blood lead level. The requirements of this paragraph shall not apply if the PHA conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the PHA received the notification of the elevated blood lead level. If the PHA conducted a risk assessment of the unit and common areas servicing the unit during that period, the PHA need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If a public health department has already conducted an evaluation of the dwelling unit in regard to the child's elevated blood lead level case, the requirements of this paragraph shall not apply.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the PHA shall immediately verify the information with the public health department or other medical health care provider. If that department or provider denies the request, such as because it does not have the capacity to verify that information, the PHA shall send documentation of the denial to its HUD field office, who shall make an effort to verify the information. If that department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the housing agency shall take the action required in paragraphs (a) and (c) of this section.

    (c) Lead-based paint hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation conducted pursuant to paragraph (a) of this section or the evaluation from the public health department, the PHA shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the local or State health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the PHA, between the date the child's blood was last sampled and the date the PHA received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and completed reduction of identified lead-based paint hazards. If the PHA conducted a risk assessment of the unit and common areas servicing the unit during that period, it is not required to conduct another risk assessment there but it shall conduct the elements of an environmental investigation not already conducted during the risk assessment. If the PHA does not complete the lead-based paint hazard reduction required by this section, the dwelling unit is in violation of the standards of 24 CFR 965.601, which incorporates the uniform physical condition standards of § 5.703(f), including that it be free of lead-based paint hazards.

    (d) Notice of lead-based paint hazard evaluation and reduction. The PHA shall notify building residents of any lead-based paint hazard evaluation or reduction activities in accordance with § 35.125.

    (e) Reporting requirement. (1) The PHA shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The PHA shall report each confirmed case of a child with an elevated blood lead level to the HUD field office and the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The PHA shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the PHA shall conduct a risk assessment of other units of the building in which a child under age 6 resides or is expected to reside on the date lead-based paint hazard reduction under paragraph (c) of this section is complete, and the common areas servicing those units within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such other units, or 60 calendar days if there are more such units.

    (2) If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, the PHA shall control the hazards, in accordance with Sec. 35.1325 or § 35.1330, in those units and common areas within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the risk assessment have been treated with interim controls or abatement.

    (3) The PHA shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (f)(1) and (2) of this section, within 10 business days of the deadline for each activity.

    (4) The requirements of this paragraph (f) of this section do not apply if:

    (i) The PHA, between the date the child's blood was last sampled and the date the PHA received the notification of the elevated blood lead level, both conducted a risk assessment of the other assisted dwelling units covered by paragraph (f)(1) of this section and the common areas servicing those units, and conducted interim controls of identified hazards in accordance with § 35.1120(b); or

    (ii) If the PHA has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the PHA received the environmental investigation report pursuant to paragraph (a) of this section; and,

    (iii) In either case, the PHA provided the HUD field office, within 10 business days after receiving the notification of the elevated blood lead level, documentation that it has conducted the activities described in this paragraph (f)(4) of this section.

    § 35.1135 [Amended]
    13. Amend § 35.1135(d) by removing the term “Environmental intervention blood lead level” and adding in its place the term “Elevated blood lead level”. 14. In § 35.1215, amend paragraph (b) by adding a sentence to the end of the paragraph to read as follows:
    § 35.1215 Activities at initial and periodic inspection.

    (b) * * * For the unit subsequently to come under a HAP contract with the housing agency for occupancy by a family with a child under age 6, paint stabilization must be completed, including clearance being achieved in accordance with § 35.1340.

    15. Revise § 35.1225 to read as follows:
    § 35.1225 Child with an elevated blood lead level.

    (a) Within 15 calendar days after being notified by a public health department or other medical health care provider that a child of less than 6 years of age living in a dwelling unit to which this subpart applies has been identified as having an elevated blood lead level, the designated party shall complete an environmental investigation of the dwelling unit in which the child lived at the time the blood was last sampled and of common areas servicing the dwelling unit. When the environmental investigation is complete, the designated party shall immediately provide the report of the environmental investigation to the owner of the dwelling unit. If the child identified as having an elevated blood lead level is no longer living in the unit when the designated party receives notification from the public health department or other medical health care provider, but another household receiving tenant-based rental assistance is living in the unit or is planning to live there, the requirements of this section apply just as they do if the child still lives in the unit. If a public health department has already conducted an evaluation of the dwelling unit in regard to the child's elevated blood lead level case, or the designated party conducted an environmental investigation of the unit and common areas servicing the unit between the date the child's blood was last sampled and the date when the designated party received the notification of the elevated blood lead level, the requirements of this paragraph shall not apply. If the designated party or the owner conducted a risk assessment of the unit and common areas servicing the unit during that period, the designated party need not conduct another risk assessment there but shall conduct the elements of an environmental investigation not already conducted during the risk assessment.

    (b) Verification. After receiving information from a person who is not a medical health care provider that a child of less than 6 years of age living in a dwelling unit covered by this subpart may have an elevated blood lead level, the designated party shall immediately verify the information with the public health department or other medical health care provider. If the public health department or provider denies the request, such as because it does not have the capacity to verify that information, the designated party shall send documentation of the denial to the HUD rental assistance program manager, who shall make an effort to verify the information. If that department or provider verifies that the child has an elevated blood lead level, such verification shall constitute notification, and the designated party shall take the action required in paragraphs (a) and (c) of this section.

    (c) Lead-based paint hazard reduction. Within 30 calendar days after receiving the report of the environmental investigation from the designated party or the evaluation from the public health department, the owner shall complete the reduction of identified lead-based paint hazards in accordance with § 35.1325 or § 35.1330. Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the environmental investigation have been treated with interim controls or abatement or the public health department certifies that the lead-based paint hazard reduction is complete. The requirements of this paragraph do not apply if the designated party or the owner, between the date the child's blood was last sampled and the date the designated party received the notification of the elevated blood lead level, already conducted an environmental investigation of the unit and common areas servicing the unit and the owner completed reduction of identified lead-based paint hazards. If the owner does not complete the lead-based paint hazard reduction required by this section, the dwelling unit is in violation of the standards of 24 CFR 982.401.

    (d) Notice of lead-based paint hazard evaluation and reduction. The owner shall notify building residents of any lead-based paint hazard evaluation or reduction activities in accordance with § 35.125.

    (e) Reporting requirement. (1) The owner shall report the name and address of a child identified as having an elevated blood lead level to the public health department within 5 business days of being so notified by any other medical health care professional.

    (2) The owner shall also report each confirmed case of a child with an elevated blood lead level to the HUD field office and the HUD Office of Lead Hazard Control and Healthy Homes within 5 business days of being so notified.

    (3) The owner shall provide to the HUD field office documentation that it has conducted the activities of paragraphs (a) through (d) of this section, within 10 business days of the deadline for each activity.

    (f) Other assisted dwelling units in the property. (1) If the environmental investigation conducted pursuant to paragraph (a) of this section identifies lead-based paint hazards, the designated party or the owner shall, for other assisted dwelling units covered by this part in which a child under age 6 resides or is expected to reside on the date lead-based paint hazard reduction under paragraph (c) of this section is complete, and the common areas servicing those units, conduct a risk assessment in accordance with § 35.1320(b) within 30 calendar days after receipt of the environmental investigation report if there are 20 or fewer such units, or 60 calendar days if there are more such units.

    (2) If the risk assessment conducted under paragraph (f)(1) of this section identifies lead-based paint hazards, the owner shall complete the reduction of the lead-based paint hazards in accordance with § 35.1325 or § 35.1330 within 30 calendar days, or within 90 calendar days if more than 20 units have lead-based paint hazards such that the control work would disturb painted surfaces that total more than the de minimis threshold of § 35.1350(d). Lead-based paint hazard reduction is considered complete when clearance is achieved in accordance with § 35.1340 and the clearance report states that all lead-based paint hazards identified in the risk assessment have been treated with interim controls or abatement.

    (3) The requirements of this paragraph (f) of this section do not apply if:

    (i) The designated party or the owner, between the date the child's blood was last sampled and the date the owner received the notification of the elevated blood lead level, both conducted a risk assessment of the other assisted dwelling units covered by paragraph (f)(1) of this section and the common areas servicing those units, and the owner conducted interim controls of identified lead-based paint hazards in accordance with § 35.1225(c); or

    (ii) The owner has documentation of compliance with evaluation, notification, lead disclosure, ongoing lead-based paint maintenance, and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report pursuant to paragraph (a) of this section; and,

    (iii) In either case, the owner provided the HUD field office, within 10 business days after receiving the notification of the elevated blood lead level, documentation that it has conducted the activities described in this paragraph (f)(3).

    (g) Data collection and record keeping responsibilities. At least quarterly, the designated party shall attempt to obtain from the public health department(s) with area(s) of jurisdiction similar to that of the designated party the names and/or addresses of children of less than 6 years of age with an identified elevated blood lead level. At least quarterly, the designated party shall also report an updated list of the addresses of units receiving assistance under a tenant-based rental assistance program to the same public health department(s), except that the report(s) to the public health department(s) is not required if the health department states that it does not wish to receive such report. If it obtains names and addresses of elevated blood lead level children from the public health department(s), the designated party shall match information on cases of elevated blood lead levels with the names and addresses of families receiving tenant-based rental assistance, unless the public health department performs such a matching procedure.

    If a match occurs, the designated party shall carry out the requirements of this section.

    16. Revise § 35.1330(a)(4)(iii) to read as follows:
    § 35.1330 Interim controls.

    (a) * * *

    (4) * * *

    (iii) A renovator course accredited in accordance with 40 CFR 745.225.

    Dated: December 14, 2016. Nani Coloretti, Deputy Secretary.
    [FR Doc. 2017-00261 Filed 1-12-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF TRANSPORTATION Saint Lawrence Seaway Development Corporation 33 CFR Part 401 RIN 2135-AA40 Civil Penalties AGENCY:

    Saint Lawrence Seaway Development Corporation (SLSDC), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    This final rule updates the maximum civil penalty amounts for violations of statutes and regulations administered by SLSDC pursuant to the Federal Civil Penalties Inflation Adjustment Improvement Act of 2015. This final rule amends our regulations to reflect the new civil penalty amounts for violations of the Seaway Regulations and Rules under the authority of the Ports and Waterways Safety Act of 1972, as amended (PWSA).

    DATES:

    This rule is effective on January 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Carrie Lavigne, Chief Counsel, SLSDC, telephone (315) 764-3231, 180 Andrews Street, Massena, NY 13362.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Improvement Act (the 2015 Act), Public Law 114-74, was signed into law. The purpose of the 2015 Act is to improve the effectiveness of civil monetary penalties (CMPs) and to maintain their deterrent effect. The 2015 Act required agencies to make an initial catch up adjustment to the CMPs they administer through an interim final rule and then to make subsequent annual adjustments for inflation that shall take effect not later than January 15. The initial catch up adjustments for inflation to the SLSDC's CMP was published in the Federal Register on June 28, 2016 and as required, did not exceed 150 percent of the amount of the CMP on the date of enactment of the Federal Civil Penalties Inflation Adjustment Act of 2015. The revised methodology for agencies for 2017 and each year thereafter provides for the improvement of the effectiveness of CMPs and to maintain their deterrent effect. Effective 2017, agencies annual adjustments for in inflation to CMPs apply only to CMPs with a dollar amount.

    The SLSDC's 2017 adjustments for inflation to the CMP set forth in this regulation were determined pursuant to the revised methodology prescribed by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires the maximum CMP to be increased by the cost-of-living adjustment. The term “cost-of-living adjustment” is defined by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. For the 2017 adjustments for inflation to CMPs, the percentage for each CMP by which the Consumer Price Index for the month of October 2016 exceeds the Consumer Price Index for the month of October 2015.

    Classification

    Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act of 2015 (Section 701(b)) requires agencies effective 2017, to make annual adjustments for inflation to CMPs notwithstanding section 553 of Title 5 United States Code. Additionally, the methodology used, effective 2017, for adjusting CMPs for inflation is given by statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The SLSDC is charged only with performing ministerial computations to determine the dollar amount of adjustments for inflation to CMPs. Accordingly, prior public notice and opportunity for public comment are not required for this rule.

    Regulatory Analysis E.O. 12866, Regulatory Review

    SLSDC has considered the impact of this rulemaking action under Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under Executive Order 12866 or Executive Order 13563. This action is limited to the adoption of adjustments of civil penalties under statutes that the agency enforces, and has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures and the policies of the Office of Management and Budget. Because this rulemaking does not change the number of entities that are subject to civil penalties, the impacts are limited.

    We also do not expect the increase in the civil penalty amount in 33 CFR 401.102 to be economically significant. Since January 1, 2010 to the present, the SLSDC assessed a total of approximately $27,000 in civil fines and penalties. Thus, increasing the current civil penalty amount would not result in an annual effect on the economy of $100 million or more.

    Regulatory Flexibility Act

    We have also considered the impacts of this notice under the Regulatory Flexibility Act. I certify that this rule will not have a significant economic impact on a substantial number of small entities. The following provides the factual basis for this certification under 5 U.S.C. 605(b). The St. Lawrence Seaway Regulations and Rules primarily relate to the activities of commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.

    Executive Order 13132 (Federalism)

    Executive Order 13132 requires SLSDC to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, the agency consults with State and local governments, or the agency consults with State and local officials early in the process of developing the proposed regulation.

    This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132.

    The reason is that this rule will generally apply to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels. Thus, the requirements of Section 6 of the Executive Order do not apply.

    Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because this rule will not have a $100 million effect, no Unfunded Mandates assessment will be prepared.

    Executive Order 12778 (Civil Justice Reform)

    This rule does not have a retroactive or preemptive effect. Judicial review of a rule based on this proposal may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.

    Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1980, we state that there are no requirements for information collection associated with this rulemaking action.

    Privacy Act

    Please note that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit http://dms.dot.gov.

    List of Subjects in 33 CFR Part 401

    Hazardous materials transportation, Navigation (water), Penalties, Radio, Reporting and recordkeeping requirements, Vessels, Waterways.

    Accordingly, the Saint Lawrence Seaway Development Corporation is amending 33 CFR part 401 as follows:

    PART 401—SEAWAY REGULATIONS AND RULES Subpart A—Regulations 1. The authority citation for subpart A of part 401 is amended to read as follows: Authority:

    33 U.S.C. 981-990, 1231 and 1232, 49 CFR 1.52, unless otherwise noted.

    2. In § 401.102, paragraph (a) is revised to read as follows:
    § 401.101 Criminal penalty.

    (a) A person, as described in § 401.101(b) who violates a regulation is liable to a civil penalty of not more than $90,063.

    Issued on December 30, 2016. Carrie Lavigne, Chief Counsel.
    [FR Doc. 2016-32050 Filed 1-12-17; 8:45 am] BILLING CODE 4910-61-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AP66 Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) amends its adjudication regulations regarding presumptive service connection, adding certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953, to December 31, 1987. This final rule establishes that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period, and who have been diagnosed with any of eight associated diseases, are presumed to have incurred or aggravated the disease in service for purposes of entitlement to VA benefits. In addition, this final rule establishes a presumption that these individuals were disabled during the relevant period of service for purposes of establishing active military service for benefits purposes. Under this presumption, affected former reservists and National Guard members have veteran status for purposes of entitlement to some VA benefits. This amendment implements a decision by the Secretary of Veterans Affairs that service connection on a presumptive basis is warranted for claimants who served at Camp Lejeune during the relevant period and for the requisite amount of time and later develop certain diseases.

    DATES:

    Effective Date: This final rule is effective March 14, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Eric Mandle, Policy Analyst, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)

    SUPPLEMENTARY INFORMATION: I. Purpose of the Final Rule

    VA amends its adjudication regulations to add certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune, North Carolina, from August 1, 1953, to December 31, 1987. This final rule establishes that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period and who have been diagnosed with any of eight associated diseases, are presumed to have incurred or aggravated the disease in service for purposes of entitlement to VA benefits. In addition, this final rule establishes a presumption that these individuals were disabled during the relevant period of service for purposes of establishing active military service for benefits purposes. Under this presumption, affected former reservists and National Guard members have veteran status for purposes of entitlement to some VA benefits.

    Section 501(a)(1) of title 38, United States Code, provides that “[t]he Secretary has authority to prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by [VA] and are consistent with those laws, including . . . regulations with respect to the nature and extent of proof and evidence and the method of taking and furnishing them in order to establish the right to benefits under such laws.” This broad authority encompasses the establishment of an evidentiary presumption of service connection and exposure under specified circumstances, provided there is a rational basis for the presumptions. In this case, the Secretary has determined that proof of qualifying service at Camp Lejeune, consistent with Public Law 112-154, the Honoring America's Veterans and Caring for Camp Lejeune Families Act of 2012 (Camp Lejeune Act), and the subsequent development of one of the eight listed diseases is sufficient to support the presumption that the resulting disease was incurred in the line of duty during active military, naval, or air service, to include qualifying reserve or National Guard service, to establish entitlement to service connection. See 38 U.S.C. 1110 and 1131.

    II. Summary of Major Provisions

    The major provisions of this final rule include the following: VA will amend 38 CFR 3.307 to establish presumptions of service connection associated with exposure to contaminants in the water supply at Camp Lejeune. This amendment presumes exposure to contaminants in the water supply at Camp Lejeune for all active duty, reserve, and National Guard personnel who served for no less than 30 days (consecutive or nonconsecutive) at Camp Lejeune during the period beginning August 1, 1953, and ending on December 31, 1987. This presumption specifically allows former reservists and National Guard members to establish veteran status by presuming that a covered disease was incurred in the line of duty and was disabling during a period of qualifying service.

    VA will also amend 38 CFR 3.309 to prescribe the eight conditions that are subject to presumptive service connection in relation to exposure to contaminants in the water supply at Camp Lejeune.

    III. Technical Correction

    In the proposed rule, VA proposed amending the heading of 38 CFR 3.307 to read “Presumptive service connection for chronic, tropical or prisoner-of-war related disease, disease associated with exposure to certain herbicide agents, or disease associated with the contaminants in the water supply at Camp Lejeune; wartime and service on or after January 1, 1947.” Additionally, VA proposed amending paragraph (a) of § 3.307 to mirror the title. In reviewing this amendment for the final rule, however, VA realized that the current and proposed text of paragraph (a) contain errors. Namely, they refer to a “chronic, tropical, prisoner of war related disease” rather than a “chronic, tropical or prisoner of war related disease,” as referenced in the heading of § 3.307. Additionally, the heading and proposed text omitted the words “exposure to” before “contaminants in the water supply.” This document corrects these errors by inserting “or” in place of the comma between “tropical” and “prisoner of war” in paragraph (a) to clarify that the terms “chronic,” “tropical,” and “prisoner of war related” refer to three separate categories of disease rather than characteristics of a single disease; and inserting “exposure to” in the heading and paragraph (a) in the phrase pertaining to contaminants in the water supply at Camp Lejeune.

    IV. Public Comments

    On September 9, 2016, VA published in the Federal Register (81 FR 62419) a notice of a proposed rulemaking to amend 38 CFR 3.307 and 3.309 to establish presumptive service connection for certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune, North Carolina, from August 1, 1953 to December 31, 1987. VA provided a 30-day public comment period, which ended on October 11, 2016, and received 290 comments on the proposed rule, one of which was received after the comment period. Although VA is not legally required to consider late-filed comments, it has reviewed, considered, and addressed all comments received in the interest of maximizing public dialogue to further serve veterans, claimants, and authorized representatives. VA received comments from various organizations and individuals, including Disabled American Veterans (DAV), Veterans of Foreign Wars (VFW), Vietnam Veterans of America (VVA), National Organization of Veterans' Advocates (NOVA), C-123 Veterans Association, Fort McClellan Veterans Stakeholders Group, Reserve Officers Association, Marine Corps Reserve Association, United Parkinson's Advocacy Council, Legal Counsel for the Elderly, Project on Government Oversight, a member of Congress, and other interested persons. VA responds to all commenters as follows.

    All of the issues raised by the commenters that concerned at least one portion of the rule can be grouped together by similar topic, and VA has organized the discussion of the comments accordingly. VA also received 85 comments from veterans and surviving spouses regarding individual claims for veterans' benefits. VA does not respond to these comments in this document as they are beyond the scope of this rulemaking.

    For the reasons set forth in the proposed rule and below, VA adopts the proposed rule as final, with changes, as explained below.

    A. 30-Day Exposure Requirement

    VA received 18 comments, including organizational comments from DAV, VVA, NOVA, Project on Government Oversight, and Legal Counsel for the Elderly, regarding its proposal that a veteran, or former reservist or National Guard member must serve no less than 30 days (consecutive or nonconsecutive) at Camp Lejeune during the period beginning August 1, 1953, and ending on December 31, 1987, to receive a presumption of service connection for the eight listed diseases based on exposure to contaminants in the water supply. Two commenters suggested changing the exposure requirement to one week and two weeks, respectively; neither commenter offered a rationale for these time limits. Several commenters suggested eliminating the exposure requirement completely, noting that the 30-day requirement was inconsistent with other toxic exposure presumptions and that it was not supported with scientific evidence. One commenter stated that the 30-day requirement would essentially exclude National Guard members from eligibility. One commenter stated that a 30-day exposure requirement would exclude veterans serving in the Naval Amphibious Force who docked at Camp Lejeune.

    1. Comparison to Prior Exposure Regulations

    VA received several comments, including from DAV, NOVA, VVA, Legal Counsel for the Elderly, and Project on Government Oversight, stating that a 30-day exposure period is inconsistent with VA's requirements for presumptive service connection based on toxic and other exposures. For example, VA has previously established regulations governing presumptive service connection for diseases associated with exposure to certain herbicide agents and certain disabilities occurring in Persian Gulf veterans. See 38 CFR 3.307, 3.309, and 3.317. These regulations do not include a minimum exposure requirement; a veteran must show that he or she served in an identified location or under enumerated circumstances to receive a presumption of service connection.

    While the commenters are correct in that VA does not require a minimum level or duration of exposure for some previously-established presumptions, VA notes that these regulations serve to provide presumptive service connection based on the specified and particular exposures, conditions, and nature of military service in accordance with the scientific and other evidence supporting them. They do not set a binding precedent for future rulemakings that address unrelated circumstances. For example, while presumptive service connection for certain disabilities occurring in Persian Gulf veterans does not require a minimum exposure during military service, 38 CFR 3.317 requires that the qualifying chronic disability must manifest to a degree of 10 percent or more no later than December 31, 2021. This regulation, though, does not require conditions associated with exposure to contaminants in the water supply at Camp Lejeune to manifest by a certain date. Similarly, 38 CFR 3.311 specifies that disabilities presumed to be associated with exposure to ionizing radiation must manifest within certain time periods after exposure to radiation (the time period varies depending on the condition in question). Nothing in this regulation requires a condition associated with exposure to contaminants in the water supply at Camp Lejeune to manifest within a certain period of time following service.

    In addition to being based on different scientific, medical, and military evidence, the prior toxic exposure regulations often stem from a specific, separate statutory authority or requirement. These statutes prescribe the method by which the Secretary may create a regulatory presumption, to include the evidentiary basis for establishing a presumption, periods in which a disability must manifest, covered disabilities, how the Secretary shall determine that a condition is associated with a given toxic exposure, and other requirements specific to the toxic exposure under review. For example, the statutory authority to award presumptive service connection for certain disabilities associated with herbicide exposure in the Republic of Vietnam prescribes the dates during which the veteran must have served within the Republic of Vietnam. See 38 U.S.C. 1116. Similarly, 38 U.S.C. 1117 prescribes the requirements for eligibility for benefits associated with service in the Persian Gulf War. Notably, this statute also grants the Secretary the authority to determine the period of time following service during which a qualifying disability must manifest. See 38 U.S.C. 1117(b).

    In the case of this regulation, Congress did not enact a specific statute authorizing the Secretary to establish compensation for disabilities presumptively related to exposure to contaminants in the water supply at Camp Lejeune. While creating this presumption via regulation fits within the authority conferred by section 501, the Secretary's rulemaking actions must have a rational basis. The Secretary has determined that, in the absence of evidence establishing an appropriate period of time for an exposure requirement, the soundest course is to maintain consistency with the Camp Lejeune Act, which establishes eligibility for VA health care for Camp Lejeune veterans who meet applicable criteria, including a 30-day service requirement. See 38 U.S.C. 1710(e)(1)(F), 38 CFR 17.400. This will help to avoid public confusion and inconsistent results, for example where some Camp Lejeune veterans would be eligible for a presumption for purposes of disability compensation, but not the statutory presumption for health care benefits.

    2. Modality of Exposure to Contaminants

    Comments from DAV and Legal Counsel for the Elderly stated that failure to consider periods of service shorter than 30 days ignores the likelihood of regular and repeated exposure to contaminants through multiple modalities. The commenters noted that the National Research Council (NRC) explored three major routes of exposure to contaminants: Inhalation, skin contact, and ingestion. The NRC's 2009 study noted that doses of contaminants from showering could provide inhalation and dermal exposures that are equivalent to ingesting two liters of water, as water temperature impacted the volatility of the contaminants. Accordingly, commenters argued that when taking into account multiple modalities of exposure, the exposure to contaminants could be much greater in a shorter time period than compared to 30 days of drinking the water. This comment was echoed by several individual commenters.

    As noted in the proposed rule, the Technical Working Group's (TWG) assessment relied on a hazard evaluation model, focusing on the strength of the evidence that a chemical is capable of causing a given health condition. The TWG did not take into account estimated levels of contamination in the water during the period of contamination at Camp Lejeune or the estimated length or intensity of exposure. This is in part because contaimination levels and exposures were not well documented. For example, the 2009 NRC committee was “not aware of any historical information that documents individual water-use patterns and behaviors of residents of base housing.” Committee on Contaminated Drinking Water at Camp Lejeune; National Research Council, Contaminated Water Supplies at Camp Lejeune, Assessing Potential Health Effects 61 (National Academies Press, 2009). Accordingly, the TWG did not characterize the risk associated with potential alternative levels of exposure (to include various modalities of exposure) of those who served or resided at Camp Lejeune during the period of contamination.

    It is also relevant to note that the scientific evidence was not analyzed by VA for sufficiency to support an expert opinion in a legal proceeding regarding causation in any individual case. Therefore, VA intimates no conclusion regarding any individual veteran's development of a disease and its relationship to exposure to contaminated water at Camp Lejeune for any purpose beyond entitlement to disability benefits administered by VA.

    In the notice of proposed rulemaking, VA acknowledged that the available scientific evidence does not provide data on levels of exposure associated with each condition and proposed to rely upon the 30-day service requirement contained in the provisions of the Camp Lejeune Act. In the absence of scientific evidence which supports establishment of an alternative service or exposure requirement, VA's determination favors consistency and parity with its own health care regulation and the statute stands. Congress understood the Camp Lejeune Act to mean that “veterans deserve the presumptions of the service connection in the bill to ensure that they receive the benefits to which they are due,” and did not specify that a different service requirement should exist for purposes of disability compensation. 158 Cong. Rec. H5430 (July 31, 2012) (statement by Rep. Dingell). Creation of a separate standard for the purposes of disability compensation would create inconsistency in the administration of benefits for Camp Lejeune veterans where the statute includes a clear service requirement for health care eligibility; inclusion of the 30-day requirement ensures consistency and parity in this regard with both the Camp Lejeune Act and VA's own regulations implementing the health care provisions of the act. For example, including a service requirement less than that in the Camp Lejeune Act could lead to the situation wherein a veteran is determined to be ineligible for VA health care on the grounds that he or she did not have the necessary 30 days of service at Camp Lejeune, but is then granted service connection on a presumptive basis based on the same service at Camp Lejuene upon filing a claim for compensation. A veteran in this situation could, via operation of this presumption, become eligible for VA health care based on their service connection rating, even though he or she would not have been eligible under the 30-day service requirement of the Camp Lejeune Act. This confusing result could raise a question as to whether VA had indirectly contravened a portion of the Camp Lejeune Act by virtue of a liberalizing evidentiary presumption meant for compensation claims.

    One commenter expressed concern with the 30-day requirement because the individual had documentation stating that his or her length of stay at Camp Lejeune was four weeks (which would be 28 days if read strictly). The individual noted that Department of Defense documentation sometimes references weeks of training, rather than days of training and expressed concern with personal and administrative burden associated with documenting presence on base for a day or two before and/or after training. As stated above, VA is adopting a 30-day requirement to ensure consistency with the Camp Lejeune Act. In adjudicating individual claims, VA is required to assist claimants in obtaining evidence and to resolve reasonable doubt in claimants' favor.

    Thus, while VA acknowledges and thanks the commenters for their input, VA is unable to make any changes based upon these comments at this time. However, VA will continue to review relevant information as it becomes available and will consider future amendments to the 30-day requirement as appropriate.

    3. Decide Claims Through Tort Law

    Another commenter felt that the statutory 30-day requirement lacked a medical basis and felt that veterans' claims should be handled through tort law rather than the disability claim process. VA notes that the 30-day requirement for health care benefits was established by Congress. Furthermore, the presumptions set forth in this rulemaking are for the purposes of administering VA disability compensation benefits only; VA expresses no view regarding the potential correlation between any given level or duration of exposure and the increased risk of disease and/or disability for any purpose beyond this rulemaking. Accordingly, VA takes no action based on this comment.

    4. Eliminate 30-Day Requirement for Health Care

    Another commenter stated that VA should not require 30 days of service at Camp Lejeune to establish entitlement to health care benefits. The service requirement to establish entitlement to health care is mandated by the Camp Lejeune Act. The Camp Lejeune Act is a statute, the provisions of which were enacted by Congress. VA lacks the legal authority to alter, amend, or otherwise change the provisions of a statute and therefore takes no action based on this comment. We discuss the difference in scope between the Camp Lejeune Act and this final rule in greater detail in section D.1, below.

    5. Conduct Additional Studies on Exposure Requirements

    A comment from VFW stated that VA should conduct additional studies to cover the impact of exposure on individuals who served less than 30 days, with the ultimate goal of reducing the 30-day exposure requirement. VA thanks VFW for its suggestion regarding conducting additional studies. However, this rulemaking pertains solely to establishing presumptions of service connection associated with exposure to contaminants in the water supply at Camp Lejeune; conducting scientific and/or medical studies is beyond the scope of this rulemaking. As such, VA makes no change to the final rule based on this comment.

    6. Miscellaneous Alternative Exposure Requirement Comments

    VA received several comments offering additional alternative minimum exposure requirements, with suggestions including a single day at Camp Lejeune and an increase to 90 days. While these comments offered alternative exposure criteria, they did not provide a rationale for the suggested alternative that was rooted in scientific, medical, or other rational basis.

    As discussed above, the notice of proposed rulemaking acknowledged that the current science does not support a specific minimum exposure level for any of the conditions, as the available scientific and medical evidence focused on hazard models when studying the long-term health effects of the contaminants. Lacking such a scientific basis, VA relied upon the only source available in deciding to establish a 30-day exposure requirement: The Camp Lejeune Act. As VA acknowledged in the notice of proposed rulemaking, the Camp Lejeune Act does not provide a legal requirement for prescribing a 30-day service requirement for the purposes of disability compensation. However, the Camp Lejeune Act and VA's prior implementation of its provisions require 30 days of service at Camp Lejeune for a veteran to establish entitlement to health care. See 38 CFR 17.400. In light of the Camp Lejeune Act, VA's implementation of its provisions through 38 CFR 17.400, and the lack of an alternative exposure requirement supported by scientific, medical, or other rational evidence, VA determined that inclusion of the 30-day requirement in this rulemaking ensures consistency and parity with both its health care regulations and the statute.

    Without a rational basis to explain and support an alternative exposure requirement, VA's rulemaking would not comply with the statutory requirements of 38 U.S.C. 501 and therefore takes no action based on these comments. VA will continue to review relevant information as it becomes available and will consider future changes to the regulation as appropriate.

    VA notes that nothing in the provisions of this rule prevents veterans without the requisite 30 days (consecutive or nonconsecutive) of service at Camp Lejeune from establishing service connection for any disease or disability on a direct basis. Direct service connection for any disease alleged to have been caused by the contaminants in the water supply at Camp Lejeune requires evidence of a current disease or disability, evidence of exposure to contaminated water at Camp Lejeune, and a medical nexus between the two, supported by a sufficient medical explanation.

    B. Definition of Service at Camp Lejeune

    VA received seven comments concerning the definition of service at Camp Lejeune for the purposes of establishing entitlement to disability benefits on a presumptive basis, as contained in proposed § 3.307(f)(7)(iii). These comments suggested that the rule make reference to specific locations within the borders of Camp Lejeune, some of which may be considered satellite camps/locations. One commenter noted that veterans may have lived in one of the specified satellite camps/locations while assigned to Camp Lejeune, or vice versa. Another commenter stated that listing specific satellite locations included within the definition of Camp Lejeune would avoid confusion for eligible veterans and minimize the risk of improper denials by claims processors who may not be aware of the satellite camps/locations. One commenter stated that the proposed rule did not include Marine Corps Air Station New River. Legal Counsel for the Elderly stated the presumption should extend to those who served in circumstances “likely” to have resulted in exposure to contaminants in the water supply at Camp Lejeune. This comment gave examples of those who served in training exercises or ships outside of Camp Lejeune but “likely” used water drawn from Camp Lejeune. An additional comment referenced Navy Amphibious Forces that docked at Camp Lejeune and most likely took on board fresh water from the Camp.

    VA makes no change based on these comments. As stated in the proposed rule, VA broadly defined service at Camp Lejeune as any service within the borders of the entirety of the United States Marine Corps Base Camp Lejeune and Marine Corps Air Station New River, North Carolina, during the period beginning on August 1, 1953, and ending on December 31, 1987, as established by military orders or other official service department records. This definition is consistent with the Camp Lejeune Act and VA's prior implementation of the act, promulgated at 38 CFR 17.400. To ensure accurate and consistent application of the definition of service at Camp Lejeune, VA will administratively provide claims processors with all necessary factual and background information to process claims in accordance with this regulation.

    Marine Corps Air Station (MCAS) New River, while located within the borders of the entirety of Camp Lejeune, falls under a separate command from Camp Lejeune itself. VA identified MCAS New River as a separate location as military orders or other official service department records may specifically denote service at or assignment to MCAS New River; failure to specify this location may result in improper denials of claims or create confusion for otherwise eligible veterans. VA notes that service at MCAS Cherry Point, which is geographically separate from Camp Lejeune (approximately 55 miles away), has a separate water source, and is under a separate command structure, does not meet the definition of service at Camp Lejeune for purposes of this rulemaking.

    VA notes that the definition of service at Camp Lejeune relies on military orders or other official service department records to establish that an individual had service at Camp Lejeune for the purposes of entitlement to presumptive service connection based on exposure to contaminants in the water supply. As discussed in the proposed rule, the 2007 United States General Accounting Office (GAO) study found that the contaminated water supply systems served housing, administrative, and recreational facilities, as well as the base hospital at Camp Lejeune. See U.S. General Accounting Office, Defense Health Care: Activities Related to Past Drinking Water Contamination at Marine Corps Base Camp Lejeune (2007). Neither the GAO nor any other available study indicated that individuals who served aboard amphibious vessels were exposed to contaminants found in the water supply at Camp Lejeune. Without evidence in official service department records documenting official orders or assignment to serve, either in an individual capacity or as part of a larger unit, at Camp Lejeune, a claimant does not meet the evidentiary standard for presumptive service connection. As such, without military orders or other official service department records reflecting service at Camp Lejeune, veterans, former reservists or National Guard members who served aboard vessels that docked at Camp Lejeune during the period of contamination are not eligible for presumptive service connection under the provisions of this rule.

    As stated in the proposed rule, veterans without the requisite 30 days (consecutive or nonconsecutive) of service at Camp Lejeune, including those who allege exposure aboard amphibious vessels without military orders or other official service department records reflecting assignment to serve at Camp Lejeune, may still establish service connection for any disease or disability on a direct basis. Direct service connection for any disease alleged to have been caused by the contaminants in the water supply at Camp Lejeune requires evidence of a current disease or disability, evidence of exposure to contaminated water at Camp Lejeune, and a medical nexus between the two, supported by a sufficient medical explanation.

    C. Benefits for Former Reservists and National Guard Members

    VA received five comments regarding benefits for former reservists and National Guard members. One commenter stated that VA should define what benefits are available to reservists under the rule, noting that the rule states reservists would be entitled to “some” benefits under the rulemaking. Similarly, another commenter stated that VA does not consider reservists and former National Guard members “veterans” unless they have a service-connected disability. Another commenter noted that reserve and National Guard status does not meet the requirements of 38 CFR 3.6, and urged VA to amend other regulations to eliminate any conflict for applying presumptions of disability to reserve and National Guard members. Finally, one commenter stated that the rule does not include reservists and asked for VA to amend the rulemaking to include reservists.

    As stated in the proposed rule, basic eligibility for VA benefits requires that an individual be a “veteran” as that term is defined in 38 U.S.C. 101(2). Reserve duty during a period of active duty for training or inactive duty for training generally does not qualify an individual as a “veteran,” because it does not constitute “active military, naval, or air service,” unless the person is disabled or dies during that period of service as prescribed by 38 U.S.C. 101(24)(B) and (C). However, under this rule, former reservists and National Guard members meeting the service criteria for presumptive service connection based on exposure to contaminants at Camp Lejeune have veteran status for the purpose of entitlement to service connection for the enumerated disabilities; there is no limitation of benefits to former reservists and National Guard members under this rule. VA makes no change based upon these comments.

    Another commenter stated that VA's inclusion of former reservists and National Guard members in the rulemaking stretches Congressional intent with regards to the definition of “veteran.” The commenter also suggested that Congress should provide guidance on the definition of a veteran, and that VA is underestimating the financial impact of this rule. As explained in the proposed rule, although 38 U.S.C. 101(24) requires a period of active duty for training or inactive duty training “during which the individual was disabled or died” for this period to constitute active military, naval, or air service, this statute was enacted at a time when the latent effects of exposures to certain harmful chemicals were unrecognized. Further, the legislative history behind this statute does not specifically explain Congress' intent in requiring that the individual “was disabled or died” during the period of service in question. As section 101(24) serves a generally beneficial purpose to recognize certain reserve and National Guard service which results in disability or death as affording veteran status for the purposes of VA disability benefits, and in light of increased medical understanding of the possible latent effects of toxic exposure, VA feels it is reasonable to include former reservists and National Guard members with qualifying service under this rule. Accordingly, VA makes no change based upon this comment.

    D. Comments Pertaining to Presumptive Disabilities

    VA received several comments regarding the disabilities included in the proposed rulemaking. These comments fell into two basic categories: One group related to the general differences between the disabilities in the proposed rule and the health care provisions in the Camp Lejeune Act, while the other comments focused on individual disabilities.

    1. Presumptive Disabilities Differ From the Camp Lejeune Act

    VA received 42 comments, including from VVA, NOVA, and Legal Counsel for the Elderly, regarding the disabilities in our proposed rulemaking and the disabilities listed in the Camp Lejeune Act. The commenters noted that VA's proposed rulemaking contained fewer and different conditions than the Camp Lejeune Act, with several commenters urging VA to adopt the list of disabilities in the Camp Lejeune Act in its entirety, without change. One commenter stated that veterans who develop a condition listed in the health care provisions of the Camp Lejeune Act but not listed as a presumptive disability would be denied compensation benefits for conditions for which health care is being provided. For the reasons enumerated below, VA makes no change based on these comments.

    As explained in the proposed rule, the Camp Lejeune Act provides medical care, but not compensation benefits, to veterans who served on active duty at Camp Lejeune for the 15 identified conditions “notwithstanding that there is insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service.” VA's more recent review of scientific evidence was undertaken to determine the appropriateness of establishing presumptions of service connection for claimants who served at Camp Lejeune. As noted in the proposed rulemaking, this review included the analysis of several hazard evaluations on the chemicals of interest conducted by multiple bodies of scientific experts and was not an evaluation of the specific risks of exposure to contaminated water at Camp Lejeune. VA's review resulted in the recognition that liver cancer and Parkinson's disease, two diseases that were not included in the Camp Lejeune Act, are conditions for which there is strong evidence of a causal relationship and evidence that the condition may be caused by exposure to the contaminants. However, at this time, VA concludes that there is insufficient evidence to establish presumptions of service connection for the following diagnosed chronic disabilities in the Camp Lejeune Act: Esophageal cancer, lung cancer, breast cancer, neurobehavioral effects, and scleroderma. As noted in the notice of proposed rulemaking, none of the evidence reviewed concluded that there is a positive association between these conditions and the volatile organic compounds of interest. The exclusion of scleroderma is addressed separately in the next section.

    Additionally, the health care provisions of the Camp Lejeune Act provide medical coverage for health effects that are not themselves diagnosed diseases or clearly associated with a specific diagnosed disease. To establish that disability arising years after service is associated with harmful exposure in service, the evidence generally must show that the disability results from a disease associated with the in-service exposure. Accordingly, in § 3.307, VA has established presumptions of service connection for specific diseases, as distinguished from general health effects that may result from specific diseases but are not themselves diseases. The available scientific evidence did not identify a specific or general diagnosis of disease associated with renal toxicity or hepatic steatosis, conditions which are included in the provisions of the Camp Lejeune Act.

    Finally, the Camp Lejeune Act included health care for female infertility and miscarriage. However, as noted in the proposed rule, the NRC's 2009 report indicated that the occurrence of female infertility and miscarriage were limited to exposure concurrent with those health effects. As such, the inclusion of these conditions in the Camp Lejeune Act does not provide a basis at this time for presuming current health effects of this type to be associated with past exposure. Additionally, as stated in the proposed rule, these two conditions are not in and of themselves disabilities for which VA can provide disability compensation.

    Accordingly, as noted by one commenter, an outcome of VA's review of the available scientific evidence, to include additional evidence that did not exist at the time the Camp Lejeune Act was passed, may result in situations where an individual receives VHA health care for a covered condition without an associated copayment under the Camp Lejeune Act, but is not eligible for presumptive service connection for disability compensation for that condition under this rulemaking. While these individuals may not be eligible for presumptive service connection under this rulemaking, they may be eligible for direct service connection for any disease alleged to have been caused by the contaminants in the water supply at Camp Lejeune, including a disease or disability covered under the Camp Lejeune Act. As noted earlier in section B, direct service connection requires evidence of a current disease or disability, evidence of exposure to contaminated water at Camp Lejeune, and a medical nexus between the two, supported by a sufficient medical explanation. Conversely, it is similarly possible that a condition not exempted from copayment under the Camp Lejeune Act, such as liver cancer or Parkinson's disease, could be granted presumptive service connection pursuant to this final rule. We note that a grant of service connection for such a condition would exempt treatment associated with that condition from copayment requirements, as VA copayments do not apply to treatment of service connected disabilities. A grant of presumptive service connection could also create an alternative basis for enrollment in the VA health care system. See 38 CFR 17.36.

    VA will continue to review relevant information as it becomes available and will consider future additions to the list of covered conditions as appropriate.

    In addition to suggesting that VA should provide disability compensation for the conditions in the Camp Lejeune Act, one commenter suggested that, alternatively, VA should change the provisions of the Camp Lejeune Act to match the eight disabilities covered in the proposed rule. The Camp Lejeune Act is a statute, the provisions of which were enacted by Congress. VA lacks the legal authority to alter, amend, or otherwise change the provisions of a statute and therefore takes no action based on this comment.

    2. Exclusion of Scleroderma as a Presumptive Disability

    Eight commenters, including the Project on Government Oversight, Legal Counsel for the Elderly, and a member of Congress, specifically questioned VA's exclusion of scleroderma as a presumptive disability. These commenters noted that scleroderma was included in the health care provisions of the Camp Lejeune Act and suggested that VA specifically include this condition as a presumptive disability. Additionally, the comment from a member of Congress stated that there was modest causal evidence from the Agency for Toxic Substances and Disease Registry (ATSDR) and the economic impact of including scleroderma would be minimal, as the number of Camp Lejeune veterans suffering from this condition is small.

    As explained in the proposed rule, due to the lack of new scientific/medical evidence (outside of the available evidence considered by the TWG) linking any of the contaminants found in the water supply with the development of scleroderma specifically, VA cannot create a presumption of service connection for Camp Lejeune veterans at this time. Though the available evidence has established a role for trichloroethylene (TCE) in the development of autoimmune diseases, the studies that specifically report on scleroderma include factors that introduce significant uncertainty into their results, to include small sample sizes and an unexplained gender effect. Although the science does not at this time support the addition of scleroderma to the list of covered diseases, VA will continue to monitor and review future studies as they become available and will consider future additions to the list of covered diseases as appropriate.

    3. Inclusion of Neurobehavioral Effects and Parkinsonism

    VA received eight comments regarding the issue of neurobehavioral effects and parkinsonism, including an organizational comment from the United Parkinson's Advocacy Council. Three commenters stated the presumptive disabilities should include neurobehavioral effects, with one commenter specifying inclusion of specific types of neurobehavioral effects. Another commenter suggested that VA include “Parkinson-like” symptoms as a presumptive disability under the general diagnosis of neurobehavioral effects. The third commenter asked if parkinsonism was included under the definition of Parkinson's disease. Another commenter stated that there is no way to definitively diagnose Parkinson's disease. The United Parkinson's Advocacy Council stated VA should include “atypical parkinsonism” in the rulemaking.

    Parkinson's disease was included in the list of presumptive disabilities due to a recommendation made by the Institute of Medicine (IOM) in their 2015 report “Review of VA Clinical Guidance for the Health Conditions Identified by the Camp Lejeune Legislation.” The IOM noted that Parkinson's disease is a specific neurobehavioral effect that may be experienced by individuals exposed to the contaminants in the water supply at Camp Lejeune.

    Parkinson's disease is medically distinguishable and separately diagnosable from a variety of parkinsonian syndromes, including drug-induced parkinsonism and neurodegenerative diseases, such as multiple systems atrophy, which have parkinsonian features combined with other abnormalities. Most notably, the pathologic findings in cases of parkinsonism show different patterns of brain injury than those noted in patients with Parkinson's disease. See Institute of Medicine of the National Academies, Veterans and Agent Orange: Update 2012, The National Academies Press (Washington, DC, 2014). The studies that have established a relationship between the contaminants in the water supply at Camp Lejeune and Parkinson's disease reported specifically on Parkinson's disease, not parkinsonism or other parkinsonian syndromes. At this time, the available evidence does not establish that parkinsonism and other manifestations of small fiber nerve damage are associated with exposure to the contaminants in the water supply at Camp Lejeune. Therefore, VA makes no change based on these comments.

    4. Adult Leukemia

    VA received 12 comments, including from the Project on Government Oversight and VFW, and one from a member of Congress, addressing the condition of adult leukemia. The commenters stated that VA should clarify the disabilities included in adult leukemia by changing the term to “leukemia,” “adult leukemias,” or by listing all sub-types of leukemia included in the definition of adult leukemia. A comment from a member of Congress specifically cited an ATSDR report, which noted all leukemia sub-types are associated with exposure to contaminants in the water supply at Camp Lejeune. The same member of Congress also stated the use of “adult leukemia” was unnecessary because all who qualify for this benefit are adults, as the rulemaking does not apply to dependents. Another commenter stated that VA should replace the term “adult leukemia” with “chronic or acute forms of lymphocytic and myeloid leukemia” to clarify what conditions are covered. VA disagrees and makes no change based on these comments.

    The term “adult leukemia” clarifies that the types of leukemia covered under this rulemaking must have their onset in adulthood. This distinction between adult and non-adult leukemias is necessary, as the disability compensation provided by this rulemaking applies only to disabilities arising in veterans, reservists, or National Guard members as a result of their exposure to contaminants in the water supply at Camp Lejeune while serving under official military orders or other official assignment. As such, the presumptions of this rulemaking do not apply to veterans, reservists or National Guard members who develop leukemia prior to qualifying service at Camp Lejeune.

    The use of the term “adult leukemia” was not intended to restrict the types of leukemia covered by this rulemaking. No sub-type of leukemia was identified in the rulemaking in order to be inclusive to all types of leukemia, including the sub-types identified by commenters. VA notes that inclusion of specific sub-types included within this definition will lead to an incomplete list, potentially confusing veterans, reservists and National Guard members who have a qualifying disability, as well as claims processors.

    5. Miscellaneous Disabilities

    VA received 53 comments, including organizational comments from the Fort McClellan Veterans Stakeholders Group, which requested inclusion of miscellaneous conditions and disabilities, both specified and unspecified, that were not the subject of the proposed rulemaking, nor were they included in the provisions of the Camp Lejeune Act. These conditions include: Hodgkin's disease, diabetes mellitus, depression, sleep apnea, throat cancer, fibroid sarcoma, prostate cancer, colon cancer, brain cancer, mesothelioma, soft tissue sarcoma, gynecomastia, prolactemia, Crohn's disease, amyloidosis, hidradenitis suppurativa, immune system toxicity, gastrointestinal cancers, other unspecified immune system effects, unspecified neurologic disorders, unspecified skin conditions, unspecified endocrine disorders, unspecified cellular mutation, cancerous and non-cancerous urinary tract conditions, unspecified kidney effects, unspecified liver effects, unspecified endocrine effects, unspecified cardiovascular disorders, and unspecified cancers. Additionally some commenters stated that VA should include additional disabilities without specifying those additions. Two commenters stated that VA should consider all diseases and disabilities as associated with exposure to contaminants in the water supply at Camp Lejeune, noting that VA should bear the burden of proof as to why any disability is unrelated to exposure to contaminants at Camp Lejeune. Another commenter suggested inclusion of conditions not identified by scientific evidence. Finally, one commenter cited a decision by the Board of Veterans' Appeals (BVA) as sufficient evidence to support adding prostate cancer to the list of presumptive disabilities. The same commenter also stated VA should consider adding hepatitis C, noting a correlation between it and prostate cancer.

    As stated in the proposed rule, VA undertook a deliberative scientific process to determine whether available scientific evidence was sufficient to support a presumption of service connection for any health condition as a result of exposure to the chemicals found in the drinking water at Camp Lejeune. This process involved an evaluation of comprehensive hazard studies conducted by several internationally respected expert bodies. VA also notes that BVA decisions are made on the facts, circumstances, and evidence of individual claims on a case-by-case basis; these cases do not set precedent. At this time, there is insufficient medical and scientific evidence to establish a presumption of service connection for any disability beyond the eight conditions included in the rulemaking; therefore, VA makes no change in response to these comments at this time.

    VA relies heavily on studies of exposed populations in order to establish such an association, and will continue to monitor future studies, especially those conducted on the Camp Lejeune population, as they become available. VA will consider additions to the list of presumptive disabilities as appropriate, should future studies provide sufficient evidence for such a change.

    As previously discussed, it is also relevant to note that the scientific evidence was not analyzed by VA for sufficiency to support an expert opinion in a legal proceeding regarding causation in any individual case. Therefore, VA intimates no conclusion regarding any individual veteran's development of a disease and its relationship to exposure to contaminated water at Camp Lejeune.

    6. Kidney Cancer

    One commenter asked why VA is not recognizing kidney cancer as a presumptive disability. As noted in the proposed rule under amended § 3.309(f), kidney cancer is one of the listed conditions VA recognizes as presumptively associated with exposure to contaminants in the water at Camp Lejeune. VA makes no change based upon this comment.

    E. Effective Date

    VA received 27 comments, including from the C-123 Veterans Association, VFW, and NOVA, concerning the effective date of the regulation. Comments included suggestions that this rule should be effective the date a claim was initially filed, even if prior to the effective date of the final rule, or on the date of onset or diagnosis of a covered illness. Other commenters stated the rule should be effective retroactively to the date an eligible veteran first served at Camp Lejeune. Some commenters stated that the rule excludes previously denied claims, and therefore VA should apply the provisions of the Nehmer v. U.S. Department of Veterans Affairs (Nehmer) court order to determine a retroactive effective date for awards. See Nehmer v. U.S. Department of Veterans Affairs, No. CV-86-6161 TEH (N.D. Cal.). One commenter suggested that the rule should be effective the date the proposed rule was published, as it should have been published as an interim final rule. Finally, one commenter asked if a “pending” claim includes the one-year period following notice of a denial as well as appeals before the BVA.

    As stated in the proposed rule, this rule will apply to claims received by VA on or after the effective date of the final rule and to claims pending before VA on that date. Under 38 CFR 3.160(c), a claim that has not been finally adjudicated (which includes claims where a final and binding decision has been issued but the appeal period has not expired) is still considered a pending claim. The rule does not apply retroactively to claims that are finally adjudicated. VA must adhere to the provisions of its change of law regulation, 38 CFR 3.114, which states that where pension, compensation, dependency and indemnity compensation is awarded or increased pursuant to a liberalizing law, or a liberalizing VA issue approved by the Secretary or by the Secretary's direction, the effective date of such award or increase shall be fixed in accordance with the facts found, but shall not be earlier than the effective date of the act or administrative issue. See also 38 U.S.C. 5110(g).

    This final regulation is based on the Secretary's broad authority under 38 U.S.C. 501(a) to “prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by the Department and are consistent with those laws, including— . . . regulations with respect to the nature and extent of proof and evidence . . . in order to establish the right to benefits under such laws.” This rulemaking authority does not explicitly afford the Secretary authority to assign retroactive effect to the regulations created thereunder, and retroactivity is heavily disfavored in the law. As explained in the proposed rule, a claimant whose claim was previously and finally denied may file a new claim to obtain a new determination of entitlement under the final regulation. Finally, VA notes that the effective date provisions of the Nehmer court order apply only to claims based on exposure to herbicides in the Republic of Vietnam during the Vietnam era and are therefore inapplicable to this final rule.

    The Administrative Procedures Act (APA) provides guidance as to when a rulemaking may be published as an interim final rule. Under the APA, a rulemaking may be published as an interim final rule if it is determined that notice and public comment “are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B). As this rulemaking involves significant economic costs, the opportunity for prior review and comment was necessary and in accordance with the public interest. VA has acted expeditiously to consider these public comments and prepare a final rulemaking. Therefore, VA makes no changes based on these comments.

    F. Date Range for Contamination

    One commenter stated the date range for exposure should be extended without specifying exact dates. The commenter stated that contamination likely still existed even after the water supply met unspecified Environmental Protection Agency (EPA) standards. Similarly, VVA stated the contamination period should be extended until December 31, 2000, the last day of the year that the Navy removed contaminated soil and other items from the sites surrounding Camp Lejeune. Another commenter stated the background information in the proposed rule regarding contamination was incorrect; this commenter stated that contamination ended in 1987 and the initial contamination warnings were in 1980. Another commenter stated VA should expand the date range to include those who served from January 1, 1947, through July 31, 1953, without further elaboration.

    As stated in the proposed rule, the Camp Lejeune Act specified a period of contamination from August 1, 1953, through December 31, 1987. This date range is likely based on some of the earliest assessments of the Camp Lejeune water supply noted in the NRC report. This period also represents the ATSDR's best estimate of the period of contamination at Camp Lejeune. In the absence of additional scientific evidence to support an expansion of the contamination period, VA makes no change based upon these comments at this time.

    G. Additional Contaminants

    VA received two comments regarding consideration of additional contaminants. One commenter stated that VA should include information about unspecified lead contamination during the 1990s. The commenter also requested inclusion of information contained in an unspecified 1997 study. Another commenter stated that VA's assessment of contaminants is incomplete, as it does not consider toxic compounds outside those noted in the rulemaking.

    As stated in the proposed rule, VA is only addressing the contamination of the water supplies by the four chemicals of interest (i.e., TCE, perchloroethylene (PCE), benzene, and vinyl chloride) that occurred between August 1, 1953, and December 31, 1987, as a result of on-base industrial activities and an off-base dry cleaning facility. Exposure events unrelated to the specified date range and sources of contamination are unrelated to the subject and scope of this rulemaking; therefore VA makes no change in response to this comment.

    H. Additional Scientific or Medical Evidence

    Two commenters stated that VA should reference additional, uncited studies, stating the rulemaking should consider the effects of exposure to solvent mixtures. One commenter stated VA should reference an unspecified study of the individuals who were actually exposed to contaminants in the water supply at Camp Lejeune. Another commenter, the Fort McClellan Veterans Stakeholders Group, without further elaboration, stated that VA uses the wrong method to evaluate toxic exposures. VA also received a comment stating that unspecified evidence exists to possibly support the addition of more disabilities. One commenter stated that the NRC did not perform a study, it merely reviewed available literature, and the 2009 NRC is flawed and outdated. This same commenter also stated that the description of the collaboration between ATSDR, VA's Camp Lejeune Science Liaison Team, and VA's Technical Workgroup (TWG) was incorrect. The commenter stated that the community was not directly involved in this collaboration. Another commenter stated it was unclear which ATSDR studies were considered in the rulemaking. Other commenters stated generally that inclusion or performance of additional studies could result in a larger list of presumptive disabilities. Finally, one commenter stated that a source with the Center for Disease Control stated it is impossible to determine the minimum level of exposure to a contaminant needed to result in negative health effects.

    VA currently has no information at its disposal to define the specific hazardous exposure levels or combinations of exposure that any one individual received, which would determine exactly who in the veteran population might be at an increased risk of experiencing adverse health effects related to their service at Camp Lejeune. As explained in the proposed rule, the VA review consisted of a hazard evaluation for the four chemicals of interest: TCE, PCE, benzene and vinyl chloride, and focused on the effects of these individual contaminants without regard to specific exposure levels. Additionally, as explained in the rulemaking, VA reviewed evidence from several internationally recognized scientific authorities, including groups other than the NRC. Regarding the description of the process employed by ATSDR, VA notes that ATSDR is an external entity and, as such, is not subject to VA's control. VA also notes that the notice of proposed rulemaking contains a full list of scientific studies and reviews cited in the rulemaking in section E, “Weight-of-Evidence Analyses Considered by the TWG.”

    VA's rule is as inclusive as possible in covering the illnesses of veterans, former reservists and National Guard members exposed to contaminants in the water supply at Camp Lejeune based on the available scientific evidence, in the absence of specific exposure information. VA makes no change based on these comments.

    I. Expedite Rulemaking

    VA received 17 comments, including an organizational comment from VFW, urging VA to expedite the rulemaking, to include publication of a final rule under which benefits may be granted. VA must adhere to the requirements of the APA, which includes a period for public comment and review of the rulemaking. VA appreciates these comments and has taken the necessary steps to ensure this rule is finalized while conforming to the legal requirements of notice and comment rulemaking.

    J. Benefits for Veterans Born at Camp Lejeune Without Service at Camp Lejeune

    One commenter asked if the rule provides compensation for veterans who were born at Camp Lejeune but do not have qualifying active duty, reserve, or National Guard service at Camp Lejeune. VA is only authorized to pay disability compensation for disability resulting from injury suffered or disease contracted in line of duty “in the active military, naval, or air service”. 38 U.S.C. 1110, 1131. Thus, VA has no authority to pay compensation for disability arising from events prior to service entry. VA makes no change based upon this comment.

    K. Standard of Evidence for Claims

    One commenter stated that the proposed rulemaking would still require eligible veterans, former reservists and National Guard members to present a medical opinion in support of their claim for a presumptive disability. As stated in the proposed rulemaking, if a veteran, former reservist or National Guard member meets the stated requirements for service at Camp Lejeune, then the subsequent development of any of the eight listed disabilities is presumed to be related to the exposure to contaminants, in the absence of clear and convincing evidence to the contrary. These presumptions do not require any further evidence to support a claim, including a medical opinion. Therefore, VA makes no change based on this comment.

    Another commenter stated that the proposed rule makes no reference for individual genetic predisposition to increased vulnerability to a specific toxin. The commenter stated this places an unrealistic burden of proof on an individual to prove that he or she suffers a disability due to exposure to toxins. VA has no information at its disposal to define the specific hazardous exposure any individual received, which could assist in determining who in the veteran population was or would be at an increased risk of suffering adverse health effects related to their service at Camp Lejeune. Furthermore, once the basic eligibility requirements of this rule are met (qualifying service and diagnosis of a listed disability), no further information, to include evidence of a genetic vulnerability to a specific toxin, is necessary. Therefore, VA makes no change based on this comment.

    Two commenters asked if a medical opinion that served as the basis of a previous denial could serve as affirmative evidence to rebut the presumption created by this rule. The circumstances of individual claims are beyond the scope of this rulemaking and VA makes no change based upon this comment. However, VA notes that 38 CFR 3.307(d), which pertains to rebuttal of presumptive service connection, specifically requires consideration of all evidence of record when determining the issue of presumptive service connection. As noted above, a claimant whose claim was previously and finally denied may file a new claim to obtain a new determination of entitlement under the final regulation. All claims are adjudicated individually based upon the entire evidentiary record and in accordance with all applicable regulations.

    Legal Counsel for the Elderly stated that VA should allow for a veteran's lay testimony to establish the occurrence of exposure to contaminants in the water supply at Camp Lejeune. VA will consider all evidence of record when deciding claims, including lay testimony. However, VA notes that current regulations provide very specific circumstances as to when a veteran's lay testimony is sufficient to establish an occurrence for the purposes of entitlement to disability benefits. For example, a veteran's lay testimony may be sufficient to establish the occurrence of an injury or event that occurred during combat, if that testimony is consistent with the circumstances, conditions, or hardships of that veteran's service, even where no official record of such incurrence exists. The purpose of this lay statement exception is to acknowledge certain circumstances where official records likely will not exist to establish a fact; in this example, it is highly unlikely that medical records will exist to document the occurrence of an injury at the time it occurred during combat. In the present rulemaking, establishing service at Camp Lejeune requires documentation of 30 days of service at Camp Lejeune by military orders or other official service department records. These documents are regularly and routinely issued by the military as a part of its normal duties in documenting personnel assignments and location and are a part of every servicemember's personnel file. As the evidence required to establish service at Camp Lejeune, and therefore satisfy the condition necessary to presume exposure to contaminants in the water supply, is readily available, VA makes no change based upon this comment.

    Similarly, one commenter stated VA should provide a “benefit of the doubt” to anyone who served at Camp Lejeune in the 1980s. As stated in the rule, this presumption of service connection applies to any veteran, to include former reserve and National Guard members, who served at Camp Lejeune during the relevant time period. This presumption reduces the evidentiary burden required to establish entitlement to disability compensation for certain claims, as further explained in the notice of proposed rulemaking. VA makes no change based upon this comment.

    L. Benefits for Family Members or Civilians

    VA received 11 comments, including an organizational comment from the United Parkinson's Advocacy Council, stating that family members or civilians who were exposed to contaminants in the water supply at Camp Lejeune should receive disability compensation. VA notes that this rulemaking provides disability compensation for qualifying veterans, former reservists or National Guard members; benefits for family members or civilians are beyond the scope of the rulemaking and therefore VA will not respond to this comment. Additionally, VA notes that there is currently no statutory authority to provide benefits to the classes of people identified by the commenters.

    M. General Support for the Rulemaking

    VA received 56 comments, including from the C-123 Veterans Association, DAV, VFW, VVA, Project on Government Oversight, Reserve Officers Association, Marine Corps Reserve Association, United Parkinson's Advocacy Council, and Legal Counsel for the Elderly, expressing support for the rulemaking in general. Many of these comments, which were received from individuals as well as organizations in the veteran community, stated appreciation for VA's actions in establishing a presumption of exposure and service connection for veterans, reservists, and National Guard members exposed to contaminants in the water supply at Camp Lejeune. VA appreciates the time and effort expended by these commenters in reviewing the proposed rule and in submitting comments, as well as their support for this rulemaking.

    N. Negative Comments

    VA received five comments indicating opposition to the rulemaking. These comments expressed disagreement with the rulemaking process in general, and presumptive service connection in particular. VA's decision to create a presumption of exposure to contaminants in the water supply at Camp Lejeune and presumptive service connection for the listed disabilities was issued after the Secretary considered the available scientific evidence and recommendations, as explained in the notice of proposed rulemaking. This evidence demonstrated at least an association between the contaminants in the water supply at Camp Lejeune and the eight listed disabilities. This evidence is supported by published reports from multiple internationally-recognized authorities, and the Secretary has determined this evidence provides a rational basis to issue regulations for presumptions of exposure and service connection. Accordingly, VA makes no change based on these comments.

    O. Character of Discharge and Eligibility for Benefits

    One commenter stated that individuals with an other than honorable discharge are excluded from eligibility under this rulemaking. This rulemaking amends 38 CFR 3.307 and 3.309; it does not affect the provisions of 38 CFR 3.12, which pertains to the character of discharge requirements for benefits eligibility. Therefore, this comment is outside the scope of the rulemaking and VA makes no change based on it.

    P. Statements About Personal Claims

    As stated previously, many commenters made general statements about their own experiences with one or more of the presumptive disabilities, non-presumptive disabilities, their personal disability claims, or their personal health care claims. Comments regarding situations involving the possible outcome of individual claims, or the medical or claims history presented by individual veterans are beyond the scope of this rulemaking. Claimants should contact their VA regional office for assistance with their individual claims.

    Q. Other Comments Unrelated to or Outside the Scope of This Rulemaking

    VA received 30 comments dealing with issues not directly related to the new presumption of exposure or the new presumptively service-connected diseases. Such comments covered a wide range of topics; examples of such comments appear below.

    One commenter stated that VA needs to update the VA Schedule for Rating Disabilities, noting that the criteria used to evaluate the diseases covered under this rulemaking are subjective. Another commenter stated that VA should evaluate individuals who were previously denied as 100 percent disabled. One commenter stated that VA should provide a zero-percent evaluation for any veteran, reservist, or former National Guard member who served at Camp Lejeune during the qualifying period. Two commenters stated that VA should provide health care in addition to disability compensation for veterans, reservists, and former National Guard members contemplated under this rulemaking. Two commenters stated that the rule does not include a mechanism for notifying eligible veterans who may be unaware of their exposure to contaminants in the water supply at Camp Lejeune. Similarly, VFW stated VA should provide notification to claimants who were previously denied benefits. VFW also stated that VA should update the Catalog of Federal Domestic Assistance titles in the rulemaking to indicate the eligibility to additional benefits available to reservists and National Guard members as a result of the rulemaking. Another commenter urged VA to change the health care priority group level for reservists and National Guard members. Another comment stated that the same standards of evidence used to prosecute a corporation that harms an individual with toxic chemicals should be re-introduced in this rulemaking. Two commenters, including the Fort McClellan Veterans Stakeholders Group and the Project on Government Oversight, stated VA should pay benefits to veterans who served at Fort McClellan. Another commenter asked what effect this rulemaking has on the Camp Lejeune Act or House Resolution 3954—The Camp Lejeune Reservist Parity Act of 2015. One commenter stated the government uses members of the armed forces as guinea pigs for vaccines that have not been approved by the Food and Drug Administration. VA received one comment that stated this policy change does not protect the rights of veterans. Another commenter stated that the contamination is a violation of the 5th Amendment rights of those who were exposed and stated the base should be evacuated. Six commenters, including the Reserve Officers Association, requested that VA create or add their information to unspecified lists/registries. Another commenter stated that Parkinson's disease should have been specifically listed as a neurobehavioral effect. One commenter stated that VA should use available scientific evidence to “dismantle” the provisions of other exposure presumptions, such as benefits related to radiation exposure. The same commenter stated that the presumption of soundness does not apply to National Guard or reserve members who did not undergo physical examination during active duty. Finally, this commenter stated that VA should consider National Guard and reserve members as exposed to herbicides while serving in Canada. Another commenter asked if VA would provide compensation to private insurers for treatment of a covered disability. Without elaborating further, one commenter stated the proposal is too limited in scope and took too long to enact; a similar comment was received stating that the rule does not provide “sufficient redress.” Another commenter stated VA should cover the cost of in-vitro fertilization or adoption for veterans experiencing female infertility. One commenter, the Reserve Officers Association, urged Congress to enact additional legislation. A comment from VFW suggested VA study the combined effects of exposure to herbicides and contaminants in the water supply at Camp Lejeune. Another commenter stated that there is nothing in writing that pertains to the individuals who were stationed at Camp Lejeune. VA received a comment stating that VA should provide former Marines with the Purple Heart. One individual stated that qualifying individuals should receive a blanket settlement from the government.

    VA does not respond to these comments because they are either unrelated to this rulemaking or beyond its scope.

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may have an annual effect on the economy of $100 million or more and may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published from FY 2004 Through Fiscal Year to Date.”

    Regulatory Flexibility Act

    The Secretary hereby certifies that these regulatory amendments will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). These amendments will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), these amendments are exempt from the regulatory flexibility analysis requirements of sections 603 and 604.

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

    Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

    Congressional Review Act

    Generally, under the Administrative Procedure Act, the required publication of a substantive rule shall be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this regulatory action is a major rule under the Congressional Review Act, 5 U.S.C. 801-808, because it may result in an annual effect on the economy of $100 million or more. Therefore, in accordance with 5 U.S.C. 801(a)(1), VA will submit to the Comptroller General and to Congress a copy of this regulatory action and VA's Regulatory Impact Analysis. Provided Congress does not adopt a joint resolution of disapproval, this rule will become effective the later of the date occurring 60 days after the date on which Congress receives the report, or the date the rule is published in the Federal Register. 5 U.S.C. 801(a)(3)(A).

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.109, Veterans Compensation for Service-Connected Disability; 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on November 16, 2016, for publication.

    Dated: January 9, 2017. Michael Shores, Acting Director, Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, Veterans.

    For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 3 as follows:

    PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for part 3, subpart A, continues to read as follows: Authority:

    38 U.S.C. 501(a), unless otherwise noted.

    2. Amend § 3.307 by revising the section heading and paragraphs (a) introductory text and (a)(1), and adding paragraph (a)(7) to read as follows:
    § 3.307 Presumptive service connection for chronic, tropical, or prisoner-of-war related disease, disease associated with exposure to certain herbicide agents, or disease associated with exposure to contaminants in the water supply at Camp Lejeune; wartime and service on or after January 1, 1947.

    (a) General. A chronic, tropical, or prisoner of war related disease, a disease associated with exposure to certain herbicide agents, or a disease associated with exposure to contaminants in the water supply at Camp Lejeune listed in § 3.309 will be considered to have been incurred in or aggravated by service under the circumstances outlined in this section even though there is no evidence of such disease during the period of service. No condition other than one listed in § 3.309(a) will be considered chronic.

    (1) Service. The veteran must have served 90 days or more during a war period or after December 31, 1946. The requirement of 90 days' service means active, continuous service within or extending into or beyond a war period, or which began before and extended beyond December 31, 1946, or began after that date. Any period of service is sufficient for the purpose of establishing the presumptive service connection of a specified disease under the conditions listed in § 3.309(c) and (e). Any period of service is sufficient for the purpose of establishing the presumptive service connection of a specified disease under the conditions listed in § 3.309(f), as long as the period of service also satisfies the requirements to establish a presumption of exposure to contaminants in the water supply at Camp Lejeune under paragraph (a)(7)(iii) of this section.

    (7) Diseases associated with exposure to contaminants in the water supply at Camp Lejeune. (i) For the purposes of this section, contaminants in the water supply means the volatile organic compounds trichloroethylene (TCE), perchloroethylene (PCE), benzene and vinyl chloride, that were in the on-base water-supply systems located at United States Marine Corps Base Camp Lejeune, during the period beginning on August 1, 1953, and ending on December 31, 1987.

    (ii) The diseases listed in § 3.309(f) shall have become manifest to a degree of 10 percent or more at any time after service.

    (iii) A veteran, or former reservist or member of the National Guard, who had no less than 30 days (consecutive or nonconsecutive) of service at Camp Lejeune during the period beginning on August 1, 1953, and ending on December 31, 1987, shall be presumed to have been exposed during such service to the contaminants in the water supply, unless there is affirmative evidence to establish that the individual was not exposed to contaminants in the water supply during that service. The last date on which such a veteran, or former reservist or member of the National Guard, shall be presumed to have been exposed to contaminants in the water supply shall be the last date on which he or she served at Camp Lejeune during the period beginning on August 1, 1953, and ending on December 31, 1987. For purposes of this section, service at Camp Lejeune means any service within the borders of the entirety of the United States Marine Corps Base Camp Lejeune and Marine Corps Air Station New River, North Carolina, during the period beginning on August 1, 1953, and ending on December 31, 1987, as established by military orders or other official service department records.

    (iv) Exposure described in paragraph (a)(7)(iii) of this section is an injury under 38 U.S.C. 101(24)(B) and (C). If an individual described in paragraph (a)(7)(iii) of this section develops a disease listed in § 3.309(f), VA will presume that the individual concerned became disabled during that service for purposes of establishing that the individual served in the active military, naval, or air service.

    3. Add § 3.309(f) to read as follows:
    § 3.309 Disease subject to presumptive service connection.

    (f) Disease associated with exposure to contaminants in the water supply at Camp Lejeune. If a veteran, or former reservist or member of the National Guard, was exposed to contaminants in the water supply at Camp Lejeune during military service and the exposure meets the requirements of § 3.307(a)(7), the following diseases shall be service-connected even though there is no record of such disease during service, subject to the rebuttable presumption provisions of § 3.307(d).

    (1) Kidney cancer.

    (2) Liver cancer.

    (3) Non-Hodgkin's lymphoma.

    (4) Adult leukemia.

    (5) Multiple myeloma.

    (6) Parkinson's disease.

    (7) Aplastic anemia and other myelodysplastic syndromes.

    (8) Bladder cancer.

    [FR Doc. 2017-00499 Filed 1-12-17; 8:45 am] BILLING CODE 8320-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 0 and 1 [FCC 16-171] Freedom of Information Act Improvement Act Implementation Order AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Federal Communications Commission amends its rules to update various sections implementing the Freedom of Information Act (FOIA) to reflect changes in the law made by the FOIA Improvement Act of 2016, to making conforming edits to reflect existing Commission FOIA practice, to streamline the Commission's FOIA procedures, and to provide for clerical corrections.

    DATES:

    Effective February 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Yates, 202-418-0886 or TTY: 202-418-0484; [email protected]

    SUPPLEMENTARY INFORMATION:

    1. This is a synopsis of the Federal Communication Commission's Order, FCC 16-171, released on December 15, 2016, amending Parts 0 and 1 of the Commission's rules to update sections implementing the FOIA. The complete text of the document is available on the Commission's Web site at http://www.fcc.gov or at https://apps.fcc.gov/edocs_public/attachmatch/FCC-16-171A1.pdf. It is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554.

    2. By this Order, we amend Part 0 of the Commission's rules to update various sections implementing the Freedom of Information Act (FOIA). On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016 (FOIA Improvement Act). The law went into effect July 1, 2016, and requires, inter alia, that agencies review their FOIA regulations and promulgate new rules in accordance with the substantive provisions of the law. These provisions included providing 90 days for requesters to file appeals of FOIA requests, ensuring that requesters are informed of avenues for FOIA dispute resolution, and providing for public posting of materials that are requested multiple times. The Commission has completed review of its FOIA regulations and in this Order adopts amendments to the rules, thus fulfilling the requirements of section 3(a) of the FOIA Improvement Act.

    3. The amendments made by this Order can generally be grouped into two categories. First are rule amendments that are required by or flow directly from changes made by the FOIA Improvement Act. These include regulatory changes specifically mandated by the FOIA Improvement Act, as well as changes that are informed by the FOIA Improvement Act. Second are rule amendments designed to conform the rules to existing Commission FOIA practice, streamline FOIA procedures, and provide for clerical corrections. A number of years have passed since the Commission's FOIA regulations were last updated, and new technology, practices, and procedures have arisen since that time. We update the regulations to reflect the current state of the Commission's FOIA process.

    4. The Commission's FOIA implementing rules are presently found at 47 CFR 0.441-0.470. The amended rules are set forth in the Appendix to this Order and are described in more detail below.

    5. The following rule changes are either required by the text of the FOIA Improvement Act or are made in response to issues raised in the FOIA Improvement Act.

    6. Section 0.251—Authority Delegated. Section 0.251 describes the authorities delegated to the General Counsel by the Commission. We add to the rule by delegating to the General Counsel the authority to act as the Chief FOIA Officer. The position of Chief FOIA Officer was created by the Open Government Act of 2007 and expanded upon by the FOIA Improvement Act.

    7. Section 0.441—General. Section 0.441 sets forth general information related to the Commission's FOIA practice. We make two changes to this section that are required by the FOIA Improvement Act. First, we include a notice that FOIA requesters may seek the assistance of the FOIA Public Liaison or the Office of Government Information Services to assist in resolving disputes, along with the procedure for engaging such assistance. These changes are specifically required by the FOIA Improvement Act. Second, in light of the FOIA Improvement Act's emphasis on the duties of the Chief FOIA Officer, including new responsibilities to offer training to agency staff and to serve as the liaison with the National Archives and Records Administration's Office of Government Information Services and the Department of Justice's Office of Information Policy, we clarify that the General Counsel serves as the Commission's Chief FOIA Officer and may exercise the responsibilities assigned to that position in the FOIA statute.

    8. Section 0.445—Publication, availability, and use of opinions, orders, policy statements, interpretations, administrative manuals, staff instructions, and frequently requested records. Section 0.445 instructs the public how to access certain publicly available documents. This rule implements various statutory requirements concerning the public availability of these documents. We amend the rule to make electronically available records that have been or are likely to be the subject of multiple FOIA requests, pursuant to the FOIA Improvement Act.

    9. Section 0.457—Records not routinely available for public inspection. Section 0.457 addresses some of the types of records that are routinely withheld from public inspection. We change the introductory paragraph to the section to articulate the reasonably foreseeable harm standard codified in the FOIA Improvement Act. We also amend section 0.457(e) to reflect changes brought about by the FOIA Improvement Act eliminating the deliberative process privilege of FOIA Exemption 5 for records more than 25 years old.

    10. Section 0.461—Requests for inspection of materials not routinely available for public inspection. Section 0.461 sets forth the rules for filing requests to view records that are not routinely available to the public. These rules govern the majority of requests under the FOIA. We extend the amount of time for requesters to file FOIA appeals (called applications for review under Commission practice) from 30 days to 90 days, consistent with the requirements of the FOIA Improvement Act. We will also make a conforming edit to section 1.115(d) of our rules.

    11. Section 0.470—Assessment of fees. Section 0.470 sets out the three fee categories of FOIA requests and the rules regarding fee waivers. Consistent with the FOIA Improvement Act, we make modifications to make clear that the agency may not charge otherwise applicable search and duplication fees when it fails to meet the notice requirements and time limits under the FOIA, unless more than 5,000 pages are necessary to respond to a single request or exceptional circumstances apply.

    12. The following rule changes are not specifically required by the FOIA Improvement Act. Instead, we adopt these rules changes to conform the rules to existing Commission FOIA practice, streamline FOIA procedures, and provide for clerical corrections.

    13. Section 0.251—Authority Delegated. Section 0.251 describes the authorities delegated to the General Counsel by the Commission. We grant to the General Counsel the authority to dismiss FOIA applications for review that are untimely, repetitious, or fail to articulate specific grounds for review. By giving the General Counsel this authority, procedurally defective requests can be dealt with efficiently and expediently without compromising substantive appeal rights, consistent with other regulations.

    14. Section 0.441—General. Section 0.441 sets forth general information related to the Commission's FOIA practice. We make two clerical changes to this rule. First, we amend this section to remove facsimile as a method of contacting the Commission regarding FOIA requests. Second, we remove a reference to the Commission's copy contractor, as the Commission no longer employs a copy contractor.

    15. Section 0.442—Disclosure to other Federal government agencies of information submitted to the Commission in confidence. Section 0.442 applies to the sharing of confidential third-party information with other Federal agencies. We make no changes to this section.

    16. Section 0.445—Publication, availability, and use of opinions, orders, policy statements, interpretations, administrative manuals, staff instructions, and frequently requested records. Section 0.445 instructs the public how to access certain publicly available documents. This rule implements various statutory requirements concerning the public availability of these documents. To reflect current Commission practice, we eliminate a reference to records being held by the Office of Media Relations. We also include a reference to the availability of records on the Electronic Document Management System (EDOCS) and through the Commission's Web site. Lastly, we remove a reference to the Commission's copy contractor, as the Commission no longer employs a copy contractor.

    17. Section 0.451—Inspection of records: Generally. Section 0.451 provides an introduction to the broad category of records that are or are not available to the public, along with specifying where in the rules the procedures for requesting those records can be found. We modify section 0.451(b)(4) (previously numbered section 0.451(b)(5)) to reflect current Commission practice, which permits the release of certain non-internal documents without requiring the filing of a FOIA request. This will facilitate the bureaus' and offices' sharing of non-internal documents without the need for a formal FOIA request. We also amend the rules to simplify the language used and consolidate related subsections.

    18. Section 0.453—Public reference rooms. Section 0.453 currently provides a listing of records routinely available in the Commission's public reference room. It derives from a time that various bureaus and offices of the Commission had individual reference rooms containing paper records for public access. These locations no longer exist, having been supplanted by one central Reference Information Center and the Commission's Web site. We amend the rule to add references to the resources available on the Commission's Web site. It is often simpler and more efficient for members of the public to access this information on the Commission's Web site rather than traveling to the Commission to inspect the records in person. Also, we delete the list of types of documents available in the reference room, and instead provide that a regularly updated list of records will be posted to the Commission's electronic reading room. Using an online list, as opposed to a list set forth in the Code of Federal Regulations, will give staff more flexibility to add to the list of routinely available records, consistent with the FOIA Improvement Act's emphasis on proactive release of records. It will also ensure that the posted list accurately reflects the current routinely available records. Lastly, we include additional information about the types of records available through the Commission's Electronic Comment Filing System (ECFS).

    19. Section 0.455—Other locations at which records may be inspected. Section 0.455 listed the various bureaus and offices of the Commission at which certain other types of records could be inspected. We delete this section in its entirety. As with section 0.453, we conclude it is more efficient to specify these records on a regularly updated online list rather than on a list in the Code of Federal Regulations.

    20. Section 0.457—Records not routinely available for public inspection. Section 0.457 articulates some of the types of records that are routinely withheld from public inspection. We update section 0.457(b)(2) in conformance with the Supreme Court's holding in Milner v. Department of the Navy, reading the plain language of FOIA Exemption 2. Consistent with existing Commission practice, we remove several outdated or inapplicable references to types of records that are generally withheld. We add a reference to withholding of some copyrighted materials, in accordance with Department of Justice guidance. Also, we make several minor clerical changes to the rules.

    21. Section 0.458—Nonpublic information. Section 0.458 contains the rules for persons who come into possession of nonpublic information as the result of an inadvertent or unauthorized release. We make no changes to this section.

    22. Section 0.459—Requests that materials or information submitted to the Commission be withheld from public inspection. Section 0.459 applies to third-party requests for confidential treatment of information given to the Commission. We make no changes to this section.

    23. Section 0.460—Requests for inspection of records which are routinely available to the public. Section 0.460 provides the rules for access to records which are routinely already available to the public. We streamline the process for requesting such records by removing the requirement that initial requests be specifically labeled and include the requester's mailing address, phone number, and email address in order to be considered valid. Instead, we provide that Commission staff may contact the requester if this information becomes necessary. We replace references to the copy contractor and instead direct parties to the Commission's Reference Information Center. We delete section 0.460(i), which provided that records inspected in person be available for seven days. Given the limited number of persons who seek to inspect records in person, this limitation is unnecessary. We also make several minor clerical changes to improve accuracy and readability.

    24. Section 0.461—Requests for inspection of materials not routinely available for public inspection. Section 0.461 sets forth the rules for filing requests to view records that are not routinely available to the public. These rules govern the majority of requests under the FOIA. Consistent with section 0.460, we remove the requirement that requests be specifically labeled and include the requester's mailing address, phone number, and email address in order to be considered valid.

    25. We also amend subsection (d)(1) to remove the use of facsimile or email to file FOIA requests; instead, requesters are directed to submit their requests either via the postal mail or through the Commission's FOIAonline portal. In section 0.461(d)(2), we clarify that the responsibility to sign FOIA response letters may be delegated to staff of the bureau or office that is the custodian of the records. We amend the provisions of section 0.461(e)(1) concerning date stamping of incoming initial requests to reflect the current procedure as implemented through FOIAonline. In section 0.461(e)(2)(i)(B)(1), we modify the situations in which the processing time may be tolled pending the outcome of a fee matter, explicitly providing that the time for processing a FOIA request will be tolled in cases where the amount of fees authorized is less than the estimated cost for completing the production. This is consistent with existing practice. We update section 0.461(e)(3) to reflect the new methods for FOIA requesters to check on the status of their requests. We also provide for consultation with other agencies regarding records in which other agencies have equities in the Commission's decision concerning the disposition of a FOIA request for those records.

    26. In section 0.461(f)(4)-(5), we update the language regarding the use of discretionary authority and segregation of records, to conform it to existing Commission practice. We modify section 0.461(g)(2) to clarify how records will be provided if a requester is unwilling to provide for an extension of time necessary to complete the production. Similar to our rules for FOIA fee waivers and confidentiality requests, in section 0.461(h)(2), we note that merely claiming that a request should be expedited is insufficient to warrant consideration. We also delete section 0.461(n), which provided that records inspected in person be available for only seven days. Given the limited number of persons who seek to inspect records in person, this limitation is unnecessary.

    27. We also make modifications to our FOIA appeals rules in section 0.461(i)-(j). Consistent with section 1.7 of the Commission's rules, appeals are considered filed upon receipt. We also note the availability of the [email protected] email inbox. Lastly, we take additional steps to limit repetitious or deficient FOIA appeals. Petitions for reconsideration will not be entertained after full Commission decisions on FOIA Applications for Review. Such an approach is more consistent with review process in the FOIA, beginning with an initial agency decision, followed by review of that decision by the head of the agency, and finally appeal to the district court.

    28. Section 0.463—Disclosure of Commission records and information in legal proceedings in which the Commission is a non-party. Section 0.463 covers the Commission's procedures for responding to Touhy requests. We make no changes to this section.

    29. Section 0.465—Request for copies of materials which are available, or made available, for public inspection. Section 0.465 specifies the rules for obtaining physical copies of documents. As the Commission does not currently employ a copy contractor, we replace references to the copy contractor and instead direct requesters to the Reference Information Center. We update the types of other media referred to in section 0.465(c)(2) to reflect current technology. We also make other minor adjustments to the language of the section to improve accuracy and readability.

    30. Section 0.466—Definitions. We make no changes to section 0.466, which sets forth definitions applicable to sections 0.467-0.468.

    31. Section 0.467—Search and review fees. Section 0.467 explains what types of fees a requester might be charged in responding to a FOIA request. We delete section 0.467(h), which provided that records inspected in person be available for seven days, and additional fees may be charged if the records are requested again after that seven day period. Given the limited number of persons who seek to inspect records in person, this rule is unnecessary.

    32. Section 0.468—Interest. Section 0.468 specifies how interest will be calculated for unpaid FOIA fees. We make no changes to this section.

    33. Section 0.469—Advance payments. Section 0.469 states the circumstances where the Commission may require advance payment of estimated fees. We make no changes to this section.

    34. Section 0.470—Assessment of fees. Section 0.470 sets out the three fee categories of FOIA requests and the rules regarding fee waivers. We make minor clerical changes to sections 0.470(a)-(b), ensuring consistent use of the term “duplication” or “duplicating,” the terms used in the FOIA. In section 0.470(c), we remove a requirement that FOIA requesters include an explanation and certification when requesting a fee status other than commercial. As a matter of practice, the Commission does not require this. If not evident from the face of the request, staff may require the requester to provide additional information regarding his or her fee status. We delete the last sentence from section 0.470(d), as it only pertains to in person inspection of records, which, as noted above, is uncommon. Lastly, to improve consistency with the FOIA and in line with current Commission practice, we modify section 0.470(f) to provide that fees will not be charged if the cost of collecting and processing the fees are greater than the actual amount of fees to be recovered.

    35. We have determined that the changes we adopt here are general statements of policy, interpretive rules, or rules of agency organization, procedure, or practice, and are therefore exempt from the notice and comment requirements of the Administrative Procedure Act.

    36. Section 603 of the Regulatory Flexibility Act, as amended, requires a regulatory flexibility analysis in notice and comment rulemaking proceedings. As we are adopting these rules without notice and comment, no regulatory flexibility analysis is required. This document does not contain any new proposed information collection(s) subject to the Paperwork Reduction Act of 1995. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002. The Commission will not send a copy of this Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of agency organization, procedure, or practice that do not “substantially affect the rights or obligations of non-agency parties.”

    List of Subjects 47 CFR Part 0

    Classified information, Freedom of information, Government publications, Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements.

    47 CFR Part 1

    Administrative practice and procedure, Government employees, Lawyers.

    Federal Comunications Commission. Katura Howard, Federal Register Liaison Officer, Office of the Secretary. Final Rules

    For the reasons discussed in the preamble, the Federal Communications amends 47 CFR parts 0 and 1 as follows:

    PART 0—COMMISSION ORGANIZATION 1. The authority citation for part 0 continues to read as follows: Authority:

    Sec. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155, 225, unless otherwise noted.

    2. Amend § 0.251 by adding paragraph (j) to read as follows:
    § 0.251 Authority delegated.

    (j) The General Counsel is delegated authority to act as the Commission's Chief FOIA Officer, as specified in 5 U.S.C. 552(j). In this role, the General Counsel is delegated authority to dismiss FOIA applications for review that are untimely, repetitious, or fail to articulate specific grounds for review.

    3. Revise § 0.441 to read as follows:
    § 0.441 General.

    (a) Any person desiring to obtain information from the Commission may do so by contacting the Consumer and Governmental Affairs Bureau (CGB). Requests for information and general inquiries may be submitted by:

    (1) Internet at http://www.fcc.gov/consumer-governmental-affairs or http://www.fcc.gov/foia.

    (2) Telephone at 1-888-CALL-FCC (1-888-225-5322).

    (3) TDD/TDY at 1-888-TELL-FCC (1-888-835-5322).

    (4) Correspondence to: Consumer and Governmental Affairs Bureau, 445 12th Street SW., Washington, DC 20554.

    (5) Visiting the Reference Information Center of the Consumer and Governmental Affairs Bureau at Room CY-A257 of the Commission's main office at 445 12th Street SW., Washington, DC 20554.

    (b) The Commission's FOIA Public Liaison is available to assist any person requesting information from the Commission in resolving any concerns related to a Freedom of Information Act request. Requesters may contact the FOIA Public Liaison to seek assistance on resolving disputes related to FOIA requests. See http://www.fcc.gov/foia/.

    (c) The Office of Government Information Services is available to provide mediation services to help resolve disputes between FOIA requesters and Federal agencies. FOIA requesters may contact the Office of Government Information Services directly to seek its assistance. See http://ogis.archives.gov/.

    (d) The General Counsel shall, subject to the authority of the Chairman, exercise the responsibilities of the Chief FOIA Officer specified in 5 U.S.C. 552(j).

    4. Revise § 0.445 to read as follows:
    § 0.445 Publication, availability, and use of opinions, orders, policy statements, interpretations, administrative manuals, staff instructions, and frequently requested records.

    (a) Adjudicatory opinions and orders of the Commission, or its staff acting on delegated authority, are mailed or delivered by electronic means to the parties, and as part of the record, are available for inspection in accordance with § 0.453.

    (b) Documents adopted by the Commission or a member of its staff on delegated authority and released through the Office of Media Relations are published in the FCC Record. Older materials of this nature are available in the FCC Reports. In the event that such older materials are not published in the FCC Reports, reference should be made to the Federal Register or Pike and Fischer Communications Regulation.

    (c) All rulemaking documents or summaries thereof are published in the Federal Register and are available on the Commission's Web site. The complete text of the Commission decision also is released by the Commission and is available for inspection and copying during normal business hours in the Reference Information Center, via the Electronic Document Management System (EDOCS), or as otherwise specified in the rulemaking document published in the Federal Register.

    (d) Formal policy statements and interpretations designed to have general applicability are published on the Commission's Web site and in the Federal Register, the FCC Record, FCC Reports, or Pike and Fischer Communications Regulation. Commission decisions and other Commission documents not entitled formal policy statements or interpretations may contain substantive interpretations and statements regarding policy, and these are published as part of the document in the FCC Record, FCC Reports or Pike and Fischer Communications Regulation. General statements regarding policy and interpretations furnished to individuals, in correspondence or otherwise, are not ordinarily published.

    (e) Copies of all records that have been released to any person under § 0.461 and that because of the nature of their subject matter, the Commission determines have become or are likely to become the subject of subsequent requests for substantially the same records, or that have been requested three or more times, are made available in electronic format.

    (f) If the documents described in paragraphs (a) through (d) of this section are published in the Federal Register, the FCC Record, FCC Reports, or Pike and Fischer Communications Regulation, they are indexed, and they may be relied upon, used or cited as precedent by the Commission or private parties in any manner. If they are not so published, they may not be relied upon, used or cited as precedent, except against persons who have actual notice of the document in question or by such persons against the Commission. No person is expected to comply with any requirement or policy of the Commission unless he or she has actual notice of that requirement or policy or a document stating it has been published as provided in this paragraph. Nothing in this paragraph, however, shall be construed as precluding a reference to a recent document that is pending publication.

    (g) Subparts A and B of this part describe the functions of the staff and list the matters on which authority has been delegated to the staff. All general instructions to the staff and limitations upon its authority are set forth in those subparts or in decisions of the Commission published in the Federal Register. Instructions to the staff in particular matters or cases are privileged and/or protected and are not published or made available for public inspection.

    (h) To the extent required to prevent a clearly unwarranted invasion of personal privacy, or to prevent disclosure of information required or authorized to be withheld by another statute, the Commission may delete identifying details or confidential information when it makes available or publishes any document described in this section. The justification for any such deletion will be fully explained in a preamble to the document.

    5. Revise § 0.451 to read as follows:
    § 0.451 Inspection of records: Generally.

    (a) Records which are routinely available for public inspection. Section 0.453 specifies those Commission records which are routinely available for public inspection and where those records may be inspected. Procedures governing requests for inspection of such records are set out in § 0.460.

    (b) Records which are not routinely available for public inspection. Records which are not specified in § 0.453 are not routinely available for public inspection. Such records fall into three categories.

    (1) The first category consists of categories of records listed in § 0.457, and of particular records withheld from public inspection under § 0.459. The Commission has determined that there is a statutory basis for withholding these records from public inspection. In some cases, the Commission is prohibited from permitting the inspection of records. This category also includes records that are the property of another agency that the Commission has no authority to release for inspection. In still other cases, the Commission is authorized, for reason of policy, to withhold records from inspection, but is not required to do so. As applicable, procedures governing demands by competent authority for inspection of these records are set forth in § 0.463.

    (2) The second category consists of records that are not specified in § 0.453 or § 0.457 and have not been withheld from inspection under § 0.459. In some cases, these records have not been identified for listing. In other cases an individualized determination is required. Procedures governing requests for inspection of these records are set forth in § 0.461. Procedures governing demands by competent authority for inspection of these records are set forth in § 0.463.

    (3) The third category consists of material previously released consistent with the agency's rules that the agency determines is not likely to become the subject of a subsequent FOIA request or otherwise likely to be of broader public interest.

    (4) Except as provided in § 0.461 and § 0.463, or pursuant to § 19.735-203 of this chapter, no officer or employee of the Commission shall permit the inspection of records which are not routinely available for public inspection under § 0.453, or disclose information contained therein. This provision does not restrict the inspection or disclosure of records described in § 0.453(b)(3).

    (c) Copies. Section 0.465 applies to requests for copies of Commission records which are routinely available for public inspection under § 0.453 and those which are made available for inspection under § 0.461. Sections 0.467 and 0.465(c)(3) apply to requests for certified copies of Commission records.

    (d) Search and copying fees. Section 0.465(c)(2) prescribes the per page fee for copying records made available for inspection under § 0.460 or § 0.461. Section 0.466 prescribes fees to cover the expense of searching for and reviewing records made available for inspection under § 0.460 or § 0.461. Review of initial fee determinations under § 0.467 through § 0.470 and initial fee reduction or waiver determinations under § 0.470(e) may be sought under § 0.461(j).

    6. Revise § 0.453 to read as follows:
    § 0.453 Public reference rooms.

    The Commission's main Web site at http://www.fcc.gov and its electronic reading room at http://www.fcc.gov/general/freedom-information-act-electronic-reading-room host the Commission's online public reference room. The Commission also maintains the FCC Reference Information Center as its public reference room at its offices in Washington, DC.

    (a) The Reference Information Center maintains files containing the record of all docketed cases, petitions for rule making and related papers. A file is maintained for each docketed hearing case and for each docketed rule making proceeding. Cards summarizing the history of such cases for the years before 1984 are available for inspection. Information summarizing the history of such cases for the years from 1984 through present is available online on the Electronic Comment Filing System (ECFS). ECFS serves as the repository for official filings in the FCC's docketed proceedings from 1992 to the present. The public can use ECFS to retrieve any document in the system, including selected pre-1992 documents.

    (b) The Commission will maintain a regularly updated listing of other routinely available records in its electronic reading room at http://www.fcc.gov/general/freedom-information-act-electronic-reading-room.

    § 0.455 [Removed]
    7. Remove § 0.455. 8. Revise § 0.457 to read as follows:
    § 0.457 Records not routinely available for public inspection.

    The records listed in this section are not routinely available for public inspection pursuant to 5 U.S.C. 552(b). The records are listed in this section by category, according to the statutory basis for withholding those records from inspection; under each category, if appropriate, the underlying policy considerations affecting the withholding and disclosure of records in that category are briefly outlined. The Commission will entertain requests from members of the public under § 0.461 for permission to inspect particular records withheld from inspection under the provisions of this section, and will weigh the policy considerations favoring non-disclosure against the reasons cited for permitting inspection in the light of the facts of the particular case. In making such requests, there may be more than one basis for withholding particular records from inspection. The Commission will permit inspection of records unless Commission staff reasonably foresees that disclosure would harm an interest protected by the exemptions described in 5 U.S.C. 552(b) or where disclosure is prohibited by law. The listing of records by category is not intended to imply the contrary but is solely for the information and assistance of persons making such requests. Requests to inspect or copy the transcripts, recordings or minutes of closed agency meetings will be considered under § 0.607 rather than under the provisions of this section.

    (a) Materials that are specifically authorized under criteria established by Executive Order (E.O.) to be kept secret in the interest of national defense or foreign policy and are in fact properly classified pursuant to such Executive Order, 5 U.S.C. 552(b)(1).

    (1) Classified materials and information will not be made available for public inspection, including materials classified under E.O. 10450, “Security Requirements for Government Employees”; E.O. 10501, as amended, “Safeguarding Official Information in the Interests of the Defense of the United States”; and E.O. 13526, “Classified National Security Information,” or any other executive order concerning the classification of records. See also 47 U.S.C. 154(j).

    (2) Materials referred to another Federal agency for classification will not be disclosed while such a determination is pending.

    (b) Materials that are related solely to the internal personnel rules and practices of the Commission, 5 U.S.C. 552(b)(2).

    (c) Materials that are specifically exempted from disclosure by statute (other than the Government in the Sunshine Act, 5 U.S.C. 552b, provided that such statute either requires that the materials be withheld from the public in such a manner as to leave no discretion on the issue, or establishes particular criteria for withholding or refers to particular types of materials to be withheld), 5 U.S.C. 552(b)(3). The Commission is authorized under the following statutory provisions to withhold materials from public inspection.

    (1) Section 4(j) of the Communications Act, 47 U.S.C. 154(j), provides, in part, that, “The Commission is authorized to withhold publication of records or proceedings containing secret information affecting the national defense.” Pursuant to that provision, it has been determined that the following materials should be withheld from public inspection (see also paragraph (a) of this section):

    (i) Maps showing the exact location of submarine cables.

    (ii) Minutes of Commission actions on classified matters.

    (iii) Maps of nation-wide point-to-point microwave networks.

    (2) Under section 213 of the Communications Act, 47 U.S.C. 213(f), the Commission is authorized to order, with the reasons therefor, that records and data pertaining to the valuation of the property of common carriers and furnished to the Commission by the carriers pursuant to the provisions of that section, shall not be available for public inspection. If such an order has been issued, the data and records will be withheld from public inspection, except under the provisions of § 0.461. Normally, however, such data and information is available for inspection.

    (3) Under section 412 of the Communications Act, 47 U.S.C. 412, the Commission may withhold from public inspection certain contracts, agreements and arrangements between common carriers relating to foreign wire or radio communication. Any person may file a petition requesting that such materials be withheld from public inspection. To support such action, the petition must show that the contract, agreement or arrangement relates to foreign wire or radio communications; that its publication would place American communication companies at a disadvantage in meeting the competition of foreign communication companies; and that the public interest would be served by keeping its terms confidential. If the Commission orders that such materials be kept confidential, they will be made available for inspection only under the provisions of § 0.461.

    (4) Section 605 of the Communications Act, 47 U.S.C. 605(a), provides, in part, that, “no person not being authorized by the sender shall intercept any communication [by wire or radio] and divulge or publish the existence, contents, substance, purport, effect, or meaning of such intercepted communications to any person.” In executing its responsibilities, the Commission regularly monitors radio transmissions. Except as required for the enforcement of the communications laws, treaties and the provisions of this chapter, or as authorized in sec. 605, the Commission is prohibited from divulging information obtained in the course of these monitoring activities; and such information, and materials relating thereto, will not be made available for public inspection.

    (5) The Trade Secrets Act, 18 U.S.C. 1905, prohibits the unauthorized disclosure of certain confidential information. See paragraph (d) of this section and § 19.735-203 of this chapter.

    (d) Trade secrets and commercial or financial information obtained from any person and privileged or confidential—categories of materials not routinely available for public inspection, 5 U.S.C. 552(b)(4) and 18 U.S.C. 1905. (1) The materials listed in this paragraph have been accepted, or are being accepted, by the Commission on a confidential basis pursuant to 5 U.S.C. 552(b)(4). To the extent indicated in each case, the materials are not routinely available for public inspection. If the protection afforded is sufficient, it is unnecessary for persons submitting such materials to submit therewith a request for non-disclosure pursuant to § 0.459. A persuasive showing as to the reasons for inspection will be required in requests submitted under § 0.461 for inspection of such materials.

    (i) Financial reports submitted by radio or television licensees.

    (ii) Applications for equipment authorizations (type acceptance, type approval, certification, or advance approval of subscription television systems), and materials relating to such applications, are not routinely available for public inspection prior to the effective date of the authorization. The effective date of the authorization will, upon request, be deferred to a date no earlier than that specified by the applicant. Following the effective date of the authorization, the application and related materials (including technical specifications and test measurements) will be made available for inspection upon request (see § 0.460). Portions of applications for equipment certification of scanning receivers and related materials will not be made available for inspection.

    (iii) Information submitted in connection with audits, investigations and examination of records pursuant to 47 U.S.C. 220.

    (iv) Programming contracts between programmers and multichannel video programming distributors.

    (v) The rates, terms and conditions in any agreement between a U.S. carrier and a foreign carrier that govern the settlement of U.S.-international traffic, including the method for allocating return traffic, except as otherwise specified by the Commission by order or by the International Bureau under delegated authority. See, e.g., International Settlements Policy Reform, IB Docket Nos. 11-80, 05-254, 09-10, RM-11322, Report and Order, FCC 12-145 (rel. Nov. 29, 2012).

    (vi) Outage reports filed under part 4 of this chapter.

    (vii) The following records, relating to coordination of satellite systems pursuant to procedures codified in the International Telecommunication Union (ITU) Radio Regulations:

    (A) Records of communications between the Commission and the ITU related to the international coordination process, and

    (B) Documents prepared in connection with coordination, notification, and recording of frequency assignments and Plan modifications, including but not limited to minutes of meetings, supporting exhibits, supporting correspondence, and documents and correspondence prepared in connection with operator-to-operator arrangements.

    (viii) Information submitted with a 911 reliability certification pursuant to 47 CFR 12.4 that consists of descriptions and documentation of alternative measures to mitigate the risks of nonconformance with certification elements, information detailing specific corrective actions taken with respect to certification elements, or supplemental information requested by the Commission with respect to such certification.

    (ix) Confidential Broadcaster Information, as defined in § 1.2206(d) of this chapter, submitted by a broadcast television licensee in a broadcast television spectrum reverse auction conducted under section 6403 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) (the “Spectrum Act”), or in the application to participate in such a reverse auction, is not routinely available for public inspection until the reassignments and reallocations under section 6403(b)(1)(B) of the Spectrum Act become effective or until two years after public notice that the reverse auction is complete and that no such reassignments and reallocations shall become effective. In the event that reassignments and reallocations under section 6403(b)(1)(B) of the Spectrum Act become effective, Confidential Broadcaster Information pertaining to any unsuccessful reverse auction bid or pertaining to any unsuccessful application to participate in such a reverse auction will not be routinely available for public inspection until two years after the effective date.

    (x) Copyrighted materials the release of which would have a substantial adverse effect on the copyright holder's potential market, except to the extent such a release can be considered fair use.

    Note to paragraph (d)(1):

    The content of the communications described in paragraph (d)(1)(vii)(A) of this section is in some circumstances separately available through the ITU's publication process, or through records available in connection with the Commission's licensing procedures.

    (2) Unless the materials to be submitted are listed in paragraph (d)(1) of this section and the protection thereby afforded is adequate, any person who submits materials which he or she wishes withheld from public inspection under 5 U.S.C. 552(b)(4) must submit a request for non-disclosure pursuant to § 0.459. If it is shown in the request that the materials contain trade secrets or privileged or confidential commercial, financial or technical data, the materials will not be made routinely available for inspection; and a persuasive showing as to the reasons for inspection will be required in requests for inspection submitted under § 0.461. In the absence of a request for non-disclosure, the Commission may, in the unusual instance, determine on its own motion that the materials should not be routinely available for public inspection.

    (e) Interagency and intra-agency memoranda or letters, 5 U.S.C. 552(b)(5). Interagency and intra-agency memoranda or letters and the work papers of members of the Commission or its staff will not be made available for public inspection, except in accordance with the procedures set forth in § 0.461. Normally such papers are privileged and not available to private parties through the discovery process, because their disclosure would tend to restrain the commitment of ideas to writing, would tend to inhibit communication among Government personnel, and would, in some cases, involve premature disclosure of their contents. The Commission will not use this deliberative process exemption to withhold records created 25 years or more before the date on which the request was received.

    (f) Personnel, medical and other files whose disclosure would constitute a clearly unwarranted invasion of personal privacy, 5 U.S.C. 552(b)(6). Under E.O. 12107, the Commission maintains an Official Personnel Folder for each of its employees. Such folders are under the jurisdiction and control, and are a part of the records, of the U.S. Office of Personnel Management. Except as provided in the rules of the Office of Personnel Management (5 CFR 293.311), such folders will not be made available for public inspection by the Commission. In addition, other records of the Commission containing private, personal or financial information will be withheld from public inspection.

    (g) Under 5 U.S.C. 552(b)(7), records compiled for law enforcement purposes, to the extent that production of such records:

    (1) Could reasonably be expected to interfere with enforcement proceedings;

    (2) Would deprive a person of a right to fair trial or an impartial adjudication;

    (3) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;

    (4) Could reasonably be expected to disclose the identity of a confidential source;

    (5) Would disclose investigative techniques or procedures or would disclose investigative guidelines if such disclosure could reasonably be expected to risk circumvention of the law; or

    (6) Could reasonably be expected to endanger the life or physical safety of any individual.

    9. Revise § 0.460 to read as follows:
    § 0.460 Requests for inspection of records which are routinely available for public inspection.

    (a) Section 0.453 specifies those Commission records which are routinely available for public inspection and the places at which those records may be inspected. Subject to the limitations set out in this section, a person who wants to inspect such records need only appear at the Reference Information Center and ask to see the records. Many records also are available on the Commission's Web site, http://www.fcc.gov and the Commission's electronic reading room, http://www.fcc.gov/general/freedom-information-act-electronic-reading-room. Commission documents are generally published in the FCC Record, and many of these documents or summaries thereof are also published in the Federal Register.

    (b) A person who wishes to inspect the records must appear at the specified location during the office hours of the Commission and must inspect the records at that location. (Procedures governing requests for copies are set out in § 0.465.) However, arrangements may be made in advance, by telephone or by correspondence, to make the records available for inspection on a particular date, and there are many circumstances in which such advance arrangements will save inconvenience. If the request is for a large number of documents, for example, a delay in collecting them is predictable. Current records may be in use by the staff when the request is made. Older records may have been forwarded to another location for storage.

    (c) The records in question must be reasonably described by the person requesting them to permit their location by staff personnel. The information needed to locate the records will vary, depending on the records requested. Advice concerning the kind of information needed to locate particular records will be furnished in advance upon request. Members of the public will not be given access to the area in which records are kept and will not be permitted to search the files.

    (d) If it appears that there will be an appreciable delay in locating or producing the records (as where a large number of documents is the subject of a single request or where an extended search for a document appears to be necessary), the requester may be directed to submit or confirm the request in writing in appropriate circumstances.

    (e)(1) Written requests for records routinely available for public inspection under § 0.453 shall be directed to the Commission's Reference Information Center pursuant to the procedures set forth in § 0.465. Requests shall set out all information known to the person making the request which would be helpful in identifying and locating the document, including the date range of the records sought, if applicable. Upon request by Commission staff, the requester shall provide his or her street address, phone number (if any), and email address (if any). Written requests shall, in addition, specify the maximum search fee the person making the request is prepared to pay (see § 0.467).

    (2) Written requests shall be delivered or mailed directly to the Commission's Reference Information Center (see § 0.465(a)).

    (f) When a written request is received by the Reference Information Center, it will be date-stamped.

    (g) All requests limited to records listed in § 0.453 will be granted, subject to paragraph (j) of this section.

    (h) The records will be produced for inspection at the earliest possible time.

    (i) Records shall be inspected within 7 days after notice is given that they have been located and are available for inspection. After that period, they will be returned to storage and additional charges may be imposed for again producing them.

    (j) In addition to the other requirements of this section, the following provisions apply to the reports filed with the Commission pursuant to 5 CFR parts 2634 and 3902.

    (1) Such reports shall not be obtained or used:

    (i) For any unlawful purpose;

    (ii) For any commercial purpose, other than by news and communications media for dissemination to the general public;

    (iii) For determining or establishing the credit rating of any individual; or

    (iv) For use, directly or indirectly, in the solicitation of money for any political, charitable, or other purpose.

    (2) Such reports may not be made available to any person nor may any copy thereof be provided to any person except upon a written application by such person stating:

    (i) That person's name, occupation and address;

    (ii) The name and address of any other person or organization on whose behalf the inspection or copying is requested; and

    (iii) That such person is aware of the prohibitions on the obtaining or use of the report. Further, any such application for inspection shall be made available to the public throughout the period during which the report itself is made available to the public.

    10. Revise § 0.461 to read as follows:
    § 0.461 Requests for inspection of materials not routinely available for public inspection.

    Any person desiring to inspect Commission records that are not specified in § 0.453 shall file a request for inspection meeting the requirements of this section. The FOIA Public Liaison is available to assist persons seeking records under this section. See § 0.441(a).

    (a)(1) Records include:

    (i) Any information that would be an agency record subject to the requirements of the Freedom of Information Act when maintained by the Commission in any format, including an electronic format; and

    (ii) Any information maintained for the Commission by an entity under Government contract.

    (2) The records in question must be reasonably described by the person requesting them to permit personnel to locate them with a reasonable amount of effort. Whenever possible, a request should include specific information about each record sought, such as the title or name, author, recipient, and subject matter of the record. Requests must also specify the date or time period for the records sought. The custodian of records sought may contact the requester to obtain further information about the records sought to assist in locating them.

    (3) The person requesting records under this section may specify the form or format of the records to be produced provided that the records may be made readily reproducible in the requested form or format.

    (b)(1) Requests shall reasonably describe, for each document requested (see § 0.461(a)(1)), all information known to the person making the request that would be helpful in identifying and locating the document, including the date range of the records sought, if applicable, and the persons/offices to be searched, if known. Upon request by Commission staff, the requester shall provide his or her street address, phone number (if any), and email address (if any).

    (2) The request shall, in addition, specify the maximum search fee the person making the request is prepared to pay or a request for waiver or reduction of fees if the requester is eligible (see § 0.470(e)). By filing a FOIA request, the requester agrees to pay all applicable fees charged under § 0.467, unless the person making the request seeks a waiver of fees (see § 0.470(e)), in which case the Commission will rule on the waiver request before proceeding with the search.

    (c) If the records are of the kinds listed in § 0.457 or if they have been withheld from inspection under § 0.459, the request shall, in addition, contain a statement of the reasons for inspection and the facts in support thereof. In the case of other materials, no such statement need accompany the request, but the custodian of the records may require the submission of such a statement if he or she determines that the materials in question may lawfully be withheld from inspection.

    (d)(1) Requests shall be

    (i) Filed electronically though the Internet at http://foiaonline.regulations.gov/; or

    (ii) Delivered or mailed to the Managing Director, Attn: FOIA Request, FCC, 445 12th Street SW., Room 1-A836, Washington, DC 20554.

    (2) For purposes of this section, the custodian of the records is the Chief of the Bureau or Office where the records are located. The Chief of the Bureau or Office may designate an appropriate person to act on a FOIA request. The Chief of the Bureau or Office may also designate an appropriate person to sign the response to any FOIA request. See § 0.461(m).

    (3) If the request is for materials submitted to the Commission by third parties and not open to routine public inspection under § 0.457(d), § 0.459, or another Commission rule or order, or if a request for confidentiality is pending pursuant to § 0.459, or if the custodian of records has reason to believe that the information may contain confidential commercial information, one copy of the request will be provided by the custodian of the records (see paragraph (e) of this section) to the person who originally submitted the materials to the Commission. If there are many persons who originally submitted the records and are entitled to notice under this paragraph, the custodian of records may use a public notice to notify the submitters of the request for inspection. The submitter or submitters will be given ten calendar days to respond to the FOIA request. See § 0.459(d)(1). If a submitter has any objection to disclosure, he or she is required to submit a detailed written statement specifying all grounds for withholding any portion of the information (see § 0.459). This response shall be served on the party seeking to inspect the records. The requester may submit a reply within ten calendar days unless a different period is specified by the custodian of records. The reply shall be served on all parties that filed a response. In the event that a submitter fails to respond within the time specified, the submitter will be considered to have no objection to disclosure of the information.

    Note to paragraph (d)(3):

    Under the ex parte rules, § 1.1206(a)(7) of this chapter, a proceeding involving a FOIA request is a permit-but-disclose proceeding, but is subject to the special service rules in this paragraph. We also note that while the FOIA request itself is a permit-but-disclose proceeding, a pleading in a FOIA proceeding may also constitute a presentation in another proceeding if it addresses the merits of that proceeding.

    (e)(1) When the request is received by the Managing Director, it will be assigned to the Freedom of Information Act (FOIA) Control Office, where it will be entered into the FOIAonline system. The request will be reviewed and, if it is determined that the request meets all the requirements of a proper FOIA request, will be designated as perfected. A FOIA request is then considered properly received. This will occur no later than ten calendar days after the request is first received by the agency.

    (2)(i) Except for the purpose of making a determination regarding expedited processing under paragraph (h) of this section, the time for processing a request for inspection of records will be tolled

    (A) While the custodian of records seeks reasonable clarification of the request;

    (B) Until clarification with the requester of issues regarding fee assessment occurs, including:

    (1) Where the amount of fees authorized is less than the estimated cost for completing the production;

    (2) Following the denial of a fee waiver, unless the requester had provided a written statement agreeing to pay the fees if the fee waiver was denied;

    (3) Where advance payment is required pursuant to § 0.469 and has not been made.

    (ii) Only one Commission request for information shall be deemed to toll the time for processing a request for inspection of records under paragraph (e)(2)(i)(A) of this section. Such request must be made no later than ten calendar days after a request is properly received by the custodian of records under paragraph (e)(1) of this section.

    (3) The FOIA Control Office will send an acknowledgement to the requester notifying the requester of the control number assigned to the request, the due date of the response, and the telephone contact number (202-418-0440) to be used by the requester to obtain the status of the request. Requesters may also obtain the status of an FOIA request via email at [email protected] or by viewing their request at http://foiaonline.regulations.gov/.

    (4) Multiple FOIA requests by the same or different FOIA requesters may be consolidated for disposition. See also § 0.470(b)(2).

    (f) Requests for inspection of records will be acted on as follows by the custodian of the records.

    (1) If the Commission is prohibited from disclosing the records in question, the request for inspection will be denied with a statement setting forth the specific grounds for denial.

    (2)(i) If records in the possession of the Commission are the property of another agency, the request will be referred to that agency and the person who submitted the request will be so advised, with the reasons for referral.

    (ii) If it is determined that the FOIA request seeks only records of another agency or department, the FOIA requester will be so informed by the FOIA Control Officer and will be directed to the correct agency or department.

    (iii) If the records in the possession of the Commission involve the equities of another agency, the Commission will consult with that agency prior to releasing the records.

    (3) If it is determined that the Commission does not have authority to withhold the records from public inspection, the request will be granted.

    (4) If it is determined that the Commission has authority to withhold the records from public inspection, the considerations favoring disclosure and non-disclosure will be weighed in light of the facts presented, and the Commission may, at its discretion, grant the request in full or in part, or deny the request.

    (5) If there is a statutory basis for withholding part of a document from inspection, to the extent that portion is reasonably segregable, that part will be deleted and the remainder will be made available for inspection. Unless doing so would harm an interest protected by an applicable exemption, records disclosed in part shall be marked or annotated, if technically feasible, to show the amount of information deleted, the location of the information deleted, and the exemption under which the deletion is made.

    (6) In locating and recovering records responsive to an FOIA request, only those records within the Commission's possession and control as of the date a request is perfected shall be considered.

    (g)(1) The custodian of the records will make every effort to act on the request within twenty business days after it is received and perfected by the FOIA Control Office. However, if a request for clarification has been made under paragraph (e)(2)(i)(A) of this section or an issue is outstanding regarding the payment of fees for processing the FOIA request is pending under paragraph (e)(2)(i)(B) of this section, the counting of time will start upon resolution of these requests. If it is not possible to locate the records and to determine whether they should be made available for inspection within twenty business days, the custodian may, upon timely notice to the requester, extend the time for action by up to ten business days, in any of the following circumstances:

    (i) It is necessary to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request.

    (ii) It is necessary to search for, collect and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or

    (iii) It is necessary to consult with another agency having a substantial interest in the determination of the request, or among two or more components of the Commission having substantial subject matter interest therein.

    (2) The custodian of the records will notify the requester in writing of any extension of time exercised pursuant to paragraph (g) of this section. The custodian of the records may also call the requester to extend the time provided a subsequent written confirmation is provided. If it is not possible to locate the records and make the determination within the extended period, the person or persons who made the request will be provided an opportunity to limit the scope of the request so that it may be processed within the extended time limit, or an opportunity to arrange an alternative time frame for processing the request or a modified request, and asked to consent to an extension or further extension. If the requester agrees to an extension, the custodian of the records will confirm the agreement in a letter or email specifying the length of the agreed-upon extension. If he or she does not agree to an extension, the request will be denied, on the grounds that the custodian has not been able to locate the records and/or to make the determination within the period for a ruling mandated by the Freedom of Information Act, 5 U.S.C. 552. In that event, the custodian will provide the requester with the records, if any, that could be located and produced within the allotted time. The requester may file an application for review by the Commission.

    (3) If the custodian of the records grants a request for inspection of records submitted to the Commission in confidence under § 0.457(d), § 0.459, or some other Commission rule or order, the custodian of the records will give the submitter written notice of the decision and of the submitter's right to seek review pursuant to paragraph (i) of this section.

    (h)(1) Requesters who seek expedited processing of FOIA requests shall submit such requests, along with their FOIA requests, to the Managing Director, as described in paragraph (d) of this section.

    (2) Expedited processing shall be granted to a requester demonstrating a compelling need that is certified by the requester to be true and correct to the best of his or her knowledge and belief. Simply stating that the request should be expedited is not a sufficient basis to obtain expedited processing.

    (3) For purposes of this section, compelling need means—

    (i) That failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or

    (ii) With respect to a request made by a person primarily engaged in disseminating information, there is an urgency to inform the public concerning actual or alleged Federal Government activity.

    (4)(i) Notice of the determination whether to grant expedited processing shall be provided to the requester by the custodian of records within ten calendar days after receipt of the request by the FOIA Control Office. Once the determination has been made to grant expedited processing, the custodian shall process the FOIA request as soon as practicable.

    (ii) If a request for expedited processing is denied, the person seeking expedited processing may file an application for review within five business days after the date of the written denial. The application for review shall be delivered or mailed to the General Counsel. (For general procedures relating to applications for review, see § 1.115 of this chapter.) The Commission shall act expeditiously on the application for review, and shall notify the custodian of records and the requester of the disposition of such an application for review.

    (i)(1) If a request for inspection of records submitted to the Commission in confidence under § 0.457(d), § 0.459, or another Commission rule or order is granted in whole or in part, an application for review may be filed by the person who submitted the records to the Commission, by a third party owner of the records or by a person with a personal privacy interest in the records, or by the person who filed the request for inspection of records within the ten business days after the date of the written ruling. The application for review shall be filed within ten business days after the date of the written ruling, shall be delivered or mailed to the General Counsel, or sent via email to [email protected], and shall be served on the person who filed the request for inspection of records and any other parties to the proceeding. The person who filed the request for inspection of records may respond to the application for review within ten business days after it is filed.

    (2) The first day to be counted in computing the time period for filing the application for review is the day after the date of the written ruling. An application for review is considered filed when it is received by the Commission. If an application for review is not filed within this period, the records will be produced for inspection.

    (3) If an application for review is denied, the person filing the application for review will be notified in writing and advised of his or her rights. A denial of an application for review is not subject to a petition for reconsideration under § 1.106 of this chapter.

    (4) If an application for review filed by the person who submitted, owns, or has a personal privacy interest in the records to the Commission is denied, or if the records are made available on review which were not initially made available, the person will be afforded ten business days from the date of the written ruling in which to move for a judicial stay of the Commission's action. The first day to be counted in computing the time period for seeking a judicial stay is the day after the date of the written ruling. If a motion for stay is not made within this period, the records will be produced for inspection.

    (j) Except as provided in paragraph (i) of this section, an application for review of an initial action on a request for inspection of records, a fee determination (see § 0.467 through § 0.470), or a fee reduction or waiver decision (see § 0.470(e)) may be filed only by the person who made the request. The application shall be filed within 90 calendar days after the date of the written ruling by the custodian of records. An application for review is considered filed when it is received by the Commission. The application shall be delivered or mailed to the General Counsel, or sent via email to [email protected] If the proceeding involves records subject to confidential treatment under § 0.457 or § 0.459, or involves a person with an interest as described in § 0.461(i), the application for review shall be served on such persons. That person may file a response within 14 calendar days after the application for review is filed. If the records are made available for review, the person who submitted them to the Commission will be afforded 14 calendar days after the date of the written ruling to seek a judicial stay. See paragraph (i) of this section. The first day to be counted in computing the time period for filing the application for review or seeking a judicial stay is the day after the date of the written ruling.

    Note to paragraphs (i) and (j):

    The General Counsel may review applications for review with the custodian of records and attempt to informally resolve outstanding issues with the consent of the requester. For general procedures relating to applications for review, see § 1.115 of this chapter.

    (k)(1)(i) The Commission will make every effort to act on an application for review of an action on a request for inspection of records within twenty business days after it is filed. In the following circumstances and to the extent time has not been extended under paragraphs (g)(1)(i), (ii), or (iii) of this section, the Commission may extend the time for acting on the application for review up to ten business days. (The total period of extensions taken under this paragraph and under paragraph (g) of this section without the consent of the person who submitted the request shall not exceed ten business days.):

    (A) It is necessary to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;

    (B) It is necessary to search for, collect and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or

    (C) It is necessary to consult with another agency having a substantial interest in the determination of the request or among two or more components of the Commission having substantial subject matter interest therein.

    (ii) If these circumstances are not present, the person who made the request may be asked to consent to an extension or further extension. If the requester or person who made the request agrees to an extension, the General Counsel will confirm the agreement in a letter specifying the length of the agreed-upon extension. If the requestor or person who made the request does not agree to an extension, the Commission will continue to search for and/or assess the records and will advise the person who made the request of further developments; but that person may file a complaint in an appropriate United States district court.

    (2) The Commission may at its discretion or upon request consolidate for consideration related applications for review filed under paragraph (i) or (j) of this section.

    (l)(1) Subject to the application for review and judicial stay provisions of paragraphs (i) and (j) of this section, if the request is granted, the records will be produced for inspection at the earliest possible time.

    (2) If a request for inspection of records becomes the subject of an action for judicial review before the custodian of records has acted on the request, or before the Commission has acted on an application for review, the Commission may continue to consider the request for production of records.

    (m) Staff orders and letters ruling on requests for inspection are signed by the official (or officials) who give final approval of their contents. Decisions of the Commission ruling on applications for review will set forth the names of the Commissioners participating in the decision.

    11. Revise § 0.465 to read as follows:
    § 0.465 Request for copies of materials which are available, or made available, for public inspection.

    (a) The Commission may award a contract to a commercial duplication firm to make copies of Commission records and offer them for sale to the public. In addition to the charge for copying, the contractor may charge a search fee for locating and retrieving the requested documents from the Commission's files.

    Note to paragraph (a):

    The name, address, telephone number, and schedule of fees for the current copy contractor, if any, are published at the time of contract award of renewal in a public notice and periodically thereafter. Current information is available at http://www.fcc.gov/foia and http://www.fcc.gov/consumer-governmental-affairs. Questions regarding this information should be directed to the Reference Information Center of the Consumer and Governmental Affairs Bureau at 202-418-0270.

    (b)(1) Records routinely available for public inspection under § 0.453 are available to the public through the Commission's Reference Information Center. Section 0.461 does not apply to such records.

    (2) Audio or video recordings or transcripts of Commission proceedings are available to the public through the Commission's Reference Information Center. In some cases, only some of these formats may be available.

    (c)(1) Contractual arrangements which have been entered into with commercial firms, as described in this section, do not in any way limit the right of the public to inspect Commission records or to retrieve whatever information may be desired. Coin-operated and debit card copy machines are available for use by the public.

    (2) The Commission has reserved the right to make copies of its records for its own use or for the use of other agencies of the U.S. Government. When it serves the regulatory or financial interests of the U.S. Government, the Commission will make and furnish copies of its records free of charge. In other circumstances, however, if it should be necessary for the Commission to make and furnish copies of its records for the use of others, the fee for this service shall be ten cents ($0.10) per page or $5 per computer disk in addition to charges for staff time as provided in § 0.467. For copies prepared with other media, such as thumb drives or other portable electronic storage, the charge will be the actual direct cost including operator time. Requests for copying should be accompanied by a statement specifying the maximum copying fee the person making the request is prepared to pay. If the Commission estimates that copying charges are likely to exceed the greater of $25 or the amount which the requester has indicated that he/she is prepared to pay, then it shall notify the requester of the estimated amount of fees. Such a notice shall offer the requester the opportunity to confer with Commission personnel with the object of revising or clarifying the request.

    Note to paragraph (c)(2):

    The criterion considered in acting on a waiver request is whether “waiver or reduction of the fee is in the public interest because furnishing the information can be considered as primarily benefiting the general public.” 5 U.S.C. 552(a)(4)(A). A request for a waiver or reduction of fees will be decided by the General Counsel as set forth in § 0.470(e).

    (3) Certified documents. Copies of documents which are available or made available, for inspection under §§ 0.451 through 0.465, will be prepared and certified, under seal, by the Secretary or his or her designee. Requests shall be in writing, specifying the exact documents, the number of copies desired, and the date on which they will be required. The request shall allow a reasonable time for the preparation and certification of copies. The fee for preparing copies shall be the same as that charged by the Commission as described in paragraph (c)(2) of this section. The fee for certification shall be $10 for each document.

    (d)(1) Computer maintained databases produced by the Commission and routinely available to the public (see § 0.453) may be obtained from the FCC's Web site at http://www.fcc.gov or if unavailable on the Commission's Web site, from the Reference Information Center.

    (2) Copies of computer generated data stored as paper printouts or electronic media and available to the public may also be obtained from the Commission's Reference Information Center (see paragraph (a) of this section).

    (3) Copies of computer source programs and associated documentation produced by the Commission and available to the public may be obtained from the Office of the Managing Director.

    (e) This section does not apply to records available on the Commission's Web site, http://www.fcc.gov, or printed publications which may be purchased from the Superintendent of Documents or private firms (see §§ 0.411 through 0.420), nor does it apply to application forms or information bulletins, which are prepared for the use and information of the public and are available upon request (see §§ 0.421 and 0.423) or on the Commission's Web site, http://www.fcc.gov/formpage.html.

    12. Revise § 0.467 to read as follows:
    § 0.467 Search and review fees.

    (a)(1) Subject to the provisions of this section, an hourly fee shall be charged for recovery of the full, allowable direct costs of searching for and reviewing records requested under § 0.460 or § 0.461, unless such fees are reduced or waived pursuant to § 0.470. The fee is based on the pay grade level of the FCC's employee(s) who conduct(s) the search or review, or the actual hourly rate of FCC contractors or other non-FCC personnel who conduct a search.

    Note to paragraph (a)(1):

    The fees for FCC employees will be modified periodically to correspond with modifications in the rate of pay approved by Congress and any such modifications will be announced by public notice and will be posted on the Commission's Web site, http://www.fcc.gov/foia/#feeschedule.

    (2) The fees specified in paragraph (a)(1) of this section are computed at Step 5 of each grade level based on the General Schedule or the hourly rate of non-FCC personnel, including in addition twenty percent for personnel benefits. Search and review fees will be assessed in 1/4 hour increments.

    (b) Search fees may be assessed for time spent searching, even if the Commission fails to locate responsive records or if any records located are determined to be exempt from disclosure.

    (c) The Commission shall charge only for the initial review, i.e., the review undertaken initially when the Commission analyzes the applicability of a specific exemption to a particular record. The Commission shall not charge for review at the appeal level of an exemption already applied. However, records or portions of records withheld in full under an exemption that is subsequently determined not to apply may be reviewed again to determine the applicability of other exemptions not previously considered. The costs of such a subsequent review, under these circumstances, are properly assessable.

    (d) The fee charged will not exceed an amount based on the time typically required to locate records of the kind requested.

    (e)(1) If the Commission estimates that search charges are likely to exceed the greater of $25 or the amount which the requester indicated he/she is prepared to pay, then it shall notify the requester of the estimated amount of fees. Such a notice shall offer the requester the opportunity to confer with Commission personnel with the object of revising or clarifying the request. See § 0.465(c)(2) and § 0.470(d).

    (2) The time for processing a request for inspection shall be tolled while conferring with the requester about his or her willingness to pay the fees required to process the request. See § 0.461(e).

    (f) When the search has been completed, the custodian of the records will give notice of the charges incurred to the person who made the request.

    (g) The fee shall be paid to the Financial Management Division, Office of Managing Director, or as otherwise directed by the Commission.

    13. Revise § 0.470 to read as follows:
    § 0.470 Assessment of fees.

    (a)(1) Commercial use requesters. (i) When the Commission receives a request for documents for commercial use, it will assess charges that recover the full direct cost of searching for, reviewing and duplicating the records sought pursuant to § 0.466 and § 0.467.

    (ii) Commercial use requesters shall not be assessed search fees if the Commission fails to comply with the time limits under § 0.461(g), except as provided in paragraph (a)(1)(iii) of this section.

    (iii) Commercial requesters may still be assessed search fees when the Commission fails to comply with the time limits under § 0.461(g) if the Commission determines that unusual circumstances apply and more than 5,000 pages are necessary to respond to the request, so long as the Commission has provided a timely written notice to the requester and has discussed with the requester (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request. Additionally, if a court has determined that exceptional circumstances exist, a failure to comply with a time limit under § 0.461(g) will be excused for the length of time provided by the court order.

    (2) Educational and non-commercial scientific institution requesters and requesters who are representatives of the news media. (i) The Commission shall provide documents to requesters in these categories for the cost of duplication only, pursuant to § 0.465 above, excluding duplication charges for the first 100 pages, provided however, that requesters who are representatives of the news media shall be entitled to a reduced assessment of charges only when the request is for the purpose of distributing information.

    (ii) Educational requesters or requesters who are representatives of the news media shall not be assessed fees for the cost of duplication if the Commission fails to comply with the time limits under § 0.461(g), except as provided in paragraph (a)(2)(iii) of this section.

    (iii) Educational requesters or requesters who are representatives of the news media may still be assessed duplication fees when the Commission fails to comply with the time limits under § 0.461(g) if the Commission determines that unusual circumstances apply and more than 5,000 pages are necessary to respond to the request, so long as the Commission has provided a timely written notice to the requester and has discussed with the requester (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request. Additionally, if a court has determined that exceptional circumstances exist, a failure to comply with a time limit under § 0.461(g) will be excused for the length of time provided by the court order.

    (3) All other requesters. (i) The Commission shall charge requesters who do not fit into any of the categories above fees which cover the full, reasonable direct cost of searching for and duplicating records that are responsive to the request, pursuant to § 0.465 and § 0.467, except that the first 100 pages of duplication and the first two hours of search time shall be furnished without charge.

    (ii) All other requesters shall not be assessed search fees if the Commission fails to comply with the time limits under § 0.461(g), except as provided in paragraph (a)(3)(iii) of this section.

    (iii) All other requesters may still be assessed search fees when the Commission fails to comply with the time limits under § 0.461(g) if the Commission determines that unusual circumstances apply and more than 5,000 pages are necessary to respond to the request, so long as the Commission has provided a timely written notice to the requester and has discussed with the requester (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request. Additionally, if a court has determined that exceptional circumstances exist, a failure to comply with a time limit under § 0.461(g) will be excused for the length of time provided by the court order.

    (b)(1) The 100 page restriction on assessment of duplication fees in paragraphs (a)(2) and (3) of this section refers to 100 paper copies of a standard size, which will normally be 81/2″ x 11″ or 11″ x 14″.

    (2) When the agency reasonably believes that a requester or group of requesters is attempting to segregate a request into a series of separate individual requests for the purpose of evading the assessment of fees, the agency will aggregate any such requests and assess charges accordingly.

    (c) When a requester believes he or she is entitled to a waiver pursuant to paragraph (e) of this section, the requester must include, in his or her original FOIA request, a statement explaining with specificity, the reasons demonstrating that he or she qualifies for a fee waiver. Included in this statement should be a certification that the information will not be used to further the commercial interests of the requester.

    (d) If the Commission reasonably believes that a commercial interest exists, based on the information provided pursuant to paragraph (c) of this section, the requester shall be so notified and given an additional ten business days to provide further information to justify receiving a reduced fee. See § 0.467(e)(2).

    (e)(1) Copying, search and review charges shall be waived or reduced by the General Counsel when “disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester.” 5 U.S.C. 552(a)(4)(A)(iii). Simply repeating the fee waiver language of section 552(a)(4)(A)(iii) is not a sufficient basis to obtain a fee waiver.

    (2) The criteria used to determine whether disclosure is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government include:

    (i) Whether the subject of the requested records concerns the operations or activities of the government;

    (ii) Whether the disclosure is likely to contribute to an understanding of government operations or activities; and

    (iii) Whether disclosure of the requested information will contribute to public understanding as opposed to the individual understanding of the requester or a narrow segment of interested persons.

    (3) The criteria used to determine whether disclosure is primarily in the commercial interest of the requester include:

    (i) Whether the requester has a commercial interest that would be furthered by the requested disclosure; and, if so

    (ii) Whether the magnitude of the identified commercial interest of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is primarily in the commercial interest of the requester.

    (4) This request for fee reduction or waiver must accompany the initial request for records and will be decided under the same procedures used for record requests.

    (5) If no fees or de minimis fees would result from processing a FOIA request and a fee waiver or reduction has been sought, the General Counsel will not reach a determination on the waiver or reduction request.

    (f) Whenever Commission staff determines that the total fee calculated under this section likely is less than the cost to collect and process the fee, no fee will be charged.

    (g) Review of initial fee determinations under § 0.467 through § 0.470 and initial fee reduction or waiver determinations under paragraph (e) of this section may be sought under § 0.461(j).

    PART 1—PRACTICE AND PROCEDURE 14. The authority citation for part 1 continues to read as follows: Authority:

    15 U.S.C. 79 et seq.; 47 U.S.C. 151, 154(i), 154(j), 155, 157, 160, 201, 225, 227, 303, 309, 310, 332, 1403, 1404, 1451, 1452, and 1455.

    15. Amend § 1.115 by revising paragraph (d) to read as follows:
    § 1.115 Application for review of action taken pursuant to delegated authority.

    (d) Except as provided in paragraph (e) of this section and in § 0.461(j) of this chapter, the application for review and any supplemental thereto shall be filed within 30 days of public notice of such action, as that date is defined in § 1.4(b). Opposition to the application shall be filed within 15 days after the application for review is filed. Except as provided in paragraph (e)(3) of this section, replies to oppositions shall be filed within 10 days after the opposition is filed and shall be limited to matters raised in the opposition.

    [FR Doc. 2016-31703 Filed 1-12-17; 8:45 am] BILLING CODE 6712-01-P
    82 9 Friday, January 13, 2017 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 65 [Doc. No. AMS-LPS-16-0014] Addition of Mandatory Country of Origin Labeling Requirements for Venison AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Agricultural Marketing Service (AMS) proposes to amend the country of origin labeling (COOL) regulation to add muscle cuts of venison and ground venison to mandatory COOL requirements. AMS is issuing this proposed rule to conform to amendments to the Agricultural Marketing Act of 1946 (Act) as mandated by the Agricultural Act of 2014 (2014 Farm Bill), that added muscle cuts of venison and ground venison to the list of covered commodities subject to mandatory COOL.

    DATES:

    Submit comments on or before March 14, 2017. Pursuant to the Paperwork Reduction Act, comments on the recordkeeping burden that would result from this proposal must be received by March 14, 2017.

    ADDRESSES:

    All comments should reference the docket number AMS-LPS-16-0014; the date of submission; and the page number of this issue of the Federal Register. Comments may also be submitted to: Julie Henderson, Director, COOL Division; Livestock, Poultry, and Seed Program, Agricultural Marketing Service, U.S. Department of Agriculture (USDA); Room 2614-S, STOP 0216; 1400 Independence Avenue SW., Washington, DC 20250-0216. AMS will make the comments available for public inspection at the above address during regular business hours or via the Internet at www.regulations.gov.

    Pursuant to the Paperwork Reduction Act (PRA), send comments regarding the accuracy of the burden estimate, ways to minimize burden, including the use of automated collection techniques or other forms of information technology, or any other aspect of this collection of information to the above address. Comments concerning the information collection under PRA also should be sent to the Desk Office for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503.

    Please be advised that all comments submitted in response to this proposed rule will be included in the record without change and will be made available to the public on the Internet at www.regulations.gov. The identity, including any personal information provided, of the individuals or entities submitting the comments will be made public.

    FOR FURTHER INFORMATION CONTACT:

    Julie Henderson, Director, COOL Division; Livestock, Poultry, and Seed Program, Agricultural Marketing Service, USDA; Room 2614-S, STOP 0216; 1400 Independence Avenue SW., Washington, DC 20250-0216; telephone (202) 720-4486; or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This proposed rule has been determined to be not significant for purposes of Executive Order 12866 or Executive Order 13563. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have a retroactive effect. The Act prohibits states or political subdivisions of a state to impose any requirement that is in addition to, or inconsistent with, any requirement of the Act. There are no civil justice implications associated with this proposed rule.

    Executive Order 13132

    This proposed rule has been reviewed under Executive Order 13132, Federalism. This Order directs agencies to construe, in regulations and otherwise, a Federal statute to preempt state law only where the statute contains an express preemption provision. No federalism implications are associated with this proposed rule.

    With regard to consultation with states, as directed by Executive Order 13132, AMS previously consulted with the states that have country of origin labeling programs. Currently, AMS has cooperative agreements with 47 states to assist in the enforcement of the COOL program and has communications with all 50 states on a regular basis.

    Background and Proposed Revisions

    AMS is proposing to add venison and ground venison to the list of covered commodities subject to mandatory COOL regulation in conformance to section 12104(b) of the Agricultural Act of 2014 (2014 Farm Bill) (Pub. L. 113-79). Retailers and suppliers would subsequently be required to keep records and provide their customers notification of the country of origin of muscle cuts and ground venison that they sell. Individuals that supply venison, whether directly to retailers or indirectly through other participants in the marketing chain, would be required to establish and maintain country of origin information for venison and supply this information to retailers. As a result, producers, handlers, manufacturers, wholesalers, importers, and retailers of venison would be affected.

    This proposed rule would amend the country of origin labeling regulations (7 CFR part 65). AMS proposes to add definitions for cervidae (§ 65.117), ground venison (§ 65.178), and venison (§ 65.270). The proposed rule would amend definitions for covered commodity (§ 65.135(a)(1) and (2)), production step (§ 65.230), raised (§ 65.235), slaughter (§ 65.250), and United States country of origin (§ 65.260(a)) by adding references to venison. AMS proposes to amend country of origin notification (§ 65.300(h)) to add references to ground venison, and responsibilities of suppliers (§ 65.500(b)(1)) to include references to venison and cervidae.

    Additional administrative changes are necessary to reflect the withdrawal of beef and pork commodities from the COOL regulations as published in the Federal Register on March 2, 2016 (81 FR 10761). Therefore, AMS is proposing to amend production step (§ 65.230), raised (§ 65.235), and United States country of origin (§ 65.260) by removing references to beef and pork from these definitions.

    AMS is seeking comments on the aforementioned definitions and requirements. AMS also invites comments concerning potential economic and other effects of this proposed rule.

    Initial Regulatory Flexibility Analysis

    Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Administrator of AMS has considered the economic effect of this action on small entities and has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities. The purpose of RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly burdened.

    Venison Industry

    In general, the supply chain for venison and ground venison consists of: Producers (ranchers); slaughterhouses, processors, importers, wholesalers, and distributors (intermediary firms); and retailers. Under this proposed rule, all entities in the supply chain would be affected. Because the venison industry is very small at all levels of the supply chain, the overall impact of this proposed rule would be insignificant. According to the 2014 North American Deer Farmers Association's Venison Council, most venison is sold to restaurants, which are not subject to COOL requirements.

    The proposed rule would impose recordkeeping requirements on venison producers and intermediary firms selling venison destined for retail channels. Individual retailers selling venison would also be subject to point of sale labeling and recordkeeping requirements. Each participant in the venison supply chain would bear recordkeeping costs as well as costs associated with modifications to their business practices.

    Producers

    USDA's National Agricultural Statistics Service (NASS) estimated that, in 2012, there were 4,042 deer farms and 1,199 elk farms, totaling 5,241 venison farms, in the U.S. This is a decrease from 7,571 in 2007. Of the venison producers identified in a Texas A&M University 2007 study,1 32 percent of survey respondents were breeding and hunting operations and 7 percent were hunting-only operations. Moreover, the trophy-hunting segment of the venison industry represents the primary end market for the breeding stock industry. Breeding and hunting and hunting-only operations are not considered to be producers of venison for consumption that are subject to COOL. Relying on the NASS and Texas A&M data, AMS assumes that 60 percent of the ranches, or 3,144 producers, raise animals for meat consumption. Virtually all venison-producing operations that would be subject to the amended COOL regulations are small businesses under the criteria established by the Small Business Administration (SBA) [13 CFR 121.201]. SBA defines small agricultural producers as those having annual receipts of less than $750,000.

    1 Anderson, D.P., Frosch, B.J., and Outlaw, J.L. Economic Impact of the United States Cervid Farming Industry. APFC Research Report 07-4, August 2007. Agricultural & Food Policy Center. Texas A&M University: College Station, TX.

    While AMS believes that venison producers already maintain birth and raising records on each animal (which may include ear tagging, radio frequency identification devices, and other related means of identification on either an animal or a lot basis) as a normal part of business operations and animal husbandry practices, venison producers may use an affidavit to proclaim where the animals they produce are born and raised, not by individual but for the whole herd. Two factors drive the cost to venison producers to comply with this proposed rule: The time to create the initial affidavit and the time to administer and maintain the affidavit annually. AMS estimates it will take each venison producer 15 minutes (0.25 hours) to create and sign the initial affidavit used to substantiate country of origin claims and carry out the purposes of this regulation. If producers sign an affidavit of country of origin on all animals in the herd, the affidavit will suffice to achieve the purposes of this regulation even if some of the venison produced ultimately is not sold to retail establishments covered by the regulation.

    For venison producers, it is assumed that the added work needed to generate an affidavit from an existing recordkeeping system for country of origin is primarily a bookkeeping task. This task may be performed by an independent bookkeeper, or in the case of operations that perform their own bookkeeping, an individual with equivalent skills. The Bureau of Labor Statistics (BLS) publishes wage rates for bookkeepers, accounting, and auditing clerks. In estimating recordkeeping costs, May 2015 wage rates and benefits published by BLS from the National Compensation Survey are used. It is assumed that this wage rate represents the cost for venison producers to hire an independent bookkeeper. In the case of venison producers who currently perform their own bookkeeping, it is assumed that this wage rate represents the opportunity cost of the producers' time for performing these tasks. The May 2015 wage rate is estimated at $23.23 per hour. For this analysis, an additional 33 percent is added to the wage rate to account for total benefits, which include Social Security, unemployment insurance, workers compensation, etc. resulting in $30.90 per hour. Recordkeeping time for venison producers to generate and sign a producer affidavit is estimated at 15 minutes (0.25 hours) per operation. This 0.25 hours multiplied by 3,144 producers at a cost of $30.90 per hour results in approximately $24,287 to generate affidavits to substantiate country of origin claims. Annual maintenance is estimated to take 5 minutes (0.083 hours) for each of the 3,144 operations at a cost of $30.90 per hour for total annual costs of $8,063. Therefore, the total cost estimates for producers are $32,351, or approximately $10.29 per firm.

    Intermediary Firms

    Any establishment that supplies retailers with venison or ground venison would be required to provide country of origin information to retailers. This includes importers, slaughterhouses, processors, wholesalers, and distributors.

    From 2011 to 2015, USDA's Foreign Agricultural Service (FAS) reported venison imports of 21.78 million pounds valued at $79.3 million. For those years, the average annual venison imports were 4.356 million pounds valued at $15.86 million, or $3.64 per pound. During this period, the United States saw a dramatic increase in venison imports, with virtually all of it originating from New Zealand. For an imported venison covered commodity, the importer of record must ensure that records provide clear product tracking from the port of entry into the U.S. to the immediate subsequent recipient. In addition, the records must accurately reflect the country of origin in relevant U.S. Customs and Border Protection entry documents and information systems. Regulated firms must maintain records to verify the accuracy of COOL declarations for a period of one year from the date of the transaction (purchase or sale of animals for slaughter, or venison meat at each point in the supply chain). AMS expects that importers already maintain records mandated by other Federal Statutes (e.g., Bioterrorism Act of 2002; Tariff Act of 1930) that would be sufficient to verify compliance with COOL.

    Of intermediaries potentially affected by the proposed rule, SBA classifies as small those manufacturing firms with less than 500 employees and wholesalers with less than 100 employees. Therefore, approximately 93 percent of the general-line grocery wholesalers are small businesses. According to NASS' 2012 Economic Census, there were a total of 2,162 meat and meat products specialty wholesaler firms. Of these, 2,043 firms had less than 100 employees, meaning approximately 95 percent of meat wholesalers are small firms. That same Census reported that 2,354 out of 2,629 (90 percent) livestock processing and slaughtering firms were in operation and classified as small businesses. USDA's Food Safety Inspection Service (FSIS) reported that 577 FSIS-inspected establishments (22 percent) in the U.S. process (i.e., slaughter and process or process-only) non-amenable species, which include venison.

    Intermediaries are generally assumed to have prior experience with COOL compliance and are expected to have lower costs needed to meet the requirements of this proposed rule than they did when COOL was first implemented. Wholesalers would incur recordkeeping costs, costs associated with supplying country of origin information to retailers, costs associated with segmenting products by country of origin, and additional handling costs. Given that venison is such a small percentage of proteins on the market, it is estimated that few intermediaries handle venison meat for sale to retail.

    Since virtually all intermediary firms are assumed to already have a recordkeeping system in place for other COOL covered commodities, it is estimated that one (1) hour will be required to add venison to the design at a cost of $45 per firm. The initial recordkeeping costs are estimated by using the Label Cost Model developed for the Food and Drug Administration (FDA) by RTI International for including additional country of origin information to a livestock processor's records ($33.75 per hour with an additional 33 percent added to cover benefit costs for a total of $45.00 per hour). While the cost will be higher for some firms and lower for others, it is believed that $45 per hour represents a reasonable estimate of average cost for all firms. Based on this calculation, it is estimated that the initial recordkeeping costs for the 577 firms specializing in livestock processing and slaughtering of non-amenable species will be approximately $25,965. Intermediaries such as handlers, processors, importers and wholesalers (except livestock processing and slaughtering) are considered to already have sufficient recordkeeping and documentation systems in place to convey COOL information for venison products. Thus, no recordkeeping, set-up, and maintenance burden is estimated for these entities.

    Maintenance activities will include inputting, tracking, and storing country of origin for venison. Since this is mostly an administrative task, the cost is estimated by using the May 2015 BLS wage rate from the National Compensation Survey for administrative support occupations ($17.40 per hour with an additional 33 percent added to cover benefit costs for a total of $23.14 per hour). This occupation category includes stock and inventory clerks and record clerks. Annual maintenance for venison processing and slaughter facilities is estimated to take 5 minutes (0.083 hours) at a cost of $23.14 per hour, for a total annual cost of $1,108. Total initial and maintenance costs for 577 livestock processing firms are estimated to be $27,073, or $46.92 per firm.

    Retailers

    According to the definition of retailer under the Perishable Agricultural Commodities Act of 1930, the number of retailers that would be affected by this proposed rule is considerably smaller than the total number of retailers nationwide. There are 4,504 retail firms subject to mandatory COOL regulations. An estimated 88 percent (3,964 out of 4,504) of retail firms are considered small businesses.

    Only a small percentage of the producers identified by the previously mentioned Texas A&M University 2007 study actually sell venison and an even smaller percentage sell venison products to retail stores subject to COOL. Venison meat is available through some specialty grocers and national chains that focus on `natural' meats. USDA's Economic Research Service supermarket sales data for venison and elk meat show that a total of 350,404 pounds were sold in supermarkets (the regulated retail firms subject to COOL) during the 5-year period from 2008 through 2012, or an average of 70,081 pounds per year. Average annual retail sales of venison are less than 2 percent of annual venison imports (70,000 divided by 4.4M pounds) without even accounting for domestic production. Most venison meat is consumed in restaurants, which are not subject to COOL requirements.

    The number of retailers selling venison is a small subset of the COOL-regulated retailer population. Retailers choosing to carry venison products would accrue additional recordkeeping costs associated with supplying country of origin information to consumers as well as additional handling costs. USDA estimates that 3 percent of retailers (135 firms out of 4,504 retailers in the U.S.) will carry venison. AMS estimates that 88 percent of these retailers will be small businesses, consistent with the overall retailer population.

    It is estimated that each of the 135 retail firms will require one (1) hour to add venison to existing data management systems. The initial recordkeeping costs for retailers are estimated by using the same Label Cost Model developed for FDA by RTI International for including additional country of origin information to a retailer's records. It is assumed that limited information, such as one-color redesign of a paper document, will be sufficient to comply with the rule's recordkeeping requirements (total salary and benefit costs of $45.00 per hour). Based on one hour per firm at $45 per hour and 135 firms, initial recordkeeping costs at retail are estimated to be approximately $6,075. The yearly storing and maintenance cost for retailers is estimated by using the May 2015 BLS wage rate from the National Compensation Survey for administrative support occupations ($23.14 for wages plus benefits per hour). Annual maintenance for retail firms is estimated to take 30 minutes (0.5 hours) on average for 135 retail firms, because only a small subset, about 3 percent, of the 4,504 retailers will sell venison, at a cost of $23.14 per hour for total annual maintenance costs of $1,562. Total initial and maintenance costs for 135 retailers are estimated to be $7,637.

    Accordingly, the Administrator of AMS has conducted this Initial Regulatory Flexibility Analysis and has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities. However, AMS invites comments concerning potential effects of this proposed rule.

    AMS has considered any significant alternatives to this proposal that accomplish the statutory objectives and minimize the significant economic impact of the proposal on small entities. AMS does not believe there are other Federal rules that may duplicate, overlap, or conflict with the proposed rule. The effect of this proposed rule would be limited to a small number of firms that produce, process, and market venison. The only effective means of achieving the results mandated by the 2014 Farm Bill is through this proposed regulatory action.

    Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA), AMS is requesting OMB approval for a new information collection to add venison as a COOL covered commodity. The overall total burden for initial set-up, annual storage, and maintenance to comply with reporting and recordkeeping requirements for 3,856 recordkeepers is estimated to be 1,873 hours. OMB previously approved information collection requirements associated with all other COOL covered commodities and regulated firms and assigned OMB control number 0581-0250. This proposed rule would increase the overall reporting and recordkeeping burden due to the anticipated increase in number of respondents from the venison industry. Therefore, a NEW information collection is required to carry out the requirements of this proposed rule. AMS intends to merge this new information collection, upon OMB approval, into the approved 0581-0250 collection.

    Below, AMS has described and estimated the annual burden, i.e., the amount of time and cost of labor, for entities to prepare and maintain information to participate in this proposed mandatory labeling program. AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes. As with all mandatory regulatory programs, recordkeeping burdens are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. The Act, as amended, provides authority for this action.

    Title: Mandatory Country of Origin Labeling Requirements for Venison Meat.

    OMB Number: 0581-NEW.

    Type of Request: This is a NEW collection.

    Abstract: The information collection requirements are essential to carry out this rule.

    COOL provisions of the Act require retailers and suppliers of COOL covered commodities to verify the accuracy of COOL claims. Only records maintained in the course of the normal conduct of the business are required to serve as verification. This proposed rule would add this recordkeeping requirement for producers, intermediaries, and retailers of venison meat. This public reporting burden is necessary to ensure conveyance and accuracy of country of origin and method of production declarations relied upon at the point of sale at retail. The public reporting burden also assures that all parties involved in supplying venison and ground venison meat to retail stores maintain and convey accurate information as required.

    AMS believes that typical venison ranching operations have already developed much of the necessary recordkeeping (for example, birth, health, feeding records, and other documentation used to manage and identify the flock or herd) through normal animal husbandry and business practices. Furthermore, producer affidavits shall also be considered acceptable records that suppliers may utilize to initiate origin claims. Therefore, the estimated incremental costs for venison producers to supplement existing records with country of origin information will be relatively small per firm. Examples of initial or start-up costs would be any additional recordkeeping burden to record the required country of origin information and transfer this information to handlers, processors, wholesalers, or retailers via records used in the normal course of business.

    Table 1 displays the estimated annual costs associated for venison producers, intermediaries, and retailers. This public reporting burden is necessary to ensure conveyance and accuracy of country of origin and method of production declarations relied upon at the point of sale at retail. The public reporting burden also assures that all parties involved in supplying covered commodities to retail stores maintain and convey accurate information as required.

    Table 1—Estimated Initial Set-Up and Estimated Annual Storage Maintenance Costs Associated With Paperwork Burden Initial & set-up costs (incurred one time only) Firms Initial costs Venison Producers 3,144 $24,287 Handlers, Processors, Importers & Wholesalers (except livestock processing & slaughtering) 0 0 Livestock Processing & Slaughtering (non-amenable species) 577 25,965 Retailers 135 6,075 Total Initial & Set-Up Costs 3,856 56,327 Annual Storing & Maintenance Costs (yearly maintenance cost burden) Firms Maintenance costs Venison Producers 3,144 8,063 Handlers, Processors, Importers & Wholesalers (except livestock processing & slaughtering) 0 0 Livestock Processing & Slaughtering (non-amenable species) 577 1,108 Retailers 135 1,562 Total Annual Storing & Maintenance Costs 3,856 10,694 Total Estimated Set-Up and Annual Maintenance Costs 67,061

    The request for approval of the new information collection is as follows:

    Estimate of Burden: Public reporting burden for initial set-up, recordkeeping, storage, and maintenance is estimated to average 14 minutes (0.24 hours) per response from all respondents (venison producers, livestock processers and slaughterers, and retailers).

    Initial Set-Up Burden

    Respondents: Producers, processors, slaughterhouses, handlers, wholesalers, importers, and retailers of venison and ground venison meat.

    Estimated Number of Respondents: 3,856.

    Estimated Number of Responses per Respondent: 1.

    Estimated Total Annual Responses: 3,856.

    Estimated Total Annual Burden on Respondents: 1,498 hours.

    Annual Storage Maintenance Burden

    Respondents: Producers, processors, slaughterhouses, handlers, wholesalers, importers, and retailers of venison and ground venison meat.

    Estimated Number of Respondents: 3,856.

    Estimated Number of Responses per Respondent: 1.

    Estimated Total Annual Responses: 3,856.

    Estimated Total Annual Burden on Respondents: 376 hours.

    Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of AMS, including whether the information will have practical utility; (2) the accuracy of AMS' estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. A 60-day period is provided to comment on the information collection burden. Comments should reference OMB No. 0581-NEW and be sent to Julie Henderson, Director, COOL Division; Livestock, Poultry, and Seed Program, Agricultural Marketing Service, USDA; Room 2614-S, STOP 0216; 1400 Independence Avenue SW., Washington, DC 20250-0216; telephone (202) 720-4486; or email [email protected] All comments received will be available for public inspection. All responses to this proposed rule will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

    Comments concerning the information collection under PRA should also be sent to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503.

    List of Subjects in 7 CFR Part 65

    Agricultural commodities, Food labeling, Meat and meat products, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, AMS proposes to amend 7 CFR part 65 as follows:

    PART 65—COUNTRY OF ORIGIN LABELING OF LAMB, CHICKEN, GOAT, AND VENISON MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADEMIA NUTS, PECANS, PEANUTS, AND GINSENG 1. The authority citation for 7 CFR part 65 continues to read as follows: Authority:

    7 U.S.C. 1621 et seq.

    2. Revise the part heading of 7 CFR part 65 as set forth above. 3. Add § 65.117 to read as follows:
    § 65.117 Cervidae.

    Cervidae means any one of the various species that are raised for the production of venison meat, such as whitetail deer, elk, fallow deer, axis deer, sika, red deer (maral), musk deer, rusa deer, antelope, nilgai, pronghorn, reindeer, and caribou.

    4. Amend § 65.135 by revising paragraphs (a)(1) and (2) to read as follows:
    § 65.135 Covered commodity.

    (a) * * *

    (1) Muscle cuts of lamb, chicken, goat, and venison;

    (2) Ground lamb, ground chicken, ground goat, and ground venison;

    5. Add § 65.178 to read as follows:
    § 65.178 Ground Venison.

    Ground venison means comminuted venison of skeletal origin that is produced in conformance with all applicable Food Safety and Inspection Service labeling guidelines.

    6. Revise § 65.230 to read as follows:
    § 65.230 Production step.

    Production step means, in the case of lamb, chicken, goat, and venison, born, raised, or slaughtered.

    7. Revise § 65.235 to read as follows:
    § 65.235 Raised.

    Raised means, in the case of lamb, chicken, goat, and venison, the period of time from birth until slaughter or in the case of animals imported for immediate slaughter as defined in § 65.180, the period of time from birth until date of entry into the United States.

    8. Revise § 65.250 to read as follows:
    § 65.250 Slaughter.

    Slaughter means the point in which a livestock animal (including chicken and cervidae) is prepared into meat products (covered commodities) for human consumption. For purposes of labeling under this part, the word harvested may be used in lieu of slaughtered.

    9. Amend § 65.260 by revising paragraph (a) to read as follows:
    § 65.260 United States country of origin.

    (a) Lamb, chicken, goat, and venison:

    10. Add § 65.270 to read as follows:
    § 65.270 Venison.

    Venison means meat produced from animals in the cervidae family.

    11. Amend § 65.300 by revising paragraph (h) to read as follows:
    § 65.300 Country of origin notification.

    (h) Labeling Ground Lamb, Ground Goat, Ground Chicken, and Ground Venison. The declaration for ground lamb, ground goat, ground chicken, and ground venison covered commodities shall list all countries of origin contained therein or that may be reasonably contained therein. In determining what is considered reasonable, when a raw material from a specific origin is not in a processor's inventory for more than 60 days, that country shall no longer be included as a possible country of origin.

    12. Amend § 65.500 by revising paragraph (b)(1) to read as follows:
    § 65.500 Recordkeeping requirements.

    (b) * * * (1) Any person engaged in the business of supplying a covered commodity to a retailer, whether directly or indirectly, must make available information to the buyer about the country(ies) of origin of the covered commodity. This information may be provided either on the product itself, on the master shipping container, or in a document that accompanies the product through retail sale. In addition, the supplier of a covered commodity that is responsible for initiating a country(ies) of origin claim, which in the case of lamb, chicken, goat, and venison is the slaughter facility, must possess records that are necessary to substantiate that claim for a period of 1 year from the date of the transaction. For that purpose, packers that slaughter animals that are tagged with an 840 Animal Identification Number device without the presence of any additional accompanying marking (i.e., “CAN” or “M”) may use that information as a basis for a U.S. origin claim. Packers that slaughter animals that are part of another country's recognized official system (e.g. Canadian official system, Mexico official system) may also rely on the presence of an official ear tag or other approved device on which to base their origin claims. In the case of cervidae, producer affidavits shall also be considered acceptable records that suppliers may utilize to initiate origin claims, provided it is made by someone having first-hand knowledge of the origin of the covered commodity and identifies the covered commodity unique to the transaction.

    Dated: January 9, 2017. Bruce Summners, Associate Administrator, Agricultural Marketing Service.
    [FR Doc. 2017-00588 Filed 1-12-17; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1260 [No. AMS-LPS-16-0071] Beef Promotion and Research; Reapportionment AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would adjust representation on the Cattlemen's Beef Promotion and Research Board (Board), established under the Beef Promotion and Research Act of 1985 (Act), to reflect changes in domestic cattle inventories since January 1, 2013, as well as changes in levels of imported cattle, beef, and beef products that have occurred since December 31, 2012, which were the cut-off dates for data used by the Agricultural Marketing Service (AMS) when the Board was last reapportioned in July 2014. These adjustments are required by the Beef Promotion and Research Order (Order) and, if adopted, would result in a decrease in Board membership from 100 to 99, effective with the U.S. Department of Agriculture's (USDA) appointments for terms beginning early in the year 2018.

    DATES:

    Submit comments on or before March 14, 2017.

    ADDRESSES:

    Comments should be posted online at www.regulations.gov. Comments received will be posted without change, including any personal information provided. All comments should reference the docket number AMS-LPS-16-0071, the date of submission, and the page number of this issue of the Federal Register. Comments may also be sent to Mike Dinkel, Agricultural Marketing Specialist; Research and Promotion Division; Livestock, Poultry, and Seed Program, AMS, USDA; Room 2610-S, STOP 0249, 1400 Independence Avenue SW., Washington, DC 20250-0249; or via fax to (202) 720-1125. Comments will be made available for public inspection at the above address during regular business hours or via the Internet at www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Mike Dinkel, Research and Promotion Division, at (301) 352-7497; fax (202) 720-1125; or by email at [email protected].

    SUPPLEMENTARY INFORMATION: Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This rule has been determined not to be significant for purposes of Executive Order 12866 or Executive Order 13563. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. The Act prohibits states or political subdivisions of a state to impose any requirement that is in addition to, or inconsistent with, any requirement of the Act. There are no civil justice implications associated with this proposed rule.

    Regulatory Flexibility Act and Paperwork Reduction Act

    Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) [5 U.S.C. 601-612], the Administrator of AMS has considered the economic effect of this action on small entities and has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities. The purpose of RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly burdened.

    In the February 2013 publication of “Farms, Land in Farms, and Livestock Operations,” USDA's National Agricultural Statistics Service (NASS) estimated that the number of operations in the United States with cattle in 2012 totaled approximately 915,000, down from 950,000 in 2009. There are approximately 270 importers who import beef or edible beef products into the United States and 198 importers who import live cattle into the United States. It is estimated that the majority of those operations subject to the Order are considered small businesses under the criteria established by the Small Business Administration (SBA) [13 CFR 121.201]. SBA generally defines small agricultural service firms as those having annual receipts of $7.5 million or less, and small agricultural producers are generally defined as those having annual receipts of less than $750,000.

    The proposed rule imposes no new burden on the industry. It only adjusts representation on the Board to reflect changes in domestic cattle inventory, as well as in cattle and beef imports. The adjustments are required by the Order and would result in a decrease in Board membership from 100 to 99.

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

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

    Background and Proposed Action

    The Board was initially appointed on August 4, 1986, pursuant to the provisions of the Act [7 U.S.C. 2901-2911] and the Order issued thereunder. Domestic representation on the Board is based on cattle inventory numbers, while importer representation is based on the conversion of the volume of imported cattle, beef, and beef products into live animal equivalencies.

    Reapportionment

    Section 1260.141(b) of the Order provides that the Board shall be composed of cattle producers and importers appointed by the Secretary of Agriculture from nominations submitted by certified producer and importer organizations. A producer may only be nominated to represent the State or unit in which that producer is a resident.

    Section 1260.141(c) of the Order provides that at least every 3 years, but not more than every 2 years, the Board shall review the geographic distribution of cattle inventories throughout the United States and the volume of imported cattle, beef, and beef products and, if warranted, shall reapportion units and/or modify the number of Board members from units in order to reflect the geographic distribution of cattle production volume in the United States and the volume of cattle, beef, or beef products imported into the United States.

    Section 1260.141(d) of the Order authorizes the Board to recommend to the Secretary modifications to the number of cattle per unit necessary for representation on the Board.

    Section 1260.141(e)(1) provides that each geographic unit or State that includes a total cattle inventory equal to or greater than 500,000 head of cattle shall be entitled to one representative on the Board. Section 1260.141(e)(2) provides that States that do not have total cattle inventories equal to or greater than 500,000 head shall be grouped, to the extent practicable, into geographically-contiguous units, each of which have a combined total inventory of not less than 500,000 head. Such grouped units are entitled to at least one representative on the Board. Each unit is entitled to an additional Board member for each additional 1 million head of cattle within the unit, as provided in § 1260.141(e)(4). Further, as provided in § 1260.141(e)(3), importers are represented by a single unit, with their number of Board members based on a conversion of the total volume of imported cattle, beef, or beef products into live animal equivalencies.

    The initial Board appointed in 1986 was composed of 113 members. Reapportionment, based on a 3-year average of cattle inventory numbers and import data, reduced the Board to 111 members in 1990 and to 107 members in 1993 before the Board was increased back to 111 members in 1996. The Board decreased to 110 members in 1999, 108 members in 2001, and 104 members in 2005; increased to 106 members in 2009; decreased to 103 members in 2011; and decreased to 100 members in 2013. This proposal would amend § 1260.141(a) by increasing the importers from 6 to 7 members, decreasing the State of Virginia from 2 members to 1 member and decreasing the State of Texas from 13 to 12 members. Overall, if adopted, it would decrease the number of Board members from 100 to 99, with appointments for terms effective early in 2018.

    The currently proposed, updated Board representation by States or geographic units is based on an average of the January 1, 2011, 2012, and 2013 inventory of cattle in the various States as reported by NASS. The proposed importer representation would be based on a combined total average of the 2011, 2012, and 2013 live cattle imports as published by USDA's Foreign Agricultural Service and the average of the 2011, 2012, and 2013 live animal equivalents for imported beef and beef products.

    In considering reapportionment, the Board reviewed cattle inventories on the date January 1 in 2014, 2015, and 2016, as well as cattle, beef, and beef product import data for the period of January 1, 2013, to December 31, 2015. The Board recommended that a 3-year average of cattle inventories and import numbers should be continued. The Board determined that an average of the January 1, 2014, 2015, and 2016 cattle inventory numbers would best reflect the number of cattle in each state or unit since publication of the last reapportionment rule published in 2014 [79 FR 46961]. The Board reviewed data published by the USDA's Economic Research Service to determine proper importer representation. The Board recommended the use of the average of a combined total of the 2013, 2014, and 2015 cattle import data and the average of the 2013, 2014, and 2015 live animal equivalents for imported beef products. The method used to calculate the total number of live animal equivalents was the same as that used in the previous reapportionment of the Board. The live animal equivalent weight was changed in 2006 from 509 pounds to 592 pounds [71 FR 47074].

    The Board's recommended reapportionment plan, if adopted, would decrease the number of representatives on the Board from 100 to 99. From the Board's analysis of USDA cattle inventories and import equivalencies, Virginia would lose one Board seat and Texas would lose one Board seat. The importers would gain one Board seat.

    The States and units affected by the reapportionment plan and the current and proposed member representation per unit are as follows:

    State/unit Current
  • representation
  • Revised
  • representation
  • Virginia 2 1 Texas 13 12 Importers 6 7

    The Board reapportionment as proposed by this rulemaking would take effect, if adopted, with appointments to fill positions early in the year 2018.

    A 60-day comment period is provided to allow interested persons to respond to this proposal. Thirty days is deemed appropriate to facilitate the adjustment of the representation on the Board, which is required by the Order at least every 3 years but not more than every 2 years, and to allow for the annual nomination and appointment process for Board appointments that will be effective early in 2018.

    List of Subjects in 7 CFR Part 1260

    Administrative practice and procedure, Advertising, Agricultural research, Imports, Meat and meat products, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, AMS proposes to amend 7 CFR part 1260 as follows:

    PART 1260—BEEF PROMOTION AND RESEARCH 1. The authority citation for 7 CFR part 1260 continues to read as follows: Authority:

    7 U.S.C. 2901-2911 and 7 U.S.C. 7401.

    2. Revise § 1260.141 paragraph (a) and the table immediately following to read as follows:
    § 1260.141 Membership of Board.

    (a) Beginning with the 2017 Board nominations and the associated appointments effective early in the year 2018, the United States shall be divided into 37 geographical units and 1 unit representing importers, for a total of 38 units. The number of Board members from each unit shall be as follows:

    Cattle and Calves 1 State/unit (1,000 head) Directors 1. Arizona 900 1 2. Arkansas 1,660 2 3. Colorado 2,600 3 4. Florida 1,680 2 5. Idaho 2,307 2 6. Illinois 1,143 1 7. Indiana 873 1 8. Iowa 3,867 4 9. Kansas 5,983 6 10. Kentucky 2,110 2 11. Louisiana 787 1 12. Michigan 1,133 1 13. Minnesota 2,347 2 14. Mississippi 923 1 15. Missouri 3,983 4 16. Montana 2,567 3 17. Nebraska 6,317 6 18. New Mexico 1,340 1 19. New York 1,450 1 20. North Carolina 803 1 21. North Dakota 1,697 2 22. Ohio 1,243 1 23. Oklahoma 4,567 5 24. Oregon 1,300 1 25. Pennsylvania 1,580 2 26. South Dakota 3,783 4 27. Tennessee 1,770 2 28. Texas 11,500 12 29. Utah 807 1 30. Virginia 1,487 1 31. Wisconsin 3,467 3 32. Wyoming 1,293 1 33. Northwest 1 Alaska 10 Hawaii 135 Washington 1,137 Total 1,282 34. Northeast 1 Connecticut 48 Delaware 16 Maine 84 Massachusetts 38 New Hampshire 32 New Jersey 28 Rhode Island 5 Vermont 260 Total 511 35. Mid-Atlantic 1 Maryland 186 West Virginia 382 Total 567 36. Southeast 3 Alabama 1,240 Georgia 1,057 South Carolina 337 Total 2,633 37. Southwest 6 California 5,183 Nevada 442 Total 5,625 38. Importers 2 6,949 7 1 2014, 2015, and 2016 average of January 1 cattle inventory data. 2 2013, 2014, and 2015 average of annual import data.
    Dated: January 9, 2017. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2017-00587 Filed 1-12-17; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Office of Procurement and Property Management 7 CFR Part 3201 RIN 0599-AA24 Designation of Product Categories for Federal Procurement AGENCY:

    Office of Procurement and Property Management, USDA.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The U.S. Department of Agriculture (USDA) is proposing to amend the Guidelines for Designating Biobased Products for Federal Procurement (Guidelines) to add 12 sections that will designate 12 product categories composed of intermediate ingredient and feedstock materials within which biobased products would be afforded procurement preference by Federal agencies and their contractors. USDA is also proposing minimum biobased contents for each of these product categories.

    DATES:

    USDA will accept public comments on this proposed rule until March 14, 2017.

    ADDRESSES:

    You may submit comments by any of the following methods. All submissions received must include the agency name and Regulatory Information Number (RIN). The RIN for this rulemaking is 0599-AA24. Also, please identify submittals as pertaining to the “Proposed Designation of Product Categories.”

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

    Email: [email protected] Include RIN number 0599-AA24 and “Proposed Designation of Product Categories” on the subject line. Please include your name and address in your message.

    Mail/commercial/hand delivery: Mail or deliver your comments to: Marie Wheat, USDA, Office of Procurement and Property Management, Room 361, Reporters Building, 300 7th St. SW., Washington, DC 20024.

    • Persons with disabilities who require alternative means for communication for regulatory information (Braille, large print, audiotape, etc.) should contact the USDA TARGET Center at (202) 720-2600 (voice) and (202) 690-0942 (TTY).

    FOR FURTHER INFORMATION CONTACT:

    Marie Wheat, USDA, Office of Procurement and Property Management, Room 361, Reporters Building, 300 7th St. SW., Washington, DC 20024; email: [email protected]; phone (202) 239-4502. Information regarding the Federal preferred procurement program (one initiative of the BioPreferred Program) is available on the Internet at http://www.biopreferred.gov.

    SUPPLEMENTARY INFORMATION:

    The information presented in this preamble is organized as follows:

    I. Authority II. Background III. Summary of Today's Proposed Rule IV. Designation of Product Categories, Minimum Biobased Contents, and Time Frame A. Background B. Product Categories and Minimum Biobased Contents Proposed for Designation C. Compliance Date for Procurement Preference and Incorporation Into Specifications V. Where can agencies get more information on these USDA-designated product categories? VI. Regulatory Information A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Regulatory Flexibility Act (RFA) C. Executive Order 12630: Governmental Actions and Interference With Constitutionally Protected Property Rights D. Executive Order 12988: Civil Justice Reform E. Executive Order 13132: Federalism F. Unfunded Mandates Reform Act of 1995 G. Executive Order 12372: Intergovernmental Review of Federal Programs H. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments I. Paperwork Reduction Act J. E-Government Act I. Authority

    The designation of these product categories is proposed under the authority of section 9002 of the Farm Security and Rural Investment Act of 2002 (the 2002 Farm Bill), as amended by the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill), and further amended by the Agricultural Act of 2014 (the 2014 Farm Bill), 7 U.S.C. 8102. (Section 9002 of the 2002 Farm Bill, as amended by the 2008 and the 2014 Farm Bills, is referred to in this document as “section 9002”.)

    II. Background

    Section 9002 provides for the preferred procurement of biobased products by Federal procuring agencies and is referred to hereafter in this Federal Register notice as the “Federal preferred procurement program.” Under the provisions specified in the “Guidelines for Designating Biobased Products for Federal Procurement” (7 CFR part 3201) (Guidelines), the USDA BioPreferred Program “designates” product categories to which the preferred procurement requirements apply by listing them in subpart B of 7 CFR part 3201.

    The term “product category” is used as a generic term in the designation process to mean a grouping of specific products that perform a similar function. As originally finalized, the Guidelines included provisions for the designation of product categories that were composed of finished, consumer products such as mobile equipment hydraulic fluids, penetrating lubricants, or hand cleaners and sanitizers.

    The 2008 and 2014 Farm Bills directed USDA to expand the scope of the Guidelines to include the designation of product categories composed of intermediate ingredients and feedstock materials. Specifically, the 2008 Farm Bill stated that USDA shall “designate those intermediate ingredients and feedstocks that are or can be used to produce items that will be subject” to the Federal preferred procurement program. The term “intermediate ingredient and feedstock” is defined in the Farm Bill as “a material or compound made in whole or in significant part from biological products, including renewable agricultural materials (including plant, animal, and marine materials) or forestry materials, that are subsequently used to make a more complex compound or product.” The term “intermediates” is used in the titles of the product categories being proposed for designation today to distinguish these proposed categories from the finished, consumer products previously designated by USDA. Additionally, in section 9001 of the 2014 Farm Bill, the term “renewable chemical” is defined as “a monomer, polymer, plastic, formulated product, or chemical substance produced from renewable biomass.” Thus, most products that are described as “renewable chemicals” will be eligible for the Federal preferred procurement program because they meet the definition of one or more of the intermediate product categories included in today's proposed rule.

    For example, the chemical substance known as citric acid, if biobased, may be considered as a renewable chemical and an intermediate ingredient for finished products in the cleaning, personal care, or textiles industries. Thus, biobased citric acid could be categorized in one or all of the following intermediate product categories that are proposed for designation today: Intermediates—Chemicals, Intermediates—Textile Processing Materials, Intermediates—Cleaner Components, or Intermediates—Personal Care Product Components. Additionally, the chemical substance known as oleic acid may be considered as a renewable chemical and an intermediate ingredient for finished products in the cleaning, personal care, or lubricant industries. Therefore, oleic acid could be categorized in one or all of the following intermediate product categories that are proposed for designation today: Intermediates—Chemicals, Intermediates—Lubricant Components, Intermediates—Cleaner Components, or Intermediates—Personal Care Product Components. These examples show that the intermediate product categories being proposed today may accommodate a variety of renewable chemical substances.

    Although the Federal government does not typically purchase large quantities of intermediate ingredients and feedstock materials, designating such materials represents a means to identify and include finished products made from such designated materials in the Federal preferred procurement program. In the August 1, 2014 Federal Register (79 FR 44641), USDA finalized amendments to the Guidelines establishing procedures for designating intermediate ingredient or feedstock categories. Today's proposed rule follows the established procedures for designating intermediate ingredient product categories. Soon, USDA will propose designating product categories comprised of finished products made from intermediate ingredients that may be categorized within the product categories proposed for designation in today's rule. Therefore, USDA requests manufacturers and members of the public to submit technical information related to the designation of such finished product categories to [email protected] Specific technical information to submit includes the following: A finished product category name, descriptions of finished products that belong in this product category, how these finished products are used, any special features of these finished products, estimated or tested biobased contents for each finished product, applicable performance standards that the finished products meet, and which intermediate ingredient and feedstock categories are used to make these finished products. Such information will be valuable in supporting the selection of product categories for designation but will be evaluated independently from today's proposed rule. Please refer to Section IV.B. of today's proposed rule for further details on the information required to designate product categories for Federal procurement preference.

    Once USDA designates a product category, procuring agencies are required, with some exceptions, to purchase biobased products within these designated product categories where the purchase price of the procurement product exceeds $10,000 or where the quantity of such products or the functionally equivalent products purchased over the preceding fiscal year equaled $10,000 or more. Procuring agencies must procure biobased products within each product category unless they determine that products within a product category are not reasonably available within a reasonable period of time, fail to meet the reasonable performance standards of the procuring agencies, or are available only at an unreasonable price. As stated in the Guidelines, biobased products that are merely incidental to Federal funding are excluded from the Federal preferred procurement program; that is, the requirements to purchase biobased products do not apply to such purchases if they are unrelated to or incidental to the purpose of the Federal contract. For example, if a janitorial service company purchases cleaning supplies to be used in the performance of a Federal contract, the cleaning supplies would be subject to the authority of the Federal preferred procurement program. However, cleaning supplies purchased to maintain the offices from which the janitorial service company manages the Federal contract would be incidental to the performance of the contract and, as such, would not be subject to the authority of the Federal preferred procurement program. In implementing the Federal preferred procurement program for biobased products, procuring agencies should follow their procurement rules and Office of Federal Procurement Policy guidance on buying non-biobased products when biobased products exist and should document exceptions taken for price, performance, and availability. The definition of “procuring agency” in section 9002 includes both Federal agencies and “a person that is a party to a contract with any Federal agency, with respect to work performed under such a contract.” Thus, Federal contractors, as well as Federal agencies, are expressly subject to the procurement preference provisions of section 9002.

    USDA recognizes that the performance needs for a given application are important criteria in making procurement decisions. USDA is not requiring procuring agencies to limit their choices to biobased products that are categorized within the product categories proposed for designation in this proposed rule. Rather, the effect of the designation of the product categories is to require procuring agencies to determine their performance needs, determine whether there are qualified biobased products that are categorized within the designated product categories that meet the reasonable performance standards for those needs, and purchase such qualified biobased products to the maximum extent practicable as required by section 9002.

    Section 9002(a)(3)(B) requires USDA to provide information to procuring agencies on the availability, relative price, and performance of such products and to recommend, where appropriate, the minimum level of biobased content to be contained in the procured products.

    Subcategorization. Most of the product categories USDA has designated for Federal preferred procurement cover a wide range of products. For some product categories, there are subgroups of products that meet different requirements, uses and/or different performance specifications. For example, within the product category “hand cleaners and sanitizers,” products that are used in medical offices may be required to meet performance specifications for sanitizing, while other products that are intended for general purpose hand washing may not need to meet these specifications. Where such subgroups exist, USDA intends to create subcategories. Thus, for example, for the product category “hand cleaners and sanitizers,” USDA determined that it was reasonable to create a “hand cleaner” subcategory and a “hand sanitizer” subcategory. Sanitizing specifications are applicable to the latter subcategory, but not the former. In sum, USDA looks at the products within each product category to evaluate whether there are groups of products within the category that have unique characteristics or that meet different performance specifications and, if USDA finds these types of differences within a given product category, it intends to create subcategories with the minimum biobased content based on the tested products within the subcategory.

    For some product categories, however, USDA may not have sufficient information at the time of proposal to create subcategories. For example, USDA may know that there are different performance specifications that metal cleaners and corrosion remover products are required to meet, but it may have information on only one type of metal cleaner and corrosion remover product. In such instances, USDA may either designate the product category without creating subcategories (i.e., defer the creation of subcategories) or designate one subcategory and defer designation of other subcategories within the product category until additional information is obtained. Once USDA has received sufficient additional information to justify the designation of a subcategory, the subcategory will be designated through the proposed and final rulemaking process.

    USDA has not created subcategories for any of the product categories being proposed for designation in today's rule. USDA requests public comment, along with supporting data, on the need to create subcategories within any of the proposed product categories. If public comments are received that support the creation of subcategories, USDA will consider the supporting data and may create subcategories in the final rule.

    Minimum Biobased Contents. The minimum biobased contents being proposed in this rule are based on products for which USDA has biobased content test data. USDA obtains biobased content data in conjunction with product manufacturer's applications for certification to use the USDA Certified Biobased Product label. Products that are certified to display the label must undergo biobased content testing by an independent, third party testing lab using ASTM D6866, “Standard Test Methods for Determining the Biobased Content of Solid, Liquid, and Gaseous Samples Using Radiocarbon Analysis”. These test data become part of the BioPreferred Program database and their use in setting the minimum biobased content for designated product categories results in a more efficient process for both the Program and manufacturers of products within the product categories.

    As a result of public comments received on the first designated product categories rulemaking proposal, USDA decided to account for the slight imprecision in the analytical method used to determine biobased content of products when establishing the minimum biobased content. Thus, rather than establishing the minimum biobased content for a product category at the tested biobased content of the product selected as the basis for the minimum value, USDA is establishing the minimum biobased content for each product category at a level three (3) percentage points lower than the tested value. USDA believes that this adjustment is appropriate to account for the expected variations in analytical results. USDA encourages procuring agencies to seek products with the highest biobased content that is practicable in all of the proposed designated product categories.

    In addition to considering the biobased content test data for each product category, USDA also considers other factors including product performance information. USDA evaluates this information to determine whether some products that may have a lower biobased content also have unique performance or applicability attributes that would justify setting the minimum biobased content at a level that would include these products. For example, a lubricant product that has a lower biobased content than others within a product category but is formulated to perform over a wider temperature range than the other products may be more desirable to Federal agencies. Thus, it would be beneficial to set the minimum biobased content for the product category at a level that would include the product with superior performance features.

    USDA also considers the overall range of the tested biobased contents within a product category, groupings of similar values, and breaks (significant gaps between two groups of values) in the biobased content test data array. For example, in a previously proposed product category, the biobased contents of 7 tested products ranged from 17 to 100 percent, as follows: 17, 41, 78, 79, 94, 98, and 100 percent. Because this is a very wide range, and because there is a significant gap in the data between the 41 percent biobased product and the 78 percent biobased product, USDA reviewed the product literature to determine whether subcategories could be created within this product category. USDA found that the available product information did not justify creating a subcategory based on the 17 percent product or the 41 percent biobased content product. Further, USDA did not find any performance claims that would justify setting the minimum biobased content based on either the 17 percent or the 41 percent biobased content products. Thus, USDA set the minimum biobased content for this product category at 75 percent, based on the product with a tested biobased content of 78 percent. USDA believes that this evaluation process allows it to establish minimum biobased contents based on a broad set of factors to assist the Federal procurement community in its decisions to purchase biobased products.

    USDA makes every effort to obtain biobased content test data on multiple products within each product category. For most designated product categories, USDA has biobased content test data on more than one product within the category. However, in some cases, USDA has been able to obtain biobased content data for only a single product within a designated product category. As USDA obtains additional data on the biobased contents of products within these designated product categories or their subcategories, USDA will evaluate whether the minimum biobased content for a designated product category or subcategory will be revised.

    Overlap with EPA's Comprehensive Procurement Guideline program for recovered content products under the Resource Conservation and Recovery Act (RCRA) Section 6002. Some of the products that are within biobased product categories designated for Federal preferred procurement under this program may also be within categories the Environmental Protection Agency (EPA) has designated under the EPA's Comprehensive Procurement Guideline (CPG) for products containing recovered (or recycled) materials. Because today's proposed rule would designate intermediate ingredient product categories rather than categories of finished, consumer-use products, USDA does not believe that there is a direct overlap between these categories and CPG categories. However, if such an overlap situation is discovered, USDA is asking manufacturers of qualifying biobased products to make additional product and performance information available to Federal agencies conducting market research to assist them in determining whether the biobased products in question are, or are not, the same products for the same uses as the recovered content products. Manufacturers are asked to provide information highlighting the sustainable features of their biobased products and to indicate the various suggested uses of their product and the performance standards against which a particular product has been tested. In addition, depending on the type of biobased product, manufacturers are being asked to provide other types of information, such as whether the product contains fossil energy-based components (including petroleum, coal, and natural gas) and whether the product contains recovered materials. Federal agencies also may review available information on a product's biobased content. Federal agencies may then use this information to make purchasing decisions based on the sustainability features of the products.

    Where a biobased product is used for the same purposes and to meet the same Federal agency performance requirements as an EPA-designated recovered content product, the Federal agency must purchase the recovered content product. For example, if a biobased hydraulic fluid is to be used as a fluid in hydraulic systems and because “lubricating oils containing re-refined oil” has already been designated by EPA for that purpose, then the Federal agency must purchase the EPA-designated recovered content product, “lubricating oils containing re-refined oil.” If, on the other hand, the biobased hydraulic fluid is to be used to address a Federal agency's certain environmental or health performance requirements that the EPA-designated recovered content product would not meet, then the biobased product should be given preference, subject to reasonable price, availability, and performance considerations.

    Federal Government Purchase of Sustainable Products. The Federal government's sustainable purchasing program includes the following three mandatory preference programs for designated products: The BioPreferred Program, the EPA's Comprehensive Procurement Guideline for products containing recovered materials, and the Environmentally Preferable Purchasing program. The Office of the Chief Sustainability Officer (OCSO) and the Office of Management and Budget (OMB) encourage agencies to implement these components comprehensively when purchasing products and services.

    Procuring agencies should note that not all biobased products are “environmentally preferable.” For example, unless cleaning products contain no or reduced levels of metals and toxic or hazardous constituents, they can be harmful to aquatic life, the environment, and/or workers. Household cleaning products that are formulated to be disinfectants are required, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), to be registered with EPA (unless they are formulated with exempt ingredients) and must meet specific labeling requirements warning of the potential risks associated with misuse of such products. When purchasing environmentally preferable cleaning products, many Federal agencies specify that products must meet Green Seal standards for institutional cleaning products or that the products have been reformulated in accordance with recommendations from the EPA's Safer Choice Program (previously known as the “Design for the Environment” (DfE) program). Both the Green Seal standards and the Safer Choice program identify chemicals of concern in cleaning products. These include zinc and other metals, formaldehyde, ammonia, alkyl phenol ethoxylates, ethylene glycol, and volatile organic compounds. In addition, both require that cleaning products have neutral pH.

    In contrast, some biobased products may be environmentally preferable to some products that meet Green Seal standards for institutional cleaning products or that have been reformulated in accordance with EPA's Safer Choice program. To fully compare products, one must look at the “cradle-to-grave” impacts of the manufacture, use, and disposal of products. USDA has been unable to perform the analyses necessary to determine the “cradle-to-grave” impacts of products within the product categories being proposed for designation because of resource constraints.

    One consideration of a product's impact on the environment is whether (and to what degree) it introduces new, fossil carbon into the atmosphere. Fossil carbon is derived from non-renewable sources (typically fossil fuels such as coal and oil), whereas renewable biomass carbon is derived from renewable sources (biomass). Qualifying biobased products offer the user the opportunity to manage his or her impact on the carbon cycle and reduce the introduction of new fossil carbon into the atmosphere.

    Other Federal Preferred Procurement Programs. Federal procurement officials should also note that many biobased products may be available for purchase by Federal agencies through the AbilityOne Program (formerly known as the Javits-Wagner-O'Day (JWOD) program). Under this program, members of organizations including the National Industries for the Blind (NIB) and SourceAmerica (formerly known as the National Industries for the Severely Handicapped) offer products and services for preferred procurement by Federal agencies. A search of the AbilityOne Program's online catalog (www.abilityone.gov) indicated that the types of intermediate ingredient product categories being proposed for designation in today's proposed rule are not available through the AbilityOne Program. USDA notes, however, that if such materials are offered at some point in the future, their procurement through the AbilityOne Program would further the objectives of both the AbilityOne Program and the Federal preferred procurement program.

    Outreach. To augment its own research, USDA consults with industry and Federal stakeholders to the Federal preferred procurement program during the development of the rulemaking packages for the designation of product categories. USDA consults with stakeholders to gather information used in determining the order of product category designation and in identifying: Manufacturers producing and marketing products that are categorized within a product category proposed for designation; performance standards used by Federal agencies evaluating products to be procured; and warranty information used by manufacturers of end user equipment and other products with regard to biobased products.

    III. Summary of Today's Proposed Rule

    USDA is proposing to designate the following product categories for Federal preferred procurement: Intermediates—Plastic Resins; Intermediates—Chemicals; Intermediates—Paint and Coating Components; Intermediates—Textile Processing Materials; Intermediates—Foams; Intermediates—Fibers and Fabrics; Intermediates—Lubricant Components; Intermediates—Binders; Intermediates—Cleaner Components; Intermediates—Personal Care Product Components; Intermediates—Oils, Fats, and Waxes; and Intermediates—Rubber Materials. In addition, USDA is proposing a minimum biobased content for each of these product categories and subcategories. Lastly, USDA is proposing a date by which Federal agencies must incorporate these designated product categories into their procurement specifications (see Section IV.E).

    USDA is working with manufacturers and vendors to make all relevant product and manufacturer contact information available on the BioPreferred Program's Web site. Steps USDA has implemented, or will implement, include: Making direct contact with submitting companies through email and phone conversations to encourage completion of product listing; coordinating outreach efforts with intermediate material producers to encourage participation of their customer base; conducting targeted outreach with industry and commodity groups to educate stakeholders on the importance of providing complete product information; participating in industry conferences and meetings to educate companies on program benefits and requirements; and communicating the potential for expanded markets beyond the Federal government, to include State and local governments, as well as the general public markets. Section V provides instructions to agencies on how to obtain this information on products within these product categories through the BioPreferred Program's Web site: http://www.biopreferred.gov.

    Comments. USDA invites public comment on the proposed designation of these intermediate ingredient product categories, including the definition, proposed minimum biobased content, and any of the relevant analyses performed during their selection. In addition, USDA invites comments and information in the following areas:

    1. We have attempted to identify relevant and appropriate performance standards and other relevant measures of performance for each of the proposed product categories. If you know of other such standards or relevant measures of performance for any of the proposed product categories, USDA requests that you submit information identifying such standards and measures, including their name (and other identifying information as necessary), identifying who is using the standard/measure, and describing the circumstances under which the product is being used.

    2. Many biobased products within the product categories being proposed for designation will have positive environmental and human health attributes. USDA is seeking comments on such attributes in order to provide additional information on the BioPreferred Program's Web site. This information will then be available to Federal procuring agencies and will assist them in making informed sustainable procurement decisions. When possible, please provide appropriate documentation to support the environmental and human health attributes you describe.

    3. Some product categories being proposed for designation today have wide ranges of tested biobased contents. For the reasons discussed later in this preamble, USDA is proposing a minimum biobased content for these product categories that would allow most of the tested products to be eligible for Federal preferred procurement. USDA welcomes comments on the appropriateness of the proposed minimum biobased contents for these product categories and whether there are potential subcategories within the product categories that should be considered.

    4. Today's proposed rule is expected to have both positive and negative impacts on individual businesses, including small businesses. USDA anticipates that the biobased Federal preferred procurement program will provide additional opportunities for businesses and manufacturers to begin supplying products under the proposed designated biobased product categories to Federal agencies and their contractors. However, other businesses and manufacturers that supply only non-qualifying products and do not offer biobased alternatives may experience a decrease in demand from Federal agencies and their contractors. Because USDA has been unable to determine the number of businesses, including small businesses, which may be adversely affected by today's proposed rule USDA requests comment on how many small entities may be affected by this rule and on the nature and extent of that effect.

    All comments should be submitted as directed in the ADDRESSES section above.

    5. As stated in Section II of today's proposed rule, USDA will soon propose designating product categories comprised of finished products made from intermediate ingredients that may be categorized within the product categories proposed for designation in today's rule. Therefore, USDA requests manufacturers and members of the public to submit technical information related to the designation of such finished product categories to [email protected] Specific technical information to submit includes the following: A finished product category name, descriptions of finished products that belong in this product category, how these finished products are used, any special features of these finished products, estimated or tested biobased contents for each finished product, applicable performance standards that the finished products meet, and which intermediate ingredient and feedstock categories are used to make these finished products. Such information will be valuable in supporting the selection of product categories for designation but will be evaluated independently from today's proposed rule. Please refer to Section IV.B. of today's proposed rule for further details on the information required to designate product categories for Federal procurement preference.

    IV. Designation of Product Categories, Minimum Biobased Contents, and Time Frame A. Background

    When designating product categories for Federal preferred procurement, section 9002 requires USDA to consider: (1) The availability of biobased products within the product categories and (2) the economic and technological feasibility of using those products.

    In considering a product's availability, USDA uses several sources of information. The primary source of information for the product categories being proposed for designation is USDA's database of manufacturers and products that have been certified to display the USDA Certified Biobased Product label. In addition, USDA performs Internet searches, contacts trade associations and commodity groups, and contacts manufacturers and vendors to identify those with biobased products within product categories being considered for designation. USDA uses the results of these same searches to determine if a product category is generally available.

    In considering a product category's economic and technological feasibility, USDA examines evidence pointing to the general commercial use of a product and its life-cycle cost and performance characteristics. This information is obtained from the sources used to assess a product's availability. Commercial use, in turn, is evidenced by any manufacturer and vendor information on the availability, relative prices, and performance of their products as well as by evidence of a product being purchased by a procuring agency or other entity, where available. In sum, USDA considers a product category economically and technologically feasible for purposes of designation if products within that product category are being offered and used in the marketplace.

    As discussed earlier, USDA has implemented, or will implement, several steps intended to educate the manufacturers and other stakeholders on the benefits of this program and the need to make relevant information, including manufacturer contact information, available to procurement officials via the BioPreferred Program Web site. Additional information on specific products within the product categories proposed for designation may also be obtained directly from the manufacturers of the products. USDA has also provided information on the BioPreferred Program Web site for manufacturers and vendors who wish to position their businesses as biobased product vendors to the Federal Government. This information can be accessed by clicking on the “Selling Biobased” tab on the left side of the home page of the BioPreferred Program's Web site.

    USDA recognizes that information related to the functional performance of biobased products is a primary factor in making the decision to purchase these products. USDA is gathering information on industry standard test methods and performance standards that manufacturers are using to evaluate the functional performance of their products. (Test methods are procedures used to provide information on a certain attribute of a product. For example, a test method might determine how many bacteria are killed. Performance standards identify the level at which a product must perform in order for it to be “acceptable” to the entity that set the performance standard. For example, a performance standard might require that a certain percentage (e.g., 95 percent) of bacteria must be killed through the use of the product.) The primary sources of information on these test methods and performance standards are manufacturers of biobased products within these product categories. Additional test methods and performance standards are also identified during meetings of the interagency council and during the review process for each proposed rule. We have listed, under the detailed discussion of each product category proposed for designation (presented in Section IV.B), the functional performance test methods, performance standards, product certifications, and other measures of performance associated with the functional aspects of products identified during the development of this Federal Register notice for these product categories.

    While this process identifies many of the relevant test methods and standards, USDA recognizes that those identified herein do not represent all of the methods and standards that may be applicable for a product category or for any individual product within the category. As noted earlier in this preamble, USDA is requesting identification of other relevant performance standards and measures of performance. As the program becomes fully implemented, these and other additional relevant performance standards will be available on the BioPreferred Program's Web site.

    To propose a product category for designation, USDA must have sufficient information on a sufficient number of products within the category to be able to assess its availability and its economic and technological feasibility. For some product categories, there may be numerous products available. For others, there may be very few products currently available. Given the infancy of the market for some product categories, it is expected that categories with only a single product will be identified.

    Further, given that the intent of section 9002 is largely to stimulate the production of new biobased products and to energize emerging markets for those products, USDA has determined it is appropriate to designate a product category or subcategory for Federal preferred procurement even when there is only a single product with a single supplier. Similarly, the documented availability and benefits of even a very small percentage of all products that may exist within a product category are also considered sufficient to support designation.

    Exemptions. Products that are exempt from the biobased procurement preference are military equipment, defined as any product or system designed or procured for combat or combat-related missions, and spacecraft systems and launch support equipment. However, USDA points out that it is not the intent of these exemptions to imply that biobased products are inferior to non-biobased products and agencies are encouraged to purchase biobased products wherever performance, availability and reasonable price indicates that such purchases are justified.

    Although each product category in today's proposed rule would be exempt from the procurement preference requirement when used in spacecraft systems or launch support application or in military equipment used in combat and combat-related applications, this exemption does not extend to contractors performing work other than direct maintenance and support of the spacecraft or launch support equipment or combat or combat-related missions. For example, if a contractor is applying a paint remover product as a step in refurbishing office furniture on a military base, the paint remover the contractor purchases should be a qualifying biobased paint remover. The exemption does apply, however, if the product being purchased by the contractor is for use in combat or combat-related missions or for use in space or launch applications. After reviewing the regulatory requirement and the relevant contract, where contractors have any questions on the exemption, they should contact the cognizant contracting officer.

    B. Product Categories and Minimum Biobased Contents Proposed for Designation

    In today's proposed rule, USDA is proposing to designate the following product categories for the Federal preferred procurement program: Intermediates—Plastic Resins; Intermediates—Chemicals; Intermediates—Paint and Coating Components; Intermediates—Textile Processing Materials; Intermediates—Foams; Intermediates—Fibers and Fabrics; Intermediates—Lubricant Components; Intermediates—Binders; Intermediates—Cleaner Components; Intermediates—Personal Care Product Components; Intermediates—Oils, Fats, and Waxes; and Intermediates—Rubber Materials.

    USDA has determined that each of these product categories meets the necessary statutory requirements—namely, that they are being produced with biobased materials and that their procurement by procuring agencies will carry out the following objectives of section 9002:

    • To increase demand for biobased products, which would in turn increase demand for agricultural commodities that can serve as feedstocks for the production of biobased products;

    • To spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and

    • To enhance the Nation's energy security by substituting biobased products for products derived from imported oil and natural gas.

    Further, USDA anticipates that the designation of these intermediate ingredient product categories will facilitate the designation of the many categories of finished consumer products that are made from these biobased intermediate ingredients. This designation of finished products made from designated ingredients was one key addition to Section 9002 made by the 2008 Farm Bill.

    In addition, because of the participation by the manufacturers of these products in the voluntary labeling initiative, USDA has sufficient information on these product categories to determine their availability and to conduct the requisite analyses to determine their biobased content and their economic and technological feasibility.

    The proposed designated product categories are discussed in the following sections.

    1. Intermediates—Plastic Resins (Minimum Biobased Content 22 Percent)

    Intermediates—Plastic Resins are materials that are typically viscous liquids with the ability to harden permanently and may exist in liquid or solid (powder or pellets) states. Intermediates—Plastic Resins may be used in a variety of finished products neat, consisting of a single resin, or as a homogeneous blend of two or more neat resins, or composite, containing two or more distinct materials such as fiber-reinforced resins. Additionally, Intermediates—Plastic Resins may be used in finished products as additives such as plasticizers, pigments, thermal stability agents, or impact modifiers.

    USDA identified 62 manufacturers and suppliers of 150 biobased Intermediates—Plastic Resins. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Plastic Resins, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 150 biobased Intermediates—Plastic Resins range in biobased content from 25 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Plastic Resins. Thus, the proposed minimum biobased content for this product category is 22 percent, based on the products with a tested biobased content of 25 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, some of these manufacturers and suppliers identified nine test methods (as shown below) used in evaluating products within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test methods identified by the manufacturers and suppliers include:

    • ASTM D256; Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics,

    • ASTM D638; Standard Test Method for Tensile Properties of Plastics,

    • ASTM D790; Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials,

    • ASTM D882; Standard Test Method for Tensile Properties of Thin Plastic Sheeting,

    • ASTM D6400; Standard Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal or Industrial Facilities,

    • ASTM D6868; Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities,

    • BPI Certification; Compostable in Municipal and Industrial Composting Facilities

    • ISO 9001; Quality Management Systems—Requirements, and

    • Vinçotte; OK COMPOST.

    USDA has been unable to obtain data on the amount of Intermediates—Plastic Resins purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics has been collected on 150 Intermediates—Plastic Resins and may be found on the BioPreferred Program's Web site.

    2. Intermediates—Chemicals (Minimum Biobased Content: 22 Percent)

    Intermediates—Chemicals are those used as reactants for organic synthesis reactions rather than for their functional properties in a chemical mixture; those used as building block chemicals and secondary chemicals such as glycerol, succinic acid, propanediol, and monomers such as lactic acid and propylene; those used for specific functional properties during manufacturing of other products such as pH regulators, flocculants, precipitants, neutralizing agents, emulsifiers, detergents, wetting agents, foaming agents, or dispersants; those that are added to end-use products for their specific functional properties including solvents for thinning and drying applications but excluding solvents used for cleaning; and those used for dyes, pigments, and scents including flavorings for non-food products such as lip balm.

    USDA identified 27 manufacturers and suppliers of 70 biobased Intermediates—Chemicals. These 27 manufacturers and suppliers do not necessarily include all manufacturers and suppliers of Intermediates—Chemicals, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 70 biobased Intermediates—Chemicals range in biobased content from 25 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Chemicals. Thus, the proposed minimum biobased content for this product category is 22 percent, based on the products with a tested biobased content of 25 percent.

    Relevant product information supplied by these manufacturers and suppliers indicates that these products are being used commercially. However, these 27 manufacturers and suppliers did not identify any applicable performance standards, test methods, or other industry measures of performance against which these products have been tested. USDA points out that the lack of identified performance standards is not relevant to the designation of a product category for Federal preferred procurement because it is not one of the criteria section 9002 requires USDA to consider in order to designate a product category for Federal preferred procurement. If and when performance standards, test methods, and other relevant measures of performance are identified for this product category, USDA will provide such information on the BioPreferred Program's Web site.

    USDA has been unable to obtain data on the amount of Intermediates—Chemicals purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these 70 Intermediate—Chemicals products and is available on the BioPreferred Program's Web site.

    3. Intermediates—Paint and Coating Components (Minimum Biobased Content 22 Percent)

    Intermediates—Paint and Coating Components are ingredients used to formulate finished waterborne or solvent borne paint and coating products. Examples of Intermediates—Paint and Coating Components include binders, pigments thickeners, curing agents, modifiers, alkyd latex resins, polyols, reactive oligomers, or reactive diluents.

    USDA identified 13 manufacturers and suppliers of 51 biobased Intermediates—Paint and Coating Components. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Paint and Coating Components, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 51 biobased Intermediates—Paint and Coating Components range in biobased content from 25 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Paint and Coating Components. Thus, the proposed minimum biobased content for this product category is 22 percent, based on the products with a tested biobased content of 25 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. However, these manufacturers and suppliers did not identify any applicable performance standards, test methods, or other industry measures of performance against which these products have been tested. USDA points out that the lack of identified performance standards is not relevant to the designation of a product category for Federal preferred procurement because it is not one of the criteria section 9002 requires USDA to consider in order to designate a product category for Federal preferred procurement. If and when performance standards, test methods, and other relevant measures of performance are identified for this product category, USDA will provide such information on the BioPreferred Program's Web site.

    USDA has been unable to obtain data on the amount of Intermediates—Paint and Coating Components purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics has been collected on these 51 Intermediates—Paint and Coating Components and may be found on the BioPreferred Program's Web site.

    4. Intermediates—Textile Processing Materials (Minimum Biobased Content 22 Percent)

    Intermediates—Textile Processing Materials are used to treat or finish textiles for the purposes of altering textile characteristics such as color, fading, wrinkle resistance, texture, or moisture management.

    USDA identified four manufacturers and suppliers of 24 biobased Intermediates—Textile Processing Materials. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Textile Processing Materials, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 24 biobased Intermediates—Textile Processing Materials range in biobased content from 25 percent to 98 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Textile Processing Materials. Thus, the proposed minimum biobased content for this product category is 22 percent, based on the products with a tested biobased content of 25 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. However, these manufacturers and suppliers did not identify any applicable performance standards, test methods, or other industry measures of performance against which these products have been tested. USDA points out that the lack of identified performance standards is not relevant to the designation of a product category for Federal preferred procurement because it is not one of the criteria section 9002 requires USDA to consider in order to designate a product category for Federal preferred procurement. If and when performance standards, test methods, and other relevant measures of performance are identified for this product category, USDA will provide such information on the BioPreferred Program's Web site.

    USDA has been unable to obtain data on the amount of Intermediates—Textile Processing Materials purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these 24 Intermediates—Textile Processing Materials and may be found on the BioPreferred Program's Web site.

    5. Intermediates—Foams (Minimum Biobased Content 22 Percent)

    Intermediates—Foams are dry polymer foams used for non-construction purposes, such as cushions for furniture.

    USDA identified seven manufacturers and suppliers of eight biobased Intermediates—Foams. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Foams, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These eight biobased Intermediates—Foams were each measured by ASTM D6866 to have 25, 30, 30, 33, 33, 40, 53, and 53 percent biobased contents. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Foams. Thus, the proposed minimum biobased content for this product category is 22 percent, based on the product with a tested biobased content of 25 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, some of these manufacturers and suppliers identified three test methods (as shown below) used in evaluating products within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test methods identified by the manufacturers and suppliers include:

    • ASTM D97; Standard Test Method for Pour Point of Petroleum Products,

    • ASTM D6868; Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities, and

    • California Technical Bulletin 117; Requirements, Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used In Upholstered Furniture.

    USDA has been unable to obtain data on the amount of Intermediates—Foams purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these eight Intermediates—Foams and may be found on the BioPreferred Program's Web site.

    6. Intermediates—Fibers and Fabrics (Minimum Biobased Content 25 Percent)

    Intermediates—Fibers and Fabrics encompasses plant and animal fibers, fibers made from plant-derived polymers that are not yet formed into more complex products such as carpet or fabrics, fabrics made from natural fibers, fabrics made from synthetic fibers, or fabrics made from a blend of the two. These materials are used to manufacture finished products such as clothing, upholstery, or drapes.

    USDA identified 16 manufacturers and suppliers of 48 biobased Intermediates—Fibers and Fabrics. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Fibers and Fabrics, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 48 biobased Intermediates—Fibers and Fabrics range in biobased content from 28 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Fibers and Fabrics. Thus, the proposed minimum biobased content for this product category is 25 percent, based on the product with a tested biobased content of 28 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, some of these manufacturers and suppliers identified seven test methods (as shown below) used in evaluating products within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test methods identified by the manufacturers and suppliers include:

    • AATCC 79; Absorbency of Textiles,

    • AATCC 197; Vertical Wicking of Textiles,

    • AATCC 198; Horizontal Wicking of Textiles,

    • ACT Physical Properties Performance Guidelines,

    • ASTM D737; Standard Test Method for Air Permeability of Textile Fabrics,

    • ASTM D6868; Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities, and

    • Oeko-Tex Standard 100; Tests for Harmful Substances in Textiles.

    USDA has been unable to obtain data on the amount of Intermediates—Fibers and Fabrics purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on 48 Intermediates—Fibers and Fabrics and may be found on the BioPreferred Program's Web site.

    7. Intermediates—Lubricant Components (Minimum Biobased Content 44 Percent)

    Intermediates—Lubricant Components are ingredients that used specifically to formulate finished lubricant products. Examples of Intermediates—Lubricant Components include base oils, base fluids, additives, or friction modifiers.

    USDA identified nine manufacturers and suppliers of 35 biobased Intermediates—Lubricant Components. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Lubricant Components, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 35 biobased Intermediates—Lubricant Components range in biobased content from 47 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Lubricants. Thus, the proposed minimum biobased content for this product category is 44 percent, based on the products with a tested biobased content of 47 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, one of these manufacturers and suppliers identified one test method used in evaluating products within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test method identified by the manufacturer and supplier is NSF H1 Nonfood Compound Product Registration Program.

    USDA has been unable to obtain data on the amount of Intermediates—Lubricant Components purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these 35 Intermediates—Lubricant Components and may be found on the BioPreferred Program's Web site.

    8. Intermediates—Binders (Minimum Biobased Content 47 Percent)

    Intermediates—Binders are materials used to provide cohesiveness throughout an entire finished product. The product category does not include adhesives and glues that are finished products used to attach the surfaces of two or more distinct and separate components to one another.

    USDA identified one manufacturer and supplier of one biobased Intermediates—Binders. This manufacturer and supplier is not expected to be the only manufacturer and supplier of biobased Intermediates—Binders, merely the only one that was identified through the USDA Certified Biobased Products in the BioPreferred Program's database. The biobased content of this Intermediates—Binders product is 50 percent, as measured by ASTM D6866. As discussed earlier, the tested value was reduced by 3 percentage points to account for the inherent variability in the test method. Thus, the proposed minimum biobased content for this product category is 47 percent.

    Information supplied by this manufacturer indicates that this product is being used commercially. However, this manufacturer and supplier did not identify any applicable performance standards, test methods, or other industry measures of performance against which this product has been tested. USDA points out that the lack of identified performance standards is not relevant to the designation of a product category for Federal preferred procurement because it is not one of the criteria section 9002 requires USDA to consider in order to designate a product category for Federal preferred procurement. If and when performance standards, test methods, and other relevant measures of performance are identified for this product category, USDA will provide such information on the BioPreferred Program's Web site.

    USDA has been unable to obtain data on the amount of Intermediates—Binders purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on this one Intermediates—Binders product and may be found on the BioPreferred Program's Web site.

    9. Intermediates—Cleaner Components (Minimum Biobased Content 55 Percent)

    Intermediates—Cleaner Components are intermediate ingredients used specifically for formulating finished cleaning products. Examples of Intermediates—Cleaner Components include chelating agents, surfactants, hydrotropes, fatty acids, or solvents.

    USDA identified eight manufacturers and suppliers of 19 different biobased Intermediates—Cleaner Components. These eight manufacturers and suppliers do not necessarily include all manufacturers and suppliers of biobased Intermediates—Cleaner Components, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 19 biobased Intermediates—Cleaner Components range in biobased content from 58 percent to 99 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Cleaner Components. Thus, the proposed minimum biobased content for this product category is 55 percent, based on the products with a tested biobased content of 58 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, one of the manufacturers and suppliers identified five test methods (as shown below) used in evaluating its product within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test methods identified by the manufacturer and supplier include:

    • ASTM D93; Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester,

    • ASTM D1133; Standard Test Method for Kauri-Butanol Value of Hydrocarbon Solvents,

    • ASTM D2887; Standard Test Method for Boiling Range Distribution of Petroleum Fractions by Gas Chromatography, and

    • EPA Method 24; Determination of Volatile Matter Content, Water Content, Density, Volume Solids, and Weight Solids of Surface Coatings.

    USDA has been unable to obtain data on the amount of Intermediates—Cleaner Components purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these 19 Intermediates—Cleaner Components and may be found on the BioPreferred Program's Web site.

    10. Intermediates—Personal Care Product Components (Minimum Biobased Content 62 Percent)

    Intermediates—Personal Care Product Components are ingredients used to formulate finished personal care products. Examples of Intermediates—Personal Care Product Components include surfactants, oils, humectants, emollients, or emulsifiers.

    USDA identified nine manufacturers and suppliers of 37 biobased Intermediates—Personal Care Product Components. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Personal Care Product Components, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 37 biobased Intermediates—Personal Care Product Components range in biobased content from 65 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Personal Care Product Components. Thus, the proposed minimum biobased content for this product category is 62 percent, based on the products with a tested biobased content of 65 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, some these manufacturers and suppliers identified 3 test methods (as shown below) used in evaluating products within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test methods identified by the manufacturers and suppliers include:

    • ASTM D6868; Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities, and

    • EPA Method 24; Determination of Volatile Matter Content, Water Content, Density, Volume Solids, and Weight Solids of Surface Coatings.

    USDA has been unable to obtain data on the amount of Intermediates—Personal Care Product Components purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on 37 Intermediates—Personal Care Product Components and may be found on the BioPreferred Program's Web site.

    11. Intermediates—Oils, Fats, and Waxes (Minimum Biobased Content 65 Percent)

    Intermediates—Oils, Fats, and Waxes include raw or modified fats and oils derived from plants or animals.

    USDA identified five manufacturers and suppliers of 24 biobased Intermediates—Oils, Fats, and Waxes. These manufacturers and suppliers do not include all manufacturers and suppliers of biobased Intermediates—Oils, Fats, and Waxes, merely those identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These 24 biobased Intermediates—Oils, Fats, and Waxes range in biobased content from 68 percent to 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Oils, Fats, and Waxes. Thus, the proposed minimum biobased content for this product category is 65 percent, based on the products with a tested biobased content of 68 percent.

    Information supplied by these manufacturers and suppliers indicates that these products are being used commercially. In addition, one of these manufacturers and suppliers identified one test method used in evaluating a product within the product category. While there may be additional test methods, as well as performance standards, product certifications, and other measures of performance, applicable to products within this product category, the test method identified by the manufacturer and supplier is California Technical Bulletin 117.

    USDA has been unable to obtain data on the amount of Intermediates—Oils, Fats, and Waxes purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these 24 Intermediates—Oils, Fats, and Waxes and may be found on the BioPreferred Program's Web site.

    12. Intermediates—Rubber Materials (Minimum Biobased Content 96 Percent)

    Intermediates—Rubber Materials are used in finished products such as rubber gloves, vehicle tires, footwear, sports apparel and equipment, bedding and pillow foams, tubing, catheters, gasketing, or cosmetic adhesives and bases.

    USDA identified one manufacturer and supplier of two biobased Intermediates—Rubber Materials. This manufacturer and supplier is not expected to be the only manufacturer and supplier of biobased Intermediates—Rubber Materials, merely the only one identified through the USDA Certified Biobased Products in the BioPreferred Program's database. These two biobased Intermediates—Rubber Materials have biobased contents of 99 percent and 100 percent, as measured by ASTM D6866. In establishing the minimum biobased content requirement for this product category, USDA did not find a reason to exclude any of the products categorized as Intermediates—Rubber Materials. Thus, the proposed minimum biobased content for this product category is 96 percent, based on the products with a tested biobased content of 99 percent.

    The Information supplied by this manufacturer and supplier indicates that these products are being used commercially. However, this manufacturer and supplier did not identify any applicable performance standards, test methods, or other industry measures of performance against which these products have been tested. USDA points out that the lack of identified performance standards is not relevant to the designation of a product category for Federal preferred procurement because it is not one of the criteria section 9002 requires USDA to consider in order to designate a product category for Federal preferred procurement. If and when performance standards, test methods, and other relevant measures of performance are identified for this product category, USDA will provide such information on the BioPreferred Program's Web site.

    USDA has been unable to obtain data on the amount of Intermediates—Rubber Materials purchased by Federal procuring agencies. As discussed earlier, the primary benefit of designating intermediate ingredient product categories is not to promote their direct purchase by Federal agencies but, rather, to establish the framework for designation of the extensive number of finished products that are made from these intermediate ingredients.

    Specific product information, including company contact, intended use, biobased content, and performance characteristics, has been collected on these two Intermediates—Rubber Materials and may be found on the BioPreferred Program's Web site.

    C. Compliance Date for Procurement Preference and Incorporation Into Specifications

    USDA intends for the final rule to take effect thirty (30) days after publication of the final rule. USDA proposes that starting from the date of publication of the final rule, procuring agencies have a one-year transition period before the procurement preference for biobased products within a designated product category takes effect. This proposed timeframe is based on section 9002(a)(3)(B)(viii) of the 2014 Farm Bill, which clearly provides a compliance date for amendments to the Guidelines of up to one year after publication of a final rule.

    Therefore, USDA is proposing a one-year period before the procurement preferences would take effect because, as indicated in 7 CFR 3201.4(c), it recognizes that Federal agencies will need sufficient time to incorporate the preferences into procurement documents and to revise existing standardized specifications. Additionally, procuring agencies will need time to evaluate the economic and technological feasibility of the available biobased products for their agency-specific uses and for compliance with agency-specific requirements.

    By the time these product categories are promulgated for designation, Federal agencies will have had a minimum of 18 months (from the date of this Federal Register notice), and much longer considering when the Guidelines were first proposed and these requirements were first laid out, to implement these requirements.

    Therefore, USDA proposes that the mandatory preference for biobased products under the designated product categories take effect one year after promulgation of the final rule, which will provide these agencies with ample time to evaluate the economic and technological feasibility of biobased products for a specific use and to revise the specifications accordingly. Some agencies may be able to complete these processes more expeditiously and not all uses will require extensive analysis or revision of existing specifications. Although it is allowing up to one year, USDA encourages procuring agencies to implement the procurement preferences as early as practicable for procurement actions involving any of the designated product categories.

    V. Where can agencies get more information on these USDA-designated product categories?

    The information used to develop this proposed rule was voluntarily submitted by the manufacturers of products that are categorized within the product categories being proposed. These manufacturers sought to participate in the BioPreferred Program's USDA Certified Biobased Product labeling initiative and submitted product information necessary for certification. Information on each of these products can be found on the BioPreferred Program's Web site (http://www.biopreferred.gov).

    Further, once the product category designations in today's proposal become final, manufacturers and vendors voluntarily may make available additional information on specific products for posting by the Agency on the BioPreferred Program's Web site. USDA has begun performing periodic audits of the information displayed on the BioPreferred Program's Web site and, where questions arise, is contacting the manufacturer or vendor to verify, correct, or remove incorrect or out-of-date information. Procuring agencies should contact the manufacturers and vendors directly to discuss specific needs and to obtain detailed information on the availability and prices of biobased products meeting those needs.

    By accessing the BioPreferred Program's Web site, agencies may also be able to obtain any voluntarily-posted information on each product concerning: Relative price; life-cycle costs; hot links directly to a manufacturer's or vendor's Web site (if available); performance standards (industry, government, military, ASTM/ISO) that the product has been tested against; and environmental and public health information.

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

    Executive Order 12866, as supplemented by Executive Order 13563, requires agencies to determine whether a regulatory action is “significant.” The Order defines a “significant regulatory action” as one that is likely to result in a rule that may: “(1) Have an annual effect on the economy of $100 million or more or adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    Today's proposed rule has been determined by the Office of Management and Budget to be not significant for purposes of Executive Order 12866. We are not able to quantify the annual economic effect associated with today's proposed rule. USDA attempted to obtain information on the Federal agencies' usage within the 12 designated product categories. These efforts were largely unsuccessful. Therefore, attempts to determine the economic impacts of today's proposed rule would require estimation of the anticipated market penetration of biobased products based upon many assumptions. In addition, because agencies have the option of not purchasing products within designated product categories if price is “unreasonable,” the product is not readily available, or the product does not demonstrate necessary performance characteristics, certain assumptions may not be valid. While facing these quantitative challenges, USDA relied upon a qualitative assessment to determine the impacts of today's proposed rule. Consideration was also given to the fact that agencies may choose not to procure products within designated product categories due to unreasonable price.

    1. Summary of Impacts

    Today's proposed rule is expected to have both positive and negative impacts to individual businesses, including small businesses. These positive and negative impacts are expected to be minimized because Federal agencies do not typically purchase significant quantities of the types of intermediate ingredient products that are the subject of today's proposed rule. However, USDA anticipates that the Federal preferred procurement program will ultimately provide additional opportunities for businesses and manufacturers to begin supplying products under the proposed designated biobased product categories to Federal agencies and their contractors. However, other businesses and manufacturers that supply only non-qualifying products and do not offer biobased alternatives may experience a decrease in demand from Federal agencies and their contractors. USDA is unable to determine the number of businesses, including small businesses, which may be adversely affected by today's proposed rule. The proposed rule, however, will not affect existing purchase orders, nor will it preclude businesses from modifying their product lines to meet new requirements for designated biobased products. Because the extent to which procuring agencies will find the performance, availability and/or price of biobased products acceptable is unknown, it is impossible to quantify the actual economic effect of the rule.

    2. Benefits of the Proposed Rule

    The designation of these product categories provides the benefits outlined in the objectives of section 9002; to increase domestic demand for many agricultural commodities that can serve as feedstocks for production of biobased products, and to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities. On a national and regional level, today's proposed rule can result in expanding and strengthening markets for biobased materials used in these product categories.

    3. Costs of the Proposed Rule

    Like the benefits, the costs of today's proposed rule have not been quantified. Two types of costs are involved: Costs to producers of products that will compete with the preferred products and costs to Federal agencies to provide procurement preference for the preferred products. Producers of competing products may face a decrease in demand for their products to the extent Federal agencies refrain from purchasing their products. However, it is not known to what extent this may occur. Pre-award procurement costs for Federal agencies may rise minimally as the contracting officials conduct market research to evaluate the performance, availability, and price reasonableness of preferred products before making a purchase.

    B. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601-602, generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

    USDA evaluated the potential impacts of its proposed designation of these product categories to determine whether its actions would have a significant impact on a substantial number of small entities. Because the Federal preferred procurement program established under section 9002 applies only to Federal agencies and their contractors, small governmental (city, county, etc.) agencies are not affected. Thus, the proposal, if promulgated, will not have a significant economic impact on small governmental jurisdictions.

    USDA anticipates that this program will affect entities, both large and small, that manufacture or sell biobased products. For example, the designation of product categories for Federal preferred procurement will provide additional opportunities for businesses to manufacture and sell biobased products to Federal agencies and their contractors. Similar opportunities will be provided for entities that supply biobased materials to manufacturers.

    The intent of section 9002 is largely to stimulate the production of new biobased products and to energize emerging markets for those products. Because the biobased product industry as a whole is still a developing market, it is unknown how many businesses will ultimately be affected by today's proposed rule. While USDA has no data on the number of small businesses that may choose to develop and market biobased products within the product categories designated by this rulemaking, the number is expected to be small because this industry is still materializing. As such, USDA anticipates that only a small percentage of all manufacturers, large or small, are expected to develop and market biobased products. Thus, the number of small businesses manufacturing biobased products affected by this rulemaking is not expected to be substantial.

    The Federal preferred procurement program may decrease opportunities for businesses that manufacture or sell non-biobased products or provide components for the manufacturing of such products. Most manufacturers of non-biobased products within the product categories being proposed for designation for Federal preferred procurement in this rule are expected to be included under the following NAICS codes: 324191 (petroleum lubricating oil and grease manufacturing), 325320 (pesticide and other agricultural chemicals manufacturing), 325411 (medicinal and botanical manufacturing), 325412 (pharmaceutical preparation manufacturing), 325510 (paint and coating manufacturing), 325612 (polish and other sanitation goods manufacturing), and 325620 (toilet preparation manufacturing). USDA obtained information on these seven NAICS categories from the U.S. Census Bureau's Economic Census database. USDA found that the Economic Census reports about 4,756 companies within these 7 NAICS categories and that these companies own a total of about 5,374 establishments. Thus, the average number of establishments per company is about 1.13. The Census data also reported that of the 5,374 individual establishments, about 5,228 (97.3 percent) have fewer than 500 employees. USDA also found that the overall average number of employees per company among these industries is about 92 and that the pharmaceutical preparation manufacturing segment (with an average of about 250) is the only segment reporting an average of more than 100 employees per company. Thus, nearly all of the businesses meet the Small Business Administration's definition of a small business (less than 500 employees, in most NAICS categories).

    USDA does not have data on the potential adverse impacts on manufacturers of non-biobased products within the product categories being designated, but believes that the impact will not be significant. Most of the product categories being proposed for designation in this rulemaking are used to produce typical consumer products widely used by the general public and by industrial/commercial establishments that are not subject to this rulemaking. Thus, USDA believes that the number of small businesses manufacturing non-biobased products within the product categories being designated and selling significant quantities of those products to government agencies affected by this rulemaking to be relatively low. Also, this proposed rule will not affect existing purchase orders and it will not preclude procuring agencies from continuing to purchase non-biobased products when biobased products do not meet the availability, performance, or reasonable price criteria. This proposed rule will also not preclude businesses from modifying their product lines to meet new specifications or solicitation requirements for these products containing biobased materials.

    After considering the economic impacts of this proposed rule on small entities, USDA certifies that this action will not have a significant economic impact on a substantial number of small entities.

    While not a factor relevant to determining whether the proposed rule will have a significant impact for RFA purposes, USDA has concluded that the effect of the rule will be to provide positive opportunities to businesses engaged in the manufacture of these biobased products. Purchase and use of these biobased products by procuring agencies increase demand for these products and result in private sector development of new technologies, creating business and employment opportunities that enhance local, regional, and national economies.

    C. Executive Order 12630: Governmental Actions and Interference With Constitutionally Protected Property Rights

    This proposed rule has been reviewed in accordance with Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and does not contain policies that would have implications for these rights.

    D. Executive Order 12988: Civil Justice Reform

    This proposed rule has been reviewed in accordance with Executive Order 12988, Civil Justice Reform. This proposed rule does not preempt State or local laws, is not intended to have retroactive effect, and does not involve administrative appeals.

    E. Executive Order 13132: Federalism

    This proposed rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Provisions of this proposed rule will not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various government levels.

    F. Unfunded Mandates Reform Act of 1995

    This proposed rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, for State, local, and tribal governments, or the private sector. Therefore, a statement under section 202 of UMRA is not required.

    G. Executive Order 12372: Intergovernmental Review of Federal Programs

    For the reasons set forth in the Final Rule Related Notice for 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), this program is excluded from the scope of the Executive Order 12372, which requires intergovernmental consultation with State and local officials. This program does not directly affect State and local governments.

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

    This proposed rule does not significantly or uniquely affect “one or more Indian tribes . . . the relationship between the Federal Government and Indian tribes, or . . . the distribution of power and responsibilities between the Federal Government and Indian tribes.” Thus, no further action is required under Executive Order 13175.

    I. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 through 3520), the information collection under this proposed rule is currently approved under OMB control number 0503-0011.

    J. E-Government Act Compliance

    USDA is committed to compliance with the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. USDA is implementing an electronic information system for posting information voluntarily submitted by manufacturers or vendors on the products they intend to offer for Federal preferred procurement under each designated product category. For information pertinent to E-Government Act compliance related to this rule, please contact Marie Wheat at (202) 239-4502.

    List of Subjects in 7 CFR Part 3201

    Biobased products, Procurement.

    For the reasons stated in the preamble, the Department of Agriculture proposes to amend 7 CFR chapter XXXII as follows:

    CHAPTER XXXII—OFFICE OF PROCUREMENT AND PROPERTY MANAGEMENT PART 3201—GUIDELINES FOR DESIGNATING BIOBASED PRODUCTS FOR FEDERAL PROCUREMENT 1. The authority citation for part 3201 continues to read as follows: Authority:

    7 U.S.C. 8102.

    2. Add §§ 3201.108 through 3201.119 to subpart B to read as follows: Sec. 3201.108 Intermediates—Plastic Resins. 3201.109 Intermediates—Chemicals. 3201.110 Intermediates—Paint and Coating Components. 3201.111 Intermediates—Textile Processing Materials. 3201.112 Intermediates—Foams. 3201.113 Intermediates—Fibers and Fabrics. 3201.114 Intermediates—Lubricant Components. 3201.115 Intermediates—Binders. 3201.116 Intermediates—Cleaner Components. 3201.117 Intermediates—Personal Care Product Components. 3201.118 Intermediates—Oils, Fats, and Waxes. 3201.119 Intermediates—Rubber Materials.
    § 3201.108 Intermediates—Plastic Resins.

    (a) Definition. Intermediates—Plastic Resins are materials that are typically viscous liquids with the ability to harden permanently and may exist in liquid or solid (powder or pellets) states. Intermediates—Plastic Resins may be used in a variety of finished products neat, consisting of a single resin, or a homogeneous blend of two or more neat resins, or composite, containing two or more distinct materials such as fiber-reinforced resins.

    Additionally, Intermediates—Plastic Resins may be used in finished products as additives such as plasticizers, pigments, thermal stability agents, or impact modifiers.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 22 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Plastic Resins. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Plastic Resins.

    § 3201.109 Intermediates—Chemicals.

    (a) Definition. Intermediates—Chemicals are those used as reactants for organic synthesis reactions rather than for their functional properties in a chemical mixture; those used as building block chemicals and secondary chemicals such as glycerol, succinic acid, propanediol, and monomers such as lactic acid and propylene; those used for specific functional properties during manufacturing of other products such as pH regulators, flocculants, precipitants, neutralizing agents, emulsifiers, detergents, wetting agents, foaming agents, or dispersants; those that are added to end-use products for their specific functional properties including solvents for thinning and drying applications but excluding solvents used for cleaning; and those used for dyes, pigments, and scents including flavorings for non-food products such as lip balm.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 22 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Chemicals. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Chemicals.

    § 3201.110 Intermediates—Paint and Coating Components.

    (a) Definition. Intermediates—Paint and Coating Components are ingredients used to formulate finished waterborne or solvent borne paint and coating products. Examples of Intermediates—Paint and Coating Components include binders, pigments thickeners, curing agents, modifiers, alkyd latex resins, polyols, reactive oligomers, or reactive diluents.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 22 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Paint and Coating Components. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Paint and Coating Components.

    § 3201.111 Intermediates—Textile Processing Materials.

    (a) Definition. Intermediates—Textile Processing Materials are used to treat or finish textiles for the purposes of altering textile characteristics such as color, fading, wrinkle resistance, texture, or moisture management.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 22 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Textile Processing Materials. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Textile Processing Materials.

    § 3201.112 Intermediates—Foams.

    (a) Definition. Intermediates—Foams are dry polymer foams used for non-construction purposes, such as cushions for furniture.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 22 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Foams. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Foams.

    § 3201.113 Intermediates—Fibers and Fabrics.

    (a) Definition. Intermediates—Fibers and Fabrics encompasses plant and animal fibers, fibers made from plant-derived polymers that are not yet formed into more complex products such as carpet or fabrics, fabrics made from natural fibers, fabrics made from synthetic fibers, or fabrics made from a blend of the two. These materials are used to manufacture finished products such as clothing, upholstery, or drapes.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 25 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Fibers and Fabrics. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Fibers and Fabrics.

    § 3201.114 Intermediates—Lubricant Components.

    (a) Definition. Intermediates—Lubricant Components are ingredients that used specifically to formulate finished lubricant products. Examples of Intermediates—Lubricant Components include base oils, base fluids, additives, or friction modifiers.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 44 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Lubricant Components. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Lubricant Components.

    § 3201.115 Intermediates—Binders.

    (a) Definition. Intermediates—Binders are materials used to provide cohesiveness throughout an entire finished product. The product category does not include adhesives and glues that are finished products used to attach the surfaces of two or more distinct and separate components to one another.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 47 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Binders. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Binders.

    § 3201.116 Intermediates—Cleaner Components.

    (a) Definition. Intermediates—Cleaner Components are intermediate ingredients used specifically for formulating finished cleaning products. Examples of Intermediates—Cleaner Components include chelating agents, surfactants, hydrotropes, fatty acids, or solvents.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 55 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Cleaner Components. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Cleaner Components.

    § 3201.117 Intermediates—Personal Care Product Components.

    (a) Definition. Intermediates—Personal Care Product Components are ingredients used to formulate finished personal care products. Examples of Intermediates—Personal Care Product Components include surfactants, oils, humectants, emollients, or emulsifiers.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 62 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Personal Care Product Components. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Personal Care Product Components.

    § 3201.118 Intermediates—Oils, Fats, and Waxes.

    (a) Definition. Intermediates—Oils, Fats, and Waxes include raw or modified fats and oils derived from plants or animals.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 65 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Oils, Fats, and Waxes. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Oils, Fats, and Waxes.

    § 3201.119 Intermediates—Rubber Materials.

    (a) Definition. Intermediates—Rubber Materials are used in finished products such as rubber gloves, vehicle tires, footwear, sports apparel and equipment, bedding and pillow foams, tubing, catheters, gasketing, or cosmetic adhesives and bases.

    (b) Minimum biobased content. The Federal preferred procurement product must have a minimum biobased content of at least 96 percent, which shall be based on the amount of qualifying biobased carbon in the product as a percent of the weight (mass) of the total organic carbon in the finished product.

    (c) Preference compliance date. No later than [date one year after the date of publication of the final rule], procuring agencies, in accordance with this part, will give a procurement preference for qualifying biobased Intermediates—Rubber Materials. By that date, Federal agencies responsible for drafting or reviewing specifications for products to be procured shall ensure that the relevant specifications require the use of biobased Intermediates—Rubber Materials.

    Dated: December 16, 2016. Gregory L. Parham, Assistant Secretary for Administration, U.S. Department of Agriculture.
    [FR Doc. 2016-31128 Filed 1-12-17; 8:45 am] BILLING CODE 3410-93-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9443; Airspace Docket No. 16-ASO-17] Proposed Amendment of Class E Airspace; Kyle-Oakley Field Airport, Murray, KY AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E airspace at Murray, KY, as the Calloway Non-Directional Beacon (NDB) has been decommissioned, requiring airspace reconfiguration at Kyle-Oakley Field Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport, and update the designation header.

    DATES:

    Comments must be received on or before February 27, 2017.

    ADDRESSES:

    Send comments on this proposal to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or 202-366-9826. You must identify the Docket No. FAA-2016-9443; Airspace Docket No. 16-ASO-17, at the beginning of your comments. You may also submit and review received comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Kyle-Oakley Field Airport, Murray, KY.

    Comments Invited

    Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers and be submitted in triplicate to the address listed above. You may also submit comments through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9443; Airspace Docket No. 16-ASO-17.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal Holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet above the surface at Kyle-Oakley Field Airport, Murray, KY. Airspace reconfiguration to within a 7 mile radius of the airport is necessary due to the decommissioning of the Calloway NDB and cancellation of the NDB approach, and for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport would be adjusted to coincide with the FAAs aeronautical database, and the airport designation header would be updated to include the airport name.

    Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO KY E5 Kyle-Oakley Field, Murray, KY [Amended] Kyle-Oakley Field Airport, KY (Lat. 36°39′52″ N., long. 88°22′22″ W.)

    That airspace extending upward from 700 feet above the surface within a 7 mile radius of Kyle-Oakley Field Airport.

    Issued in College Park, Georgia, on December 29, 2016. Debra L. Hogan, Acting Manager, Operations Support Group Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2017-00284 Filed 1-12-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9118; Airspace Docket No. 16-AGL-3] Proposed Amendment of Class D and E Airspace for the Following North Dakota Towns; Wahpeton, ND; Hettinger, ND; Fargo, ND; Grand Fork, ND; Carrington, ND; Cooperstown, ND; Pembina, ND; Rugby, ND; Devils Lake, ND; Bottineau, ND; Valley City, ND and Gwinner, ND AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Wahpeton/Harry Stern Airport, Wahpeton, ND; Hettinger Municipal Airport, Hettinger, ND; Gwinner-Roger Melroe Field, Gwinner, ND; and Rugby Municipal Airport, Rugby, ND. Decommissioning of non-directional radio beacons (NDBs), cancellation of NDB approaches, and implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at these airports. This action would also update the geographic coordinates and airport names for certain airports listed also under these airports in the Class D and E airspace areas.

    DATES:

    Comments must be received on or before February 27, 2017.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No. FAA-2016-9118; Airspace Docket No. 16-AGL-3 at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Ron Laster, Contract Support, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5879.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace in the respective Class D and E airspace areas at Wahpeton/Harry Stern Airport, Wahpeton, ND; Hettinger Municipal Airport, Hettinger, ND; Gwinner-Roger Melroe Field, Gwinner, ND; Rugby Municipal Airport, Rugby, ND; Hector International Airport, Fargo, ND; Grand Forks Air Force Base, Grand Forks, ND; Carrington Municipal Airport, Carrington, ND; Pembina Municipal Airport, Pembina, ND; Bottineau Municipal Airport, Bottineau, ND; Cooperstown Municipal Airport, ND; Devils Lake Regional Airport, Devils Lake, ND, and Barnes County Municipal Airport, Valley City, ND.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9118/Airspace Docket No. 16-AGL-3.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying:

    Geographic coordinates in Class D airspace for Hector International Airport, Fargo, ND; Class E airspace extending upward from 700 feet above the surface:

    Within a 6.4-mile radius (previously a 7-mile radius) of Harry Stern Airport, Wahpeton, ND, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 6.4-mile radius (previously a 7-mile radius) of Hettinger Municipal Airport, Hettinger, ND, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 6.5-mile radius (previously a 7-mile radius) of Gwinner-Roger Melroe Field, Gwinner, ND; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

    Within a 6.3-mile radius (previously a 7-mile radius) of Rugby Municipal Airport, Rugby, ND; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

    Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures that would enhance the safety and management of standard instrument approach procedures for IFR operations at these airports. The geographic coordinates would be adjusted for Hector International Airport, Fargo, ND; Grand Forks Air Force Base, Grand Forks, ND; Barnes County Municipal Airport, Valley City, ND; Pembina Municipal Airport, Pembina, ND; Devils Lake VOR/DME; Devils Lake Regional Airport, Devils Lake, ND; Carrington Municipal Airport, Carrington, ND; Bottineau Municipal Airport, Bottineau, ND; Cooperstown Municipal Airport, ND, as well as the airport names for Barnes County Municipal Airport (formerly Valley City/Barnes County Municipal), Valley City, ND, and Devils Lake Regional Airport (formerly Devils Lake Municipal Airport), Devils Lake, ND, to coincide with the FAA's aeronautical database.

    Class D and E airspace designations are published in paragraph 5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 5000 Class D Airspace. AGL ND D Fargo, ND [Amended] Hector International Airport, ND (Lat. 46°55′14″ N., long. 96°48′57″ W.)

    That airspace extending upward from the surface to and including 3,400 feet MSL within a 4.5-mile radius of Hector International Airport.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. AGL ND E2 Devils Lake, ND [Amended] Devils Lake Regional Airport, ND (Lat. 48°06′53″ N., long. 98°54′30″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.)

    Within a 4-mile radius of Devils Lake Regional Airport, and within 3 miles each side of the Devils Lake VOR/DME 134° radial extending from the 4-mile radius to 8.7 miles southeast of the VOR/DME and within 2.3 miles each side of the Devils Lake VOR/DME 324° radial extending from the 4-mile radius to 8.7 miles northwest of the VOR/DME. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Designated as an Extension to a Class D or Class E Surface Area. AGL ND E4 Fargo, ND [Amended] Fargo, Hector International Airport, ND (Lat. 46°55′14″ N., long. 96°48′57″ W.) Fargo VORTAC (Lat. 46°45′12″ N., long. 96°51′05″ W.)

    That airspace extending upward from the surface within 1.7 miles each side of the Fargo VORTAC 009° radial, extending from the 4.5-mile radius of Hector International Airport to 7.8 miles south of the airport.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL ND E5 Bottineau, ND [Amended] Bottineau Municipal Airport, ND (Lat. 48°49′50″ N., long. 100°25′02″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Bottineau Municipal Airport, and that airspace extending upward from 1,200 feet above the surface within an area bounded on the north by lat. 49°00′00″ N., on the east by long. 99°49′00″ W., on the south by the 10.5-mile radius of Rugby, ND, Class E airspace area, and on the west by the 47-mile radius of the Minot, ND, Class E airspace area.

    AGL ND E5 Carrington, ND [Amended] Carrington Municipal Airport, ND (Lat. 47°27′04″ N., long. 99°09′05″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Carrington Municipal Airport; and that airspace extending upward from 1,200 feet above the surface bounded on the north by the 22-mile arc south of Devils Lake VOR/DME, on the east by V-170, on the south by V-55, on the west by long. 99°30′00″ W., and on the northwest by V-169.

    AGL ND E5 Cooperstown, ND [Amended] Cooperstown Municipal Airport, ND (Lat. 47°25′22″ N., long. 98°06′21″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.) Fargo, Hector International Airport, ND (Lat. 46°55′14″ N., long. 96°48′57″ W.) Grand Forks AFB, ND (Lat. 47°57′41″ N., long. 97°24′04″ W.) Jamestown VOR/DME (Lat. 46°55′58″ N., long. 98°40′44″ W.) Valley City, Barnes County Municipal Airport, ND (Lat. 46°56′28″ N., long. 98°01′05″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Cooperstown Municipal Airport and that airspace extending upward from 1,200 feet above the surface within an area bounded on the north by V-430; on the northeast by the 34-mile radius of Grand Forks AFB; on the southeast by the 40-mile radius of Fargo, Hector International Airport; on the south by V-2/V-510 east of Valley City, ND, the 7.9-mile radius of Barnes County Municipal Airport, and V-2/V-510 west of Valley City, ND; on the southwest by the 16.5-mile radius of Jamestown VOR/DME; on the west by V-170; and on the northwest by the 22-mile radius of Devils Lake VOR/DME.

    AGL ND E5 Devils Lake, ND [Amended] Devils Lake Regional Airport, ND (Lat. 48°06′53″ N., long. 98°54′30″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.)

    That airspace extending upward from 700 feet above the surface within an 8.7-mile radius of Devils Lake Regional Airport and that airspace extending upward from 1,200 feet above the surface within a 22-mile radius of Devils Lake VOR/DME.

    AGL ND E5 Gwinner, ND [Amended] Gwinner-Roger Melroe Field, ND (Lat. 46°13′06″ N., long. 97°38′36″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Gwinner-Roger Melroe Field Airport.

    AGL ND E5 Hettinger, ND [Amended] Hettinger Municipal Airport, ND (Lat. 46°00′54″ N., long. 102°39′22″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Hettinger Municipal Airport; and that airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 46°20′00″ N., long. 102°58′00″ W., to lat. 46°20′00″ N., long. 102°44′00″ W., to lat. 45°45′00″ N., long. 102°09′00″ W., to lat. 45°45′00″ N., long. 102°58′00″ W., to the point of beginning, excluding that airspace within V-491.

    AGL ND E5 Pembina, ND [Amended] Pembina Municipal Airport, ND (Lat. 48°56′33″ N., long. 97°14′27″ W.) Humboldt VORTAC (Lat. 48°52′09″ N., long. 97°07′02″ W.) Grand Forks AFB, ND (Lat. 47°57′41″ N., long. 97°24′03″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.2-mile radius of Pembina Municipal Airport, and within 1.8 miles each side of Humboldt VORTAC 132/312° radials extending from the 6.2-mile radius to 7 miles southeast of the airport; and that airspace extending upward from 1,200 feet above the surface beginning at lat. 49°00′00″ N., long. 97°30′01″ W.; to lat. 48°48′00″ N., long. 97°30′01″ W.; to lat. 48°18′34″ N., long. 98°39′53″ W.; thence clockwise around a 15.3-mile radius of Devils Lake VOR/DME to V-430; thence east along V-430 to the intersection of a 34-mile radius of Grand Forks AFB; thence clockwise along the 34-mile radius of Grand Forks AFB to the North Dakota/Minnesota state boundary; thence north along the state boundary to the United States/Canada border; thence west along the United States/Canada border to the point of beginning, excluding that airspace within all Federal airways.

    AGL ND E5 Rugby, ND [Amended] Rugby Municipal Airport, ND (Lat. 48°23′25″ N., long. 100°01′27″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Rugby Municipal Airport; and that airspace extending upward from 1,200 feet above the surface within a 13-mile radius of Rugby Municipal Airport, and within 8.1 miles north and 4.2 miles south of the 115° bearing from the airport extending from the 13-mile radius to 16.1 miles east of the airport, and within 8.5 miles south and 3.8 miles north of the 314° bearing from the airport extending from the 13-mile radius to 16.1 miles northwest of the airport, excluding that airspace within Minot, ND, and Rolla, ND, Class E airspace areas, and excluding all Federal airways.

    AGL ND E5 Valley City, ND [Amended] Barnes County Municipal Airport, ND (Lat. 46°56′28″ N., long. 98°01′05″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4 mile radius of Barnes County Municipal Airport; and that airspace extending upward from 1,200 feet above the surface within a 7.9-mile radius of the airport, and within 4 miles southwest and 8.3 miles northeast of the 133° bearing from the airport extending from the 7.9-mile radius to 21.8 miles southeast of the airport.

    AGL ND E5 Wahpeton, ND [Amended] Harry Stern Airport, ND (Lat. 46°14′40″ N., long. 96°36′26″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Harry Stern Airport and that airspace extending upward from 1,200 feet above the surface within a 25-mile radius of Harry Stern Airport bounded on the east by the Minnesota border and on the west by V-181.

    Issued in Fort Worth, Texas, on December 15, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2017-00286 Filed 1-12-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2016-D-3401] Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition” that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

    DATES:

    We are extending the comment period on the notice that published in the Federal Register of November 23, 2016 (81 FR 84516). Submit either electronic or written comments by February 13, 2017.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-3401 for “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2579.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of November 23, 2016 (81 FR 84516), we published a notice announcing the availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition.” The draft guidance explains the scientific review approach we plan to use for evaluating scientific evidence submitted to us in citizen petitions to determine whether a particular isolated or synthetic non-digestible carbohydrate that is added to food should be added to our definition of “dietary fiber” that is found in the Nutrition and Supplement Facts label final rule, which appeared in the Federal Register of May 27, 2016 (81 FR 33742). Only those isolated or synthetic non-digestible carbohydrates that meet the definition can be declared as a dietary fiber on a Nutrition and Supplement Facts label. We provided a 60-day comment period that was scheduled to close on January 23, 2017.

    Elsewhere in this issue of the Federal Register, we have published a notice to reopen the comment period for a related notice that appeared in the Federal Register of November 23, 2016 (81 FR 84595). We requested scientific data, information and comments in the related November 23, 2016, notice to help us evaluate the potential beneficial physiological effects on human health of 26 specific isolated or synthetic non-digestible carbohydrates that are added to food so that we may determine whether any of them should be added to our definition of dietary fiber in our Nutrition Facts and Supplement Facts label final rule. The November 23, 2016, notice also announced the availability of a document entitled “Science Review of Isolated and Synthetic Non-Digestible Carbohydrates,” which summarizes a scientific literature review that we conducted of clinical studies associated with the 26 specific isolated or synthetic non-digestible carbohydrates. The original comment period for this notice closed on January 9, 2017.

    We have received requests to extend the comment period for the isolated or synthetic non-digestible carbohydrates draft guidance. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the draft guidance.

    We have considered the requests and are extending the comment period for the draft guidance until February 13, 2017. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. The extended comment period deadline February 13, 2017, for the draft guidance also coincides with the reopened comment period for our related request for scientific data, information, and comments for the November 23, 2016, notice.

    Dated: January 10, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-00724 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF STATE 22 CFR Part 121 [Public Notice: 9852] Notice of Inquiry; Request for Comments Regarding United States Munitions List Category XII AGENCY:

    Department of State.

    ACTION:

    Notice of Inquiry, request for comments.

    SUMMARY:

    The Department of State requests comments from the public regarding recent revisions to Category XII of the United States Munitions List (USML). In light of the ongoing transition of the USML to a more “positive list” pursuant to the President's Export Control Reform (ECR) initiative, the Department requests that the public comment on (1) alternatives to controls on certain items when “specially designed for a military end user,” (2) the scope of the control in paragraph (b)(1), and (3) certain technical parameters that the Department is evaluating to replace “specially designed” controls.

    DATES:

    The Department of State will accept comments on this Notice of Inquiry until March 14, 2017.

    ADDRESSES:

    Interested parties may submit comments by one of the following methods:

    Email: [email protected] with the subject line, “Request for Comments Regarding USML Category XII.”

    Internet: At www.regulations.gov, search for this notice using its docket number, DOS-2017-0002.

    Comments submitted through www.regulations.gov will be visible to other members of the public; the Department will publish all comments on the Directorate of Defense Trade Controls Web site (www.pmddtc.state.gov). Therefore, commenters are cautioned not to include proprietary or other sensitive information in their comments.

    FOR FURTHER INFORMATION CONTACT:

    Mr. C. Edward Peartree, Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2792; email [email protected].gov. ATTN: Request for Comments Regarding USML Category XII.

    SUPPLEMENTARY INFORMATION:

    On December 10, 2010, the Department provided notice to the public of its intent, pursuant to the ECR initiative, to revise the USML to create a “positive list” that describes controlled items using, to the extent possible, objective criteria rather than broad, open-ended, subjective, or design intent-based criteria (see 75 FR 76935). As a practical matter, this meant revising USML categories so that, with some exceptions, the descriptions of defense articles that continued to warrant control under the USML did not use catch-all phrases to control unspecified items. As a general matter, the defense articles that warranted control under the USML were those that provided the United States with a critical military or intelligence advantage. All other items were to become subject to the Export Administration Regulations. Since that time, the Department has published final rules setting forth revisions for eighteen USML categories, each of which has been reorganized into a uniform and more positive list structure.

    The advantage of revising the USML into a more positive list is that its controls can be tailored to satisfy the national security and foreign policy objectives of the U.S. government by maintaining control over those defense articles that provide a critical military or intelligence advantage, or otherwise warrant control under the International Traffic in Arms Regulations (ITAR), without inadvertently controlling items in normal commercial use. This approach, however, requires that the lists be regularly revised and updated to account for technological developments, practical application issues identified by exporters and reexporters, and changes in the military and commercial applications of items affected by the list. In addition, the USML and the Commerce Control List require regular revision in order to ensure that they satisfy the national security and foreign policy objectives of the reform effort, which are to (i) improve interoperability of U.S. military forces with allied countries, (ii) strengthen the U.S. industrial base by, among other things, reducing incentives for foreign manufacturers to design out and avoid U.S.-origin content and services, which ensures continued U.S. visibility and control, and (iii) allow export control officials to focus government resources on transactions that pose greater concern.

    Comments on Specially Designed for a Military End User Parameters: On October 12, 2016, the Department published a final rule amending USML Category XII, effective December 31, 2016 (81 FR 70340). In the final rule, the Department adopted control text in seven subparagraphs that controls specific items when they are specially designed for a military end user. The term military end user is defined in the new Note to Category XII, as the national armed services (army, navy, marine, air force, or coast guard), national guard, national police, government intelligence or reconnaissance organizations, or any person or entity whose actions or functions are intended to support military end uses. As the Note further states, an item is not specially designed for a military end user if it was developed for both military and non-military end users, or if the item was created for no specific end user. The Note also provides that contemporaneous documents are required to support the design intent; otherwise, use by a military end user establishes that the item is specially designed for a military end user.

    As stated in the final rule, the Department adopted this control based on original design intent because the Department and its interagency partners cannot yet articulate objective technical criteria that would establish a bright line between military and commercial and civil systems. The Department is soliciting additional public input, asking for suggested control parameters for these seven entries in the final rule:

    1. (b)(6) Light detection and ranging (LIDAR), laser detection and ranging (LADAR), or range-gated systems, specially designed for a military end user.

    2. (c)(1) Binoculars, bioculars, monoculars, goggles, or head or helmet-mounted imaging systems (including video-based articles having a separate near-to-eye display), as follows:

    (iii) Having an infrared focal plane array or infrared imaging camera, and specially designed for a military end user.

    3. (c)(3) Electro-optical reconnaissance, surveillance, target detection, or target acquisition systems, specially designed for articles in this subchapter or specially designed for a military end user.

    4. (c)(4) Infrared search and track (IRST) systems having one of the following: (ii) Specially designed for a military end user.

    5. (c)(5) Distributed aperture systems having a peak response wavelength exceeding 710 nm specially designed for articles in this subchapter or specially designed for a military end user.

    6. (c)(6) Infrared imaging systems, as follows:

    (viii) Gimbaled infrared systems, as follows:

    (B) Specially designed for articles in this subchapter or specially designed for a military end user.

    and

    7. (c)(7) Terahertz imaging systems as follows: (ii) Specially designed for a military end user.

    Comments on Scope of Paragraph (b)(1): Paragraph (b)(1) includes all laser target designators and coded target markers that can mediate the delivery of ordnance to a target. This includes a laser target designator or coded target marker that may also be used for other purposes, including battlefield target handoff or communication of battlefield intelligence information. The Department requests that the public comment on this provision.

    Comments to Assist with the Evaluation of Potential Control Parameters: The Department is also evaluating several potential parameters. The Department is requesting that the public comment on these parameters to aid in its evaluation. Specifically, the Department requests comment on whether any civil or commercial items are described by the following parameters, including items for which civil or commercial use is anticipated in the next five years:

    A. Free-space laser communication systems specially designed for articles in this subchapter.

    B. Binoculars, bioculars, monoculars, goggles, or head or helmet-mounted imaging systems (including video-based articles having a separate near-to-eye display), having any of the following:

    (i) A dynamically gain modulated image intensifier tube incorporating a GaAs, GaInAs, or other III-V semiconductor photocathode with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm;

    (ii) An image intensifier tube incorporating a photocathode with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm and incorporating a focal plane array in the tube vacuum space;

    (iii) Fusing outputs of multiple infrared focal plane arrays each having a peak response at a wavelength greater than 1,000 nm;

    (iv) An infrared focal plane array with a peak response in the wavelength range exceeding 1,000 nm but not exceeding 2,500 nm with a total noise floor less than 75 electrons at an operating temperature of 300 K; or

    (v) An infrared focal plane array with a peak response in the wavelength range exceeding 7,500 nm, and a laser illuminator or pointer.

    C. Weapon sights (i.e., with a reticle), aiming or imaging systems (e.g., clip-on), specially designed to mount to a weapon or to withstand weapon shock or recoil, with or without an integrated viewer or display, and also incorporating or specially designed to incorporate any of the following:

    (i) An image intensifier tube having a multi-alkali photocathode with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm and a luminous sensitivity exceeding 350 microamps per lumen;

    (ii) An image intensifier tube having a GaAs, GaInAs, or other III-V semiconductor photocathode, with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm; or

    (iii) An image intensifier tube having a photocathode with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm and a focal plane array in the tube vacuum space.

    D. Infrared imaging systems, as follows: Mobile reconnaissance, mobile scout, or mobile surveillance systems, that provide real-time target geolocation at ranges greater than 3 km (e.g., LRAS3, CIV, HTI, SeeSpot, MMS).

    E. Infrared imaging systems, as follows: Gimbaled infrared systems (e.g., T-bar, yoke, ball turrets, or pods), as follows and specially designed parts and components therefor:

    (i) Having a root mean square (RMS) stabilization better (less) than 25 microradians and incorporating an infrared camera having a peak response at a wavelength exceeding 1,000 nm with an optical angular resolution (i.e., detector instantaneous field-of-view) of 25 microradians or less;

    (ii) Having an RMS stabilization better (less) than 25 microradians for any payload having any dimension of 15 inches or greater; or

    (iii) Specially designed for articles in this subchapter or specially designed for a military end user.

    F. Image intensifier tubes having all the following, and specially designed parts and components therefor:

    (i) A peak response in the wavelength range exceeding 400 nm but not exceeding 1,050 nm;

    (ii) A multi-alkali photocathode with a luminous sensitivity of 1,300 microamps per lumen or greater; and

    (iii) A limiting resolution of 64 line pairs per millimeter or greater.

    G. Image intensifier tubes having all of the following, and specially designed parts and components therefor:

    (i) A peak response in the wavelength range exceeding 400 nm but not exceeding 1,050 nm;

    (ii) A GaAs, GaInAs, or other III-V compound semiconductor photocathode having a luminous sensitivity of 1,800 microamps per lumen or greater; and

    (iii) A limiting resolution of 57 line pairs per millimeter or greater.

    H. Image intensifier tubes having all of the following, and specially designed parts and components therefor:

    (i) A peak response in the wavelength range exceeding 1,050 nm but not exceeding 2,000 nm; and

    (ii) A GaAs, GaInAs, or other III-V compound semiconductor photocathode having a radiant sensitivity of 10 milliamps per watt or greater.

    I. Infrared focal plane arrays or dewars specially designed for optical augmentation reduction.

    J. Infrared focal plane array dewar assemblies with peak response in the wavelength range greater than 3,000 nm but not exceeding 14,000 nm, and having a variable aperture mechanism.

    K. Infrared focal plane arrays having all of the following:

    (i) A peak response in the wavelength range exceeding 710 nm but not exceeding 1,100 nm;

    (ii) A non-binned pixel pitch of 10 microns or greater;

    (iii) More than 1,024 detector elements in any direction; and

    (iv) Total noise of 3 electrons or less at an input light level of 1 millilux, in a binned or non-binned operating mode, and measured at an ambient operating temperature of 300 K.

    L. Infrared focal plane arrays having greater than 81,920 but not exceeding 327,680 detector elements, a peak response in the wavelength range 1,100 nm but not exceeding 1,700 nm, and any of the following:

    (i) Noise equivalent irradiance less than 829 million photons per centimeter squared per second;

    (ii) Readout integrated circuits capable of pulse interval modulation decoding or pulse repetition frequency decoding (e.g., an asynchronous detector read out integrated circuit, frame rates windowed or non-windowed greater than 2,000 Hz); or

    (iii) Temperature dependent non-uniformity correction (e.g., without the use of a temperature stabilization)

    Note:

    Noise equivalent irradiance is defined as a ratio with the numerator comprised of the focal plane noise floor in units of electrons at a focal plane array temperature of 300 K and the denominator as the multiplied value of detector area in square centimeters, spectral quantum efficiency at 1,550 nm, and an integration time of 0.032 seconds.

    M. Infrared focal plane arrays having greater than 327,680 detector elements, a peak response in the wavelength range exceeding 1,100 nm but not exceeding 1,700 nm, and any of the following:

    (i) Noise equivalent irradiance less than 1.54 billion photons per centimeter squared per second;

    (ii) A readout integrated circuits capable of pulse interval modulation decoding or pulse repetition frequency decoding (e.g., an asynchronous detector read out integrated circuit, frame rates windowed or non-windowed greater than 2,000 Hz); or

    (iii) Temperature dependent non-uniformity correction (e.g., without the use of temperature stabilization)

    Note:

    Noise equivalent irradiance is defined as a ratio with the numerator comprised of the focal plane noise floor in units of electrons at a focal plane array temperature of 300 K and the denominator as the numerator to the multiplied value of detector area in square centimeters, spectral quantum efficiency at 1,550 nm, and an integration time of 0.032 seconds.

    N. Infrared focal plane arrays having greater than 327,680 detector elements, a peak response in the wavelength range exceeding 1,700 nm but not exceeding 3,000 nm, and any of the following:

    (i) Readout integrated circuits capable of pulse interval modulation decoding or pulse repetition frequency decoding (e.g. an asynchronous detector read out integrated circuit, frame rates windowed or non-windowed greater than 2,000 Hz);

    (ii) A total noise floor less than 75 electrons at an operating temperature of 300 K; or

    (iii) A detector pitch less than or equal to 20 microns.

    O. Infrared focal plane arrays having an internal quantum efficiency exceeding 10 percent anywhere in the wavelength range exceeding 3,000 nm but not exceeding 7,500 nm and any of the following:

    (i) A detector pitch less than 12.5 microns; or

    (ii) More than 1,331,200 detector elements.

    P. Infrared focal plane arrays having a peak response in the wavelength range exceeding 7,500 nm but not exceeding 30,000 nm, and all of the following:

    (i) A detector element of the photon, not thermal, type;

    (ii) A detector pitch less than or equal to 30 microns; and

    (iii) Greater than or equal to 262,144 detector elements.

    Q. Infrared focal plane arrays having a peak response in the wavelength range exceeding 7,500 nm but not exceeding 14,000 nm and all of the following:

    (i) A detector element of the photon, not thermal, type;

    (ii) Greater than 300 detector elements; and

    (iii) Time delay integration of detector elements.

    R. Microbolometer focal plane arrays having an unfiltered response in the wavelength range exceeding 7,500 nm but not exceeding 14,000 nm and any of the following:

    (i) Vacuum packaged and specially designed to withstand weapon shock; or

    (ii) Greater than 328,000 detector elements with a detector pitch less than or equal to 14 microns.

    S. Infrared focal plane arrays specially designed to provide distinct outputs corresponding to more than one spectral band, and having all the following:

    (i) Multiple spectral bands with a photo-response in the wavelength range exceeding 1,100 nm but not exceeding 14,000 nm; and

    (ii) A detector element pitch less than 50 microns.

    T. Digital low-light-level sensors incorporating a photocathode and a focal plane array within the vacuum space, with a peak response in the wavelength range exceeding 400 nm but not exceeding 2,000 nm, and having any of the following:

    (i) A photocathode with a luminous sensitivity greater than 1,800 microamps per lumen; or

    (ii) Greater than 2,040,000 focal plane array detector elements.

    U. Analog readout integrated circuits specially designed for articles in this subchapter.

    and

    V. Digital readout integrated circuits specially designed for focal plane arrays having a peak spectral response in the wavelength band exceeding 1,100 nm but not exceeding 30,000 nm, a digital signal output, and any of the following:

    (i) Dynamic range greater than 54 dB; or

    (ii) Pixel read-out rate greater than 540 million bits per second.

    The Department will review all comments from the public. If a rulemaking is warranted based on the comments received, the Department will respond to comments received in a proposed rulemaking in the Federal Register.

    C. Edward Peartree, Office Director, Defense Trade Controls Policy, Bureau of Political-Military Affairs, Department of State.
    [FR Doc. 2017-00651 Filed 1-12-17; 8:45 am] BILLING CODE 4710-25-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-1113] RIN 1625-AA00 Safety zone; Tennessee River, Mile 446.0 to 454.5 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a safety zone for all waters of the Tennessee River, beginning at mile marker 446.0 and ending at mile marker 454.5 during periods of high water flow. High water flow is determined by flow rates that have reached or exceeded 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0. This proposed safety zone is necessary to provide safety for mariners transiting on the Tennessee River during periods of high water flow. Entry into this area will be prohibited unless specifically authorized by the Captain of the Port Ohio Valley or designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before January 30, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2015-1113 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 Petty Officer Ashley Schad, MSD Nashville, Nashville, TN, at 615-736-5421 or at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order 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 Captain of the Port Ohio Valley is proposing to establish a safety zone for all waters of the Tennessee River, from mile 446.0 to 454.5 during periods of high water flow. This proposed safety zone is necessary to provide safety for mariners transiting on the Tennessee River during periods of high water flow. There have been temporary final rules issued in the past establishing a safety zone on the Tennessee River beginning at mile marker 446.0 and ending at mile marker 454.5 when flow rates reached or exceeded 100,000 cubic feet per second at Chickamauga lock and dam. Examples of these previous temporary final rules were published under docket numbers USCG-2013-0025 and USCG-2011-1148. This proposed rulemaking is also necessary to more efficiently effect necessary safety measures during emergent high water events in the future by reducing administrative burden and the amount of paperwork required for multiple individual rulemakings. The Tennessee River beginning at mile marker 446.0 and ending at 454.5 poses a navigational hazard during periods of high water flow. A high water flow determination for this area is established when flow rates reach or exceed 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0. The Captain of the Port Ohio Valley has determined that additional safety measures are necessary to protect all mariners during periods of high water flow. Therefore, the Coast Guard proposes to establish a permanent safety zone on specified waters of the Tennessee River triggered by high water flow. This proposed regulation would be in effect whenever flow rates reach or exceed 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0.

    The Coast Guard proposes this rulemaking under the authority in 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The Captain of the Port Ohio Valley is proposing to establish a safety zone for all waters of the Tennessee River beginning at mile marker 446.0 and ending at mile marker 454.5. Vessels or persons would not be able to enter into, depart from, or move within this area without permission from the Captain of the Port Ohio Valley or designated representative. Persons or vessels requiring entry into or passage through the proposed safety zone will be required to request permission from the Captain of the Port Ohio Valley, or designated representative. They can be contacted on VHF-FM Channel 13, 16, or through Coast Guard Sector Ohio Valley at 1-800-253-7465. This proposed rule would be effective during periods of high water flow when flow rates reach or exceed 100,000 cubic feet per second at Chickamauga lock and dam. The Captain of the Port Ohio Valley would inform the public through broadcast notices to mariners during periods of high water flow when the safety zone is established as well as when flow rates fall below 100,000 cubic feet per second and the safety zone is no longer in effect.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

    E.O.s 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. E.O. 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 E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would only be impacted during times of high water which pose dangerous navigational hazards when flow rates exceed 100,000 cubic feet per second at Chickamauga lock and dam. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 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 E.O. 13132.

    Also, this proposed rule does not have tribal implications under E.O. 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 proposed rule involves a safety zone lasting only during periods of high water flow measured by Chickamauga lock and dam. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to 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 165

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

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

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

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

    2. Add § 165.844 to read as follows:
    § 165.844 Safety Zone; Tennessee River, Mile 446.0 to 454.5; Chattanooga, TN

    (a) Location. All waters of the Tennessee River beginning at mile marker 446.0 and ending at mile marker 454.5 at Chattanooga, TN.

    (b) Effective date. This rule is effective during periods of high water flow when flow rates reach or exceed 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0.

    (c) Periods of Enforcement. This rule will be enforced whenever flow rates reach or exceed 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0. The Captain of the Port Ohio Valley or a designated representative will inform the public through broadcast notice to mariners of the enforcement period for the safety zone.

    (d) Regulations.

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

    (2) Persons or vessels desiring entry into or passage through the zone must request permission from the Captain of the Port Ohio Valley or a designated representative. U. S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465.

    (3) All persons and vessels shall comply with the instructions of the Captain of the Port Ohio Valley and designated U.S. Coast Guard patrol personnel. On-scene U.S. Coast Guard patrol personnel include commissioned, warrant, and petty officers of the U.S. Coast Guard.

    Dated: January 10, 2017. M.B. Zamperini, Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
    [FR Doc. 2017-00696 Filed 1-12-17; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 111 Seamless Acceptance Program 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 the mail preparation requirements governing participation in the Seamless Acceptance Program.

    DATES:

    Submit comments on or before February 13, 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 “Seamless Acceptance Program.” 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:

    Seamless Acceptance is an option for entering commercial mailings. It leverages full-service mailing technology by using scans from USPS® mail processing equipment and hand held devices to automate verification and payment for commercial First-Class Mail cards, letters, and flats, Periodicals, Standard Mail letters and flats, and Bound Printed Matter Flats. Mailers may participate in the Seamless Acceptance Program by contacting the PostalOne! Helpdesk at 1-800-522-9085. To participate in the Seamless Acceptance Program, mailers must meet the standards in DMM 705.22.0. Additional information, including information regarding verification and associated assessments under the Seamless Acceptance Program, is provided in Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, 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 22.0, to read as follows:]

    22.0 Seamless Acceptance Program 22.1 Description

    Seamless Acceptance uses Intelligent Mail barcodes, electronic documentation (eDoc), and scans from USPS mail processing equipment and hand held devices, to automate verification of and payment for First-Class Mail cards, letters, and flats, Periodicals, Standard Mail letters and flats, and Bound Printed Matter flats. Additional information, including information regarding verification and associated assessments on the Seamless Acceptance Program, is provided in Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com/node/581.

    22.2 Approval

    Mailers may seek authorization to participate in the Seamless Acceptance Program by contacting the PostalOne! Helpdesk at 1-800-522-9085.

    22.3 Basic Standards

    First-Class Mail, Periodicals, and Standard Mail letters and flats and BPM barcoded flats, are potentially eligible for Seamless Acceptance. All mailpieces, including basic and nonautomation must be prepared as outlined in 23.0; mailers must meet the following standards:

    a. Meet all the content and price eligibility standards for the price claimed.

    b. Prepare 90% Full-Service eligible volume

    c. Participate in the Seamless Parallel Program

    d. Participate in eInduction under 20.0 for DMU-verified origin entry or destination entry-drop shipments.

    22.3.1 Intelligent Mail Barcode Exception

    Under special circumstances where mailers are unable to use an Intelligent Mail Barcode on every piece an exception may be granted by Business Mailer Support (BMS); see 608.8 for contact information.

    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. 2016-32057 Filed 1-12-17; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2015-0730; FRL-9958-24-OAR] RIN 2060-AS93 National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology Review AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; Notice of public hearing and extension of comment period.

    SUMMARY:

    On December 28, 2016, the Environmental Protection Agency (EPA) published a notice to announce its proposed amendments to the National Emission Standards for Hazardous Air Pollutants for the Manufacturing of Nutritional Yeast source category. The notice also requested public comment on the proposed amendments. The EPA is announcing that a public hearing will be held. In addition, the EPA is extending the public comment period.

    DATES:

    The public hearing will be held on January 25, 2017. Written comments must be received on or before February 24, 2017.

    ADDRESSES:

    The public hearing will be held on January 25, 2017, at the EPA's North Carolina campus located at 109 T.W. Alexander Drive, Research Triangle Park, NC 27711. The hearing will convene at 10:00 a.m. (Eastern Time) and will conclude no later than 4:00 p.m. (Eastern Time). If there are no additional registered speakers, the EPA will end the hearing 2 hours after the last registered speaker has concluded their comments. The EPA will make every effort to accommodate all speakers. The EPA's Web site for the rulemaking, which includes the proposal and information about the hearing, can be found at: https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards.

    For information on submitting your written comments, refer to the proposed reconsideration notice published at 81 FR 95810 in the Federal Register on December 28, 2016.

    FOR FURTHER INFORMATION CONTACT:

    If you would like to present oral testimony at the public hearing, registration will begin on January 13, 2017. To register to speak at a hearing, please contact Aimee St. Clair at (919) 541-1063 or at [email protected] The last day to pre-register to present oral testimony in advance will be January 23, 2017. If using email, please provide the following information: The time you wish to speak, name, affiliation, address, email address, and telephone number. Time slot preferences will be given in the order requests are received. Additionally, requests to speak will be taken the day of the hearing at the hearing registration desk, although preferences on speaking times may not be able to be fulfilled. Please note that registration requests received before each hearing will be confirmed by the EPA via email. We cannot guarantee that we can accommodate all timing requests and will provide requestors with the next available speaking time, in the event that their requested time is taken. Please note that the time outlined in the confirmation email received will be the scheduled speaking time. Again, depending on the flow of the day, times may fluctuate. Please note that any updates made to any aspect of the hearing will be posted online at: https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards. While the EPA expects the hearing to go forward as set forth above, we ask that you monitor our Web site or contact Aimee St. Clair at (919) 541-1063 or at [email protected] to determine if there are any updates to the information on the hearing. The EPA does not intend to publish a notice in the Federal Register announcing any such updates.

    Questions concerning the rule that was published in the Federal Register on December 28, 2016, should be addressed to Allison Costa, Office of Air Quality Planning and Standards, Sector Policies and Programs Division (E140), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number:(919) 541-1322; facsimile number: (919) 541-3470; email address: [email protected]

    Public hearing: The proposal for which the EPA is holding the public hearing was published in the Federal Register on December 28, 2016, and is available at: https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards, and also in Docket ID No. EPA-HQ-OAR-2015-0730. The public hearing will provide interested parties the opportunity to present oral comments regarding the EPA's proposed standards, including data, views, or arguments concerning the proposal. The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as any oral comments and supporting information presented at the public hearing. The period for providing written comments to the EPA will remain open until February 24, 2017.

    Commenters should notify Aimee St. Clair if they will need specific equipment or if there are other special needs related to providing comments at the public hearing. The EPA will provide equipment for commenters to make computerized slide presentations if we receive special requests in advance. Oral testimony will be limited to 5 minutes for each commenter. The EPA encourages commenters to submit to the docket a copy of their oral testimony electronically (via email or CD) or in hard copy form.

    Because the hearing will be held at a U.S. government facility, individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. Please note that the REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. If your driver's license is issued by Minnesota, Missouri or the State of Washington, you must present an additional form of identification to enter the federal building. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses, and military identification cards. In addition, you will need to obtain a property pass for any personal belongings you bring with you. Upon leaving the building, you will be required to return this property pass to the security desk. No large signs will be allowed in the building, cameras may only be used outside of the building, and demonstrations will not be allowed on federal property for security reasons.

    The public hearing schedule, including lists of speakers, will be posted on the EPA's Web site at: https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards. Verbatim transcripts of the hearing and written statements will be included in the docket for the rulemaking. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearing to run either ahead of schedule or behind schedule.

    How can I get copies of this document and other related information?

    The EPA has established a docket for the proposed rule, “National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology Review,” under Docket ID No. EPA-HQ-OAR-2015-0730, available at http://www.regulations.gov.

    Dated: January 9, 2017. Mary Henigin, Acting Director, Office of Air Quality Planning and Standards.
    [FR Doc. 2017-00762 Filed 1-12-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 122 and 123 [EPA-HQ-OW-2016-0376; FRL-9957-40-OW] RIN 2040-AF67 Public Notification Requirements for Combined Sewer Overflows to the Great Lakes Basin AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing a rule to implement section 425 of the Consolidated Appropriations Act of 2016, which requires EPA to work with the Great Lakes states to establish public notification requirements for combined sewer overflow (CSO) discharges to the Great Lakes. The proposed requirements address signage, notification of local public health departments and other potentially affected public entities, notification to the public, and annual notice provisions.

    The proposed rules, when finalized, will protect public health by ensuring timely notification to the public and to public health departments, public drinking water facilities and other potentially affected public entities, including Indian tribes. Timely notice may allow the public to take steps to reduce their potential exposure to pathogens associated with human sewage, which can cause a wide variety of health effects, including gastrointestinal, skin, ear, respiratory, eye, neurologic, and wound infections.

    DATES:

    Comments must be received on or before March 14, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2016-0376 to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (e.g., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-s.

    FOR FURTHER INFORMATION CONTACT:

    Kevin Weiss, Office of Wastewater Management, Water Permits Division (MC4203), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-0742; email address: [email protected].

    SUPPLEMENTARY INFORMATION: Table of Contents I. General Information A. Does this action apply to me? B. What action is the Agency proposing? C. What is the Agency's authority for taking this action? II. Background A. Combined Sewer Overflows From Municipal Wastewater Collection Systems B. Combined Sewer Overflows to the Great Lakes Basin C. The CSO Control Policy and Clean Water Act Framework for Reducing and Controlling Combined Sewer Overflows D. NPDES Regulations Addressing CSO Reporting E. Section 425 of the Consolidated Appropriations Act of 2016—Requirements for Public Notification of CSO Discharges to the Great Lakes Basin F. Examples of Existing Public Notification Practices in CSO Communities G. Existing State-Level Public Notification Requirements for CSOs in the Great Lakes Basin H. Working With the Great Lakes States and Requesting Public Input III. Proposed Requirements A. Overview of Proposal B. Types of Notification 1. Signage 2. Initial and Supplemental Notice to Local Public Health Officials and Other Potentially Affected Public Entities 3. Initial and Supplemental Notice to the Public 4. Annual CSO Notice C. Public Notification Plans D. Implementation 1. Section 122.38 Requirements 2. Required Permit Condition E. Additional Considerations 1. Definitions 2. List of Treatment Works 3. Adjusting Deadlines To Avoid Economic Hardship 4. Notification of CSO Volumes 5. Treated Discharges 6. More Stringent State Requirements 7. Reporting 8. Ambient Monitoring IV. Incremental Costs of Proposed Rule V. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information A. Does this action apply to me?

    Entities within the Great Lakes Basin potentially regulated by this proposed action include:

    Category Examples of regulated entities North American
  • industry
  • classification
  • system (NAICS)
  • code
  • Federal and state government EPA or state NPDES permit authorities 924110 Local governments NPDES permittees with a CSO discharge to the Great Lakes Basin 221320

    This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated or otherwise affected by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in § 122.32 title 40 of the Code of Federal Regulations, and the discussion in the preamble. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

    B. What action is the Agency proposing?

    EPA is proposing a rule to establish public notification requirements for CSOs to the Great Lakes Basin. The proposed rule would implement Section 425 of the Consolidated Appropriations Act of 2016 (Pub. L. 114-113) (hereafter referred to as “Section 425”), which requires EPA to work with the Great Lake states to establish public notice requirements for CSO discharges to the Great Lakes and prescribes minimum requirements for such notice. EPA sought and considered public input during the development of the proposed rule.

    This proposal includes required methods for CSO permittees in the Great Lakes Basin to provide public notification of CSO discharges and for the minimum content of such notification. The proposed requirements for methods of providing public notice of CSO discharges include signage, initial and supplemental notice to potentially affected public entities and to the public, and an annual notice that allows for analysis of trends in combined sewer system performance and the operator's plans for CSO controls. In addition, EPA proposes requirements for Great Lakes Basin CSO permittees to develop a public notification plan that reflects community-specific details (e.g., proposed monitoring locations, means for disseminating information to the public) as to how the permittee would implement the proposed public notification requirements. EPA proposes that Great Lakes Basin CSO permittees would submit the public notification plan to the NPDES permitting authority (“Director”) within six months after publication of a final regulation. The public notification plan would provide a means of public engagement on the details of implementation of the notification requirements.

    Under the proposal, the public notification provisions, including the requirement to develop a public notification plan, would be implemented through two regulatory mechanisms. First, EPA proposes to add a new section to the NPDES permit regulations, to be codified at 40 CFR 122.38, establishing the public notification requirements for Great Lakes CSO permittees. The proposed requirements in § 122.38 would apply directly to Great Lakes CSO permittees until their NPDES permits are next reissued after publication of a final regulation.

    EPA proposes that the requirements for developing the public notification plan and the methods of notification other than the annual notice would directly apply to CSO permittees that discharge to the Great Lakes Basin six months after publication of a final regulation. EPA proposes that the annual notice requirements would directly apply one year after publication of a final regulation to allow permittees time to collect data for a full year. Under this proposal, the Director could extend the compliance dates for notification and/or submittal of the public notification plan for individual communities if the Director determines the community needs additional time to comply in order to avoid undue economic hardship.

    Second, under this proposal, the public notification requirements for CSO discharges to the Great Lakes Basin would be implemented as a condition in NPDES permits when they are next reissued after publication of a finale regulation. EPA proposes that when the permittee's CSO NPDES permit is reissued, the permit would be required to include a permit condition addressing public notification of CSO discharges to the Great Lakes Basin. The proposed permit condition would incorporate the proposed requirements in § 122.38 for signage, methods of notification and annual notice, as well as requirements to provide specific information relevant to the permittee's implementation of the notification requirements. This two-stage implementation approach would ensure that the requirements of Section 425 will be implemented during the interim period before the permit condition is incorporated into the relevant NPDES permits, consistent with Section 425, which requires implementation by December 18, 2017.

    The objectives of these proposed requirements are to:

    • Ensure timely notice to the public of CSO discharges. This notice is intended to alert members of the public to CSO discharges which may allow them to take steps to reduce their potential exposure to pathogens associated with the discharges.

    • Ensure timely notice to local public health departments, public drinking water facilities and other potentially affected public entities, including Indian tribes, of CSO discharges. This notice is intended to alert these entities to specific CSO discharges and support the development of appropriate responses to the discharges, such as ensuring that beach closures and advisories reflect the most accurate and up-to-date information or adjusting the intake or treatment regime of drinking water treatment facilities that have intakes from surface waters affected by CSO discharges.

    • Provide the community and interested stakeholders with effective and meaningful follow-up notification that allows for analysis of trends in combined sewer system (CSS) performance and provides stakeholders with information on the CSS operator's plans to control CSO discharges. This information is intended to help the community understand the current performance of their collection system and how the community's ongoing investment to reduce overflows would address the impacts of CSOs.

    C. What is the Agency's authority for taking this action?

    The authority for this rule is Section 425 of the Consolidated Appropriations Act of 2016 (Pub. L. 114-113) and the Federal Water Pollution Control Act, 33 U.S.C. 1251 et seq., including sections 1314(i), 1318, 1342 and 1361(a).

    II. Background A. Combined Sewer Overflows From Municipal Wastewater Collection Systems

    Municipal wastewater collection systems collect domestic sewage and other wastewater from homes and other buildings and convey it to wastewater treatment plants for treatment and disposal. The collection and treatment of municipal sewage and wastewater is vital to the public health in our cities and towns. In the United States, municipalities historically have used two major types of sewer systems—separate sanitary sewer systems and CSSs.

    Municipalities with separate sanitary sewer systems use that system solely to collect domestic sewage and convey it to a publicly owned treatment works (POTW) treatment plant for treatment. These municipalities also have separate sewer systems to collect surface drainage and stormwater, known as “municipal separate storm sewer systems” (MS4s). Separate sanitary sewer systems are not designed to collect large amounts of runoff from rain or snowmelt or provide widespread surface drainage, although they typically are built with some allowance for some amount of stormwater or groundwater that enters the system as a result of storm events.

    The other type of sewer system, CSSs, is designed to collect both sanitary sewage and stormwater runoff in a single-pipe system. This type of sewer system provides the primary means of surface drainage by carrying rain and snowmelt away from streets, roofs, and other impervious surfaces. CSSs were among the earliest sewer systems constructed in the United States and were built until the first part of the 20th century.

    Under normal, dry weather conditions, combined sewers transport all of the combined wastewater (sewage and stormwater runoff) collected to a sewage treatment plant for treatment. However, under wet weather conditions when the volume of wastewater and stormwater exceeds the capacity of the CSS or treatment plant, these systems are designed to divert some of the combined flow prior to reaching the POTW treatment plant and to discharge combined stormwater and sewage directly to nearby streams, rivers and other water bodies. These discharges of sewage from a CSS that occur prior to the POTW treatment plant are referred to as combined sewer overflows or CSOs. Depending on the CSS infrastructure design, CSO discharges may be untreated or may receive some level of treatment, such as solids settling in a retention basin and disinfection, prior to discharge.

    CSO discharges contain human and industrial waste, toxic materials, and debris as well as stormwater. CSO discharges can be harmful to human health and the environment because they introduce pathogens (e.g., bacteria, viruses, protozoa) and other pollutants to receiving waters, causing beach closures, water quality impairment, and contaminate drinking water supplies and shellfish beds. CSOs can also cause depleted oxygen levels which can impact fish and other aquatic populations.

    CSSs serve a total population of about 40 million people nationwide. Most communities with CSSs are located in the Northeast and Great Lakes regions, particularly in Illinois, Indiana, Maine, Michigan, New York, Ohio, Pennsylvania, and West Virginia. Although large cities like Chicago, Cleveland, and Detroit have CSSs, most communities with CSSs have fewer than 10,000 people. Most CSSs have multiple CSO discharge locations or outfalls, with some larger communities with combined sewer systems having hundreds of CSO outfalls.

    B. Combined Sewer Overflows to the Great Lakes Basin

    As of September 2015, 859 active NPDES permits for CSO discharges had been issued in 30 states plus the District of Columbia and Puerto Rico. Of these 859 permits, 190 permits 1 are for CSO discharges to waters located in the watershed for the Great Lakes and the Great Lakes System (“Great Lakes Basin”).2 The 190 permits for CSO discharges to the Great Lakes Basin have been issued to 182 communities 3 or permittees. These permittees are located in the states of New York, Pennsylvania, Ohio, Michigan, Illinois, Indiana, and Wisconsin. CSO communities are scattered across the Great Lakes Basin, with the greatest concentration in Ohio, southeastern Michigan and northeastern Indiana discharging to Lake Erie, and in northern Indiana and southwestern Michigan discharging to Lake Michigan (see Figure 1). Hereafter, the owner or operator of a CSS is referred to as a “CSO permittee.”

    1 EPA identified 184 CSO permits in the Great Lakes Basin in the 2016 Report to Congress: Combined Sewer Overflows into the Great Lakes Basin (EPA 833-R-16-006). EPA has adjusted that estimate to reflect additional information. First, six CSO permittees identified in the Report to Congress were subtracted because their permit coverage had been terminated due to sewer separation or other reasons. Second, EPA conducted a GIS analysis and verified with States that 12 permits for CSO discharges to the Great Lakes Basin were not identified in the 2016 Great Lakes CSO Report to Congress. A list of these 18 permits is available in the docket for this rulemaking.

    2 Section 425 specifies in Section 425(a)(4) that the term “Great Lakes” means “any of the waters as defined in the Section 118(a)(3) of the Federal Water Pollution Control Act (33 U.S.C. 1292).” This, therefore, includes Section 118(a)(3)(B), which defines “Great Lakes” as “Lake Ontario, Lake Erie, Lake Huron (including Lake St. Clair), Lake Michigan, and Lake Superior, and the connecting channels (Saint Mary's River, Saint Clair River, Detroit River, Niagara River, and Saint Lawrence River to the Canadian Border);” and Section 118(a)(3)(C), which defines “Great Lakes System” as “all the streams, rivers, lakes, and other bodies of water within the drainage basin of the Great Lakes.” Collectively, EPA is referring to the Great Lakes and the Great Lakes System as the “Great Lakes Basin.”

    3 The number of CSO communities in the Great Lakes Basin is different than the number of CSO permits. Four CSO communities have more than one CSO NPDES permit. These include Metropolitan Water Reclamation District of Greater Chicago (MWRDGC) (4 permits); Wayne County, MI (4 permits); Oakland County, MI (2 permits); and the City of Oswego, NY (2 permits). For the purposes of counting communities, communities with multiple CSO permits are counted as one CSO community.

    EP13JA17.001

    EPA recently summarized available information on the occurrence and volume of discharges from CSOs to the Great Lakes Basin during 2014 (see Report to Congress: Combined Sewer Overflows into the Great Lakes Basin (EPA 833-R-16-006)), contained in the public docket for this rulemaking. As summarized in this report, seven states reported 1,482 events where untreated sewage was discharged from CSOs to the Great Lakes Basin in 2014 and an additional 187 CSO events where treated sewage was discharged. For the purposes of the Report, treated discharges referred to CSO discharges that received a minimum of:

    • Primary clarification (removal of floatables and settleable solids may be achieved by any combination of treatment technologies or methods that are shown to be equivalent to primary clarification);

    • Solids and floatable disposal; and

    • Disinfection of effluent, if necessary to meet water quality standards and protect human health, including removal of harmful disinfection chemical residuals, where necessary.

    Additional information regarding CSO discharges to the Great Lakes Basin, including the Report to Congress, is available at https://www.epa.gov/npdes/combined-sewer-overflows-great-lakes-basin. Table 1 provides the size distribution of the 182 CSO communities in the Great Lakes Basin.

    Table 1—Great Lakes Basin CSO Communities by Community Population Community Population Over 50,000 10,000-49,999 Under 10,000 Total Number of CSO Communities 32 70 80 182 Permits issued to Metropolitan Water Reclamation District of Greater Chicago and Wayne County used the population for Chicago and Wayne County, respectively.

    As stated above, CSOs can cause human health and environmental impacts.4 CSOs often discharge simultaneously with other wet weather sources of water pollution, including stormwater discharges from various sources including municipal separate storm sewers, wet weather sanitary sewer overflows (SSOs) from separate sanitary sewer systems, and nonpoint sources of pollution. The cumulative effects of wet weather pollution can make it difficult to identify and assign specific cause-and-effect relationships between CSOs and observed water quality problems. The environmental impacts of CSOs are most apparent at the local level.5

    4 Report to Congress—Implementation and Enforcement of the Combined Sewer Overflow Control Policy. EPA 833-R-01-003, 2002; Report to Congress—Impacts and Control of CSOs and SSOs. EPA 833-R-04-001, 2004; Report to Congress: Combined Sewer Overflows to the Lake Michigan Basin. EPA 833-R-07-007, 2007. See https://www.epa.gov/npdes/combined-sewer-overflows-policy-reports-and-training.

    5 Report to Congress—Impacts and Control of CSOs and SSOs. EPA 833-R-04-001, 2004. See https://www.epa.gov/npdes/combined-sewer-overflows-policy-reports-and-training.

    C. The CSO Control Policy and Clean Water Act Framework for Reducing and Controlling Combined Sewer Overflows

    The Clean Water Act (CWA) establishes national goals and requirements for maintaining and restoring the nation's waters. CSO discharges are point sources subject to the technology-based and water quality-based requirements of the CWA under NPDES permits. Technology-based effluent limitations for CSO discharges are based on the application of best available technology economically achievable (BAT) for toxic and nonconventional pollutants and best conventional pollutant control technology (BCT) for conventional pollutants. BAT and BCT effluent limitations for CSO discharges are determined based on “best professional judgment.” CSO discharges are not subject to permit limits based on secondary treatment requirements that are applicable to discharges from POTWs.6 Permits authorizing discharges from CSO outfalls must include more stringent water quality-based requirements, when necessary, to meet water quality standards (WQS).

    6Montgomery Environmental Coalition et al. v. Costle, 646 F.2d 568, 592 (D.C. Cir. 1980).

    EPA issued the CSO Control Policy on April 19, 1994 (59 FR 18688). The CSO Control Policy “represents a comprehensive national strategy to ensure that municipalities, permitting authorities, water quality standards authorities, and the public engage in a comprehensive and coordinated effort to achieve cost-effective CSO controls that ultimately meet appropriate health and environmental objectives.” (59 FR 18688). The policy assigns primary responsibility for implementation and enforcement to NPDES permitting authorities (generally referred to as the “Director” in the NPDES regulations) and water quality standards authorities.

    The policy also established objectives for CSO permittees to: (1) Implement “nine minimum controls” and submit documentation on their implementation; and (2) develop and implement a long-term CSO control plan (LTCP) to ultimately result in compliance with the CWA, including water quality-based requirements. In describing NPDES permit requirements for CSO discharges, the CSO Control Policy states that the BAT/BCT technology-based effluent limitations “at a minimum include[s] the nine minimum controls.” (59 FR 18696) One of the nine minimum controls is “Public notification to ensure that the public receives adequate notification of CSO occurrences and CSO impacts.”

    In December 2000, as part of the Consolidated Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554), Congress amended the CWA by adding Section 402(q). This amendment is commonly referred to as the “Wet Weather Water Quality Act of 2000.” It requires that each permit, order, or decree issued pursuant to the CWA after the date of enactment for a discharge from a municipal combined sewer system shall conform to the CSO Control Policy.

    D. NPDES Regulations Addressing CSO Reporting

    The NPDES regulations require NPDES permits to include requirements for monitoring discharges, including CSO discharges, and reporting the results, on a case-by-case basis with a frequency dependent on the nature and effect of the discharge, but in no case less than once a year (see 40 CFR 122.44(i)(2)). In addition, permits must require that permittees orally report to the NPDES permitting authority any noncompliance with NPDES permits related to CSO discharges that may endanger human health or the environment within 24 hours from the time the permittee becomes aware of the circumstances, and in writing within 5 days (see § 122.41(l)(6)). Permits must also require reporting of other noncompliance related to CSOs when their discharge monitoring reports are submitted (see § 122.41(l)(7)).

    On October 22, 2015, EPA published a final rule to modernize CWA reporting for municipalities, industries, and other facilities by converting to an electronic data reporting system. Known as the NPDES Electronic Reporting Rule, or E-Reporting Rule, this final rule requires regulated entities and state and federal regulators to report electronically data required by the NPDES permit program instead of filing written paper reports. EPA is phasing in the requirements of the E-Reporting Rule over a five-year period. Starting on December 21, 2016, permittees will begin submitting their Discharge Monitoring Reports (DMRs) electronically. Starting on December 21, 2020, permittees will begin submitting electronically certain other NPDES reports, including “Sewer Overflow/Bypass Event Reports,” which may include information on some CSO discharges. Under the rule, Table 2 of Appendix A of Part 127 identifies data elements that are required to be reported in a DMR for CSO discharges (pursuant to § 122.41(4)(i)) after December 21, 2016, and in “Sewage Overflow/Bypass Event Reports” (pursuant to §§ 122.41(l)(6) or (7) and 122.41(m)(3)) submitted after December 21, 2020. A subset of the data elements that are required to be reported that are relevant to public notification of a CSO discharge include the following data elements:

    • Sewer Overflow Cause;

    • Duration of Sewer Overflow (hours);

    • Sewer Overflow Discharge Volume (gallons);

    • Corrective Actions Taken or Planned for Sewer Overflow; and

    • Type of Potential Impact of Sewer Overflow.

    In addition, starting on December 21, 2020, NPDES authorities are required to provide, and update as appropriate, information regarding the following data elements for each CSO permittee:

    • Long-Term CSO Control Plan (LTCP) Permit Requirements and Compliance;

    • Nine Minimum CSO Controls Developed;

    • Nine Minimum CSO Controls Implemented;

    • LTCP Submission and Approval Type;

    • LTCP Approval Date;

    • Enforceable Mechanism and Schedule to Complete LTCP and CSO Controls;

    • Actual Date Completed LTCP and CSO Controls;

    • Approved Post-Construction Compliance Monitoring Program; and

    • Other CSO Control Measures with Compliance Schedule.

    EPA is working with states to define data standards for the sewer overflow data elements in 40 CFR 127, Appendix A, and how this data can be best presented on EPA's Enforcement and Compliance History Online (ECHO) Web site.7

    7https://echo.epa.gov.

    E. Section 425 of the Consolidated Appropriations Act of 2016—Requirements for Public Notification of CSO Discharges to the Great Lakes Basin

    Section 425 was enacted as part of the 2016 Consolidated Appropriations Act and did not amend the CWA. Section 425(b)(1) requires EPA to work with the Great Lakes states to establish public notice requirements for CSO discharges to the Great Lakes Basin. Section 425(b)(2) provides that the notice requirements are to address the method of the notice, the contents of the notice, and requirements for public availability of the notice. Section 425(b)(3)(A) provides that at a minimum, the contents of the notice are to include the dates and times of the applicable discharge; the volume of the discharge; and a description of any public access areas impacted by the discharge. Section 425(b)(3)(B) provides that the minimum content requirements are to be consistent for all affected states.

    Section 425(b)(4)(A) calls for follow-up notice requirements that provide a description of each applicable discharge; the cause of the discharge; and plans to prevent a reoccurrence of a CSO discharge to the Great Lakes Basin consistent with section 402 of the Federal Water Pollution Control Act (33 U.S.C. 1342) or an administrative order or consent decree under such Act. Section 425(b)(4)(B) provides for annual publication requirements that list each treatment works from which the Administrator or the affected state receive a follow-up notice.

    Section 425(b)(5) requires that the notice and publication requirements described in Section 425 shall be implemented by not later than December 18, 2017. However, the Administrator of the EPA may extend the implementation deadline for individual communities if the Administrator determines the community needs additional time to comply in order to avoid undue economic hardship. Finally, Section 425(b)(6) clarifies that “[n]othing in this subsection prohibits an affected State from establishing a State notice requirement in the event of a discharge that is more stringent than the requirements described in this subsection.”

    F. Examples of Existing Local Public Notification Practices in CSO Communities

    In 1995, EPA published a guidance entitled “Combined Sewer Overflows—Guidance for Nine Minimum Controls” 8 to assist with the implementation of the 1994 CSO Policy. As mentioned above, one of the nine minimum controls called for in that policy is “public notification to ensure that the public receives adequate notification of CSO occurrences and CSO impacts.” The 1995 guidance recognizes that the most appropriate mechanism for public notification will probably vary with local circumstances, such as the character and size of the use area and means of public access to waters affected by CSOs. The guidance also provides examples of potential measures for notifying the public about CSO events that were available at the time, including:

    8https://www.epa.gov/sites/production/files/2015-10/documents/owm0030_2.pdf.

    • Posting at affected use areas;

    • Posting at selected public places;

    • Posting at CSO outfalls;

    • Notices in newspapers or on radio and TV news programs;

    • Letter notification to affected residents that reflect long-term restrictions; and

    • Telephone hot lines.

    While the general themes identified in the 1995 guidance are still useful and appropriate, the significant technology changes that have occurred since then allow for a much wider set of tools to be used in public notification. EPA's 2016 document “National Pollutant Discharge Elimination System Compendium of Next Generation Compliance Examples 9  ” provides examples of CSO notification using current technology. This compendium describes examples of CSO public notice efforts in New York and Ohio and provides examples of CSO public notification outside the Great Lakes Basin.

    9https://www.epa.gov/compliance/compendia-next-generation-compliance-examples-water-air-waste-and-cleanup-programs.

    In addition to those examples outlined in the Next Generation Compliance Compendium, EPA has summarized other existing public notification practices for CSO discharges both to the Great Lakes Basin and to other waters.10

    10 see “Summary of CSO Public Notification provisions,” Docket ID No. EPA-HQ-OW-2016-0376 at http://www.regulations.gov.

    Existing public notice practices summarized in these two resources include, but are not limited to:

    • The NPDES permit for CSO discharges from the City of Seattle, Washington requires the city to implement a web-based public notification system to inform the citizens of when and where CSOs occur. Seattle and King County maintain a real-time public notification Web site that has CSO overflow information updated with available data every 10 minutes for King County sites, and every 60 minutes for Seattle sites.

    • The City of Cambridge, Massachusetts and the City of Chelsea, Massachusetts post signs at all CSO structures and at public access locations and other sites identified by the Massachusetts Department of Environmental Protection. Cities notify local health agents and local watershed advocacy groups by email and issue an annual press release discussing past CSOs. Cambridge also provides the following information on its Web site:

    ○ General information regarding CSOs, including their potential health impacts;

    ○ Locations of CSO discharges in the Charles River and Alewife Brook watersheds;

    ○ The overall status of all CSO abatement programs;

    ○ Web links to CSO communities and watershed advocacy groups; and

    ○ The most recent information on all CSO activations and volumes in both watersheds.

    • The District of Columbia Water and Sewer Authority (DC Water) operates CSO Event Indicator Lights to notify river users of CSO discharges. A red light must be illuminated during a CSO occurrence and a yellow light must be illuminated for 24 hours after a CSO has stopped.

    • Connecticut's two-part Public Act: “An Act Concerning The Public's Right to Know of a Sewage Spill” requires the Connecticut Department of Energy and Environmental Protection (DEEP) to provide a map indicating the CSOs anticipated to occur during certain storm events.

    • The Vermont Department of Environmental Conservation (DEC) posts on its Web site a report of any sewage release that reaches waters of the State.

    • The Allegheny County Sanitary Authority (ALCOSAN) raises orange flags signifying CSOs have occurred at eight locations along the Allegheny, Monongahela and Ohio rivers during and after CSO discharge events. ALCOSAN also provides notifications of sewer overflows via text message and/or email.

    • Sanitation District No. 1 (SD1) of Northern Kentucky issues an email advisory when a rainfall of 0.25 inches or more is predicted or recorded. They also issue an advisory when the Ohio River level exceeds 38 feet. Advisories will remain in effect for 72 hours after rainfall and 72 hours after river levels have fallen below 38 feet.

    • Onondaga County, New York maintains a “Save the Rain” Web site which serves as a notification system to alert the public of the occurrence of CSO events and as a prediction of elevated bacteria levels in Onondaga Lake and its tributaries. The discharge status of CSO outfalls are mapped on this Web page. The information on the map is updated using a model to anticipate the quantity of rainfall that will trigger each CSO.

    • The Metropolitan Sewer District (MSD) of Greater Cincinnati issues a CSO advisory via a CSO hotline or email alert when a rainfall of 0.25 inches or more is predicted or recorded or when water levels in area rivers and streams are elevated and could cause a CSO to occur. Advisories will remain in place for 72 hours after a rainfall event and 72 hours after water levels in area waterways have returned to normal. Actual occurrences of CSO discharges are reported and summarized in reports that are posted on MSD's Web site.

    G. Existing State-Level Public Notification Requirements for CSOs in the Great Lakes Basin

    EPA worked with the Great Lake states to identify existing state-level notification requirements for CSO discharges to the Great Lakes Basin, which are summarized in the proposed rule docket, see “Summary of State CSO Public Notification Requirements in the Great Lakes Basin” See Docket ID No. EPA-HQ-OW-2016-0376 at http://www.regulations.gov. Almost all of the NPDES permits for CSO discharges to the Great Lakes Basin currently require some level of public notification to ensure citizens receive adequate information regarding CSO occurrences and CSO impacts. Permit requirements which add specificity to this requirement and additional state public notification requirements are discussed below. Table 2 summarizes some of the main components of existing Great Lakes state programs that relate to public notification of CSO discharges.

    Table 2—Summary of State Program Requirements for Public Notice Requirements for CSO Discharges to the Great Lakes Basin NY PA OH MI IN IL WI State CSO public notification regulation X X X Requires Public Notification Plan X / X X X Requires CSO Outfall Signs X X X X X X Alert system (text/email) X / X X Immediate notification of local public health department and drinking water supply X X X X Annual reporting on CSO discharges X X / X `X' indicates all CSO discharges to the Great Lakes Basin are subject to requirement. `/ ' indicates that some CSO discharges to the Great Lakes Basin are subject to requirement. Illinois

    All forty Illinois CSO communities in the Great Lakes Basin are in the Metropolitan Water Reclamation District of Greater Chicago (MWRD) service area. The NPDES permits for these CSO communities provide that public notification programs may be developed in conjunction with MWRD. MWRD's NPDES permits for each of its four treatment plants require MWRD to develop a public notification plan. MWRD is implementing its plan by:

    • Providing the public with the opportunity to sign up for emails and/or text messages when a confirmed CSO discharge or diversion to Lake Michigan occurs.

    • Posting a map of the city's waterways showing the status of discharges at CSO outfalls.

    Indiana

    Indiana requires NPDES CSO permittees to:

    • Post signs within the permittee's jurisdiction at access points to an affected water or to make attempts to do so when access is not on community property.

    • Provide notification to the affected public, local health departments and drinking water suppliers having surface water intakes located within ten miles downstream of a discharging CSO outfall whenever information indicates that a CSO discharge is occurring or is imminent based on predicted or actual precipitation or a related event.

    • Incorporate CSO notification procedures into the permittee's CSO operational plan which must be approved by the Indiana Department of Environmental Management. A member of the public may request that the department reevaluate the CSO notification procedures.

    Michigan

    Michigan state regulations and permits require CSO permittees to:

    • Notify the Michigan Department of Environmental Quality (DEQ); local health departments; a daily newspaper of general circulation in the county or counties in which the municipality is located; and a daily newspaper of general circulation in the county in which CSO discharges occurred immediately, but not more than 24 hours after the discharge begins.

    ○ Initial notification that the discharge is occurring is to be by telephone or other manner required by DEQ.

    ○ At the conclusion of the discharge, in writing or in another manner required by DEQ, additional notice provides more detailed information including the volume and quality of the discharge as measured pursuant to procedures and analytical methods approved by the department, reason for discharge, receiving water or land affected, date and time discharge began and ended, and compliance status.

    • Contact each municipality annually whose jurisdiction contains waters that may be affected by the discharge and provide immediate notification of CSO discharges to these municipalities if requested.

    • Test the affected waters for E. coli to assess the risk to the public health as a result of the discharge and provide the test results to the affected local county health departments and to DEQ. The testing is to be done at locations specified by each affected local county health department. This testing requirement may be waived by the affected local county health department if it is determined that such testing is not needed to assess the public health risks.

    Michigan state regulations require Michigan DEQ to:

    • Promptly post the notification on its Web site upon being notified of a discharge.

    • Maintain and publish a list of occurrences of discharges of untreated or partially treated sewage that have been reported. The list is to be posted on the department's Web site and published annually and made available to the general public.

    New York

    New York state statutes, regulations, and permits require CSO permittees to:

    • Install and maintain signs at all CSO outfalls owned and operated by the permittee.

    • Implement a public notification program to inform citizens of the location and occurrence of CSO events.

    • Notify the local public health department of CSO discharges immediately, but in no case later than two hours after discovery.

    • Notify any adjoining municipality that may be affected as soon as possible, but no later than four hours from discovery of the CSO discharge.

    CSO communities can report CSO discharges to a state operated electronic notification system, NY-Alert. The NY-Alert system provides public health departments, adjoining municipalities and subscribing citizens with notice of CSO discharges.

    CSO permittees are required to submit an annual report to the state that describes implementation of 14 CSO best management practices. The state uses this and other information to prepare an annual report on sewer system discharges. The New York Department of Environmental Conservation's Web site includes a map of CSO outfalls in New York that provides information about CSO discharges.

    Ohio

    Ohio state regulations and permits require CSO permittees to:

    • Install and maintain signs at all regulated outfalls, including CSOs; and

    • Notify public water supply operators as soon as practicable if a spill, overflow, bypass, or upset reaches a water of the state within a set distance of a public water supply intake.

    Public notification plans and annual reporting of CSO discharges are required on a case-by-case basis.

    Pennsylvania

    The NPDES permit for Erie, Pennsylvania (the only city with a CSS in Pennsylvania that discharges to the Great Lakes Basin) requires Erie to submit an annual CSO status report to the state, which is available to the public upon request.

    Wisconsin

    Of Wisconsin's two CSO permittees, one permit does not specify any public notification requirements. The other requires the permittee to have a public notification process in place and to make personal contact with affected members of the public in the event of an overflow.

    H. Working With the Great Lake States and Requesting Public Input

    EPA has worked with the Great Lakes states on creating proposed requirements to implement Section 425 of the 2016 Consolidated Appropriations Act. NPDES program officials in each state with CSO discharges to the Great Lakes Basin have described existing state notification requirements, shared insights on implementation issues and provided individual perspectives on what should be included in the proposed rule.

    On August 1, 2016, EPA published a document in the Federal Register requesting stakeholder input regarding potential approaches for developing public notice requirements for CSO discharges to the Great Lakes Basin under Section 425. As part of this effort, EPA held a public “listening session” on September 14, 2016, which provided stakeholders and other members of the public an opportunity to share their views regarding potential new public notification requirements for CSO discharges to the Great Lakes Basin. A summary of the oral comments made at the public listening session is included in the docket for this rulemaking.11 In addition, the Agency requested written comments. EPA received 40 unique written comments and a total of 787 written comments, all of which were submitted to the docket (see EPA-HQ-OW-2016-0376-2 through EPA-HQ-OW-2016-0376-41). These comments have informed the development of the proposed rule and are discussed throughout the preamble below.

    11 See Docket ID No. EPA-HQ-OW-2016-0376 at http://www.regulations.gov.

    III. Proposed Requirements A. Overview of Proposal

    The proposed requirements to implement Section 425 are based on an evaluation of current notification requirements and practices in the Great Lakes Basin and elsewhere, and input from officials in the Great Lakes states and the public, including input received in response to EPA's August 1, 2016 request. The proposal clarifies EPA's expectations for CSO permittees discharging to the Great Lakes Basin to provide public notification to ensure that the public receives adequate notification of CSO occurrences and CSO impacts. The proposed requirements would conform to the CSO Control Policy by specifying requirements for implementation of one of the nine minimum controls for the CSO discharges addressed by Section 425.

    EPA proposes requirements for public notification of CSO discharges to the Great Lakes Basin to be codified at 40 CFR 122.38. This section would apply directly to Great Lakes Basin CSO permittees six months after publication of a final rule, except for annual notice requirements which would apply one year after publication. EPA proposes to implement section 425(b)(5)(B) of the Consolidated Appropriations Act of 2016 by providing that the NPDES permitting authority (referred to in the NPDES regulations as the Director) could extend the compliance dates for notification and/or submittal of the public notification plan for individual communities if the Director determines the community needs additional time to comply in order to avoid undue economic hardship.

    The proposed requirements address signage, initial and supplemental notification of local public health departments and other potentially affected public entities (which may include neighboring municipalities, public drinking water utilities, state and county parks and recreation departments and Indian tribes) whose waters may be potentially impacted, initial and supplemental notification of the public and annual notice to the public and the Director.

    EPA further proposes to require NPDES permittees authorized to discharge CSOs to the Great Lakes Basin to develop a public notification plan that would provide community-specific details (e.g., proposed flow monitoring locations, means for disseminating information to the public) as to how they would implement the notification requirements. Under the proposed rule, CSO permittees in the Great Lakes Basin would be required to seek and consider input from local public health departments, any potentially affected public entities and Indian tribes whose waters may be impacted by the permittee's CSO discharges in developing the public notification plan that would be submitted to the Director. The proposal would require the plan to be made available to the public and to be submitted to the Director within six months of the date the final rule is published.

    Ultimately, public notice requirements for CSO discharges in the Great Lakes Basin would be incorporated as requirements in NPDES permits when such permits are next reissued at least six months after the date the final regulation is published. (This process will follow normal permit reissuance timelines). Under both proposed §§ 122.21(j)(8)(iii) and 122.38(d), the public notification plan would be submitted to the Director as part the Great Lakes Basin CSO permittee's application for a renewed permit. The plan would provide information to the Director to inform the development of a NPDES permit condition implementing the public notification requirements. EPA proposes minimum requirements at § 122.42(f) for a permit condition for all permits issued for CSO discharges within the Great Lakes Basin. See Preamble section III.D.2. for a discussion of the proposed permit condition.

    B. Types of Notification

    EPA proposes to require several types of public notification, as follows:

    • Signage;

    • Initial and supplemental notice to local public health department and other potentially affected public entities, such as drinking water utilities, public beach and recreation agencies;

    • Initial and supplemental notice to the public; and

    • Annual CSO notice to the Director and the public.

    The types of notification are discussed below.

    1. Signage

    Signage at CSO outfalls and public access areas potentially impacted by CSO discharges can raise public awareness of the potential for CSO discharges and impacts. EPA's 1995 guidance, “Combined Sewer Overflows—Guidance for Nine Minimum Controls” 12 provides examples of signage that can be used to notify the public of CSO discharges, such as posting at affected use areas (e.g., along a beach front), selected public places (e.g., public information center at a public park or beach) and posting at CSO outfalls where outfalls are visible and the affected shoreline area is accessible to the public.13

    12 See “Combined Sewer Overflow Guidance for Nine Minimum Controls” EPA 832-B-95-003, (1995). https://www.epa.gov/sites/production/files/2015-10/documents/owm0030_2.pdf.

    13 The 2016 “National Pollutant Discharge Elimination System Compendium of Next Generation Compliance Examples” and the 2016 “Summary of CSO Public Notification provisions” EPA-HQ-OW-2016-0376, identify additional examples of signage used by CSO communities.

    EPA proposes that the Great Lakes Basin CSO permittee provide adequate signage where signage is feasible at CSO outfalls and potentially impacted public access areas. The Agency proposes that signage contain at a minimum the following information:

    • The name of the combined sewer system operator;

    • A description of the discharge (e.g., untreated human sewage, treated wastewater);

    • Notice that sewage may be present in the water; and

    • The permittee's contact information, including a telephone number, NPDES permit number and outfall number as identified in the NPDES permit.

    EPA also proposes that the Great Lakes Basin CSO permittee conduct periodic maintenance of the sign to ensure that it is legible, visible and factually correct.

    The proposal would require the permittee to provide signage at potentially affected public areas. The permittee's identification of potentially affected public areas where signage is required is to be based on a review and consideration of local conditions and circumstances of a particular community. This determination may be informed by the identification of sensitive areas in the community's long term CSO control plan (LTCP). Under today's proposal, when a Great Lakes Basin CSO permit is reissued, the NPDES authority will determine specific locations where signs are required and will identify in the permit the location of any outfall where a sign is not required because it is not feasible.

    EPA requests comment on providing more specific regulatory language that would require signage at locations other than the CSO outfalls, such as potentially impacted public access areas and selected public places that CSO discharges may impact.

    One commenter on the August 1, 2016 notice suggested that signs at public access areas include quick response codes that could provide a link to either a public health department's Web site or the permittees Web site. EPA requests comment on requiring quick response codes on signs. EPA also requests comment on the proposed signage requirements and on whether the proposal includes the appropriate minimum information to be included on signs.

    EPA notes that several of the Great Lakes states do not require signage at every CSO outfall for various reasons, such as limited or no public access to the area or the infeasibility for the permittee to physically access the outfall point for inspections and maintenance of signs. For example, Ohio does not require signs at outfalls that are not accessible to the public by land or by recreational use of the water body.14 Indiana allows for alternatives to signs for outfalls located on private property or that are outside the jurisdiction of the CSO discharger.15 New York allows permittees to apply for a waiver from the requirement to install a sign under limited circumstances which are listed in the state's regulations.16

    14 Ohio Admin. Code 3745-33-08 (2011), available at http://codes.ohio.gov/oac/3745-33-08.

    15 See 327 IAC 5-2.1-6 (2003), available at http://www.in.gov/legislative/iac/iac_title?iact=327.

    16 See 6 NYCRR 750-1.12 (2003), available at http://www.dec.ny.gov/regs/2485.html.

    The Agency requests comment on specific situations where it may not be feasible to provide signage at a CSO outfall. In addition, the Agency requests comment on alternative or additional regulatory criteria to clarify or describe where signs are not possible. The Agency also requests comment on whether it is appropriate to remove the proposed qualification that signage be feasible and instead require signage at all CSO outfalls.

    EPA recognizes that the Great Lake NPDES authorities require permittees to install signs at many CSO outfalls and potentially impacted public access areas. EPA proposes that where a permittee has installed a sign at a CSO outfall or potentially impacted public access area before the effective date of this rule, the sign does not have to meet the minimum requirements specified in the proposed rule until the sign is replaced or reset. EPA requests comment on this approach. The Agency requests comment on any specific language with regard to the proposed signage requirements that may be inconsistent with existing signs, and whether the proposed language should be adjusted to provide more flexibility.

    EPA does not propose to prescribe the specific circumstances under which other methods of notice such as indicator lights (as used by the District of Columbia Water and Sewer Authority) or alert flags (as used by the Allegheny County Sanitary Authority) must be used. These types of notification may not be appropriate for every CSO community in the Great Lakes Basin. Rather, such requirements may be established on a permit-by-permit basis where appropriate. Nothing in the proposed rule or Section 425 would, however, preclude any Great Lakes state from establishing such requirements.

    2. Initial and Supplemental Notice to Local Public Health Officials and Other Potentially Affected Public Entities

    Local public health officials play a vital role in responding to environmental risks. Local public health organizations typically have a role in water quality monitoring of waterways and public beaches and in providing swimming and beach advisories and beach closures. Timely notice of CSO discharges to local public health departments can provide information needed to determine appropriate actions such as issuing swimming or beach advisories or beach closures.

    When CSOs discharge into sources of drinking water, operators of drinking water facilities that have intakes in waters impacted by the discharge can make adjustments to their intake and treatment procedures after receiving notice of the CSO discharge.

    EPA proposes that the operator of a CSO outfall in the Great Lakes Basin provide initial notice of the CSO discharge as soon as possible to the local public health department (or if there is no local health department, to the state health department), any potentially affected public entity (such as the superintendent of a public drinking water supply with potentially affected intakes), and Indian tribes whose waters may be affected, but no later than four hours after becoming aware as determined by monitoring, modeling or other means of a CSO discharge. The initial notice would be required to include, at a minimum, the following information:

    • The location of the discharge(s) and the water body that received the discharge(s);

    • The location and a description of any public access areas that may be potentially impacted by the discharge;

    • The date(s) and time(s) that the discharge commenced or the time the permittee became aware of the discharge;

    • Whether, at the time of the notification, the discharge has ended or is continuing and, if the discharge(s) has ended, the approximate time that the discharge ended; and

    • A point of contact for the CSO permittee.

    EPA proposes that the CSO permittee describe the location of the discharge. Typically, this would be the location of the CSO outfall that is discharging. However, for larger combined sewer systems with multiple outfalls, where CSO discharges occur at multiple locations at the same time, the CSO permittee may provide a description of the area in the waterbody where discharges are occurring and does not have to identify the specific location of each discharge. This approach may be more protective in that it may provide for a better description of potentially impacted areas, and could avoid delays associated with identifying when individual discharges commenced.

    EPA also proposes that Great Lakes Basin CSO permittees be required to seek and consider input from local public health departments and other potentially affected entities to develop protocols for providing notification. Under the proposal, the CSO permittee is to seek and consider input from local health departments and other potentially affected entities prior to submitting its public notification plan initially and resubmitting as part of the process for reapplying for their permit.

    The Agency anticipates that the Great Lakes Basin CSO permittee will establish protocols that will address the timing of notification. This could include predictive notifications that are based on weather forecasts. Under the proposed rule, the public notification plan would help inform the development of NPDES permit requirements that would specify the timing of this notification. EPA anticipates that this approach would allow for the consideration of community-specific factors, development of programs and changes in technology.

    Timely notice of CSO discharges to public health departments, drinking water facilities and other affected municipal entities and Indian tribes is critical to the effectiveness and timeliness of their response. EPA does not propose to prescribe the specific means (e.g., email, phone call) for this notice. Rather, the proposed rule would allow the CSO discharger to seek and consider input from local public health departments and other potentially affected public entities to determine the most appropriate way to provide this notice.

    EPA proposes that the timeframe for initial notice to local public health departments and other potentially affected public entities be as soon as possible, but no later than four hours after the Great Lakes Basin CSO permittee becomes aware of the CSO discharge as determined by monitoring, modeling or other means. EPA expects, however, that as technologies change and communities and states improve their notice protocols, communities may be able to notify public health departments and the public in less than four hours. In addition, nothing in the proposed rule would preclude the permitting authority from establishing a maximum timeframe for notification that is more stringent (shorter) than four hours. EPA anticipates that NPDES permit authorities would consider more stringent notification timeframes based on a variety of factors, including the nature of the receiving waters, technology advances and the experience and progress of the permittee. EPA notes that New York and Connecticut require CSO permittees to notify public health departments within two hours. Both states have state-run Web sites that facilitate notification. The Agency also notes that most Great Lake states currently have not established a state Web site to facilitate public notification. EPA specifically requests comment on the appropriate maximum timeframe for providing initial notification to the local public health department and other potentially affected entities. The Agency also requests comment on the minimum contents of the initial and supplemental notification to the local public health department and other potentially affected entities.

    Section 425(b)(3)(A)(ii) provides that public notice requirements also must include the volume of the discharge. EPA recognizes that for a number of reasons, determining the volume of a CSO discharge within the short timeframe provided for the initial notice may not be practical. EPA therefore proposes that notification of the volume of the discharge may occur in a supplemental notice that would be required within 24 hours of the end of the CSO discharge. EPA proposes this approach because the initial notification that a CSO discharge may occur or is occurring should not be delayed by waiting until the discharge stops or volume estimates are developed. EPA is concerned that requiring the Great Lakes Basin CSO permittee to include the volume of the CSO discharge as part of the initial notification would mean that the initial notification would need to be delayed, which would in turn cause delays in responding to the overflow. In addition, requiring an estimate or calculation of the discharge volume as part of the initial notification may discourage predictive notifications. It is critical that the local public health department and other affected municipalities or tribes be notified of the occurrence of the event as soon as possible without delays associated with waiting for the discharge to end or determining the CSO volume. Accordingly, EPA proposes that the CSO permittee may either provide notification of the time the discharge ended and the volume of the CSO discharge as part of the initial notification when CSO discharges are of a short enough duration to allow for this information to be known, or as a separate supplemental notification within 24 hours of the end of the CSO discharge.

    EPA requests comment on whether 24 hours from the time the permittee becomes aware that the discharge ended is the appropriate time period for completing notification. EPA also requests comment on whether the proposed minimum requirements for the 24-hour supplemental notice are sufficient and appropriate.

    The proposed requirement to provide a volume estimate would not mandate monitoring or direct measurement of CSO discharges. As discussed below, EPA proposes that the operator of a CSS with CSO discharges to the Great Lakes Basin develop a public notification plan that, among other things, describes for each outfall how the volume and duration of CSO discharges would be measured or estimated. In addition, as discussed below, EPA proposes that NPDES permits for CSO discharges to the Great Lakes Basin specify the location of CSO discharges that must be monitored for volume and discharge duration and the location of CSO discharges where CSO volume and duration may be estimated rather than monitored.

    In addition to seeking comment generally on the proposed requirements for notifying local health departments and other potentially affected public entities, EPA requests comment specifically on whether the initial notice to public health departments and other potentially affected entities should also be provided to the Director and/or the state public health agency.

    3. Initial and Supplemental Notice to the Public

    Initial notice of CSO discharges to the public via text alerts, social media, posting on a Web site, or other appropriate means can be an effective, efficient means of alerting the public to CSO discharges in a timely manner. This initial notice may allow the public to make informed decisions regarding areas where they would visit and recreate. EPA proposes requirements for the Great Lakes Basin CSO permittee to provide initial notification to the public within four hours of becoming aware as determined by monitoring, modeling or other means of the CSO discharge. Under the proposal, the Great Lakes Basin CSO permittee would be required to use electronic media, such as text, email, and social media alerts to subscribers, or posting a notice on its public access Web site, to provide members of the public with notice of CSO discharges. Other electronic media that could be used include broadcast media (radio and/or television) and newspaper Web sites. However, EPA is not proposing a specific type of electronic media to be used by all CSO communities as electronic media technologies and usage continue to change and the availability and appropriateness of different media options will vary from community to community. EPA seeks comment on whether public notice by broadcast media and/or local newspapers should be required for all CSO permittees in the Great Lakes Basin, or whether this specificity is better addressed in permits.

    EPA proposes the same minimum information content requirements that it proposes for the initial notice to the local public health department, with the exception that a point of contact for the discharger is not included in the notice to the general public. EPA does not propose to require that a point of contact be provided in the notice for the public because this could generate a large number of calls or emails to the CSO permittee that could hinder the permittee's ability to respond to the CSO discharge and to communicate with public health officials and other affected municipal entities.

    EPA also proposes that the Great Lakes Basin CSO permittee provide a supplemental notice specifying the time the discharge ended and the volume of the CSO discharge unless this information has already been provided in the initial notice. EPA proposes that the supplemental public notice would be required within 24 hours of the end of the CSO discharge.

    As mentioned above, EPA received a number of comment in response to the August 1, 2016 Federal Register document, in writing and at the public listening session on September 14, 2016, regarding notification methods and timeframes for notification to the public. One commenter recommended that information on how to receive email or text alerts should be provided to the public on the permittee's Web site and in wastewater bill mailings. EPA requests comment on whether the proposed regulation should include specific requirements for the permittee to make information on how to receive alerts available to the public.

    One commenter indicated that it would not be possible to estimate system-wide CSO volumes within 24 hours, given the size of their system, size of the storm, number of outfalls, number of receiving waters, and other complex factors that are considered to determine overflow locations, timing, and volumes. Another commenter recommended that the supplemental notice be required within 24 to 48 hours. Another commenter recommended that the Great Lakes Basin CSO permittee be given five days before discharge volume estimates must be provided. Other commenters advocated for real-time or faster alerts such as requiring public notification within 15 minutes, if possible. Another commenter suggested that if real time monitoring is not feasible, all discharges should be required to notify the public within two hours of the start of the CSO discharge.

    Other commenters expressed concerns about the time it would take to provide detailed notification. For example, one comment said reporting in-depth on volume, length of discharge and preventative measures for each CSO event would take resources away from more critical water quality initiatives. EPA requests comment on whether the 24-hour time period is appropriate and whether the minimum information requirements for the 24-hour notice are appropriate.

    EPA requests comment on providing a longer timeframe than four hours for small communities to make the initial notification, such as eight or twelve hours as well as appropriate population thresholds (e.g., under 2,000 or 1,000) for such a requirement. Some of the representatives of the Great Lakes states expressed concerns that introducing an alternative timeframe for initial reporting for small communities could create confusion in the regulated community. EPA requests comment on the appropriateness of the proposed four-hour time period and on whether all communities should be subject to the same four-hour maximum timeframe for providing initial notification.

    Some commenters responding to the August 1, 2016 Federal Register document raised concerns that overuse of text alerts of CSO discharges to the public could be counter-productive because the public could be over saturated by the alerts and the alerts overly simplify a complex message about health risks. Another commenter raised concerns that supplemental notifications indicating that CSO discharges have ceased may send an incorrect message that the waters are safe. EPA requests comment on allowing permittees flexibility to use different mechanisms for providing initial and supplemental notice (e.g. text/email alerts and Web site notice for initial notification and limiting supplemental notice to posting information on the permittees Web site).

    4. Annual CSO Notice

    EPA proposes that all permittees authorized to discharge a CSO to the Great Lakes Basin are required to make an annual notice available to the public by the first of May each year. In addition, EPA proposes that the permittee notify the Director of the availability of the annual notice. The information in the annual notice would provide the public with a comprehensive understanding of how the permittee's CSS is performing and of the permittee's CSO control program. The Agency proposes that the annual notice would include a summary of both the prior year's discharges and upcoming implementation of CSO controls. EPA proposes that the annual notice include at a minimum:

    • A description of the availability of the permittee's public notification plan and a summary of significant modifications to the plan that were made in the past year;

    • A description of the location, treatment provided, and receiving water of each CSO outfall;

    • The date, location, duration, and volume of each wet weather CSO discharge that occurred during the past calendar year;

    • The date, location, duration, and volume of each dry weather CSO discharge that occurred during the past calendar year;

    • A summary of available monitoring data from the past calendar year;

    • A description of any public access areas impacted by the discharge;

    • Representative rain gauge data in total inches to the nearest 0.1 inch that resulted in each CSO discharge;

    • A point of contact; and

    • A concise summary of implementation of the nine minimum controls and the status of implementation of the long-term CSO control plan (or other plans to reduce or prevent CSO discharges), including:

    ○ A description of key milestones remaining to complete implementation of the plan; and

    ○ A description of the average annual number of CSO discharges anticipated after implementation of the long-term control plan (or other plan relevant to reduction of CSO overflows) is completed.

    The proposed elements of the annual notice summarize the information provided in the initial and supplemental notifications to the public and provide additional follow-up information required in Section 425(b)(4)(A). Section 425(b)(4)(A) requires inclusion of follow-up notice requirements that provide a description of “(i) each applicable discharge; (ii) the cause of the discharge; and (iii) plans to prevent a reoccurrence of a combined sewer overflow discharge to the Great Lakes Basin consistent with section 402 of the Federal Water Pollution Control Act (33 U.S.C. 1342) or an administrative order or consent decree under such Act.”

    EPA proposes an annual notice requirement that would address the information required by Section 425(b)(4)(A)(ii) and (iii) by requiring a summary of how the CSO permittee is implementing the nine minimum controls and their LTCP. The summary would include a description of key milestones remaining to complete implementation of the LTCP and a description of the anticipated average annual number of CSO discharges after the LTCP is completed.

    As described in section II.C of this preamble, Section 402(q) of the CWA (33 U.S.C. 1342(q)), provides that NPDES permits and enforcement orders for discharges from combined sewer systems “shall conform” to the 1994 CSO Control Policy. By requiring the annual report to summarize how the permittee is implementing the nine minimum controls and LTCP, the proposed rule would result in a description of the permittee's plans under their permit, administrative order or consent decree, “consistent with section 402 of the Federal Water Pollution Control Act (33 U.S.C. 1342) or an administrative order or consent decree under such Act” as required by Section 425(b)(4)(A)(iii). This information is intended to provide the public with a description of the current performance of their system as well as progress on CSO reduction. This notice can serve to increase public awareness, and enable the public to better understand the community's current and future investments into collection system infrastructure. This can promote stronger public support for actions necessary to reduce CSOs. EPA requests comment on the proposed elements of the annual notice.

    EPA anticipates that any community that already generates an annual CSO report would ensure that the required elements of the proposed rule are addressed in that report and then use that annual CSO report to comply with the annual notice requirements proposed today, rather than generating a separate report solely to meet these new requirements. Communities choosing this approach under the proposed rule would need to ensure that the annual report is published to their Web site by the date specified in the proposed rule (May 1 of each calendar year).

    EPA requests comment on requiring permittees to supplement the annual notice by providing quarterly notice of a description of each CSO discharge, the cause of the discharge, and plans to prevent a reoccurrence of the CSO discharge. This approach may assist interested members of the public in following the status of CSO remediation efforts in their communities in a more up-to-date timeframe. EPA requests comment on this approach or other means of updating the public more frequently than annually.

    C. Public Notification Plans

    EPA proposes requirements for public notification plans at § 122.38(d). The Agency proposes that Great Lakes Basin CSO permittees be required to develop and submit to the Director a public notification plan within six months after publication of a final rule and then as part of the permittee's application for permit renewal. In addition, EPA proposes at § 122.38(e) that, prior to submitting the proposed public notification plan, CSO permittees must seek and consider input from the local public health department (or if there is no local health department, the state health department) and potentially affected public entities and Indian tribes whose waters may be affected by CSO discharges.

    The public notification plans are intended to provide system-specific detail (e.g., proposed monitoring locations, means for disseminating information to the public) describing the discharger's public notification efforts. The plan will enhance communication with public health departments and other potentially affected public entities and Indian tribes whose waters may be affected by the CSO discharge. The plan would also assist NPDES permit writers in establishing public notification permit conditions. In addition, the plan would provide the public with a better understanding of the permittee's public notification efforts.

    Under the proposal, the plan would describe:

    • The permittee's signage program;

    • The identification of municipal entities that may be affected by the permittee's CSO discharges;

    • Input from the health department and other potentially affected entities;

    • Protocols for the initial and supplemental notice of the public, public health departments and other public entities;

    • How the volume and duration of CSO discharges would be determined; and

    • Protocols for making the annual notice available to the public.

    Regarding signage, the plan would describe what information is in the message on the signs and identify any CSO outfall where a sign under § 122.38(a)(1) is not and will not be provided, explain why a sign at that location is not feasible. The plan would also describe the maintenance protocols for signage, such as inspection intervals and replacement schedule.

    Section 425(b)(3)(A)(iii) of the 2016 Consolidated Appropriations Act provides that public notice for CSO discharges is to include a description of any public access areas impacted by the discharge. EPA proposes to lay the groundwork for this provision by requiring that public notification plans identify which municipalities and other public entities may be affected by the permittee's CSO discharges. Potentially affected public entities whose waters may be affected by the CSO discharge could include adjoining municipalities, public drinking water utilities, state and county parks and recreation departments. Such areas may have already been identified in the CSO permittee's LTCP, which should identify CSO discharges to sensitive areas.17 In deciding which public entities and Indian tribes are “potentially impacted” and should be contacted for their input, the Great Lakes Basin CSO permittee should evaluate:

    17 The CSO Policy clarifies EPA's expectation that a permittee's LTCP give the highest priority to controlling overflows to sensitive areas. The Policy provides that sensitive areas, as determined by the NPDES authority in coordination with State and Federal agencies, as appropriate, include designated Outstanding National Resource Waters, National Marine Sanctuaries, waters with threatened or endangered species and their habitat, waters with primary contact recreation, public drinking water intakes or their designated protection areas, and shellfish beds. (59 FR 18692).

    • The location of the CSO discharge point and what users of that waterbody may exist in the surrounding region;

    • The direction of flow in the receiving water and uses of that waterbody, or connected waterbodies, downstream of the CSO discharge point;

    • The presence of public access areas near, or downstream of, the discharge point;

    • The presence of drinking water supply systems near, or downstream of, the discharge point; and

    • The presence of municipal entities, Indian tribes, and/or parks and recreation department lands near, or downstream of, the discharge point.

    EPA proposes that the plan would identify any municipality and Indian tribe that was contacted for input on public notification protocols. In addition, the plan would provide a summary of the comments and any recommendations from these entities, as well as a summary of the significant comments and recommendations provided by the local public health department(s).

    Local public health departments, public entities, and Indian tribes whose waters may be affected by a CSO discharge are in a unique position to recommend the timing, means and content of the public notification requirements addressed in this proposal. Seeking input from these entities would allow the permittee to reflect in the public notification plan the needs and preferences of these entities with regard to notice of CSO discharges. Also, these groups can help inform decisions regarding what is the most appropriate means of communicating information to the public, taking into consideration specific populations in the community and their access to various electronic communication methods and social media. For example, if there is a segment of the population without access to cell phones or computers, or who would incur costs by receiving text notifications, the consulted entities may suggest other communications means that would be more appropriate to reach these groups (e.g., radio broadcast, postings in public places, announcements through community flyers).

    The plan would also be required to describe how the volume and duration of CSO discharges would be either measured or estimated. If the Great Lakes Basin CSO permittee intends to use a model to estimate discharge volumes and durations, the plan would be required to summarize the model and describe how the model was or would be calibrated. CSO permittees that are a municipality or sewer district with a population of 75,000 or more must calibrate their model at least once every 5 years.

    EPA requests comment on the minimum elements of a plan listed in § 122.38(c) and whether additional minimum requirements may be appropriate. Other such elements could include: A description of outreach that would be conducted to alert the public of the notification system and how to subscribe or otherwise gain access to the information, and information on how the public notification plan would be made available to the public. In addition, EPA seeks comment on requiring Great Lakes Basin CSO permittees to seek and consider input from public health departments and other potentially affected entities in developing their public notification plans. EPA also requests comment on whether the final rule should specifically require that the permittee provide an opportunity for members of the public to review and comment on the public notification plan, as was suggested by one commenter responding to the August 1, 2016 Federal Register document.

    EPA proposes that the Great Lakes Basin CSO permittee make its public notification plan available to the public on the permittee's Web site (if it has a Web site) and periodically provide information in bill mailings and by other appropriate means on how to view the notification plan. The EPA seeks comment on whether there should be specific requirements for requiring notice of the plan and if so, how the plan should be made available. In addition, EPA seeks comment on whether there should be specific requirements for requiring notice of when significant modifications are made to the plan.

    D. Implementation

    EPA proposes to implement the public notification provisions as a stand-alone regulatory requirement until the proposed required condition is incorporated into the NPDES permit of the Great Lakes Basin CSO permittee. Section 425(b)(5) of the 2016 Consolidated Appropriations Act provides that the notice and publication requirements described in the Act are to be implemented by “not later than” December 18, 2017. The Act also provides that the Administrator of the EPA may extend the implementation deadline for individual communities if the Administrator determines the community needs additional time to comply in order to avoid undue economic hardship. The Agency recognizes that if NPDES permits were the only means of implementing these requirements, permits would have to be reissued with these requirements before they would take effect. Given the current status of CSO permits in the Great Lakes Basin, it would take over five years for the proposed public notification requirements to be incorporated into all permits. Implementing the public notification requirements by regulation would result in all Great Lakes Basin CSO permittees establishing their public notification system within the same timeframe, and is more consistent with the implementation deadline in Section 425(b)(5)(A).

    In addition to Section 425 of the Consolidated Appropriations Act of 2016, EPA's authority for these public notification requirements includes Sections 304(i) and 308 of the CWA, which provide broad authority to issue procedural requirements for reporting (including procedures to make information available to the public) and to require point source owners and operators to establish and maintain records, make reports, monitor, and provide other “reasonably required” information.

    The requirements of § 122.38(a) (signage and notification requirements), § 122.38(b) (annual notice), § 122.38(c) (reporting) would be enforceable under the CWA prior to incorporation into a permit as requirements of CWA section 308. With respect to the public notification plan, the requirement to develop a public notification plan consistent with § 122.38(d) and (e) would also be enforceable under the CWA as a requirement of CWA section 308. Once public notification requirements are incorporated into an NPDES permit, they would enforceable as a condition of permit issued under CWA section 402.

    The details and content of the public notification plan, however, would not be enforceable under § 122.38(d) or as effluent limitations of the permit, unless the document or the specific details with the plan were specifically incorporated into the permit. Under the proposed approach, the contents of the public notification plan would instead provide a road map for how the permittee would comply with the requirements of the permit (or with the requirements of § 122.38(a)-(c) prior to inclusion in the permit as a permit condition). Once the public notification requirements are incorporated into the permit as a permit condition, the plan could be changed based on adaptions made during the course of the permit term, thereby allowing the permittee to react to new technologies, circumstance and experience gained and to make adjustments to its program to provide better public notification and better comply with the permit. This approach would allow the CSO permittee to modify and continually improve its approach during the course of the permit term without requiring the permitting authority to review each change as a permit modification.

    1. Section 122.38 Requirements

    As discussed in detail above, a new § 122.38 would set forth requirements that would apply to all permittees with CSO discharges to the Great Lakes Basin. Under the proposed rule, Great Lakes Basin CSO permittees would be required to develop a public notification plan, after seeking and considering input from public health departments and other potentially affect public entities. EPA proposes that the plan must be submitted to the Director and made available to the public within six months of publication of the final rule. Proposed § 122.38 would also require implementation of the signage and notice to affected public entities and the public within six months of publication of the final rule. Thus, a Great Lakes Basin CSO permittee would be required to develop its plan and implement it within six months of the final rule.

    EPA has considered how much time it should take to implement public notification requirements. EPA also recognizes that every Great Lakes Basin CSO permittee already provides some public notification, in order to implement one of the nine minimum control measures in the 1994 CSO Control Policy. However, small communities in particular may not provide public notification to the extent that would be required under the proposed rule. Therefore, EPA seeks comment on whether six months is adequate for implementing the proposed public notification requirements, including development of a public notification plan. In particular, EPA seeks comment on whether some (e.g., small) communities should have more time than others to implement public notification requirements and/or whether there should be additional time to implement the signage or notification requirements after the public notification plan is developed, submitted to the Director, and made available to the public, and if so, how much additional time should be allowed. For example, should municipal permittees with a population of less than 10,000, or in the case of sewerage districts, a service population of less than 10,000, be required to submit a public notification plan to the Director within nine or 12 months after the publication of the final rule, rather than six months?

    2. Required Permit Condition

    EPA's long-term objective is to use NPDES permits to implement public notice requirements for CSO discharges in the Great Lakes Basin. To that end, EPA proposes to revise both the permit application regulation requirements in § 122.21(j) and to add a required permit condition for NPDES permits issued for these discharges. EPA proposes to add § 122.21(j)(8)(iii) to require the CSO permittees in the Great Lakes Basin to submit a public notification plan to the Director with its permit application (and any updates to its plan that may have occurred since the last plan submission). EPA also proposes to add a new condition at § 122.42(f) that would apply to permits for CSO discharges to the Great Lakes Basin. The proposed provision would ensure that CSO public notice requirements are incorporated into the NPDES permit where they can be updated as appropriate with each permit cycle. Public notification plans, submitted with subsequent permit applications, would reflect changes in collection systems and technology, as well as public notice practices. By requiring the Great Lakes Basin CSO permittee to include its updated public notice plan with its permit application, the Director would have the information that would be needed for including requirements for public notification in the permit when it is reissued.

    The proposed required permit condition would provide flexibility in a number of areas to allow NPDES permit writers to address in their plans the particular circumstances of each community (e.g., size of community, differences in public access areas potentially impacted by a CSO discharge). This provision would not preclude the Great Lake states from modifying the condition to establish more stringent public notification requirements (see Section 425(b)(6) of the 2016 Consolidated Appropriations Act).

    As outlined in § 122.42(f) of the proposed rule, permits for CSO discharges within the Great Lakes Basin would, at a minimum:

    • Require implementation of the public notification requirements in § 122.38(a);

    • Specify the information that must be included on outfall signage;

    • Specify outfalls and public access areas where signs are required;

    • Specify the timing and minimum information for providing initial notification to local public health departments and other potentially affected entities and the public;

    • Specify the location of CSO discharges that must be monitored for volume and discharge duration and the location of CSO discharges where CSO volume and duration may be estimated;

    • Require submittal of an annual notice;

    • Specify protocols for making the annual notice available to the public; and

    • Require all CSO discharges be reported electronically either in a discharge monitoring report or as a non-compliance event.

    Section 402(q) of the CWA requires NPDES permits for discharges from combined sewers to “conform” to the 1994 CSO Control Policy. One of the “Nine Minimum Controls” identified in the Policy is that NPDES permits for CSO discharges require public notification to ensure that the public receives adequate notification of CSO occurrences and CSO impacts. The proposed required permit condition would conform to the 1994 CSO Control Policy's minimum control to provide the public with “adequate notification” and would further provide specificity to better implement the public notification provision identified in the Policy. Including this provision in permits would give the Great Lakes states an opportunity to update and fine-tune public notice requirements to reflect continued development of the permittee's public notice effort, ensure consistency with state legislative and regulatory requirements for public notification, reflect new technologies and be informed by public input. In addition, by including public notification requirements as a condition in permits, the public would have a formalized opportunity to comment on the proposed permit conditions.

    E. Additional Considerations 1. Definitions

    EPA proposes to add three definitions to the NPDES regulations, “Combined Sewer System,” “Combined Sewer Overflows,” and “Great Lakes Basin.” The proposed definition of combined sewer system is based on the description of combined sewer system found in the 1994 CSO Policy. The Policy provides that “A combined sewer system (CSS) is a wastewater collection system owned by a state or municipality (as defined by § 502(4) of the CWA) which conveys sanitary wastewaters (domestic, commercial and industrial wastewaters) and storm water through a single-pipe system to a Publicly Owned Treatment Works (POTW) Treatment Plant (as defined in § 403.3(p)).” The proposed definition of combined sewer overflow also conforms to the description of CSO in the CSO Policy which provides that a “CSO is the discharge from a CSS at a point prior to the POTW Treatment Plant.”

    The 2016 Consolidated Appropriations Act specifies in Section 425(a)(4) that the term “Great Lakes” means “any of the waters as defined in the § 118(a)(3) of the Federal Water Pollution Control Act (33 U.S.C. 1292).” This, therefore, includes § 118(a)(3)(B), which defines “Great Lakes” as “Lake Ontario, Lake Erie, Lake Huron (including Lake St. Clair), Lake Michigan, and Lake Superior, and the connecting channels (Saint Mary's River, Saint Clair River, Detroit River, Niagara River, and Saint Lawrence River to the Canadian Border);” and § 118(a)(3)(C), which defines “Great Lakes System” as “all the streams, rivers, lakes, and other bodies of water within the drainage basin of the Great Lakes.” Collectively, EPA is referring to the Great Lakes and the Great Lakes System as the “Great Lakes Basin.”

    2. List of Treatment Works

    Section 425(b)(4)(B) provides that EPA shall work with the Great Lakes states to establish annual publication requirements that list each treatment works from which the Administrator or the affected state receive a follow-up notice. EPA has developed a Web page that identifies the communities in the Great Lakes Basin with CSO discharges.18 In the future, EPA will update this Web page with information on how to access the annual notices of these communities.

    18https://www.epa.gov/npdes/combined-sewer-overflows-great-lakes-basin.

    3. Adjusting Deadlines To Avoid Economic Hardship

    Section 425(b)(5)(A) of the 2016 Appropriations Act provides that the notice and publication requirements of the provision must be implemented by not later than December 17, 2017, unless the EPA Administrator determines the community needs additional time to comply in order to avoid undue economic hardship. All of the Great Lakes states are authorized to administer the NPDES program. Because EPA proposes to implement Section 425 as part of the NPDES permit program, under proposed § 122.38(f), this determination would be made by the Director. As the NPDES authority, the state is in a better position to evaluate the economic conditions and financial capability of the permittee as they have worked with individual communities to ensure implementation of their LTCPs.

    EPA proposes that the Great Lakes Basin CSO permittee must submit a public notification plan to the Director of the NPDES program not later than six months after publication of a final rule. The Great Lakes Basin CSO permittee would be required to comply with the public notice requirements of § 122.38 by six months for initial and supplemental notifications and 12 months in the case of annual notification, after publication of a final rule, unless the Director specifies a later date to avoid economic hardship. Under the proposed rule at § 122.38(e), the Director may extend the compliance dates for public notification under § 122.38(a), annual notice under § 122.38(b), and/or public notification plan submittal under § 122.38(c) for individual communities if the Director determines the community needs additional time to comply in order to avoid undue economic hardship. The proposed rule would require the Director to notify the Regional Administrator of the extension and the reason for the extension. In addition, the Director would be required to post on its Web site a notice that includes the name of the community and the new compliance date(s). EPA also proposes to amend 40 CFR 123.25, which sets forth the requirements of an approved state NPDES program, to include a requirement for Great Lakes States to have the authority to implement the public notification requirements in § 122.38. No revision to § 123.25 would be needed with respect to proposed revisions to § 122.21(j) and § 122.42, as both of those sections are already included in § 123.25. As noted above in section II.G of today's preamble, all of the Great Lakes States already have some form of public notification requirements, therefore EPA does not anticipate that any Great Lakes state would need to revise its regulations or seek additional authority from the legislature to implement proposed § 122.38 or revised § 122.21(j) and § 122.42.

    EPA requests comment on this proposed implementation of Section 425(b)(5)(B).

    4. Notification of CSO volumes

    Most NPDES permits for CSO discharges to the Great Lakes Basin require the permittee to report CSO volumes in DMRs. In addition, CSO discharge volume information is typically needed to implement the nine minimum controls and LTCPs under the CSO Policy. One of the nine minimum controls identified in the CSO Control Policy addresses monitoring to effectively characterize CSO impacts and the efficacy of CSO controls. Similarly, one of the minimum elements of a LTCP is characterization monitoring and modeling of the CSS. In addition, the post-construction compliance monitoring program in the CSO Policy calls for effluent and ambient monitoring. EPA has issued technical guidance on monitoring and modeling of CSO discharges.19 EPA has also identified examples of where CSO monitoring technologies have also been used by regulators and communities to better identify significant pollution and noncompliance problems in the “NPDES Compendium of Next Generation Compliance Examples.” 20

    19 See “Combined Sewer Overflows—Guidance for Monitoring and Modeling” EPA-832-B-99-022, 1999 and “CSO Post Construction Compliance Monitoring Guidance”, EPA-833-K-11-001, 2012). https://www.epa.gov/npdes/combined-sewer-overflows-csos.

    20 See https://www.epa.gov/compliance/compendia-next-generation-compliance-examples-water-air-waste-and-cleanup-programs.

    Typically, CSO permittees use a combination of monitoring and modeling to estimate CSO volume. This approach is reflected in many CSO permits that require monitoring of CSO discharges from some outfalls, and for other outfalls allows for estimating CSO discharge volumes by modeling or some other means. For larger collection systems with multiple outfalls, the permit may require monitoring the volume discharged at the most active outfalls with the largest discharge volumes. CSO permits may provide that for less active CSO outfalls, the permittee report volume in the DMR based on estimates. In some cases, volume estimates for DMR reporting purposes are based on models which were developed to characterize flows in the collection system as part of developing and implementing a LTCP. These models can vary in complexity, and may be calibrated by periodic flow measurements or other data from various locations in the collection system.

    The Agency recognizes that for many CSO permittees, CSO monitoring efforts have tended to become more robust as monitoring technology has evolved and continues to evolve. In general, EPA encourages CSO permittees to consider using monitoring to determine CSO discharge durations and volume. Traditionally, the cost of installing and maintaining monitoring sensors has been high when compared to modeling. However, the cost of monitoring technologies has decreased and is expected to continue to do so. In addition, new tools are being developed to communicate, analyze and display data collected by these monitoring technologies. One example of a CSO community with a more comprehensive monitoring program is the City of Seattle, WA. The NPDES permit for CSO discharges in Seattle (WA0031682) requires the permittee to use automatic flow monitoring equipment to monitor the discharge volume, discharge duration, storm duration and precipitation at all 86 CSO outfalls from the CSS. In another example, the Capital Region Water (CRW) in Harrisburg, PA is conducting a pilot study to evaluate the potential use of CSO activation monitoring equipment.21 CRW will use the results of this pilot study to determine which technology to implement to send an alert each time a monitored CSO outfall begins discharging.

    21 See the Consent Decree between Harrisburg, PA, Capital Region Water (CRW), the Pennsylvania Department of Environmental Protection and EPA (U.S. District Court for the Middle District of Pennsylvania, Civil Action No. 1:15-cv-00291-WWC). (https://www.epa.gov/sites/production/files/2015-02/documents/cityofharrisburg-cd.pdf.)

    Some of the public comments received in response to EPA's August 1, 2016 Federal Register document discussed several challenges associated with volume measurement and reporting. Some commenters suggested that wastewater monitoring devices may be placed in a harsh environment and require active maintenance. One commenter suggested that the configuration of a CSO outfall may present unique and challenging circumstances which make monitoring difficult. For example, discharges from the outfall may include contributions from separate storm sewers or wastewater flows may be influenced by currents and tides in the receiving water.

    Many commenters discussed the importance of flexibility for Great Lakes Basin CSO permittees to determine the data collection method that works best for their community. A commenter also recommended that CSO discharge volume be noticed in a simplified way that is easier to understand for the public, such as small, medium, or large discharges. Another commenter indicated that installing, operating, and maintaining meters at each of their 52 CSO locations would be cost prohibitive.

    The proposed rule would require the Great Lakes Basin CSO permittee to provide an estimate of CSO discharges volumes as part of the supplemental notice to the initial notification to the local public health department and other potentially affected public entities and the supplemental notification to the public. The proposal would require this information within 24-hours of becoming aware that the CSO discharge has ended. In addition, the proposal would require the CSO discharger to provide the volume of each CSO discharge that occurred during the past calendar year in the annual notice. EPA anticipates that the information in the annual notice may reflect refinements in the volume and duration estimates provided at the time of the supplemental notification, and therefore these numbers may not be the same. EPA requests comment on the adequacy of a 24-hour reporting window for reporting CSO discharge volume and duration data. EPA also requests comment on whether these data should be required to be reported for each outfall, or whether it would be appropriate to allow for reporting aggregated data at the water body or stream or river segment level.

    Under the proposed approach, where a CSO permittee has CSO discharges occurring at multiple locations at the same time, the CSO permittee would not have to estimate the volume discharged for each outfall, but would be allowed to make an estimate of the cumulative volume of CSOs discharged to a given waterbody. This approach would simplify the information provided to the public and focus on individual watersheds. This is consistent with the proposed notification requirements for outfalls, which would not require identification of individual outfalls in all cases. EPA requests comment on this approach.

    Under the proposed approach, the Great Lake states would determine which outfalls must be monitored and where volume estimates are appropriate for the purpose of public notification when reissuing CSO permits. This approach would provide flexibility for adapting volume reporting requirements that would be consistent with and build on ongoing compliance and implementation monitoring and could respond to technology advancements that occur in the future. The flexibility would also allow states and permittees to focus on system specific priorities (e.g., highest priority outfalls, predictive modeling).

    5. Treated Discharges

    Section 425(b)(1) of the 2016 Consolidated Appropriations Act requires EPA to work with the Great Lake states to establish public notice requirements for CSO discharges. The Agency recognizes that some CSO discharges receive treatment, including solids removal and disinfection, such that the end-of-pipe discharge may meet state water quality standards, including standards for bacteria indicators designed to protect recreational uses. Under the proposal and consistent with Section 425(b)(1), permittees would be required to provide public notice for all CSO discharges, regardless of the level or type of treatment a CSO received, if any, prior to discharge. However, nothing in the proposed rule would preclude permittees from also describing the level of treatment that various CSO discharges receive.

    EPA received comments at the listening session on September 14, 2016 in response to EPA's August 1, 2016 Federal Register document that indicate that some municipalities with engineered treatment systems for CSO discharges do not believe primary treated and disinfected CSO discharges should be subject to the same public notification requirements as untreated discharges. In addition, some state workgroup members have also made this recommendation, including those from Michigan and Indiana.

    The Agency requests comment on whether it would be appropriate to establish alternative public notice requirements for CSO discharges that are treated to a specified level (e.g., primary treatment plus disinfection). EPA requests comment on whether the final regulations should provide additional flexibility for Great Lakes Basin CSO permittees to recommend in their public notification plan different public notification procedures for treated CSO discharges as compared to untreated CSO discharges. One approach would be to provide the NPDES authority with flexibility to not require initial notification requirements in the permit for treated CSO discharges. Another approach would be to only establish initial notification requirements in proposed § 122.38 for CSO discharges that are not in compliance with permit limits or that do not receive at least primary treatment and disinfection. EPA requests comment on this flexibility. The existing practices in the state of Indiana allow such flexibility.22 Other states, such as New York, require public notification for all CSO discharges, including treated discharges.23 Still another approach is to limit initial notification of treated CSO discharges to public health officials and other impacted communities. However, EPA notes that traditional bacteria indicators that are used in state water quality standards may not be the best indicators of viral and other pathogens associated with fecal contamination.24 CSO discharges that only receive primary treatment prior to disinfection and that meet water quality standards based on indicator bacteria may have levels of viruses and other pathogens that are higher than discharges of wastewater that are treated by secondary treatment processes prior to disinfection. This is because bacteria respond to water treatment processes and environmental degradation processes differently than viruses. In addition, particles in wastewater may shield pathogens from disinfection.25 CSO discharges that only receive primary treatment prior to disinfection may also have higher levels of trihalomethanes and other disinfection byproducts due to the higher concentration of chlorine needed to disinfect and potential interactions with particles in the wastewater.

    22 Indiana's interpretation is based on the stated purposes in 327 IAC 5-2.1-1, and the definitions of “Affected Public” and “Affected Waters” in 327 IAC 5-2.1-3(1) & (2). These provisions signify the intent of the notification rule is to properly warn citizens of possible health impacts from exposure to waterborne pathogens/E. coli related to CSO events. Notifications to health departments and drinking water suppliers are also related primarily to waterborne pathogen concerns. Any “treated” CSOs in Indiana must meet the minimum treatment requirements of the Federal CSO Policy (which includes disinfection). “Treated” CSO discharges are regulated in Indiana's NPDES permits with appropriate effluent sampling and numeric limitations for E. coli applied during the defined recreational season. As these “treated” CSO discharges must comply with E. coli limitations which are protective of full body contact recreational uses, such discharges are not considered to be imminent risks to human health (in regards to waterborne pathogens), any more than are discharges from wastewater treatment plant outfalls which disinfect and discharge continuously. Therefore, public notification for “treated” CSO discharges is not required in Indiana.

    23 New York Environmental Conservation Law § 17-0826-a requires public notification for all CSO discharges.

    24 “Review of Coliphages as Possible Indicators of Fecal Contamination for Ambient Water Quality,” EPA, 820-R-15-098, April 17, 2015.

    25 “Impact of Wet-Weather Peak Flow Blending on Disinfection and Treatment: A Case Study at Three Wastewater Treatment Plants,” Interstate Environmental Commission, March, 2008.

    Some of the entities from whom input is sought in the plan development may prefer to receive notice of all CSO discharges, regardless of treatment status, because of the potential risks posed by elevated pathogen levels (e.g., drinking water facilities may want notification because of concerns about elevated levels of viruses or other pathogens in the source water).

    6. More Stringent State Requirements

    Consistent with Section 425(b)(6) of the 2016 Consolidated Appropriations Act, nothing in the proposal would prohibit a Great Lakes state from establishing notice requirements for Great Lakes Basin CSO permittees in that state that are more stringent than the requirements proposed today. The NPDES regulations specifically allow for state NPDES permit authorities to establish permit requirements that are more stringent than the permit conditions specified at § 122.42 (see § 123.25(a)).

    7. Reporting

    Most NPDES permits for CSO discharges to the Great Lakes Basin require all CSO discharges be reported in a DMR at a frequency specified in the permit or within 24 hours pursuant to § 122.41(l)(6). As discussed in section II.D of today's preamble, the NPDES electronic reporting rule requires that these reports be made electronically. EPA proposes that all NPDES permits for CSO discharges to the Great Lakes Basin require that all CSO discharges are reported electronically. In addition, the Agency proposes a provision in § 122.43(f) that would require Great Lakes Basin CSO permittees to electronically report any CSO discharge that occurred during the past calendar year that has not been previously reported pursuant to a permit requirement by May 1 of the following calendar year.

    These proposed provisions are intended to ensure that the NPDES electronic database has complete information on CSO discharges to the Great Lakes Basin and to minimize any potential discrepancies between a permittee's annual notice and the NPDES electronic database.

    8. Ambient Monitoring

    One municipality has suggested that a targeted approach to public notification that prioritizes high-use recreational areas may reduce health risks more than an overly broad, general notification requirement. They suggested a targeted public notification approach could include monitoring the water quality of recreational areas for E. coli and cyanobacteria, public notification, posting water quality advisories, predictive modeling and source tracking. They suggested posting information from predictive models and the previous day E. coli sampling results on multiple Web sites and working with local television stations, newspapers, and radio stations to provide public notice.

    The proposed rule would not mandate ambient monitoring for all CSO permittees as part of a public notification program. However, the proposal would provide flexibility for such approaches to be incorporated into an NPDES permit. EPA requests comment on when ambient monitoring and predictive monitoring of ambient water conditions should be incorporated as a requirement for the public notification program.

    IV. Incremental Costs of Proposed Rule

    The economic analysis estimates the incremental costs of requiring operators of a CSO discharge to the Great Lakes Basin to provide public notification of CSO discharges. Table 3 summarizes the estimated incremental costs for the proposed rule.

    Table 3—Annual Incremental Costs by Respondent Category [Average of first three years] Respondents Labor costs Capital/
  • start-up/
  • O&M costs
  • Total
    CSO permittees with a population of less than 10,000 80 $102,114 $55,251 $157,365 CSO permittees with a population of between 10,000 and 50,000 70 118,894 1,296 120,190 CSO permittees with a population of more than 50,000 32 86,720 3,456 90,176 States 7 17,526 0 17,526 Totals 325,254 60,003 385,257

    The average incremental cost per CSO permittee is about $2,000 per CSO permittee per year. These estimates are all below the threshold level established by statute and various executive orders for determining that a rule has a significant or substantial impact on affected entities. See further discussion in Section V of this document.

    The Economic Analysis assumes that costs will be borne by Great Lakes Basin CSO permittees in the form of one-time implementation activities that would occur within one to two years, once per year activities including an annual notice, and ongoing activities that would occur during and after CSO discharges. The Economic Analysis also assumes costs for state agencies, mainly in the review of CSO permittee plans and reports.

    V. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is not a significant regulatory action and therefore this proposal was not submitted to the Office of Management and Budget (OMB) for review. The final rule may be submitted to OMB for review.

    B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2562.01. The ICR is summarized here; a complete copy can be found in the docket.

    As discussed in section II.C of today's notice, NPDES permits for CSO discharges to the Great Lakes Basin should require permittees to provide public notification to ensure that the public receives adequate notification of CSO occurrences and CSO impacts. The information burden associated with this provision is approved in “Information Collection Request for NPDES Program (Renewal)”, OMB Control No. 2040-0004, EPA ICR No. 0229.21. EPA has developed an additional analysis to provide a better, updated estimate of the public notification requirements proposed today. The analysis used to develop these estimates is described in “ICR Supporting Statement, Information Collection Request: Public Notification Requirements for CSOs in the Great Lakes Basin,” EPA ICR number 2562.01. Key estimates and assumptions in the analysis include:

    • 93% percent of existing outfalls for all CSO permittees have installed signs and that they are being maintained;

    • Approximately half of the CSO permittees already have a system for developing estimates of the occurrence and volume of discharges from CSO outfalls;

    • Each Great Lakes Basin CSO permittee already operates a Web site that can be modified to provide the public with notification of an CSO event;

    • Larger CSO communities may have access to listserv technology;

    • Electronic technology significantly reduces the burden of providing initial and supplemental notification to the public and to local public health departments and other affected public entities;

    • Much of the effort in developing public notification plan are included in burden estimates for the individual public notification components in the proposal. The activities attributed to the burden for the public notification plan include preparation of the document describing the public notification activities.

    • The burdens on NPDES authority are applied to one-fifth of all Great Lakes Basin CSO permits within each state beginning in year 2 of the ICR to account for the five year permit term.

    The public notification requirements in this proposed rule are designed to alert the public and public health departments, and other potentially affected entities of CSO discharges in a more wide-spread and timely manner than is currently practiced. The notification requirements which involve distribution of CSO discharge related information (e.g., CSO discharge location, receiving waterbody, time started, time ended, volume) to the public and affected local governmental agencies would enable potentially affected parties to take action that may help prevent serious health effects that may otherwise occur if they were to remain unaware of the occurrence of CSO discharges.

    Respondents/affected entities: The ICR covers information that must be provided by operators of combined sewer systems (Great Lakes Basin CSO permittees) that discharge within the watershed of the Great Lakes Basin. In addition, the ICR covers information burdens of the seven NPDES authorized States that are implementing the program.

    Respondent's obligation to respond: Compliance with the notification requirements would be mandatory. Requirements for public notification of CSO discharge are part of the “nine minimum controls” established as part of EPA's CSO Control Policy. Section 425 of the consolidated Appropriations Act of 2016 (Pub. L. 114-113) requires EPA to work with the Great Lakes states to establish these public notice requirements.

    Estimated number of respondents: EPA has identified 182 CSO communities that discharge to the Great Lakes Basin and seven state NPDES permitting authorities.

    Frequency of response: Responses include one-time implementation activities, such as signage, activities that occur once per year, such as providing annual notice, and ongoing activities that would occur during and after CSO discharge events.

    Total estimated burden: EPA estimates that the burden of implementing the rule would be 8,641 hours per year. Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: EPA estimates that the rule would cost $385,257 per year during the three year ICR period. This is the total annual incremental cost for all 182 Great Lakes Basin CSO permittees. The average incremental cost per CSO permittee is about $2,000 per year and the average incremental cost per state NPDES authority is about $2,500.

    EPA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

    Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to OIRA [email protected], Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 13, 2017. The EPA will respond to any ICR-related comment in the final rule.

    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. The small entities subject to the requirements of this action are small governmental jurisdictions. The Agency has determined that 152 (83%) of the 182 communities discharging CSOs to the Great Lakes Basin are governmental jurisdictions with a population of less than 50,000 and thus can be classified as small entities and may experience an impact of between 0% and 0.75% of annual revenue. Details of this analysis are presented in the Economic Analysis for the proposed rule (see “Economic Analysis for the Proposed Public Notification of CSOs to the Great Lakes Rule,” EPA, 2016).

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538. EPA has conducted an economic analysis examining the potential burden to state, tribal and local governments. Details of this analysis are presented in the economic analysis for the proposed rule (see “Economic Analysis for the Proposed Public Notification of CSOs in the Great Lakes Rule,” EPA, 2016). EPA estimates that the costs of rule to states, tribes and local governments will be well below $100 million per year. In addition, EPA compared the estimated annualized cost of the rule and revenue estimates for small local governments using four estimates of revenue data. The annualized compliance cost as a percentage of annual government revenues were all well below 1% for all four revenue estimate methods. EPA concludes that the impact of the rule is very unlikely to reach or exceed 1% of small local government revenue.

    EPA has provided small local governments an opportunity to share their views regarding potential new public notification requirements for CSO discharges in the Great Lakes Basin as part of the September 14, 2016 listening session and August 1, 2016 request for stakeholder input discussed in Section I.K of this notice. EPA is also encouraging the Great Lake states to notify small local governments affected by this rule about the opportunity to review and comment on this proposal.

    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.

    The rule proposes a requirement for CSO permittees to notify the public of CSO discharges. This requirement includes the development of a public notification plan and the release of an annual notice that includes monitoring data. The incremental impact to state permitting authorities is estimated to be $2,503.71 annually per state. The incremental impact to local permittees may range from a total of $1,000 to $3,000 annually per CSO permittee, depending on the number of CSO events and preparation time for the annual notice. Details of this analysis are presented in “Economic Analysis for the Public Notification Requirements for Combined Sewer Overflow discharges within the Great Lakes Basin,” which is available in the docket for the proposed rule (Docket ID No. EPA-HQ-OW-2016-0376 http://www.regulations.gov).

    Keeping with the spirit of E.O. 13132 and consistent with EPA's policy to promote communications between EPA and state and local governments, EPA met with state and local officials throughout the process of developing the proposed rule and received feedback on how potential new regulatory requirements would affect them. EPA engaged in extensive outreach via conference calls to affected states to enable officials of affected state to have meaningful and timely input into the development of the proposed rule. EPA also held a public listening session and solicited written comments from the public and impacted stakeholder groups, including affected municipalities, to inform the development of the public notice proposed requirements. See Docket ID No. EPA-HQ-OW-2016-0376 to the Federal eRulemaking Portal: http://www.regulations.gov.

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

    This action does not have tribal implications as specified in Executive Order 13175 since it does not have a direct substantial impact on one or more federally recognized tribes. No tribal governments are authorized NPDES permitting authorities and none of the combined sewer systems subject to this rule are located on Indian nation lands.

    The proposed rule would address the way in which municipalities share information with the public, public health departments, and potentially impacted communities (including Indian tribes) about CSOs in the Great Lakes Basin. EPA therefore evaluated the proximity of CSSs that would be subject to the proposed rule in relation to Indian lands. EPA identified six CSO permittees with the potential to affect waters near four Indian nations in New York State:

    Seneca Nation of Indians (SNI): The Dunkirk WWTP is located south of the Cattaraugus Reservation. The Buffalo Sewer Authority and Niagara Falls WWTP are located close to SNI lands within the city of Niagara Falls, NY and Buffalo, NY (where the Seneca casinos are located).

    Tuscarora Nation (TN): The Tuscarora Nation lands are located directly between the Niagara Falls WWTP and Lockport WWTP but not on the Niagara River or Eighteen Mile Creek.

    Tonawanda Seneca Nation (TSN): The Medina WWTP is located 10 miles north of the Tonawanda Seneca Nation lands.

    St. Regis Mohawk Tribe (SRMT): Any of the three WWTP plants along the St. Lawrence River would be of concern to the Mohawks at Akwesasne. SRMT is directly impacted by the Massena WWTP as the St. Lawrence River goes directly thru the heart of Akwesasne, the St. Regis Mohawk Tribe's reservation lands.

    Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, 26 EPA conducted outreach to tribal officials during the development of this action. EPA contacted the above mentioned tribes through outreach conducted by EPA's Office of Environmental Justice to ensure they were aware of the public listening session held regarding this rulemaking, and the associated opportunity to provide written comments to the Agency. In addition, the proposed rule would require Great Lakes Basin CSO permittees to consult with potentially affected Indian Tribes whose waters may be affected by a CSO discharge prior to submitting the public notification plan. This requirement would ensure that needs of tribes using potentially affected waters are considered in terms of timing of notification, the type of information that is provided, and the means by which public notification is communicated.

    26https://www.epa.gov/sites/production/files/2013-08/documents/cons-and-coord-with-indian-tribes-policy.pdf.

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

    This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The proposed rule would, in some cases, increase public awareness of CSO discharges to the Great Lakes Basin, including information about public use areas such as beaches that may be impacted by contaminated CSO discharges, and by doing so could decrease health risks for children, infants, and adults.

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

    This action is not subject to Executive Order 13211, because it does not significantly affect energy supply, distribution or use.

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    EPA determined that the human health or environmental risk addressed by this action would not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. This action affects the way in which Great Lakes Basin CSO permittees communicate information regarding CSO discharges to the public. It does not change any current human health or environmental risk standards.

    However, because the proposed rule would address the way in which information about CSO discharges is communicated to the public, EPA did reach out to environmental justice organizations to specifically solicit input on what may be the best approaches to reaching environmental justice communities with this information. Prior to the public listening session on September 14, 2016, EPA contacted over 800 environmental justice stakeholders through the Office of Environmental Justice Listserv, to ensure they were aware of the listening session and the opportunity to provide written input to the Agency through the public docket.

    In addition, the proposed rule would require the Great Lakes Basin CSO permittee to consult with local public health departments and potentially affected public entities when developing the public notification plan. These consultations may alert the Great Lakes Basin CSO permittee to specific environmental justice community considerations regarding the best ways to effectively communicate this information. EPA requests comment on this requirement and whether it is expected to sufficiently account for the needs of environmental justice communities that may utilize waters that could be affect by a CSO discharge to the Great Lakes Basin.

    List of Subjects 40 CFR Part 122

    Environmental protection, Administrative practice and procedure, Combined sewer overflow, Confidential business information, Hazardous substances, Reporting and recordkeeping requirements, Water pollution control, Water pollution, public notification, reporting.

    40 CFR Part 123

    Environmental protection, Administrative practice and procedure, Combined sewer overflow, Hazardous substances, Indians—lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Water pollution control, Water pollution, public notification, reporting.

    Dated: December 16, 2016. Gina McCarthy, Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 122 as follows:

    PART 122—EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM 1. The authority citation for part 122 continues to read as follows: Authority:

    The Clean Water Act, 33 U.S.C. 1251 et seq.

    2. Amend § 122.2 by adding the definitions for “Combined sewer overflow,” “Combined sewer system,” and “Great Lakes Basin” in alphabetical order to read as follows:
    § 122.2 Definitions.

    Combined sewer overflow (CSO) means a discharge from a combined sewer system (CSS) at a point prior to the Publicly Owned Treatment Works (POTW) Treatment Plant (defined at § 403.3(r) of this chapter).

    Combined sewer system (CSS) means a wastewater collection system owned by a State or municipality (as defined by section 502(4) of the CWA) which conveys sanitary wastewaters (domestic, commercial and industrial wastewaters) and storm water through a single-pipe system to a Publicly Owned Treatment Works (POTW) Treatment Plant (as defined at § 403.3(r) of this chapter).

    Great Lakes Basin means the waters defined as “Great Lakes” and “Great Lakes System” as those terms are defined in § section 132.2 of this chapter.

    3. Amend § 122.21 by adding paragraph (j)(8)(iii).
    § 122.21 Application for a permit (applicable to State programs, see § 123.25).

    (j) * * *

    (8) * * *

    (iii) Public Notification Plan for CSO discharges to the Great Lakes Basin. Each applicant that discharges a combined sewer overflow to the Great Lakes Basin as defined in § 122.2 must submit a public notification plan developed in accordance with § 122.38 as part of its permit application. The public notification plan shall describe any significant updates to the plan that may have occurred since the last plan submission.

    4. Add § 122.38 to read as follows:
    § 122.38 Public Notification requirements for CSO discharges to the Great Lakes Basin.

    (a) All permittees authorized to discharge a combined sewer overflow (CSO) to the Great Lakes Basin (“Great Lakes Basin CSO permittee”) must provide public notification of CSO discharges as described in this paragraph after [date 6 months after publication of final rule]. Public notification shall consist of:

    (1) Signage. (i) The Great Lakes Basin CSO permittee shall ensure that there is adequate signage where signage is feasible at CSO outfalls and potentially impacted public access areas. At a minimum, signs shall include:

    (A) The name of the Great Lakes Basin CSO permittee,

    (B) A description of the discharge (e.g., untreated human sewage, treated wastewater) and notice that sewage may be present in the water, and

    (C) The Great Lakes Basin CSO permittee contact information, including a telephone number, NPDES permit number and outfall number as identified in the NPDES permit.

    (ii) The Great Lakes Basin CSO permittee shall perform periodic maintenance of signs to ensure that they are legible, visible and factually correct.

    (iii) Where a permittee has before [date 6 months after publication of final rule] installed a sign at a CSO outfall or potentially impacted public access area that is consistent with state requirements, the sign is not required to meet the minimum requirements specified in paragraph (a)(1)(i) of this section until the sign is replaced or reset.

    (2) Notification of Local Public Health Department and other potentially affected public entities. (i) As soon as possible, but no later than four (4) hours after becoming aware by monitoring, modeling or other means that a CSO discharge has occurred, the Great Lakes Basin CSO permittee shall provide initial notice of the CSO discharge to the local public health department (or if there is no local health department, to the state health department), any potentially affected public entities (such as municipalities, public drinking water utilities, state and county parks and recreation departments), and Indian Tribes whose waters may be affected. Such initial notice shall, at a minimum, include the following information:

    (A) The water body that received the discharge(s);

    (B) The location of the discharge(s). Where CSO discharges from the same system occur at multiple locations at the same time, the Great Lakes Basin CSO permittee may provide a description of the area in the waterbody where discharges are occurring and identification of the public access areas potentially impacted by the discharge, and the permittee is not required to identify the specific location of each discharge;

    (C) The date(s) and time(s) that the discharge(s) commenced or the time the permittee became aware of the discharge(s) or when discharges are expected to occur;

    (D) Whether, at the time of the notification, the discharge(s) is continuing or has ended. If the discharge(s) has ended, the approximate time that the discharge ended; and

    (E) A point of contact for the CSO permittee.

    (ii) Within twenty-four (24) hours after becoming aware by monitoring, modeling or other means that the CSO discharge(s) has ended, the Great Lakes Basin CSO permittee shall provide the following supplemental information to the public health department and affected public entities and Indian Tribes receiving the initial notice under paragraph (a)(2)(i) of this section unless the information had been provided in an earlier notice:

    (A) The measured or estimated volume of the discharge(s). Where CSO discharges from the same system occur at multiple locations at the same time, the Great Lakes Basin CSO permittee may provide an estimate of the cumulative volume discharged to a given waterbody; and

    (B) The approximate time that the discharge(s) ended.

    (3) Notification of the Public. (i) As soon as possible, but no later than four (4) hours after becoming aware by monitoring, modeling or other means that a CSO discharge has occurred, the Great Lakes Basin CSO permittee shall provide public notification of CSO discharges. The Great Lakes Basin CSO permittee shall provide public notification of CSO discharges electronically, such as by text, email, social media alerts to subscribers or by posting a notice on its public access Web site, and by other appropriate means (e.g. newspaper, radio, television).

    (ii) At a minimum, the notice shall include:

    (A) The water body that received the discharge(s);

    (B) The location of the discharge(s). Where CSO discharges from the same system occur at multiple locations at the same time, the Great Lakes Basin CSO permittee may provide a description of the area in the waterbody where discharges are occurring and identification of the public access areas potentially impacted by the discharge, and the permittee is not required to identify the specific location of each discharge;

    (C) The date(s) and time(s) that the discharge(s) commenced or the time the permittee became aware of the discharge(s); and

    (D) Whether, at the time of the notification, the discharge(s) is continuing or has ended. If the discharge(s) has ended, the approximate time that the discharge(s) ended.

    (iii) Within twenty-four (24) hours after becoming aware by monitoring, modeling or other means that the CSO discharge(s) has ended, the Great Lakes Basin CSO permittee shall update the electronic notice with the following information unless the information had been provided in an earlier notice:

    (A) The measured or estimated volume of the discharge(s). Where CSO discharges from the same system occur at multiple locations at the same time, the Great Lakes Basin CSO permittee may provide an estimate of the cumulative volume discharged to a given waterbody; and

    (B) The approximate time that the discharge(s) ended, unless this information was provided in an earlier notice.

    (b) Annual Notice. By May 1 of each calendar year (or an earlier date specified by the Director), all permittees authorized to discharge a CSO to the Great Lakes Basin shall make available to the public an annual notice describing the CSO discharges from its outfall(s) that occurred in the previous calendar year and shall provide the Director with notice of how the annual notice is available. Permittees that are owners or operators of a satellite collection system with one or more CSO outfalls shall provide the annual notice to the public and a copy of the annual notice to the operator of the POTW treatment plant providing treatment for its wastewater. At a minimum, the annual notice shall include:

    (1) Information on the availability of the permittee's public notification plan and a summary of significant modifications to the plan that were made in the past year;

    (2) A description of the location, treatment provided and receiving water for each CSO outfall;

    (3) The date, location, duration, and volume of each wet weather CSO discharge that occurred during the past calendar year. Where CSO discharges from the same system occur at multiple locations at the same time, the Great Lakes Basin CSO permittee may provide an estimate of the cumulative volume discharged to a given waterbody;

    (4) The date, location, duration, and volume of each dry weather CSO discharge that occurred during the past calendar year;

    (5) A summary of available monitoring data for CSO discharges from the past calendar year;

    (6) A description of any public access areas impacted by each CSO discharge;

    (7) Representative rain gauge data in total inches to the nearest 0.1 inch that resulted in a CSO discharge;

    (8) A point of contact; and

    (9) A concise summary of implementation of the nine minimum controls and the status of implementation of the long-term CSO control plan (or other plans to reduce or prevent CSO discharges), including:

    (i) A description of key milestones remaining to complete implementation of the plan; and

    (ii) A description of the average annual number of CSO discharges anticipated after implementation of the long-term control plan (or other plan relevant to reduction of CSO overflows) is completed.

    (c) Reporting. By May 1 of each calendar year (or an earlier date specified by the Director), all permittees authorized to discharge a CSO to the Great Lakes Basin shall electronically report any CSO discharge that occurred during the past calendar year that has not been previously reported pursuant to a permit requirement. to the initial recipient, as defined in 40 CFR 127.2(b), in compliance with 40 CFR 127 using the discharge monitoring report (NPDES Data Group 3, Appendix A to 40 CFR 127) or the Sewer Overflow Event Report (NPDES Data Group 9, Appendix A to 40 CFR 127).

    (d) Public Notification Plan. The Great Lakes Basin CSO permittee shall develop a public notification plan that describes how the Great Lakes Basin CSO permittee will ensure that the public receives adequate notification of CSO occurrences and CSO impacts. The Great Lakes Basin CSO permittee must provide notice of the availability of the plan on the permittee's Web site (if it has a Web site), and periodically provide information in bill mailings and by other appropriate means on how to view the notification plan. The Great Lakes Basin CSO permittee must submit its public notification plan to the Director by [date 6 months after publication of a final rule] and as part of a permit application under § 122.21(j)(8)(iii). The plan must:

    (1) Identify the location of signs required under paragraph (a)(1) of this section and the location of any CSO outfall where a sign is not feasible. Where a sign has not been provided at an outfall, the plan shall explain why a sign at that location is not feasible.

    (2) Describe the message used on signs required under paragraph (a)(1) of this section;

    (3) Describe protocols for maintaining signage (e.g., inspections at set intervals);

    (4) Identify (with points of contact) the municipalities, public drinking water supplies, public parks with water access, Indian Tribe(s), and describe other sensitive area(s) identified in the permittee's long-term CSO control plan, that may be affected by the permittee's CSO discharges;

    (5) Summarize significant comments and recommendations raised by the local public health department under paragraph (e) of this section;

    (6) Identify other affected public entities and Indian Tribes whose waters may be affected by a CSO discharge that were contacted under paragraph (e) of this section and provide a summary of their significant comments and recommendations;

    (7) Describe protocols for the initial and supplemental notice to public health departments and other public entities;

    (8) Describe protocols for the initial and supplemental notice to the public;

    (9) Describe, for each outfall, how the volume and duration of CSO discharges shall be either measured or estimated for the purposes of complying with paragraphs (a)(2)(B)(i), (a)(3)(C)(i), (b)(2), and (b)(3) of this section. If the Great Lakes Basin CSO permittee intends to use a model to estimate discharge volumes and durations, the plan must summarize the model and describe how the model was or will be calibrated. CSO permittees that are a municipality or sewer district with a population of 75,000 or more must calibrate their model at least once every 5 years; and

    (10) Describe protocols for making the annual notice described in paragraph (b) of this section available to the public and to the Director.

    (e) Prior to submitting the public notification plan, or resubmitting under § 122.21(j)(8)(iii), the Great Lakes Basin CSO permittee must:

    (1) Seek input from the local public health department (or if there is no local health department, the state health department), to:

    (i) Develop recommended protocols for providing notification of CSO discharges to the public health department. The protocols will specify which CSO discharges are subject to notification, the means of notification, timing of notification and other relevant factors; and

    (ii) Develop recommendations for providing notice to the general public of CSO discharges electronically and by other appropriate means.

    (2) Seek input from other potentially affected public entities and Indian Tribes whose waters may be affected by a CSO discharge.

    (3) Consider the recommendations of the public health department and other potentially affected entities in developing protocols in its public notification plan for providing notification of CSO discharges to the public health department and potentially affected public entities and Indian Tribes.

    (f) The Director may extend the compliance dates in paragraphs (a), (b), and (d) of this section for individual communities if the Director determines the community needs additional time to comply in order to avoid undue economic hardship. Where the Director extends the compliance date of any of these requirements for a community, the Director shall notify the Regional Administrator of the extension and the reason for the extension. The Director shall post on its Web site a notice that includes the name of the community and the new compliance date(s). The notice shall remain on the Director's Web site until the new compliance date.

    5. Amend § 122.42 by adding paragraph (f) to read as follows:
    § 122.42 Additional conditions applicable to specified categories of NPDES permits (applicable to State NPDES programs, see § 123.25).

    (f) Public Notification requirements for CSO discharges to the Great Lakes Basin. Any permit issued for combined sewer overflow (CSO) discharges to the Great Lakes Basin must:

    (1) Require implementation of the public notification requirements in § 122.38(a);

    (2) Specify the information that must be included on outfall signage, which, at a minimum, must include those elements in § 122.38(a)(1)(i);

    (3) Specify outfalls and public access areas where signs are required pursuant to § 122.38(a)(1)(i);

    (4) Specify the timing and minimum information required for providing initial and supplemental notification to:

    (i) Local public health department and other potentially affected entities under § 122.38(a)(2); and

    (ii) The public under § 122.38(a)(3).

    (5) Specify the location of CSO discharges that must be monitored for volume and discharge duration and the location of CSO discharges where CSO volume and duration may be estimated;

    (6) Require submittal of an annual notice in accordance with § 122.38(b);

    (7) Specify protocols for making the annual notice under § 122.38(b) available to the public; and

    (8) Require all CSO discharges be electronically reported in a discharge monitoring report or a sewer overflow event report pursuant to 40 CFR 122.41(l)(6) or (7).

    PART 123—STATE PROGRAM REQUIREMENTS 6. The authority for part 123 continues to read as follows: Authority:

    Clean Water Act, 33 U.S.C. 1251 et seq.

    7. Amend § 123.25 by revising paragraph (a)(46) and adding paragraph (a)(47) to read as follows:
    § 123.25 Requirements for permitting.

    (a) * * *

    (46) For states that wish to receive electronic documents, 40 CFR part 3—(Electronic Reporting); and

    (47) For a Great Lakes State, § 122.38.

    [FR Doc. 2016-31745 Filed 1-12-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 710 [EPA-HQ-OPPT-2016-0426; FRL-9956-28] RIN 2070-AK24 TSCA Inventory Notification (Active-Inactive) Requirements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The recent amendments to the Toxic Substances Control Act (TSCA) require EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA is proposing to require a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. EPA would also accept such notices for chemical substances that were processed. EPA would use these notifications to distinguish active substances from inactive substances. EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. EPA is also proposing to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume. Upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active. EPA is proposing the procedures regarding the manner in which such retrospective and forward-looking activity notifications must be submitted, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality.

    DATES:

    Comments must be received on or before March 14, 2017.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0426, by one of the following methods.

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

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

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Myrta R. Christian, Chemistry, Economics, and Sustainable Strategies Division (Mailcode 7401M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8498; email address: [email protected].

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. Does this action apply to me?

    You may be affected by this action if you domestically manufactured, imported, or processed chemical substances listed on the TSCA Chemical Substance Inventory for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016. You may also be affected by this action if you intend to domestically manufacture, import, or process chemical substances listed on the TSCA Chemical Substance Inventory in the future. The following list of North American Industrial Classification System (NAICS) codes are not intended to be exhaustive, but rather provides a guide to help readers determine whether this action may apply to them:

    • Chemical manufacturing or processing (NAICS code 325).

    • Petroleum and Coal Products Manufacturing (NAICS code 324).

    In addition, the discussion in Unit III.A. describes in more detail which chemical substances would and would not be subject to reporting under this proposed action. You may also consult 40 CFR 710.3 and 710.4, as well as the proposed regulatory text in this document, for further information on the applicability of exemptions to this proposed rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. B. What is the Agency's authority for taking this action?

    EPA is proposing this rule under TSCA section 8(b), 15 U.S.C. 2607(b). As described in more detail in Unit II.A., TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law 114-182. The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public.

    Note that TSCA's statutory definition of “manufacture” includes importing. Accordingly, the regulatory definition of “manufacture” for this rule includes importation. All references to manufacturing in this notice should be understood to also encompass importing. Where EPA's intent is to specifically refer to domestic manufacturing or importing (both activities constitute “manufacture”), this notice will do so expressly.

    C. What action is the Agency taking?

    Pursuant to TSCA section 8(b)(4)(A), EPA is proposing procedural, retrospective notification requirements for persons who manufactured chemical substances on the TSCA Inventory as described in Unit III.A. Persons who manufactured these chemical substances for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, would be required to notify the Agency of certain information described in Unit III.C., including chemical identity and the date range when manufacture occurred in that ten-year time period. EPA would use the chemical identity information obtained from this retrospective reporting to designate as active those chemical substances on the TSCA Inventory for which notices were received. If no notice is received during this retrospective reporting for a chemical substance subject to designation on the TSCA Inventory, then that substance would be designated as inactive. EPA would require date range information in order to obtain confirmation that the chemical substance in question had indeed been manufactured or processed between June 21, 2006 and June 21, 2016.

    Pursuant to TSCA section 8(b)(5)(B), EPA is also proposing procedural, forward-looking notification requirements for persons who intend to manufacture or process inactive chemical substances on the TSCA Inventory. After EPA's first publication of the TSCA Inventory that includes active and inactive designations determined by the retrospective reporting, persons who intend to manufacture or process for nonexempt commercial purposes those chemical substances designated as inactive on the TSCA Inventory would be required to notify the Agency of certain information described in Unit III.C. Such notification must occur before the actual date of manufacturing or processing. EPA is proposing that notification, which shall include chemical identity and the actual date of manufacturing or processing, occur no more than 30 days before the actual date of manufacturing or processing.

    Included in this proposed rule are electronic reporting requirements described in Unit III.D. that are similar to those established in 2013 for reporting other kinds of information to EPA under TSCA sections 4, 5, 8(a), and 8(d). See 78 FR 72818, December 4, 2013 (FRL 9394-6). The Agency is proposing to require submitters to use EPA's Central Data Exchange (CDX), the Agency's electronic reporting portal, for reporting information under this proposed rule. The information would be submitted to the Agency under TSCA section 8(b), but the practical rationales for requiring submissions to proceed through CDX, cited in 2013, are also pertinent here by analogy.

    Also included in this proposal are amendments to 40 CFR part 710, which conform the definitions applicable to these reporting requirements with those that apply to Chemical Data Reporting rule requirements (definitions found at 40 CFR 704.3 and 711.3) and the submission of Premanufacture Notifications (definitions found at 40 CFR 720.3). EPA believes that basing Section 8(b) reporting on definitions that are already familiar to the public from CDR and PMN reporting would reduce the potential for confusion and reduce the burden of rule familiarization. EPA is not proposing to modify the 40 CFR part 710 definitions in any manner that either is not conforming to Part 704, 710, or 720, or is a purely technical correction (e.g., eliminating references to the Canal Zone from the definition of “State”). Any other changes to the definitions in 40 CFR part 710 are beyond the scope of this proposal.

    Included in this proposed rule are procedures for persons who co-manufacture or co-process a reportable chemical substance. These procedures would allow the submission of a single commercial activity notification in single instances of co-manufacturing or co-processing of a particular volume of a chemical substance. These proposed procedures are similar to Chemical Data Reporting rule requirements (40 CFR 711.22) when two or more persons are involved in a particular manufacture or import transaction. EPA believes that allowing a single notification for co-manufacturers and co-processors would serve to provide the Agency with the information necessary to designate a chemical substance as active on the TSCA Inventory while reducing duplicative reporting.

    Also included in this proposed rule are requirements for filing a joint submission when specific chemical identity information is claimed confidential by a supplier. If an importer cannot provide the specific chemical identity of a reportable substance to EPA because the information is claimed confidential by a supplier, and therefore is unknown to the importer, the importer would be required to ask the supplier to provide the confidential chemical identity information directly to the Agency in a joint submission. If a domestic manufacturer or processor cannot provide the specific chemical identity of a reportable substance to EPA because the chemical identity of a reactant is claimed confidential by a supplier, and therefore is unknown to the domestic manufacturer or processor, the manufacturer or processor would be required to ask the supplier to provide the confidential chemical identity information directly to the Agency in a joint submission. EPA would only accept joint submissions that are submitted electronically using CDX. This requirement is similar to Chemical Data Reporting rule requirements (40 CFR 711.15) and would allow EPA to obtain the information necessary to identify the specific chemical identity of a reportable substance and designate it as active on the TSCA Inventory.

    D. Why is the Agency taking this action?

    TSCA section 8(b)(4)(A) requires EPA to issue a final retrospective reporting rule by June 22, 2017. These proposed reporting requirements would enable EPA to fulfill a statutory obligation to designate chemical substances on the TSCA Inventory as active or inactive in U.S. commerce. This proposed rule is not intended to indicate conclusions about the risks of chemical substances on the TSCA Inventory. Nonetheless, the designation of a chemical substance as active or inactive would be relevant to the Agency's prioritization of chemical substances in U.S. commerce under TSCA section 6(b).

    Furthermore, TSCA section 8(b)(5) establishes a forward-looking notification requirement that goes into effect as soon as EPA designates inactive substances. EPA is proposing to establish the procedural framework whereby manufacturers and processors would discharge their notice obligations under this section of TSCA.

    E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing the proposed reporting requirements for manufacturers and processors. This analysis, which is available in the docket, is discussed in Unit VI. and is briefly summarized here (Ref. 1).

    During the retrospective (or “start-up”) period, between approximately June 2017 and June 2018, typical costs per firm are estimated at $1,346 per submission (with an estimated seven chemicals per submission), with possible additional costs at $40.22 per CDX registration in the event that the submitter is not currently registered in CDX. Among manufacturers, an estimated 6,169 firms would undertake rule familiarization with 4,692 completing compliance determination, form completion, and recordkeeping. For manufacturers, the total burden during start-up is estimated at 86,783 hours with an associated total cost of $6.68 million. For processors, the estimate of the universe of potentially affected firms is 161,550 who might initiate rule familiarization. For processors initiating rule familiarization, the cost would be 4 hours per firm (about $300 per firm). EPA believes that it is unlikely that 100% of processors will initiate rule familiarization and that the percentage will be less. EPA estimates that only 100 processors will complete compliance determination, form completion, and recordkeeping. For the 100 processors who complete a submission with one chemical, the burden during start-up is estimated at 692 hours with an associated cost of $0.05 million. Lastly, for 469 new CDX registrations (for individuals lacking previous experience with electronic reporting to EPA), burden during start-up is estimated at 249 hours with an associated cost of $0.02 million.

    The rule has minimal burden and cost implications related to ongoing reporting after the start-up year. The forward-looking (or “Ongoing”) reporting after June 2018 involves compliance determination, form completion, and recordkeeping for twenty manufacturers and/or processors per year. Burden and cost are estimated to total 142 burden hours per year with an associated cost of $10,790 per year.

    Agency activities due to the rule include CDX and Chemical Information Submission System (CISS) capacity expansions, time to manage commercial activity notices, and increased costs incurred when making revisions to the TSCA Inventory. Associated costs are estimated at $3.84 million during start-up, and $0.20 million annually thereafter.

    Combining Industry and Agency cost estimates, and annualizing over a 10-year period, the total cost of the rule is estimated at $7.22 million per year using a 3% discount rate, and at $8.77 million per year using a 7% discount rate.

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

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

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Background A. Overview of Applicable Authority

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current a list of chemical substances manufactured or processed in the United States. In 1977, EPA promulgated a rule under TSCA section 8(a), 15 U.S.C. 2607(a), to provide the information necessary for EPA to compile a list of chemical substances that had been in commerce since January of 1975 (Ref. 2). This list is known as the TSCA Chemical Substance Inventory (or simply the “TSCA Inventory”). Since compiling the initial TSCA Inventory, EPA regularly adds new chemical substances that have completed new chemical review requirements pursuant to TSCA section 5(a), 15 U.S.C. 2604(a), and that have been manufactured or processed for nonexempt commercial purposes. EPA maintains the TSCA Inventory as the authoritative list of all the chemical substances reported to the Agency for inclusion on the TSCA Inventory.

    1. Retrospective reporting under TSCA section 8(b)(4)(A). TSCA section 8(b)(4)(A) requires EPA to promulgate a rule that requires manufacturers to notify the Agency, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the TSCA Inventory that was manufactured for nonexempt commercial purpose during the 10-year period ending on June 21, 2016. If EPA receives a valid notice for a chemical substance on the TSCA Inventory, EPA must designate that chemical substance as an active substance. If EPA receives no valid notice for a chemical substance on the TSCA Inventory (and that is subject to designation), EPA must designate that chemical substance as an inactive substance.

    2. Forward-looking reporting under TSCA section 8(b)(5)(B). TSCA section 8(b)(5)(B) requires persons who intend to manufacture or process chemical substances for nonexempt commercial purposes in the future that are designated on the TSCA Inventory as inactive to notify EPA prior to the date that these chemicals are to be manufactured or processed. Upon receiving a valid notice, EPA must change the designation of the chemical substance from inactive to active.

    3. Processors. TSCA section 8(b)(4)(A) indicates that the Administrator may require processors to report similarly to manufacturers under the rule. This proposed rule would not require processors to report during the retrospective reporting period. However, once EPA has designated a chemical substance as an inactive substance, the processing of that chemical substance for a non-exempt commercial purpose would be unlawful, unless the processor first submits a notice as required by TSCA section 8(b)(5)(B). Therefore, this proposed rule would allow processors to report during the retrospective reporting period, extended to not later than 360 days after the date on which the final rule is published in the Federal Register (which will be 180 days after EPA's publication of the first version of the TSCA Inventory with preliminary commercial activity designations). Processors could report any chemical substance that they had processed for a nonexempt commercial purpose during the 10-year period ending on June 21, 2016. The extended submission period for processors would allow processors time to evaluate whether they wish to voluntarily report chemical substances that have not been reported by manufacturers or importers and that are preliminarily designated as inactive on EPA's publication of the first version of the revised TSCA Inventory. (These designations would be merely preliminary so there would not yet be an obligation to report under TSCA Section 8(b)(5)(B).) If EPA receives no notice on a chemical substance that is subject to designation, EPA then must designate that preliminarily inactive substance as actually inactive. Hence, persons who processed a chemical substance between June 2006 and June 2016 may wish to report under TSCA section 8(b)(4)(A) in order to avoid a subsequent obligation to curtail processing on the day that EPA designates the substance as inactive, under TSCA section 8(b)(5)(B). Processing could resume as soon as the notice under TSCA section 8(b)(5)(B) is submitted, but processors may nonetheless find it less disruptive to ensure that the chemical substance is earlier reported as active under TSCA section 8(b)(5)(A).

    4. General provisions. General provisions for TSCA section 8(b) rules appear in 40 CFR part 710. These provisions include definitions that apply to reporting under this proposed rule and also describe the scope of the Inventory. For example, 40 CFR 710.1 describes requirements for EPA to compile and keep current the TSCA Inventory of chemical substances manufactured or processed for commercial purposes, including the periodic updates to the Inventory to include new chemical substances reported under TSCA section 5(a) and commercialized for nonexempt purposes. In addition, the definitions in TSCA section 3 apply to this rulemaking.

    5. Electronic reporting under the Government Paperwork Elimination Act (GPEA). GPEA, 44 U.S.C. 3504, provides that, when practicable, Federal organizations should use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), provides that any requirement in title 40 of the CFR to submit a notice directly to the Agency can be satisfied with an electronic submission that meets certain conditions once the Agency published a document in the Federal Register announcing that EPA is prepared to receive certain documents in electronic form (Ref. 3). For more information about CROMERR, go to http://www.epa.gov/cromerr.

    III. Summary of Proposed Rule

    EPA is proposing reporting and procedural requirements for manufacturers and processors of chemical substances pursuant to TSCA section 8(b).

    A. What chemical substances would be reportable under this rule?

    1. Reportable chemical substances. As a general matter, the retrospective reporting requirement of this proposed rule would apply to chemical substances listed on the TSCA Inventory that were manufactured for a nonexempt commercial purposes during the 10-year period ending on June 21, 2016. This lookback period is set by statute. TSCA also establishes forward-looking reporting requirements, at section 8(b)(5)(B), with respect to chemical substances listed on the TSCA Inventory that EPA designates as inactive. The TSCA Inventory is available at https://www.epa.gov/tsca-inventory.

    2. Exemptions from reporting. i. Statutory background. This proposed rule provides exemptions from reporting based on sections 8(b)(4) and (5) and the general objectives that EPA can infer from that text. Unlike the reporting that informed the initial compilation of the TSCA Inventory (which arose under TSCA section 8(a)), the reporting requirements described in this proposed rule arise directly under TSCA section 8(b). EPA must finalize the retrospective reporting requirements by June 22, 2017, and all mandatory reporting under TSCA section 8(b)(4) must be completed by not later than 180 days thereafter. TSCA section 8(b)(4) and 8(b)(5) reporting requirements apply to “each chemical substance,” found on the TSCA Inventory, subject to the provision that reporting obligations shall only be triggered by manufacturing or processing for a “nonexempt commercial purpose.” The retrospective reporting requirements under TSCA section 8(b)(4) are expressed as being “subject to the limitations” of TSCA section 8(a)(5)(A). TSCA section 8(a)(5)(A), in turn, specifies that “to the extent feasible,” EPA shall: (1) Avoid requiring reporting that is “unnecessary or duplicative;” (2) “minimize the cost of compliance” to small manufacturers and processors; and (3) apply reporting obligations to the persons likely to have information relevant for effective implementation.

    Furthermore, as EPA interprets its statutory authority, the reporting is intended to support two key objectives. First, to enable EPA to determine which reportable chemical substances are active in U.S. commerce. EPA will accomplish this based on notices received. Reportable chemical substances for which no notices are received would be considered inactive in U.S. commerce. See TSCA section 8(b)(4)(A)(iii). Second, with respect to chemical substances identified as being active in commerce that are listed on the confidential portion of the TSCA Inventory, to require that persons manufacturing or processing such chemical substances request that existing claims for protection against disclosure of the specific chemical identity be maintained. See TSCA sections 8(b)(4)(B)(ii), 8(b)(4)(C), 8(b)(5).

    ii. Excluded chemical substances. If a chemical substance is not listed on the TSCA Inventory, then by the terms of TSCA sections 8(b)(4) and (5), it is not subject to reporting under this proposed rule. For example, chemical substances that are manufactured under a TSCA section 5(h) exemption are not added to the TSCA Inventory. Accordingly, this proposed rule would not require that reporting occur with respect to such substances. This is reflected in the proposed definitions at 40 CFR 710.23, which are drafted in such a manner that if a chemical substance was not on the TSCA Inventory as of June 22, 2016, it would not be subject to reporting.

    Naturally occurring chemical substances also are proposed to be excluded from reporting under this proposed rule, so long as the manufacturing and processing of such substances meets the criteria set forth in 40 CFR 710.27(b). When EPA required manufacturers and processors to submit notices in support of the original compilation of the TSCA Inventory in 1977, EPA made clear that reporting on naturally occurring chemical substances would not be necessary, as these substances would automatically be included in the Inventory as a category: “Naturally Occurring Chemical Substances,” 42 FR 64578 (1977). EPA proposes to simply designate the whole category of Naturally Occurring Chemical Substances as active substances, by rule, without the need for reporting to differentiate among such substances.

    Finally, this proposed rule would not require manufacturers to report chemical substances that are on both the non-confidential portion of the TSCA Inventory and the interim list of active substances described in TSCA section 8(b)(6). Such reporting would be unnecessary, since EPA already has reporting data to establish that the chemical substance was in active commerce at some time between June 21, 2006 and June 21, 2016. Furthermore, for such substances, there are no existing claims for protection against disclosure of the specific identity of the chemical substance for any party to elect to maintain or not maintain. With respect to chemical substances on the confidential portion of the TSCA Inventory, however, such reporting still serves a statutory function under TSCA sections 8(b)(4)(B)(ii) and 8(b)(4)(C), even where there is already adequate evidence, prior to reporting, that the substance was in active commerce during the lookback period.

    Regarding the composition of the interim list of active substances, TSCA section 8(b)(6) requires EPA to compile an interim list of active substances reported under 40 CFR part 711 for the purposes of TSCA section 6(b), before promulgation of the rule. The definition of the interim list is somewhat ambiguous, since it refers to the “reporting period that most closely preceded June 22, 2016.” The term “reporting period” is not defined under 40 CFR part 711. In light of the definitional ambiguity of TSCA section 8(b)(6) and EPA's weighing of the statutory objectives noted previously, EPA has construed the “interim list of active substances” to include 2012 CDR data, which avoids delay of this proposed rule, but would allow for the 2016 CDR data to give rise to a reporting exemption as soon as they are publicly released in final form. Under the proposal, manufacturers and processors of chemical substances on the non-confidential portion of the Inventory would be exempt from reporting if the manufacture of that chemical substance was already reported (by any party) in response to 2012 or 2016 CDR.

    iii. Manufacturing or processing for an exempt commercial purpose. TSCA section 8(b) directs EPA to limit reporting obligations to manufacturing and processing for “nonexempt commercial purpose.” This phrase had a commonly-accepted usage at the time that TSCA was amended, in 2016. See, for example, “Certain New Chemicals; Receipt and Status Information” (referencing TSCA section 5 requirements as applying to manufacture for “nonexempt commercial purpose”) (Ref. 4), and “2016 Chemical Data Reporting Frequent Questions” (associating “nonexempt commercial purpose” with exemptions codified at 40 CFR 720.30 and 40 CFR 711.10(a)) (Ref. 5). Since reporting under TSCA section 8(b) is a form of existing chemical reporting, EPA construes the phrase “nonexempt commercial purpose” consistent with the manner in which the 40 CFR 720.30 exemptions from pre-manufacture reporting requirements were adapted for use in the CDR at 40 CFR 711.10. Thus, for example, the manufacturing or processing of chemical substances solely in small quantities for research and development would not trigger reporting obligations under this proposed rule. Similarly, the manufacturing or processing of impurities, or byproducts that have no subsequent commercial purpose, would not trigger reporting obligations under this proposed rule. Finally, since the CDR integrates reporting exemptions for persons who import chemical substances solely as part of articles with reporting exemptions for nonexempt commercial purposes (see 40 CFR 711.10), EPA construes the TSCA 8(b) reference to “nonexempt commercial purpose” as also encompassing this article exemption. Further supporting this interpretation, EPA believes it would be incongruous to establish a more comprehensive reporting obligation for the import of inactive existing chemical substances under TSCA section 8(b)(5) (i.e., including import as part of an article), than would be applicable to the import of new chemical substances under TSCA section 5 (i.e., excluding import as part of an article).

    3. Chemical substances added to the Inventory on or after June 22, 2016. In this proposed rule, chemical substances added to the Inventory on or after June 22, 2016 would be designated as active, without the need for any reporting to establish that the chemical substance is active and without the need for any statement by manufacturers or processors indicating whether such persons wish to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance. Reporting under TSCA section 8(b)(4) is based on manufacturing or processing, for non-exempt commercial purposes, that occurred between June 21, 2006 and June 21, 2016. TSCA section 8(b)(4)(A)(iii) directs EPA to classify a chemical substance as inactive if no notice of manufacturing or processing is received by EPA. A substance added to the Inventory on or after June 22, 2016, however, would be added so recently that it has no manufacturing or processing overlapping with the lookback period. It would be illogical to designate a very recent addition to the Inventory as inactive, on the grounds that the chemical substance was too recently added to the Inventory to be captured in the retrospective reporting of current manufacturing and processing. Furthermore, if a chemical substance was added to the Inventory on or after June 22, 2016, then any claim for the protection against disclosure of the specific chemical identity of such a substance would be a new claim rather than the maintenance of an existing claim for protection of the information. For the reasons presented previously, EPA construes TSCA section 8(b)(4) reporting requirements to be limited to chemical substances that were added to the Inventory prior to June 22, 2016.

    B. When would reporting be required?

    1. Retrospective reporting period for manufacturers. This proposed rule would require manufacturers to report to the Agency not later than 180 days after the final rule is published in the Federal Register. The 180-day time period for this retrospective reporting for manufacturers is the maximum time allowed under TSCA section 8(b)(4)(A). Following this retrospective reporting for manufacturers, EPA would include the active and inactive designations, determined by the notices received, on the TSCA Inventory.

    2. Retrospective reporting period for processors. This proposed rule would allow processors to report to the Agency not later than 360 days after the final rule is published in the Federal Register. The 360-day time period for this retrospective reporting for processors would allow processors to search EPA's publication of a first draft of the TSCA Inventory with active designations and draft inactive designations, based on retrospective reporting by manufacturers, and to report only those chemical substances not already reported. This first draft of the TSCA Inventory with active designations and draft inactive designations would not have the legal effect of actually designating any chemical substance as inactive. Processors would have the option to simply not report under TSCA section 8(b)(4) and continue processing until such time when EPA has actually designated a chemical substance as inactive. At such time, any further processing of the chemical substance, without prior notification to EPA, would be prohibited by section 8(b)(5). Prior notification would allow EPA to add the chemical substance to the TSCA Inventory as an active substance.

    3. Forward-looking reporting. After EPA completes its review of the notices submitted under TSCA section 8(b)(4)(A), it must designate as inactive any chemical substance (subject to designation) for which no notice was received. TSCA section 8(b)(5)(B) provides that, once a chemical substance has been designated as inactive, any person who intends to manufacture or process that inactive substance for a nonexempt commercial purpose must first notify the Agency before the date on which the inactive substance is manufactured or processed. EPA proposes to furthermore limit the submission period for such notices, so that they may not be submitted more than 30 days before the actual date of manufacturing or processing.

    The 30-day time period for forward-looking reporting is based on EPA's experience with Premanufacture Notices (PMNs). Although persons often form the intent to commercially manufacture or process chemical substances several months ahead of time, EPA's experience with processing PMNs is that business decisions, technical difficulties, and other unforeseen circumstances may delay a company's plans to commercialize. EPA believes that a commercial activity notice reflects a more tentative or provisional intent to manufacture or process if it is submitted more than 30 days prior to the actual date of manufacturing or processing of the chemical substance. As such, it is less reliable as evidence that placement as active Inventory is warranted. Reassigning chemical substances from inactive to active status, based on relatively unreliable indicia of intent to manufacture, could affect the reliability of the Inventory designations. Therefore, this proposed rule would require that forward-looking reporting of chemical substances designated as inactive on the TSCA Inventory occur not earlier than 30 days before companies intend to manufacturing or processing for nonexempt commercial purposes.

    C. What information would be reported?

    1. Retrospective reporting period for manufacturers. This proposed rule would require that manufacturers reporting for the retrospective reporting period provide certain information including chemical identity, type of commercial activity (i.e., whether it is domestic manufacture and/or import), date range of manufacture for nonexempt commercial purpose during the 10-year reporting period ending on June 21, 2016, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

    2. Retrospective reporting period for processors. This proposed rule would allow processors to report for the retrospective reporting period, provided that the processor reports timely and consistent with the pertinent reporting requirements, including providing certain information such as chemical identity, date range of processing for nonexempt commercial purpose during the 10-year reporting period ending on June 21, 2016, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

    3. Forward-looking reporting. TSCA section 8(b)(5) requires that manufacturers and processors of inactive substances notify EPA before the date on which they manufacture or process an inactive substance for non-exempt commercial purposes. This proposed rule stipulates that they would do so in the following manner: By reporting certain information including chemical identity, type of commercial activity (i.e., whether it is domestic manufacture, import, and/or processing), actual date of manufacturing or processing for nonexempt commercial purpose, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

    4. Reporting forms. EPA developed two versions of a Notice of Activity (NOA) reporting form for submitting the information described in this proposed rule for the two reporting scenarios, retrospective and forward-looking (Ref. 6). NOA Form A (EPA Form No. TBD-1) would be used by manufacturers for the retrospective reporting period. It would also be used by processors who report for the retrospective reporting period. NOA Form B (EPA Form No. TBD-2) would be used by manufacturers and processors for forward-looking reporting. The new NOA forms are based on EPA's Notice of Commencement (NOC) form (Ref. 7), since much of the information submitted in an NOC form is the same or similar to the information proposed in the NOA.

    Any person required to report under this proposed rule would provide the information identified in the relevant version of the NOA forms to the extent it is known to or reasonably ascertainable by them. Drafts of the two versions of the proposed NOA reporting forms are available in the docket for public review (Ref. 6).

    As noted previously, these forms require very basic explanatory information about the type of commercial activity at issue (domestic manufacture, import, or processing) as well as the date range over which the activity occurred or the date when the activity is intended to resume. The collection of this explanatory information is intended to reduce the likelihood of receiving erroneous notices (e.g., notices regarding commercial activity outside the lookback period), to support EPA's capacity to inquire into the accuracy of activity notices, and thus to increase the reliability of commercial activity designations on the TSCA Inventory.

    D. How would information be submitted to EPA?

    In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d) (Ref. 8). The final rule followed two previous rules requiring similar electronic reporting of information submitted to the Agency for TSCA Chemical Data Reporting and Pre-Manufacture Notifications. This proposed rule would require electronic reporting similar to the requirements established in 2013 for submitting certain other information under TSCA (see 711.35 and 720.40). This proposed rule would require submitters to use EPA's CDX, the Agency's electronic reporting portal, and EPA's Chemical Information Submission System (CISS), a web-based reporting tool, for all reporting under this proposed rule in accordance with section 3.2000 of 40 CFR part 3 (CROMERR) (Ref. 3).

    This proposed rule would require persons submitting notices of activity to EPA under TSCA section 8(b) to follow these same electronic reporting procedures used for other TSCA submissions, i.e., to register with EPA's CDX and use CISS to prepare a data file for submission. Registration in CDX enables CDX to authenticate identity and verify authorization. To register, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, and selects a user name and password. Users who have previously registered with CDX for other submissions would be able to add the “Submission for Chemical Safety and Pesticide Program” service to their current registration in CDX and use the CISS web-based reporting tool.

    EPA developed the Chemical Information Submission System (CISS) for use in submitting data electronically under TSCA sections 4, 5, 8(a), and 8(d) to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers and uses “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. CISS works with CDX to secure online communication and provides user-friendly navigation. The NOA forms described in this proposed rule will be included in an e-NOA software module in CISS. Once a user completes entry of the relevant data fields and metadata information in the appropriate NOA form, the CISS reporting tool validates the submission by performing a basic error check. CISS also allows the user to choose “Preview,” “Save,” or “Submit.” When “Submit” is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then submits the data via CDX. Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as “Submitted.” The user can also login to the application and download their Copy of Record.

    EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization and more easily save a copy for their records or future use. The resource and time requirements to review, process, store, and retrieve data by the Agency would also be reduced.

    Any person submitting a reporting form could claim any part or all of the form as confidential. Except as otherwise provided in this proposed rule, any information that is claimed as confidential would be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2.

    E. How would CBI claims and requests be handled?

    Notices pursuant to this rulemaking may contain two different types of CBI assertions: Claims for protection of information other than specific chemical identify, and requests to maintain existing claims for protection of specific chemical identify.

    1. Information other than specific chemical identity. For all new claims for protection (i.e., for all CBI assertions under this rule other than requests to maintain existing claims for protection of specific chemical identity), TSCA section 14(c)(1)(B) and 14(c)(5) require that persons claiming CBI must provide a specific, certification statement regarding the basis for the CBI claims. In addition, this proposed rule would require that all such claims be substantiated at the time of submission, except for claims for information exempted from substantiation under section 14(c)(2). In view of the rapid EPA review of claims required by section 14(g)(1), and in order to reduce the likelihood of unwarranted claims, EPA believes that a concurrent substantiation is required. EPA will review a representative subset of these claims as specified by section 14(g)(1).

    2. Requests to maintain existing CBI claims for chemical identity. Requests to maintain existing CBI claims for specific chemical identity on Form A are governed in part by TSCA sections 8(b)(4)(C-E). TSCA section 8(b)(4)(C), in particular, requires EPA to issue a rule to establish a review plan for these requests. That review plan must specify a time when the Form A CBI requests for specific chemical identity are to be substantiated. EPA will be conducting a separate rulemaking to establish this review plan. Therefore, this proposal does not include mandatory substantiation requirements for Form A CBI requests for chemical identity. Mandatory substantiation requirements will be part of the review plan promulgated under section 8(b)(4)(C). However, the Agency proposes to allow companies to submit early substantiation at the same time that their Form A is filed, if they so choose. As long as the period between the date these earlier substantiations are received and the due date to be established in the review plan (yet to be proposed) is not more than five years, these early substantiations would exempt the company from the requirement to submit additional substantiation for their Form A under the terms of the review plan. See section 8(b)(4)(D)(i). EPA will review requests to maintain CBI claims for specific chemical identity in accordance with the 8(b)(4)(D) review plan in the timeframe mandated by section 8(b)(4)(E).

    Any manufacturer or processor submitting an active chemical notification under TSCA section 8(b)(4)(A) may seek to maintain an existing CBI claim for specific chemical identity, regardless of whether that person asserted the original claim that caused the specific chemical identity to be treated as confidential. EPA believes this is the correct interpretation of “a manufacturer or processor . . . that seeks to maintain an existing claim for protection of against disclosure” of specific chemical identity. A number of manufacturers and processors may legitimately benefit from the confidential status of a specific chemical identity, and the initial claimant may no longer exist. EPA does not believe that Congress intended for specific confidential chemical identities to be disclosed without providing the opportunity for manufacturers and processors to make a request that the identities should remain confidential simply because the original claimants no longer manufacture the chemical substances.

    Pursuant to TSCA section 8(b)(4)(B)(iv), EPA would move an active chemical substance from the confidential portion of the Inventory to the non-confidential portion if no manufacturer or processor submitting an active chemical notification under TSCA section 8(b)(4)(A) requests to maintain the existing CBI claim for the specific identity of that chemical substance. See proposed 710.37(a).

    Requests to maintain existing CBI claims for specific chemical identity on Form B are governed by TSCA section 8(b)(5)(B), which provides that the request to maintain the claim must be substantiated not later than 30 days after submitting Form B. See section 8(b)(5)(B)(ii)(II). Proposed substantiation requirements for Form B CBI claims for chemical identity are found in section 710.37(a)(1)(ii).

    Although TSCA section 8(b)(5) provides that substantiation for requests to maintain existing CBI claims for specific chemical identity must be provided not later than 30 days after submitting a Form B, persons submitting a Form B may find it more efficient to simply provide the substantiation for a CBI claim for specific chemical identity at the time of filing. Section 8(b)(5)(iii)(II) provides that the Agency shall “promptly” review CBI claims for specific chemical identity in Form B. The Agency intends to review these claims within 90 days of receipt of the substantiation.

    IV. Request for Comments

    EPA is seeking public comment on all aspects of this proposed rule, including specific issues throughout this document, as well as other issues discussed in this Unit.

    A. Considerations for the Agency's Economic Impact Analysis

    EPA has evaluated the potential costs for manufacturers and processors of chemical substances reportable under this proposed rule (Ref. 1). EPA is specifically seeking additional information and data that the Agency could consider in developing the final economic analysis. In particular, EPA is seeking data that could facilitate the Agency's further evaluation of the potentially affected industry and firms, including data related to potential impacts for those small businesses that would be subject to reporting.

    B. Electronic Reporting

    Requiring electronic reporting under this proposed rule that is similar to those established in 2013 for other TSCA reporting, EPA expects to save time, improve data quality, and provide efficiencies for both submitters and the Agency. EPA is specifically interested in comments related to the adoption of the existing mechanisms and procedures for use in transmitting the notices proposed in this rule, including comments related to the extent to which potential reporting entities are already familiar with these mechanisms and procedures because of their existing use for other TSCA reporting. EPA is also interested in feedback on how electronic reporting affects potential reporting entities in terms of reporting time, reporting efficiency, and potential burden associated with training to use the electronic systems (i.e., CDX and CISS).

    V. References

    The following is a listing of the documents that are specifically referenced in this proposed rule. The docket includes these references and other information considered by EPA. For assistance in locating these other documents, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT.

    1. 2016. EPA. Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (RIN 2070-AK24, December 21, 2016). 2. 1977. EPA. Inventory Reporting Requirements; Final Rule. Federal Register (42 FR 64572, December 23, 1977) (FRL 817-1). 3. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL 7977-1). 4. 2010. EPA. Certain New Chemicals; Receipt and Status Information; Notice. Federal Register (75 FR 71688, November 24, 2010) (FRL 8852-1). 5. 2016. EPA. 2016 Chemical Data Reporting Frequent Questions. https://www.epa.gov/chemical-data-reporting/2016-chemical-data-reporting-frequent-questions. 6. 2016. EPA. Notice of Activity Form A and Form B; Draft. 7. 2009. EPA. Notice of Commencement Form; Final. 8. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL 9394-6). 9. 2016. EPA. Information Collection Request for the TSCA section 8(b) Proposed Reporting Requirements for TSCA Inventory Notification Active-Inactive (EPA ICR No. 2517.01). 10. 2016. EPA. Small Entity Analysis Report for the Proposed Rule: TSCA Inventory Notification Requirements (December 16, 2016). VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is not a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

    B. Paperwork Reduction Act (PRA)

    The information collection activities associated with this proposed rule have been submitted to OMB for review and approval under the PRA, 44 U.S.C. 3501 et seq. Specifically, EPA has prepared an Information Collection Request (ICR) to estimate the potential burden and costs associated with the proposed requirements (Ref. 9). The ICR, which is available in the docket, has been assigned the EPA ICR No. 2517.01 (OMB Control No. 2070-[new]). You can find a copy of the ICR in the docket for this proposed rule (Ref. 9), and it is briefly summarized here.

    Start-Up Year Burden/Cost (Retrospective). Covers respondents/affected entities, i.e., persons who manufacture chemical substances.

    Respondents' obligation to respond: Mandatory.

    Estimated number of respondents: 4,692.

    Frequency of response: Once and on-occasion.

    Estimated burden: 86,783 hours. The term “burden” is defined at 5 CFR 1320.3(b).

    Estimated cost: $6.68 million.

    Note that an additional number of respondents (i.e., processors), as high as 161,550, are each assumed to undergo four hours of rule familiarization (about $300 per firm), but would likely not be required to submit information. This is based on an assumption that 100 percent of processor firms would undertake rule familiarization. However, EPA believes that it is unlikely that 100% of processors would initiate rule familiarization and that the actual percentage would be lower. Although this count, and the associated burden and costs, are not included in the estimates, the estimated burden and costs account for the bulk of total start-up costs (88%). In addition, the estimated burden and costs includes 469 CDX registrations in addition to NOA submissions.

    Ongoing Annual Burden/Cost (Forward-looking): Covers respondents/affected entities, i.e., persons who manufacture or process chemical substances.

    Respondents' obligation to respond: Mandatory.

    Estimated number of respondents: 20.

    Frequency of response: On-occasion.

    Total estimated burden: 142 hours.

    Total estimated cost: $10,790.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and included on any related collection instrument (e.g., the form).

    Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 13, 2017. EPA will respond to any ICR-related comments in the final rule.

    C. Regulatory Flexibility Act (RFA)

    EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et seq., that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule would not have a significant economic impact on a substantial number of small entities if the rule has a very small level of impact on the small entities subject to the rule.

    The small entities subject to the requirements of this action are manufacturers, and processors of chemical substances. As the most burdensome conditions are incurred during the start-up year for manufacturers, these reporters are the subject of the quantitative analysis with other reporters and other years assessed by inference. The detailed analysis is available in the docket (Ref. 10).

    The quantitative analysis addresses the “most affected” subset of entities who are expected to incur the highest typical burden under the proposed rule as entities manufacturing (or importing) chemicals that must submit NOAs involving an average of seven chemicals per entity in the start-up year. These small entities most directly regulated by this rule are small businesses in NAICS 325: Chemical Manufacturing, and 324: Petroleum and Coal Products Manufacturing reporting during the start-up year. EPA has determined that all of the small entities (comprising about 96% of the total number of entities) within the scope of the quantitative analysis would experience an impact of less than 1% of revenues. This analysis follows EPA guidance on Regulatory Flexibility Act (RFA) and Small Business Regulatory Enforcement Fairness Act (SBREFA) analyses. Per this guidance document, the preferred measure of economic impacts is the “sales test:” Annualized compliance costs as a percentage of sales (or revenue or receipts when sales data are not readily available). This measure is termed “cost impact percentage” in the small entity analysis.

    Additional groups of small entities may be affected by the rule and are expected to incur similar or lesser impacts, by inference. First, processors submitting NOAs during the start-up year are expected to incur a smaller unit burden with one chemical per NOA, and therefore experience similar or lesser impacts than manufacturers. Secondly, all reporters in future years, with lower counts and relatively smaller unit burdens, would therefore incur much lower impact than entities during the start-up year, Therefore, inferences drawn regarding small entity impacts on the most affected group may be extended to characterize the impacts on processors during the start-up year and all entities for future years.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action is not expected to impose enforceable duty on any state, local or tribal governments, and the requirements imposed on the private sector are not expected to result in annual expenditures of $100 million or more for the private sector. As such, EPA has determined that the requirements of UMRA sections 202, 203, 204, or 205 do not apply to this action.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications because it would not have any 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

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

    This action does not have tribal implications because it is not expected to have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).

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

    EPA interprets Executive Order 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 Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 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 a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use.

    I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

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

    This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action would not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment.

    List of Subjects in 40 CFR Part 710

    Environmental protection, Chemicals, Reporting and Recordkeeping, TSCA Inventory.

    Dated: December 23, 2016. James J. Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

    Therefore, it is proposed that 40 CFR chapter I be amended as follows:

    PART 710—[AMENDED] 1. The authority citation for part 710 would continue to read as follows: Authority:

    15 U.S.C. 2607(a).

    2. Redesignate §§ 710.1 through 710.4 as subpart A under the following subpart A heading: PART 710—COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY Subpart A—General Provisions Sec. 710.1 Scope and compliance. 710.3 Definitions. 710.4 Scope of the Inventory. Subpart B—Commercial Activity Notification 710.23 Definitions. 710.25 Persons subject to the notification requirement. 710.27 Activities for which notification is not required. 710.29 Information required in the notification. 710.30 When to submit notifications. 710.33 Co-manufacturers and co-processors. 710.35 Recordkeeping requirements. 710.37 Confidentiality claims. 710.39 Electronic filing. 3. Revise § 710.1 paragraph (b) to read as follows: Subpart A—General Provisions
    § 710.1 Scope and compliance.

    (b) This part applies to the activities associated with the compilation of the TSCA Chemical Substance Inventory (TSCA Inventory) and the designation of chemical substances on the TSCA Inventory as active or inactive in U.S. commerce.

    4. Revise § 710.3 paragraph (d) to read as follows:
    § 710.3 Definitions.

    (d) The following definitions also apply to this part:

    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

    Administrator means the Administrator of the U.S. Environmental Protection Agency, any employee or authorized representative of the Agency to whom the Administrator may either herein or by order delegate his/her authority to carry out his/her functions, or any other person who will by operation of law be authorized to carry out such functions.

    Article means a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design.

    Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).

    CASRN means Chemical Abstracts Service Registry Number.

    Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that “chemical substance” does not include: (1) Any mixture; (2) any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide; (3) tobacco or any tobacco product, but not including any derivative products; (4) any source material, special nuclear material, or byproduct material; (5) any pistol, firearm, revolver, shells, and cartridges; and (6) any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

    Commerce means trade, traffic, transportation, or other commerce (1) between a place in a State and any place outside of such State or (2) which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State.

    Customs territory of the United States means the 50 States, Puerto Rico, and the District of Columbia.

    Distribute in commerce and distribution in commerce means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold after its introduction into commerce.

    Domestic means within the geographical boundaries of the 50 United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.

    EPA means the U.S. Environmental Protection Agency.

    Importer means any person who imports any chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States. “Importer” includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate, (1) the consignee, (2) the importer of record, (3) the actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20, or (4) the transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144.

    Impurity means a chemical substance which is unintentionally present with another chemical substance.

    Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or that is intentionally present for the purpose of altering the rate(s) of such chemical reaction(s).

    Inventory means the TSCA Chemical Substance Inventory, which is EPA's comprehensive list of confidential and non-confidential chemical substances manufactured or processed in the United States for non-exempt commercial purpose that EPA compiled and keeps current under section 8(b) of the Act.

    Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances. When a chemical substance, manufactured other than by import, is: (1) Produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process, then that chemical substance is co-manufactured by the producing manufacturer and the person contracting for such production.

    Manufacture for commercial purposes means: (1) To manufacture, produce, or import with the purpose of obtaining an immediate or eventual commercial advantage, and includes, among other things, the “manufacture” of any amount of a chemical substance or mixture (i) for commercial distribution, including for test marketing, or (ii) for use by the manufacturer, including use for product research and development or as an intermediate. (2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes.

    Manufacturer means a person who manufactures a chemical substance.

    Mixture means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that “mixture” does include (1) any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination are not new chemical substances, and (2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water, so long as the nonhydrated form is itself not a new chemical substance.

    New chemical substance means any chemical substance which is not included on the Inventory.

    Person includes any individual, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal Government.

    Process means to process for commercial purposes. Process includes the preparation of a chemical substance or mixture, after its manufacture, (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (2) as part of a mixture or article containing the chemical substance or mixture.

    Process for commercial purposes means the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes.

    Processor means any person who processes a chemical substance or mixture.

    Site means a contiguous property unit. Property divided only by a public right-of-way will be considered one site. More than one manufacturing plant may be located on a single site. (1) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. (2) The site for an importer who imports a chemical substance described in § 710.25 is the U.S. site of the operating unit within the person's organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer.

    Small quantities solely for research and development (or “small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product”) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.

    State means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States.

    Technically qualified individual means a person (1) who because of his/her education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision, (2) who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and (3) who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition.

    Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce.

    United States, when used in the geographic sense, means all of the States, territories, and possessions of the United States.

    5. Add a new subpart B to read as follows: Subpart B—Commercial Activity Notification
    § 710.23 Definitions.

    The following definitions also apply to subpart B of this part.

    Active substance means any interim active substance, any naturally occurring chemical substance as defined by § 710.27(b), any substance added to the TSCA Inventory on or after June 22, 2016, and any chemical substance subject to commercial activity designation that the Administrator designated as active based on the receipt of a notice under this subpart.

    Central Data Exchange or CDX means EPA's centralized electronic document reporting portal, or its successors.

    Chemical substance subject to commercial activity designation means a chemical substance that requires a designation as either an active or an inactive substance. A chemical substance is subject to commercial activity designation if it was added to the TSCA Inventory before June 22, 2016, it is not an interim active substance, it is not a naturally occurring chemical substance as defined by § 710.27(b), and it has not yet been designated by the Administrator as either an active or an inactive substance.

    Chemical Information Submission System or CISS means EPA's web-based reporting tool for preparing and submitting a Notice of Activity.

    e-NOA means EPA's software module within CISS for generating and completing Notice of Activity forms A and B.

    Existing claim for protection of specific chemical identity against disclosure is a claim to continue protection of specific chemical identity of a chemical substance that is listed on the confidential portion of the TSCA Inventory.

    Inactive substance means any chemical substance subject to commercial activity designation, that the Administrator designates as inactive based on the lack of receipt of a notice under this subpart.

    Interim active substance means any chemical substance that was reported, pursuant to 40 CFR part 711, as having been manufactured in either 2010 or 2011. After such time when EPA has made public a compiled list of chemical substances that were reported, pursuant to 40 CFR part 711, as having been manufactured in either 2012, 2013, 2014, or 2015, the term shall also include any such additional chemical substances that were there reported as having been manufactured in those additional years.

    Known to or reasonably ascertainable by means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

    Lookback period means the period beginning on June 21, 2006 and ending on June 21, 2016.

    Reportable chemical substance means a chemical substance that is listed on the TSCA Inventory and that is either: (1) A chemical substance subject to commercial activity designation for which notification is required or allowed under § 710.25(a) and § 710.25(b), (2) an interim active substance for which notification is required under § 710.25(a), or (3) an inactive substance for which notification is required under § 710.25(c).

    Submission period means the applicable period for submitting a Notice of Activity under § 710.25.

    § 710.25 Persons subject to the notification requirement.

    The following persons are subject to the requirements of this subpart.

    (a) Who must submit the Notice of Activity Form A? Any person who manufactured a chemical substance subject to commercial activity designation or who manufactured an interim active substance that is on the confidential portion of the TSCA Inventory, at any time during the lookback period, except as provided in § 710.27, must submit a Notice of Activity Form A as specified under § 710.29 and § 710.30.

    (b) Who else may submit the Notice of Activity Form A? Any person who processed a chemical substance subject to commercial activity designation, at any time during the lookback period, except as provided in § 710.27, may submit a Notice of Activity Form A as specified under § 710.29 and § 710.30.

    (c) Who must submit the Notice of Activity Form B? Any person who intends to manufacture or process an inactive chemical substance, except as provided in § 710.27, after the effective date of the Administrator's designation of such chemical substance as an inactive substance, must submit a Notice of Activity Form B as specified under § 710.29 and § 710.30.

    § 710.27 Activities for which notification is not required.

    (a) In general. The following activities do not trigger notification requirements under this subpart:

    (1) The manufacturing or processing of a chemical substance solely in small quantities for research and development.

    (2) The import of a chemical substance as part of an article.

    (3) The manufacturing or processing of a chemical substance as described in § 720.30(g) or (h).

    (b) Manufacturing or processing naturally occurring chemical substances. The following activities do not trigger notification requirements under this subpart:

    (1) The manufacture of a naturally occurring chemical substance, as described in § 710.4(b). Some chemical substances can be manufactured both as described in § 710.4(b) and by means other than those described in § 710.4(b). If a person manufactures a chemical substance by means other than those described in § 710.4(b), this exemption is inapplicable, regardless of whether the chemical substance also could have been produced as described in § 710.4(b). This exemption does not cover the manufacture of a chemical substance from a naturally occurring chemical substance.

    (2) The processing of a naturally occurring chemical substance only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water.

    § 710.29 Information required in the notification.

    (a) Reporting information to EPA. Any person who reports information to EPA, including post-notification substantiation of confidentiality claims under § 710.37(b), must do so using the e-NOA software module, the CISS reporting tool, and the CDX electronic reporting portal provided by EPA at the addresses set forth in § 710.39. For notices of activity under § 710.25(a) and § 710.25(b), the submission must include all information described in paragraph (b) of this section. For a Notice of Activity under § 710.25(c), the submission must include all information described in paragraph (c) of this section. A person must submit a separate form for each chemical substance that the person is required to report. CDX, CISS, and e-NOA allow a person to report multiple chemical substances in one session that will be transmitted to EPA on separate forms. Using e-NOA and registering in CDX are described in instructions available from EPA at the Web sites set forth in § 710.39.

    (b) Information to be reported on the Notice of Activity Form A. Any person submitting a Notice of Activity Form A under § 710.25(a) or § 710.25(b) must submit the information described in this paragraph for each reportable chemical substance during the submission period specified in § 710.30(a). A person submitting information under § 710.25(a) or § 710.25(b) must report information to the extent that such information is known to or reasonably ascertainable by that person. A notice must be submitted for each chemical substance for which the person is required to report. A person reporting information under § 710.25(a) or § 710.25(b) must report the following:

    (1) Information specified in § 710.29(d).

    (2) The type of commercial activity for each reportable chemical substance: Whether the chemical substance was domestically manufactured in the United States, imported into the United States, or both domestically manufactured in the United States and imported into the United States during the lookback period.

    (3) The first date and the last date that each reportable chemical substance was domestically manufactured in the United States, imported into the United States, or both domestically manufactured in the United States and imported into the United States during the lookback period.

    (c) Information to be reported on a Notice of Activity Form B. Any person submitting a Notice of Activity Form B under § 710.25(c) must provide the information described in this paragraph for each inactive chemical substance intended to be manufactured or processed at the time specified in § 710.30(b). A person submitting information under § 710.25(c) must report information to the extent that such information is known to or reasonably ascertainable by that person. A notice must be submitted for each chemical substance that the person intends to manufacture or process. A person submitting a notice of activity under § 710.25(c) must report the following:

    (1) Information specified in § 710.29(d).

    (2) The type of intended commercial activity for the inactive substance: Whether the inactive substance is intended to be domestically manufactured in the United States, imported into the United States, processed in the United States, or a particular combination of these.

    (3) The actual date by which the inactive substance is to be domestically manufactured in the United States, imported into the United States, or processed in the United States.

    (d) Information to be reported on either the Notice of Activity Form A or Form B.

    (1) Company. The name of the submitting company.

    (2) Authorized official. The name and address of the authorized official for the submitting company.

    (3) Technical contact. The name and telephone number of a person who will serve as technical contact for the submitting company and who will be able to answer questions about the information submitted by the company to EPA.

    (4) Chemical-specific information. The correct CA Index name as used to list the chemical substance on the Inventory and the correct corresponding CASRN must be submitted for each reportable chemical substance. Persons who wish to report chemical substances listed on the confidential portion of the TSCA Inventory must report the chemical substances using a TSCA Accession Number and generic name.

    (i) If an importer submitting a notice cannot provide the information specified in § 710.29(d)(4) because it is unknown to the importer and claimed as confidential by the supplier of the chemical substance or mixture, the importer must ask the supplier to provide the specific chemical identity information directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must include instructions for submitting chemical identity information electronically, using e-NOA, CISS, and CDX (see § 710.39), and for clearly referencing the importer's submission. Contact information for the supplier, a trade name or other name for the chemical substance or mixture, and a copy of the request to the supplier must be included with the importer's submission with respect to the chemical substance.

    (ii) If a manufacturer or processor submitting a notice cannot provide the information specified in § 710.29(d)(4) because the reportable chemical substance is manufactured or processed using a reactant having a specific chemical identity that is unknown to the manufacturer or processor and claimed as confidential by its supplier, the manufacturer or processor must ask the supplier of the confidential reactant to provide the specific chemical identity of the confidential reactant directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must include instructions for submitting chemical identity information electronically using e-NOA, CISS, and CDX (see § 710.39), and for clearly referencing the manufacturer's or processor's submission. Contact information for the supplier, a trade name or other name for the chemical substance, and a copy of the request to the supplier must be included with the manufacturer's or processor's submission with respect to the chemical substance.

    (iii) EPA will only accept joint submissions that are submitted electronically using e-NOA, CISS, and CDX (see § 710.39) and that clearly reference the primary submission to which they refer.

    (5) Certification statement. The authorized official must certify that the submitted information has been completed in compliance with the requirements of this part and that the confidentiality claims made on the form are true and correct using the certification statement in this paragraph.

    (i) The certification must be signed and dated by the authorized official for the submitting company.

    (ii) The following is the required certification language:

    “I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge is, true, accurate, and complete. I am aware there are significant penalties for submitting incomplete, false and/or misleading information, including the possibility of fine and imprisonment for knowing violations.”

    § 710.30 When to submit notifications.

    (a) When must a Notice of Activity Form A be submitted? The Notice of Activity Form A required to be submitted under § 710.25(a) must be submitted during the applicable submission period.

    (1) Manufacturers. The submission period for manufacturers under § 710.25(a) begins on [date on which the final rule is published in the Federal Register] and ends on [180 days after the date on which the final rule is published in the Federal Register].

    (2) Processors. The submission period for processors under § 710.25(b) begins on [date on which the final rule is published in the Federal Register] and ends on [360 days after the date on which the final rule is published in the Federal Register].

    (b) When must a Notice of Activity Form B be submitted? The Notice of Activity Form B required to be submitted under § 710.25(c) must be submitted before a person manufactures or processes the inactive substance, but not more than 30 days prior to the actual date of manufacturing or processing.

    § 710.33 Co-manufacturers and co-processors.

    (a) Notice of Activity submitted by co-manufacturers. When, in a single instance of manufacturing or importing a particular volume of a chemical substance during the lookback period, two or more persons qualify as the manufacturer or importer of that volume, they may determine among themselves who should make the required submission under § 710.25(a). If no notice is submitted as required under this subpart, EPA will hold each such person liable for failure to submit a notice.

    (b) Notice of activity by prospective co-manufacturers or co-processors. If two or more persons intend to manufacture, import, or process a particular volume of an inactive substance, such that multiple persons would qualify as the manufacturer, importer, or processor of that volume, they may determine among themselves who will submit the required notice under § 710.25(c). If no notice is submitted as required under this subpart, all of the persons remain subject to the reporting requirements, and EPA will hold each such person liable for a failure to submit a notice prior to the date of manufacturing, importing, or processing.

    § 710.35 Recordkeeping requirements.

    Each person who is subject to the notification requirements of this part must retain records that document any information reported to EPA. Records relevant to a notice of activity under § 710.25(a) and § 710.25(b) must be retained for a period of 5 years beginning on the last day of the submission period. Records relevant to a notice of activity under § 710.25(c) must be retained for a period of 5 years beginning on the day that the notice was submitted.

    § 710.37 Confidentiality claims.

    (a) Chemical identity. Any persons submitting information under this part may request to maintain an existing claim of confidentiality for the specific chemical identity of a reportable chemical substance only if the identity of the chemical substance is listed on the confidential portion of the TSCA Inventory as of the time the notice is submitted for that chemical substance under this part. Any such requests to maintain an existing claim of confidentiality must be made at the time the information is submitted. If no person submitting the information specified in § 710.29(d)(4) for a particular chemical substance requests that the claim be maintained, EPA will treat the specific chemical identity of that chemical substance as not subject to a confidentiality claim and will move the chemical substance to the public portion of the TSCA Inventory. Except as set forth in this subsection, information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2. The following steps must be taken to maintain an existing claim of confidentiality for the specific chemical identity of a reportable chemical substance.

    (1) Substantiation of requests.

    (i) Notice of Activity Form A. A person requesting to maintain an existing claim of confidentiality for specific chemical identity may submit with the notice detailed written answers to the questions in paragraph (1)(iii) of this section, signed and dated by an authorized official. If these early answers are received less than five years before the date on which substantiation is due pursuant to TSCA Section 8(b)(4)(D)(i) the early answers will be deemed to be substantiations made under TSCA Section (8)(b)(4)(D)(i) and the person will be exempt from further substantiation requirements under Section (8)(b)(4)(D)(i). Early answers that do not include the answers to questions in paragraph (1)(iii) of this section will not be deemed to be substantiations made under the TSCA section (8)(b)(4)(D)(i) requirement.

    (ii) Notice of Activity Form B. A person requesting to maintain an existing claim of confidentiality for specific chemical identity must submit detailed written answers to the questions in paragraph (1)(iii) of this section within 30 days of submitting the notice, signed and dated by an authorized official. If this information is not submitted within 30 days of submitting the notice, EPA will consider the specific chemical identity as not subject to a confidentiality claim and may make the information public without further notice.

    (iii) Substantiation questions.

    (A) What harmful effects to your competitive position, if any, or to your supplier's competitive position, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

    (B) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

    (C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?

    (D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured for a commercial purpose by anyone?

    (E) Is the fact that the chemical substance is being manufactured for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?

    (F) What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured for a commercial purpose?

    (G) To what extent has the fact that this chemical substance is manufactured for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

    (H) Does this particular chemical substance leave the site of manufacture in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?

    (I) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product?

    (J) For what purpose do you manufacture the chemical substance?

    (K) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

    (2) Identification of claims. If any of the information contained in the answers to the questions listed in paragraph (a)(1)(iii) of this section is asserted to be confidential, the submitter must clearly identify the information that is claimed as confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”

    (b) Information other than specific chemical identity. Any persons submitting information under this part may assert a claim of confidentiality for information other than specific chemical identity. Any such confidentiality claims must be made at the time the information is submitted. Confidentiality claims will apply only to the information submitted with the claim. Confidentiality claims cannot be made when a response field on a reporting form is left blank or designated as not known or reasonably ascertainable. Except as set forth in this section, information claimed as confidential in accordance with this subsection will be treated and disclosed in accordance with 40 CFR part 2. The following steps must be taken to assert a claim of confidentiality for information other than specific chemical identity. If no claim is asserted at the time the information is submitted, or if the following steps are not taken, EPA will consider the information as not subject to a confidentiality claim and may make the information public without further notice.

    (1) Substantiation of claims. A person asserting a claim of confidentiality for information other than specific chemical identity must submit detailed written answers to the following questions at the time of submission, signed and dated by an authorized official.

    (i) For what period of time do you request that the information be maintained as confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.

    (ii) Information submitted to the EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question #1?

    (iii) What measures have you taken to protect the information claimed as confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information be considered confidential?

    (iv) Is the information contained in any publicly available material such as the Internet, publicly available databases, promotional publications, annual reports, or articles? If so, specify which.

    (v) Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?

    (vi) Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.

    (vii) For each item or category of information claimed as confidential, explain with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?

    (viii) Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If you assert that the information is voluntarily submitted information, please explain whether the information is the kind that would customarily not be released to the public.

    (ix) Whether you assert the information as voluntary or involuntary, please address why disclosure of the information would tend to lessen the availability to the EPA of similar information in the future.

    (x) If you believe any information to be (a) trade secret(s), please so state and explain the reason for your belief. Please attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade secret(s).

    (xi) Explain any other issue you deem relevant.

    (2) Identification of claims. If any of the information contained in the answers to the questions listed in paragraph (b)(1) of this section is asserted to be confidential, the submitter must clearly identify the information that is claimed as confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”

    (3) Certification statement for claims. In submitting a claim of confidentiality, a person must certify the truth of the following four statements concerning all information which is claimed as confidential:

    (i) My company has taken reasonable measures to protect the confidentiality of the information.

    (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law.

    (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person.

    (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

    § 710.39 Electronic filing.

    (a) EPA will accept information submitted under this subpart only if submitted in accordance with this section. All information must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, Notices of Activity and any associated information must be generated and completed using the e-NOA software module.

    (b) Obtain instructions for registering in CDX as follows:

    (1) Web site. The CDX Registration User Guide is available at https://www.epa.gov/sites/production/files/documents/cdx_registration_guide_v0_02.pdf. To register in CDX, go to https://cdx.epa.gov and follow the appropriate links.

    (2) Telephone. Contact the EPA CDX Help Desk at 1-888-890-1995.

    (3) Email. Email the EPA CDX Help Desk at [email protected].

    (c) Obtain instructions for using the e-NOA software module as follows:

    (1) Web site. Go to the EPA New Chemicals under the Toxic Substances Control Act Web site at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn and follow the appropriate links.

    (2) Telephone. Contact the EPA TSCA Hotline at 1-202-554-1404.

    (3) Email. Email the EPA TSCA Hotline at [email protected].

    [FR Doc. 2016-31923 Filed 1-12-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [IB Docket No. 98-96; FCC 16-179] 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission) proposes to withdraw as an accounting authority and transition its functions and duties to private accounting authorities. The Commission seeks comment on a transition plan and a timetable to implement an orderly transition to the privatization of the accounts-settlement function.

    DATES:

    Comments due on or before March 14, 2017, and reply comments due on or before April 13, 2017.

    ADDRESSES:

    You may submit comments, identified by IB Docket 98-96, by any of the following methods:

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

    Federal Communications Commission's Web site: http://www.fcc.gov/cgb/ecfs. Follow the instructions for submitting comments.

    People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected] or phone: 202-418-0530 or TTY: 202-418-0432.

    Email: [email protected] Include IB Docket No. 98-96 in the subject line of the message.

    Mail: Commercial overnight mail (other than U.S. Postal Service Express Mail, and Priority Mail, must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. U.S. Postal Service first-class, Express, and Priority mail should be addressed to 445 12th Street SW., Washington, DC 20554.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Dana Shaffer, Office of Managing Director at (202) 418-0832.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Second Further Notice of Proposed Rulemaking (Second FNPRM), FCC 16-179, IB Docket No. 98-96, adopted on December 22, 2016, and released on December 30, 2016. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street SW., Room CY-A257, Portals II, Washington, DC 20554, and may also be purchased from the Commission's copy contractor, BCPI, Inc., Portals II, 445 12th Street SW., Room CY-B402, Washington, DC 20554. Customers may contact BCPI, Inc. via their Web site, http://www.bcpi.com, or call 1-800-378-3160. This document is available in alternative formats (computer diskette, large print, audio record, and braille). Persons with disabilities who need documents in these formats may contact the FCC by email: [email protected] or phone: 202-418-0530 or TTY: 202-418-0432.

    I. Procedural Matters A. Ex Parte Rules—Permit-But-Disclose

    1. The proceeding this Second FNPRM initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules.1 Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    1 47 CFR 1.1200 et seq.

    B. Comment Period and Procedures

    2. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington DC 20554.

    People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

    C. Initial Regulatory Flexibility Analysis

    3. As required by the Regulatory Flexibility Act of 1980 (RFA),2 the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities of the policies and rules proposed in this Second FNPRM. The IRFA is found near the end of this document. We request written public comment on the analysis. Comments must be filed in accordance with the same deadlines as comments filed in response to this Second FNPRM, and must have a separate and distinct heading designating them as responses to the IRFA. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this Second FNPRM, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration.

    2See 5 U.S.C. 603.

    4. Copies to Private Accounting Authorities and Governmental Users. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Second Further Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the current U.S.-certified private accounting authorities: Mackay Communications, Inc., Astrium Services Business Communications Inc., Seven Seas Communications Inc., Omnet, Inc., KFS World Communications dba GLOBE WIRELESS, GMPCS Personal Communications, Inc., ShipCom, L.L.C. (formerly M M R Radio, L.L.C.), Stratos Mobile Networks Inc., Exxon Communications Company, Vizada, Inc., Raytheon Service Co., Telemar USA LLC, MVS USA Inc., A-N-D Group Plc, Selex ES Ltd, Selex ES Ltd, NSSLGlobal, Airtime Billing Department.

    D. Initial Paperwork Reduction Analysis

    5. This document does not contain a proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA, Pub. L. 104-13). In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    II. Introduction

    6. In this Second Further Notice of Proposed Rulemaking (2016 Accounting Authority Second FNPRM), we propose to transition the functions and duties performed by the Commission as an accounting authority to private accounting authorities. In doing so, we seek to revisit findings in the 1999 Report and Order and Further Notice of Proposed Rulemaking (1999 Accounting Authority Order & FNPRM), 3 which included the Commission's decision that it should withdraw as an accounting authority in the maritime mobile and maritime mobile-satellite radio services.4 The Commission tentatively concluded that a three-year transition period following adoption of a Report and Order was appropriate to permit the preparation and implementation of a plan to ensure a smooth, non-disruptive transition to private accounting authorities, and to develop the transition plan.5 Although in that Order the Commission concluded that “the Commission shall cease operating as an accounting authority for settling accounts for maritime mobile, maritime satellite, aircraft,6 and handled terminal radio services,” and that “a transition period is necessary to allow for an orderly transition to a full privatization of the accounts-settlement function,” we stopped short of proscribing a transition plan, instead seeking further comment “on a number of proposals regarding how best to implement this transition.” 7

    3 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services and Withdrawal of the Commission as an Accounting Authority in the Maritime Mobile and the Maritime Mobile-Satellite Radio Services, Report and Order and Further Notice of Proposed Rulemaking, 15 FCC Rcd 20703 (1999) (1999 Accounting Authority Order & FNPRM).

    4Id.

    5Id. at 20717.

    6 The focus of this FNPRM is the effect on maritime communications, as the Commission has not, for several years, settled aeronautical accounts. It is important to note, however, that our withdrawal as accounting authority of last resort would include a cessation in our settling of accounts for maritime mobile, maritime satellite, aircraft, and handled terminal radio services, as we previously concluded.

    7Id.

    7. The completion of a plan based on those comments, however, was subsequently delayed. Thus, no definitive timeline for the transition to implement our decision in the Order to withdraw as accounting authority has been established.

    8. We continue to believe that it is in the public interest for the Commission to withdraw as an accounting authority. Given the passage of time, we now, in this 2016 Accounting Authority Second FNPRM, seek further comment on the appropriate transition plan and period to implement our decision in the 1999 Accounting Authority Order & FNPRM to withdraw as an accounting authority in the maritime mobile and maritime mobile-satellite radio services.

    III. Background

    9. International maritime mobile communications are HF or VHF radio communications between a ship and a coast station operated by the telecommunications operator in the country in which the station is located, and international maritime mobile-satellite communications services are conducted by satellite. Payment for the services provided by the telecommunications operators involves interaction with an entity known as an “accounting authority,” which settles an account between the telecommunications operator and the customer. In practice, the telecommunications operator, the earth or coast station, sends its bill either to the accounting authority that the customer has designated to act for it or to an “accounting authority of last resort,” which, as the name implies, settles accounts for customers that have not designated a particular accounting authority. The function of the accounting authority, also referred to as a “clearinghouse” or “settlement authority,” involves presenting the bill to the customer, accepting payment from the customer, and remitting the collected funds to the telecommunications operator.

    10. Historically, most nations required individual ships to settle their accounts with their telecommunications provider; however, since 1934, the Commission has acted as an accounting authority in the United States, to settle accounts for maritime, aircraft, and hand-held terminal radio services to both private users and other U.S. federal government agencies. Over time, the Commission has reduced its accounting authority or clearinghouse function related to the maritime mobile radio services and the satellite-based services, including aeronautical and hand-held terminals. The primary reason for this reduction is that private accounting authorities provide similar account settlement services for U.S. users. Certification and operation of private accounting authorities are governed under part 3 of our rules, which ensure that qualified applicants are authorized as accounting authorities and that such authorities, once approved, have adequate guidance of the standard of conduct required of them by the Commission. We believe that this process has been working effectively.8 Currently, there are twenty-two entities certified as U.S. private accounting authorities.9

    8See Letter from Bruce Henoch, Inmarsat, to Accounting Authority Certification Office, Federal Communications Commission (dated April 20, 2015); Letter from Robert Swanson, Airbus Defense and Space, to Marlene Dortch, Federal Communications Commission (dated January 30, 2015); Letter from Steven Chernoff, Lukas, Nace, Gutierrez, and Sachs, LLP, to Accounting Authority Certification Officer, Federal Communications Commission (April 15, 2015) (providing inventories of accounting authority settlements).

    9 Some of these private accounting authorities may not currently settle accounts for maritime services; however, our certification does not limit any certified U.S. accounting authority to the settlement of accounts for only one class of service.

    11. When the Commission last considered this matter more than fifteen years ago, it found no public policy reason for the Commission's continued function as an accounting authority,10 and concluded in the Report and Order section of the decision, therefore, that the Commission should withdraw as a clearinghouse for the settlement of accounts in the maritime mobile radio, maritime mobile-satellite, and other satellite-based communications services.11 The Commission tentatively concluded that it should not designate a new accounting authority of last resort,12 and that a three year transition plan was sufficient to ensure a smooth transition.13 The Commission sought further comment on these tentative conclusions.14

    101999 Accounting Authority Order & FNPRM at 20709.

    11Id. at 20723.

    12Id. at 20715.

    13Id. at 20718.

    14Id. at 20715, 20723.

    IV. Discussion

    12. In the Order portion of the 1999 R&O and FNPRM, the Commission announced its decision to withdraw from the accounting authority function. Additionally, it revised section 3.10(e) to make explicit the authorities' obligations not to discriminate,15 grandfathered the accounting authority of EXXON to permit it to continue to settle accounts only for its ships, and provided guidance to allow applicants to amend their pending applications in light of the change to section 3.10(e). In the Second FNPRM, the Commission requested comments on two issues. First, the Commission sought comment on whether to appoint or allow an entity to take over the Commission's function as the accounting authority of last resort, require customers to pre-subscribe to an accounting authority or to designate an accounting authority on every message, or to develop a formula to spread undesignated messages among several private accounting authorities. Second, the Commission tentatively concluded that the appropriate phase-out period was three years following Federal Register publication of a final order, and invited comment.

    15 47 CFR 3.10(e).

    A. Withdrawal by the Commission From the Accounting Authority Function

    13. In the 1999 R&O and FNPRM, the Commission decided to withdraw from performing the functions of an accounting authority, and to leave the settlement of accounts to the private accounting authorities subject to part 3 of our rules. Although the Commission never implemented a transition plan, many users of the Commission's services subsequently have transitioned to one of these accounting authorities. We continue to believe that it is in the public interest for the Commission to withdraw as an accounting authority and seek comment on our proposals to do so below. The function of an accounting authority is not necessarily a governmental function, but can be performed equally well by privately owned entities, subject to Commission oversight under our part 3 rules.16 Since the Commission last visited this issue, U.S. private accounting authorities have continued to succeed in providing these functions.17 We anticipate that our action to step away from the functions of an accounting authority will create further competition for the settlement of maritime and satellite accounts, and may thereby encourage the industry to provide the public with more choices in obtaining settlement of their accounts.

    16 The FCC's withdrawal as an accounting authority will in no way change the rules by which we certify and monitor private entities serving as accounting authorities for maritime mobile and maritime satellite services. See 47 CFR 3.1 et seq.

    17See 1999 R&O and FNPRM, 15 FCC Rcd at 20706-09, paragraphs 7-12; See Letter from Bruce Henoch, Inmarsat, to Accounting Authority Certification Office, Federal Communications Commission (dated April 20, 2015); Letter from Robert Swanson, Airbus Defense and Space, to Marlene Dortch, Federal Communications Commission (dated January 30, 2015); Letter from Steven Chernoff, Lukas, Nace, Gutierrez, and Sachs, LLP, to Accounting Authority Certification Officer, Federal Communications Commission (dated April 15, 2015) (providing inventories of accounting authority settlements).

    14. Since 1999, the number of users relying on the Commission to provide accounting authority services has decreased,18 even as the activity handled by other accounting authorities, in general, appears to have increased in scope. We recognize that an immediate departure of the Commission as an accounting authority will require those U.S. international ship and satellite operators currently handled by the Commission to select an alternative accounting authority. We also believe, unlike in 1999 when we suggested a three-year transition period, that maritime operators are far better prepared to adjust to the departure of the Commission as the accounting authority. First, the Commission possesses the ability to contact current users and thereby their expedite transition. Second, through outreach and coordination with the maritime industry, Commission staff have learned that many of those entities using the Commission's accounting authority services have anticipated the change, and they have initiated a transition process in contracting with other accounting authorities. Consequently, we believe that most maritime mobile satellite users will be able to accommodate this change, and that they will act promptly to select an alternative accounting authority. We therefore, recommend a one year transition period and seek comment on this recommendation.

    18See supra n.5.

    15. We continue to believe that we should not designate a new accounting authority of last resort, but, rather, customers should designate an accounting authority for each call or should presubscribe for the services of an accounting authority.19 We seek further comment on this tentative conclusion.

    19See id. at 20715 (tentatively concluding not to designate a new accounting authority of last resort).

    B. Government Agencies

    16. In the 1999 R&O and FNPRM we acknowledged that the Commission at that time acted as the accounting authority for the maritime and satellite communications of a majority of U.S. governmental agencies.20 At the time, because we anticipated that Government agency users might have special needs that differ from other users, we requested the agencies to address this issue in their comments.21

    20See 1999 R&O and FNPRM, 15 FCC Rcd at 20709, para. 13.

    21See 1999 R&O and FNPRM, 15 FCC Rcd at 20709, para. 13.

    17. In their 1998 comments, the United States Coast Guard urged the Commission to maintain a default accounting authority, provide ample notice to affected users and small vessel organizations, provide a smooth transition process to a new default accounting authority, and ensure the economic impact on small entities is non-significant.22 The National Telecommunications and Information Administration (NTIA), in coordination with the Interdepartment Radio Advisory Committee (which includes the Coast Guard), expressed concern that the Commission's withdrawal might lead to disruption or curtailment of communication services to federal users, as well as increased cost to the taxpayer.23 They requested that the FCC retain its accounting authority, or, in the alternative, noted that most government agencies operate on a three year budget cycle, and asked that the FCC defer termination of its accounting authority responsibility “until an [sic] alternative billing and payment arrangements ensuring uninterrupted service can be established.24 NTIA further urged that the FCC either retain its accounting authority, or designate an authority of last resort that would “not charge more than the Commission currently charges its accounts until users are notified and given a chance to select their own accounting authority or accept the terms offered.” 25

    22 Letter from J.D. Hersey, Jr., Chief, Spectrum Management Division, to Magalie Roman Salas, FCC Secretary, August 21, 1998.

    23See Comments of the National Telecommunications and Information Administration, filed August 24, 1998, at page 2.

    24Id.

    25 Letter from William T. Hatch, Acting Associate Administrator, National Telecommunications and Information Administration, to Magalie Roman Salas, FCC Secretary, October 29, 1998.

    18. We agree that, as part of an effective plan for the Commission to withdraw as an accounting authority, U.S. Government agencies must have in place alternate arrangements upon the Commission's withdrawal to ensure that critical communications are not disrupted. In the more than fifteen years, since our 1999 decision, Commission staff have contacted the various government agencies informing them of the Commission's intent to terminate its accounting authority; as a result, many of these various agencies, have moved to alternative accounting authorities for some or all of their services.26 In light of this trend, and the more than fifteen years impacted entities have had to transition to a new accounting authority, we seek comment on the appropriate time period to complete the Commission's transition from serving as accounting authority for government agencies. Movement of government agencies anticipating our change in function suggests that a transition period shorter than the three-year period previously proposed is appropriate to accommodate these particular changes, including anticipated government budget planning changes. We propose that the transition period for government and non-government entities be the same. We seek comment on whether one year suffices for government agencies to transition to an alternative accounting authority. Alternatively, we invite comment on whether this period should be longer or shorter.

    26 Commission staff have confirmed the removal of many of the terminals once billed to these agencies from the FCC as the accounting authority.

    C. Accounting Authority of Last Resort

    19. The Commission historically has served as the “accounting authority of last resort” for the United States, which resulted in the Commission receiving from foreign telecommunications operators all accounts for which the customer did not designate a specific accounting authority.27 In 1999, we tentatively concluded that we should not designate a new accounting authority of last resort.28 Instead, we found that customers should designate an accounting authority for each call or should presubscribe for the services of an accounting authority.29 We noted, however, that in order to prevent a deleterious effect on safety communications, the Commission must take care to ensure a seamless transition to new accounting authorities.30

    27See 1999 R&O and FNPRM, 15 FCC Rcd at 20715, paragraph 25.

    28Id. at para. 26.

    29Id.

    30Id. at para. 27 (citing Coast Guard Comments at 1).

    20. We continue to believe that, although the functions of an accounting authority of last resort may still be necessary to address infrequent situations where an authority is or cannot be designated due to circumstances beyond the control of the user, it remains the basic responsibility of the user, whether a private or governmental entity, to provide for an accounting authority to handle its calls. However, as we withdraw as an accounting authority, we tentatively conclude, based on the commenters' urging us, in 1998, to either retain our accounting authority or ensure an alternative is in place before withdrawing,31 that it will be necessary to have an alternative arrangement in place that will eliminate the possibility of messages being sent without having an accounting authority necessary to settle accounts. We seek comment on possible approaches to ensure an alternative is in place: (1) Requiring all customers to pre-subscribe to an accounting authority or to designate an accounting authority on every message; (2) developing a formula to spread undesignated messages among several private accounting authorities; and/or (3) appointing through comparative selection one of the private accounting authorities as the new authority of last resort.

    31 Letter from J.D. Hersey, Jr., Chief, Spectrum Management Division, to Magalie Roman Salas, FCC Secretary, August 21, 1998. See, also Comments of the National Telecommunications and Information Administration, filed August 24, 1998, at page 2 and Letter from William T. Hatch, Acting Associate Administrator, National Telecommunications and Information Administration, to Magalie Roman Salas, FCC Secretary, October 29, 1998.

    Table 1—Government Agencies Who Use the Commission as an Accounting Authority Defense Information Systems Agency Department of Agriculture Department of Air Force Department of the Army Department of Commerce Department of Defense—Office of Secretary of Defense Department of Energy Department of Health and Human Services Department of Homeland Security—United States Coast Guard Department of Justice Department of Justice—Federal Bureau of Investigation Department of Justice—U.S. Drug Enforcement Administration Department of the Interior Department of the Navy Department of State Department of Transportation Department of Treasury Department of Veteran Affairs Federal Aviation Administration Federal Emergency Management Agency National Aeronautics and Space Administration National Science Foundation On-Site Inspection Agency U.S. Environmental Protection Agency U.S. General Services Administration United States Information Agency U.S. Postal Service

    21. Given the reduction of reliance on the FCC as an accounting authority and the resulting lower volume of customers 32 who will be affected when we withdraw as accounting authority (see Table 1 above), we tentatively conclude that the best alternative is the first option noted above, to require all customers to pre-subscribe to an accounting authority or to designate an accounting authority on every message. We seek comment on this tentative conclusion as well as the merits of each of the three proposals. For example, is it technically feasible, for U.S. maritime and satellite radio traffic for which no accounting authority is designated and for which the customer is not able or willing to designate an accounting authority on every message, to allow the provider to bill for such traffic through a certified accounting authority of its choice? Is this feasible for a ship-to-shore radiotelephone call made through a foreign coast station? In the alternative, is it feasible to allow public coast stations to designate their own “default” accounting authority in order to send bills to mariners who have not chosen/designated a private accounting authority? 33 Is there a need for the Commission to adopt additional qualifying criteria for an existing accounting authority to serve as a designated accounting authority of last resort? If so, what should the additional criteria be? We also seek comment on any potential enforcement or authority issues that may arise from each of the proposed alternatives for providing an accounting authority of last resort. We also request that commenting parties propose any other viable alternatives that help ensure a smooth transition while relieving the Commission from performing this function.

    32 We note that, for 2016, traffic billed by the FCC as accounting authority to private and/or third parties is exclusively satellite traffic, and ask commenters to address whether that fact, coupled with the potential to allow providers to choose a U.S. accounting authority to bill traffic for which no accounting authority has been designated by the customer, mitigates any concerns regarding a potential gap in service once the FCC withdraws as accounting authority of last resort.

    33 There are few users of maritime public coast stations now due to the closure worldwide of public coast stations; however, ensuring the safety of such users is important. We, therefore, seek comment on what different approaches may be necessary for radio communications via a foreign public coast station versus satellite communications via a mobile satellite communications provider.

    22. We note that withdrawal of the Commission as an accounting authority without an effective transition plan could leave a gap for some U.S. maritime and satellite radio traffic for which no accounting authority is designated. Thus, during any transition period and subsequently, we intend to conduct outreach to make users aware of our decision and their options for ensuring that they continue to receive the services of an accounting authority.

    23. In any event, we believe that an accounting authority, whether selected by the ship, the provider, or a competent default accounting authority, must be in place for distress and safety telecommunications on board ships, particularly when a maritime mobile satellite system is being used. We therefore seek comment on whether, if we decline to designate an accounting authority, we should designate an accounting authority of last resort specifically for Global Maritime Distress and Safety System (GMDSS) mobile satellite communications.34 Although maritime distress and certain safety communications are provided at no charge, other types of safety communications do incur a charge. If neither the designated nor a competent default accounting authority exists, then foreign earth stations may have no way to bill the U.S. satellite user. As a result, the user may, through no fault of its own, find that its ship earth station has been barred for non-payment of bills. We understand that, although a ship mobile device has been “barred” from the network provider (e.g., foreign earth station), a ship can still initiate a ship-to-shore distress alert. In such a situation, however, it could not communicate further with the Coast Guard, even if those further communications are safety related. A ship on the high seas that has been barred from such communications may be a danger to itself and others, as well as a potential problem for the Coast Guard. We agree with commenters that any change in accounting authorities must ensure that critical communications are not disrupted. First, during any transition period that we adopt, we will notify users of GMDSS mobile satellite communications of our decision to withdraw as an accounting authority and of their need to select a new accounting authority. Moreover, we seek comment, not only on designation of an accounting authority of last resort for all users, including GMDSS mobile satellite and GMDSS maritime mobile communications, but also on whether there are other options to ensure that the Commission's withdrawal as accounting authority would not cause ship stations to become barred because they were unaware that they need to choose a new accounting authority.

    34 INMARSAT continues to be the only worldwide maritime mobile satellite system providing these safety communications. INMARSAT will commission a new ship terminal intended to carry distress and safety communications only if the application designates an accounting authority.

    24. We also invite comment whether advancements in technology and the business community could reduce the burdens associated with our proposal to withdraw as accounting authority of last resort. Technological changes may mitigate concerns that stem from the fact that the Commission's service as the accounting authority of last resort has made it unnecessary for users to be aware that they may select a private accounting authority. We can promptly notify users which relied on the Commission as accounting authority of last resort for the need to select an alternative accounting authority. In doing so, we seek comment on notifying users from the past seven years. Alternatively, should we make the period of users which relied on the Commission as carrier of last resort shorter or longer? In addition, the Commission could review on a periodic basis the plan it adopts to ensure that the need for accounting authority services is being met, including distress and safety communications on board ships, and determine whether further modifications are appropriate.

    Initial Regulatory Flexibility Analysis

    1. As required by the Regulatory Flexibility Act (RFA),35 the Commission prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in this Second Further Notice of Proposed Rulemaking (Second FNPRM). Written comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadline for comments on this Second FNPRM. The Commission will send a copy of this Second FNPRM, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).36 In addition, this Second FNPRM and IRFA (or summaries thereof) will be published in the Federal Register.37

    35 5 U.S.C. 603. The RFA, 5 U.S.C. 601-612 has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 847 (1996).

    36 5 U.S.C. 603(a).

    37Id.

    A. Need for and Objectives of, the Notice

    2. In this Second Further Notice of Proposed Rulemaking (Second FNPRM), we propose to transition the functions and duties performed by the Commission as an accounting authority to private accounting authorities. In doing so, we seek to revisit findings in the 1999 Report and Order and Further Notice of Proposed Rulemaking (1999 Accounting Authority Order & FNPRM),38 which included the Commission's decision that it should withdraw as an accounting authority in the maritime mobile and maritime mobile-satellite radio services. The Commission tentatively concluded that a three-year transition period following adoption of a Report and Order was appropriate to permit the preparation and implementation of a plan to ensure a smooth, non-disruptive transition to private accounting authorities, and to develop the transition plan.39 The completion of the plan was subsequently delayed and until now, the proceeding has been inactive.

    38 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services and Withdrawal of the Commission as an Accounting Authority in the Maritime Mobile and the Maritime Mobile-Satellite Radio Services, Report and Order and Further Notice of Proposed Rulemaking, 15 FCC Rcd 20703 (1999) (1999 R&O and FNPRM). The Commission as part of its Further Notice of Proposed Rulemaking sought comments to be filed by comments August 23, 1999, and replies by September 8, 1999.

    39 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services and Withdrawal of the Commission as an Accounting Authority in the Maritime Mobile and the Maritime Mobile-Satellite Radio Services, Order, 14 FCC Rcd 13504 (1999). The order extended the deadline for filing comments to October 25, 1999 and reply comments to November 29, 1999. The extension of time was made to allow for a fuller record.

    3. In this 2016 Accounting Authority Second FNPRM, we now seek comment on whether the findings in the 1999 Accounting Authority Order & FNPRM remain in the public interest. As such, we seek input on whether the Commission should withdraw as an accounting authority in the maritime mobile and maritime mobile-satellite radio services. In doing so, we seek information on whether interested parties continue to support the Commission's 1999 decision and if not, why that decision should be revisited or amended.

    B. Legal Basis

    4. This Second Further Notice of Proposed Rulemaking is adopted pursuant to Sections 1, 4(i), 4(j), 11, 201-205, 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 161, 201-205, and 303(r).

    C. Description and Estimate of the Number of Small Entities To Which the Rules Will Apply

    5. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted.40 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 41 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.42 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.43

    40 5 U.S.C. 603(b)(3).

    41 5 U.S.C. 601(6).

    42 5 U.S.C. 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.”

    43 15 U.S.C. 632.

    6. The rules proposed in this Second Notice of Proposed Rulemaking apply to entities providing account-settlement services for maritime mobile and maritime mobile-satellite radio services. Small businesses may be able to become accounting clearinghouses, as the establishment of such a function does not appear to involve high implementation costs. The rules also apply to existing maritime mobile and maritime satellite customers who have not presubscribed to a U.S. accounting authority and are, therefore, billed through the FCC as the accounting authority of last resort. An estimated thirty small entities have been billed for traffic by the FCC as an accounting authority in 2016. The proposed action in this Second Notice of Proposed Rulemaking does not appear to involve high implementation costs for such entities.

    D. Reporting, Recordkeeping, and Other Compliance Requirements

    7. The proposed action in this Second Further Notice of Proposed Rulemaking would affect those entities already certified and those applying for certification as a private accounting authority in the maritime mobile, maritime mobile-satellite, aeronautical and other satellite-based radio services. The amended rule, however, merely clarifies an existing requirement imposed on accounting authorities. It, therefore, does not alter the reporting, recordkeeping or other compliance requirements of certified accounting authorities.

    E. Steps Taken To Minimize Significant Economic Impact on Small Entities and Significant Alternatives Considered

    8. As stated above, we propose to transition the functions and duties performed by the Commission as an accounting authority to private accounting authorities. In doing so, we seek to revisit findings in 1999 Accounting Authority Order & FNPRM),44 which included the Commission's decision that it should withdraw as an accounting authority in the maritime mobile and maritime mobile-satellite radio services. We seek comment on the impact of our proposals on small entities and on any possible alternatives that could minimize the impact of our rules on small entities.

    44 1998 Biennial Regulatory Review—Review of Accounts Settlement in the Maritime Mobile and Maritime Mobile-Satellite Radio Services and Withdrawal of the Commission as an Accounting Authority in the Maritime Mobile and the Maritime Mobile-Satellite Radio Services, Report and Order and Further Notice of Proposed Rulemaking, 15 FCC Rcd 20703 (1999) (1999 R&O and FNPRM). The Commission as part of its Further Notice of Proposed Rulemaking sought comments to be filed by comments August 23, 1999, and replies by September 8, 1999.

    F. Federal Rules That Overlap, Duplicate or Conflict With These Pr