Federal Register Vol. 81, No.3,

Federal Register Volume 81, Issue 3 (January 6, 2016)

Page Range371-718
FR Document

81_FR_3
Current View
Page and SubjectPDF
81 FR 717 - National Stalking Awareness Month, 2016PDF
81 FR 715 - National Slavery and Human Trafficking Prevention Month, 2016PDF
81 FR 711 - National Mentoring Month, 2016PDF
81 FR 515 - Sunshine Act Meeting; National Science BoardPDF
81 FR 470 - Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use ActPDF
81 FR 470 - Environmental Management Site-Specific Advisory Board, Savannah River SitePDF
81 FR 569 - Funding Availability for Small Shipyard Grant Program; Application DeadlinePDF
81 FR 488 - Notice of the General Services Administration's Labor-Management Relations Council MeetingPDF
81 FR 481 - Registration Review Interim Decisions; Notice of AvailabilityPDF
81 FR 478 - Registration Review; Draft Human Health and Ecological Risk Assessments; Notice of AvailabilityPDF
81 FR 559 - Notifications to the Congress of Proposed Commercial Export LicensesPDF
81 FR 484 - Proposed Information Collection Request; Comment Request; Title I of the Marine Protection, Research, and Sanctuaries ActPDF
81 FR 517 - Privacy Act of 1974; Systems of RecordsPDF
81 FR 380 - Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Nebraska; Sewage Sludge IncineratorsPDF
81 FR 414 - Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Nebraska; Sewage Sludge IncineratorsPDF
81 FR 461 - Chlorinated Isocyanurates From Spain and the People's Republic of China: Final Results of the Expedited Sunset Reviews of the Antidumping Duty OrdersPDF
81 FR 410 - Determining Which Structures, Systems, Components and Functions are Important to SafetyPDF
81 FR 516 - Request To Amend License To Import Radioactive WastePDF
81 FR 461 - Rural Utilities Service Guarantees for Bonds and Notes Issued for Electrification or Telephone PurposesPDF
81 FR 516 - Request To Amend License To Export Radioactive WastePDF
81 FR 515 - Request To Amend a License To Import Radioactive WastePDF
81 FR 371 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1PDF
81 FR 412 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1PDF
81 FR 572 - Proposed Collection; Comment Request for Notice 2009-52PDF
81 FR 459 - National Advisory Committee for Implementation of the National Forest System Land Management Planning RulePDF
81 FR 459 - Information Collection; Fire & Aviation Management Medical Qualifications ProgramPDF
81 FR 487 - Order Declares Wypoint Telecom, Inc.'s International Section 214 Authorization TerminatedPDF
81 FR 512 - Notice of Public Meeting; Western Montana Resource Advisory CouncilPDF
81 FR 513 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-ASTM International StandardsPDF
81 FR 512 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on Mechanical Stratigraphy and Natural Deformation in Eagle Ford Formation and Equivalent Boquillas Formation, South-Central and West Texas (Eagle Ford II)PDF
81 FR 513 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Chemical & Biological Defense ConsortiumPDF
81 FR 465 - 36(b)(1) Arms Sales NotificationPDF
81 FR 378 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture SystemPDF
81 FR 491 - Vaccines and Related Biological Products Advisory Committee; Notice of MeetingPDF
81 FR 489 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of NoticePDF
81 FR 489 - Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for CommentsPDF
81 FR 568 - Petition for Exemption; Summary of Petition Received; Daedalus Drone Services, LLCPDF
81 FR 492 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
81 FR 493 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 492 - National Institute of Mental Health; Notice of Closed MeetingsPDF
81 FR 493 - National Institute of Mental Health; Notice of Closed MeetingPDF
81 FR 492 - National Institute on Drug Abuse Notice of Closed MeetingPDF
81 FR 463 - 36(b)(1) Arms Sales NotificationPDF
81 FR 514 - National Advisory Committee for Labor Provisions of U.S. Free Trade Agreements; Notice of Open MeetingPDF
81 FR 511 - Notice of Intent To Prepare an Environmental Impact Statement for the Prairie Band Potawatomi Nation's Proposed Trust Acquisition and Gaming Facility Project, DeKalb County, IllinoisPDF
81 FR 498 - Notice of Revocation of Customs Brokers' LicensesPDF
81 FR 496 - Notice of Issuance of Final Determination Concerning Certain Multifunction Printer ProductsPDF
81 FR 469 - Board of Regents, Uniformed Services University of the Health Sciences; Notice of Federal Advisory Committee MeetingPDF
81 FR 396 - Updating Competitive Bidding RulesPDF
81 FR 488 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 486 - Information Collections Being Submitted for Review and Approval to the Office of Management and BudgetPDF
81 FR 485 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 471 - Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
81 FR 471 - Notice of Commission Staff AttendancePDF
81 FR 472 - RE Barren Ridge 1 LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 477 - AltaGas Pomona Energy Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 473 - Blythe Solar II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 471 - Greeley Energy Facility, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 472 - GDF SUEZ Energy Resources NA, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 474 - ENGIE Retail, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 474 - ENGIE Portfolio Management, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 474 - Supplemental Notice of Technical ConferencePDF
81 FR 476 - Startrans IO, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 476 - National Fuel Gas Supply Corporation; Notice of Request Under Blanket AuthorizationPDF
81 FR 473 - Combined Notice of Filings #3PDF
81 FR 475 - Combined Notice of Filings #2PDF
81 FR 477 - Combined Notice of Filings #1PDF
81 FR 494 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal AgenciesPDF
81 FR 495 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 549 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 1060PDF
81 FR 541 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Order ExposurePDF
81 FR 535 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Add a Fee To Be Charged To Transfer Agents of DTC-Eligible Issues Subject to a Corporate ActionPDF
81 FR 536 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting New Rules To Reflect the Implementation of Pillar, the Exchange's New Trading Technology PlatformPDF
81 FR 525 - Submission for OMB Review; Comment RequestPDF
81 FR 548 - Submission for OMB Review; Comment RequestPDF
81 FR 554 - Submission for OMB Review; Comment RequestPDF
81 FR 540 - Submission for OMB Review; Comment RequestPDF
81 FR 541 - Proposed Collection; Comment RequestPDF
81 FR 555 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify the Fees for Managed Data SolutionsPDF
81 FR 544 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify the Fees for Managed Data SolutionsPDF
81 FR 526 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of RiverFront Dynamic Unconstrained Income ETF and RiverFront Dynamic Core Income ETF Under NYSE Arca Equities Rule 8.600PDF
81 FR 551 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify the Fees for Managed Data SolutionsPDF
81 FR 468 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee MeetingPDF
81 FR 514 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”)PDF
81 FR 566 - Public HearingPDF
81 FR 523 - FY 2015 Annual Compliance ReportPDF
81 FR 573 - Loan Guaranty: Specially Adapted Housing Assistive Technology Grant ProgramPDF
81 FR 509 - 60-Day Notice of Proposed Information Collection: Indian Housing Block Grant (IHBG) Program ReportingPDF
81 FR 510 - 60-Day Notice of Proposed Information Collection: Public Housing Operating Subsidy-AppealsPDF
81 FR 509 - 60-Day Notice of Proposed Information Collection: Public Housing Operating Fund Program: Operating Budget and Related FormPDF
81 FR 463 - Marine Mammals; File No. 18824PDF
81 FR 462 - Endangered Species; File No. 19716PDF
81 FR 382 - Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS)PDF
81 FR 415 - National Pollutant Discharge Elimination System (NPDES) Municipal Separate Storm Sewer System General Permit RemandPDF
81 FR 579 - Energy Conservation Program: Energy Conservation Standards for Ceiling Fan Light KitsPDF
81 FR 398 - Supplemental Nutrition Assistance Program (SNAP) Photo Electronic Benefit Transfer (EBT) Card Implementation RequirementsPDF
81 FR 504 - Ideation and Prototype Multi-Phase Prize CompetitionPDF
81 FR 435 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Alexander Archipelago Wolf as an Endangered or Threatened SpeciesPDF
81 FR 635 - Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap ParticipantsPDF

Issue

81 3 Wednesday, January 6, 2016 Contents Agriculture Agriculture Department See

Food and Nutrition Service

See

Forest Service

See

Rural Utilities Service

Antitrust Division Antitrust Division NOTICES Changes under National Cooperative Research and Production Act: ASTM International Standards, 513-514 2015-33268 Cooperative Research Group on Mechanical Stratigraphy and Natural Deformation in Eagle Ford Formation and Equivalent Boquillas Formation, South-Central and West Texas, Eagle Ford II, 512-513 2015-33267 National Chemical and Biological Defense Consortium, 513 2015-33266 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission RULES Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants, 636-709 2015-32320 Defense Department Defense Department NOTICES Arms Sales, 463-468 2015-33251 2015-33265 Meetings: Board of Regents, Uniformed Services University of the Health Sciences, 469-470 2015-33243 Judicial Proceedings since Fiscal Year 2012 Amendments Panel, 468-469 2015-33202 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Program: Standards for Ceiling Fan Light Kits, 580-633 2015-33071 NOTICES Filing of Self-Certification of Coal Capability under the Powerplant and Industrial Fuel Use Act, 470-471 2015-33317 Meetings: Environmental Management Site-Specific Advisory Board, Savannah River Site, 470 2015-33316
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Nebraska -- Designated Facilities and Pollutants; Sewage Sludge Incinerators, 380-382 2015-33292 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Nebraska -- Designated Facilities and Pollutants; Sewage Sludge Incinerators, 414-415 2015-33291 National Pollutant Discharge Elimination System: Municipal Separate Storm Sewer System General Permit Remand Rule, 415-435 2015-33174 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Title I of the Marine Protection, Research, and Sanctuaries Act, 484-485 2015-33295 Human Health and Ecological Risk Assessments Draft; Registration Review, 478-481 2015-33298 Registration Review Interim Decisions, 481-484 2015-33300 Federal Aviation Federal Aviation Administration NOTICES Petitions for Exemptions; Summaries, 568-569 2015-33259 Federal Communications Federal Communications Commission RULES Competitive Bidding, 396-397 2015-33241 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 485-488 2015-33238 2015-33239 2015-33240 Terminations of Authority: Wypoint Telecom, Inc., 487 2015-33271 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 473, 475-478 2015-33223 2015-33224 2015-33225 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: AltaGas Pomona Energy Inc., 477 2015-33234 Blythe Solar II, LLC, 473-474 2015-33233 ENGIE Portfolio Management, LLC, 474 2015-33229 ENGIE Retail, LLC, 474 2015-33230 GDF SUEZ Energy Resources NA, Inc., 472-473 2015-33231 Greeley Energy Facility, LLC, 471 2015-33232 RE Barren Ridge 1, LLC, 472 2015-33235 Meetings: Commission Technical Conference, 474-475 2015-33228 Preliminary Permit Applications: Energy Resources USA, Inc., 471 2015-33237 Refund Effective Dates: Startrans IO, LLC, 476 2015-33227 Requests under Blanket Authorization: National Fuel Gas Supply Corp., 476-477 2015-33226 Staff Attendances, 471-472 2015-33236 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: 12-Month Finding on a Petition to List the Alexander Archipelago Wolf, 435-458 2015-32473 Food and Drug Food and Drug Administration RULES Medical Devices: Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System, 378-380 2015-33264 NOTICES Meetings: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, 489 2015-33262 Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data, 489-491 2015-33261 Vaccines and Related Biological Products Advisory Committee, 491-492 2015-33263 Food and Nutrition Food and Nutrition Service PROPOSED RULES Supplemental Nutrition Assistance Program: Photo Electronic Benefit Transfer Card Implementation Requirements, 398-410 2015-33053 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Fire and Aviation Management Medical Qualifications Program, 459-461 2015-33273 Meetings: National Advisory Committee for Implementation of the National Forest System Land Management Planning Rule, 459 2015-33275 General Services General Services Administration NOTICES Meetings: Labor-Management Relations Council, 488-489 2015-33302 Health and Human Health and Human Services Department See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

RULES Health Insurance Portability and Accountability Act Privacy Rule and the National Instant Criminal Background Check System, 382-396 2015-33181
Homeland Homeland Security Department See

U.S. Customs and Border Protection

NOTICES Ideation and Prototype Multi-Phase Prize Competition, 504-508 2015-32744
Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Housing Block Grant Program Reporting, 509-510 2015-33187 Public Housing Operating Fund Program; Operating Budget and Related Form, 509 2015-33185 Public Housing Operating Subsidy; Appeals, 510-511 2015-33186 Indian Affairs Indian Affairs Bureau NOTICES Environmental Impact Statements; Availability, etc.: Prairie Band Potawatomi Nation's Proposed Trust Acquisition and Gaming Facility Project, DeKalb County, IL, 511-512 2015-33247 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:, 572-573 2015-33276 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Chlorinated Isocyanurates from Spain and the People's Republic of China, 461-462 2015-33290 Justice Department Justice Department See

Antitrust Division

NOTICES Proposed Consent Decrees under CERCLA, 514 2015-33194
Labor Department Labor Department NOTICES Meetings: National Advisory Committee for Labor Provisions of U.S. Free Trade Agreements, 514-515 2015-33248 Land Land Management Bureau NOTICES Meetings: Western Montana Resource Advisory Council, 512 2015-33270 Maritime Maritime Administration NOTICES Funding Availability: Small Shipyard Grant Program; Application Deadline, 569-572 2015-33315 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 493 2015-33255 National Institute of Mental Health, 492-494 2015-33253 2015-33254 National Institute of Neurological Disorders and Stroke, 492 2015-33256 National Institute on Drug Abuse, 492 2015-33252 National Oceanic National Oceanic and Atmospheric Administration NOTICES Permits: Endangered Species; File No. 19716, 462-463 2015-33182 Marine Mammals; File No. 18824, 463 2015-33183 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 515 2016-00027 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1, 371-378 2015-33280 PROPOSED RULES Determining Which Structures, Systems, Components and Functions are Important to Safety, 410-412 2015-33287 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1, 412-414 2015-33279 NOTICES Requests to Export Nuclear Waste, 516-517 2015-33284 Requests to Import Nuclear Waste, 515-516 2015-33282 2015-33286 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Privacy Act; Systems of Records, 517-523 2015-33294 Postal Regulatory Postal Regulatory Commission NOTICES FY 2015 Annual Compliance Report, 523-525 2015-33192 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Mentoring Month (Proc. 9385), 711-714 2016-00114 National Slavery and Human Trafficking Prevention Month (Proc. 9386), 715-716 2016-00116 National Stalking Awareness Month (Proc. 9387), 717-718 2016-00136 Rural Utilities Rural Utilities Service NOTICES Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes, 461 2015-33285 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 525, 540-541, 548-549, 554-555 2015-33210 2015-33211 2015-33212 2015-33213 2015-33214 Self-Regulatory Organizations; Proposed Rule Changes: Depository Trust Co., 535-536 2015-33218 NASDAQ OMX BX, Inc., 555-559 2015-33209 NASDAQ OMX PHLX, LLC, 541-544, 549-554 2015-33206 2015-33219 2015-33220 NASDAQ Stock Market, LLC, 544-548 2015-33208 New York Stock Exchange, LLC, 536-540 2015-33217 NYSE Arca, Inc., 526-535 2015-33207 State Department State Department NOTICES Notifications to the Congress of Proposed Commercial Export Licenses, 559-566 2015-33297 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 495-496 2015-33221 Minimum Standards to Engage in Urine Drug Testing for Federal Agencies: Certified Laboratories and Instrumented Initial Testing Facilities, 494-495 2015-33222 Susquehanna Susquehanna River Basin Commission NOTICES Public Hearings, 566-568 2015-33193 Transportation Department Transportation Department See

Federal Aviation Administration

See

Maritime Administration

Treasury Treasury Department See

Internal Revenue Service

Customs U.S. Customs and Border Protection NOTICES Customs Brokers' Licenses; Revocations, 498-504 2015-33246 Final Determinations of Country of Origin: Certain Multifunction Printer Products, 496-498 2015-33245 Veteran Affairs Veterans Affairs Department NOTICES Loan Guarantees: Specially Adapted Housing Assistive Technology Grant Program, 573-577 2015-33190 Separate Parts In This Issue Part II Energy Department, 580-633 2015-33071 Part III Commodity Futures Trading Commission, 636-709 2015-32320 Part IV Presidential Documents, 711-718 2016-00114 2016-00116 2016-00136 Reader Aids

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

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

81 3 Wednesday, January 6, 2016 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0156] RIN 3150-AJ63 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1 AGENCY:

Nuclear Regulatory Commission.

ACTION:

Direct final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Holtec International (“Holtec,” or “the applicant”) HI-STORM 100 Cask System listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 9, Revision 1, to Certificate of Compliance (CoC) No. 1014. Amendment No. 9, Revision 1, changes cooling time limits for thimble plug devices (TPDs), removes certain testing requirements for the fabrication of Metamic HT neutron-absorbing structural material, and reduces certain minimum guaranteed values (MGV) used in bounding calculations for this material. Amendment No. 9, Revision 1, also changes fuel definitions to classify certain boiling water reactor (BWR) fuel within specified guidelines as undamaged fuel.

DATES:

The direct final rule is effective March 21, 2016, unless significant adverse comments are received by February 5, 2016. If the direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only of comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

ADDRESSES:

You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0156. Address questions about NRC dockets to Carol Gallagher, telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-5175, email: [email protected]; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Obtaining Information and Submitting Comments II. Procedural Background III. Background IV. Discussion of Changes V. Voluntary Consensus Standards VI. Agreement State Compatibility VII. Plain Writing VIII. Environmental Assessment and Final Finding of No Significant Environmental Impact IX. Paperwork Reduction Act Statement X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality XIII. Congressional Review Act XIV. Availability of Document I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2015-0156 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0156.

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

Please include Docket ID NRC-2015-0156 in the subject line of your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Procedural Background

This rule is limited to the changes contained in Amendment No. 9, Revision 1, to CoC No. 1014 and does not include other aspects of the Holtec HI-STORM 100 Cask System design. The NRC is using the “direct final rule” procedure to issue this amendment because it represents a limited and routine change to an existing CoC and is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on March 21, 2016. If the NRC receives significant adverse comments on this direct final rule by February 5, 2016, the NRC will publish a Federal Register notice withdrawing the direct final rule, and will address the comments in a subsequent Federal Register notice for a final rule based on the companion proposed rule published in the Proposed Rule section of this issue of the Federal Register. Absent the need for significant modifications to the proposed revisions that would require republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications.

For detailed instructions on filing comments, please see the ADDRESSES section of this document.

III. Background

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule to add a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule (65 FR 25241; May 1, 2000) that approved the HI-STORM 100 Cask System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214, “List of approved spent fuel storage casks,” as CoC No. 1014. Most recently, the NRC issued a final rule effective on March 11, 2014 (78 FR 78165), that approved the HI-STORM 100 Cask System design amendment subject to this rulemaking and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1014, Amendment No. 9.

IV. Discussion of Changes

On July 1, 2014, Holtec submitted a request to the NRC to revise CoC No. 1014 to supersede Amendment 9 with Amendment 9, Revision 1. Amendment No. 9, Revision 1, changes cooling time limits for TPDs, removes certain testing requirements for the fabrication of Metamic HT, and reduces certain MGVs used in bounding calculations for this material. Amendment No. 9, Revision 1, also changes fuel definitions to classify certain boiling water reactor (BWR) fuel within specified guidelines as undamaged fuel. The changes to the CoC and Technical Specifications (TS) Appendices are identified with revisions bars in the margin of each document.

As a revision, the CoC and its associated TS will supersede the previous version of the CoC No. 1014, Amendment No. 9 CoC and its TSs in their entirety. A revision in lieu of a new amendment is justified on the grounds that:

• Equipment for CoC No. 1014, Amendment No. 9, cask systems has been placed in service by several general licensees, all of whom were made aware of Holtec's revision request and supported it;

• No new canisters are being requested to be added to CoC No. 1014, Amendment No. 9, cask systems;

• No new systems, components, or structures are requested to be added to CoC No. 1014, Amendment No. 9, cask systems;

• The requested changes have minor field and administrative implementation impacts on general licensees; and

• The requested changes are applicable to CoC No. 1014, Amendment No. 9, in their entirety.

Each of the applicant's proposed changes is discussed below.

1. Reduced Cooling Time Limit for TPDS

The TPDs are a form of non-fuel hardware inserted into guide tubes used in some pressurized water reactor (PWR) fuel assemblies and made radioactive by exposure to neutrons during reactor operation. Supporting its proposal to reduce the cooling time limits for TPDs, the applicant noted that TPDs are not considered in any of the thermal analyses of CoC No. 1014, Amendment No. 9, so that in order to comply with this amendment, general licensees must perform an evaluation under 10 CFR 72.212 to ensure that maximum fuel storage decay heat limits are met. The applicant stated that, currently, cooling times for TPDs exposed to typical fuel burnups in a reactor core are long, preventing many TPDs from being stored in the dry multi-purpose canisters (MPC) that contain spent fuel and non-fuel hardware with “activation products,” or components or constituents made radioactive by exposure to neutrons in the reactor core. The applicant proposed to reduce the required cooling times so that general license users can have greater flexibility to store a larger population of TPDs.

The principal activation product from the irradiation of TPDs in a reactor core is Cobalt-60 (Co-60), which has a half-life (the time it takes to lose half its radioactivity) of 5 years. The applicant calculated that the Co-60 source for a TPD with a five-year cooling time after exposure to a fuel burnup of 63,000 megawatt-days per metric ton of uranium (MWD/MTU) or less is 141 curies. The maximum Co-60 activity of TPDs is 240 curies. The applicant selected 141 curies Co-60 as the design basis Co-60 activity for each TPD, so that any TPD can be stored in a HI-STORM MPC so long as the TPD has a cooling time of 5 years or greater after a burnup of 63,000 MWD/MTU or less, as required by the TSs.

The applicant also calculated the dose rates from a HI-STORM 100 overpack with an MPC for BWR and for PWR fuels using allowable burnup and cooling times from the proposed Revision 1 to CoC No. 1014, Amendment No. 9. These calculated dose rates were less than the allowable values in the TSs for the currently-approved Amendment No. 9.

The NRC staff reviewed the applicant's proposed revisions to its final safety analysis report (FSAR) and finds that the proposed change would have no impact on a fuel rod's internal pressure or cladding temperatures. The NRC staff finds the storing of TPDs to be acceptable because, as non-fuel components, they present no risk of rupturing and releasing fission products, fission product gases, or any other material detrimental to the internals of the cask. Nor would the storage of TPDs prevent the retrieval of spent fuel from a cask. General licensees will, however, continue to be required under 72.212 to evaluate and ensure that cell heat loads per canister remain below the applicable limits as listed in the FSAR and TSs prior to loading.

2. Removing or Revising Certain Metamic-HT Fabrication Testing Requirements

Metamic-HT is a neutron-absorbing structural material used for internal components of MPCs, which hold spent fuel assemblies and other radioactive fuel components inside storage casks. The applicant proposed changing Metamic-HT fabrication testing requirements to: Remove testing using a 1-inch collimated neutron beam; remove Charpy V-notch and lateral expansion testing; remove thermal conductivity testing; revise testing requirements for fuel basket welds; change re-testing criteria when a component fails to meet an MGV by requiring only the failed property to be re-tested (not all MGVs); and add the ability to conduct 100% testing of an MGV property within a lot if a sample within the lot fails re-testing. According to the applicant, these changes are to improve Metamic-HT testing, or ease undue burden, because some testing requirements were overly conservative and created a lengthy testing process, while others did not affect the safety analysis.

The requirement for the use of a 1-inch neutron beam is based on Interim Staff Guidance (ISG)-23, “Application of ASTM Standard Practice C1671-07 when performing technical reviews of spent fuel storage and transportation packaging licensing actions.” ISG-23 concludes that a beam between 1 cm and 2.54 cm is acceptable for qualification and acceptance testing of neutron absorbing materials. The ISG also states, however, that “a visual inspection should be conducted on all neutron absorbing materials intended for service,” and that as part of that visual inspection, “it is important to ensure that there are no defects that might lead to problems in service; such as delaminations or cracks that could appear on clad neutron absorbing materials.” The staff finds that in this instance, a visual inspection of all neutron-absorbing materials intended for service, along with other fabrication testing measures called for in ISG-23, such as minimum plate thickness testing, will provide adequate assurance against significant defects in Metamic HT without the need for neutron beam testing.

The Charpy V-notch test is a measure of a given material's toughness under impact loading to study temperature-dependent ductile-to-brittle transitions. As temperature decreases, a metal's ability to absorb the energy of an impact—its ductility—decreases, and at some temperature, its ductility may suddenly drop almost to zero. This sharp transition to brittleness is essentially unidentified in metals with a face-centered cubic (FCC) crystal structure, however, and Metamic-HT is an aluminum composite with an FCC-based metal matrix. The staff therefore concludes that the Charpy V-notch test is not necessary for Metamic-HT.

Proposing to remove the thermal conductivity testing requirement for Metamic-HT during fabrication, the applicant noted that there is little variability in this material's thermal conductivity when fabricated according to the manufacturing manual.

The NRC staff evaluated the applicant's proposal and finds that the thermal conductivity of Metamic-HT is stable for normal operating temperatures (200 °C to 500 °C), so that removal of this testing requirement would have no impact on any of the previously approved NRC staff evaluations. The proposed change is therefore considered acceptable.

The applicant also intends to employ a new qualified welding process called Friction Stir Welding (FSW), for external basket joints. Allowing the use of FSW of the Metamic HT basket does not change the safety basis as evaluated by the staff in HI-STORM 100, Amendment No. 9, with respect to basket structural performance. Since the basket corners utilize the same welded joint configuration specified in amendment No. 9 and prior amendments, the primary consideration is that of weld process and qualification, rather than structural performance of the weld itself.

Based on its review of the application, the staff determined that the methods used to qualify the weld joint were sufficiently robust to demonstrate a structural performance comparable to the welding method described in previous amendments. The loading conditions and the fully supported boundary conditions of the peripheral basket panels result in calculated joint stresses below their full capacity. The staff therefore concludes that this margin accounts for any differences in welding procedures, should they arise in the future. The staff's conclusions in this regard only apply to the basket corner welds and shim arrangement defined by this revision.

3. Changing Minimum Guaranteed Values for Metamic-HT Analyses

Using the guidance of the American Society of Mechanical Engineers (ASME) Section II, Mandatory Appendix 5, “Guideline on the Approval of New Materials Under the ASME Boiler and Pressure Vessel Code,” Holtec determined the mechanical properties of Metamic-HT at ambient and various other higher and lower temperatures. It then analyzed its test data using statistical methods to determine minimum, average, and mean values of the material's structural properties. In addition, the applicant established a design value MGV for each of the various properties. An MGV is an arbitrary value for any given property below the lowest measured value from the test data. The MGV is then demonstrated or guaranteed to be exceeded for every manufactured lot of Metamic HT through lot testing.

The MGVs for Metamic-HT are used in calculations to demonstrate that structural components made with this material will satisfy engineering requirements, such as stress or deflection limits to ensure acceptable hardness of the component in service. Using MGV values produces a bounding calculation for any given engineering requirement.

To support its proposal for reducing some of these MGVs, Holtec used differing MGV values in structural calculations for developing stress/strain curves from finite element analysis, a method of computing displacements, stresses, and strains at defined points along the length, width, or within a cross-section of a given component.

Holtec's calculations determined that a positive margin of safety for basket performance criteria remains even with an average reduction of approximately 10 percent in MGVs for material yield stress, ultimate strength, and Young's modulus, a measure of a material's elasticity (ability to resume its original dimensions) under lengthwise tension or compression. The applicant also reported a calculated reduction of 20 percent of the MGV for area criteria measured during a tensile test. Positive margins remain in the criteria for peak stress, maximum deflection, and crack propagation. These minimum values are guaranteed to be met by the imposition of a sampling test plan based on the standards for critical service parts. The applicant also proposed to add the ability to conduct 100 percent testing of an MGV property within a lot if a sample fails re-testing.

This is the same change Holtec made to the HI-STORM 100 Flood/Wind (FW) Multipurpose MPC Storage System, CoC—No. 1032 using an acceptable evaluation that complied with 10 CFR 72.48, “Changes, tests, and experiments.” The NRC staff reviewed these results and finds the proposed changes acceptable, because an adequate safety margin remains for basket performance criteria even with the reduced MGVs.

4. New Spent Fuel Definitions

Holtec proposed to add new definitions for “undamaged fuel assembly,” and “repaired/reconstituted fuel assembly” to provide further clarity for cask system users and greater consistency with NRC guidance for classifying fuel. In addition, the applicant says that these definitions will help some BWR users who have older, low-enriched, channeled BWR fuel with potential cladding defects that these users want to load for dry storage without prior placement in a damaged fuel container. A discussion of the definition changes follows.

4.a. Definition of “Undamaged Fuel Assembly”

The applicant proposed the new definition for “undamaged fuel assembly” to read: “a) a fuel assembly without known or suspected cladding defects greater than pinhole leaks or hairline cracks and that can be handled by normal means; or b) a BWR fuel assembly with an intact channel and a maximum average initial enrichment of 3.3 percent U-235 by weight (wt-percent) that has no known or suspected grossly breached spent fuel rods and can be handled by normal means.” Under this definition, an “undamaged fuel assembly” may be a repaired and reconstituted fuel assembly.

The applicant noted that with the currently approved definition, inspections to classify the fuel cladding of channeled BWR fuel as undamaged may be prohibitively costly and/or unjustifiable for maintaining worker radiation exposures as low as reasonably achievable. Holtec also noted, however, that a particular subset of older, less-enriched fuel has been shown to remain subcritical even with significant cladding damage and rearrangement of the fuel rods inside the channel. If this fuel does not have gross cladding breaches (defined as breaches larger than pinhole leaks or hairline cracks), can be handled by normal means, and has enrichment less than or equal to 3.3 weight-percent, Holtec asserted, the fuel does not require a damaged fuel container and is not limited to certain basket locations in the HI-STORM 100 Cask System's MPC model 68 designed for BWR fuel.

Under the NRC's ISG-1, “Classifying the Condition of Spent Nuclear Fuel for Interim Storage and Transportation Based on Function,” undamaged fuel may contain some cladding defects if it is safeguarded from high temperatures and/or oxidation and does not contain gross cladding breaches. Because HI-STORM 100 Cask System MPCs are backfilled with helium and shown to keep peak fuel cladding temperatures below the limits in ISG 11, “Cladding Considerations for the Transportation and Storage of Spent Fuel,” the staff has determined that this fuel is protected during storage from temperatures that would lead to gross ruptures. Also, as long as the fuel meets ISG-1 and does not already contain a gross breach, the staff concludes that there are no means for the release of fuel fragments during storage. In addition, fuel that contains an assembly defect may be considered undamaged under ISG-1 if the fuel can still meet fuel-specific and system-related functions. The NRC staff will therefore also consider repaired and/or reconstituted assemblies meeting these functions as undamaged under the applicant's proposed revised definition.

4.b. Definition of “Repaired/Reconstituted Fuel Assembly”

As part of Amendment No. 9, Revision 1, Holtec proposed a new definition for a repaired or reconstituted fuel assembly as one that “contains dummy fuel rod(s) that displaces [sic] an amount of water greater than or equal to the original fuel rod(s) and/or which contains structural repairs so it can be handled by normal means.” The applicant proposed this definition for clarification purposes and as a subset of the definition of “undamaged fuel.” It is a common practice to repair a nuclear fuel assembly by removing a damaged fuel rod and replacing it with a dummy rod to allow the assembly to be returned to the reactor core. The NRC has approved this use in specific applications, and has provided guidance to 10 CFR part 50 licensees to ensure that the repair is performed within the requirements of the licensee's 10 CFR part 50 TSs and does not create an unreviewed safety question. Because a repaired/reconstituted fuel assembly is restored to a condition within the bounds of its original design and safety analysis, the NRC staff finds this type of assembly to be a subset of “undamaged fuel,” and concludes that the applicant's proposed definition is consistent with ISG-1 and therefore acceptable.

5. Conclusions

As documented in its Safety Evaluation Report (SER), the NRC staff performed a detailed safety evaluation of this proposed CoC amendment request. There are no significant changes to cask design requirements in the proposed CoC amendment. Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control. If there is no loss of containment, shielding, or criticality control, the environmental impacts would be not be significant. This amendment does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposures or offsite dose rates from the implementation of Amendment No. 9, Revision 1, would remain well within 10 CFR part 20 radiation safety limits. Therefore, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment (EA) supporting the May 1, 2000, final rule approving the original HI-STORM 100 Cask System CoC. There will be no significant changes in the types or amounts of any effluent released, no significant increase in individual or cumulative radiation exposures, and no significant increase in the potential for or consequences of radiological accidents.

This direct final rule revises the HI-STORM 100 Cask System listing in 10 CFR 72.214 by adding Amendment No. 9, Revision 1, to CoC No. 1014. The revision consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified in the SER.

The revised HI-STORM 100 Cask System design, when used under the conditions specified in the CoC, the TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into HI-STORM 100 Cask Systems that meet the criteria of Amendment No. 9, Revision 1, to CoC No. 1014 under 10 CFR 72.212.

V. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the Holtec HI-STORM 100 Cask System design listed in § 72.214, “List of Approved Spent Fuel Storage Casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

VI. Agreement State Compatibility

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements using mechanisms consistent with the particular State's administrative procedure laws, but classifying an NRC rule as Category “NRC” does not confer regulatory authority on the State.

VII. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

VIII. Environmental Assessment and Finding of No Significant Environmental Impact A. The Action

The action is to amend 10 CFR 72.214 to revise the Holtec HI-STORM 100 Cask System listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 9, Revision 1, to CoC No. 1014. Under the National Environmental Policy Act (NEPA) of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement (EIS) is not required. The NRC has made a finding of no significant impact on the basis of this EA.

B. The Need for the Action

The need for this direct final rule is to allow users of HI-STORM 100 Cask Systems under Amendment 9, Revision 1, to load for dry storage under a general license some PWR fuel assemblies with shorter cooling times for TPDs, and some BWR fuel assemblies that would otherwise have to remain in spent fuel storage pools. Specifically, Amendment No. 9, Revision 1, changes cooling time limits for TPDs, removes certain testing requirements for the fabrication of Metamic HT neutron-absorbing structural material, and reduces certain MGVs used in bounding calculations for this material. Amendment No. 9, Revision 1, also changes fuel definitions to classify certain BWR fuel within specified guidelines as undamaged fuel, which could avert the worker radiation exposures that would otherwise be necessary to put this fuel into containers before loading them into MPCs.

C. Environmental Impacts of the Action

On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the EA for the 1990 final rule. The EA for this Amendment No. 9, Revision 1, tiers off of that EA for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under NEPA. As stated in the Council on Environmental Quality's 40 Frequently Asked Questions, the tiering process makes each EIS/EA of greater use and meaning to the public as the plan or program develops without duplication of the analysis prepared for the previous impact statement.

Holtec HI-STORM 100 Cask Systems are designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of confinement, shielding, and criticality control. If there is no loss of confinement, shielding, or criticality control, the environmental impacts would be insignificant. This revision does not reflect a significant change in design or fabrication of the cask. There are no significant changes to cask design requirements in the proposed CoC revision. In addition, because there are no significant design or process changes, any resulting occupational exposures or offsite doses from the implementation of Amendment No. 9, Revision 1, would remain well within 10 CFR part 20 radiation protection limits. Therefore, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that differ significantly from the environmental impacts evaluated in the EA supporting the July 18, 1990, final rule. There will be no significant change in the types or amounts of any effluent released, no significant increase in individual or cumulative radiation exposures, and no significant increase in the potential for or consequences of radiological accidents. The NRC staff documented these safety findings in the SER.

D. Alternative to the Action

The alternative to this action is to deny approval of Amendment No. 9, Revision 1, and end the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent fuel into a HI-STORM 100 Cask System in accordance with the changes described in proposed Amendment No. 9, Revision 1, would have to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, each separate exemption request, thereby increasing the administrative burden on the NRC and the costs to each licensee. The environmental impacts of this no-action alternative would therefore be the same as or more than those for the action itself.

E. Alternative Use of Resources

Approval of Amendment No. 9, Revision 1, to CoC No. 1014 would result in no irreversible commitments of resources.

F. Agencies and Persons Contacted

No agencies or persons outside the NRC were contacted in connection with the preparation of this EA.

G. Finding of No Significant Impact

The environmental impacts of the action have been reviewed as required by the NRC's 10 CFR part 51 regulations. Based on the foregoing EA, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an EIS for this direct final rule is not necessary.

IX. Paperwork Reduction Act Statement

This rule does not contain any information collection requirements, and is therefore not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number.

X. Regulatory Flexibility Certification

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec. These entities do not fall within the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

XI. Regulatory Analysis

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is provided in 10 CFR 72.214. On May 1, 2000 (65 FR 25241), the NRC issued an amendment to 10 CFR part 72 that approved the HI-STORM 100 Cask System design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214.

On July 1, 2014, Holtec submitted an application to revise the HI-STORM 100 Cask System as described in Section III, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No. 9, Revision 1, and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into a HI-STORM 100 Cask System under the changes described in Amendment No. 9, Revision 1, to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of the direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the EA, the direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

XII. Backfitting and Issue Finality

For the reasons set forth below, the NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule, and therefore, a backfit analysis is not required.

This direct final rule revises CoC No. 1014, Amendment No. 9, for the Holtec HI-STORM 100 Cask System, as currently listed in 10 CFR 72.214, “List of Approved Spent Fuel Storage Casks.” Amendment No. 9, Revision 1, reduces cooling time limits for TPDs in some fuel assemblies, removes a thermal conductivity testing requirement for the fabrication of Metamic HT neutron-absorbing structural material, and reduces the MGVs used in bounding calculations for this material. Amendment No. 9, Revision 1, also changes fuel definitions to classify certain BWR fuel within specified guidelines as undamaged fuel.

According to the certificate holder, casks have been manufactured under Amendment No. 9, the subject of this revision. Although Holtec (applicant, certificate holder) has manufactured some casks under the existing CoC No. 1014, Amendment No. 9, that is being revised by this direct final rule, Holtec, as the certificate holder, is not subject to backfitting protection under 10 CFR 72.62. Moreover, Holtec requested the change and requested to apply it to the existing casks manufactured under Amendment No. 9. Therefore, even if the certificate holder were deemed to be an entity protected from backfitting, this request represents a voluntary change and is not backfitting for Holtec.

Under 10 CFR 72.62, general licensees are entities that are protected from backfitting, and in this instance, Holtec has provided casks under CoC No. 1014, Amendment No. 9, to general licensees at the Braidwood, Byron, Farley, Hatch, and Vogtle reactor facilities. General licensees are required, pursuant to 10 CFR 72.212, to ensure that each cask conforms to the terms, conditions, and specifications of a CoC, and that each cask can be safely used at the specific site in question. Because the casks purchased and delivered under CoC No. 1014 Amendment No. 9, must now be evaluated under 10 CFR 72.212 consistent with the revisions in CoC No. 1014 Amendment 9, Revision 1, this change in the evaluation method and criteria constitutes a change in a procedure required to operate an independent spent fuel storage installation (ISFSI) and, therefore, would constitute backfitting under 10 CFR 72.62(a)(2).

In this instance, however, the affected general licensees voluntarily indicated their willingness to comply with the revised CoC. In order to provide these general licensees adequate time to implement the revised CoC, it now also incorporates a condition that provides general licensees 180 days from the effective date of Revision 1 to implement the changes authorized by this revision and to perform the required evaluation. Therefore, although the general licensees are entities that are protected from backfitting, this request represents a voluntary change and is not backfitting for the general licensees.

In addition, the changes in CoC No. 1014, Amendment 9, Revision 1, do not apply to casks manufactured to the initial CoC 1014 or subsequent Amendments of CoC 1014. These changes therefore have no effect on current ISFSI general licensees using casks manufactured to the initial CoC 1014 or other amendments of CoC No. 1014. Thus, the NRC approval of CoC No. 1014, Amendment No. 9, Revision 1, does not constitute backfitting for general licensed users of the Holtec HI-STORM 100 Cask System that were manufactured to the initial CoC No. 1014 or to other amendments of CoC No. 1014, under 10 CFR 72.62, 10 CFR 50.109(a)(1), or the issue finality provisions in 10 CFR part 52.

For these reasons, no backfit analysis or additional documentation addressing the issue finality criteria in 10 CFR part 52 has been prepared by the NRC.

XIII. Congressional Review Act

The Office of Management and Budget has not found this to be a major rule as defined in the Congressional Review Act.

XIV. Availability of Documents

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

Document ADAMS
  • accession No.
  • Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A941 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A ML15156A956 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B ML15156A970 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A-100U ML15156A982 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B-100U ML15156B000 Preliminary CoC 1014 Amendment No. 9, Revision 1 Safety Evaluation Report ML15156B011 Request for Revision Application dated July 1, 2014 ML14182A486 Notification by general licensees of voluntary acceptance of Revision 1 requirements dated August 28, 2015 ML15240A233 Interim Staff Guidance 1, Classifying the Condition of Spent Nuclear Fuel for Interim Storage and Transportation Based on Function ML071420268 Interim Staff Guidance 11, Revision 3, Cladding Considerations for the Transportation and Storage of Spent Fuel ML033230335 Interim Staff Guidance 23, Application of ASTM Standard Practice C1671-07 when performing technical reviews of spent fuel storage and transportation packaging licensing actions ML103130171

    The NRC may post materials related to this document, including public comments, on the Federal rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0156. The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0156); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC adopts the following amendments to 10 CFR part 72:

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

    Section 72.44(g) also issued under Nuclear Waste Policy Act secs. 142(b) and 148(c), (d) (42 U.S.C. 10162(b), 10168(c), (d)).

    Section 72.46 also issued under Atomic Energy Act sec. 189 (42 U.S.C. 2239); Nuclear Waste Policy Act sec. 134 (42 U.S.C. 10154).

    Section 72.96(d) also issued under Nuclear Waste Policy Act sec. 145(g) (42 U.S.C. 10165(g)).

    Subpart J also issued under Nuclear Waste Policy Act secs. 117(a), 141(h) (42 U.S.C. 10137(a), 10161(h)).

    Subpart K also issued under sec. 218(a) (42 U.S.C. 10198).

    2. In § 72.214, Certificate of Compliance No. 1014 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1014.

    Initial Certificate Effective Date: May 31, 2000.

    Amendment Number 1 Effective Date: July 15, 2002.

    Amendment Number 2 Effective Date: June 7, 2005.

    Amendment Number 3 Effective Date: May 29, 2007.

    Amendment Number 4 Effective Date: January 8, 2008.

    Amendment Number 5 Effective Date: July 14, 2008.

    Amendment Number 6 Effective Date: August 17, 2009.

    Amendment Number 7 Effective Date: December 28, 2009.

    Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170).

    Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.

    xxxx

    Amendment Number 9, Revision 1, Effective Date: March 21, 2016.

    Safety Analysis Report (SAR) Submitted by: Holtec International.

    SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

    Docket Number: 72-1014.

    Certificate Expiration Date: May 31, 2020.

    Model Number: HI-STORM 100.

    Dated at Rockville, Maryland, this 22nd day of December, 2015.

    For the Nuclear Regulatory Commission.

    Glenn M. Tracy, Acting, Executive Director for Operations.
    [FR Doc. 2015-33280 Filed 1-5-16; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2015-N-4408] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective January 6, 2015. The classification was applicable on November 2, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Jason Roberts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6400, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&CAct, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.

    On February 23, 2015, INVO Bioscience, submitted a request for classification of the INVOcellTM Intravaginal Culture System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on November 2, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 884.6165 (21 CFR 884.6165).

    Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an intravaginal culture system will need to comply with the special controls named in this final order. The device is assigned the generic name intravaginal culture system, and it is identified as a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization (IVF) or intravaginal culture procedures.

    FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1:

    Table 1—Intravaginal Culture System Risks and Mitigation Measures Identified risks Mitigation measures Damage to gametes and/or embryos or disruption of the IVF process Nonclinical performance testing.
  • Shelf life testing.
  • Clinical testing.
  • Sterilization validation.
  • Labeling.
  • Patient injury (e.g., hypersensitivity, toxicity, abrasion, discomfort) Nonclinical performance testing.
  • Shelf life testing.
  • Biocompatibility.
  • Clinical testing.
  • Sterilization validation.
  • Labeling.
  • Infection Sterilization validation.
  • Reprocessing validation.
  • Nonclinical performance testing.
  • Shelf life testing.
  • Clinical testing.
  • Labeling.
  • Transfer of incorrect embryos to patient Labeling.

    FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.

    Intravaginal culture system devices are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the intravaginal culture system they intend to market.

    II. Environmental Impact, No Significant Impact

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

    III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

    IV. Reference

    The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov.

    1. DEN150008: De novo Request per 513(f)(2) from INVO Bioscience, dated February 23, 2015. List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows:

    PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES 1. The authority citation for 21 CFR part 884 continues to read as follows: Authority:

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

    2. Add § 884.6165 to subpart G to read as follows:
    § 884.6165 Intravaginal culture system.

    (a) Identification. An intravaginal culture system is a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.

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

    (1) Clinical performance testing must demonstrate the following:

    (i) Comfort and retention of the intravaginal culture device;

    (ii) Adverse vaginal tissue reactions associated with intravaginal culture;

    (iii) Maximum number of gametes and/or embryos that can be placed in a device; and

    (iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes.

    (2) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

    (i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage;

    (ii) Endotoxin testing on gamete and embryo-contacting components of the device;

    (iii) Cleaning and disinfection validation of reusable device components;

    (iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation period and subsequent embryo extraction; and

    (v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period.

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

    (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.

    (5) Shelf life testing must demonstrate that the device maintains its performance characteristics and the packaging of device components labeled as sterile maintain integrity and sterility for the duration of the shelf life.

    (6) Labeling for the device must include:

    (i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events;

    (ii) Validated methods and instructions for reprocessing of reusable components;

    (iii) The maximum number of gametes or embryos that can be loaded into the device;

    (iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture; and

    (v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk (e.g., antibiotics) and to support continued embryonic development over the intravaginal culture period.

    (7) Patient labeling must be provided and must include:

    (i) Relevant warnings, precautions, and adverse effects and complications;

    (ii) Information on how to use the device;

    (iii) The risks and benefits associated with the use of the device; and

    (iv) A summary of the principal clinical device effectiveness results.

    Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-33264 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 62 [EPA-R07-OAR-2015-0733; FRL-9941-06-Region 7] Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Nebraska; Sewage Sludge Incinerators AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking direct final action to approve the Clean Air Act (CAA) section 111(d)/129 negative declaration for the state of Nebraska, for existing sewage sludge incinerator (SSI) units. This negative declaration certifies that existing SSI units subject to sections 111(d) and 129 of the CAA do not exist within the jurisdiction of Nebraska. EPA is accepting the negative declaration in accordance with the requirements of the CAA.

    DATES:

    This direct final rule will be effective March 7, 2016, without further notice, unless EPA receives adverse comment by February 5, 2016. If EPA receives adverse comment, we will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0733, to http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Paula Higbee, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7028 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:

    I. Background II. Analysis of State Submittal III. Statutory and Executive Order Reviews I. Background

    The CAA requires that state regulatory agencies implement the emission guidelines and compliance times using a state plan developed under sections 111(d) and 129 of the CAA. The general provisions for the submittal and approval of state plans are codified in 40 CFR part 60, subpart B and 40 CFR part 62, subpart A. Section 111(d) establishes general requirements and procedures on state plan submittals for the control of designated pollutants. Section 129 requires emission guidelines to be promulgated for all categories of solid waste incineration units, including SSI units. Section 129 mandates that all plan requirements be at least as protective and restrictive as the promulgated emission guidelines. This includes fixed final compliance dates, fixed compliance schedules, and Title V permitting requirements for all affected sources. Section 129 also requires that state plans be submitted to EPA within one year after EPA's promulgation of the emission guidelines and compliance times.

    States have options other than submitting a state plan in order to fulfill their obligations under CAA sections 111(d) and 129. If a State does not have any existing Sewage Sludge Incineration (SSI) units for the relevant emissions guidelines, a letter can be submitted certifying that no such units exist within the State (i.e., negative declaration) in lieu of a state plan. The negative declaration exempts the State from the requirements of subpart B that would otherwise require the submittal of a CAA section 111(d)/129 plan.

    On March 21, 2011 (76 FR 15372), the EPA established emission guidelines and compliance times for existing SSI units. The emission guidelines and compliance times are codified at 40 CFR 60, Subpart MMMM. In order to fulfill obligations under CAA sections 111(d) and 129, NDEQ submitted a negative declaration letter to EPA on December 6, 2012. The submittal of this declaration exempts NDEQ from the requirement to submit a state plan for existing SSI units.

    II. Analysis of State Submittal

    In this Direct Final action, EPA is amending part 62 to reflect receipt of the negative declaration letter from the NDEQ, certifying that there are no existing SSI units subject to 40 CFR part 60, subpart MMMM, in accordance with Section 111(d) of the CAA. If a designated facility (i.e., existing SSI unit) is later found within NDEQ's jurisdiction after publication of this Federal Register action, then the overlooked facility will become subject to the requirements of the Federal plan for that designated facility, including the compliance schedule. The Federal plan will no longer apply, if we subsequently receive and approve the 111(d) plan from the jurisdiction with the overlooked facility. EPA is publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this Federal Register, we are publishing a separate document that will serve as the proposed rule to approve the negative declaration if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in any subsequent final rule based on the proposed rule.

    III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This action is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing section 111(d)/129 plan submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a section 111(d)/129 plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a section 111(d)/129 plan submission, to use VCS in place of a section 111(d)/129 plan submission that otherwise satisfies the provisions of the Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 7, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving Nebraska's section 111(d)/129 plan revision for SSI sources may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

    List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Reporting and recordkeeping requirements, Sewage sludge incinerators.

    Dated: December 23, 2015. Mark Hague, Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 62 as set forth below:

    PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS 1. The authority citation for part 62 continues to read as follows: Authority:

    42 U.S.C. et seq.

    Subpart CC—Nebraska
    2. Subpart CC is amended by adding an undesignated center heading and § 62.6917 to read as follows: Air Emissions Standards of Performance for New Sewage Sludge Incinerators
    § 62.6917 Identification of plan—negative declaration.

    Letter from the Nebraska Department of Environmental Quality received December 6, 2012, certifying that there are no Sewage Sludge Incinerator units subject to 40 CFR part 60, subpart MMMM.

    [FR Doc. 2015-33292 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 164 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS) AGENCY:

    Office for Civil Rights, Department of Health and Human Services.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Health and Human Services (HHS or “the Department”) is issuing this final rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving a firearm. The NICS is a national system maintained by the Federal Bureau of Investigation (FBI) to conduct background checks on persons who may be disqualified from receiving firearms based on Federally prohibited categories or State law. Among the persons subject to the Federal mental health prohibitor established under the Gun Control Act of 1968 and implementing regulations issued by the Department of Justice (DOJ) are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence or mental illness, incompetency, condition, or disease. Under this final rule, only covered entities with lawful authority to make the adjudications or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes, are permitted to disclose the information needed for these purposes. The disclosure is restricted to limited demographic and certain other information needed for NICS purposes. The rule specifically prohibits the disclosure of diagnostic or clinical information, from medical records or other sources, and any mental health information beyond the indication that the individual is subject to the Federal mental health prohibitor.

    DATES:

    Effective date: This final rule is effective on February 5, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Andra Wicks, 202-205-2292.

    SUPPLEMENTARY INFORMATION: I. Background

    On January 16, 2013, President Barack Obama announced 23 executive actions aimed at curbing gun violence across the nation. Those actions include efforts by the Federal government to strengthen the national background check system, and a specific commitment to “[a]ddress unnecessary legal barriers, particularly relating to the Health Insurance Portability and Accountability Act, that may prevent States from making information available to the background check system.” The National Instant Criminal Background Check System (NICS) is the system used to determine whether a potential firearms recipient is statutorily prohibited from possessing or receiving a firearm. The Department proposed, and now finalizes, a modification to the HIPAA Privacy Rule to permit certain covered entities to disclose to the NICS the identities of persons who are not allowed to possess or receive a firearm because they are subject to the Federal mental health prohibitor.

    The National Instant Criminal Background Check System (NICS)

    The Brady Handgun Violence Prevention Act of 1993, Public Law 103-159 (Brady Gun Law), and its implementing regulations, are designed to prevent the transfer of firearms by licensed dealers to individuals who are not allowed to possess or receive them as a result of restrictions contained in either the Gun Control Act of 1968, as amended (Title 18, United States Code, Chapter 44), or State law. The Gun Control Act identifies several categories (known as “prohibitors”) of individuals 1 who are prohibited from engaging in the shipment, transport, receipt, or possession of firearms, including convicted felons and fugitives. Most relevant for the purposes of this rule is the Federal mental health prohibitor, which, pursuant to Department of Justice (DOJ) regulations, applies to individuals who have been involuntarily committed to a mental institution, for reasons such as mental illness or drug use; 2 found incompetent to stand trial or not guilty by reason of insanity; or otherwise determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or unable to manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease.3 4

    1 See 18 U.S.C. 922(g) and (n) and implementing regulations at 27 CFR 478.11 and 27 CFR 478.32.

    2 The regulation, at 27 CFR 478.11, defines “Committed to a mental institution” as a formal commitment to the institution by a court or other lawful authority. The term does not apply to a person voluntarily admitted to a mental institution or in a mental institution merely for observation.

    3 The term used in the statute is “adjudicated as a mental defective. The term includes a finding of insanity in a criminal case, and a finding of incompetence to stand trial or a finding of not guilty by reason of lack of mental responsibility pursuant to the Uniform Code of Military Justice. 27 CFR 478.11.

    4 This rule refers to the involuntary commitments and other applicable adjudications as, collectively, “adjudications that make an individual subject to the Federal mental health prohibitor.”

    The Brady Gun Law established the NICS to help enforce these prohibitions, as well as State law prohibitions on the possession or receipt of firearms.5 The NICS Index, a database administered by the Federal Bureau of Investigation (FBI), collects and maintains certain identifying information about individuals who are subject to one or more Federal prohibitors and thus who are ineligible to purchase firearms. As of 2012, the NICS Index also contains information on persons who are subject to State law prohibitions on the possession or receipt of firearms.6 The minimum information required in a NICS Index record consists of: The name of the ineligible individual; the date of birth; sex; and codes indicating the applicable prohibitor, the submitting entity, and the agency record supporting the prohibition (e.g., an order for involuntary commitment). For individuals subject to the Federal mental health prohibitor, only the fact that the individual is subject to that prohibitor is submitted to the NICS; underlying diagnoses, treatment records, and other identifiable health information are not provided to or maintained by the NICS. A NICS background check queries the NICS Index and certain other national databases 7 to determine whether a prospective buyer's identifying information matches any prohibiting records contained in the databases. The NICS Index can be accessed only for the limited purposes authorized by regulation (see 28 CFR 25.6(j)) and cannot be used for other purposes, including general law enforcement activities.

    5 See Public Law 103-159, 18 U.S.C. 921-925, and implementing regulations at 28 CFR 25.1 through 25.11 (establishing NICS information system specifications and processes) and 27 CFR part 478 (establishing requirements and prohibitions for commerce in firearms and ammunition, including requirements related to conducting NICS background checks); and 42 U.S.C. 3759(b) (allocating a percentage of certain DOJ funds for State reporting of NICS data).

    6 See Statement Before the Senate Judiciary Committee, Subcommittee on Crime and Terrorism at a hearing entitled, “THE FIX GUN CHECKS ACT: BETTER STATE AND FEDERAL COMPLIANCE, SMARTER ENFORCEMENT” (November 15, 2011), by David Cuthbertson, Assistant Director, Criminal Justice Information Services Division, Federal Bureau of Investigation. Testimony available at: http://www.justice.gov/ola/testimony/112-1/11-15-11-fbi-cuthbertson-testimony-re-the-fix-gun-checks-act.pdf. We note also that State law may be more restrictive than Federal law in some cases.

    7 The other databases include the Interstate Identification Index, which contains criminal history record information; and the National Crime Information Center, which includes, e.g., information on persons subject to civil protection orders and arrest warrants. Additional information is available at, http://www.fbi.gov/about-us/cjis/nics/general-information/nics-overview.

    The potential transfer of a firearm from a Federal Firearms Licensee (FFL) to a prospective buyer proceeds as follows: First, the prospective buyer is required to provide personal information on a Firearms Transaction Record (ATF Form 4473). Unless the prospective buyer has documentation that he or she qualifies for an exception to the NICS background check requirement under 18 U.S.C. 922(t)(3),8 the FFL contacts the NICS—electronically, by telephone, or through a State level point of contact—and provides certain identifying information about the prospective buyer from ATF Form 4473.9

    8 These exceptions are listed in the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) regulation at 27 CFR 478.102(d). For example, a NICS check would not be required where the potential recipient of a firearm has presented a valid State permit or license, provided conditions at 27 CFR 478.102(d)(1) are met.

    9 The form collects the prospective buyer's name; demographic information such as address, place and date of birth, gender, citizenship, race and ethnicity; and “yes” or “no” answers to questions about the person's criminal history and other potential prohibitors. The form is available at ­http://www.atf.gov/forms/download/atf-f-4473-1.pdf.

    The FFL then receives a response that the prospective firearm transfer may proceed or is delayed. The transfer is delayed if the prospective buyer's information matches a record contained in one of the databases reviewed. If there is a match, a NICS examiner reviews the record to determine whether the information it contains is, in fact, prohibiting, and then either: (1) If the record does not contain prohibiting information, advises the FFL to proceed with the transaction; (2) if the record does contain prohibiting information, denies the transaction (due to ineligibility); or (3) if it is unclear based solely on the existing information in the record whether it is prohibiting, delays the transaction pending further research.10 The NICS examiner does not disclose the reason for the determination to the FFL (e.g., the FFL would not learn that the individual was ineligible due to the Federal mental health prohibitor). In case of a delay, if the NICS examiner does not provide a final instruction to the FFL within three business days of the initial background check request, the FFL may proceed with the transaction.11

    10 For example, a “delay” response may mean that further research is required because potentially prohibitive criteria exist, but the matched records are incomplete, See Federal Bureau of Investigation (FBI) Fact Sheet at: www.fbi.gov/about-us/cjis/nice/general-information/fact-sheet.

    11 Some States have waiting periods that also must be complied with before a firearm may be transferred, regardless of whether a proceed response from NICS is received by the FFL within three business days.

    Although FFLs are required in most cases to request a background check through the NICS before transferring a firearm to a prospective buyer,12 Federal law does not require State agencies to report to the NICS the identities of individuals who are prohibited from purchasing firearms under either Federal or State prohibitors, and not all States report complete information to the NICS or the databases checked by it. Following the shooting at Virginia Tech University in 2007, and other tragedies involving the illegal use of firearms, Congress enacted the NICS Improvement Amendments Act (NIAA) of 2007, Public Law 110-180. Among other provisions, the NIAA requires Federal agencies to make accessible to the NICS the identities of individuals known by the agencies to be subject to one or more prohibitors, and it authorizes incentive grants for States to provide such information when it is in their possession.13 In addition, some States have enacted legislation requiring the reporting of the identities of ineligible individuals to databases accessible to the NICS or to a State level repository responsible for submitting information to the relevant databases.

    12 See 27 CFR 478.102. Exceptions to this requirement are referenced in FN 8 above, and listed in the regulation at 27 CFR 478.102(d).

    13 Eligibility for these grants is limited to States that have implemented a “relief from disabilities” program for individuals who are prohibited from possessing or receiving firearms for mental health reasons. Such programs must provide that a State court, board, commission, or other lawful authority shall grant the relief if, based on the circumstances regarding the disabilities and the person's record and reputation, the person is not likely to pose a danger to public safety, and granting the relief would not be contrary to the public interest. See Public Law 110-180, Section 105.

    States generally report criminal history information to the other relevant databases that are checked by the NICS; however, many States continue to report little if any information concerning individuals subject to the Federal mental health prohibitor (or the other Federal prohibitors) to the NICS Index.14 As a result, the NICS does not have access to complete information about all individuals who are subject to one or more of the Federal prohibited categories or who are prohibited from possessing or receiving firearms under State law.

    14 Federal law does not require States to submit reports to any of the three databases (the NICS Index, the III, and NCIC) accessed during a NICS Check.

    The HIPAA Privacy Rule and NICS Reporting

    The Privacy Rule, promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Title II, Subtitle F—Administrative Simplification, Public Law 104-191, establishes federal protections to ensure the privacy and security of protected health information (PHI) and establishes an array of individual rights with respect to one's own health information. HIPAA applies to covered entities, which include health plans, health care clearinghouses, and health care providers that conduct certain standard transactions (such as billing insurance) electronically. HIPAA covered entities may only use and disclose PHI with the individual's written authorization, or as otherwise expressly permitted or required by the HIPAA Privacy Rule.

    The Privacy Rule seeks to balance individuals' privacy interests with important public policy goals including public health and safety. In doing so, the Privacy Rule allows, subject to certain conditions and limitations, uses and disclosures of PHI without individuals' authorization for certain law enforcement purposes, to avert a serious threat to health or safety, and where required by State or other law, among other purposes.15

    15 See 45 CFR 164.512.

    As stated above, individuals who are subject to the Federal mental health prohibitor are ineligible to purchase a firearm because they have been “committed to a mental institution” or “adjudicated as a mental defective.” 16 DOJ regulations define these categories to include persons who have been involuntarily committed to a mental institution for reasons such as mental illness or drug use; have been found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or unable to manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. In many cases, these records are not subject to HIPAA. Records of individuals adjudicated as incompetent to stand trial, or not guilty by reason of insanity, originate with entities in the criminal justice system, and these entities are not HIPAA covered entities. Likewise, involuntary civil commitments usually are made by court order, and thus, records of such formal commitments typically originate with entities in the justice system. In addition, many adjudications determining that individuals are a danger to themselves or others, or are incapable of managing their own affairs, occur through a legal process in the court system.

    16 See 18 U.S.C. 922(g)(4).

    However, because of the variety of State laws, there may be State agencies, boards, commissions, or other lawful authorities outside the court system that are involved in some involuntary commitments or mental health adjudications that make an individual subject to the Federal mental health prohibitor. Moreover, we understand that some States have designated repositories to collect and report to the NICS the identities of individuals subject to the Federal mental health prohibitor. We believe that certain of these lawful authorities or repositories also may be HIPAA covered entities (e.g., a State health agency may be a covered entity).

    As we described in the NPRM, where the record of an involuntary commitment or mental health adjudication originates with a HIPAA covered entity, or the HIPAA covered entity is the State repository for such records, there are two ways in which covered entities can currently report to the NICS (without the individual's authorization). First, a covered entity can disclose the relevant information to the NICS where a State has enacted a law that requires (and does not merely authorize) such reporting.17 Second, where a State has not enacted such a law, a HIPAA covered entity that performs both health care and non-health care functions (e.g., NICS reporting) could become a hybrid entity under HIPAA so that the Privacy Rule applies only to its health care functions. A covered entity can achieve hybrid entity status by designating its health care components as separate from other components, documenting the designation, and implementing policies and procedures to prevent unauthorized access to PHI by the entity's non-covered components.18 Under these circumstances, the covered entity can report prohibitor information through its non-HIPAA covered NICS reporting unit without restriction under the Privacy Rule. These provisions remain in effect and are not altered by the amendments to the Privacy Rule that we issue today.

    17 See 45 CFR 164.512(a). Note that disclosures for NICS purposes would not fall under the Privacy Rule's provisions permitting disclosures for law enforcement purposes (which apply to specific law enforcement inquiries) or to avert a serious threat to health or safety (which require an imminent threat of harm). See 45 CFR 164.512(f) and (j).

    18 See 45 CFR 164.103, 164.105; 67 FR 53182 (8/14/2002).

    However, despite these avenues for disclosure, many States still were not reporting to the NICS essential information on persons prohibited from possessing firearms for reasons related to mental health; concerns were raised that the HIPAA Privacy Rule's restrictions on covered entities' disclosures of PHI might be preventing certain States from reporting the relevant information to the NICS.

    In addition, in July 2012, the U.S. Government Accountability Office (GAO) reported to Congress on the results of a survey of six States that it had assessed as part of a performance audit of the progress made by DOJ and the States in implementing the NIAA.19 In the report, the GAO wrote that “officials from 3 of the 6 States we reviewed said that the absence of explicit State-level statutory authority to share mental health records was an impediment to making such records available to NICS.” 20 The report also stated that, although the number of records provided by the States to the NICS had increased by 800 percent between 2004 and 2011, this increase was largely due to efforts by only 12 States. The report raised the possibility that States that do not report to the NICS the identities of individuals who are prohibited from possessing firearms for reasons related to mental health may experience challenges to reporting related to the HIPAA Privacy Rule.

    19 See GAO-12-684, Gun Control: Sharing Promising Practices and Assessing Incentives Could Better Position Justice to Assist States in Providing Records for Background Checks.

    20 We note that the GAO Report uses the term “mental health records” to refer to identifying information on individuals who are subject to the Federal mental health prohibitor. To avoid implying that mental health records are collected by NICS, the Department uses the terms “identities,” “information,” or “data” in place of “mental health records.” GAO-12-684, p. 12.

    II. The ANPRM Background

    On April 23, 2013, the Department published an Advance Notice of Proposed Rulemaking (ANPRM) requesting public input on these issues (78 FR 23872). The ANPRM explained that the Department was considering creating an express permission in the HIPAA Privacy Rule for reporting information relevant to the Federal mental health prohibitor to the NICS by those HIPAA covered entities that (a) are responsible for the involuntary commitments or other adjudications that make individuals subject to the Federal mental health prohibitor, or (b) are designated by a State to report to the NICS. In the ANPRM, the Department indicated that such an amendment might produce clarity regarding the Privacy Rule and help make it simpler for States to report the identities of such individuals to the NICS.

    To inform our efforts to address any issues in this area, we requested comments on a series of questions concerning the nature and scope of the problem of underreporting and whether a modification to the Privacy Rule would help address these issues. We also requested comments on any implications of a modification to the Privacy Rule for the mental health community or for the treatment of individuals, and how the Department might address any unintended consequences of such a modification. We received over 2,050 comments in response from individuals, State agencies, health care providers, associations of health care professionals, consumer advocacy groups, and other stakeholders.

    A number of commenters supported creating an express permission as a way to remove a potential barrier to an important and necessary public safety measure, which could help keep firearms out of the hands of individuals who should not have them by strengthening the background check system. Many others generally expressed concern that the NICS, the Federal mental health prohibitor, and the contemplated HIPAA permission would infringe on their Second Amendment right to bear arms and the right to be afforded due process of law under the U.S. Constitution. In addition, many individual commenters, as well as health care providers, organizations representing providers, and consumer advocacy groups, emphasized the importance of protecting individuals' health information privacy. These commenters raised concerns regarding the possible adverse consequences an express permission to report certain information could have on the patient-provider treatment relationship and individuals' willingness to seek needed mental health care.21

    21 Please see the ANPRM for a more thorough discussion of public comments and responses. 78 FR 23872 (April 23, 2013).

    III. Summary of the NPRM

    After considering the public comments received on the ANPRM, we published a Notice of Proposed Rulemaking (NPRM) on January 7, 2014,22 proposing to use the Department's broad authority under HIPAA to specify the permitted uses and disclosures of PHI by HIPAA covered entities. The NPRM proposed to revise 45 CFR 164.512 of the Privacy Rule by adding a new category of permitted disclosures to 45 CFR 164.512(k), which addresses uses and disclosures for specialized government functions. The NPRM proposed new provisions at (k)(7) that would permit certain covered entities to disclose the limited demographic and certain other information needed for NICS reporting purposes.

    22 See 79 FR 784 (January 7, 2014).

    We indicated in the NPRM that there is a strong public safety need for this information to be accessible to the NICS and that some States are currently under-reporting or not reporting this information at all. Further, although most of the information relevant to the Federal mental health prohibitor is held by entities that are not covered by HIPAA, for those few HIPAA covered entities that may be involved in the relevant commitments or adjudications, the Privacy Rule's existing paths for disclosure did not appear to be sufficient. We explained that, to the extent that some covered entities perform adjudicatory or repository functions in States that have not enacted laws requiring reporting to the NICS, and that a subset of those may be unable to achieve hybrid entity status due to administrative challenges or other reasons, an express permission would provide clarity and remove a barrier to their reporting.

    However, to address concerns regarding an express permission's potential to harm the patient-provider relationship or deterring individuals from seeking needed mental health care, we proposed to narrowly tailor the permission to report information on individuals subject to the Federal mental health prohibitor in a number of ways. Specifically, we proposed to limit: (1) Which covered entities could use or disclose PHI for NICS reporting purposes, (2) to whom the PHI could be disclosed, and (3) the scope of the information that could be used or disclosed.

    First, the NPRM proposed a new paragraph at 164.512(k)(7)(i) to permit certain NICS disclosures only by those covered entities that function as repositories of information relevant to the Federal mental health prohibitor on behalf of a State or that are responsible for ordering the involuntary commitments or other adjudications that make an individual subject to the Federal mental health prohibitor. The Federal prohibitor regulations define an involuntary commitment as a formal commitment of a person to a mental institution by a court, board, commission, or other lawful authority. The other applicable adjudications include determinations by a court, board, commission, or other lawful authority that persons are a danger to themselves or others, or lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease.23 The prohibitor does not apply to individuals in a psychiatric facility for observation or who have been admitted voluntarily; thus, the proposed rule would not have permitted disclosures with respect to those individuals.

    23 See 27 CFR 478.11 (Definitions).

    With respect to repositories of Federal mental health prohibitor information, we explained further that we did not intend to require States to formally designate the entities responsible for NICS reporting, but that we would expect States to be able to identify the relevant entities.

    We noted in the NPRM that our understanding was that lawful authority for performing such adjudications and repository functions rests, for the most part, with entities that operate outside the scope of HIPAA. However, in the interest of public safety, we wanted to ensure that relevant adjudications could be reported in the subset of States in which HIPAA covered entities may make, or collect and report records of, these determinations.

    We explained further that, in permitting only entities involved in these adjudicatory or repository/reporting functions to use or disclose Federal mental health prohibitor information for NICS purposes, the proposal would not create a permission for most treating providers to disclose PHI about their own patients for these purposes. We agreed with the commenters on the ANPRM who argued that encouraging voluntary treatment is critical to ensuring positive outcomes for individuals' health as well as the public's safety, and explained that the NPRM was designed to balance that goal and the public safety interests served by the NICS. We also agreed that non-health care entities bear primary responsibility for collection and reporting of information relevant to the Federal mental health prohibitor in most States. However, where a HIPAA covered entity is a board, commission, or other lawful authority that makes involuntary commitments or other adjudications that result in individuals being subject to the Federal mental health prohibitor, we believed those entities too were likely to hold records of the relevant commitments and adjudications.

    We requested public comment on the extent to which some States may have vested responsibility for Federal mental health prohibitor reporting in HIPAA covered entities, to what extent records needed for NICS reporting are created or maintained by covered entities, and whether there are circumstances in which health care providers would need to report the identity of an individual subject to the Federal mental health prohibitor to a State designated records repository or directly to the NICS. We also requested comment on the types of additional guidance from OCR and/or the NICS that would be helpful for understanding to which covered entities, and under what circumstances, the proposed permission would apply.

    Second, we proposed a new paragraph at (k)(7)(ii) providing that a covered entity identified in (k)(7)(i) may use or disclose Federal mental health prohibitor information for NICS purposes only directly to the NICS or to an entity designated by the State as a repository of data for purposes of reporting to the NICS. By clearly delimiting the permitted recipients of such disclosures, we explained that the rule would ensure that covered entities do not exceed the intended scope of the permission by disclosing information relevant to the Federal mental health prohibitor to, for example, law enforcement agencies that do not operate as repositories of data for purposes of reporting to the NICS.24 We requested comment on whether there are States in which a type of entity not described in this proposed paragraph is responsible for NICS reporting and thus, should be able to receive NICS data from a HIPAA covered entity.

    24 We did not propose to change the Privacy Rule's existing permissions to use or disclose PHI for specific law enforcement investigations, as provided in 45 CFR 164.512(f).

    Third, we proposed a new paragraph at (k)(7)(iii) to limit the information permitted to be used or disclosed to what is needed for purposes of reporting to the NICS. This is consistent with the Privacy Rule provision that generally requires covered entities to make reasonable efforts to limit the PHI used or disclosed to the minimum necessary to accomplish the intended purpose. Specifically, in the proposed regulation text, we made clear that only the limited demographic and certain other information needed for purposes of reporting to the NICS could be reported under the permission. We indicated that, at the time, we believed that the necessary information would be the data elements needed to create a NICS Index record: (1) Name of the individual; (2) date of birth; (3) sex; (4) a code or notation indicating that the individual is subject to the Federal mental health prohibitor; (5) a code or notation representing the reporting entity; and (6) a code identifying the agency record supporting the prohibition. The proposed regulation text expressly provided that the proposed modification would not permit the use or disclosure of clinical or diagnostic information for NICS reporting purposes. We requested comment on whether, and in what circumstances, HIPAA covered entities or other entities, such as courts, currently report to a records repository or directly to the NICS information that was not listed in the proposed paragraph.

    In addition, we explained that we were also considering permitting the disclosure of some or all the following additional data elements, which are optional fields for a NICS Index entry, for NICS reporting purposes: Social Security number, place of birth, State of residence, height, weight, eye color, hair color, and race. As we noted in the NPRM, from what we understand, these elements are not included in every NICS record, but often are used to confirm that a prospective firearm recipient matches a record searched by the NICS or to eliminate “false positive” background check results. We requested public comment on this issue.

    We also proposed to limit the permission to uses and disclosures about individuals who are subject to the Federal mental health prohibitor and not to apply it to disclosures about individuals subject only to State mental health prohibitors. However, we requested comment on this aspect of the scope of the permission, specifically with regard to whether the permission should be broadened to allow covered entities to also disclose the identities of individuals who are prohibited by State law from possessing or receiving firearms for reasons related to mental health.

    Finally, we also explained that the proposed permission would apply only with respect to the PHI of individuals subject to the Federal mental health prohibitor and not to the PHI of those persons who may be subject to the other Federal prohibitors listed at 18 U.S.C. 922(g). The lack of an express HIPAA permission for reporting information relevant to the Federal mental health prohibitor was a limited problem and we had not heard that there was a similar issue with respect to the other prohibitors. Thus, for example, a covered entity would not be able to use the proposed permission to use or disclose information about an individual who is an unlawful user of or addicted to any controlled substance (18 U.S.C. 922(g)(3)), except to the extent the individual was also subject to the Federal mental health prohibitor. We also noted that other laws could impact disclosures related to the other Federal prohibitors, including 18 U.S.C. 922(g)(3).25

    25 The ability of certain entities to report individuals who are subject to the Federal prohibitor at 18 U.S.C. 922(g)(3) may be affected by the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR part 2, administered by the Substance Abuse and Mental Health Services Administration (SAMHSA).

    IV. Provisions of the Final Regulation

    This final rule adopts the modifications to the HIPAA Privacy Rule as proposed. After considering the comments we received, we continue to believe that the creation of a limited express permission in the HIPAA Privacy Rule to use or disclose certain information relevant to the Federal mental health prohibitor for NICS purposes is necessary to address barriers related to HIPAA and to ensure that relevant information can be reported for this important public safety purpose. Furthermore, this narrowly tailored rule appropriately balances public safety goals with important patient privacy interests to ensure that individuals are not discouraged from seeking voluntary treatment.

    Under this final rule, covered entities that order involuntary commitments or make other adjudications that subject individuals to the Federal mental health prohibitor, or that serve as repositories of the relevant data, are permitted to use or disclose the information needed for NICS reporting of such individuals either directly to the NICS or to a State repository of NICS data. Thus, if a covered health care entity also has a role in the relevant mental health adjudications or serves as a State data repository, it now may disclose the relevant information for NICS reporting purposes under this new permission even if it is not designated as a HIPAA hybrid entity or required by State law to report. This final rule does not create an express permission for covered entities to disclose for NICS reporting purposes the PHI of individuals who are subject to State-only mental health prohibitors.

    The Department's rationale for adopting the provisions in this final rule, along with further clarifications and interpretations of the provisions, is explained below in the responses to the public comments on the NPRM.

    V. Analysis of and Responses to Public Comments

    We received more than 430 public comments in response to the NPRM, including from advocacy organizations, associations of health care and mental health professionals, a state mental health agency, and individual members of the public. A summary of the comments we received on the proposed rule and our responses follow.

    A. Comments Regarding Creating an Express Permission for NICS Reporting in the HIPAA Privacy Rule

    Comments: A number of commenters expressed general support for including an express permission in the HIPAA Privacy Rule for reporting certain information to the NICS, stating that the rule change would help increase the reporting of information to the NICS, reduce the ability of individuals with serious mental health problems to obtain firearms, and ultimately lessen the risk of harm to the individuals themselves, law enforcement, and the public.

    Several advocacy organizations involved in gun violence prevention agreed with our statements in the NPRM that the HIPAA Privacy Rule and, in some cases, perceptions of the Privacy Rule, may create a barrier to certain entities reporting to the NICS, and that the proposed modification would address this problem. For example, the comment submitted by Mayors Against Illegal Guns (MAIG) indicated that mental health treatment facilities in seven States currently are required by State law to report Federal mental health prohibitor information either directly to the NICS or to State agencies that report to the NICS, which indicates that mental health facilities do in some cases hold the relevant records. MAIG inferred from this information that there likely are other States in which HIPAA covered entities have information that should be reported to the NICS, but that the entities may not be reporting due to concerns about the HIPAA Privacy Rule's restrictions on disclosures. MAIG also cited statements from interviews its researchers conducted with State officials about issues related to NICS reporting and noted that officials from nine States and the District of Columbia had expressed concern that HIPAA, or other privacy requirements, generally prohibited sending records to the NICS, and thus that reporting would violate such requirements. MAIG asserted that whether these cited concerns were based on real or perceived barriers, its research indicated that making clear the ability to report without violating privacy laws tended to greatly improve state reporting rates, and that the proposed modifications to the Privacy Rule similarly would help states improve their record submissions.26

    26 MAIG, Fatal Gaps, How Missing Records in the Federal Background Check System Put Guns in the Hands of Killers (Nov. 2011).

    A number of commenters asserted that increasing reporting to the NICS could, in turn, help to decrease rates of gun violence. One of these commenters cited research indicating that, in one State, having a mental health adjudication record in the NICS database appeared to reduce the chance of a person committing a first violent crime.27

    27 The commenter cited Jeffrey Swanson, Preventing Gun Violence Involving People with Serious Mental Illness in REDUCING GUN VIOLENCE IN AMERICA, INFORMING POLICY WITH EVIDENCE AND ANALYSIS (eds. Daniel W. Webster and Jon S. Vernick, 2013). The study authors note that, “[c]onsidering separately the subgroup of people with serious mental illness who do not have criminal records, our data seem to suggest that the Brady Law background checks can have some positive effect, if enforced. In those with a gun-disqualifying mental health record, risk of violent criminal offending declined significantly after Connecticut began reporting gun-disqualifying mental health records to the NICS.” The authors also describe the limitations of the study and add, “[t]hese findings do not prove a causal relationship between the background check system and reduced violent crime.”

    In addition, a number of commenters, including the American Medical Association (AMA), and the American Psychiatric Association (APA), expressed appreciation that the proposed rule would appropriately balance protecting public safety and preserving the patient-physician relationship by narrowly defining the scope of the permission. The AMA stated that its view on the issue of reporting patient information to the NICS is governed by the association's Code of Medical Ethics and policies adopted by the AMA's policy making body. The AMA indicated that the Code of Ethics supports strong protections for patient privacy and, in most cases, requires physicians to keep patient medical records strictly confidential. If there must be a breach in confidentiality, such as for public health or safety reasons, the disclosures must be as narrow in scope as possible. In light of these considerations, the AMA expressed support for the Department's approach.

    In contrast, many commenters did not support adding an express permission in the HIPAA Privacy Rule for reporting certain information about persons subject to the Federal mental health prohibitor for NICS purposes. Several commenters asserted that there are only “perceived barriers” related to HIPAA, not real ones, so changing HIPAA would be unlikely to increase the reporting of mental health prohibitor information for NICS purposes. One commenter suggested that, rather than facing obstacles to reporting, States may be choosing not to report on certain categories of prohibited individuals for reasons unrelated to HIPAA—for example, because the States do not believe the individuals pose a danger.

    Other comments, some of which highlighted the importance of early and appropriate mental health intervention as the most effective way to prevent violence related to mental illness, expressed concern that the proposed permission would discourage individuals from seeking needed treatment. For example, the National Association of Psychiatric Health Systems (NAPHS) predicted that the public perception of the proposed rule would be that, if an individual disclosed information to a therapist, the therapist would be required to “report” the patient. This commenter argued that, as a result, the proposed rule would create a chilling effect on individuals' willingness to discuss issues in treatment that could lead to positive resolution rather than violence directed toward themselves or others. A number of commenters also expressed concern that the proposed rule would unfairly target persons with mental illness and perpetuate unfounded and damaging stereotypes about persons with mental illness by sending a message to the public that the Department perceives mental illness as inextricably linked with violence.

    Some commenters expressed general concern regarding the effects of the proposed rule on individuals' privacy interests. A number of these commenters argued that communications between patients and their health care providers should be kept confidential under all circumstances.

    Response: After considering the comments, we continue to believe that the creation of a limited express permission in the HIPAA Privacy Rule to disclose information relevant to the Federal mental prohibitor for NICS purposes is necessary to address barriers to reporting. In particular, to the extent that some States do not require reporting by law, and reporting entities in those States may face administrative or other challenges in creating a hybrid entity, the HIPAA Privacy Rule may create impediments to reporting that cannot be cured through mere guidance. Therefore, we believe such an express permission will serve an important public safety interest by removing a barrier to reporting that may exist in certain circumstances and thereby potentially increase reporting by States that historically have reported little or no Federal mental health prohibitor data to the NICS due to concerns about violating the Privacy Rule.

    Further, we believe that the limitations contained in the narrowly tailored express permission we adopt appropriately respond to commenters' important concerns about discouraging individuals who need mental health treatment from seeking care. First, we limit the permission to only those covered entities that order the involuntary commitments or make the other adjudications that cause individuals to be subject to the Federal mental health prohibitor, or that serve as repositories of such information for NICS reporting purposes. Thus, the rule does not affect most treating providers or create a permission for them to disclose PHI about their own patients for these purposes. Second, we permit such entities to disclose NICS data only to designated repositories or the NICS. Third, we limit the information that may be disclosed to certain demographic or other information that is necessary for NICS reporting. Finally, we do not expand the permission to encompass State law prohibitor information. These aspects of the provision are discussed more fully below. By limiting the permission in these ways, we protect the patient-provider relationship. Further, we believe these limitations carefully balance an individual's privacy interests with the public safety interest in reporting certain information to the NICS.

    In response to concerns that the rule unfairly singles out individuals with mental illness, we emphasize, as we did in the proposed rule, that a mental health diagnosis does not, in itself, make an individual subject to the Federal mental health prohibitor, which requires an involuntary commitment or adjudication that the individual poses a danger to self or others or lacks the mental capacity to contract or manage his or her own affairs.

    In addition, the Department continues to support efforts by the Administration to dispel negative attitudes and misperceptions relating to mental illness and to encourage individuals to seek voluntary mental health treatment. With the implementation of the Affordable Care Act, millions of Americans who did not previously have coverage will receive coverage for mental health services.

    B. Comments Regarding the Scope of the Permission Expanding to State Law Prohibitors

    Comments: We received several comments in response to our question about whether the permission should be expanded to include State law prohibitors. Of these, a minority of commenters supported expanding the proposed rule to permit disclosures of information about individuals who are subject to State-only mental health prohibitors (i.e., State prohibitors that have different criteria than the Federal mental health prohibitor). Several commenters who advocated for the disclosure of such information for NICS reporting purposes asserted that State law prohibitors would be effective only if accurate and adequate information were submitted to the NICS. One of these commenters argued that State efforts to report disqualifying records to the NICS should be encouraged, not curtailed by confusion over the applicability of the HIPAA Privacy Rules. The commenter also argued that it would create greater confusion not to include the same express permission with respect to State mental health prohibitor information as was proposed for the reporting of information related to the Federal mental health prohibitor.

    Another commenter who supported a permission to disclose information about individuals who are subject to State-only mental health prohibitors argued that increasing the disclosures to the NICS about individuals who are prohibited by State law (but perhaps not Federal law) from purchasing firearms could address the situation in which a person who is subject to a prohibitor in the person's State of residence enters another State temporarily for the sole purpose of obtaining a firearm and then returns to the State where ownership is prohibited with a firearm. This commenter voiced the concern that, if the State of residence does not provide information about individuals who are subject to State law prohibitors to the Federal background check system, a FFL in another State would not know that the individual is subject to a prohibitor.

    Several commenters asserted that an express permission to disclose information about individuals who are subject to State mental health prohibitors would help to avoid a misinterpretation that HIPAA prohibits disclosures of PHI relevant to State mental health prohibitors in circumstances when HIPAA otherwise would not. Another commenter argued that, as some State law prohibitors were enacted before HIPAA, State legislators would not have foreseen HIPAA-related obstacles to disclosure or the resulting need to require reporting to the NICS by law; as a result, those States may not have laws in place to require the reporting of State law prohibitors.

    One commenter who supported extending the permission argued that the reporting of State mental health prohibitors would be consistent with congressional intent, as expressed through statutes aimed at preventing gun violence. The commenter asserted that the NICS was established under the Brady Gun Law to serve as a central aggregated database of information regarding the identities of individuals who are prohibited from possessing firearms under any Federal, State, or local law.

    In contrast, a number of commenters, including several associations of mental health professionals, expressed concern that expanding the reporting permission to apply to State law mental health prohibitors would involve more treating health care providers in NICS reporting, and that individuals would not seek treatment for mental health problems if they felt that simply by seeking treatment they could be reported to the NICS.

    Several commenters, including two mental health professional associations, expressed concern that State mental health prohibitors are being expanded in an overly broad manner that will further negative attitudes and misperceptions about mental illness. The commenters pointed to an example of a State statute that requires health care providers to report to the NICS the identities of all individuals with intellectual disabilities, as well as individuals who voluntarily commit themselves to a mental institution.

    The CCDRTF provided additional examples of State law mental health prohibitors that are significantly broader than the Federal mental health prohibitor and expressed concern that many of these State prohibitors apply to individuals without the benefit of an adjudication by a court, board, commission or other lawful authority, as provided for under the Federal prohibitor.28 This commenter asserted that the Federal mental health prohibitor forbids the reporting of information to the NICS about individuals who are subject to broader State mental health prohibitors due to a lack of equivalent procedural protections for such individuals; therefore, this commenter argued, to permit reporting related to State mental health prohibitors would violate the Supremacy Clause and raise due process concerns.

    28 This commenter described laws enacted in four States. According to the commenter, New York law requires all mental health professionals to report any person undergoing treatment that is “likely to engage in conduct that would result in serious harm to self or others” (citing N.Y. Mental Hygiene. Law § 9.46), while New York's SAFE Act requires mental health treatment providers to report covered individuals to a state database without an adjudicatory process (citing N.Y. Mental Hygiene Law § 9.46). In California, the commenter stated, prohibitors apply to individuals undergoing voluntary inpatient treatment (citing 30 Cal. Welf. & Inst. Code § 8100(a)); and apply to individuals involuntarily held as inpatients under 72-hour holds (citing Cal. Welf. & Inst. Code § 8103(f) and Cal. Welf. & Inst. Code § 5150) without the types of adjudications contemplated under the Federal mental health prohibitor (citing 18 U.S.C. 922(g); U.S. v. Rehlander, 666 F.3d 45, 50 (1st Cir. 2012). Finally, the commenter noted that Illinois and Hawaii have prohibitors that apply to all individuals who have received particular diagnoses (citing 31 430 Ill. Comp. Stat. 65/8(g) (intellectual disability) and (s) (developmental disability); Haw. Rev. Stat. Ann. § 134-7(c) (persons with significant DSM diagnosed disorder).

    A number of commenters who opposed the reporting of State mental health prohibitors expressed concern that the broadest State law prohibitors would become the de facto national standard if the NICS were to include State law prohibitors. Others raised concerns about the increased complexity involved in accurately maintaining the NICS database with the addition of State law prohibitor records, including challenges associated with avoiding or identifying duplicate reports, resulting in less reliability, increased inaccuracy, and improper denial of rights, as well as adding complexity to appeals.

    Response: We share the concerns of commenters that, due to the breadth of some State law prohibitors, the inclusion of State-only prohibitors in the permission would increase the involvement of treating providers in NICS reporting, which could negatively affect patient-provider treatment relationships and discourage some individuals from seeking care. While we note that the NICS currently receives some information on State law prohibitors, given these concerns and the importance of protecting the patient-provider relationship, we do not think it is appropriate to expand the permission with respect to HIPAA covered entities. We agree with the commenters who stated that the health and safety of individuals and the public is best served if persons with mental illness obtain appropriate treatment; by limiting the permission to the narrower Federal mental health prohibitor, and carefully tailoring the permission in the ways described throughout this preamble, this final rule is designed to ensure that such persons are not discouraged from seeking care.

    With respect to some commenters' concerns about State mental health prohibitors being ineffective without a HIPAA disclosure permission, we note that the Privacy Rule does not affect the reporting of State law prohibitors by non-HIPAA covered entities, which are the entities that maintain most of the relevant information. Moreover, to the extent that covered entities maintain relevant State law prohibitor information and a State wants to ensure that the reporting of this information can occur, the Privacy Rule provides certain other avenues for disclosure, as we have described elsewhere. For example, although our balancing of interests limits this express permission under HIPAA to disclosures related to the Federal mental health prohibitor, this rule does not prevent State legislators from differently balancing the privacy, health, and public safety issues involved with respect to their State level mental health prohibitors—nor does the Federal mental health prohibitor itself prohibit reporting to the NICS of State law prohibitor information, as a commenter asserted. If State legislators determine that information related to a State-only prohibitor should be disclosed despite any potential chilling effect on seeking treatment, they can enact a State law requiring the relevant entities to report such information. Alternatively, the relevant covered entities can create a hybrid entity, separating their HIPAA covered health care functions from their NICS reporting or repository functions, such that the information maintained by the covered health care component is subject to the Privacy Rule, while information held by the non-covered component can be reported without regard to the Privacy Rule.

    We disagree with the commenters who argued that excluding State-only mental health prohibitor information from the permission will create confusion. We do not think this will occur because this final rule clearly indicates that it applies where firearm possession is prohibited under a specific provision in Federal law. We also note that the rule delineates the types of covered entities that are permitted to disclose, the information they are permitted to share, the categories of individuals covered by the permission, and the entities to which they can make such disclosures. In addition, we intend to work with DOJ to develop additional guidance on the categories within the Federal mental health prohibitor. Moreover, we do not believe this final rule will create a misperception that HIPAA always prohibits the reporting to the NICS of individuals who are subject to State-only mental health prohibitors. As explained elsewhere in this preamble, the Privacy Rule already permits uses and disclosures of PHI that are required by law, including State law reporting requirements; also, HIPAA covered entities that perform both health care and non-health care functions (e.g., NICS reporting) are permitted to create hybrid entities under HIPAA so that the Privacy Rule applies only to their health care functions. This final rule does not change those provisions.

    Finally, we do not agree that Congress intended for State (or local) law prohibitor information to be reported to the NICS in all circumstances, such as where doing so would conflict with countervailing privacy concerns due to the treatment relationship between patients and health care providers. Therefore, this final rule balances a variety of important interests, including protecting the privacy of individuals' personal health information, ensuring access to needed mental health care services, and advancing the public safety interests in ensuring that persons who are prohibited by Federal law from purchasing or possessing a firearm for mental health reasons do not gain access to firearms.

    Entities Permitted To Report

    Comment: Several commenters, including the AMA and the National Association of Psychiatric Health Systems, expressed support for the proposal to limit the permission to only those entities in a State that are directly involved in the relevant adjudications or maintain records of them for NICS reporting purposes. These commenters expressed appreciation for the narrow drafting of the NPRM based on the need to support provider-patient relationships and encourage individuals with mental illness to seek appropriate care.

    However, several advocacy organizations and many individuals argued that direct treatment providers should not be permitted to report information about their patients to the NICS under any circumstances (i.e., even if they are, or are part of, the entity that orders involuntary commitments or conducts other relevant adjudications, or serves as a repository of NICS data). Some of these commenters argued that reports to the NICS database should come only from the judiciary.

    Finally, we did not receive responses to the question we posed in the NPRM about whether additional types of covered entities within a State (other than those identified in the proposed regulatory text) might be expected, and thus should be permitted under the Privacy Rule, to report data to the NICS or to a State repository.

    Response: We agree with the commenters who emphasized the need to protect the provider-patient relationship, and this final rule addresses such concerns by limiting the permission to those covered entities that also perform an adjudicatory or data repository function. Furthermore, as described more fully elsewhere in this preamble, the permission does not extend to broader State law prohibitors, which may not require a formal adjudication or involuntary commitment and whose inclusion likely would involve more treatment providers in NICS reporting.

    In response to comments arguing that only entities in the court system should be permitted to report to NICS, it is our understanding, based on public comments and our fact finding, that courts do not create or maintain records of all of the involuntary commitments or other adjudications that make individuals subject to the Federal mental health prohibitor. Therefore, for the NICS database to include reports of all persons subject to the mental health prohibitor, it is necessary for certain other entities that create or maintain such information to be able to report. We believe this permission will help strengthen the background check system to ensure that individuals who are prohibited from purchasing or possessing firearms are prevented from obtaining them. We also acknowledge the concerns of commenters who argued that providers should not be permitted to report information about their patients under any circumstances. As explained in more detail elsewhere in this preamble, to address these and other concerns, we have carefully tailored this final rule to limit the involvement health care providers, and to prevent disclosures of diagnostic or clinical information for NICS reporting purposes.

    Demographic and Certain Other Information Permitted To Be Reported

    Comment: Many commenters specifically voiced support for the NPRM's proposal not to permit the disclosure of diagnostic or clinical information for NICS reporting purposes. (We also noted in the NPRM that the NICS does not request or contain such information.) For example, the American Medical Association stated that it strongly supported restricting the information disclosed to the limited demographic and other information needed for reporting, as the NPRM proposed. To support the point that NICS reporting is sufficiently limited, another commenter pointed out that the information that is reported to the NICS generally is provided by the individual to a FFL on the required application for the firearm.

    In contrast, one commenter asserted that, as written, the proposed permission would grant discretion to state entities to determine the scope of “demographic and certain other information” to be reported and argued further that DOJ (specifically ATF), not HHS, has authority to define the “minimum” information required by NICS.

    In response to our request for comment on whether, and in what circumstances, entities currently report, or should be permitted to report, additional data elements needed to confirm an individual's identity, the Connecticut Department of Mental Health and Addiction Services (DMHAS) asserted that certain additional data elements are helpful in confirming whether an individual is appropriately excluded from gun purchase or possession in cases where multiple individuals share the same name and date of birth. Several other commenters agreed that permitting the disclosure of additional data elements for NICS reporting purposes would allow more accurate verification of an individual's identity, resulting in fewer erroneous denials, and would facilitate the correction and updating of NICS entries.

    The Connecticut DMHAS and others suggested the inclusion of some or all of the following specific data elements: Social Security number, place of birth, state of residence, height, weight, eye color, hair color, and race. Social Security number and race were cited as the most reliable indicators of an individual's true identity.

    Response: We agree with the commenters who stated that limiting the permission to exclude diagnostic and clinical information appropriately balances individuals' privacy interests and public safety priorities. We also agree that there may be data elements beyond those needed to create the NICS record (i.e., the individual's name, sex, and date of birth; as well as codes identifying (1) the Federal mental health prohibitor, (2) the record documenting the involuntary commitment or adjudication, and (3) the entity from which the record initiated) that may be helpful in verifying identity and excluding false matches. Given that, the final rule provides some flexibility for States or reporting entities. We do not specify in the regulatory text which data elements may be disclosed, but clarify in this preamble that what generally would be considered the information “needed for purposes of reporting to the [NICS]” in § 164.512(k)(7)(iii)(A) would be the data elements required to create a NICS record, as well as the following elements to the extent necessary to exclude false matches: Social Security number, State of residence, height, weight, place of birth, eye color, hair color, and race (and we note that the Federal Bureau of Investigations (FBI) and not ATF has the authority to define the information required by NICS). As indicated above, these are the same elements that were identified in the NPRM.

    C. Comments Regarding the NICS and the Federal Mental Health Prohibitor

    Comment: Many commenters raised concerns about infringement of individuals' Second Amendment right to bear arms without due process. A number of these commenters specifically expressed concern that an individual could be reported to the NICS without a formal adjudication through the court system and argued that due process under the Constitution would require a hearing in a court of law before an individual could be made subject to the Federal mental health prohibitor.

    Response: We acknowledge the views of the commenters. However, as we explained in the NPRM, these concerns relate to the Federal mental health prohibitor rather than the HIPAA Privacy Rule or this final rule, and thus are outside the scope of this rule. This final rule addresses HIPAA-related barriers to entities reporting certain information to the NICS about individuals who are subject to the Federal mental health prohibitor. The rule does not expand the categories of federally prohibited persons or modify the criteria for determining that a person is subject to the Federal mental health prohibitor.

    Comment: Several disability rights advocates and others asserted that the rule would not result in a decrease in gun violence because mental illness alone does not make a person more likely to commit violence against others. The Consortium for Citizens with Disabilities Rights Task Force (CCDRTF) cited studies indicating that mental illness alone is not statistically related to future violence and that even severe mental illness without drug use or a history of violence is not linked with future violence.29 Several commenters also noted that persons with mental illness are more likely to be the victims of violence than its perpetrators. Alternatively, several commenters argued that, even if there were a link between mental illness and gun violence, the proposed rule is not needed because mechanisms already are in place in place to prevent harm from patients who are a threat to themselves or the public.

    29 CCDRTF cited Eric B. Elbogen & Sally C. Johnson, The Intricate Link Between Violence and Mental Disorder: Results from the National Epidemiologic Survey on Alcohol and Related Conditions, 66 Arch. Gen. Psychiatry 152, 157 (Feb. 2009); David J. Vinkers, et al., Proportion of Crimes Attributable to Mental Disorders in the Netherlands Population, 11 World Psychiatry 134 (June 2012). CCDRTF also indicated that other studies showed a modest relationship between serious mental illness and violence, but that other factors (e.g., substance abuse, age, gender and lower economic status) contribute more to increasing the likelihood of committing violence than mental illness alone. They cited R. Van Dorn, et al., Mental Disorder and Violence: Is There a Relationship Beyond Substance Use?, 47 Social Psychiatry and Psychiatric Epidemiology 487, 499 (2012).

    Response: We acknowledge the views of the commenters. However, these commenters address the applicability of the Federal mental health prohibitor itself. This final rule does not expand the existing categories of persons prohibited from owning a firearm or modify other Federal or State laws pertaining to firearms purchases. Therefore, these comments are beyond the scope of this rule.

    Comment: Several commenters raised questions about individuals' ability to correct erroneous NICS reports or to have their rights restored when they no longer pose a danger to themselves or others. A number of commenters recommended assuring that the appeals process is free of delay, inexpensive, and easy for individuals to initiate.

    Other commenters asserted that the expense to remove oneself from the NICS database is prohibitive for some individuals. As a result, the commenters said, individuals effectively become subject to a lifelong restriction on their Second Amendment right to bear arms, even after they recover from the condition that led to their adjudication and are eligible to apply for relief from disabilities under the Federal mental health prohibitor. Similarly, one commenter argued that, once an individual is reported to the NICS, the “relief from disabilities” process 30 is inadequate for remediation due to a lack of Federal funding to support State programs, and wide variability in State programs to provide relief as a result. Another commenter recommended allocating additional funding to support State “relief from disabilities” programs.

    30 See footnote 13 above.

    Response: These comments are outside the scope of the rule. However, we acknowledge the commenters' concerns with respect to opportunities for remediation and note that individuals who believe they are wrongly denied the purchase of a firearm can visit https://forms.fbi.gov/nice-appeals-request-form to find out more information and appeal their denial. In addition, the NICS Improvement Amendments Act of 2007 authorized grants for States that implement programs for “relief from disabilities” in accordance with the Act.31 These programs are required to establish processes by which an individual who is subject to the Federal mental health prohibitor may apply for relief to the State where the relevant commitment or adjudication occurred. While States' processes for granting relief vary, the Act requires that relief be granted if it can be established that the circumstances regarding the disability and the applicant's record and reputation are such that the applicant will not be likely to act in a manner dangerous to public safety, and the granting of relief would not be contrary to the public interest.32

    31 The DOJ Bureau of Justice Statistics provides state data on NICS Act Record Improvement Program (NARIP) Awards (available at http://www.bjs.gov/index.cfm?ty=tp&tid=491#promising).

    32 See Public Law 110-180, Section 105.

    Comment: A number of commenters expressed concern that a finding of mental incompetence by the Veterans Administration (VA), which could make an individual subject to the Federal mental health prohibitor and cause the individual to be reported to the NICS, may be based solely on a determination that the veteran is unable to handle financial affairs, without regard to dangerousness. The commenters argued that these veterans do not receive due process before being made subject to the Federal mental health prohibitor and believed that the proposed rule would exacerbate this problem.

    Response: We note that, as a federal agency, the VA is required by law to report prohibited persons to the Attorney General, who oversees the NICS.33 This final rule does not affect that requirement or change the procedures relating to adjudications that make individuals subject to the Federal mental health prohibitor.34

    33 See NICS Improvement Amendments Act of 2007 Sec. 101, 18 U.S.C. 922 note (2002).

    34 We refer commenters to the VA regulations for information about the due process afforded to veterans as part of VA competency determinations. See 38 CFR 3.353 and 38 CFR 3.103.

    D. Other Comments

    Comment: A few commenters expressed concern that covered entities would misinterpret the proposed permission as a requirement to report information about their patients to the NICS. Another commenter expressed concern that the standards for reporting NICS data will be adopted by courts as a new standard of care for health care providers, exposing covered entities that do not report to increased liability. The commenter requested that the Department clarify that the HIPAA permission is permissive, not mandatory.

    Response: This final rule establishes permission for certain HIPAA covered entities—those with lawful authority to make the adjudications or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes—are permitted to disclose the information needed for these purposes. The rule does not create a requirement to disclose. In addition, as explained at length in the NPRM and above, the rule does not apply to most treating providers, but only to those covered entities that are responsible for the involuntary commitments or other adjudications that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of such data. However, we note that covered entities have a responsibility to comply with all applicable laws, and this final rule does not preempt State or other laws that may require reporting to the NICS.

    Comment: One commenter recommended that the Department evaluate whether the rule would have the unintended consequence of permitting the reporting of individuals based on mere medical findings.

    Response: As we explain above, the rule does not create a broad permission for treating providers to report information about their patients to the NICS. Rather, the rule is narrowly tailored to permit limited disclosures of information about individuals who are subject to the Federal mental health prohibitor, which applies only where an individual has been involuntarily committed or otherwise has received a relevant adjudication from a court, board, commission, or other lawful authority.

    Comment: One commenter recommended training for the workforce members of reporting entities to ensure that they understand the applicable reporting protocols sufficiently to avoid making erroneous reports.

    Response: We agree that training is generally beneficial to assure compliance with applicable standards. Further, to the extent that reporting entities also are HIPAA covered entities, the Privacy Rule requires those entities to train workforce members on the policies and procedures with respect to the privacy and security of individuals' health information. Where applicable, such training would include ensuring that workforce members have copies of the entity's policies and procedures implementing this final rule's limited permission for uses or disclosures of PHI for NICS reporting purposes.

    Comment: One commenter recommended establishing a mechanism to inform mental health patients and their caregivers about the patients' status in the NICS.

    Response: We decline to provide for such a mechanism in this final rule because it is outside the scope of the rule. Nothing in this rule, however, precludes covered entities from informing individuals that information about them has been provided to the NICS.

    Comment: Several commenters expressed concern that, by allowing multiple entities within a State to report to the NICS, the proposed rule would create complexity, inaccuracy, and delay in processing appeals, particularly if the FBI refers the individual back to the reporting entity for resolution.

    Response: To the extent that the involvement of multiple entities in NICS reporting may affect the appeals process in a state, this issue exists apart from HIPAA. Each State determines the entity or entities responsible for reporting NICS data, depending on where the records documenting a person's status as subject to one or more of the Federal prohibitors are created or maintained. As a result, a variety of entities, including judicial, law enforcement, public health, and other entities in a State, already may be involved in NICS reporting and appeals.

    Comment: A few commenters expressed concern that, as a result of the proposed rule, some families may choose not to seek involuntary commitment proceedings for a family member who needs treatment, but whose livelihood depends on the ability to possess a firearm (e.g., first responders and members of the military), because the commitment would result in a report to the NICS and the loss of the patient's livelihood.

    Response: We note that the Federal mental health prohibitor makes the purchase or possession of firearms by prohibited individuals unlawful regardless of whether an individual is reported to the NICS, and this final rule does not change who is subject to the Federal mental health prohibitor. This final rule also does not affect law enforcement and military entities' authorities with respect to making their workforce decisions.

    Comment: One commenter asked whether covered entities are obligated to update information they have submitted to the NICS when an individual's circumstances change.

    Response: Section 102(c)(1)(B) of the NIAA requires States to update, correct, modify, or remove a record from the NICS if they determine that the person is not prohibited or has received “relief from disabilities” under the mental health prohibitor.

    Comment: A number of commenters argued that the proposed regulation would contravene congressional intent, arguing that Congress did not intend to change HIPAA protections for NICS purposes. The commenters stated that legislation on this topic had been considered and rejected and specifically cited S. 649 (the “Fix Gun Checks Act”), which was considered by the Senate on April 18, 2013, but did not receive a vote.

    Similarly, some commenters asserted that Congress could have included any desired changes to HIPAA when it passed the NICS Improvements Amendments Act, but did not do so. Therefore, the commenters argued, Congress did not intend to modify HIPAA for NICS reporting purposes.

    Response: That Congress did not enact S. 649 does not provide relevant evidence of congressional intent with respect to the scope of the HIPAA Privacy Rule. The absence of a provision in the NIAA to modify HIPAA does not imply that Congress intended to prevent any revisions of the HIPAA Privacy Rule with respect to the NICS. The HIPAA statute confers broad authority on the Department to specify the permitted uses and disclosures of PHI by HIPAA covered entities, and NIAA does not affect this statutory authority.

    Comment: Several disability rights organizations asserted that the proposed rule did not provide sufficient evidence of HIPAA barriers to reporting in any State to fulfill a requirement of the Administrative Procedure Act (APA) that there be a rational connection between the facts found by a Federal agency through the rulemaking process and the regulatory choice made.35

    35 5 U.S.C. Subchapter II.

    Response: We disagree with the commenters. As stated above, we understand from other comments that at least seven States currently rely on HIPAA covered entities (such as mental health facilities) to report Federal mental health prohibitor data to the NICS. These seven States have laws regarding such reporting, but other States may not. To the extent that any other State does not require NICS-related disclosures by law and the State has not enacted legislation addressing the problem, the Privacy Rule, prior to the effective date of this final rule, would have prevented such disclosures by HIPAA covered entities that do not have hybrid entity status.36 Therefore, there are sufficient data demonstrating that HIPAA's disclosure restrictions can be a barrier to NICS reporting, and thus to the development of an accurate and comprehensive NICS database. The data support finalizing this modification to the Privacy Rule, which removes barriers while limiting the circumstances under which covered entities may disclose PHI to the NICS and limiting the types of PHI that may be disclosed.

    36 We note that at least three states have laws permitting, but not requiring the disclosure of mental health records to the NICS: Missouri, New Jersey and West Virginia. See Mo. Rev. Stat. 630.140 (2013); N.J. Stat. Ann. 30:4-24.3 (2013); W.Va. Code 61-7A-3 (2013).

    We know of one State in particular in which the Privacy Rule's disclosure restrictions posed challenges for NICS reporting. The State of New York had a statute requiring mental health facilities in the State to report NICS data to the State mental health agency, the State's designated repository of NICS data.37 As a result, the Privacy Rule permitted such disclosures to the repository as required-by-law disclosures. However, the statute did not expressly require the mental health agency, which was a covered entity under HIPAA that did not have hybrid entity status, to report the data it collected to the NICS; the Privacy Rule thus did not permit the agency to disclose this data. Ultimately, the legislature needed to revise the statute to expressly require the agency to report the data to the NICS.38

    37 2008 N.Y. Laws 491, codified at N.Y. Mental Hyg. §§ 7.09(j); 13.09(g), 31.11(5), 33.13(b), (c) (2011); N.Y. Jud. Ct. Acts § 212(q) (2011).

    38 NY Secure Ammunition and Firearms Enforcement (SAFE) Act of 2013.

    In addition to removing barriers, an additional benefit of the rule as described more fully below is that it provides clarity about the applicability of the Privacy Rule and its relationship to State law in this area, as well as provides an avenue for NICS reporting that may obviate the need to enact legislation at the State level.

    Comment: One commenter requested that the Department clarify how HIPAA's preemption provisions would apply to State laws requiring or prohibiting covered entities' disclosures of NICS data.

    Response: We clarify that this final rule does not change HIPAA's existing preemption provisions, which provide that the HIPAA rules preempt contrary State laws (with certain exceptions, such as where the contrary provision of State law is more stringent than the HIPAA provision).39 Accordingly, because the Privacy Rule, as modified by this final rule, only permits (but does not require) the disclosure for NICS reporting purposes, State laws that prohibit such disclosures are not contrary to the Privacy Rule, and covered entities in States with such laws remain subject to any applicable prohibitions against the disclosures under State law. That is, the covered entity could comply with both HIPAA and such State law by not disclosing PHI to the NICS.

    39 See 45 CFR 160.203.

    Moreover, HIPAA contains an express permission for disclosures that are required by other law, such as State law. Accordingly, State laws that require disclosures, for any purposes, remain in effect, as such laws are not contrary to the Privacy Rule.

    Comment: One commenter expressed concern that the rule would create an opportunity for the abuse of private information, for example, by allowing the government to disarm political dissidents who seek mental health care, or making it possible for medical personnel to abuse their authority and remove an individual's rights for illegitimate reasons.

    Response: Concerns about governmental or private actors taking advantage of this permission to target vulnerable persons are addressed by the procedural framework built into the statute that established the Federal mental health prohibitor and its implementing regulations, which this final rule does not change. As we previously have noted, the Federal mental health prohibitor, which makes an individual reportable to the NICS, applies only to the extent that the individual is involuntarily committed or determined by a court, board, commission, or other lawful authority to be a danger to self or others, or is unable to manage his or her own affairs due to a mental illness or condition. 40 These involuntary commitments and other adjudications are not made independently by individual health care providers without any form of official legal review.

    40 18 U.S.C. 922(g)(4); 27 CFR 478.11.

    Comments: Some commenters expressed concern that, by relaxing HIPAA's privacy requirements, the proposed rule could result in increased disclosures of private health information to the government. Several commenters argued that the Federal government has a poor record on protecting individuals' privacy and should not be entrusted with health information. In contrast, another commenter noted that Federal law, including the Privacy Act, prohibits access to the information in the NICS database outside of the limited purposes authorized by law, and information about specific firearms transfers is destroyed the day after the transaction.

    Response: We agree that it is important to protect the privacy and security of the information that is reported to the NICS and we note that the NICS is subject to specific privacy and security protections.41 In addition, we again emphasize that only very limited information may be disclosed under this rule, and disclosures of diagnostic or clinical information are expressly prohibited.

    41 See 63 FR 58303 (October 30, 1998), codified at 28 CFR part 25.

    Comment: Finally, one commenter requested clarification on whether, in States where a covered entity is also a lawful authority that orders involuntary commitments or conducts other adjudications that make individuals subject to the Federal mental health prohibitor, there is intended to be a separation between the covered entity and lawful authority functions of the entity.

    Response: We note that, under the Privacy Rule, both before and after the modification made in this final rule, a covered entity could provide for such separation by operating as a hybrid entity, and disclose information through its non-HIPAA covered NICS reporting unit. However, it is our understanding that some covered entities may be unable to achieve hybrid entity status for administrative or other reasons. This is another reason for including the express permission described in the final rule.

    VI. Regulatory Analyses A. Introduction

    We have prepared a regulatory impact statement in compliance with Executive Order 12866 (September 1993, Regulatory Planning and Review), Executive Order 13563 (January 2011, Improving Regulation and Regulatory Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (UMRA) (March 22, 1995, Pub. L. 104-4), and Executive Order 13132 on Federalism.

    1. Executive Order 12866 and Executive Order 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, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget.

    A regulatory impact analysis must be prepared for all major rules that have economically significant effects ($100 million or more in any one year) 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 government or communities (58 FR 51741). Because the final rule does not contain any new requirements or prohibitions for covered entities, we estimate that the rule will be cost neutral. We did not receive public comments on this assumption or information indicating that covered entities will incur any costs as a result of the rule.

    Although we expect the economic impact of the rule, including non-quantifiable costs and savings discussed in the regulatory analysis below, to be less than $100 million annually, we nevertheless conducted an analysis of the costs of the final rule.

    2. Entities Subject to the Rule

    This final rule applies only to covered entities that function as repositories of information relevant to the Federal mental health prohibitor on behalf of a State or that are responsible for ordering the involuntary commitments or other adjudications that make an individual subject to the Federal mental health prohibitor. We do not have sufficient data to determine the number of affected entities, but, based on the information available to us, we believe there would be very few. Our understanding is that, for the most part, formal adjudications and repository functions of this nature are conducted by entities, such as court systems or law enforcement agencies, that are not covered by HIPAA. In addition, even covered entities in some states will not be affected because they currently do not face HIPAA barriers to reporting either because state law requires reporting or they have created hybrid entities, as described above in the preamble. We did not receive public comments on the number of covered entities that will be affected by this rule.

    B. Why is this rule needed?

    This final rule is needed to ensure that, where HIPAA covered entities make adjudications causing individuals to become subject to the Federal mental health prohibitor, or serve as repositories of records of such adjudications on behalf of States, those covered entities can report the identities of those individuals to the NICS. This rule change can help further the important public safety goal of strengthening the background check system to ensure that individuals who are prohibited from purchasing or possessing firearms are not able to obtain them. Specific permission under the Privacy Rule for these disclosures is necessary to the extent that some States have not enacted laws requiring reporting to the NICS, but a covered entity in the State is nevertheless responsible for such reporting and does not become a hybrid entity. Importantly, the final rule permits only a small subset of HIPAA covered entities (i.e., those that perform the relevant mental health adjudications or repository functions) to use or disclose only limited, non-clinical information, for NICS purposes. This narrowly tailored permission permits these important uses or disclosures for public safety to occur while maintaining a separation between reporting functions and the mental health treatment a patient might be receiving.

    C. Qualitative Analysis of Unquantified Costs

    The rule is cost neutral with respect to HIPAA covered entities. The rule does not require entities that already have a NICS reporting process in place to change their current system and does not create new reporting or recordkeeping requirements for any covered entity. The small number of covered entities that are newly permitted to report to the NICS or a State repository under the rule can begin to report and may need to develop policies and procedures to do so. As the Privacy Rule only allows the use or disclosure of information, and does not require it, any resulting burden of reporting and associated procedures are attributable to the choice made by an entity to report information, the Federal statutory mental health prohibitor, and the NICS system itself. See 28 CFR part 25, subpart A. We acknowledge that those entities that choose to begin reporting may wish to address this change in their HIPAA policies and procedures, as well as explain their procedures to office staff. However, the rule does not require any changes to existing HIPAA policies and procedures. In addition, with respect to training, the rule does not require workforce training beyond what is already required under the HIPAA Privacy and Security Rules. We expect that entities that choose to report under the rule would also take steps to ensure that their office staff have copies of the new policies and procedures, which would not involve any significant additional costs. We did not receive public comments contradicting these assumptions or estimating the number of entities that might begin to report to the NICS for the first time, if any.

    To the extent that the rule permits some covered entities to report to the NICS for the first time, there may be an increase in the number of individuals whose identities are newly included in the NICS and who are denied a firearm transfer as a result. Therefore, there may be a concomitant increase in applications for “relief from disabilities” in states that provide such a relief program. However, any burden to individuals completing and submitting the relief application form is attributable to the Federal mental health prohibitor and the procedures established by the State where the commitment or adjudication occurred. The procedures for applying for relief in States that have established mental health prohibitor “relief from disabilities” programs pursuant to the NICS Improvement Amendments Act of 2007 vary.

    We received a number of comments on the NPRM asserting that creating an express permission in the Privacy Rule for NICS reporting would discourage individuals from seeking needed mental health care. We appreciate these concerns and agree with commenters who asserted that individuals' health and the public's safety are best served by encouraging appropriate treatment. We also recognize that discouraging treatment could increase the burden of untreated mental conditions to individuals, in the form of increased suffering and loss of productivity; to the health care system, when individuals with untreated mental illness need emergency hospitalization, for example; and to the public's safety. However, many of these commenters expressed the mistaken belief that the permission would allow or require most mental health care providers to report their patients to the NICS.

    As explained above, we have carefully and narrowly tailored the final rule to apply only to a small number of covered entities that may be responsible for the adjudications that make an individual subject to the Federal mental health prohibitor, or that serve as repositories of data about such adjudications. The rule generally maintains a separation between treatment functions and NICS reporting functions. In addition, the rule does not permit the use or disclosure of any diagnostic or clinical information, or any other information about an individual that is not needed for NICS reporting purposes. Because of these strict limitations on the permitted uses and disclosures, we believe that individuals will not be dissuaded from seeking needed mental health care services as a result of the rule.

    Finally, we recognize the intangible burden to individuals of the negative attitudes and misperceptions associated with mental health conditions. We note that the Federal mental health prohibitor does not apply to all individuals with mental health conditions, but instead to a subset of individuals who have been involuntarily committed or determined by a lawful authority to be a danger to themselves or others, or unable to manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. This rule permits a limited number of HIPAA covered entities to report to the NICS the identities of individuals in a particular subcategory of persons who are currently prohibited by Federal law from possessing firearms. This permission facilitates the enforcement of prohibitions that were established by the Gun Control Act. Therefore, we do not expect that this rule will exacerbate negative attitudes or misperceptions associated with mental health conditions.

    D. Qualitative Analysis of Unquantified Benefits

    While we believe that there may be benefits to public safety as a result of the rule, we are not able to monetize the value of such benefits.

    For example, by removing a barrier to reporting, the rule may result in increased reporting to the NICS of individuals who may pose a risk of gun violence related to a serious mental health condition. To the extent that this rule permits covered entities to report those individuals' identities for NICS purposes, the rule provides a public safety benefit. One comment submitted in response to the NPRM noted that increased reporting could contribute to lowering the substantial financial costs of gun violence itself, which was estimated at $174 billion in medical and lost productivity expenses in 2010.42 However, we do not have information about whether, or how many, covered entities would begin to report or increase reporting to the NICS as a result of the rule, nor do we have a basis for estimating the impact, if any, on the financial costs associated with gun violence.

    42 This comment cited Miller TR. The Cost of Firearm Violence. Children's Safety Network Economics and Data Analysis Resource Center, at Pacific Institute for Research and Evaluation, December 2012.

    An additional benefit of the rule is that it provides clarity about the applicability of the Privacy Rule and its relationship to State law. Specifically, the rule alleviates the concerns of State lawmakers who, according to several commenters on the ANPRM, may be reluctant to pursue State legislation requiring entities to report Federal mental health prohibitor information for NICS purposes because of a misconception that the HIPAA Privacy Rule would preempt such requirements. As explained more fully above, the Privacy Rule permits uses and disclosures that are required by law, and thus would not preempt a State law requiring disclosures to NICS. However, to the extent that State lawmakers harbor this misconception, this preamble clarifies HIPAA's preemption provisions and the final rule provides an avenue for NICS reporting that may obviate the need to enact legislation at the State level.

    E. Additional Regulatory Analyses 1. Regulatory Flexibility Act

    The RFA requires agencies to analyze and consider options for reducing regulatory burden if a rule will impose a significant burden on a substantial number of small entities. The Act requires the head of the agency either to certify that the rule will not impose such a burden or to perform a regulatory flexibility analysis and consider alternatives to lessen the burden. For the reasons explained more fully above in the summary of costs and benefits, it is not expected that the rule will result in compliance costs for covered entities of any size because the rule does not impose new requirements. Therefore, the Secretary certifies that the rule will not have a significant impact on a substantial number of small entities.

    2. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require spending in any one year $100 million in 1995 dollars, updated annually for inflation. In 2013, that threshold is approximately $141 million dollars. UMRA does not address the total cost of a rule. Rather, it focuses on certain categories of cost, mainly those “Federal mandate” costs resulting from: (1) Imposing enforceable duties on State, local, or Tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, State, local, or Tribal governments under entitlement programs. As this rule does not impose enforceable duties or affect entitlement programs, UMRA does not require us to prepare an analysis of the costs and benefits of the rule. Nonetheless, we have done so in accordance with Executive Orders 12866 and 13563, and present this analysis in sections C and D above.

    3. Federalism

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.

    The Federalism implications of the HIPAA Privacy and Security Rules were assessed as required by Executive Order 13132 and published as part of the preambles to the final rules on December 28, 2000 (65 FR 82462, 82797) and February 20, 2003 (68 FR 8334, 8373), respectively. This final rule does not impose requirements, or any associated costs, on State and local governments. Regarding preemption, the preamble to the final Privacy Rule explained that the HIPAA statute dictates the relationship between State law and Privacy Rule requirements. Therefore, the Privacy Rule's existing preemption provisions do not raise Federalism issues, and these provisions are not affected by this rule.

    One commenter argued that a permission for entities other than States to report to the NICS would bypass the decisions of the States regarding the submission of reports and, therefore, raises federalism implications. In response, we again emphasize that this rule does not require covered entities to make disclosures that are prohibited by State law, nor does it prevent disclosures required by State law. Further, States retain discretion to determine which entities within the State are authorized to report information to the NICS. For these reasons, the rule does not have Federalism implications.

    F. Accounting Statement

    Whenever a rule is considered a significant rule under Executive Order 12866, we are required to develop an accounting statement indicating the costs associated with the rule. As explained above, we expect that the rule is cost neutral. We did not receive public comments on any unanticipated costs associated with the rule, including costs to covered entities that choose to amend written HIPAA policies and procedures or to provide additional training to staff.

    VII. Collection of Information Requirements

    This final rule does not contain requests or requirements to report information to the government, nor does it impose new requirements for recordkeeping or disclosures to third-parties or the public. Therefore, the requirements of the Paperwork Reduction Act with respect to information collections do not apply.

    List of Subjects in 45 CFR Part 164

    Administrative practice and procedure, Computer technology, Electronic information system, Electronic transactions, Employer benefit plan, Health, Health care, Health facilities, Health insurance, Health records, Hospitals, Medicaid, Medical research, Medicare, Privacy, Reporting and recordkeeping requirements, and Security.

    For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR Subtitle A, Subchapter C, part 164, as set forth below:

    PART 164—SECURITY AND PRIVACY 1. The authority citation for part 164 continues to read as follows: Authority:

    42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Public Law 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2(note)); and secs. 13400-13424, Public Law 111-5, 123 Stat. 258-279.

    2. Amend § 164.512 by adding paragraph (k)(7) to read as follows:
    § 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required.

    (k) * * *

    (7) National Instant Criminal Background Check System. A covered entity may use or disclose protected health information for purposes of reporting to the National Instant Criminal Background Check System the identity of an individual who is prohibited from possessing a firearm under 18 U.S.C. 922(g)(4), provided the covered entity:

    (i) Is a State agency or other entity that is, or contains an entity that is:

    (A) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; or

    (B) A court, board, commission, or other lawful authority that makes the commitment or adjudication that causes an individual to become subject to 18 U.S.C. 922(g)(4); and

    (ii) Discloses the information only to:

    (A) The National Instant Criminal Background Check System; or

    (B) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; and

    (iii)(A) Discloses only the limited demographic and certain other information needed for purposes of reporting to the National Instant Criminal Background Check System; and

    (B) Does not disclose diagnostic or clinical information for such purposes.

    Dated: December 30, 2015. Sylvia M. Burwell, Secretary.
    [FR Doc. 2015-33181 Filed 1-4-16; 4:15 pm] BILLING CODE 4153-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [GN Docket No. 12-268; WT Docket Nos. 14-70, 05-211; RM-11395; FCC 15-80] Updating Competitive Bidding Rules AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    In this document, the Commission announces that on December 10, 2015, the Office of Management and Budget (OMB) approved, on an emergency basis, for a period for six months, a revision to an approved information collection to implement a modified collection requirement under 47 CFR 1.2105(c)(4) contained in the Part 1 Report and Order, Updating Competitive Bidding Rules, FCC 15-80. This document is consistent with the Part 1 Report and Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of the rule and requirement.

    DATES:

    47 CFR 1.2105(c)(4), published at 80 FR 56764 on September 18, 2015, is effective on January 6, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Contact Cathy Williams, [email protected], (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    This document announces that, on December 10, 2015, OMB approved, on an emergency basis, a revision to an approved information collection to implement a modified information collection requirement under 47 CFR 1.2105(c)(4), published at 80 FR 56764 on September 18, 2015. The OMB Control Number is 3060-0995. The Commission publishes this document as an announcement of the effective date of the rule and requirement. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0995, in your correspondence. The Commission will also accept your comments via the Internet if you send them to [email protected].

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Synopsis

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received emergency approval from OMB on December 10, 2015 for the revised information collection requirements contained in the information collection 3060-0995, Section 1.2105(c), Bidding Application and Certification Procedures; Sections 1.2105(c) and Section 1.2205, Prohibition of Certain Communications.

    Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

    No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0995. The foregoing document is required by the Paperwork Reduction Act of 1995, Pub. L. 104-13, October 1, 1995, and 44 U.S.C. 3507.

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-0995.

    OMB Approval Date: December 10, 2015.

    OMB Expiration Date: June 30, 2016.

    Title: Section 1.2105(c), Bidding Application and Certification Procedures; Sections 1.2105(c) and Section 1.2205, Prohibition of Certain Communications.

    Form No.: N/A.

    Respondents: Business or other for-profit entities; Not-for-profit institutions; State, local or Tribal government.

    Number of Respondents and Responses: 10 respondents; 10 responses.

    Estimated Time per Response: 1.5 hours to 2 hours.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in sections 154(i), 309(j), and 1452(a)(3) of the Communications Act of 1934, as amended, 47 U.S.C. 4(i), 309(j)(5), and 1452(a)(3), and section 1.2105(c)(4) of the Commission's rules, 47 CFR 1.2105(c)(4).

    Total Annual Burden: 50 hours.

    Total Annual Cost: $9,000.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission will take all reasonable steps to protect the confidentiality of all Commission-held data of a reverse auction applicant consistent with the confidentiality requirements of the Spectrum Act and the Commission's rules. See 47 U.S.C. 1452(a)(3); 47 CFR 1.2206. In addition, to the extent necessary, a full power or Class A television broadcast licensee may request confidential treatment of any report of a prohibited communication submitted to the Commission that is not already being treated as confidential pursuant to section 0.459 of the Commission's rules. See 47 CFR 0.459. Forward auction applicants are entitled to request confidentiality in accordance with section 0.459 of the Commission's rules, 47 CFR 0.459.

    Needs and Uses: In the Broadcast Incentive Auction Report and Order, Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, FCC 14-50, the Commission adopted a new rule for forward auction applicants prohibiting certain communications in the context of the television broadcast incentive auction (BIA), and amended an existing rule to require forward auction applicants that make or receive a communication that is prohibited under the new rule to file a report of such a communication with the Commission. See 47 CFR 1.2105(c)(4), 1.2105(c)(6). Subsequently, as a result of amendments to various other provisions in section 1.2105(c) adopted in the Part 1 Report and Order, the new rule for forward auction applicants prohibiting certain communications in the context of the BIA and the amended reporting requirement for forward auction applicants were redesignated as 1.2105(c)(4) and 1.2105(c)(6), respectively, without any changes to the scope or substance of either rule. See 47 CFR 1.2105(c)(4), 1.2105(c)(6). The Commission's rules prohibiting certain communications in Commission auctions are designed to reinforce existing antitrust laws, facilitate detection of collusive conduct, and deter anticompetitive behavior, without being so strict as to discourage procompetitive arrangements between auction participants. They also help assure participants that the auction process will be fair and objective, and not subject to collusion. The revised information collection implements the modified, BIA-specific rule in section 1.2105(c)(4) by making clear the responsibility of parties who receive information that potentially violates the rules to promptly submit a report notifying the Commission, thereby helping the Commission enforce the prohibition on covered parties, and further assuring incentive auction participants that the auction process will be fair and competitive. The prohibited communication reporting requirement required of covered parties will enable the Commission to ensure that no bidder gains an unfair advantage over other bidders in its auctions and thus enhances the competitiveness and fairness of Commission's auctions. The information collected will be reviewed and, if warranted, referred to the Commission's Enforcement Bureau for possible investigation and administrative action. The Commission may also refer allegations of anticompetitive auction conduct to the Department of Justice for investigation.

    Federal Communications Commission. Sheryl Todd, Deputy Secretary, Office of the Secretary.
    [FR Doc. 2015-33241 Filed 1-5-16; 8:45 am] BILLING CODE 6712-01-P
    81 3 Wednesday, January 6, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Parts 271, 272, 273, 274, and 278 RIN 0584-AE45 Supplemental Nutrition Assistance Program (SNAP) Photo Electronic Benefit Transfer (EBT) Card Implementation Requirements AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    Under Section 7(h)(9) of the Food and Nutrition Act of 2008, as amended (the Act), States have the option to require that a Supplemental Nutrition Assistance Program (SNAP) Electronic Benefit Transfer (EBT) card contains a photo of one or more household members. The Act and existing program regulations further provide that a State that implements a photo on the EBT card shall establish procedures to ensure that any other appropriate member of the household or any authorized representative of the household may use the card. This proposed rule would provide clear parameters on these requirements. In addition, this rule proposes to amend program regulations to codify guidance that was issued December 29, 2014, requiring States that intend to implement the photo EBT card option to submit a comprehensive Implementation Plan that addresses certain operational issues to ensure State implementation is consistent with all Federal requirements and that program access is protected for participating households. In this proposed rule, the United States Department of Agriculture (the Department or USDA) would clarify that the State option to place a photo on an EBT card is a function of issuance. Pursuant to this, State agencies would be prohibited from having photo EBT card requirements affect the eligibility process. This includes ensuring that the option is appropriately implemented in a manner that does not impose additional conditions of eligibility or adversely impact the ability of appropriate household members to access the nutrition assistance they need. Failure to cooperate may result in penalties, including loss of federal financial participation. The proposed rule would also codify other program updates to reflect the current operations of the program.

    DATES:

    Written comments must be received on or before March 7, 2016 to be assured of consideration.

    ADDRESSES:

    The Food and Nutrition Service, USDA, invites interested persons to submit written comments on this proposed rule. Comments may be submitted in writing by one of the following methods:

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

    Mail: Send comments to Vicky T. Robinson, Chief, Retailer Management and Issuance Branch, Rm. 426, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, Virginia 22302.

    • All written comments submitted in response to this proposed rule will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identity of the individuals or entities submitting the comments will be subject to public disclosure. FNS will make the written comments publicly available on the Internet via http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Vicky T. Robinson, Chief, Retailer Management and Issuance Branch, Rm. 426, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, Virginia 22302, 703-305-2476.

    SUPPLEMENTARY INFORMATION:

    Background Acronyms or Abbreviations

    In the discussion of this proposed rule, we use the following acronyms or other abbreviations to stand in for certain words or phrases:

    Phrase Acronym,
  • abbreviation,
  • or symbol
  • Code of Federal Regulations CFR. Electronic Benefit Transfer EBT. Food and Nutrition Act of 2008, as amended Act. Food and Nutrition Service FNS. Personal Identification Number PIN. Point of Sale POS. Supplemental Nutrition Assistance Program SNAP. United States Code U.S.C. U.S. Department of Agriculture the Department or USDA.

    Under Section 7(h)(9) of the Act, 7 U.S.C. 2016(h)(9), States have the option to require that a SNAP EBT card contain a photo of one or more household members. The statute also stipulates that if a State agency chooses to place photographs on EBT cards, the State must establish procedures to ensure that any appropriate member of the household or any authorized representative of the household may utilize the card.

    Pursuant to this statutory provision, existing regulations in 7 CFR 274.8(b)(5)(iv) provide that should a State agency require a photo on EBT cards, it must also establish procedures to ensure this same participant access is maintained. However, recent State implementation of the photo EBT card option revealed significant legal and operational complexities and challenges associated with having a photo on the card that, in the Department's view, calls for more regulatory guidance in this area. As a result, the Department is proposing to amend regulations in several areas to more explicitly define participant protections that must be maintained as well as implementation requirements if the State agency elects to implement a photo EBT card. In particular, this proposed regulation would clarify that the State option to place a photograph on an EBT card is a function of issuance. Pursuant to this, State agencies would be prohibited from having photo EBT card requirements affect the household eligibility or the certification process. Moreover, this rule would clarify the right of all household members and their authorized representatives to use the EBT card, regardless of whether their photo is on the card, and further define the responsibility of State agencies to ensure that retailers understand photo EBT requirements when processing transactions involving SNAP.

    Implications of Photo EBT Card Option

    While the photo EBT card option was provided to States through the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, few States have implemented the option to date. However, recent efforts have shown that implementation of the photo EBT card option involves complex legal, operational, and civil rights issues that, if not well planned and implemented, can adversely affect access for program participants. Recent photo EBT card rollouts have had major implementation issues, raising concerns about program access, and leading to confusion in the retailer community.

    These issues in turn prompted the Department to issue guidance on the subject on December 29, 2014. This proposed rule would expand on and codify this guidance to help ensure clients' access to benefits is maintained in practice and that sufficient measures are taken to ensure access before the photo EBT option is rolled out.

    There has been some question as to whether adding the photo to an EBT card adds value to the integrity of SNAP. Statute requires that any household member or any authorized representative must be able to use the EBT card, regardless of whether their photo is on the card. For this reason, and because trafficking often involves a willing retailer, placing a photo on the EBT card will have limited impact in addressing fraud. In fact, some State agencies have investigated the possible benefits of adding the photo and, upon further analysis, decided it was not worth the cost to do so. Nevertheless, the Act provides States with the option to implement the photo on the EBT card and these proposed regulations are intended to fill the existing policy gaps in this area for the reasons cited above.

    Discussion of the Rule's Provisions State Agency Requirements for Photo EBT Card Implementation

    This proposed rule provides that State agencies would be required to meet certain requirements in order to implement a photo EBT card policy. The implementation requirements firmly establish SNAP policy that the photo EBT card option is a function of issuance and not a condition of eligibility; certification policy may not be impacted by the implementation of the option; all appropriate household members and authorized representatives, as defined in 7 CFR 273.2(n)(3), shall continue to be able to use the EBT card; program access is not inhibited at retail stores; and program access and program integrity are ensured through all stages of the process. A State considering a photo EBT card policy will need to lay out how it will operationalize the policy and develop and implement an Implementation Plan and photo EBT option that upholds all SNAP requirements.

    To establish the requirements for the photo EBT card provisions, a new section would be codified in 7 CFR 274.8(f), addressing all the requirements associated with implementing a photo EBT card policy. Changes are also proposed to paragraphs within 7 CFR part 273 to further clarify that photo EBT card processes do not impact the certification of eligible households.

    Minimum Requirements

    Implementation of the photo EBT card option takes substantial resources and requires substantial changes to State systems and procedures. Due to these challenges, States that have recently implemented photo EBT card implementations have had significant issues with providing timely, accurate, and fair service to SNAP applicants and participants and with meeting other statutory and regulatory requirements. For this reason, the Department would require that States demonstrate to FNS successful administration of SNAP based on SNAP performance standards to be eligible to implement the photo EBT card option. Successful program administration would be based on an evaluation of metrics related to program access, the State's payment error rate, the State's Case and Procedural Error Rate, application processing timeliness, including 7-day expedited service and the 30-day processing standards, timeliness of recertification actions, and other metrics, as determined by the Secretary, that may be relevant to the implementation of a State's photo EBT card option. States would need to document in the Implementation Plan that they are meeting FNS performance expectations. The Department is interested in comments from the public about other metrics that FNS should consider in the context of determining successful program administration including metrics related to access to benefits. These performance standards will allow FNS to evaluate whether clients are receiving timely, accurate, and fair service before the State may be eligible to implement a photo EBT card option. This provision would be codified in 7 CFR 274.8(f)(1).

    Function of Issuance

    The proposed rule clarifies that the photo EBT card option is a function of issuance and not a condition of certification. Any implementation of the photo EBT card option must not impact certification of households. State agencies shall not deny or terminate a household based solely on whether one or more household members comply with the requirement to have a photo on the EBT card.

    The State agency's photo EBT card policy must not affect the certification process for purposes of determining eligibility regardless of whether an individual has his/her photo placed on the EBT card. For example, an application would be considered complete and be subject to 7 and 30-day processing timelines regardless of the status of the photo. Application processing timeliness requirements would not be different for photo EBT cards. This provision would be codified in 7 CFR 274.8(f)(2).

    Voluntary vs Mandatory

    The proposed rule would allow for State agencies to implement the SNAP photo EBT card on a mandatory or voluntary basis. Regardless of whether the photo is mandatory or voluntary, clients must be informed that their household's certification will not be impacted by whether they agree to the photo. If the policy is mandatory, State agencies must establish which member(s) of the household would be required to be photographed and must establish procedures that allow eligible nonexempt household members who do not agree to the photo to come into compliance at a later time. The photo may be of the head of household and/or other participating nonexempt household member(s). State agencies must issue benefits to compliant or exempt household members and, as noted earlier, non-compliance with a photo requirement by household members who choose not to be photographed must not negatively impact the household's eligibility determination.

    If the policy is voluntary, clients would be able to elect to have their photo on the household EBT card but would not be required to do so and would not have to be in an exempted category to opt out of the photo option. State agencies implementing a voluntary photo EBT card policy would be required to make clients aware of the voluntary nature of the photo and the fact that benefit issuance would not be impacted by their decision to have or not have a photo on their card. In voluntary implementations, households would opt in to have a photo on their cards rather than opt out of the option. Therefore, EBT cards with photos would not be the default.

    FNS has concerns that States implementing voluntary photo EBT card policies to date have been unsuccessful in communicating the nature of the program to clients and remains concerned about how such lack of information could affect SNAP households, especially those with non-applicant heads of household. The Department is seeking comment about suggestions for how to strengthen the requirements on States to provide clear and effective information that ensures clients understand the State's photo EBT policies. Additionally, to ensure States' implementation of the photo EBT option does not create disparate impacts on members of any protected class, as proposed, States would not be allowed to photograph non-applicants or put their photo on an EBT card, regardless of whether the State's program is voluntary or mandatory. As proposed, States could not offer non-applicant heads of households the option to opt in to have their photos taken to ensure that clients would not be pressured by States, intentionally or inadvertently, to have a photo taken. Nevertheless, FNS would like to better understand if there is any potential benefit of allowing non-applicants to have their photograph taken under a voluntary implementation and whether such benefits outweigh potential problems.

    These provisions would be codified in 7 CFR 274.8(f)(3) and 7 CFR 27.8(f)(4).

    Exemptions

    Because recent implementation by States showed inconsistency and confusion in the application of State-defined exemption criteria, the Department is making clear in this proposed rule who must be exempted from photo EBT card requirements. State implementation showed there were circumstances where even exempt clients as defined by those States, such as the elderly, disabled, or domestic violence victims, were not actually exempted from the photo EBT requirement. In addition, many clients were not clearly informed that they were exempt under the State's exemption criteria and were under the impression that they had to comply with the State's photo EBT card policy in order to receive program benefits.

    To ensure that a State's photo EBT card requirement will not place undue burden on vulnerable clients, the proposed rule requires States implementing a mandatory implementation to exempt, at a minimum, the elderly, the disabled, children under 18, homeless households, and victims of domestic violence. FNS proposes that victims of domestic violence would be able to self-attest and States would not be permitted to require clients to submit documentation to verify that they have been victims of domestic violence. The ability to self-attest must be applied equally regardless of whether the victim is a female or male. A State agency may establish additional exempted categories, including, but not limited to, categories described in hardship criteria as specified in 7 CFR 273.2(e)(2).

    As noted in the previous section, as proposed, non-applicants shall not be required nor permitted to have their photographs taken or put on EBT cards. This provision would be codified in 7 CFR 274.8(f)(4).

    Serving Clients With Hardship

    The proposed rule requires that State agencies have sufficient capacity and a process to issue photo EBT cards, taking into account households that face hardship situations as determined by the State agency and that would receive non photo EBT cards. These hardship conditions include, but are not limited to: Illness, transportation difficulties, care of a household member, hardships due to residency in a rural area, prolonged severe weather, or work or training hours which prevent the household from having photos taken in-office.

    Issuance of Photo EBT Card

    There are a variety of SNAP policy and operational questions that States must consider in developing their issuance process for photo EBT cards, including the technical aspects relating to software, hardware, and the taking, storage, and security of photos.

    The proposed rule would require that States demonstrate sufficient capacity to issue photo EBT cards before they may receive an authorization from FNS to implement the option. As noted in the previous section on hardship, any State implementing a photo EBT card option would have to establish a process to issue cards to households that may not be able to reach a local office due to a hardship condition. Furthermore, the process for issuing and activating photo EBT cards must not inhibit or delay access to benefits nor cause a gap in access to benefits for any eligible households. Any card issued as part of the implementation of the photo EBT card option may not count against the household as part of the maximum threshold of replacement cards as specified in 7 CFR 274.6(b)(5) and 7 CFR 274.6(b)(6). Most importantly, as noted earlier, non-compliance with a photo requirement cannot impact the eligibility determination of the household as the photo EBT card option is an issuance function, not a condition of eligibility.

    States that have recently implemented a photo EBT policy have struggled with operational challenges during the transition from regular EBT cards to photo EBT cards. In one State, some clients lost access to their benefits during the period between the deactivation of their previous EBT card and activation of the new EBT photo card. This proposed rule would require that States implementing the photo EBT card option establish a process to ensure that the replacement of cards does not disrupt households' access to benefits, consistent with the requirements of 7 U.S.C. 2016(h)(9). Additionally, State card issuance procedures developed for new SNAP households would need to ensure adherence to the application processing standards of 7 days in the case of expedited households and 30 days for all other households, as required by 7 CFR 273.2(g) and 7 CFR 273.2(i).

    As proposed, if a household meets expedited criteria in 7 CFR 273.2(i), the State must issue benefits and issue the EBT card to the entire household without delay. Regardless of whether the State's photo EBT policy is voluntary or mandatory, the State could not delay, hold in abeyance, or prorate benefits for any household that meets expedited criteria in order to obtain a photo on the EBT card. Under a mandatory implementation, a non-exempt household member could be required to comply at the next recertification after expedited benefits have been issued to the household. If the non-exempt household member is not in compliance by the time the household is recertified, then the State could determine whether that member's share of benefits must be held in abeyance prospectively. Under the proposed rule, State agencies implementing a photo EBT card option must also meet the card replacement issuance card requirements stipulated in 7 CFR 274.6, which, among other things require States to issue replacement EBT cards within 2 business days following notice by the household that the card has been lost, stolen, or damaged.

    This provision would be codified in 7 CFR 274.8(f)(6).

    Prorating Household Benefits When Photo EBT Card Is Mandatory

    State agencies would not be able to deny benefits to an entire household because a nonexempt household member(s), required by the State to be photographed, refuses to be photographed. Unless the household meets expedited criteria, this proposed rule would require the State to issue a prorated share of benefits to the remaining household members, so they can use their share of the benefits that they are entitled to receive.

    As proposed, for multi-person households, that would be a straight pro-ration of benefits. The State would divide the household's benefit allotment by the household size and multiply that number by the number of household members to be issued benefits. To illustrate, if a four-person household's monthly benefit allotment is $200 and one nonexempt household member does not comply with the requirement to have a photo placed on the EBT card, the $200 would be divided by 4 to equal $50, and then multiplied by 3 to equal $150. The $150 amount would be posted and available for use by the household. Any decision that impacts benefits under this provision would be subject to fair hearings in accordance with 7 CFR 273.15. For a single person household, the State agency would hold the entire benefit in abeyance until the household complies. This proposed provision is addressed in 7 CFR 274.8(f)(7) of the regulation.

    Benefits Held for Noncompliance

    FNS proposes that the pro-rated benefit amounts held for noncompliance with a State's photo EBT card requirement would be tracked and retained for future issuance by the State agency if and when any noncompliant household member(s) that previously chose not to be photographed comes into compliance. The pro-rated benefits withheld for that individual or individuals must promptly be issued within two business days of the time the individual(s) comes into compliance. Benefits withheld for non-compliance would not remain authorized for perpetuity and States must treat such benefits in accordance with the same timeframe used for handling expungements under 7 CFR 274.2(h)(2). This would allow States to better manage benefits that have not been issued.

    This proposed provision is addressed in 7 CFR 274.8(f)(8) of the regulation.

    Household and Authorized Representatives Card Usage

    The Food and Nutrition Act requires States implementing photo EBT to “establish procedures to ensure that any other appropriate member of the household or any authorized representative of the household may utilize the card.” All household members, authorized representatives as defined in 7 CFR 273.2(n)(3), and non-applicants applying on behalf of others have a right to access SNAP benefits by using the household EBT card with a valid PIN even if their picture is not on the card or there is no picture on the card. The State agency must take steps to ensure that individuals who are not pictured on the card can continue to access SNAP benefits in accordance with the Section 7(h)(9)(B) of the Act.

    The ability for authorized representatives to use the card is particularly critical to ensure food access for the elderly, disabled, or other homebound recipients who may have difficulty getting to grocery stores and require assistance in obtaining food.

    This provision would be codified in 7 CFR 274.8(f)(9).

    Client and Staff Training

    This proposed rule would require that States ensure all staff and clients are trained on photo EBT card requirements. At a minimum, this training would include information about whether the photo EBT card is voluntary or mandatory, that all appropriate household members and authorized representatives are able to use the card, and with regards to mandatory implementation, which household members (if any) must comply with the photo requirement, which household members and/or household applicant categories are exempt. This proposed rule would also require that all retailer and client notices pertaining to the photo EBT card must also clearly describe the following statutory and regulatory requirement: All household members and any authorized representative of the household regardless of whether they are pictured on the card, may utilize the card without having to submit additional verification of identity as long as the transaction is secured by the use of the PIN. This proposed rule would also stipulate that State agencies may not specifically reference groups exempt from the photo requirement in any materials designed for retailers, as providing the categories of exempt groups may encourage speculation as to the age or circumstances of cardholders. External stakeholder materials should simply note that EBT cards without a photo are also valid. This provision would be codified in 7 CFR 274.8(f)(10).

    Retailer Education and Responsibilities

    Although retailer participation in SNAP is authorized and managed by USDA, this rule, as proposed, recognizes State agencies opting to implement a photo EBT card would impact SNAP transactions at the point of sale. Per the statutory requirement, State agencies are required to ensure access to benefits by household members other than the member(s) whose photo is on the card, as well as authorized representatives. Therefore, in paragraph 7 CFR 274.8(f)(10), this proposed rule would require State agencies to provide information to all retailers about the State agencies' implementation and operational plans so retailers are prepared for the changes, as well as to convey the Federal rules stipulating that all household members and authorized representatives must be allowed to use the EBT card regardless of the picture on the card. Furthermore, Federal rules prohibit retailers from treating SNAP participants differently from other customers at the point of sale. According to the equal treatment regulation in 7 CFR 278.2(b), SNAP customers cannot be singled out for special treatment in any way.

    A State agency would need to provide documentary evidence that all retailers in the State and contiguous areas, including smaller independent retailers, have received notices from the State that explain the statutory and regulatory requirements related to photos on EBT cards described above and have a full understanding of those requirements. State agencies would be required to describe in the Implementation Plan when they will provide FNS with this documentary evidence in advance of implementation. This provision would be codified in 7 CFR 274.8(f)(11).

    Interoperability

    Section 7(j) of the Act requires that EBT cards be interoperable, which means that they can be used in any State regardless of where the benefits were issued. Without sufficient education for clients and retailers in both the implementing State and neighboring States, the implementation of the photo EBT card option could inhibit this required access to benefits. For example, a SNAP recipient who lives in a State with a photo EBT card may find it more convenient or cost effective to shop in another bordering State that does not have photo EBT cards. Likewise, a SNAP recipient may live in a State without a photo EBT card requirement, but shop in a State with such a card requirement. To ensure interoperability, clients, and retailers must be fully informed that the photo EBT cards remain interoperable and that authorized retailers must accept EBT cards from all States as long as the household member or authorized representative presents the valid PIN. Before introducing the new photo EBT cards, this proposed rule would require State agencies to conduct sufficient outreach to clients and retailers, including those in contiguous areas, to ensure access to benefits is not inhibited and all parties understand their rights and responsibilities.

    This provision would be codified in 7 CFR 274.8(f)(12).

    Advance Planning Document

    As the Act allows for photo EBT cards, appropriate implementation and administration of this option is an allowable State administrative cost which FNS would reimburse at approximately 50 percent. To ensure that FNS does not exceed the SNAP budget authority for State administration, States should be aware that any EBT contract modifications that increase costs must be approved by FNS before they may be signed. Increased EBT costs, whether contractual or resulting from other sources, also require an Implementation Advance Planning Document Update. This provision would be codified in 7 CFR 274.8(f)(13).

    Implementation Plan

    In 7 CFR 274.8(f)(14), this proposed rule would require State agencies to submit an Implementation Plan prior to photo EBT implementation that delineates how the State will operationalize this option. Upon receipt of the State's Implementation Plan, FNS would review the plan and either issue an approval, request modifications before an approval could be granted, or issue an approval subject to conditions. In cases where the Department finds that the steps outlined in the Implementation Plan are not sufficient for a successful implementation, the Department might issue an approval subject to conditions, such as requiring the State agency to demonstrate a rollout in a pilot in a selected region of the State before the State may be approved to implement statewide or, FNS might approve the Implementation Plan for a statewide implementation upon the completion of an appropriate successful pilot project that establishes the State agency's ability to implement a full statewide rollout. Should a State be required to implement a pilot before statewide implementation, that requirement would be documented as a condition of the State's Implementation Plan approval, along with any information that the State must report to FNS before the State may be granted approval to implement statewide.

    FNS expects that the process for FNS review and approval of photo EBT Implementation Plans will take at least 120 days. Obtaining FNS approval of the Implementation Plan is the first step States must take. However, a State may not actually issue EBT cards with photos until FNS has given the State an authorization to do so as described below. The multi-step approval process ensures that the State carries out the steps detailed in the Implementation Plan and has the opportunity to make any adjustments needed prior to issuing EBT cards with photos. Similarly if FNS has approved an Implementation Plan subject to conditions, such as requiring the State agency to conduct a pilot prior to statewide implementation, the State may not issue EBT cards with photos in the context of the pilot until FNS has given the State an authorization to do so. Approval from FNS would also be necessary for a State to proceed from pilot to statewide implementation. Any movement to implement without prior approval would be viewed as a violation of program requirements and could result in additional penalties including a loss of Federal financial participation.

    FNS would not consider a State eligible or authorize a State to proceed with a photo EBT card option unless that State meets performance requirements noted earlier and established in 7 CFR 274.8(f)(1). States would need to demonstrate in the Implementation Plan that they are meeting FNS performance expectations. The Implementation Plan would also be required to include a description of the State's card issuance procedures, a detailed description of how client protections such as processing timelines and benefit access will be preserved, specific information about exempted recipients, a description of how the State will obtain photographs for the EBT card, training materials and training plans for State staff, examples of letters and other materials communicating the policy to recipients and to retailers, a proposed timeline for implementation, and any other information as required by the Secretary. If a State agency plans to disclose SNAP applicant or client data in accordance with 7 CFR 272.1(c) for purposes of implementing photo EBT cards, such as to obtain photos from another source like the State's Department of Motor Vehicles the proposed rule requires the State to also include any necessary memoranda of understanding as part of its Implementation Plan. Any information collected for the purpose of SNAP must be securely stored and can only be shared in accordance with 7 CFR 272.1(c).

    State Implementation Plans would also be required to describe: The specific action steps that the State agency and its EBT contractor must take in order to implement the photo EBT card option as planned, together with the anticipated timetable for each step; the State's capacity to issue photo EBT cards; and the submission of the documentation that all retailers, including small and independent retailers, would receive notice from the State about the photo EBT card policy. The plan would also need to describe how the State will ensure that the photo EBT cards are provided to clients and activated at the same time or before the active non-photo cards are deactivated. With regard to the State's capacity to issue photo EBT cards, the plan would include the description of the capacity at the facility where photo EBT cards will be produced, both for transitional and ongoing production, and assurance that the State and its EBT contractor will continue to meet regulatory timeliness requirements for all EBT card issuances. The Implementation Plan should also describe measures against which the photo EBT card implementation will be evaluated for the post-implementation evaluation required by 7 CFR 274.8(f)(16), and how the requisite data will be collected.

    The State would also be required to include in its plan for FNS review all applicable written policy changes necessary to implement the photo EBT card option, as well as copies of all materials that will be used to inform clients, retailers and other stakeholders regarding photo EBT card implementation. Along with these materials, the States would need to provide a detailed description of how the notifications, communication, policies, and procedures regarding the implementation of the photo EBT card option will comply with all applicable civil rights laws.

    Finally, the State would need to provide a description of the mechanisms in place to handle complaint calls and questions from clients, retailers, and external stakeholders and address any other issues related to the photo EBT card option, as well as detail how substantive information about those complaints will be tracked and reported. A State would not be authorized to issue EBT cards with photos until FNS grants the State an authorization to implement as specified by 7 CFR 274.8(f)(15).

    Upon approval of the Implementation Plan, the State would be allowed to proceed with tasks described in the Implementation Plan, as modified by the approval, but not proceed to issuing actual cards until FNS provides authorization to implement.

    An approved Implementation Plan would be considered public and would be posted on the FNS Web site. The Department is interested in receiving comments on any benefits and concerns of posting the approved Implementation Plan.

    Authorization To Issue Photo EBT Cards

    The authorization to implement would allow the State agency to begin issuing EBT cards with photos. After the Implementation Plan is approved, FNS will review State actions at an appropriate time interval to ensure that the process and steps outlined by the State agency in the Implementation Plan have in fact been carried out in a satisfactory manner. For example, prior to obtaining authorization to implement, a State would need to confirm and/or demonstrate that robust client and retailer outreach, as detailed in its Implementation Plan, has been completed.

    If FNS finds that the State agency has not acted in accordance with the steps outlined in the State's photo EBT Implementation Plan, FNS could deny authorization for the State to issue EBT cards with photos until the State has done so in a satisfactory manner. FNS could also require the State to implement in a phased manner, which may include criteria as determined by the Secretary. This provision would be codified in 7 CFR 274.8(f)(15).

    Post-Implementation Assessment and Evaluation

    As already noted, 7 CFR 274.8(f)(16) would require States to submit to FNS a post-implementation evaluation conducted by from an independent evaluator, which describes the State's implementation to date, including any issues that arose and how they were addressed, the degree to which State staff, clients and retailers properly understood and implemented the relevant policies and procedures, and in the case of a mandatory implementation, the number of clients that complied with adding the photo or did not comply, and the number that had their share of the benefits withheld from issuance and for how long. The evaluation must include, at a minimum, a survey of retailers and clients to measure their understanding of the State's photo EBT policy, and a report which includes the number of households and percent of households with photo EBT cards in the State and the number and scope of complaints related to photo EBT implementation, including a detailed summary of the types of complaints, the SNAP performance metrics as established in section 7 CFR 274.8(f)(1) and other information as determined by the Secretary.

    For States implementing a mandatory implementation, the report must also detail the amounts and percent of benefits withheld for non-compliance, the number of households affected by the withholding of benefits due to noncompliance, the number and percent of persons exempt from the photo EBT card requirement, and the number and percent of exempted households and persons who opted to have the photo on the EBT card.

    State agencies would be required to deliver this report to FNS within 120 days of implementation. This report would cover the first 90 days of implementation. The Department reserves the right to conduct its own review of the State's implementation.

    Ongoing Monitoring

    Based on observed implementation to date, there is cause for concern about possible impacts of photo EBT implementations, both as they are first implemented and over time. There is a need for additional assurance on an ongoing basis that state implementation of photo EBT cards is carried out in a manner consistent with all relevant laws and regulations, including Federal civil rights laws, that protect households' ability to access or utilize SNAP benefits for which they are eligible, and in a manner that does not adversely impact program participation.

    As set forth in the proposed rule, in addition to the post-implementation report, a State agency that has implemented a photo EBT policy would be required to provide to FNS, on an ongoing basis, data on established metrics to monitor the impact of the photo EBT policy. The reporting requirements might require State agencies to conduct additional surveys, evaluations, or reviews of their operations, as determined by the Secretary. These ongoing reporting requirements would include information on the amounts and percent of benefits withheld for non-compliance, the number of households affected by the withholding of benefits due to non-compliance, the number and percent of household exempt from the photo EBT card requirement, benefit redemption rates, participation rates, the number and percent of households exempt from photo EBT cards who opted out of the photo requirement, the number and percent of exempted households who opted to have the photo on the EBT card, and any other information as requested by the Secretary. We are interested in receiving comments on other data that should be required from States on an ongoing basis, how frequently States should be required to report, or any other feedback relevant to the ongoing monitoring of this policy. As with other Program information and plans, this information would be available to the public upon request, subject to the Freedom of Information Act provisions.

    While staff, client, and retailer education is a critical component, it is not always a perfect indicator of whether actual barriers to access exist in practice. In the context of housing discrimination, “testers” have been utilized to proactively determine whether fair housing laws are being upheld consistently. One question is whether a similar mechanism should be used to ensure that, in practice, SNAP participants and their authorized representatives are able to use their benefits to purchase food at authorized retailers, regardless of whether they are pictured on the EBT card. We invite comment on this question as well as on the topic of how to verify appropriate implementation on an ongoing basis, particularly on ongoing mechanisms for identifying access issues resulting from photo EBT cards.

    Modifying Implementation of Photo EBT Option

    As part of FNS's management and oversight responsibilities, FNS regularly conducts management evaluation reviews of State agencies' administration and operation of SNAP to determine compliance with program requirements. FNS will conduct management evaluation reviews, as appropriate, to monitor State implementation of photo EBT cards.

    If FNS identifies deficiencies in a State's implementation or operations, FNS may require a corrective action plan consistent with 7 CFR 275.16 to reduce or eliminate deficiencies. If a State does not take appropriate actions to address the deficiencies, FNS would consider possible actions such as requiring an updated photo EBT Implementation Plan, suspension of implementation and/or withholding funds in accordance with 7 CFR 276.4. Along these lines the Department is seeking comments on whether a State should be required to stop or suspend issuing photos on EBT cards if the State agency fails to establish procedures to ensure that all members of the household or any authorized representatives of the household are able to utilize the card, and what requirements, if any, should apply to that process.

    Provisions Beyond 7 CFR 274.8(f)

    Beyond Part 7 CFR 274.8(f), changes are proposed to 7 CFR parts 271, 272, 273, and other paragraphs within Parts 274 and 278. While some of these changes are related to photo EBT card requirements, others involve updating SNAP regulations or enhancing integrity provisions.

    7 CFR Part 271

    The Department proposes to amend the definition of Identification (ID) card in 7 CFR 271.2. ID card in this definition refers to a card that was issued when program benefits were issued in the form of food stamp coupons. This ID card, which was used to establish the recipient as eligible to receive food stamp coupons, such as when picking up coupons at the State office or other central location is no longer widely used in the program. Today, program benefits are automatically deposited into the household's EBT account each month and are redeemed through EBT cards. The PIN on the EBT card establishes whether a household recipient or authorized representative can redeem program benefits. However, this ID is still used in Alaska to identify households that are dependent upon hunting and fishing for subsistence. The definition for Identification (ID) would be amended to reflect only cases in which ID cards are currently used in the Program.

    7 CFR Part 272

    The Department proposes changes to 7 CFR part 272 to ensure that regulatory language is in line with current program operations. In alignment with the change to 7 CFR 271.2, FNS proposes removing all references to “ID card” associated with the obsolete paper coupons. It would result in the removal of 7 CFR 272.1(g)(30) and 7 CFR 272.1(g)(47).

    7 CFR Part 273

    FNS proposes several changes to 7 CFR part 273. The Department proposes adding language in 7 CFR 273.2(a)(1) to clarify that the implementation of the photo EBT card option cannot be treated as a condition of eligibility as it is a function of issuance. Further, this paragraph would be amended to ensure that, for the purpose of certification, States shall not treat households subject to a photo EBT card policy differently from households not subject to a photo EBT card policy. To ensure that expedited and standard application processing requirements are still met in photo EBT card situations, 7 CFR 273.2(a)(2) would be revised by adding that State agencies shall ensure that processing times are not delayed by implementation of the photo EBT card option. Third, the Department proposes to clarify the rules governing interviews in 7 CFR 273.2(e). State agencies may not require an in person interview solely for the purpose of taking a photo. Since this option is a function of issuance and not a condition of eligibility, households must be treated equally with regards to certification activities regardless of whether they are subject to or choose to comply with a photo requirement. However, households may be called in for a photo to be taken as a matter of issuance, not eligibility. In 7 CFR 273.2(n)(2), the reference to the ID card would be removed as it is obsolete. In 7 CFR 273.2(n)(3), the proposed language would change the word ID to EBT card. The proposal would change “its ID card and benefits” to “the EBT card.”

    7 CFR Part 274

    The Department proposes changes to 7 CFR 274.8(b)(5)(ii) to modify EBT cards in States implementing the photo EBT card option, in accordance with 7 CFR 274.8(f). States would be required to add text to all EBT cards to ensure retailers are aware that all household members and authorized representatives must be allowed to use the EBT card even if their photo is not on the card or no photo is on the card. Experience has shown that, when a photo is included on the EBT card, some retailers believe the card may only be used by the person pictured. In concert with other required measures to ensure that retailers understand the State's photo EBT implementation, adding a statement on photo EBT cards would help alleviate confusion at retailer checkout and ensure compliance with the Federal statute that requires all household members and authorized members be able to access program benefits. This rule would propose that the States print the text: “Any user with valid PIN can use SNAP benefits on card and need not be pictured.” or alternative text approved by FNS. The Department is willing to consider alternative language suggested by States as long as it achieves the same goal of clearly informing retailers and clients as to the correct policy in this area.

    7 CFR Part 278

    The Department is proposing changes in Part 278 to remove language that is no longer in line with program operations and update language to enhance program integrity. The Department has recently become aware of instances in which SNAP authorized retailers, unauthorized retailers, and other individuals have purchased multiple EBT cards illegally. Generally, these individuals are not SNAP recipients. Frequently they use three or more EBT cards at a time and use the cards to purchase a large amount of eligible foods that are then used to replenish store inventory or sold as inventory to other retailers or restaurants. To address this area of potential fraud in which individuals use multiple cards they have procured illegally, the Department is proposing new language to require retailers to ask for identification of anyone who presents three or more EBT cards at checkout. Specifically, this proposed rule would require SNAP authorized retailers to ask these individuals for photo identification, such as a driver's license, and an explanation as to why multiple cards are being used. Furthermore, should the store believe there is a potential for fraud, retailers would be allowed to record information from the individual's identification, EBT card number, and reason for using three or more EBT cards. The retailers would be required to report this information to the USDA OIG Fraud Hotline. If the retailer suspects fraud is being committed and the individual refuses to show identification, the retailer has the option to deny a sale when three or more EBT cards are being used during a transaction. The Department understands that occasionally an individual or an individual shopping for an elderly client working for an authorized group home or other authorized facility may use multiple cards in order to purchase food legally for clients. Given these concerns regarding program access and program integrity, the Department is interested in comments from the public on whether there are other possible approaches to preventing individuals from using multiple EBT cards that they have obtained illegally, such as establishing a dollar threshold for individuals using three or more cards. These changes are proposed in 7 CFR 278.2(h).

    The Department also proposes the removal of two paragraphs, (i) and (k) in 7 CFR 278.2. The paragraphs refer to an outdated method of establishing identity and operations based on paper coupons. These paragraphs currently represent a redundancy and could cause confusion as they refer to an ID card that is only used in Alaska. This process has been replaced by the EBT system. Furthermore, the proof of eligibility is established through EBT and other systems implemented by State agencies.

    7 CFR 274.7(i) already addresses this procedure by establishing that State agencies shall implement a method to ensure that access to prepared meals and hunting fishing equipment is limited to eligible households. Eligible households are defined in 7 CFR 274.7(g) and (h).

    Procedural Matters Executive Order 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, of reducing costs, of harmonizing rules, and of promoting flexibility.

    This proposed rule has been determined to be significant and was reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

    Regulatory Impact Analysis

    As required for all rules that have been designated as Significant by the Office of Management and Budget, a Regulatory Impact Analysis (RIA) was developed for this proposed rule. The full RIA is included in the supporting documents of the rule docket at www.regulations.gov. The following summarizes the conclusions of the regulatory impact analysis.

    Need for Action: This proposed rule would incorporate into regulation and expand on guidance that was issued December 29, 2014 to certain State agencies. Based on observed implementation to date, there is cause for concern about possible impacts of photo EBT programs, both as they are first implemented and over time. This guidance requires States that intend to implement the photo EBT card option to submit a comprehensive Implementation Plan for FNS approval that addresses key operational issues to ensure State implementation complies with all Federal requirements and that program access is protected for participating households.

    In this proposed rule, the Department would clarify that the State option to place a photo on an EBT card is a function of issuance. Pursuant to this, State agencies would be prohibited from having photo EBT requirements affect the eligibility process. This includes ensuring that the photo EBT option is implemented in a manner that does not impose additional conditions of eligibility or adversely impact the ability of eligible Americans to access the nutrition assistance they need.

    Benefits: The Department anticipates that this proposed rule will provide qualitative benefits to State Agencies, SNAP participants, and authorized retailers. The Act and existing program regulations provide that States that implement a photo on the EBT card must establish procedures to ensure that any other appropriate member of the household or any authorized representative of the household may use the card. This proposed rule will provide clear parameters for States wishing to implement photo EBT to ensure that State implementation is consistent with all Federal requirements and that program access is protected for participating households, which will safeguard the rights of clients, provide training to staff, clients, and retailers, and improve program administration.

    Costs: States choosing the photo EBT option may incur additional administrative costs, which may vary based on the size and scope of the State's operations and whether implementation of the photo EBT card option is mandatory or voluntary. Regardless of whether the option is mandatory or voluntary, all States that implement photo EBT cards will incur certain implementation costs to include: Preparing an implementation plan, communications and training for program staff, clients, and retailers, ongoing training costs to maintain an understanding of Photo EBT policies, programming costs for mandatory policies, and costs for the post-implementation assessment, evaluation and on-going monitoring. States with mandatory photo EBT will also incur costs associated with prorating and storing benefits for noncompliant household members that choose not to be photographed. The Department estimates the total cost to be approximately $9.8 million over five years, assuming six States choose to implement a mandatory Photo EBT policy. Costs would be lower if some or all of these States choose to implement voluntary, rather than mandatory, Photo EBT policies. The estimate of six States is based on information from State legislatures that are either currently considering or discussing the possibility of considering such a policy. Given the projected timelines for these legislative actions, the Department assumes that the costs of implementing a Photo EBT system will be phased in over a five year period, as all six States are unlikely to approve and implement the policy in the same year. The two States that have already implemented photo EBT as a State option will not be required to retroactively submit Implementation Plans, but may continue to incur minimal costs associated with ongoing training and monitoring required for program staff, clients, and retailers.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Pursuant to that review, it has been certified that this proposed rule would not have a significant impact on a substantial number of small entities. This proposed rule primarily impacts State agencies. As part of the requirements, State agencies would have to educate retailers about the photo EBT card. There will not be a substantial impact on small entities such as small retailers since the treatment of clients with EBT cards and photo EBT cards do not vary. Minimal changes will be required of retailers. Retailers will need to be aware that some clients may present photo EBT cards but clients shall not be treated any differently. In addition, retailers will be required to request identification of individuals using three or more EBT cards. This is not expected to create a burden on retailers.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and Tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local or Tribal governments, in the aggregate, or the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, Section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule.

    This proposed rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments or the private sector of $100 million or more in any one year. Thus, the proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA.

    Executive Order 12372

    The Supplemental Nutrition Assistance Program is listed in the Catalog of Federal Domestic Assistance Programs under 10.551. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V, and related Notice (48 FR 29115, June 24, 1983), this program is included in the scope of Executive Order 12372 which requires intergovernmental consultation with State and local officials.

    Executive Order 13132

    Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under Section (6)(b)(2)(B) of Executive Order 13121.

    The Department has determined that this proposed rule does not have Federalism implications. This rule does not impose substantial or direct compliance costs on State and local governments. Therefore, under Section 6(b) of the Executive Order, a Federalism summary impact statement is not required.

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This proposed rule is intended to have retroactive effect unless so specified in the Effective Dates section of the final rule. State agencies that have already implemented a photo EBT card must meet all requirements of regulations except the requirement to submit an Implementation Plan prior to State's planned implementation date. Prior to any judicial challenge to the provisions of the final rule, all applicable administrative procedures must be exhausted.

    Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. On February 18, 2015, the agency held a consultation. During the consultation, no comments were received on the proposal. We are unaware of any current Tribal laws that could be in conflict with the proposed rule.

    Civil Rights Impact Analysis

    FNS has reviewed this proposed rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on program participants on the basis of religion, age, race, color, national origin, sex, political beliefs, or disability. After a careful review of the rule's intent and provisions and understanding the intent of this rule is to in part to protect the civil rights of recipients, FNS has determined that this rule is not expected to adversely affect the participation of protected individuals in the Supplemental Nutrition Assistance Program.

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; 5 CFR 1320) requires the Office of Management and Budget (OMB) to approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number.

    In accordance with the Paperwork Reduction Act of 1995, this proposed rule does not contain information collections that are subject to review and approval by the Office of Management and Budget.

    This rule proposes reporting requirements for States to submit to FNS an Implementation Plan, a post-implementation evaluation of the photo EBT implementation, and related on-going measures. As the PRA requirements are applicable to collection of information from ten or more respondents, there are no information collection requirements that are subject to OMB review at this time. Should the number of estimated respondents reach ten or more, FNS will publish a notice for comment and submit the applicable requirements to OMB for review and approval.

    E-Government Act Compliance

    The Department 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.

    List of Subjects 7 CFR Part 271

    Food stamps, Grant programs-Social programs, Reporting and recordkeeping requirements.

    7 CFR Part 273

    Administrative practice and procedure, Aliens, Claims, Employment, Food stamps, Fraud, Government employees, Grant programs-social programs, Income taxes, Reporting and recordkeeping requirements, Students, Supplemental Security Income (SSI), Wages.

    7 CFR Part 274

    Food stamps, Grant programs-social programs, Reporting and recordkeeping requirements.

    7 CFR 278

    Banks, banking, Food stamps, Grant programs-social programs, Penalties, Reporting and recordkeeping requirements, Surety bonds.

    Accordingly, 7 CFR parts 271, 273, 274, 278 are proposed to be amended as follows:

    1. The authority citation for parts 271, 273, 274 and 278 is revised to read as follows: Authority:

    7 U.S.C. 2011-2036c.

    PART 271—GENERAL INFORMATION AND DEFINITIONS 2. In § 271.2, revise the definition of Identification (ID) card to read as follows
    § 271.2 Definitions.

    Identification (ID) card means a card for the purposes of 7 CFR 278.2(j).”

    PART 272—REQUIREMENTS FOR PARTICIPATING STATE AGENCIES
    § 272.1 [Amended]
    3. In § 272.1, remove and reserve paragraphs (g)(30) and (47). PART 273—CERTIFICATION OF ELIGIBLE HOUSEHOULD 4. In § 273.2: a. Amend paragraph (a)(1) by adding to the end of the third sentence the words “, including in the implementation of a photo EBT card policy” b. Amend paragraph (a)(2) by adding a new fourth sentence before the last sentence the words “ ” c. Amend paragraph (e)(1) by adding a new fourth sentence after the third sentence. d. Amend paragraph (n)(2) by removing in the third sentence the words “and on the food stamp identification (ID) card, as provided in 7 CFR 274.10(a)(1) of this chapter” and by removing the last sentence. e. Amend paragraph (n)(3) by removing the word “ID card and benefits” and adding it its place adding the word “EBT card.”

    The additions read as follows:

    § 273.2 Office operations and application processing.

    (a) * * *

    (1) * * * The State agency's photo EBT card policy must not affect the certification process for purposes of determining eligibility regardless whether an individual has his/her photo placed on the EBT card. * * *

    (2) * * * States must meet application processing timelines, regardless of whether a State agency implements a photo EBT card policy. * * *

    (e) * * * State agencies may not require an in person interview solely to take a photo. * * *

    PART 274—ISSUANCE AND USE OF PROGRAM BENEFITS 5. In § 274.8: a. Redesignate paragraphs (b)(5)(ii) through (iv) as paragraphs (b)(5)(iii) through (v), respectively, and adding a new paragraph (b)(5)(ii). b. Add paragraph (f).

    The additions read as follows:

    § 274.8 Functional and technical EBT system requirements.

    (b) * * *

    (5) * * *

    (ii) State agencies that implement the photo EBT card option in accordance with paragraph (f) of this section must print on the EBT cards the text “Any user with valid PIN can use SNAP benefits on card and need not be pictured.” or similar alternative text approved by FNS.

    (f) State agency requirements for photo EBT card implementation—(1) Minimum requirements. Prior to implementation, State agencies must be performing sufficiently well in program administration to be eligible to implement the photo EBT card option. Prior to implementation, State agencies must demonstrate to FNS successful administration of SNAP based on SNAP performance standards. Successful program administration will take into account at a minimum the metrics related to program access, the State's payment error rate, the State's Case and Procedural Error Rate, application processing timeliness, including both the 7-day expedited processing and the 30-day processing standards, timeliness of recertification actions, and other metrics, as determined by the Secretary, that may be relevant to the State agency's implementation of photo EBT cards.

    (2) Function of issuance. The photo EBT card option is a function of issuance and not a condition of eligibility. Any implementation of the option to place a photo on the EBT card must not impact the certification of households. An application will be considered complete with or without a photo and a case shall be certified regardless of the status of a photo in accordance with timeframes established under 7 CFR 273.2. If a State agency chooses to implement a voluntary photo EBT card policy, issuance shall not be impacted. If a State agency chooses to implement a mandatory photo EBT card policy, a State agency may not deny or terminate a household because a household member who is exempted by paragraph (f)(4) of this section does not comply with the requirement to place a photo on the EBT card.

    (3) Voluntary vs mandatory. (i) State agencies shall have the option to implement a photo on EBT cards on a mandatory or voluntary basis. Regardless of whether the photo is mandatory or voluntary, the certification process must not be altered in order to facilitate photos, and clients must be informed that certification will not be impacted by whether or not a photo is on the card.

    (ii) Under mandatory implementation, State agencies must exempt certain clients, as stated in paragraph (f)(4) of this section. State agencies must establish which member(s) of the household would be required to be photographed and the procedures that allow eligible nonexempt household members who do not agree to the photo to come into compliance at a later time.

    (iii) Under voluntary implementation, clients must be clearly informed of the voluntary nature of the option. Applicant members of households are not required to be in an exempted category to opt out of the photo requirement. States shall not require a photo be taken during a voluntary implementation and clients must opt in to have a photo on their card.

    (4) Exemptions. Under a mandatory implementation, the State agency must exempt, at a minimum, the elderly, the disabled, children under 18, homeless households, and victims of domestic violence. A victim of domestic violence shall be able to self-attest and cannot be required to submit documentation to prove domestic violence. The ability to self-attest must be applied equally regardless of if the victim is a female or male. Non-applicants cannot have a photo taken for an EBT card whether or not they desire to have their photo taken. A State agency may establish additional exempted categories.

    (5) Serving clients with hardship. State agencies must have sufficient capacity and a process to issue photo EBT cards, taking into account households that meet hardship conditions and who would receive non photo EBT card. Examples of hardship conditions include, but are not limited to: Illness, transportation difficulties, care of a household member, hardships due to residency in a rural area, prolonged severe weather, or work or training hours which prevent the household from being available during having photos taken in-office.

    (6) Issuance of photo EBT card. (i) States can require households to come in to be photographed, but cannot do so for the purposes of certification. The amount of time provided to households to come in and be photographed needs to be sufficient and reasonable and be documented in the Implementation Plan as required in paragraph (f)(14) of this section. If a household meets expedited criteria, the State must issue the benefits to the entire household without delay. Regardless of whether the State's photo EBT policy is voluntary or mandatory, the State may not delay, hold in abeyance, or prorate benefits for any household that meets expedited criteria in order to obtain a photo on the EBT card. Card issuance procedures for new SNAP households must ensure adherence to application processing standards as required in 7 CFR 273.2(g) and (i). Additionally, State agencies shall not store photos that are collected in conjunction with its photo EBT card policy but are not placed on an EBT card.

    (ii) The process for issuing and activating photo EBT cards must not disrupt, inhibit or delay access to benefits nor cause a gap in access for ongoing benefits for eligible households.

    (iii) Any card issued as part of the implementation of the photo EBT card option may not count against the household as part of the card replacement threshold defined in 7 CFR 274.6(b)(5).

    (7) Prorating household benefits when photo EBT cards are mandatory. For multi-person households, State agencies shall not withhold benefits for an entire household because nonexempt household members do not comply with the photo EBT card policy. If benefits of the nonexempt household member(s) are to be withheld, a prorated share of benefits shall be issued to the household member(s) that are in compliance with or are exempt from the photo requirement. Benefits that are not issued as a result of individual(s) not being in compliance with the photo requirement must be held and promptly issued once individual(s) comply with the requirement to have their photo placed on the card. For example, if there are four household members and one household member is not in compliance with the photo requirement, 3/4 of the household's monthly benefit allotment must be issued, and 1/4 of the benefit allotment must be held in abeyance and allowed to accrue until the household member complies. For a single person household, the State agency would hold all the benefits in abeyance until the household complies.

    (8) Benefits held for noncompliance. Benefits held for noncompliance with the photo EBT card requirement must be withheld from issuance in accordance with paragraph (f)(6) of this section. Benefits withheld for non-compliance shall not remain authorized for perpetuity and States must treat such benefits in accordance with the same timeframe used for handling expungements under 7 CFR 274.2(h)(2). If the noncompliant member comes into compliance, the non-expired benefits must be issued within two business days of when the client has their photo taken by the State agency. Any action to withhold benefits from issuance is subject to fair hearings in accordance with 7 CFR 273.15.

    (9) Household and authorized representatives card usage. The State agency must establish procedures to ensure that all appropriate household members and any authorized representatives, as defined in 7 CFR 273.2(n)(3), can access SNAP benefits for the household regardless of who is pictured on the card or if there is no picture.

    (10) Client and staff training. State agencies must ensure staff and clients are properly trained on photo EBT card requirements. At a minimum, this training shall include: Whether the State option is voluntary or mandatory, who must comply with the photo requirement, which household members are exempt, and that all appropriate household members and authorized representatives are able to use the card regardless of who is pictured on the card or if there is no picture.

    (i) All staff and client training materials must clearly describe the following statutory and regulatory requirements:

    (A) Retailers must allow all appropriate household members and any authorized representative of the household, regardless of whether they are pictured on the card, to utilize the card without having to submit additional verification of identity as long as the transaction is secured by the use of the PIN;

    (B) EBT cards with or without a photo are valid in any State; and

    (C) Retailers must treat all SNAP clients in the same manner as non-SNAP clients;

    (ii) State agencies may not specifically reference which categories of individuals are exempt from the photo EBT requirement in any materials to retailers.

    (11) Retailer education and responsibility. State agencies must conduct sufficient education of retailers if photos are used on cards. The State agency must clearly inform all retailers in the State and contiguous areas of implementation. State agency communications with retailers must clearly state:

    (i) All household members, authorized representatives, and individuals authorized by the household are entitled to use the EBT card regardless of the picture on the card if the EBT card is presented with the valid PIN;

    (ii) Retailers must treat all SNAP clients in the same manner as non-SNAP clients in accordance with 7 CFR 278.2(b);

    (iii) Retailers must not prohibit appropriate household members or authorized representatives from using an EBT card because they are not pictured on the card or there is no picture on the card;

    (iv) EBT cards from any State are valid with or without a photo.

    (12) Interoperability. Interoperability of EBT cards will remain the same regardless of whether or not there is a photo and regardless of which State issued the card. State agencies must conduct sufficient education of clients and retailers, including retailers in contiguous areas, to inform them that the photo EBT cards remain interoperable and authorized retailers must accept EBT cards from all States as long as the household member or authorized representative uses a valid PIN.

    (13) Advance Planning Document. Appropriate implementation and administration of the photo EBT card consistent with all applicable requirements is an allowable State administrative cost that FNS shall reimburse at 50 percent in accordance with 7 CFR 277.9. Increased costs related to placing photos on the EBT card, whether contractual or produced from other sources, require an Implementation Advance Planning Document Update.

    (14) Implementation Plan. (i) State agencies must submit an Implementation Plan for approval prior to implementation that delineates how the State agency will operationalize the photo EBT option. FNS shall review the plan and issue an approval, request modifications prior to granting approval, or issue an approval subject to conditions. In cases where FNS finds that the steps outlined in the Implementation Plan are not sufficient for a successful implementation, FNS may issue an approval subject to conditions, such as requiring the State agency to implement a successful pilot in a selected region of the State before a statewide implementation. Should a State be required to implement a pilot before statewide implementation, that requirement would be documented in the State's Implementation Plan approval, along with any information the State must report to FNS before expansion approval would be provided by FNS.

    (ii) State agencies must demonstrate successful administration of SNAP based on SNAP performance standards as established in paragraph (f)(1) of this section. State agencies shall not issue EBT cards with photos before the State's Implementation Plan is approved and the State agency has also received FNS authorization to proceed to issue photo EBT cards.

    (iii) The Implementation Plan shall include but not be limited to a description of card issuance procedures, a detailed description of how client protections and ability to use SNAP benefits will be preserved, specific information about exempted recipients and the State agency's exemption criteria, a description of how the State agency will obtain photographs for the EBT card, training materials and training plans for State agency staff, examples of letters and other materials communicating the policy to clients and retailers, and a timeline for the implementation. If the State agency plans to share SNAP client data in accordance with 7 CFR 272.1(c) for purposes of implementing its photo EBT card option, the State agency must also include any draft memoranda of understanding as part of its Implementation Plan. Any information collected must be securely stored and can only be shared for the purpose of SNAP in accordance with 7 CFR 272.1(c).

    (iv) The Implementation Plan shall also address the anticipated timetable with specific action steps for the State agency and contractors, if any, that may be involved regarding implementation of the photo EBT card option, the State agency's capacity to issue photo EBT cards, and the logistics that shall allow for activation of the photo EBT card simultaneously or followed by deactivation of the active non-photo EBT card. This shall also include the description of the capacity at the facility where the photo EBT cards will be produced, both for transition and ongoing production, and confirmation that the State agency and any contractor will continue to meet regulatory time requirements for all EBT card issuances and replacements, including for expedited households. The Implementation Plan must also include indicators related to the photo EBT card implementation that will be collected and analyzed for the post implementation evaluation required by paragraph (f)(16) of this section.

    (v) The State agency shall provide all applicable proposed written policy for staff to implement the photo EBT card option to FNS for review. State agencies shall include copies of all materials that will be used to inform clients, retailers and other stakeholders regarding photo EBT card implementation. In addition, the State agencies shall provide a detailed description of how the notifications, communication, policies, and procedures regarding the implementation of any new photo EBT card option will comply with applicable civil rights laws.

    (vi) The State agency's Implementation Plan shall also include:

    (A) An education component for retailers and clients to ensure all eligible household members and authorized representatives are able to use the EBT card and understand the timeframes associated with the implementation and rollout,

    (B) A description of the resources that will be in place to handle complaint calls from clients, retailers, and external stakeholders, and

    (C) A description of procedures to address unexpected events related to the photo EBT card option,

    (D) Upon approval of the Implementation Plan by FNS, the State may proceed with tasks described in the Implementation Plan, as modified by the approval, but may not proceed to issuing actual cards until it receives FNS authorization to do so. FNS may also require the State to implement in a phased manner, which may include criteria as determined by the Secretary.

    (15) Authorization to issue photo EBT cards. States agencies shall not be permitted to issue EBT cards with photos until FNS provides an explicit authorization to issue photo EBT cards. After an Implementation Plan is approved, FNS will review the State agency's actions at an appropriate time interval to ensure that the process and steps outlined by the State agency in the Implementation Plan are fulfilled. In cases where the State agency has not acted consistently with the process and steps outlined in its photo EBT card Implementation Plan, FNS may deny authorization for the State agency to issue EBT cards with photos until the State agency has done so successfully.

    (16) Post implementation assessment and evaluation. State agencies must submit to FNS a post-implementation assessment that provides FNS with a report of the results of its implementation, including any issues that arose and how they were resolved, the degree to which State agency staff, clients and retailers properly understood and implemented the new provisions.

    (i) This report shall be delivered to FNS within 120 days of implementation. This report shall cover the first 90 days of implementation. The Department also reserves the right to conduct its own review of the State agency's implementation. The State agency's post-implementation report shall include at a minimum:

    (A) A survey of clients conducted by an independent evaluator to demonstrate their clear understanding of the State agency's photo EBT policy;

    (B) A survey of retailers conducted by an independent evaluator that demonstrates evidence that at least 80% of retailers, including smaller independent retailers, demonstrate a full understanding of the policies related to the photo EBT card;

    (C) The amount and percent of benefits held for noncompliance if mandatory;

    (D) The number and percent of households with photo EBT cards;

    (E) The number of households affected by withholding for noncompliance, if mandatory;

    (F) The number and percent of households exempt from the photo EBT card requirement if mandatory;

    (G) ????????????

    (H) The number and percent of exempted households who opted for photo EBT cards if mandatory;

    (I) The number and scope of complaints related to the implementation of the policy;

    (J) The State agency's Case and Procedural Error Rate; and

    (K) SNAP performance metrics as established in section 7 CFR 274.8(f)(1) and other SNAP performance metrics that may have been adversely affected by the implementation of the State agency's photo EBT card option, as determined by the Secretary.

    (ii) Reserved.

    (17) Ongoing monitoring. FNS will continue to monitor and evaluate the operation of the option and may require additional information from the State on an ongoing basis.

    (18) Modifying implementation of photo EBT option If any review or evaluation of a State's operations, including photo EBT operation implementation, finds deficiencies, FNS may require a corrective action plan consistent with 7 CFR 275.16 to reduce or eliminate deficiencies. If a State does not take appropriate actions to address the deficiencies, FNS would consider possible actions such as requiring an updated photo EBT Implementation Plan, suspension of implementation and/or withholding funds in accordance with 7 CFR 276.4.

    PART 278—PARTICIPATION OF RETAIL FOOD STORES, WHOLESALE FOOD CONCERNS AND INSURED FINANCIAL INSTITUTIONS 6. In § 278.2, revise paragraph (h) and remove and reserve paragraphs (i) and (k).

    The revision reads as follows:

    § 278.2 Participation of retail food stores.

    (h) Identifying benefit users. Retailers must accept payment from EBT cardholders who have proper PIN regardless of which State the card is from or whether the individual is pictured on the card. However, benefits may not knowingly be accepted from persons who have no right to possession of benefits. Where photo EBT cards are in use, the person presenting the photo EBT card need not be pictured on the card, nor does the individual's name need to match the one on the card if States includes names on the card. Retailers shall ask for identification from any individual using three or more EBT cards and an explanation as to why multiple cards are being used. The identified individual's name does not need not match the name on the EBT cards, but rather is to be used for the limited purposes of reporting suspected fraud. Should a retailer believe that fraud is occurring the retailer may record the individual's information, such as a driver's license information, as well as the EBT card number, and the reason for using 3 or more cards. If a retailer collects such information due to suspected fraud, the retailer shall be required to report the individual to the USDA OIG Fraud Hotline. If an individual presents 3 or more EBT cards and does not show identification when requested by the retailer, the retailer has the option to deny the sale if fraud is suspected.

    Dated: December 22, 2015. Kevin Concannon, Under Secretary for Food, Nutrition, and Consumer Services.
    [FR Doc. 2015-33053 Filed 1-5-16; 8:45 am] BILLING CODE 3410-30-P
    NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 [Docket No. PRM-50-112; NRC-2015-0213] Determining Which Structures, Systems, Components and Functions are Important to Safety AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Petition for rulemaking; notice of docketing and request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has received a petition for rulemaking (PRM) requesting that the NRC amend its “Domestic licensing of production and utilization facilities” regulations to define the term “important to safety” and provide a set of specific criteria for determining which structures, systems, components (SSCs), and functions are “important to safety.” The petition, dated July 20, 2015, was submitted by Kurt T. Schaefer (the petitioner) and was supplemented on August 31, 2015. The petition was docketed by the NRC on September 4, 2015, and was assigned Docket Number PRM-50-112. The NRC is examining the issues raised in this petition to determine whether it should be considered in rulemaking. The NRC is requesting public comments on this petition for rulemaking.

    DATES:

    Submit comments by March 21, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0213. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    For technical questions contact Robert Beall, Office of Nuclear Reactor Regulation, telephone: 301-415-3847, email: [email protected] For questions related to the PRM process contact Anthony de Jesús, Office of Administration, telephone: 301-415-1106, email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0213 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0057.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2015-0213 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. The Petitioner

    On July 20, 2015, Mr. Kurt T. Schaefer filed a PRM with the Commission, PRM-50-112 (ADAMS Accession No. ML15278A208), which was subsequently supplemented on August 31, 2015 (ADAMS Accession No. ML15278A211). The petitioner states that he is a nuclear engineer with over 40 years of nuclear experience, and 30 years of nuclear power plant licensing experience. The petitioner claims to have taught numerous classes related to § 50.59 of title 10 of the Code of Federal Regulations (CFR), “Changes, test, and experiments.” The petitioner notes that he is a nuclear licensing contractor and consultant, and that he is “supporting utility and vendor implementation of the United Arab Emirates Federal Authority of Nuclear Regulation (FANR) version of 10 CFR 50.59.”

    III. The Petition

    The petitioner requests that the NRC amend 10 CFR 50.2, “Definitions,” to include a definition of “Important to safety” that provides specific criteria for determining what SSCs and functions are “important to safety.”

    IV. Discussion of the Petition

    The petitioner requests that the NRC amend its regulations in 10 CFR 50.2 to include a definition with specific criteria for determining what SSCs and functions are “important to safety.” The petitioner states that “[t]he nuclear industry is on its third generation of engineers and regulators with no clear definition of what is `important to safety' ” and that “there is no excuse for not having a concise set of functional criteria defining such a used term.”

    The petitioner notes that the “NRC staff's current position is that SSCs `important to safety' consists of two subcategories, `safety-related' and `nonsafety-related'.” The petitioner asserts that while safety-related SSCs are defined in 10 CFR 50.2, “the regulations do not provide an equivalent set of criteria for determining which nonsafety-related SSCs are `important to safety.' ” The petitioner notes that there is very little agreement about what “nonsafety-related structures, systems and components (SSCs) should be categorized as `important to safety'.” Furthermore, the petitioner states that “there is only a general description of what is `important to safety' in 10 CFR 50 Appendix A, and the regulations do not provide a specific set of criteria for determining which SSCs are `important to safety'.” The petitioner states that NRC Generic Letter 84-01, “NRC use of the terms, `Important to Safety' and `Safety Related',” and its attachments (January 5, 1984; ADAMS Accession No. ML031150515), sought to clarify the NRC staff's use of these terms, but did not “provide a specific set of criteria for determining which nonsafety-related SSCs are to be categorized as `important to safety'.” The petitioner asserts that this lack of clarity is problematic because “important to safety” is used “in numerous regulations and NRC guidance documents.” The petitioner notes that consequently, “there are regulations, regulatory guidance and routinely generated regulatory evaluations, based on SSCs with no specific criteria that determines what are the applicable SSCs.”

    The petitioner requests that the NRC define “important to safety” as SSCs and functions that are:

    (a) Safety-related SSCs (including supporting auxiliaries) as defined in 10 CFR 50.2 and their associated safety-related functions;

    (b) Equipment and function(s) assumed or used to mitigate the anticipated operational occurrences and non-accident events evaluated in the Final Safety Analysis Report (as updated) or Design Control Document Tier 2 safety analyses;

    (c) Equipment and functions assumed or used to prevent or mitigate internal events that involve common cause failures and/or failures beyond the 10 CFR part 50, appendix A, single failure criterion, which have been postulated to demonstrate some specific mitigation capability in accordance with regulatory requirements, as described in the Final Safety Analysis Report (as updated) or Design Control Document Tier 2;

    (d) Equipment and functions whose failure or malfunction could impair the ability of other equipment to perform a safety-related function;

    (e) Equipment and functions requiring (for ensuring nuclear safety) elevated quality assurance or design requirements (i.e., special treatment), but not to full safety-related standards;

    (f) Nonsafety-related readiness functions of installed plant equipment and their associated plant condition(s) assumed, prior to the initiation of an accident, in any accident safety analysis described in the Final Safety Analysis Report (as updated) or Design Control Document Tier 2;

    (g) Nonsafety-related structures, systems, components and functions specifically included in the plant design to control the release of radioactive materials within 10 CFR part 20 limits, as described in the Final Safety Analysis Report (as updated) or Design Control Document Tier 2;

    (h) Specific (10 CFR 50.150) aircraft impact assessment design features and functional capabilities, as described in the Final Safety Analysis Report (as updated) or Design Control Document Tier 2;

    (i) Fukushima Dai-ichi accident mitigation related new or modified manual actions and equipment (including associated functional capabilities), as described in the current plant licensing basis; and

    (j) Severe accident mitigation related new or modified manual actions and equipment (including associated functional capabilities), as described in the current plant licensing basis.

    V. Specific Requests for Comments

    The NRC is seeking advice and recommendations from the public on the PRM. We are particularly interested in comments and supporting rationale from the public on the following:

    1. On January 5, 1984, the NRC issued Generic Letter 84-01, “NRC Use of the Terms, `Important to Safety' and Safety Related',” to address concerns on the NRC use of the terms “important to safety” and “safety related” and provided the NRC staff's position on safety classification. In SECY-85-119, “Issuance of Proposed Rule on the Important-To-Safety Issue,” dated April 5, 1985 (ADAMS Accession No. ML15322A002), the NRC staff requested Commission approval to clarify the terms “important to safety” and “safety related” through rulemaking. The proposed rule would have defined these terms generally and clarified specifically the nature and extent of certain affected quality assurance requirements. The NRC staff also looked at determining what equipment should be classified as important to safety and what requirements are imposed on this class of equipment. In the Staff Requirements Memorandum (SRM) to SECY-85-119, SRM-SECY-85-119, “Issuance of Proposed Rule on the Important-To-Safety Issue,” dated December 31, 1985 (ADAMS Accession No. ML15322A003), the Commission disapproved the NRC staff's proposed rulemaking actions. In the SRM, the Commission informed the NRC staff that the proposed rule did not adequately differentiate nor clarify the terms “Important-to-Safety” and “Safety Related.” The Commission reiterated in the SRM that it continues to believe that it is necessary to resolve the apparent confusion surrounding usage of the term “Important-to-Safety.” In SECY-86-164, “Proposed Rule on the Important-To-Safety,” dated May 29, 1986 (ADAMS Accession No. ML15322A005), the NRC staff recommended changes to the proposed rule in SECY-85-119 that would address the Commission comments in the SRM to SECY-85-119. In a memo from the Secretary of the Commission dated June 24, 1991 (ADAMS Accession No. ML15322A006), the request for rulemaking in SECY-86-164 was withdrawn. Please provide any new information and analysis that could provide the basis for changes to the NRC's regulations.

    2. The NRC requests specific examples where the lack of a formal NRC definition (i.e., codified in 10 CFR chapter I) of the terms, “safety related,” and “important to safety” directly resulted in adverse consequences to external stakeholders. The NRC's evaluation of the cost and benefits of adopting a formal definition would be enhanced if commenters provided a quantitative estimate of the costs and/or unachieved benefits due to the lack of formal definitions of these two terms.

    3. What regulations would have to be revised to reflect the new definition, and what would be the nature (objective) of the revision for each provision of the regulation which must be revised?

    4. What, if any, guidance would be needed to implement the new definition, and what should be the scope, level of detail, and content of the guidance?

    VI. Conclusion

    The NRC has determined that the petition meets the threshold sufficiency requirements for docketing a petition for rulemaking under 10 CFR 2.802, “Petition for rulemaking,” and the petition has been docketed as PRM-50-112. The NRC will examine the issues raised in PRM-50-112 to determine whether they should be considered in rulemaking.

    Dated at Rockville, Maryland, this 30th day of December, 2015.

    For the Nuclear Regulatory Commission.

    Annette L. Vietti-Cook, Secretary of the Commission.
    [FR Doc. 2015-33287 Filed 1-5-16; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0156] RIN 3150-AJ63 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International (Holtec or the applicant) HI-STORM 100 Cask System listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 9, Revision 1, to Certificate of Compliance (CoC) No. 1014. Amendment No. 9, Revision 1, changes cooling time limits for thimble plug devices, removes certain testing requirements for the fabrication of Metamic HT neutron-absorbing structural material, and reduces certain minimum guaranteed values used in bounding calculations for this material. Amendment No. 9, Revision 1, also changes fuel definitions to classify certain boiling water reactor fuel within specified guidelines as undamaged fuel.

    DATES:

    Submit comments by February 5, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0156. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-5175, email: [email protected]; U.S. Nuclear Regulatory Commission, Washington DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0156 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0156.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2015-0156 in the subject line of your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Procedural Background

    This proposed rule is limited to the changes contained in Amendment No. 9, Revision 1, to CoC No. 1014 and does not include other aspects of the Holtec HI-STORM 100 Cask System design. Because the NRC considers this action noncontroversial and routine, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register. Adequate protection of public health and safety continues to be ensured. The direct final rule will become effective on March 21, 2016. If the NRC receives significant adverse comments on this proposed rule by February 5, 2016, then the NRC will publish a Federal Register notice withdrawing the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to these proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications.

    For additional procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the Federal Register.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule (65 FR 25241; May 1, 2000) that approved the HI-STORM 100 Cask System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214, “List of approved spent fuel storage casks,” as CoC No. 1014. Most recently, the NRC issued a final rule effective on March 11, 2014 (78 FR 73379), that approved the HI-STORM 100 Cask System design amendment subject to this rulemaking and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1014, Amendment No. 9.

    IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.

    V. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document ADAMS
  • accession No.
  • Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A941 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A ML15156A956 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B ML15156A970 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A-100U ML15156A982 Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B-100U ML15156B000 Preliminary CoC 1014 Amendment No. 9, Revision 1 Safety Evaluation Report ML15156B011 Request for Revision Application dated July 1, 2014 ML14182A486 Notification by general licensees of voluntary acceptance of Revision 1 requirements dated August 28, 2015 ML15240A233 Interim Staff Guidance 1, Classifying the Condition of Spent Nuclear Fuel for Interim Storage and Transportation Based on Function ML071420268 Interim Staff Guidance 11, Revision 3, Cladding Considerations for the Transportation and Storage of Spent Fuel ML033230335 Interim Staff Guidance 23, Application of ASTM Standard Practice C1671-07 when performing technical reviews of spent fuel storage and transportation packaging licensing actions ML103130171

    The NRC may post materials related to this document, including public comments, on the Federal rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0156. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0156); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is proposing to adopt the following amendments to 10 CFR part 72:

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

    Section 72.44(g) also issued under Nuclear Waste Policy Act secs. 142(b) and 148(c), (d) (42 U.S.C. 10162(b), 10168(c), (d)).

    Section 72.46 also issued under Atomic Energy Act sec. 189 (42 U.S.C. 2239); Nuclear Waste Policy Act sec. 134 (42 U.S.C. 10154).

    Section 72.96(d) also issued under Nuclear Waste Policy Act sec. 145(g) (42 U.S.C. 10165(g)).

    Subpart J also issued under Nuclear Waste Policy Act secs. 117(a), 141(h) (42 U.S.C. 10137(a), 10161(h)).

    Subpart K also issued under sec. 218(a) (42 U.S.C. 10198).

    2. In § 72.214, Certificate of Compliance No. 1014 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1014.

    Initial Certificate Effective Date: May 31, 2000.

    Amendment Number 1 Effective Date: July 15, 2002.

    Amendment Number 2 Effective Date: June 7, 2005.

    Amendment Number 3 Effective Date: May 29, 2007.

    Amendment Number 4 Effective Date: January 8, 2008.

    Amendment Number 5 Effective Date: July 14, 2008.

    Amendment Number 6 Effective Date: August 17, 2009.

    Amendment Number 7 Effective Date: December 28, 2009.

    Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012. (ADAMS Accession No. ML12213A170).

    Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1 on March 21, 2016.

    Amendment Number 9, Revision 1, Effective Date: March 21, 2016.

    SAR Submitted by: Holtec International.

    SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

    Docket Number: 72-1014.

    Certificate Expiration Date: May 31, 2020.

    Model Number: HI-STORM 100.

    Dated at Rockville, Maryland, this 22nd day of December, 2015. For the Nuclear Regulatory Commission.

    Glenn M. Tracy, Acting, Executive Director for Operations.
    [FR Doc. 2015-33279 Filed 1-5-16; 8:45 am] BILLING CODE 7590-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 62 [EPA-R07-OAR-2015-0733; FRL-9941-05-Region 7] Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Nebraska; Sewage Sludge Incinerators AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to approve the Clean Air Act (CAA) section 111(d)/129 negative declaration for the state of Nebraska, for existing sewage sludge incinerator (SSI) units. This negative declaration certifies that existing SSI units subject to sections 111(d) and 129 of the CAA do not exist within the jurisdiction of Nebraska. EPA is accepting the negative declaration in accordance with the requirements of the CAA.

    DATES:

    Comments must be received on or before February 5, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0733, to http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Paula Higbee, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7028 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    In the final rules section of this Federal Register, EPA is approving the state's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this Federal Register.

    List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Reporting and recordkeeping requirements, Sewage sludge incinerators.

    Dated: December 23, 2015. Mark Hague, Regional Administrator, Region 7.
    [FR Doc. 2015-33291 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 122 [EPA-HQ-OW-2015-0671; FRL-9939-88-OW] RIN 2040-AF57 National Pollutant Discharge Elimination System (NPDES) Municipal Separate Storm Sewer System General Permit Remand AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing changes to the regulations governing small municipal separate storm sewer system (MS4) permits to respond to a remand from the United States Court of Appeals for the Ninth Circuit in Environmental Defense Center, et al. v. EPA, 344 F.3d 832 (9th Cir. 2003). In that decision, the court determined that the regulations for providing coverage under small MS4 general permits did not provide for adequate public notice and opportunity to request a hearing. Additionally, the court found that EPA failed to require permitting authority review of the best management practices (BMPs) to be used at a particular MS4 to ensure that the small MS4 permittee reduces pollutants in the discharge from their systems to the “maximum extent practicable” (MEP), the standard established by the Clean Water Act for such permits. EPA's proposal would revise the small MS4 regulations to ensure that the permitting authority determines the adequacy of BMPs and other requirements and provides public notice and the opportunity to request a public hearing on the requirements for each MS4. The proposal would not establish any new substantive requirements for small MS4s.

    DATES:

    Comments must be received on or before March 21, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2015-0671, 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 (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Greg Schaner, Office of Wastewater Management, Water Permits Division (M4203), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-0721; 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 taking? C. What is the Agency's authority for taking this action? II. Background A. Statutory and Regulatory Overview B. MS4 Permitting Requirements III. Judicial Review of the Phase II Rule and Partial Remand A. Decision in Environmental Defense Center et al. v. EPA B. EPA Action Following the Partial Remand of the Phase II Rule IV. Scope of This Rulemaking V. EPA's Evaluation and Selection of Rulemaking Options A. Current Permitting Authority Practice B. Description of Process Used To Evaluate Options C. Considerations in Evaluating Options 1. Permitting Authority Review 2. Public Participation Requirements 3. Other Factors Considered VI. Analysis of Options for Proposal A. Option 1—The Traditional General Permit Approach 1. Current Examples of Clear, Specific, and Measurable Permit Requirements 2. Types of Permit Language Lacking Sufficient Detail To Qualify as Clear, Specific, and Measurable 3. Summary/Description of Proposed Rule Changes B. Option 2—Procedural Approach C. Option 3—State Choice Approach VII. Incremental Costs of Proposed Rule Options VIII. 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 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 stormwater permitting authorities 924110 Local governments Operators of small municipal separate storm sewer systems 924110

    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 taking?

    EPA is proposing a change to its regulations governing the way in which small MS4s obtain coverage under National Pollutant Discharge Elimination System (NPDES) general permits. The proposal results from a decision by the Ninth Circuit U.S. Court of Appeals in Environmental Defense Center, et al. v. EPA, in 344 F.3d 832 (9th Cir. 2003) (“EDC decision”), which found that EPA regulations for obtaining coverage under a small MS4 general permit did not provide for adequate public notice, the opportunity to request a hearing, or permit authority review to determine whether the BMPs selected by each MS4 in its stormwater management program (SWMP) meets the Clean Water Act (CWA) requirements including the requirement to “reduce pollutants to the maximum extent practicable.” The preamble discusses two options for addressing the remand, and a third option that is a hybrid of the two alternatives. One option (called the “Traditional General Permit Approach”) would align the process for issuing small MS4 general permits with the way NPDES general permits are issued for other categories of discharges. This would entail requiring the permitting authority to establish within the permit all requirements that MS4s must meet within the term of the general permit to meet the standard applicable to MS4s (to reduce pollutants to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA), which would be subject to public notice and comment and an opportunity to request a hearing. A second option (called the “Procedural Approach”) would add procedural requirements to the existing rule structure that would require the MS4 to inform the permitting authority in its Notice of Intent (NOI) to be covered by the permit of the BMPs it would undertake through its SWMP. Under the Procedural Approach, the public would be given an opportunity to comment on the proposed BMPs and request a hearing, and the permitting authority would have the opportunity to require changes to the proposed BMPs before the permitting authority authorizes a discharge under the general permit. A third option (called the “State Choice Approach”) would enable the permitting authority to choose between the Traditional General Permit and Procedural Approaches, or to implement a combination of these approaches in issuing and authorizing coverage under a general permit.

    C. What is the agency's authority for taking this action?

    The authority for this rule is the Federal Water Pollution Control Act, 33 U.S.C. 1251 et seq., including sections 402 and 501.

    II. Background A. Statutory and Regulatory Overview

    Stormwater discharges are a significant cause of water quality impairment because they contain a variety of pollutants such as sediment, nutrients, chlorides, pathogens, metals, and trash. Furthermore, the increased volume and velocity of stormwater discharges that result from the creation of impervious cover can alter streams and rivers by causing scouring and erosion. These surface water impacts threaten public health and safety due to flooding and pollutants; lead to economic losses to property and fishing industries; increase drinking water treatment costs; and decrease opportunities for recreation, swimming, and wildlife uses.

    Stormwater discharges are subject to regulation under section 402(p) of the CWA. Under this provision, Congress required only the following stormwater discharges to be subject to NPDES permitting requirements: Stormwater discharges for which NPDES permits were issued prior to February 4, 1987; discharges “associated with industrial activity”; discharges from MS4s serving populations of 100,000 or more; and any stormwater discharge determined by EPA or a state to “contribute . . . to a violation of a water quality standard or to be a significant contributor of pollutants to waters of the United States.” With respect to MS4s, section 402(p)(3)(B) provides that NPDES permits may be issued on a system-wide or jurisdiction-wide basis, and requires that MS4 NPDES permits “include a requirement to effectively prohibit non-stormwater discharges into the storm sewers” and require “controls to reduce the discharge of pollutants to the maximum extent practicable . . . and such other provisions as the Administrator or the State determines appropriate for the control of such pollutants.”

    EPA developed the stormwater regulations under section 402(p) in two phases, as directed by the statute. In the first phase, under section 402(p)(4), EPA promulgated regulations establishing application and other requirements for NPDES permits for stormwater discharges from medium (serving populations of 100,000 to 250,000) and large (serving populations of 250,000 or more) MS4s, and stormwater discharges associated with industrial activity. EPA published the final Phase I rule on November 16, 1990 (55 FR 47990).

    The Phase I rule, among other things, defined “municipal separate storm sewer” as publicly-owned conveyances or systems of conveyances that discharge to waters of the U.S. and are designed or used for collecting or conveying stormwater, are not combined sewers, and are not part of a publicly-owned treatment works at 40 CFR 122.26(b)(8). EPA included construction sites disturbing five acres or more in the definition of “stormwater discharges associated with industrial activity” at 40 CFR 122.26(b)(14)(x).

    In the second phase, under section 402(p)(5) and (6), EPA was required to conduct a study to identify other stormwater discharges that needed further controls “to protect water quality,” report to Congress on the results of the study, and to designate for regulation additional categories of stormwater discharges not regulated in Phase I on the basis of the study and in consultation with state and local officials. EPA promulgated the Phase II rule on December 8, 1999, designating discharges from certain small MS4s and from small construction sites (disturbing equal to or greater than one acre and less than five acres) and requiring NPDES permits for these discharges (64 FR 68722, December 8, 1999). A regulated small MS4 is generally defined as any MS4 that is not already covered by the Phase I program and that is located within the urbanized area boundary as determined by the latest U.S. Decennial Census. Separate storm sewer systems such as those serving military bases, universities, large hospital or prison complexes, and highways are also included in the definition of “small MS4.” 40 CFR 122.26(b)(16). In addition, the Phase II rule includes authority for EPA (or states authorized to administer the NPDES program) to require NPDES permits for currently unregulated stormwater discharges by a designation process. 40 CFR 122.26(a)(9)(i)(C) and (D). Other small MS4s located outside of an urbanized area may be designated as a regulated small MS4 if the NPDES permitting authority determines that its discharges cause, or have the potential to cause, an adverse impact on water quality. See 40 CFR 122.32(a)(2) and 123.35(b)(3).

    B. MS4 Permitting Requirements

    The Phase I regulations are primarily application requirements that identify components that must be addressed in applications for individual permits from large and medium MS4s. The regulations at 40 CFR 122.26(d)(2)(iv) require these MS4s to develop a SWMP, which is considered by EPA or the authorized state permitting authority when establishing permit conditions to reduce pollutants to the MEP.

    Like the Phase I rule, the Phase II rule requires regulated small MS4s to develop and implement SWMPs. 40 CFR 122.34(a) requires that SWMPs be designed to reduce pollutants discharged from the MS4 “to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act,” and requires that the SWMPs include six “minimum control measures.” The minimum control measures are: Public education and outreach, public participation and involvement, illicit discharge detection and elimination, construction site runoff control, post construction runoff control, pollution prevention and good housekeeping. 40 CFR 122.34(b). Under the Phase II rule, a regulated small MS4 may seek coverage under an available general permit or may apply for an individual permit. To be authorized to discharge under a general permit, the rule requires submission of an NOI to be covered by the general permit containing a description of the BMPs to be implemented and the measurable goals for each of the BMPs, including timing and frequency, as appropriate. 40 CFR 122.33(a)(1), 122.34(d)(1).

    EPA anticipated that under the first two or three permit cycles, whether individual permits or general permits, BMP-based SWMPs implementing the six minimum control measures would, if properly implemented, “be sufficiently stringent to protect water quality, including water quality standards, so that additional, more stringent and/or more prescriptive water quality based effluent limitations will be unnecessary.” (64 FR 68753, December 8, 1999). In the final Phase II rule preamble, EPA also stated that it “has intentionally not provided a precise definition of MEP to allow maximum flexibility in MS4 permitting. MS4s need the flexibility to optimize reductions in storm water pollutants on a location-by-location basis. . . . Therefore, each permittee will determine appropriate BMPs to satisfy each of the six minimum control measures through an evaluative process.” (64 FR 68754, December 8, 1999).

    The Agency described this process in the preamble to the Phase II rule as an “iterative process” of developing, implementing, and improving stormwater control measures contained in SWMPs. As EPA further stated in the preamble to the Phase II rule, “MEP should continually adapt to current conditions and BMP effectiveness and should strive to attain water quality standards. Successive iterations of the mix of BMPs and measurable goals will be driven by the objective of assuring maintenance of water quality standards. . . . If, after implementing the six minimum control measures there is still water quality impairment associated with discharges from the MS4, after successive permit terms the permittee will need to expand or better tailor its BMPs within the scope of the six minimum control measures for each subsequent permit.” (64 FR 68754, December 8, 1999).

    III. Judicial Review of the Phase II Rule and Partial Remand A. Decision in Environmental Defense Center et al. v. EPA

    The Phase II rule was challenged in petitions for review filed by environmental groups, municipal organizations, and industry groups, resulting in a partial remand of the rule. Environmental Defense Center v. U.S. Environmental Protection Agency, 344 F.3d. 832 (9th Cir. 2003). The court remanded the Phase II rule's provisions for small MS4 NPDES general permits because they lacked procedures for permitting authority review and public notice and the opportunity to request a hearing on NOIs submitted under general MS4 permits.

    In reviewing how the Phase II rule provided for general permit coverage for small MS4s, the court found that NOIs under the rule were not like NOIs for other NPDES general permits. Other general permits contain the specific effluent limitations and conditions applicable to the class of dischargers for which the permit is available, and authorization to discharge under a general permit is obtained by filing an NOI in which the discharger agrees to comply with the terms of the general permit. In contrast, the court held that under the Phase II rule, because the NOI submitted by the MS4 contains the information as to what the MS4 decides it will do to reduce pollutants to the MEP, it is the “functional equivalent” of a permit application. Environmental Defense Center v. U.S. Environmental Protection Agency, 344 F.3d. at 857. Because the CWA requires public notice and the opportunity to request a public hearing for all permit applications, the court held that failure to require public notice and the opportunity for a public hearing for NOIs under the Phase II rule is contrary to the Act. 344 F.3d. at 858.

    Similarly, the court found the Phase II rule allows the MS4 to identify the BMPs that it will undertake in its SWMP without any permitting authority review. The court held that the lack of review “to ensure that the measures that any given operator of a small MS4 has decided to undertake will in fact reduce discharges of pollutants to the maximum extent practicable” also does not comport with CWA requirements. The court stated, “That the Rule allows a permitting authority to review an NOI is not enough; every permit must comply with the standards articulated by the Clean Water Act, and unless every NOI issued under general permit is reviewed, there is no way to ensure that such compliance has been achieved.” 344 F.3d. at 855 n.32.

    The court therefore vacated and remanded “those portions of the Phase II Rule that address these procedural issues . . . so that EPA may take appropriate action to comply with Clean Water Act.” 344 F.3d. at 858.

    B. EPA Action Following the Partial Remand of the Phase II Rule

    EPA issued interim guidance to address the need for permitting authority review of NOIs and to provide for public notice and opportunity for public hearing in April 2004. This guidance memorandum, Implementing the Partial Remand of the Stormwater Phase II Regulations Regarding Notices of Intent and NPDES General Permitting for Phase II MS4s, outlined recommendations as to how permitting authorities should retroactively provide for public notice and the opportunity to request a hearing, provided options for holding a public hearing if granting a request, and highlighted ways to conduct appropriate review of NOIs already submitted.1 The memorandum also provided guidance on ways to ensure the requisite public notice and review opportunities and permitting authority review of NOIs under new general permits. As a result of the EDC decision, EPA Regions that issue NPDES permits have taken various approaches to provide opportunity for public review. For example, EPA Region 1, the permitting authority for Massachusetts and New Hampshire, uses its Web site to post NOIs and notices of availability for public comment, as well as the annual reports submitted by each permitted MS4.2 EPA Region 6, the permitting authority in New Mexico and in Indian Country in Oklahoma and New Mexico, has established a Web site with information on how to submit comments and opportunity to request a public hearing, and posts the NOI and each MS4's SWMP on its Web site.3 EPA Region 10, the permitting authority in Idaho, has only issued individual permits to small MS4s in that state.

    1 EPA. April 16, 2004. Memo from James Hanlon, Director, Office of Wastewater Management to EPA Water Management Division Directors in EPA Regions I-X. http://www.epa.gov/npdes/pubs/hanlonphase2apr14signed.pdf.

    2http://www.epa.gov/region1/npdes/stormwater/2003-permit-archives.html.

    3http://www.epa.gov/region6/water/npdes/sw/sms4/sms4noi.htm.

    In addition, the EPA Regions and some authorized state permitting authorities have included more specific and definitive requirements in small MS4 general permits, rather than leaving the identification of stormwater controls needed to reduce pollutants to the MEP, protect water quality and meet the water quality requirements of the CWA up to the permittees. In the time since promulgation of the Phase II rule and the partial remand of the rule, permits for small MS4 discharges have evolved, both to reflect the advancement and improvement in stormwater management approaches and techniques and to reflect the need for the specific requirements for compliance with the CWA to be incorporated into MS4 permits. Please see Section V.A of this preamble for a detailed discussion of current EPA and state permitting practices for small MS4 NPDES permits.

    IV. Scope of This Rulemaking

    The proposed revisions to the Phase II MS4 NPDES permitting requirements are solely for the purpose of responding to the partial remand of the Phase II rule in Environmental Defense Center v. U.S. Environmental Protection Agency, 344 F.3d. 832 (9th Cir. 2003) with respect to small MS4 general permits. To conform to the court's decision, the rule needs to ensure that permitting authorities determine what requirements are needed to reduce pollutants from each permitted small MS4 “to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act,” as currently required for small MS4 permits under 40 CFR 122.34(a). The proposed rule must also require NPDES permitting authorities to provide the public with the opportunity to review, submit comments, and request a public hearing on these requirements.

    EPA is not reopening any of the substantive requirements that were promulgated in the Phase II rule (nor is EPA reopening or seeking comment on any aspect of the Phase I rule, which is described in this preamble for informational purposes only). In addition, EPA will address the other aspect of the Ninth Circuit's remand regarding possible regulation of stormwater discharges from forest roads in a separate action.

    V. EPA's Evaluation and Selection of Rulemaking Options A. Current Permitting Authority Practice

    The EPA collected information on how NPDES permitting authorities have been administering their small MS4 general permits in the years since the EDC decision and the issuance of the EPA's guidance on implementing the remand and compiled this information in a state-by-state spreadsheet (titled Current NPDES Authority Practices in Administering Small MS4 General Permits, EPA, 2015), which is available in the docket for the proposed rule at http://www.regulations.gov under Docket ID No. EPA-HQ-OW-2015-0671. This information provides a basis for understanding how and to what degree different rule options would affect the current MS4 general permit programs in different states.

    This research indicates that permitting authorities are using an array of approaches to provide permit coverage to their small MS4s, many of which are unique to the specific state. EPA's guidance following the EDC decision suggested ways to implement a general permit program that would be consistent with the court's ruling. As mentioned, some states chose to develop more definitive general permits that do not rely on MS4 identification of BMPs to establish requirements that meet the applicable CWA standards. Other states require that each NOI undergo individualized permitting authority review and a dedicated public comment period prior to authorizing the discharge. Still other states require the MS4 to provide for public notice and the opportunity to submit comments on the NOI and the SWMP document being submitted. Notwithstanding the disparity in approaches between NPDES authorities, this information has equipped EPA with a sense of how the different options under consideration would be implemented if promulgated, and what types of adjustments may be necessary in some programs depending on the rule approach that is adopted. EPA used the approaches being implemented in certain states to inform the proposed rule options.

    Not surprisingly, general permits are used as the permitting vehicle to authorize small MS4 discharges in the vast majority of states (i.e., 43 of 50 states, which represents 94 percent of the 6789 permitted small MS4s). In the remaining states, individual permits are issued to their small MS4 permittees. In the 43 states where general permits are used, 26 of these permitting authorities make their NOIs publicly available through a Web site or some other means, and 27 indicate that they provide a “waiting period” of some length between the time the NOI is submitted and discharge authorization. Currently, most states are not providing a second public comment period for individual NOIs (in addition to the public comment period for the draft general permit). However, 12 states have established such a comment period. EPA notes that four states require the prospective small MS4 permittee to provide for its own public comment period for the NOI and, in some cases, the SWMP. In 23 states, the permitting authority requires the SWMP document to be submitted for review along with the NOI; in 14 of these states, the permitting authority reviews and approves the SMWP document. See Current NPDES Authority Practices in Administering Small MS4 General Permits, EPA, 2015.

    EPA also found some states that have moved to develop general permits with more clear and specific requirements as a way of cutting down on the need for additional review procedures for individual NOIs. For instance, rather than requiring NOIs with information on BMPs and measurable goals, California and Washington include in their general permits the specific tasks, milestones, and schedules that are to be met by each permittee. Therefore, once coverage under the general permit in these states is authorized, the enforceable components of the permit are locked in place for each permittee, and the permitting authority is no longer required to review the information submitted by individual MS4s prior to authorizing the discharge. What matters is whether the permittee is complying with the specific requirements of the permit.

    B. Description of Process Used To Evaluate Options

    EPA met separately with various categories of stakeholders during the development of the proposed rulemaking. The purpose of these meetings was to obtain individual feedback from stakeholders on the type of regulatory changes that would best address the court remand, and which would work best considering how Phase II general permits have been administered to date. The following is a summary of what EPA learned from these meetings.

    EPA participated in several meetings with the Association of Clean Water Administrators and their member state stormwater coordinators, and met with the Environmental Council of the States. Many state permitting authority staff appeared receptive to the idea of clarifying in the regulations that the general permit should define all of the applicable requirements necessary to reduce the discharge of pollutants from the MS4 to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA. At the same time, some state staff questioned how they would incorporate requirements into their general permits in a way that would work for all MS4s within their state, given the large number and diversity of the municipal entities regulated. Other state staff indicated a concern for retaining the correct balance between establishing detailed, prescriptive requirements and providing flexibility where appropriate. There are also a few state permitting authorities that are implementing an approach similar to what is being described as the “Procedural Approach” (see Section VI.B), and some expressed the interest in finding a way in the proposed rule to accommodate this approach. Most state permitting staff appeared concerned with the prospect of spending additional time and resources to implement a procedural approach requiring individualized review and public notice of all NOIs, as discussed in the court's decision. Other state permitting staff suggested exploring the concept of allowing permitting authorities to choose which option to follow, without restricting the rule to one approach. Alternatively, a few state permitting staff suggested that permitting authorities be allowed to apply a hybrid of the two approaches, whereby a state could implement one permit using the Traditional General Permit Approach (e.g., for traditional MS4s) and another permit using the Procedural Approach (e.g., for non-traditional MS4s), or use a blend of the options for issuing a general permit and authorizing coverage under the permit.

    EPA met with organizations representing state and local elected officials, as well as with small MS4 permittees and organizations that include small MS4s as members. MS4s, in particular, are interested in retaining the flexibility of the existing Phase II regulations, where they are able to make decisions on which BMPs are implemented locally based on factors that are unique to their municipality and environmental concerns. At the same time, many of these same MS4s understand the need for permit requirements that are clear to all parties and the public.

    EPA also met with representatives from a number of environmental, non-profit organizations. Many of the representatives expressed an interest in seeing the quality of small MS4 permits improve, and appeared to be supportive of the concept of adopting the Traditional General Approach as a way of addressing the remand. Asked at what point in the current permitting process their organizations tend to provide input, most indicated that they focus their attention on providing comments at the proposed permit stage, as compared to submitting comments on individual NOIs. That being said, a few representatives indicated that they have submitted comments on individual NOIs pertaining to the proposed water quality implementation plans of several small MS4s.

    C. Considerations in Evaluating Options

    Any option for responding to the remand must meet the CWA requirements for public participation and transparency in section 402(b)(3), consistent with the Ninth Circuit's decision. When individual permits are issued to small MS4s, the standard process for issuing an NPDES permit applies. This process provides for public participation and permitting authority determination as to what set of permit terms and conditions satisfy the requirement to reduce the discharge of pollutants from the MS4 to the MEP, to protect water quality, and to meet the applicable water quality requirements of the CWA. While the court's opinion focused on the Phase II rule's requirement for the NOI to be covered by a general permit, and the procedural steps that need to be taken with respect to the NOI in order for the rule to comply with the CWA, the court's fundamental concern was that the permitting authority must determine which MS4 permit requirements are sufficient to reduce the discharge of pollutants to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA, and that the public have the opportunity to review and comment on those permit requirements and to request a hearing. For example, the court stated that “every permit must comply with the standards articulated by the Clean Water Act, and unless every NOI issued under a general permit is reviewed, there is no way to ensure that such compliance has been achieved.” EDC v. EPA. 344 F.3d at 855, n. 32. Accordingly, EPA has determined that certain factors must be met by any option to revise the rule, as discussed in subsections 1 (Permitting Authority Review), 2 (Public Participation Requirements), and 3 (Other Factors Considered).

    1. Permitting Authority Review

    The court viewed the NOI as the document that identifies the requirements necessary to meet the MEP standard: “Because a Phase II NOI establishes what the discharger will do to reduce discharges to the `maximum extent practicable,' the Phase II NOI crosses the threshold from being an item of procedural correspondence to being a substantive component of a regulatory scheme.” 344 F.3d at 853. As a result, the role of the permitting authority to determine which requirements are necessary to meet the applicable statutory standard is not, according to the court, accomplished under this scheme. In addition, the court observed that because 40 CFR 122.34(a) in the 1999 Phase II rule states that compliance with the SWMP written by the MS4 constitutes compliance with the MEP standard (without providing for further action by the permitting authority), the regulation put the MS4 in charge of establishing its own requirements. “Therefore, under the Phase II Rule nothing prevents the operator of a small MS4 from misunderstanding or misrepresenting its own stormwater situation and proposing a set of minimum measures for itself that would reduce discharges by far less than the maximum extent practicable.” 344 F.3d at 855.

    While EPA has always expected the permitting authority to establish the necessary requirements for reducing discharges to the MEP, protecting water quality, and satisfying the appropriate water quality requirements of the CWA, the existing regulations do not fully address the permitting authorities' responsibilities in this regard. To be consistent with the court's decision, one criterion that any option must meet is that it must ensure the permitting authority provides a final determination on whether the requirements to which the MS4 is subject, whether articulated fully in the permit itself or defined in whole or part by the MS4 operator in the NOI, meet the NPDES requirements to reduce discharges to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the Act.

    2. Public Participation Requirements

    The court's other concern was that MS4s would choose what requirements apply to them, without being subject to the public participation procedures applicable to all NPDES permit applications and permits, which is contrary to CWA section 402(b)(3). As discussed, the court found the NOI to be the “functional equivalent” of a permit application. The importance of the NOI as identified by the court was that the NOI contained the requirements that would be considered to meet the applicable standards and therefore this was the document that needed to be subject to public notice. See 344 F.3d at 857. To be consistent with the court's decision, any option chosen must provide for public notice and the opportunity to request a public hearing on what is considered necessary for a permitted MS4 to meet the requirement to reduce discharges to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA, regardless of where those requirements are defined.

    3. Other Factors Considered

    General permits are premised on the idea that the terms and conditions of the permit are the same for all entities covered by the general permit and that handling permitting for multiple entities in one proceeding is more efficient. In the context of MS4 permits, the Phase II rule sought to establish a general permit scheme that allows each MS4 to address the specific conditions that prevail in its jurisdiction. As stated in the Phase II preamble, “The pollutant reductions that represent MEP may be different for each small MS4, given the unique local hydrologic and geologic concerns that may exist and the differing possible pollutant control strategies. Therefore, each permittee will determine appropriate BMPs to satisfy each of the six minimum control measures through an evaluative process.” (64 FR 68754, December 8, 1999). While the court clearly rejected EPA regulations to the extent that the court found they established a system of MS4 self-regulation, it also recognized the value in having MS4 input on what it could do to meet the MEP standard. “Involving regulated parties in the development of individualized stormwater pollution control programs is a laudable step . . . But EPA is still required to ensure that the individual programs adopted are consistent with the law.” 344 F.3d at 856. There is a need for strong MS4 input into the implementation of the program, and for that reason EPA made flexibility an underlying principle of the Phase II regulations. Individual permits provide the greatest ability to define MS4-specific requirements and small MS4s always have the option of seeking an individual permit if this would best accommodate their specific circumstances. However, with over 94 percent of regulated small MS4s currently covered by general permits, an important consideration for this rulemaking is how to provide flexibility to MS4s while retaining the general permit option in a manner that comports with the remand. The challenge is to balance the flexibility provided to the MS4 to determine how best it can meet the applicable regulatory requirements with the permitting authorities' responsibility to ensure that the terms and conditions to which MS4s will be held accountable are adequate to reduce the discharge to the MEP, protect water quality, and satisfy the appropriate water quality requirements of the CWA. In selecting any regulatory option to comport with the court remand, EPA will consider the need for maintaining this balance in light of the nearly 15-year history of implementing the Phase II program, and the considerable knowledge and expertise about implementing stormwater controls that have emerged during that time.

    Another factor requiring consideration is the impact on existing authorized NPDES state permitting programs. Currently 46 states and one territory are authorized under section 402(b) to administer the NPDES permit program in their jurisdictions. EPA recognizes that states have limited resources and face different challenges in meeting the permitting demands within their various NPDES programs. Immediately after the EDC decision, EPA sought to provide state permitting authorities with potential interim strategies that would balance the need to move forward with implementing the Phase II program, while acknowledging the need for state flexibility in how permitting decisions need to be made. See Implementing the Partial Remand of the Stormwater Phase II Regulations Regarding Notices of Intent & NPDES General Permitting for Phase II MS4s (EPA, 2004).4 As discussed more fully elsewhere in this preamble, authorized states [and EPA regional permitting authorities] have taken a variety of approaches in response to the court's decision (and in some cases, decisions by state courts) and EPA guidance. A significant consideration in this rulemaking is the extent to which states would need to make changes to comply with the rule and consideration of the need to minimize disruption to existing state programs, particularly for those states that have chosen approaches that already comport with the EDC decision. EPA clarifies that if, upon promulgation of the final rule, a state is already implementing an approach that is consistent with the final rule EPA would not expect that the permitting authority would need to make any changes to its current approach. Similarly, it is EPA's intention that permitting authorities that only issue individual permits to small MS4s (e.g., EPA Region 10 in Idaho, Delaware, Michigan, and Oregon) would not need to make any changes because the process for issuing individual permits already encompasses the necessary permitting attributes found missing in the Phase II regulations by the Ninth Circuit (i.e., permitting authority determination, public notice, and opportunity to request a hearing). However, state permitting authorities that are using general permits and are currently not implementing strategies that address the core problems found by the court will need to make some degree of change to their general permit process for small MS4s to comply with the modified regulations.

    4 See http://www.epa.gov/npdes/pubs/hanlonphase2apr14signed.pdf.

    VI. Analysis of Options for Proposal

    EPA is proposing three rule options for public comment, each of which would address the Ninth Circuit remand. Each of these options shares in common the fact that, as a result of the permitting process, the permitting authority must determine which requirements a small MS4 must meet in order to satisfy the Phase II regulatory requirement “to reduce the discharge of pollutants from [the] MS4 to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirement of the Clean Water Act.” The key difference between the options, especially between the “Traditional General Permit Approach” (Option 1) and the “Procedural Approach” (Option 2), is that they make this determination at different points in time during the permitting process. For Option 1 (the “Traditional General Permit Approach”), the determination as to what requirements are needed to reduce the discharge of pollutants to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA is made as part of the initial issuance of the general permit. By contrast, under Option 2 (the “Procedural Approach”), the permitting authority would make this determination after reviewing each individual NOI and after public comment and the opportunity for a hearing on the NOI. Each of these options is described more fully in this section, as is a third option (the “State Choice Approach”), which would give the permitting authority the discretion to determine whether it will administer Option1 or Option 2, or a hybrid of options chosen for the final rule.

    A. Option 1—Traditional General Permit Approach

    The “Traditional General Permit Approach” provides a mechanism for addressing the procedural deficiencies identified by the court by requiring all substantive permit requirements to be in the general permit. The rationale behind the Traditional General Permit Approach is that by requiring permitting authorities to include any and all requirements that establish what is necessary to “. . . reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriating water quality requirements of the Clean Water Act,” the minimum required procedural steps to issue a final general permit, including providing public notice and the minimum 30-day comment period on the draft permit, and the opportunity to request a public hearing, will fulfill the permitting authority review and public participation requirements of the CWA that the court found missing from the Phase II regulations.

    Under the proposed Traditional General Permit Approach, the NPDES authority must establish in any small MS4 general permit the full set of requirements that are deemed adequate “to reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act,” and the administrative record would explain the rationale for its determination. The permittee would have the opportunity, as it always has had, to provide feedback on what requirements are established in the general permit during the development of the draft permit and to submit comments during the public comment period. Furthermore, the permittee could continue to have flexibility in determining how it will implement the permit requirements based on considerations such as pollutant removal and cost effectiveness. However, once the permit is issued, and the terms and conditions in the permit are fixed for the term of the permit, neither the development of a SWMP document nor the submittal of an NOI for coverage would represent new permit requirements. In turn, because the permit contains all of the requirements that will be used to assess permittee compliance, the permitting authority would no longer need to rely on the MS4's NOI as the mechanism for ascertaining what will occur during the permit term. Under this approach, the function of the NOI would be more similar to that of any other general permit NOI, and more specifically other stormwater general permits, where the NOI is used to establish certain minimum facts about the discharger, including the operator's contact details, the discharge location(s), and confirmation that the operator is eligible for permit coverage and has agreed to comply with the terms of the permit. By removing the possibility that effluent limits could be proposed in the NOI (and for that matter in the SWMP) and made part of the permit once permit coverage is provided, the NOI would no longer look and function like an individual permit application, as the court found with respect to MS4 NOIs under the Phase II regulations currently in effect. Therefore, it would not be necessary to carry out the type of additional permitting authority review and public participation steps contemplated by the court.

    Under the proposed Traditional General Permit Approach, 40 CFR 122.34(a) would be revised to expressly require the permitting authority to articulate in sufficient detail in the permit what is required to meet the minimum statutory and regulatory requirements, and to ensure that the applicable requirements are enforceable and understandable to the permittee and the public. A general permit would need to make it clear to all what level of effort is expected of the permittee during the permit term for each permit provision. These proposed revisions to 40 CFR 122.34(a) respond to the court's finding that under the Phase II rule, “the operator of a small MS4 has complied with the requirement of reducing discharges to the `maximum extent practicable' when it implements its stormwater management program, i.e., when it implements its Minimum Measures. 40 CFR 122.34(a).” 344 F.3d at 856. The court continued, “Nothing in the Phase II regulations requires that NPDES permitting authorities review these Minimum Measures to ensure that the measures that any given operator of a small MS4 had decided to undertake will in fact reduce discharges to the maximum extent practicable.” 344 F.3d at 855. By clearly shifting the decision as to what is needed to meet the MEP standard and water quality requirements from the permittee to the permitting authority, the Traditional General Permit Approach would address the court's concern.

    EPA continues to view MEP as iterative, in that each successive permit needs to define what is required to meet the MEP standard for that permit term. The Traditional General Permit Approach would clarify that the requirements for meeting MEP (and to protect water quality and satisfy CWA water quality requirements) would be required to be established in each successive permit by the permitting authority, while the SWMP implemented by the MS4 would be a planning and programmatic document that the MS4 would be able to update and revise during the permit term as necessary to comply with the terms of the permit. In other words, this option would make it clear that the SWMP document would not contain enforceable requirements. Likewise, it would be unnecessary for the NOI to identify the BMPs selected in the SWMP for each minimum control measure nor for it to undergo public or permitting authority review prior to discharge authorization under the general permit.

    Moreover, it was never EPA's intent that the SWMP required by 40 CFR 122.34(a) itself be considered enforceable under the permit. Rather, the SWMP was intended to be the means for the MS4 to engage in an adaptive management process during the term of the permit. “EPA envisions application of the MEP standards as an iterative process. MEP should continually adapt to current conditions and BMP effectiveness and should strive to attain water quality standards.” (64 FR 68754, December 8, 1999).

    The Traditional General Permit Approach would include regulatory text to reflect EPA's guidance to permitting authorities regarding the types of permit requirements for MS4s that are considered most effective. For instance, EPA advises permitting authorities to use permit conditions that are “clear, specific, and measurable.” See MS4 Permit Improvement Guide5 (p. 5-6), and Revisions to the November 22, 2002 Memorandum Establishing Total Maximum Daily Load (TMDL) Wasteload Allocations (WLAs) for Storm Water Sources and NPDES Permit Requirements Based on Those WLAs6 (p. 5). The MS4 Permit Improvement Guide explains EPA's recommendation as follows:

    5 EPA. 2010. MS4 Permit Improvement Guide. Office of Wastewater Management. Washington, DC. EPA 833-R-10-001. http://water.epa.gov/polwaste/npdes/stormwater/upload/ms4permit_improvement_guide.pdf.

    6 EPA. November 26, 2014. Memo from Andrew Sawyers, Director, Office of Wastewater Management to EPA Water Management Division Directors in EPA Regions I-X. http://water.epa.gov/polwaste/npdes/stormwater/upload/EPA_SW_TMDL_Memo.pdf.

    In order for permit language to be clear, specific, measurable and enforceable, each Permit Requirement will ideally specify: What needs to happen; Who needs to do it; How much they need to do; When they need to get it done; and Where it is to be done.

    For each Permit Requirement: `What' is usually the stormwater control measure or activity required. `Who' in most cases is implied as the permittee (although in some cases the permitting authority may need to specify who exactly will carry out the requirement if there are co-permittees or the MS4 will rely on another entity to implement one of the minimum control measures). `How much' is the performance standard the permittee must meet (e.g., how many inspections). `When' is a specific time (or a set frequency) when the stormwater control measure or activity must be completed. `Where' indicates the specific location or area (if necessary). These questions will help determine compliance with the permit requirement.

    The proposed rule for the Traditional General Permit Approach would obligate the permitting authority to establish requirements that are “clear, specific, and measurable.” See proposed 40 CFR 122.34(a). The proposed rule further explains that effluent limitations may be expressed as BMPs that include, but are not limited to, “specific tasks, BMP design requirements, performance requirements or benchmarks, schedules for implementation and maintenance, and frequency of actions.” Id. Where permits incorporate clear, specific, and measurable requirements, EPA expects there to be greater certainty and understanding as to what must be accomplished during each permit term.

    A foundational principle of MS4 permits is that from permit term to permit term iterative progress will be made towards meeting water quality objectives, and that adjustments in the form of modified permit requirements will be made where necessary to reflect current water quality conditions, BMP effectiveness, and other current relevant information. This principle is incorporated into the proposed Traditional General Permit Approach in the requirement for NPDES authorities to revisit permit requirements during the permit issuance process, and to make any necessary changes in order to ensure that the subsequent permit continues to meet the NPDES requirements “to reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), protect water quality, and to satisfy the water quality requirements of the Clean Water Act.” Thus, in advance of issuing any successive small MS4 general permit, the permitting authority would need to review, among other things, information on the relative progress made by permittees to meet applicable milestones, compliance problems that may have arisen, the effectiveness of the required activities and selected BMPs under the existing permit, and any improvements or degradation in water quality. Sources of this information include, but are not limited to:

    • Past annual reports;

    • Current SWMP documents;

    • NPDES MS4 audit reports, construction/industrial/commercial site inspection reports;

    • Monitoring and other information on quality of receiving waters;

    • Existing MS4 permit requirements; and

    • Approved TMDLs that include wasteload allocations applicable to small MS4s.

    1. Current Examples of Clear, Specific, and Measurable Permit Requirements

    As discussed in the previous section, a key component of the proposed Traditional General Permit Approach is that permits be written with sufficient clarity and specificity to enable permittees, the public, and regulatory authorities alike to understand what is required to measure progress. EPA acknowledges that meeting the requirement to include more detailed terms and conditions in small MS4 permits and to ensure, among other things, that the permit terms satisfy the regulatory requirement to reduce pollutant discharges from the MS4 to the MEP (and meet the requirement to protect water quality and meet the appropriate water quality requirements of the CWA) will not be easy for some states. States that have not already written permits in this way would need to evaluate the quality of the existing SWMPs, the track record of each MS4 in implementing their respective SWMPs, the types of BMPs that have proven effective, and information that may suggest what is necessary to address existing water quality conditions, including whether additional requirements are needed to address an applicable TMDL. Among other factors that the state would need to consider when issuing a new, or the next, general permit are how long the MS4 has been permitted, the degree of progress made by the small MS4 permittees as a whole and for individual MS4s as well, the reasons for any lack of progress, and the capability of these MS4s to achieve more focused requirements. EPA finds promise in some of the strategies that EPA and state permitting authorities are already implementing, which will serve as useful models to those permitting authorities needing advice on how to write their permits under the proposed Traditional General Permit Approach. For example, permitting authorities may find that subcategorizing MS4s by experience, size, or other factors, and creating different requirements for each subcategory, may be desirable. Permitting authorities may also consider whether watershed-wide general permits may be an option, especially where the receiving waters are impaired.

    In addition to the model permit language in the MS4 Permit Improvement Guide, EPA recently compiled a number of examples where small MS4 general permits have already included requirements that are clear, specific, and measurable in a document entitled MS4 General Permits and the Six Minimum Control Measures: A National Compendium of Clear, Specific, and Measurable Requirements, which can be accessed in the docket for this proposed rule. Additional examples of clear, specific, and measurable permit requirements in MS4 general permits, focusing on post-construction requirements and water quality-based effluent limits, are included in EPA's Municipal Separate Storm Sewer System Permits: Post-Construction Performance Standards & Water Quality-Based Requirements: A Compendium of Permitting Approaches.7 The fact that many permitting authorities have already included provisions that would qualify as clear, specific, and measurable under the proposed rule indicates that making this a requirement for all permits is reasonable and achievable. EPA requests comment on what additional examples should be highlighted as being clear, specific, and measurable in current small MS4 general permits.

    7 EPA. 2014. Municipal Separate Storm Sewer System Permits: Post-Construction Performance Standards & Water Quality-Based Requirements: A Compendium of Permitting Approaches. Office of Water. Washington, DC. EPA 833.R.14.003. http://water.epa.gov/polwaste/npdes/stormwater/upload/sw_ms4_compendium.pdf.

    2. Types of Permit Language Lacking Sufficient Detail To Qualify as Clear, Specific, and Measurable

    Just as there are a number of examples to be highlighted where states are already writing their permits consistent with the proposed Traditional General Permit Approach, EPA also found permits that lack adequate detail and would not qualify as clear, specific, and measurable under the proposed rule modifications. Permit requirements that do not appear to have the type of detail that would be needed under the proposed rule approach may have some of the following characteristics:

    • Permit provisions that simply copy the language of the Phase II regulations verbatim without providing further detail on the level of effort required or that do not include the minimum actions that must be carried out during the permit term. For instance, where a permit includes the language in 40 CFR 122.34(b)(4)(ii)(B) (i.e., requiring “. . . construction site operators to implement appropriate erosion and sediment control best management practices”) and does not provide further details on the minimum set of accepted practices, the requirement would not provide clear, specific, and measurable requirements within the intended meaning of the proposed Traditional General Permit Approach. The same would also be true if the permit just copies the language from the other minimum control measure provisions in 40 CFR 122.34(b) without further detailing the particular actions and schedules that must be achieved during the permit term.

    • Permit requirements that include “caveat” language, such as “if feasible,” “if practicable,” “to the maximum extent practicable,” and “as necessary” or “as appropriate” unless defined. Without defining parameters for such terms (for example, “infeasible” means “not technologically possible or not economically practicable and achievable in light of best industry practices”), this type of language creates uncertainty as to what specific actions the permittee is expected to take, and is therefore difficult to comply with and assess compliance.

    • Permit provisions that preface the requirement with non-mandatory words, such as “should” or “the permittee is encouraged to . . . .” This type of permit language makes it difficult to assess compliance since it is ultimately left to the judgment of the permittee as to whether it will comply. EPA notes that the Phase II regulations include “guidance” in places (e.g., 40 CFR 122.34(b)(1)(ii), (b)(2)(ii), and (b)(3)(iv)), which suggest practices for adoption by MS4s and within permits, but does not mandate that they be adopted. This guidance language is intended for permitting authorities to consider in establishing their permit requirements. While permitting authorities may find it helpful to their permittees to include guidance language within their permits in order to provide suggestions to their permittees, such language would not qualify as a permit requirement under the proposed Traditional General Permit Approach.

    • Permit requirements that lack a measurable component. For instance, several permits include language implementing the construction minimum control measure that requires inspections “at a frequency determined by the permittee” based on a number of factors. This type of provision includes no minimum frequency that can be used to measure adequacy and, therefore, would not constitute a measurable requirement for the purposes of the proposed rule.

    • Permit requires the development of a plan to implement one of the minimum control measures, but does not include details on the minimum contents or requirements for the plan, or the required outcomes, deadlines, and corresponding milestones. For example, some permits require the MS4 to develop a plan to implement the public education minimum control measure, which informs the public about steps they can take to reduce stormwater pollution. The requirement leaves all of the decisions on what specific actions will be taken during the permit term to comply with this provision to the MS4 permittee, thus enabling almost any type of activity, no matter how minor or insubstantial, to be considered compliance with the permit. In EPA's view, this type of permit provision would not qualify as a clear, specific, and measurable requirement under the proposed Traditional General Permit Approach.

    3. Summary/Description of Proposed Rule Changes

    The following is a section-by-section summary of the proposed regulatory changes.

    Proposed Changes to 40 CFR 122.33

    The following changes to 40 CFR 122.33 are proposed to complement the changes made to implement the Traditional General Permit Approach option:

    • Throughout the section references to “you” or “your” would be replaced with references to “the operator.” This change is proposed for consistency with revisions to 40 CFR 122.34 and 40 CFR 122.35.

    • The requirements for obtaining coverage under a general permit would now be the same as those for any other general permit in 40 CFR 122.28(b)(2). The NOI would no longer be required to include information on the MS4's BMPs and measurable goals.

    • The requirements for applying for an individual permit would be consolidated in 40 CFR 122.33(b)(2), whereas these requirements now appear in both 40 CFR 122.31 and in 40 CFR 122.34(d).

    • The deadline of March 10, 2003 for MS4s wishing to implement a program that differed from 40 CFR 122.34 to submit an individual permit application would be removed since the date has passed and is no longer relevant. Similarly, the deadline of March 10, 2003 for MS4s designated for regulation by 40 CFR 122.32(a)(1) would be deleted since the date has passed and is no longer relevant.

    Proposed Changes to 40 CFR 122.34

    Most of the proposed changes to 40 CFR 122.34 are made to clarify that it is the permitting authority's responsibility, and not that of the small MS4 permittee, to establish permit terms that meet the small MS4 regulatory standard (i.e., “. . . to reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act.”), and to delineate the requirements for implementing the six minimum control measures, other more stringent effluent limitations as necessary, as well as other requirements. The proposed modifications do not alter the existing, substantive requirements of the six minimum control measures in 40 CFR 122.34(b), but instead emphasize the way in which the permitting authority makes the determination as to what requirements are included in small MS4 permits, including general permits. For instance, a typical change in the proposed Traditional General Permit Approach is made in 40 CFR 122.34(b)(3)(ii), which transfers the obligation to address certain categories of non-stormwater discharges from the small MS4 operator (referred to as “you”) to the permitting authority by requiring that “the permit must require the permittee to address the following categories of non-storm water discharges.” Otherwise, unless specified, there is no change to the language of the existing rule.

    Proposed Changes to 40 CFR 122.34(a)

    The following changes to 40 CFR 122.34(a) are proposed:

    • The proposed regulatory text clarifies that the permitting authority is required to include in any small MS4 permit conditions that ensure pollutant discharges from the MS4 are reduced to the MEP, are protective of water quality, and satisfy the water quality requirements of the CWA. In order to ensure that these permit conditions are of adequate detail and their meaning is clear to all parties, the proposed rule emphasizes that permit requirements must be written in a “clear, specific, and measurable” form. This language is consistent with the recommendation in EPA's MS4 Permit Improvement Guide (2010), which advised permitting authorities to write MS4 permits with permit provisions that are “clear, specific, measurable, and enforceable.” In addition, the proposed regulatory text for the Traditional General Permit Approach emphasizes that the permit requirements must be adequate to collectively meet the regulatory standard, that is: “to reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act (CWA).” EPA notes that no changes are proposed to the wording of this regulatory standard.

    • The proposed regulatory text reiterates that effluent limitations may be in the form of BMPs, and provides examples of how these BMP requirements may appear in the permit, such as in the form of specific tasks, BMP design requirements, performance requirements or benchmarks, schedules for implementation and maintenance, and the frequency of actions. This list of examples is not intended to be exclusive, and EPA anticipates that permitting authorities will, over time, develop other ways to establish requirements that are consistent with this language. It is EPA's view that this proposed language serves the same underlying purpose as the provision it modifies in the current regulation (i.e., “. . . narrative effluent limitations requiring implementation of best management practices (BMPs) are generally the most appropriate form of effluent limitations when designed satisfy technology requirements . . . and to protect water quality.”)

    • The following provision from the existing regulations is proposed to be removed: “Implementation of best management practices consistent with the provisions of the storm water management program required pursuant to this section and the provisions of the permit required pursuant to § 122.33 constitutes compliance with the standard of reducing pollutants to the `maximum extent practicable.' ” The court in EDC found this sentence to be particularly problematic in light of the lack of permitting authority review of NOIs. Based in part on this language, the court observed that “the operator of a small MS4 needs to do nothing more than decide for itself what reduction in discharges would be the maximum practical reduction.” EDC at 855. Furthermore, the court found that “under the Phase II Rule, nothing prevents the operator of a small MS4 from misunderstanding or misrepresenting its own stormwater situation and proposing a set of minimum measures for itself that would reduce discharges by far less than the maximum extent practicable.” Id. EPA addresses these concerns by removing this language, and instead clarifying, as it does through the other proposed changes to 40 CFR 122.34(a), that it is the permitting authority who is responsible for establishing requirements that constitute compliance with requirement to reduce the discharge of pollutants from the MS4 to the MEP, to protect water quality, and to satisfy the water quality requirements of the CWA.

    • The language in the existing regulations providing permittees with up to five years from the date of permit issuance to implement their SWMPs is modified to apply to new permittees, recognizing that this 5-year period has passed for existing permittees. Another clarification is included to explain that when a permit is expiring and a new permit is being developed, the permitting authority must ensure that the new permit meets the requirements of 40 CFR 122.34(a) based on current water quality conditions, the record of BMP effectiveness, and other current relevant information. This revision would not change the status quo; it merely recognizes that first-time small MS4 permittees have up to five years to develop and implement their SWMPs, while small MS4s that have already been permitted will have developed and implemented their SWMP when they reapply for permit coverage or submit an NOI under the next small MS4 general permit.

    Proposed Changes to 40 CFR 122.34(b)

    The following changes are proposed to be made to 40 CFR 122.34(b):

    • In the proposed regulatory text, the small MS4 operator is still required to develop a SWMP; however, the stated purpose of the SWMP is clarified to emphasize the fact that it is a tool for describing how the permittee will comply with the permit requirements implementing the six minimum control measures, and does not contain effluent limitations or permit conditions. The effluent limitations and other enforceable conditions would be stated in the permit itself. The proposed regulatory text for the Traditional General Permit Approach would clarify that for general permits, documentation of the measurable goals in the SWMP should include schedules that are consistent with any deadlines already established in the general permit. The purpose of this proposed requirement is to preserve the SWMP as a tool for permittees to describe [in more detail] how the MS4 will implement the BMPs required by the permit and to document updates to the SWMP as needed during the permit term if changes are called for to comply with the permit. This language is intended to support the underlying clarification in the proposal that it is in the permit where the enforceable requirements are established, while the role of the SWMP document or other document(s) is to describe in writing how the permittee will comply with these requirements. Under this formulation, a permittee's failure to develop a SWMP document would constitute a violation of the permit, but a permittee's failure to install a specific control measure that is described in the SWMP document would not be a violation of the permit, unless the permit required that this specific control measure be installed as a required BMP. EPA notes that the proposed regulatory text also includes language to clarify that whether or not the SWMP can be found in one document or a series of documents, there should be a written description in some form that explains how the permittee will comply with the permit's minimum control measure requirements. In other words, the “SWMP document” refers to the documentation, whether located in one place or comprised of multiple documents (e.g., ordinances, manuals, documented procedures, and other documentation), that is the written form of the permittee's SWMP. Reference to a “document” in the proposed rule is not intended to create a new documentation requirement.

    • Changes in various provisions in 40 CFR 122.34(b)(1) through (6) are proposed to emphasize the permitting authority's role in including requirements that address the minimum control measures as compared to the current regulations, which give this responsibility to the MS4. In most instances, the proposed modifications are merely changing a few words to switch from the first person (i.e., “you”) to the third person (i.e., “the MS4”). The proposed modifications do not alter the existing, substantive requirements of the six minimum control measures in 40 CFR 122.34(b).

    Proposed Changes to 40 CFR 122.34(d)

    The following changes are proposed to be made to 40 CFR 122.34(d).

    • The proposed regulatory text for the Traditional General Permit Approach would remove existing paragraph (d) from 40 CFR 122.34. The information required to be included in permit applications for individual permits in paragraph (d)(1) would be moved to 40 CFR 122.33(b)(2)(i). This information would no longer be required to be submitted with NOIs. Because EPA and many states have issued menus of BMPs, paragraph (d)(2) is no longer relevant, and under the Traditional General Permit Approach, paragraph (d)(3) would also no longer be needed.

    • For general permits, the information required to be included in the NOI would track with the requirements for general permits in 40 CFR 122.28(b)(2)(ii). See discussion on 40 CFR 122.33. There would be no change to the requirement that an MS4 seeking an individual permit must submit an application with its proposed BMPs to implement the six minimum control measures and measurable goals for BMP implementation.

    Proposed Changes to 40 CFR 122.34(e) and (f)

    The following changes are proposed to be made to 40 CFR 122.34(e) and (f):

    • The proposal would consolidate the current requirements in 40 CFR 122.34(e)(1) and (f) under one section, 40 CFR 122.34(c), entitled “Other applicable requirements.”

    • EPA proposes to remove the guidance in the current regulations at § 122.34(e)(2). The guidance reflects EPA's recommendation for the initial round of permit issuance, which has already occurred for all permitting authorities. The phrasing of the guidance language no longer represents EPA policy with respect to including additional, more stringent requirements. EPA has found that a number of permitting authorities are already including specific requirements in their small MS4 permits that address not only wasteload allocations in TMDLs, but also other more stringent requirements that are in addition to the six minimum measures irrespective of the status of EPA's 40 CFR 122.37 evaluation. See EPA's Municipal Separate Storm Sewer System Permits—Post-Construction Performance Standards & Water Quality-Based Requirements: A Compendium of Permitting Approaches (2014). Based on the advancements made by specific permitting programs, and information that points to stormwater discharges continuing to cause waterbody impairments around the country, EPA has advised in guidance that permitting authorities write MS4 permits with provisions that are “clear, specific, measurable, and enforceable,” incorporating such requirements as clear performance standards, and including measurable goals or quantifiable targets for implementation. See EPA's MS4 Permit Improvement Guide (2010). This guidance is a more accurate reflection of the Agency's current views on how the Phase II regulations should be implemented than the guidance currently in 40 CFR 122.34(e)(2).

    Proposed Renumbering of 40 CFR 122.34(c) and (g)

    The following changes are proposed to be made to 40 CFR 122.34(c) and (g):

    • The existing “qualifying local program” provision currently in 40 CFR 122.34(c) would be renumbered as 40 CFR 122.34(e).

    • The “evaluation and assessment” provision currently in 40 CFR 122.34(g) would be renumbered as 40 CFR 122.34(d). Conforming changes would be made to 40 CFR 122.35 to update the cross-references in that section.

    B. Option 2—Procedural Approach

    Another option, called the “Procedural Approach,” for which EPA requests comment would address the remand by incorporating additional permitting authority and public review steps into the existing regulatory framework for providing coverage to small MS4s under general permits. EPA is not proposing specific regulatory text for this option, but has included a detailed description of how the Procedural Approach would work. In addition to comments on the merits of the option, EPA solicits comments recommending specific regulatory text for this option.

    Under the existing regulation, 40 CFR 122.34(d)(1), MS4s seeking authorization to discharge under a general permit must submit an NOI that identifies the BMPs that the MS4 will implement for each of the six minimum control measures. The NOI must also state the measurable goals for each of the BMPs, including the timing and frequency of their implementation. Under the Procedural Approach, once an MS4 operator submits its NOI requesting coverage under the general permit, an additional step would take place in which the permitting authority would review, and the public would be given an opportunity to comment and request a hearing on, the merits of the MS4's proposed BMPs and measurable goals for complying with the requirement to reduce discharges to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA.

    Under the “Procedural Approach” option, the existing regulatory requirement for the small MS4 to submit an NOI with the BMPS and measurable goals as provided in 40 CFR 122.34(d) and the requirement in 40 CFR 122.34(a) to develop, implement, and enforce a SWMP to meet the six minimum measures and to reduce pollutant discharges to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA would be retained. In this option, the NOI would continue to be used in the same way as the court considered the NOI in the EDC case. The NOI would continue to serve as the document that describes the BMPs and measurable goals that would be considered to be the enforceable requirements applicable to the permittee, in addition to the terms and conditions of the general permit. While a SWMP would still need to be developed, it would not establish enforceable requirements beyond those identified in the NOI that would have undergone public notice and comment and permitting authority review.

    The process would occur in the following sequence: Following the receipt of an NOI for coverage under the general permit, the permitting authority would review the NOI to assess whether the proposed BMPs and measurable goals meet the requirements to reduce pollutants to the MEP, protect water quality, and satisfy the water quality requirements of the CWA. If not, the permitting authority would request supplemental information or revisions as necessary to ensure that the submission satisfies the regulatory requirements. Once satisfied with the submission, the Procedural Approach would require the permitting authority to provide public notice of the NOI and an opportunity to request a hearing on the NOI, in accordance with 40 CFR 124.10 through 124.13. After consideration of comments received and a hearing, if held, the permitting authority would provide notice of its decision to authorize coverage under the general permit and with the specific requirements each MS4 must meet, in accordance with 40 CFR 124.15, or as provided by state law for providing notice of a final permit decision in authorized states. Upon completion of this process, the MS4-specific requirements in the NOI, together with the terms and conditions set forth in the general permit, would be incorporated as requirements of the permit for the particular MS4.

    Where the state is the permitting authority, it would also provide EPA an opportunity to review the individual NOIs and submit comments or objections to the state regarding the adequacy of the NOI before it is made available for public review, consistent with requirements under 40 CFR part 124 for NPDES permit applications and under 40 CFR 123.44 for draft permits. This two-step Procedural Approach is similar to the procedure used to establish “terms of the nutrient management plan” permit requirements proposed by concentrated animal feeding operations (CAFOs) seeking coverage under a general permit under 40 CFR 122.23(h). While Option 2 still relies on the use of a general permit, it follows several of the same process steps as those used for an individual permit.

    Some states, including Minnesota and Texas, have used a similar procedural approach as a way to address the problems identified in the EDC decision. In Minnesota, for example, the state has developed a detailed form that must be completed by any small MS4 seeking coverage under the Minnesota general permit, which when completed will become in effect its SWMP document (referred to as a “Stormwater Pollution Prevention Plan Document” of “SWPPP Document”). The state then reviews the MS4's submission and determines whether revisions are needed to meet the requirements of the permit. After any necessary revisions, the state provides public notice of the NOI and SWPPP Document, and makes them available for public review and comment, and for any requests to hold a public hearing. After considering public comments, the state then makes a final determination on whether to authorize coverage under the general permit, and, if authorized, the contents of the SWPPP Document (as revised when necessary following public comment) become enforceable under the general permit. The Minnesota approach gives MS4s flexibility by providing a range of options from which an MS4 can choose for its particular circumstances. It also provides the public with the opportunity to review the MS4's proposed choices and the permitting authority's determination of adequacy, and to provide comment and request a hearing. The MS4's proposed program for implementing the six minimum measures goes into effect only after the state has made an affirmative determination that the MS4's program has met the burden of showing that pollutant discharges will be reduced to the MEP, will be protective of water quality, and will satisfy the appropriate water quality goals of the CWA, thus providing the necessary permitting authority review.

    Texas also reviews individual MS4 program documents to determine whether they meet the minimum permit and regulatory requirements. In contrast to the more detailed NOI checklist used by Minnesota, Texas uses a relatively short NOI form but requires the MS4 to submit its entire SWMP document for review after the general permit is issued. It does so with the intent to have the SWMP document identify the MS4-specific enforceable requirements, rather than to have this information contained in the NOI. Texas requires the MS4 to provide the public notice of the state's preliminary determination to authorize coverage under the general permit in accordance with the SWMP document and an opportunity to comment on the SWMP document and request a hearing. Comments on the adequacy of the SWMP document and requests for public hearings are submitted directly to the state and the state also determines whether there is sufficient interest to hold a public hearing on the SWMP document.

    Under the Procedural Approach, EPA would preserve one of the core attributes of the existing regulations, that is the flexibility afforded the MS4 to identify the BMPs that it determines are needed to meet the minimum regulatory requirements to reduce pollutant discharges to the MEP, to protect water quality, and to satisfy the water quality requirements of the CWA in its SWMP. This approach may appeal to states that accept the notion that the MS4 should have the initial opportunity to propose the BMPs that it believes will meet the regulatory requirements, and that each program may differ substantially from MS4 to MS4.

    However, the need to undergo a second round of public notice and comment at the state level, in addition to the one provided for the general permit, for approximately 6800 small MS4s, may be seen as a drawback due to the additional workload placed on permitting authorities that do not already follow this approach. The value added by the second comment period is also a consideration. Staff in Minnesota's program reported that while they received over 1500 comments in response to proposing the state-level general permits, only a handful of comments were submitted on the individual MS4 NOI and SWPPP Document submissions during the second public comment period. Staff in Texas' program reported that the state received no comments when it provided public notice on the individual MS4 SWMPs.

    Another factor to consider is that under the Procedural Approach some changes to the BMPs and measurable goals identified in the NOI during the term of the permit could constitute a modification to the permit, and would be subject to permit modification procedures applicable to all NPDES permits. See 40 CFR 122.62 and 122.63. For example, if the MS4 decides to discontinue implementing a particular BMP that it included in its NOI (and which became an enforceable permit requirement) and to substitute a different BMP, a permit modification would be needed. It is not clear whether states are currently using permit modification procedures to process changes to a MS4's SWMP. One possibility for addressing the need for change would be for the permitting authority to establish in the general permit itself a process for making changes to the SWMP without triggering the permit modification procedures, as long as it identifies what changes could be made and under what circumstances. EPA seeks comment on whether to provide in the regulations the option for modifying the general permit under the minor modification procedures in 40 CFR 122.63 for “nonsubstantial revisions” to BMPs, as provided for changes to terms of a CAFO's nutrient management plan that are “not substantial” under 40 CFR 122.42(e)(6). EPA also seeks comment on what criteria should apply for distinguishing between when a change to BMPs is “substantial” requiring a full public participation process or “not substantial” that would be subject to public notice but not public comment under a permit modification process similar to the process in 40 CFR 122.42(e)(6).

    Like several other states, Texas requires the MS4s to provide local public notice and the opportunity to provide comments on individual MS4 NOIs (or the SWMP, as in Texas). What stands out in the Texas approach is that, even though the MS4 must provide the necessary notice, public comments are submitted to the state agency, and the state clearly maintains the decision making over the adequacy of the MS4's SWMP to meet permit and regulatory requirements. The state does so by reviewing the SWMP document before it is public noticed and evaluating for itself any public comments on the SWMP document and whether there is sufficient interest to require a public hearing. EPA seeks comment on whether a rule establishing a procedural approach should enable permitting authorities that rely on the MS4 to public notice its NOI to be able to use this approach to satisfy the public notice requirement for the individual NOIs. If allowed, should it be limited to when the State clearly makes the ultimate decisions about what requirements are sufficient to meet the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of CWA?

    The Texas approach appears to differ from the current procedures that apply to NPDES permits outlined in 40 CFR part 124 in the level of detail about the various procedural requirements such as who must be notified of the proposed action. In this respect, the Texas program resembles EPA's approach to establishing or changing terms of nutrient management plans under CAFO general permits by modifying selected elements of the public participation requirements that apply to individual permits, for example, by shortening the length of public comment period or the period for requesting a public hearing (see 40 CFR 122.23(h)(1) and 122.42(e)(6)), or by allowing web-based public notice alternatives in addition to those identified in 40 CFR 124.10 (c). If EPA chooses to adopt this option, it would largely rely on the existing requirements in 40 CFR part 124 to govern what procedures are necessary to approve the BMPs in the NOI as enforceable provisions of the general permit. However, as discussed, EPA is considering some variations in these 40 CFR part 124 procedural requirements similar to those applicable to incorporating terms of the nutrient management plan into CAFO permits.

    Based on the experiences of states that use a similar procedural approach, EPA estimates that conducting individualized reviews of NOIs and requiring an additional notice and comment period for the initial authorization and subsequent permit modifications in states that do not already provide it would require a significant dedication of staff time, in an amount estimated at 24 hours per MS4. Based on Minnesota's experience, EPA expects the workload to be greatest in the first permit cycle but to decrease by some amount in subsequent cycles as the permitting authority takes advantage of efficiencies gained from having gone through the process before and as the quality of the MS4 submissions improve over time. For states that already use a two-step process, some modest amount of workload increase may be necessary to ensure that all of the process steps are carried out, including additional time needed to process and approve SWMP modifications that change the BMPs in the NOI that have been approved and have become enforceable terms of the permit.

    The following regulatory modifications are envisioned if the Procedural Approach is selected for the final rule.

    • Include additional language indicating that to the extent that the permitting authority chooses to rely on the MS4 operator to describe in its NOI the BMPs, measurable goals, schedules, and other activities in its SWMP that it plans to implement to reduce pollutant discharges to the MEP, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA, the permitting authority will need to incorporate these as enforceable elements of the permit in accordance with the procedures for public notice, the opportunity to request a hearing, and permitting authority final determination in 40 CFR part 124.

    • With respect to determining the appropriate 40 CFR part 124 procedures to follow, one model that EPA could utilize in crafting applicable rule language is the regulatory procedures in 40 CFR 122.23(h) for CAFO general permits. While the CAFO and MS4 programs differ fundamentally from one another in many ways, there are some aspects of the CAFO general permit procedures that could be modified in a manner that would make them suitable to small MS4 general permits. Thus, based on some of the key elements of the CAFO general permit procedures in 40 CFR 122.23(h), EPA is considering including the following provisions in revised 40 CFR 122.33(b)(1) as subparagraphs (i)-(iii):

    —At a minimum, the operator must include in the NOI the BMPs that it proposes to implement to comply with the permit, the measurable goals for each BMP, the person or persons responsible for implementing the SWMP, and any additional information required in the NOI by the general permit. —The Director must review the NOI to ensure that it includes adequate information to determine if the proposed BMPs, timelines, and any other actions are adequate to reduce the discharge of pollutants from the MS4 to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act. When the Director finds that additional information is necessary to complete the NOI or clarify, modify, or supplement previously submitted material, the Director may request such additional information from the MS4 operator. —If the Director makes a preliminary determination that the NOI contains the required information and that the proposed BMPs, schedules, and any other actions necessary to reduce the discharge of pollutants from the MS4 to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act, the permitting authority must notify the public of its proposal to authorize the MS4 to discharge under the general permit and, consistent with 40 CFR 124.10, make available for public review and comment and opportunity for public hearing the NOI, and the specific BMPs, milestones, and schedules from the NOI that the Director proposes to be incorporated into the permit as enforceable requirements. The process for submitting public comments and hearing requests, and the hearing process if a hearing is granted, must follow the procedures applicable to draft permits in 40 CFR 124.11 through 124.13. The permitting authority must respond to significant comments received during the comment period, as provided in 40 CFR 124.17, and, if necessary revise the proposed BMPs and/or timelines to be included as terms of the permit. —When the Director authorizes coverage for the MS4 to discharge under the general permit, the specific elements identified in the NOI are incorporated as terms and conditions of the general permit for that MS4. The permitting authority must, consistent with 40 CFR 124.15, notify the MS4 operator and inform the public that coverage has been authorized and of the elements from the NOI that are incorporated as terms and conditions of the general permit applicable to the MS4.

    • To accompany these regulatory changes, EPA is also considering specifying what specific information the MS4 will need to provide as part of the NOI in order to obtain coverage under a general permit that will use a procedural approach, such as the approach described previously. The MS4 would need to provide the same information as is required for an application for an individual permit under proposed 40 CFR 122.33(b)(2)(ii). This includes general background information as specified in § 122.21(f) as well as the information currently required by 40 CFR 122.34(d), and any other information requested by the permitting authority.

    • If the final rule includes the Procedural Approach or allows for a hybrid approach under Option 3 (the “State Choice Approach”), authorized states would need to revise their approved programs to include the option(s) chosen by the permitting authority and to establish or reference the public notice and comment, hearing request, and other procedures necessary to implement the chosen option(s).

    For both the Procedural Approach and State Choice Approach (see Section VI.C), the Agency chose to describe the regulatory changes that would accompany these options if promulgated as opposed to providing line-by-line rule text changes as it has for the Traditional General Permit Approach. In EPA's view, presenting the rule language in this way will aid in the public's review of the three different options as compared to presenting three different sets of line-by-line changes.

    EPA requests comment on whether the Agency should adopt as its final rule option the procedural approach for permitting small MS4s. EPA has concerns with adopting this approach as the sole rule option since it would require all but a handful of permitting authorities to change their permitting procedures to conform to this new approach. Due to these concerns, EPA also separately requests comment (see next section) on whether the final rule should give permitting authorities a choice of which approach, either the Traditional General Permit Approach or the Procedural Approach, to adopt for their permitting program, or whether there is support for allowing permitting authorities to use a combination of these two approaches.

    Among the concerns EPA has with choosing Option 2 for the final rule is the increase in workload for permitting authorities that would be associated with reviewing and approving, and providing for notice and comment, and providing public hearing opportunities, on each individual NOI. For many permitting authorities, the advantage of providing flexibility to MS4s to propose what they believe will meet the applicable regulatory standards will be outweighed by the resource-intensive procedures that this approach requires. In EPA's discussions with state permitting authorities, the Agency heard a number of concerns about their ability to implement new procedures such as these from a staff and resource perspective. Permitting authorities are also concerned about making individual decisions on what set of MS4 actions are sufficient to meet the regulatory requirements without the benefit of established standards to assist them in making these determinations. Concerns were also raised by many MS4 permittees, who emphasized the effects of these procedures on the timeliness of their discharge authorization, and the fear that states will turn to MS4s to conduct more notice and comment procedures on their behalf. EPA notes that there are also those states that are supportive of making the procedural approach a part of the final rule in some way or form.

    Beyond the workload concerns raised about this option, EPA observes that the need for flexibility among MS4s to develop and implement individually tailored SWMPs is different than the type of flexibility required for CAFO operators in developing and implementing nutrient management plans. AFO permit operators must consider where several key and interdependent variables must be considered to account for site-specific factors such as type of crop grown, soil type, terrain, choice of method for calculating application rates, in particular with respect to land application requirements. Each MS4 faces unique circumstances, but for the most part, the BMPs used to meet minimum control measures are not interdependent in the same way as choices needed to develop land application rates under CAFO regulations. EPA and states have developed menus of different BMPs for the various minimum control measures. As discussed previously, some states have developed detailed manuals for the selection, design, installation, and maintenance of allowable BMPs, which further standardizes the practices to be used for pollutant control at MS4s. Also, the need for small MS4 flexibility may have been greater when the small MS4 program was first established. However, this flexibility may be less critical now that most small MS4s have established programs, and they and the corresponding permitting authorities have gained experience in implementing various BMPs and evaluating the results. Permitting authorities already have the flexibility to issue different general permits or include different general permit terms and conditions for different categories of MS4, such as when there is a new group of MS4s that have not been previously regulated (for example, because a new Census is published creating additional urbanized areas) and a group of existing MS4s that may be on their third or fourth permit. By including specific requirements that only apply to some of the MS4s, they undergo permitting authority review and public comment as part of the process and can be part of the general permit itself. (This would be analogous to EPA's Multi Sector General Permit for Stormwater from Industrial Activity, in which different requirements apply to different sectors in the Appendices to the permit).8 For truly unique situations or in instances where the MS4 wishes to implement a different program, individual permits are always an alternative. These factors point to the benefit of using the Traditional General Permit Approach as the preferred way to modify the general permitting regulations for small MS4s. Though there would certainly be increases in workload associated with the Traditional General Permit Approach, EPA's permits and a growing number of state general permits are being written in this manner and therefore would not require significant alteration. Additionally, as the list of examples of clear, specific, and measurable provisions in general permits grows, presumably other states should be able to take advantage of these ideas for their own permits, and thereby save on permit development time. Requiring the procedural approach on a national level would impose pressures on state programs that arguably can be handled in the general permit itself, and therefore avoided.

    8http://water.epa.gov/polwaste/npdes/stormwater/upload/msgp2015_finalpermit.pdf.

    C. Option 3—State Choice Approach

    EPA requests comments on a third option, which would allow permitting authorities to choose either the Traditional General Permit Approach or the Procedural Approach, or some combination of the two as best suits their needs and circumstances. For example, a state could choose to use Option 1 for small MS4s that have fully established programs and uniform core requirements, and Option 2 for MS4s that it finds would benefit from the additional flexibility to address unique circumstances, such as some non-traditional MS4s. Alternatively, a state could apply a hybrid of the two approaches within one permit by defining some elements within the general permit, which are deemed to reduce the discharge of pollutants to the MEP, to protect water quality, and to satisfy the water quality requirements of the CWA, and enabling other elements to be established through a separate process that allows for more MS4-specific actions, using the Procedural Approach. An example of such a hybrid approach might be where a state incorporates into its general permit a requirement to implement certain minimum construction BMP requirements, such as implementation of provisions set forth in a separate statewide manual, which constitute compliance with the regulatory requirements, but leaves it to the MS4 to propose the BMPs that it will implement to meet the public education and outreach requirements of the permit. The former permit requirements would implement the Traditional General Permit Approach and would require no further permitting authority review and public participation procedures during the process of authorizing individual MS4 discharges; however, for the management practices that the MS4 proposes for its public education and outreach, the permitting authority would need to follow the Procedural Approach for incorporating these standards into the permit as requirements of the permit. The benefit of the State Choice Approach is that the fundamental CWA requirements of permitting authority review and public participation would be met irrespective of whether this occurs as a result of the permit issuance itself or whether these procedures take place in a second step that occurs after permit issuance but before the MS4 is authorized to discharge under the permit. This approach would provide for more options for permit development other than traditional individual or general permits. EPA will continue to encourage greater specificity in establishing clear, specific, and measurable permit terms and conditions in the general permit itself, and expects to provide guidance to assist permitting authorities in accomplishing this objective. Nevertheless, the Agency recognizes that permitting authorities may prefer some flexibility in determining the balance between the efficiencies of a general permit and the desirability of providing maximum flexibility to small MS4s in how they will meet the MEP standard.

    The particular balance between specificity and flexibility a state chooses could evolve over time as the program continues to mature. The benefit of this option may be that it is the least disruptive to how state programs operate now and would impose the least burden on state permitting authorities, unless a state determines that for its situation (e.g., number and variability among small MS4s, available resources, requirements under state law, etc.) more choices in structuring permits would be desirable. If EPA adopts this option as part of the final rule, the following rule changes would be necessary:

    • Adopt the rule changes proposed in this document associated with the Traditional General Permit Approach, as modified pursuant to public comment; and

    • Adopt the rule changes described in the discussion under Option 2.

    EPA requests comment on whether the final rule should adopt Option 3, as opposed to selecting either Option 1 or Option 2 in the final rule. EPA is also interested in comments from permitting authorities as to which approach they are likely to choose (i.e., Option 1 or Option 2, or a hybrid) if Option 3 is finalized.

    EPA also requests comment on whether under Option 3, EPA should consider establishing which permit requirements must be developed using the Traditional General Permit Approach (Option 1), and which may be developed using the Procedural Approach (Option 2). For instance, EPA is interested in finding out whether there is support for requiring permitting authorities to use Option 1 to develop permit conditions implementing the minimum control measures in 40 CFR 122.34(b), while providing the permitting authority with the choice of whether to use an Option 2 approach to establish any more stringent effluent limitations, such as those based on an approved TMDL. Using this approach, the general permit would define the specific actions, performance requirements, and implementation schedules considered necessary to reduce pollutant discharges to the MEP, to protect water quality, and to satisfy the water quality requirements of the CWA. However, this approach would provide the permitting authority the additional flexibility to allow the MS4 to propose in its NOI the specific components of a TMDL implementation plan in order to comply with permit requirements based on applicable wasteload allocation(s). To ensure that the specific actions and timelines of the TMDL plan are properly incorporated as elements of the permit, the permitting authority would then be required to review and approve the small MS4's proposed plan using the process required by the Procedural Approach (Option 2). Additionally, with respect to this concept of specifying which aspects of the small MS4 regulations must be incorporated into permits using the Option 1 approach, while allowing some permit conditions to be developed using the Option 2 approach, EPA requests comment on which permit requirements should be required to be established using Option 1 and which should be given the flexibility to be established using Option 2.

    VII. Incremental Costs of Proposed Rule Options

    The economic analysis estimates the incremental costs of modifying the Phase II MS4 regulations to address the court's remand. EPA assumed that all other costs accrued as a result of the existing small MS4 program, which were accounted for in the economic analysis accompanying the 1999 final Phase II MS4 regulations, remain the same and are not germane to the economic analysis, unless the proposed rule change would affect the baseline program costs. In this respect, EPA focused only on new costs that may be imposed as a result of implementing any of the three options being proposed for comment. It is, therefore, unnecessary to reevaluate the total program costs of the Phase II rule, since those costs were part of the original economic analysis conducted for the 1999 Phase II rule (see 64 FR 68722, December 8, 1999). For further information, refer to the Economic Analysis that is included in the proposed rule docket.

    The following table summarizes the estimated costs for each of the proposed rule options under consideration.

    Proposed rule option Net present value Annualized cost 1—Traditional General Permit Approach $9,579,921 $802,477 2—Procedural Approach 8,279,962 693,584 3—State Choice Approach 9,189,933 769,809

    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 VIII of this document.

    The Economic Analysis assumes that all costs will be borne by NPDES permitting authorities in the form of increased administrative costs to write more detailed permits for Option 1, or to review and approve and process comments on NOIs submitted for general permit coverage for Option 2. Likewise, Option 3 costs reflect the estimated increase in NPDES permitting authority workload (for both EPA and state permitting authorities), which is a function of an assumed amount of NPDES permitting authorities who will choose to implement Option 1 versus Option 2. EPA does not attribute new costs to regulated small MS4s beyond what they are already subject to under the Phase II regulations. This is because the focus of the proposed rule is on the administrative manner in which general permits are issued and/or coverage under those permits is granted. EPA is changing through this rulemaking any of the underlying requirements in the Phase II regulations to which small MS4s are subject.

    EPA chose conservative assumptions about impacts on state workloads, meaning that the estimated economic costs of the policy change are most likely lower than what is actually presented. For instance, EPA did not reduce the number of hours necessary for permitting authorities to draft specific permits pursuant to the Option 1 requirements in the second and third permit term despite the fact that the Agency expects that most permitting authorities, after drafting a specific permit to address Option 1 for the first time would spend less time in subsequent rounds reissuing the same permit. Similarly, in its modeling of Option 2, EPA did not reduce the average number of hours to review each NOI in the second and third permit term, even though EPA expects that most NOIs would address any deficiencies after the first review, therefore resulting in less review time needed in subsequent rounds.

    EPA considers the cost assumptions in Option 1 to be conservative because as more permitting authorities write general permits to establish requirements consistent with the proposed Option 1, other permitting authorities could use and build on those examples, reducing the amount of time it takes to draft the permit requirements. EPA has issued guidance to permitting authorities on how to write better MS4 permits (EPA 2010 and EPA 2014), and has included additional examples of permit language from existing permits in the docket for this rule. See General Permits and the Six Minimum Control Measures: A National Compendium of Clear, Specific, and Measurable Requirements. EPA also anticipates providing further guidance once the rule is promulgated to assist states in implementing the new rule requirements, which should make permit writing more efficient.

    VIII. Statutory and Executive Orders 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 a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket for this action. In addition, EPA prepared an analysis of the potential costs associated with this action. This analysis, “Economic Analysis for the Proposed Municipal Separate Storm Sewer System (MS4) General Permit Remand Rule,” is summarized in Section V.II and is available in the docket.

    B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2040-0004.

    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. Although small MS4s are regulated under the Phase II regulations, this rule does not propose changes to the underlying requirements to which these entities are subject. Instead, the focus of this rule is on ensuring that the process by which NPDES permitting authorities authorize discharges from small MS4s using general permits. This action will have an impact on state government agencies that administer the Phase II MS4 permitting program. The impact to states that are NPDES permitting authorities may range from $6,792,106 to $11,356,092 annually. Details of this analysis are presented in “Economic Analysis for the Proposed Municipal Separate Storm Sewer System (MS4) General Permit Remand Rule.”

    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. This action does not significantly or uniquely affect small governments because this rulemaking only affects the way in which state permitting authorities administer general permit coverage to small MS4s. Nonetheless, EPA consulted with small governments concerning the regulatory requirements that might indirectly affect them, as described in section V.B.

    E. Executive Order 13132: Federalism

    This rule will not have substantial direct effects on the states, 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 changes to the way in which NPDES permitting authorities, including authorized state government agencies, provide general permit coverage to small MS4s. The impact to states which are NPDES permitting authorities may range from $6,792,106 to $11,356,092 annually, depending upon the rule option that is finalized. Details of this analysis are presented in “Economic Analysis for the Proposed Municipal Separate Storm Sewer System (MS4) General Permit Remand Rule,” which is available in the docket for the proposed rule at http://www.regulations.gov under Docket ID No. EPA-HQ-OW-2015-0671.

    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 proposed options would affect them. EPA engaged in extensive outreach via conference calls to authorized states and regulated MS4s to gather input on how EPA's current regulations are affecting them, and to enable officials of affected state and local governments to have meaningful and timely input into the development of the options presented in this proposed rule.

    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. The proposed rule affects the way in which small MS4s are covered under a general permit for stormwater discharges and primarily affects the NPDES permitting authorities. No tribal governments are authorized NPDES permitting authorities. The rule could have an indirect impact on an Indian tribe that is a regulated MS4 in that the NOI required for coverage under a general permit may be changed as a result of the rule (if finalized) or may be subject to closer scrutiny by the permitting authority and more of the requirements could be established as enforceable permit conditions. However, the substance of what an MS4 must do in its SWMP will not change significantly as a result of this rule. Thus, Executive Order 13175 does not apply to this action.

    Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, EPA conducted outreach to tribal officials during the development of this action. EPA spoke with tribal members during a conference call with the National Tribal Water Council to gather input on how tribal governments are currently affected by MS4 regulations and may be affected by the options in this proposed rule. Based on this outreach and additional, internal analysis, EPA confirmed that this proposed action would have little tribal impact and would be of little interest to tribes.

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

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

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

    This action is not subject to Executive Order 13211, because it 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 will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This action affects the procedures by which NPDES permitting authorities provide general permit coverage for small MS4s, to help ensure that small MS4s “reduce the discharge of pollutants to the maximum extent practicable (MEP), to protect water quality and to satisfy the water quality requirements of the Clean Water Act.” It does not change any current human health or environmental risk standards.

    List of Subjects in 40 CFR Part 122

    Environmental protection, Storm water, Water pollution.

    Dated: December 17, 2015. 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. Revise § 122.33 to read as follows:
    § 122.33 Requirements for obtaining permit coverage for regulated small MS4s.

    (a) The operator of any regulated small MS4 under § 122.32 must seek coverage under an NPDES permit issued by the applicable NPDES permitting authority. If the small MS4 is located in an NPDES authorized State, Tribe, or Territory, then that State, Tribe, or Territory is the NPDES permitting authority. Otherwise, the NPDES permitting authority is the EPA Regional Office.

    (b) The operator of any regulated small MS4 must seek authorization to discharge under a general or individual NPDES permit, as follows:

    (1) If seeking coverage under a general permit issued by the Director, the operator must submit a Notice of Intent (NOI) consistent with § 122.28(b)(2). The operator may file its own NOI, or the operator and other municipalities or governmental entities may jointly submit an NOI. If the operator wants to share responsibilities for meeting the minimum measures with other municipalities or governmental entities, the operator must submit an NOI that describes which minimum measures it will implement and identify the entities that will implement the other minimum measures within the area served by the MS4.

    (2)(i) If seeking authorization to discharge under an individual permit and wishing to implement a program under § 122.34, the operator must submit an application to the appropriate NPDES permitting authority that includes the information required under § 122.21(f) and the following:

    (A) The best management practices (BMPs) that the operator or another entity proposes to implement for each of the storm water minimum control measures described in § 122.34(b)(1) through (6);

    (B) The measurable goals for each of the BMPs including, as appropriate, the months and years in which the operator will undertake required actions, including interim milestones and the frequency of the action;

    (C) The person or persons responsible for implementing or coordinating the storm water management program;

    (D) An estimate of square mileage served by the small MS4; and

    (E) Any additional information that the NPDES permitting authority requests.

    (ii) If seeking authorization to discharge under an individual permit and wishing to implement a program that is different from the program under § 122.34, the operator will need to comply with the permit application requirements in § 122.26. The operator will need to submit both parts of the application requirements in § 122.26 (d)(1) and (2) at least 180 days before the operator proposes to be covered by an individual permit. The operator does not need to submit the information required by § 122.26(d)(1)(ii) and (d)(2) regarding its legal authority, unless the operator intends for the permit writer to take such information into account when developing other permit conditions.

    (iii) If allowed by the Director, the operator of the regulated small MS4 and another regulated entity may jointly apply under either paragraph (b)(2)(i) or (ii) of this section to be co-permittees under an individual permit.

    (3) If the regulated small MS4 is in the same urbanized area as a medium or large MS4 with an NPDES storm water permit and that other MS4 is willing to have the small MS4 participate in its storm water program, the parties may jointly seek a modification of the other MS4 permit to include the small MS4 as a limited co-permittee. As a limited co-permittee, the operator of the small MS4 will be responsible for compliance with the permit's conditions applicable to its jurisdiction. If the operator of the small MS4 chooses this option it will need to comply with the permit application requirements of § 122.26, rather than the requirements of paragraph (b)(2)(i) of this section. The operator of the small MS4 does not need to comply with the specific application requirements of § 122.26(d)(1)(iii) and (iv) and (d)(2)(iii) (discharge characterization). The operator of the small MS4 may satisfy the requirements in § 122.26 (d)(1)(v) and (d)(2)(iv) (identification of a management program) by referring to the other MS4's storm water management program.

    (4) Guidance for paragraph (b)(3) of this section. In referencing an MS4's storm water management program, the regulated small MS4 should briefly describe how the existing program will address discharges from the small MS4 or would need to be supplemented in order to adequately address the discharges. The regulated small MS4 should also explain its role in coordinating storm water pollutant control activities in the MS4, and detail the resources available to the MS4 to accomplish the program.

    (c) If the regulated small MS4 is designated under § 122.32(a)(2), the operator of the MS4 must apply for coverage under an NPDES permit, or apply for a modification of an existing NPDES permit under paragraph (b)(3) of this section, within 180 days of notice, unless the NPDES permitting authority grants a later date.

    3. Revise § 122.34 to read as follows:
    § 122.34 Minimum permit requirements for regulated small MS4 permits.

    (a) General requirement for regulated small MS4 permits. In each permit issued under this section, the Director must include permit conditions that establish in specific, clear, and measurable terms what is required to reduce the discharge of pollutants from the MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act. For the purposes of this section, effluent limitations may be expressed as requirements to implement best management practices (BMPs) with clear, specific, and measurable requirements, including, but not limited to, specific tasks, BMP design requirements, performance requirements or benchmarks, schedules for implementation and maintenance, and frequency of actions. For permits being issued to a small MS4 for the first time, the Director may specify a time period of up to 5 years from the date of permit issuance for the permittee to fully comply with the conditions of the permit and to implement necessary BMPs. Each successive permit must meet the requirements of this section based on current water quality conditions, record of BMP effectiveness, and other relevant information.

    (b) Minimum control measures. The permit must include requirements that ensure the permittee implements, or continues to implement, the minimum control measures in paragraphs (b)(1) through (6) of this section during the permit term. The permit must also require a written storm water management program document or documents that, at a minimum, describe how the permittee intends to comply with the permit's requirements for each minimum control measure.

    (1) Public education and outreach on storm water impacts. (i) The permit must require implementation of a public education program to distribute educational materials to the community or conduct equivalent outreach activities about the impacts of storm water discharges on water bodies and the steps that the public can take to reduce pollutants in storm water runoff.

    (ii) Guidance for permitting authorities and regulated small MS4s. The permittee may use storm water educational materials provided by the State, Tribe, EPA, environmental, public interest or trade organizations, or other MS4s. The public education program should inform individuals and households about the steps they can take to reduce storm water pollution, such as ensuring proper septic system maintenance, ensuring the proper use and disposal of landscape and garden chemicals including fertilizers and pesticides, protecting and restoring riparian vegetation, and properly disposing of used motor oil or household hazardous wastes. EPA recommends that the program inform individuals and groups how to become involved in local stream and beach restoration activities as well as activities that are coordinated by youth service and conservation corps or other citizen groups. EPA recommends that the permit require the permittee to tailor the public education program, using a mix of locally appropriate strategies, to target specific audiences and communities. Examples of strategies include distributing brochures or fact sheets, sponsoring speaking engagements before community groups, providing public service announcements, implementing educational programs targeted at school age children, and conducting community-based projects such as storm drain stenciling, and watershed and beach cleanups. In addition, EPA recommends that the permit should require that some of the materials or outreach programs be directed toward targeted groups of commercial, industrial, and institutional entities likely to have significant storm water impacts. For example, providing information to restaurants on the impact of grease clogging storm drains and to garages on the impact of oil discharges. The permit should encourage the permittee to tailor the outreach program to address the viewpoints and concerns of all communities, particularly minority and disadvantaged communities, as well as any special concerns relating to children.

    (2) Public involvement/participation. (i) The permit must require implementation of a public involvement/participation program that complies with State, Tribal, and local public notice requirements.

    (ii) Guidance for permitting authorities and regulated small MS4s. EPA recommends that the permit include provisions addressing the need for the public to be included in developing, implementing, and reviewing the storm water management program and that the public participation process should make efforts to reach out and engage all economic and ethnic groups. Opportunities for members of the public to participate in program development and implementation include serving as citizen representatives on a local storm water management panel, attending public hearings, working as citizen volunteers to educate other individuals about the program, assisting in program coordination with other pre-existing programs, or participating in volunteer monitoring efforts. (Citizens should obtain approval where necessary for lawful access to monitoring sites.)

    (3) Illicit discharge detection and elimination. (i) The permit must require the development, implementation, and enforcement of a program to detect and eliminate illicit discharges (as defined at § 122.26(b)(2)) into the small MS4. At a minimum, the permit must require the permittee to:

    (A) Develop, if not already completed, a storm sewer system map, showing the location of all outfalls and the names and location of all waters of the United States that receive discharges from those outfalls;

    (B) To the extent allowable under State, Tribal or local law, effectively prohibit, through ordinance, or other regulatory mechanism, non-storm water discharges into the storm sewer system and implement appropriate enforcement procedures and actions;

    (C) Develop and implement a plan to detect and address non-storm water discharges, including illegal dumping, to your system; and

    (D) Inform public employees, businesses, and the general public of hazards associated with illegal discharges and improper disposal of waste.

    (ii) The permit must require the permittee to address the following categories of non-storm water discharges or flows (i.e., illicit discharges) only if they are identified as significant contributors of pollutants to the small MS4: Water line flushing, landscape irrigation, diverted stream flows, rising ground waters, uncontaminated ground water infiltration (as defined at 40 CFR 35.2005(b)(20)), uncontaminated pumped ground water, discharges from potable water sources, foundation drains, air conditioning condensation, irrigation water, springs, water from crawl space pumps, footing drains, lawn watering, individual residential car washing, flows from riparian habitats and wetlands, dechlorinated swimming pool discharges, and street wash water (discharges or flows from fire fighting activities are excluded from the effective prohibition against non-storm water and need only be addressed where they are identified as significant sources of pollutants to waters of the United States).

    (ii) Guidance for permit writers and regulated small MS4s. EPA recommends that the permit require the plan to detect and address illicit discharges include the following four components: Procedures for locating priority areas likely to have illicit discharges; procedures for tracing the source of an illicit discharge; procedures for removing the source of the discharge; and procedures for program evaluation and assessment. EPA recommends that the permit require the permittee to visually screen outfalls during dry weather and conduct field tests of selected pollutants as part of the procedures for locating priority areas. Illicit discharge education actions may include storm drain stenciling, a program to promote, publicize, and facilitate public reporting of illicit connections or discharges, and distribution of outreach materials.

    (4) Construction site storm water runoff control. (i) The permit must require the permittee to develop, implement, and enforce a program to reduce pollutants in any storm water runoff to the small MS4 from construction activities that result in a land disturbance of greater than or equal to one acre. Reduction of storm water discharges from construction activity disturbing less than one acre must be included in the program if that construction activity is part of a larger common plan of development or sale that would disturb one acre or more. If the NPDES permitting authority waives requirements for storm water discharges associated with small construction activity in accordance with § 122.26(b)(15)(i), the permittee is not required to develop, implement, and/or enforce a program to reduce pollutant discharges from such sites. The permit must require the development and implementation of, at a minimum:

    (A) An ordinance or other regulatory mechanism to require erosion and sediment controls, as well as sanctions to ensure compliance, to the extent allowable under State, Tribal, or local law;

    (B) Requirements for construction site operators to implement appropriate erosion and sediment control best management practices;

    (C) Requirements for construction site operators to control waste such as discarded building materials, concrete truck washout, chemicals, litter, and sanitary waste at the construction site that may cause adverse impacts to water quality;

    (D) Procedures for site plan review which incorporate consideration of potential water quality impacts;

    (E) Procedures for receipt and consideration of information submitted by the public, and

    (F) Procedures for site inspection and enforcement of control measures.

    (ii) Guidance for permit writers and regulated small MS4s. Examples of sanctions to ensure compliance include non-monetary penalties, fines, bonding requirements and/or permit denials for non-compliance. EPA recommends that the procedures for site plan review include the review of individual pre-construction site plans to ensure consistency with local sediment and erosion control requirements. Procedures for site inspections and enforcement of control measures could include steps to identify priority sites for inspection and enforcement based on the nature of the construction activity, topography, and the characteristics of soils and receiving water quality. EPA also recommends that the permit encourage the permittee to provide appropriate educational and training measures for construction site operators. The permit should also include a requirement for the permittee to require a storm water pollution prevention plan for construction sites within the MS4's jurisdiction that discharge into the system. See § 122.44(s) (NPDES permitting authorities' option to incorporate qualifying State, Tribal and local erosion and sediment control programs into NPDES permits for storm water discharges from construction sites). Also see § 122.35(b) (The NPDES permitting authority may recognize that another government entity, including the permitting authority, may be responsible for implementing one or more of the minimum measures on your behalf.)

    (5) Post-construction storm water management in new development and redevelopment. (i) The permit must require the development, implementation, and enforcement of a program to address storm water runoff from new development and redevelopment projects that disturb greater than or equal to one acre, including projects less than one acre that are part of a larger common plan of development or sale, that discharge into the small MS4. The permit must ensure that controls are in place that would prevent or minimize water quality impacts. The permit must require the permittee to:

    (A) Develop and implement strategies which include a combination of structural and/or non-structural best management practices (BMPs) appropriate for the community;

    (B) Use an ordinance or other regulatory mechanism to address post-construction runoff from new development and redevelopment projects to the extent allowable under State, Tribal or local law; and

    (C) Ensure adequate long-term operation and maintenance of BMPs.

    (ii) Guidance for permit writers and regulated small MS4s. If water quality impacts are considered from the beginning stages of a project, new development and potentially redevelopment provide more opportunities for water quality protection. EPA recommends that the permit ensure that BMPs chosen: Be appropriate for the local community; minimize water quality impacts; and attempt to maintain pre-development runoff conditions. In choosing appropriate BMPs, EPA encourages the permittee to participate in locally-based watershed planning efforts, which attempt to involve a diverse group of stakeholders including interested citizens. When developing a program that is consistent with this measure's intent, EPA recommends that the permit require the permittee to adopt a planning process that identifies the municipality's program goals (e.g., minimize water quality impacts resulting from post-construction runoff from new development and redevelopment), implementation strategies (e.g., adopt a combination of structural and/or non-structural BMPs), operation and maintenance policies and procedures, and enforcement procedures. In developing the program, the permit should also require the permittee to assess existing ordinances, policies, programs and studies that address potential impacts of storm water runoff to water quality. In addition to assessing these existing documents and programs, the permit should require the permittee to provide opportunities to the public to participate in the development of the program. Non-structural BMPs are preventative actions that involve management and source controls such as: Policies and ordinances that provide requirements and standards to direct growth to identified areas, protect sensitive areas such as wetlands and riparian areas, maintain and/or increase open space (including a dedicated funding source for open space acquisition), provide buffers along sensitive water bodies, minimize impervious surfaces, and minimize disturbance of soils and vegetation; policies or ordinances that encourage infill development in higher density urban areas, and areas with existing infrastructure; education programs for developers and the public about project designs that minimize water quality impacts; and measures such as minimization of percent impervious area after development and minimization of directly connected impervious areas. Structural BMPs include: Storage practices such as wet ponds and extended-detention outlet structures; filtration practices such as grassed swales, sand filters and filter strips; and infiltration practices such as infiltration basins and infiltration trenches. EPA recommends that the permit ensure the appropriate implementation of the structural BMPs by considering some or all of the following: Pre-construction review of BMP designs; inspections during construction to verify BMPs are built as designed; post-construction inspection and maintenance of BMPs; and penalty provisions for the noncompliance with design, construction or operation and maintenance. Storm water technologies are constantly being improved, and EPA recommends that the permit requirements be responsive to these changes, developments or improvements in control technologies.

    (6) Pollution prevention/good housekeeping for municipal operations. (i) The permit must require the development and implementation of an operation and maintenance program that includes a training component and has the ultimate goal of preventing or reducing pollutant runoff from municipal operations. Using training materials that are available from EPA, the State, Tribe, or other organizations, the program must include employee training to prevent and reduce storm water pollution from activities such as park and open space maintenance, fleet and building maintenance, new construction and land disturbances, and storm water system maintenance.

    (ii) Guidance for permit writers and regulated small MS4s. EPA recommends that the permit address the following: Maintenance activities, maintenance schedules, and long-term inspection procedures for structural and non-structural storm water controls to reduce floatables and other pollutants discharged from the separate storm sewers; controls for reducing or eliminating the discharge of pollutants from streets, roads, highways, municipal parking lots, maintenance and storage yards, fleet or maintenance shops with outdoor storage areas, salt/sand storage locations and snow disposal areas operated by the permittee, and waste transfer stations; procedures for properly disposing of waste removed from the separate storm sewers and areas listed (such as dredge spoil, accumulated sediments, floatables, and other debris); and ways to ensure that new flood management projects assess the impacts on water quality and examine existing projects for incorporating additional water quality protection devices or practices. Operation and maintenance should be an integral component of all storm water management programs. This measure is intended to improve the efficiency of these programs and require new programs where necessary. Properly developed and implemented operation and maintenance programs reduce the risk of water quality problems.

    (c) Other applicable requirements. (1) Any more stringent effluent limitations, including permit requirements that modify, or are in addition to, the minimum control measures based on an approved total maximum daily load (TMDL) or equivalent analysis that determines such limitations are needed to protect water quality.

    (2) Other applicable NPDES permit requirements, standards and conditions established in the individual or general permit, developed consistent with the provisions of §§ 122.41 through 122.49, as appropriate.

    (d) Evaluation and assessment requirements. The permit must require the permittee to:

    (1) Evaluation. Evaluate permit compliance, the appropriateness of its identified best management practices, and progress towards achieving identified measurable goals.

    Note to paragraph (d)(1): The NPDES permitting authority may determine monitoring requirements for the permittee in accordance with State/Tribal monitoring plans appropriate to the watershed. Participation in a group monitoring program is encouraged.

    (2) Recordkeeping. Keep records required by the NPDES permit for at least 3 years, and to submit such records to the NPDES permitting authority when specifically asked to do so. The permit must require the permittee to make records, including a written description of the storm water management program, available to the public at reasonable times during regular business hours (see § 122.7 for confidentiality provision). (The permittee may assess a reasonable charge for copying. The permit may allow the permittee to require a member of the public to provide advance notice.)

    (3) Reporting. Unless the permittee is relying on another entity to satisfy its NPDES permit obligations under § 122.35(a), the permit must require the permittee to submit annual reports to the NPDES permitting authority for the first permit term. For subsequent permit terms, the permit must require that permittee to submit reports in year two and four unless the NPDES permitting authority requires more frequent reports. The report must include:

    (i) The status of compliance with permit conditions, an assessment of the appropriateness of the permittee's identified best management practices and progress towards achieving its identified measurable goals for each of the minimum control measures;

    (ii) Results of information collected and analyzed, including monitoring data, if any, during the reporting period;

    (iii) A summary of the storm water activities the permittee plans to undertake during the next reporting cycle;

    (iv) A change in any identified best management practices or measurable goals for any of the minimum control measures; and

    (v) Notice that the permittee is relying on another governmental entity to satisfy some of the permit obligations (if applicable), consistent with § 122.35(a).

    (e) Qualifying local program. If an existing qualifying local program requires the permittee to implement one or more of the minimum control measures of paragraph (b) of this section, the NPDES permitting authority may include conditions in the NPDES permit that direct the permittee to follow that qualifying program's requirements rather than the requirements of paragraph (b) of this section. A qualifying local program is a local, State or Tribal municipal stormwater management program that imposes the relevant requirements of paragraph (b) of this section.

    4. Amend § 122.35 by revising the second and third sentences of paragraph (a)(3) to read as follows:
    § 122.35 As an operator of a regulated small MS4, may I share the responsibility to implement the minimum control measures with other entities.

    (a) * * *

    (3) * * * In the reports you must submit under § 122.34(d)(3), you must also specify that you rely on another entity to satisfy some of your permit obligations. If you are relying on another governmental entity regulated under section 122 to satisfy all of your permit obligations, including your obligation to file periodic reports required by § 122.34(d)(3), you must note that fact in your NOI, but you are not required to file the periodic reports.* * *

    [FR Doc. 2015-33174 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R7-ES-2015-0167; FF07C00000 FXES11190700000 167F1611MD] Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Alexander Archipelago Wolf as an Endangered or Threatened Species AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of 12-month petition finding.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Alexander Archipelago wolf (Canis lupus ligoni) as an endangered or threatened species and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). The petitioners provided three listing options for consideration by the Service: Listing the Alexander Archipelago wolf throughout its range; listing Prince of Wales Island (POW) as a significant portion of its range; or listing the population on Prince of Wales Island as a distinct population segment (DPS). After review of the best available scientific and commercial information, we find that listing the Alexander Archipelago wolf is not warranted at this time throughout all or a significant portion of its range, including POW. We also find that the Alexander Archipelago wolf population on POW does not not meet the criteria of the Service's DPS policy, and, therefore, it does not constitute a listable entity under the Act. We ask the public to submit to us any new information that becomes available concerning the threats to the Alexander Archipelago wolf or its habitat at any time.

    DATES:

    The finding announced in this document was made on January 6, 2016.

    ADDRESSES:

    This finding is available on the Internet at http://www.regulations.gov at Docket No. FWS-R7-ES-2015-0167. Supporting documentation we used in preparing this finding will be available for public inspection, by appointment, during normal business hours at the U.S. Fish and Wildlife Service, Anchorage Fish and Wildlife Field Office, 4700 BLM Rd., Anchorage, AK 99507-2546. Please submit any new information, materials, comments, or questions concerning this finding to the above street address.

    FOR FURTHER INFORMATION CONTACT:

    Soch Lor, Field Supervisor, Anchorage Fish and Wildlife Field Office (see ADDRESSES); by telephone at 907-271-2787; or by facsimile at 907-271-2786. If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION: Background

    Section 4(b)(3)(B) of the Act (16 U.S.C. 1531 et seq.), requires that, for any petition to revise the Federal Lists of Endangered and Threatened Wildlife and Plants that contains substantial scientific or commercial information that listing the species may be warranted, we make a finding within 12 months of the date of receipt of the petition. In this finding, we will determine that the petitioned action is: (1) Not warranted, (2) warranted, or (3) warranted, but the immediate proposal of a regulation implementing the petitioned action is precluded by other pending proposals to determine whether species are endangered or threatened, and expeditious progress is being made to add or remove qualified species from the Federal Lists of Endangered and Threatened Wildlife and Plants. Section 4(b)(3)(C) of the Act requires that we treat a petition for which the requested action is found to be warranted but precluded as though resubmitted on the date of such finding, that is, requiring a subsequent finding to be made within 12 months. We must publish these 12-month findings in the Federal Register.

    This finding is based upon the “Status Assessment for the Alexander Archipelago Wolf (Canis lupus ligoni)” (Service 2015, entire) (hereafter, Status Assessment) and the scientific analyses of available information prepared by Service biologists from the Anchorage Fish and Wildlife Field Office, the Alaska Regional Office, and the Headquarters Office. The Status Assessment contains the best scientific and commercial data available concerning the status of the Alexander Archipelago wolf, including the past, present, and future stressors. As such, the Status Assessment provides the scientific basis that informs our regulatory decision in this document, which involves the further application of standards within the Act and its implementing regulations and policies.

    Previous Federal Actions

    On December 17, 1993, the Service received a petition, from the Biodiversity Legal Foundation, Eric Holle, and Martin Berghoffen, to list the Alexander Archipelago wolf as an endangered or threatened species under the Act. On May 20, 1994, we announced a 90-day finding that the petition presented substantial information indicating that the requested action may be warranted, and we initiated a status review of the Alexander Archipelago wolf and opened a public comment period until July 19, 1994 (59 FR 26476). On August 26, 1994, we reopened the comment period on the status review to accept comments until October 1, 1994 (59 FR 44122). The Service issued its 12-month finding that listing the Alexander Archipelago wolf was not warranted on February 23, 1995 (60 FR 10056).

    On February 7, 1996, the Southwest Center for Biological Diversity, Biodiversity Legal Foundation, Save the West, Save America's Forests, Native Forest Network, Native Forest Council, Eric Holle, Martin Berghoffen, and Don Muller filed suit in the U.S. Court for the District of Columbia challenging the Service's not-warranted finding. On October 9, 1996, the U.S. District Court remanded the 12-month finding to the Secretary of the Interior, instructing him to reconsider the determination “on the basis of the current forest plan, and status of the wolf and its habitat, as they stand today” (96 CV 00227 DDC). The Court later agreed to the Service's proposal to issue a new finding on June 1, 1997. On December 5, 1996, we published a document announcing the continuation of the status review for the Alexander Archipelago wolf and opening a public comment period until January 21, 1997 (61 FR 64496). The comment period was then extended or reopened through three subsequent publications (61 FR 69065, December 31, 1996; 62 FR 6930, February 14, 1997; 62 FR 14662, March 27, 1997), until it closed on April 4, 1997.

    Prior to the publication of a 12-month finding, however, the U.S. Forest Service (USFS) issued the 1997 Tongass Land and Resource Management Plan Revision, which superseded the 1979 version of the plan. In keeping with the U.S. District Court's order that a finding be based upon the “current forest plan,” the District Court granted us an extension until August 31, 1997, to issue our 12-month finding so that the petitioners, the public, and the Service could reconsider the status of the Alexander Archipelago wolf under the revised Tongass Land and Resource Management Plan. Therefore, the Service reopened the public comment period on the status review of the Alexander Archipelago wolf from June 12, 1997, to July 28, 1997 (62 FR 32070, June 12, 1997), and we then reevaluated all of the best available information on the Alexander Archipelago wolf, as well as long-term habitat projections for the Tongass National Forest included in the 1997 Tongass Land and Resource Management Plan Revision. On September 4, 1997, we published a 12-month finding that listing the Alexander Archipelago wolf was not warranted (62 FR 46709).

    On August 10, 2011, we received a petition dated August 10, 2011, from the Center for Biological Diversity and Greenpeace, requesting that the Alexander Archipelago wolf be listed as an endangered or threatened species under the Act and critical habitat be designated. Included in the petition was supporting information regarding the subspecies' taxonomy and ecology, distribution, abundance and population trends, causes of mortality, and conservation status. The petitioners also requested that we consider: (1) Prince of Wales Island (POW) as a significant portion of the range of the Alexander Archipelago wolf; and (2) wolves on POW and nearby islands as a distinct population segment. We note here that a significant portion of the range is not a listable entity in and of itself, but instead provides an independent basis for listing and is part of our analysis to determine whether or not listing as an endangered or threatened species is warranted. We published the 90-day finding for the Alexander Archipelago wolf on March 31, 2014, stating that the petition presented substantial information indicating that listing may be warranted (79 FR 17993).

    On June 20, 2014, the Center for Biological Diversity, Greenpeace, Inc., and The Boat Company (collectively, plaintiffs) filed a complaint against the Service for failure to complete a 12-month finding for the Alexander Archipelago wolf within the statutory timeframe. On September 22, 2014, the Service and the aforementioned plaintiffs entered into a stipulated settlement agreement stating that the Service shall review the status of the Alexander Archipelago wolf and submit to the Federal Register a 12-month finding as to whether listing as endangered or threatened is warranted, not warranted, or warranted but precluded by other pending proposals, on or before December 31, 2015. In Fiscal Year 2015, the Service initiated work on a 12-month finding for the Alexander Archipelago wolf.

    On September 14, 2015, the Service received a petition to list on an emergency basis the Alexander Archipelago wolf as an endangered or threatened species under the Act. The petition for emergency listing was submitted by Alaska Wildlife Alliance, Cascadia Wildlands, Center for Biological Diversity, Greater Southeast Alaska Conservation Community, Greenpeace, and The Boat Company. The petitioners stated that harvest of the Alexander Archipelago wolf in Game Management Unit (GMU) 2, in light of an observed recent population decline, would put the population in danger of extinction. On September 28, 2015, the Service acknowledged receipt of the petition for emergency listing to each of the petitioners. In those letters, we indicated that we would continue to evaluate the status of the Alexander Archipelago wolf as part of the settlement agreement and that if at any point we determined that emergency listing was warranted, an emergency rule may be promptly developed.

    This document constitutes the 12-month finding on the August 10, 2011, petition to list the Alexander Archipelago wolf as an endangered or threatened species. For additional information and a detailed discussion of the taxonomy, physical description, distribution, demography, and habitat of the Alexander Archipelago wolf, please see the Status Assessment for Alexander Archipelago Wolf (Canis lupus ligoni) (Service 2015, entire) available under Docket No. FWS-R7-ES-2015-0167 at http://www.regulations.gov, or from the Anchorage Fish and Wildlife Field Office (see ADDRESSES).

    Current Taxonomy Description

    Goldman (1937, pp. 39-40) was the first to propose the Alexander Archipelago wolf as a subspecies of the gray wolf. He described C. l. ligoni as a dark colored subspecies of medium size and short pelage (fur) that occupied the Alexander Archipelago and adjacent mainland of southeastern Alaska. Additional morphometric analyses supported the hypothesis that wolves in southeastern Alaska were phenotypically distinct from other gray wolves in Alaska (Pedersen 1982, pp. 345, 360), although results also indicated similarities with wolves that historically occupied coastal British Columbia, Vancouver Island, and perhaps the contiguous western United States (Nowak 1983, pp. 14-15; Friis 1985, p. 82). Collectively, these findings demonstrated that wolves in southeastern Alaska had a closer affinity to wolves to the south compared to wolves to the north, suggesting that either C. l. ligoni was not confined to southeastern Alaska and its southern boundary should be extended southward (Friis 1985, p. 78) or that C. l. ligoni should be combined with C. l. nubilus, the subspecies that historically occupied the central and western United States (Nowak 1995, p. 396). We discuss these morphological studies and others in detail in the Status Assessment (Service 2015, “Morphological analyses”).

    More recently, several molecular ecology studies have been conducted on wolves in southeastern Alaska and coastal British Columbia, advancing our knowledge of wolf taxonomy beyond morphometric analyses. Generally, results of these genetic studies were similar, suggesting that coastal wolves in southeastern Alaska and coastal British Columbia are part of the same genetic lineage (Breed 2007, pp. 5, 27, 30; Weckworth et al. 2011, pp. 2, 5) and that they appear to be genetically differentiated from interior continental wolves (Weckworth et al. 2005, p. 924; Munoz-Fuentes et al. 2009, p. 9; Weckworth et al. 2010, p. 368; Cronin et al. 2015, pp. 1, 4-6). However, interpretation of the results differed with regard to subspecific designations; some authors concluded that the level of genetic differentiation between coastal and interior continental wolves constitutes a distinct coastal subspecies, C. l. ligoni (Weckworth et al. 2005, pp. 924, 927; Munoz-Fuentes et al. 2009, p. 12; Weckworth et al. 2010, p. 372; Weckworth et al. 2011, p. 6), while other authors asserted that it does not necessitate subspecies status (Cronin et al. 2015, p. 9). Therefore, the subspecific identity, if any, of wolves in southeastern Alaska and coastal British Columbia remained unresolved. As a cautionary note, the inference of these genetic studies depends on the type of genetic marker used and the spatial and temporal extent of the samples analyzed; we review these studies and their key findings as they relate to wolf taxonomy in detail in the Status Assessment (Service 2015, “Genetic analyses”).

    In the most recent meta-analysis of wolf taxonomy in North America, Chambers et al. (2012, pp. 40-42) found evidence for differentiating between coastal and inland wolves, although ultimately the authors grouped wolves in southeastern Alaska and coastal British Columbia with wolf populations that historically occupied the central and western United States (C. l. nubilus). One of their primary reasons for doing so was because coastal wolves harbored genetic material that also was found only in historical samples of C. l. nubilus (Chambers et al. 2012, p. 41), suggesting that prior to extirpation of wolves by humans in the western United States, C. l. nubilus extended northward into coastal British Columbia and southeastern Alaska. However, this study was conducted at a broad spatial scale with a focus on evaluating taxonomy of wolves in the eastern and northeastern United States and therefore was not aimed specifically at addressing the taxonomic status of coastal wolves in western North America. Further, Chambers et al. (2012, p. 41) recognized that understanding the phylogenetic relationship of coastal wolves to other wolf populations assigned as C. l. nubilus is greatly impeded by the extirpation of wolves (and the lack of historical specimens) in the western United States. Lastly, Chambers et al. (2012, p. 2) explicitly noted that their views on subspecific designations were not intended as recommendations for management units or objects of management actions, nor should they be preferred to alternative legal classifications for protection, such as those made under the Act. Instead, the authors stated that the suitability of a subspecies as a unit for legal purposes requires further, separate analysis weighing legal and policy considerations.

    We acknowledge that the taxonomic status of wolves in southeastern Alaska and coastal British Columbia is unresolved and that our knowledge of wolf taxonomy in general is evolving as more sophisticated and powerful tools become available (Service 2015, “Uncertainty in taxonomic status”). Nonetheless, based on our review of the best available information, we found persuasive evidence suggesting that wolves in southeastern Alaska and coastal British Columbia currently form an ecological and genetic unit worthy of analysis under the Act. Although zones of intergradation exist, contemporary gene flow between coastal and interior continental wolves appears to be low (e.g., Weckworth et al. 2005, p. 923; Cronin et al. 2015, p. 8), likely due to physical barriers, but perhaps also related to ecological differences (Munoz-Fuentes et al. 2009, p. 6); moreover, coastal wolves currently represent a distinct portion of genetic diversity for all wolves in North America (Weckworth et al. 2010, p. 363; Weckworth et al. 2011, pp. 5-6). Thus, we conclude that at most, wolves in southeastern Alaska and coastal British Columbia are a distinct subspecies, C. l. ligoni, of gray wolf, and at least, are a remnant population of C. l. nubilus. For the purpose of this 12-month finding, we assume that the Alexander Archipelago wolf (C. l. ligoni) is a valid subspecies of gray wolf that occupies southeastern Alaska and coastal British Columbia and, therefore, is a listable entity under the Act.

    Species Information Physical Description

    The Alexander Archipelago wolf has been described as being darker and smaller, with coarser and shorter hair, compared to interior continental gray wolves (Goldman 1937, pp. 39-40; Wood 1990, p. 1), although a comprehensive study or examination has not been completed. Like most gray wolves, fur coloration of Alexander Archipelago wolves varies considerably from pure white to uniform black, with most wolves having a brindled mix of gray or tan with brown, black, or white. Based on harvest records and wolf sightings, the black color phase appears to be more common on the mainland of southeastern Alaska and coastal British Columbia (20-30 percent) (Alaska Department of Fish and Game [ADFG] 2012, pp. 5, 18, 24; Darimont and Paquet 2000, p. 17) compared to the southern islands of the Alexander Archipelago (2 percent) (ADFG 2012, p. 34), and some of the gray-colored wolves have a brownish-red tinge (Darimont and Paquet 2000, p. 17). The variation in color phase of Alexander Archipelago wolves is consistent with the level of variation observed in other gray wolf populations (e.g., Central Brooks Range, Alaska) (Adams et al. 2008, p. 170).

    Alexander Archipelago wolves older than 6 months weigh between 49 and 115 pounds (22 and 52 kilograms), with males averaging 83 pounds (38 kilograms) and females averaging 69 pounds (31 kilograms) (British Columbia Ministry of Forests, Lands and Natural Resource Operations [BCMO] 2014, p. 3; Valkenburg 2015, p. 1). On some islands in the archipelago (e.g., POW) wolves are smaller on average compared to those on the mainland, although these differences are not statistically significant (Valkenburg 2015, p. 1) (also see Service 2015, “Physical description”). The range and mean weights of Alexander Archipelago wolves are comparable to those of other populations of gray wolves that feed primarily on deer (Odocoileus spp.; e.g., northwestern Minnesota) (Mech and Paul 2008, p. 935), but are lower than those of adjacent gray wolf populations that regularly feed on larger ungulates such as moose (Alces americanus) (e.g., Adams et al. 2008, p. 8).

    Distribution and Range

    The Alexander Archipelago wolf currently occurs along the mainland of southeastern Alaska and coastal British Columbia and on several island complexes, which comprise more than 22,000 islands of varying size, west of the Coast Mountain Range. Wolves are found on all of the larger islands except Admiralty, Baranof, and Chichagof islands and all of the Haida Gwaii, or Queen Charlotte Islands (see Figure 1, below) (Person et al. 1996, p. 1; BCMO 2014, p. 14). The range of the Alexander Archipelago wolf is approximately 84,595 square miles (mi2) (219,100 square kilometers [km2]), stretching roughly 932 mi (1,500 km) in length and 155 mi (250 km) in width, although the northern, eastern, and southern boundaries are porous and are not defined sharply.

    The majority (67 percent) of the range of the Alexander Archipelago wolf falls within coastal British Columbia, where wolves occupy all or portions of four management “regions.” These include Region 1 (entire), Region 2 (83 percent of entire region), Region 5 (22 percent of entire region), and Region 6 (17 percent of entire region) (see Figure 1, below). Thirty-three percent of the range of the Alexander Archipelago wolf lies within southeastern Alaska where it occurs in all of GMUs 1, 2, 3, and 5, but not GMU 4. See the Status Assessment (Service 2015, “Geographic scope”) for a more detailed explanation on delineation of the range.

    The historical range of the Alexander Archipelago wolf, since the late Pleistocene period when the last glacial ice sheets retreated, was similar to the current range with one minor exception. Between 1950 and 1970, wolves on Vancouver Island likely were extirpated by humans (Munoz-Fuentes et al. 2010, pp. 547-548; Chambers et al. 2012, p. 41); recolonization of the island by wolves from mainland British Columbia occurred naturally and wolves currently occupy Vancouver Island.

    In southeastern Alaska and coastal British Columbia, the landscape is dominated by coniferous temperate rainforests, interspersed with other habitat types such as sphagnum bogs, sedge-dominated fens, alpine areas, and numerous lakes, rivers, and estuaries. The topography is rugged with numerous deep, glacially-carved fjords and several major river systems, some of which penetrate the Coast Mountain Range, connecting southeastern Alaska and coastal British Columbia with interior British Columbia and Yukon Territory. These corridors serve as intergradation zones of variable width with interior continental wolves; outside of them, glaciers and ice fields dominate the higher elevations, separating the coastal forests from the adjacent inland forest in continental Canada.

    Within the range of the Alexander Archipelago wolf, land stewardship largely lies with State, provincial, and Federal governments. In southeastern Alaska, the majority (76 percent) of the land is located within the Tongass National Forest and is managed by the USFS. The National Park Service manages 12 percent of the land, most of which is within Glacier Bay National Park. The remainder of the land in southeastern Alaska is managed or owned by the State of Alaska (4 percent), Native Corporations (3 percent), and other types of ownership (e.g., private, municipal, tribal reservation; 5 percent). In British Columbia (entire), most (94 percent) of the land and forest are owned by the Province of British Columbia (i.e., Crown lands), 4 percent is privately owned, 1 percent is owned by the federal government, and the remaining 1 percent is owned by First Nations and others (British Columbia Ministry of Forests, Mines, and Lands 2010, p. 121).

    BILLING CODE 4333-15-P EP06JA16.000 BILLING CODE 4333-15-C Life History

    In this section, we briefly describe vital rates and population dynamics, including population connectivity, of the Alexander Archipelago wolf. For this 12-month finding, we considered a population to be a collection of individuals of a species in a defined area; the individuals in a population may or may not breed with other groups of that species in other places (Mills 2013, p. 3). We delineated wolves into populations based on GMUs in southeastern Alaska and Regions in British Columbia (coastal portions only) because these are defined areas and wolf populations are managed at these spatial scales (see Figure 1). For example, GMU 2 comprises one population of wolves on POW and adjacent islands.

    Abundance and Trend

    Using the most recent and best available information, we estimate a current, rangewide population of 850-2,700 Alexander Archipelago wolves. The majority (roughly 62 percent) occurs in coastal British Columbia with approximately 200-650 wolves in the southern portion (Regions 1 and 2; about 24 percent of rangewide population) and 300-1,050 wolves in the northern portion (Regions 5 and 6; about 38 percent of rangewide population) (see Figure 1). In southeastern Alaska, we estimate that currently the mainland (GMUs 1 and 5A) contains 150-450 wolves (about 18 percent of rangewide population), the islands in the middle portion of the area (GMU 3) contain 150-350 wolves (about 14 percent of rangewide population), and the southwestern set of islands (GMU 2) has 50-159 wolves (95 percent confidence intervals [CI], mean = 89 wolves; about 6 percent of rangewide population) (Person et al. 1996, p. 13; ADFG 2015a, p. 2). Our estimates are based on a variety of direct and indirect methods with the only empirical estimate available for GMU 2, which comprises POW and surrounding islands. See the Status Assessment (Service 2015, “Abundance and density”) for details on derivation, assumptions, and caveats.

    Similar to abundance, direct estimates of population trend of the Alexander Archipelago wolf are available only for GMU 2 in southeastern Alaska. In this GMU, fall population size has been estimated on four occasions (1994, 2003, 2013, and 2014). Between 1994 and 2014, the population was reduced from 356 wolves (95 percent CI = 148-564) (Person et al. 1996, pp. 11-12; ADFG 2014, pp. 2-4) to 89 wolves (95 percent CI = 50-159) (ADFG 2015a, pp. 1-2), equating to an apparent decline of 75 percent (standard error [SE] = 15), or 6.7 percent (SE = 2.8) annually. Although the numerical change in population size over the 20-year period is notable, the confidence intervals of the individual point estimates overlap. The most severe reduction occurred over a single year (2013-2014), when the population dropped by 60 percent and the proportion of females in the sample was reduced from 0.57 (SE = 0.13) to 0.25 (SE = 0.11) (ADFG 2015a, p. 2). In the remainder of southeastern Alaska, the trend of wolf populations is not known.

    In British Columbia, regional estimates of wolf population abundance are generated regularly using indices of ungulate biomass, and, based on these data, the provincial wolf population as a whole has been stable or slightly increasing since 2000 (Kuzyk and Hatter 2014, p. 881). In Regions 1, 2, 5, and 6, where the Alexander Archipelago wolf occurs in all or a portion of each of these regions (see Distribution and Range, above), the same trend has been observed (BCMO 2015a, p. 1). Because estimates of population trend are not specific to the coastal portions of these regions only, we make the necessary scientific assumption that the trend reported for the entire region is reflective of the trend in the coastal portion of the region. This assumption applies only to Regions 5 and 6, where small portions (22 and 17 percent, respectively) of the region fall within the range of the Alexander Archipelago wolf; all of Region 1 and nearly all (83 percent) of Region 2 are within the range of the coastal wolf (see Figure 1). Thus, based on the best available information, we found that the wolf populations in coastal British Columbia have been stable or slightly increasing over the last 15 years. See the Status Assessment (Service 2015, “Abundance and density”) for a more thorough description of data assumptions and caveats.

    Reproduction and Survival

    Similar to the gray wolf, sizes of litters of the Alexander Archipelago wolf can vary substantially (1-8 pups, mean = 4.1) with inexperienced breeding females producing fewer pups than older, more experienced mothers (Person and Russell 2009, p. 216). Although uncommon, some packs fail to exhibit denning behavior or produce litters in a given year, and no pack has been observed with multiple litters (Person and Russell 2009, p. 216). Age of first breeding of the Alexander Archipelago wolf is about 22 to 34 months (Person et al. 1996, p. 8).

    We found only one study that estimated survival rates of Alexander Archipelago wolves. Based on radio-collared wolves in GMU 2 between 1994 and 2004, Person and Russell (2008, p. 1545) reported mean annual survival rate of wolves greater than 4 months old as 0.54 (SE = 0.17); survival did not differ between age classes or sexes, but was higher for resident wolves (0.65, SE = 0.17) compared to nonresidents (i.e., wolves not associated with a pack; 0.34, SE = 0.17). Average annual rates of mortality attributed to legal harvest, unreported harvest, and natural mortality were 0.23 (SE = 0.12), 0.19 (SE = 0.11), and 0.04 (SE = 0.05), respectively, and these rates were correlated positively with roads and other landscape features that created openings in the forest (Person and Russell 2008, pp. 1545-1546).

    In 2012, another study was initiated (and is ongoing) in GMU 2 that involves collaring wolves, but too few animals have been collared so far to estimate annual survival reliably (n = 12 wolves between 2012 and May 2015). Nonetheless, of those 12 animals, 5 died from legal harvest, 3 from unreported harvest, and 1 from natural causes; additionally, the fate of 2 wolves is unknown and 1 wolf is alive still (ADFG 2015b, p. 4). Thus, overall, harvest of Alexander Archipelago wolves by humans has accounted for most of the mortality of collared wolves in GMU 2. Our review of the best available information did not reveal any estimates of annual survival or mortality of wolves on other islands or the mainland of southeastern Alaska and coastal British Columbia.

    Dispersal and Connectivity

    Similar to gray wolves, Alexander Archipelago wolves either remain in their natal pack or disperse (Person et al. 1996, p. 10), here defined as permanent movement of an individual away from its pack of origin. Dispersers typically search for a new pack to join or associate with other wolves and ultimately form a new pack in vacant territories or in vacant areas adjacent to established territories. Dispersal can occur within or across populations; when it occurs across populations, then population connectivity is achieved. Both dispersal and connectivity contribute significantly to the health of individual populations as well as the taxon as a whole.

    Dispersal rates of the Alexander Archipelago wolf are available only for GMU 2, where the annual rate of dispersal of radio-collared wolves was 39 percent (95 percent CI = 23 percent, n = 18) with adults greater than 2 years of age composing 79 percent of all dispersers (Person and Ingle 1995, p. 20). Minimum dispersal distances from the point of capture and radio-collaring ranged between 8 and 113 mi (13 and 182 km); all dispersing wolves remained in GMU 2 (Person and Ingle 1995, p. 23). Successful dispersal of individuals tends to be short in duration and distance in part because survival of dispersing wolves is low (annual survival rate = 0.16) (e.g., Peterson et al. 1984, p. 29; Person and Russell 2008, p. 1547).

    Owing to the rugged terrain and island geography across most of southeastern Alaska and coastal British Columbia, population connectivity probably is more limited for the Alexander Archipelago wolf compared to the gray wolf that inhabits interior continental North America. Of the 67 Alexander Archipelago wolves radio-collared in GMU 2, none emigrated to a different GMU (Person and Ingle 1995, p. 23; ADFG 2015c, p. 2); similarly, none of the four wolves collared in northern southeastern Alaska (GMU 1C and 1D) attempted long-distance dispersal, although the home ranges of these wolves were comparatively large (ADFG 2015c, p. 2). Yet, of the three wolves opportunistically radio-collared on Kupreanof Island (GMU 3), one dispersed to Revillagigedo Island (GMU 1A) (USFS 2015, p. 1), an event that required at least four water crossings with the shortest being about 1.2 mi (2.0 km) in length (see Figure 1). Thus, based on movements of radio-collared wolves, demographic connectivity appears to be more restricted for some populations than others; however, few data exist outside of GMU 2, where the lack of emigration is well documented but little is known about the rate of immigration.

    Likewise, we found evidence suggesting that varying degrees of genetic connectivity exist across populations of the Alexander Archipelago wolf, indicating that some populations are more insular than others. Generally, of the populations sampled, gene flow was most restricted to and from the GMU 2 wolf population (Weckworth et al. 2005, p. 923; Breed 2007, p. 19; Cronin et al. 2015, Supplemental Table 3), although this population does not appear to be completely isolated. Breed (2007, pp. 22-23) classified most wolves in northern coastal British Columbia (Regions 5 and 6) as residents and more than half of the wolves in the southern portion of southeastern Alaska (GMUs 1A and 2) as migrants of mixed ancestry. Further, the frequency of private alleles (based on nuclear DNA) in the GMU 2 wolf population is low relative to other Alexander Archipelago wolves (Weckworth et al. 2005, p. 921; Breed 2007, p. 18), and the population does not harbor unique haplotypes (based on mitochondrial DNA), both of which suggest that complete isolation has not occurred. Thus, although some genetic discontinuities of Alexander Archipelago wolves is evident, likely due to geographical disruptions to dispersal and gene flow, genetic connectivity among populations seems to be intact, albeit at low levels for some populations (e.g., GMU 2). The scope of inference of these genetic studies depends on the type of genetic marker used and the spatial and temporal extent of the samples analyzed; we review key aspects of these studies in more detail in the Status Assessment (Service 2015, “Genetic analyses,” “Genetic connectivity”).

    Collectively, the best available information suggests that demographic and genetic connectivity among Alexander Archipelago wolf populations exists, but at low levels for some populations such as that of GMU 2, likely due to geographical disruptions to dispersal and gene flow. Based on the range of samples used by Breed (2007, pp. 21-23), gene flow to GMU 2 appears to be uni-directional, which is consistent with the movement data from wolves radio-collared in GMU 2 that demonstrated no emigration from that population (ADFG 2015c, p. 2). These findings, coupled with the trend of the GMU 2 wolf population (see “Abundance and Trend,” above), suggest that this population may serve as a sink population of the Alexander Archipelago wolf; conversely, the northern coastal British Columbian population may be a source population to southern southeastern Alaska, as suggested by Breed (2007, p. 34). This hypothesis is supported further with genetic information indicating a low frequency of private alleles and no unique haplotypes in the wolves occupying GMU 2. Nonetheless, we recognize that persistence of this population may be dependent on the health of adjacent populations (e.g., GMU 3), but conclude that its demographic and genetic contribution to the rangewide population likely is lower than other populations such as those in coastal British Columbia.

    Ecology

    In this section, we briefly describe the ecology, including food habits, social organization, and space and habitat use, of the Alexander Archipelago wolf. Again, we review each of these topics in more detail in the Status Assessment (Service 2015, entire).

    Food Habits

    Similar to gray wolves, Alexander Archipelago wolves are opportunistic predators that eat a variety of prey species, although ungulates compose most of their overall diet. Based on scat and stable isotope analyses, black-tailed deer (Odocoileus hemionus), moose, mountain goat (Oreamnos americanus), and elk (Cervus spp.), either individually or in combination, constitute at least half of the wolf diet across southeastern Alaska and coastal British Columbia (Fox and Streveler 1986, pp. 192-193; Smith et al. 1987, pp. 9-11, 16; Milne et al. 1989, pp. 83-85; Kohira and Rexstad 1997, pp. 429-430; Szepanski et al. 1999, p. 331; Darimont et al. 2004, p. 1871; Darimont et al. 2009, p. 130; Lafferty et al. 2014, p. 145). Other prey species regularly consumed, depending on availability, include American beaver (Castor canadensis), hoary marmot (Marmota caligata), mustelid species (Mustelidae spp.), salmon (Oncorhynchus spp.), and marine mammals (summarized more fully in the Status Assessment, Service 2015, “Food habits”).

    Prey composition in the diet of the Alexander Archipelago wolf varies across space and time, usually reflecting availability on the landscape, especially for ungulate species that are not uniformly distributed across the islands and mainland. For instance, mountain goats are restricted to the mainland and Revillagigedo Island (introduced). Similarly, moose occur along the mainland and nearby islands as well as most of the islands in GMU 3 (e.g., Kuiu, Kupreanof, Mitkof, and Zarembo islands); moose distribution is expanding in southeastern Alaska and coastal British Columbia (Darimont et al. 2005, p. 235; Hundertmark et al. 2006, p. 331). Elk also occur only on some islands in southeastern Alaska (e.g., Etolin Island) and on Vancouver Island. Deer are the only ungulate distributed throughout the range of the Alexander Archipelago wolf, although abundance varies greatly with snow conditions. Generally, deer are abundant in southern coastal British Columbia, where the climate is mild, with their numbers decreasing northward along the mainland due to increasing snow depths, although they typically occur in high densities on islands such as POW, where persistent and deep snow accumulation is less common.

    Owing to the disparate patterns of ungulate distribution and abundance, some Alexander Archipelago wolf populations have a more restricted diet than others. For example, in GMU 2, deer is the only ungulate species available to wolves, but elsewhere moose, mountain goat, elk, or a combination of these ungulates are available. Szepanski et al. (1999, pp. 330-331) demonstrated that deer and salmon contributed equally to the diet of wolves on POW (GMU 2), Kupreanof Island (GMU 3), and the mainland (GMUs 1A and 1B) (deer = 45-49 percent and salmon = 15-20 percent), and that “other herbivores” composed the remainder of the diet (34-36 percent). On POW, “other herbivores” included only beaver and voles (Microtus spp.), but on Kupreanof Island, moose also was included, and on the mainland, mountain goat was added to the other two herbivore prey species. Therefore, we hypothesize that wolves in GMU 2, and to a lesser extent in parts of GMU 3, are more vulnerable to changes in deer abundance compared to other wolf populations that have a more diverse ungulate prey base available to them.

    Given the differences in prey availability throughout the range of the Alexander Archipelago wolf, some general patterns in their food habits exist. On the northern mainland of southeastern Alaska, where deer occur in low densities, wolves primarily eat moose and mountain goat (Fox and Streveler 1986, pp. 192-193; Lafferty et al. 2014, p. 145). As one moves farther south and deer become more abundant, they are increasingly represented in the diet, along with correspondingly smaller proportions of moose and mountain goat where available (Szepanski et al. 1999, p. 331; Darimont et al. 2004, p. 1869). On the outer islands of coastal British Columbia, marine mammals compose a larger portion of the diet compared to other parts of the range of the Alexander Archipelago wolf (Darimont et al. 2009, p. 130); salmon appear to be eaten regularly by coastal wolves in low proportions (less than 20 percent), although some variation among populations exists. Generally, the diet of wolves in coastal British Columbia appears to be more diverse than in southeastern Alaska (e.g., Kohira and Rexstad 1997, pp. 429-430; Darimont et al. 2004, pp. 1869, 1871), consistent with a more diverse prey base in the southern portion of the range of the Alexander Archipelago wolf. We review these diet studies and others in the Status Assessment (Service 2015, “Food habits”).

    One of the apparently unusual aspects of the Alexander Archipelago wolf diet is consumption of marine-derived foods. However, we found evidence suggesting that this behavior is not uncommon for gray wolves in coastal areas or those that have inland access to marine prey (e.g., spawning salmon). For example, wolves on the Alaska Peninsula in western Alaska have been observed catching and eating sea otters (Enhydra lutris), using offshore winter sea ice as a hunting platform and feeding on marine mammal carcasses such as Pacific walrus (Odobenus rosmarus divergens) and beluga whale (Delphinapterus leucas) (Watts et al. 2010, pp. 146-147). In addition, Adams et al. (2010, p. 251) found that inland wolves in Denali National Park, Alaska, ate salmon in slightly lower but similar quantities (3-17 percent of lifetime diet) compared to Alexander Archipelago wolves (15-20 percent of lifetime diet; Szepanski et al. 1999, p. 327). These findings and others suggest that marine-derived resources are not a distinct component of the diet of the Alexander Archipelago wolf. Nonetheless, marine prey provide alternate food resources to coastal wolves during periods of the year with high food and energy demands (e.g., provisioning of pups when salmon are spawning; Darimont et al. 2008, pp. 5, 7-8) and when and where abundance of terrestrial prey is low.

    Social Organization

    Wolves are social animals that live in packs usually composed of one breeding pair (i.e., alpha male and female) plus offspring of 1 to 2 years old. The pack is a year-round unit, although all members of a wolf pack rarely are observed together except during winter (Person et al. 1996, p. 7). Loss of alpha members of a pack can result in social disruption and unstable pack dynamics, which are complex and shift frequently as individuals age and gain dominance, disperse from, establish or join existing packs, breed, and die (Mech 1999, pp. 1197-1202). Although loss of breeding individuals impacts social stability within the pack, at the population level wolves appear to be resilient enough to compensate for any negative impacts to population growth (Borg et al. 2015, p. 183).

    Pack sizes of the Alexander Archipelago wolf are difficult to estimate owing to the heavy vegetative cover throughout most of its range. In southeastern Alaska, packs range from one to 16 wolves, but usually average 7 to 9 wolves with larger packs observed in fall than in spring (Smith et al. 1987, pp. 4-7; Person et al. 1996, p. 7; ADFG 2015c, p. 2). Our review of the best available information did not reveal information on pack sizes from coastal British Columbia.

    Space and Habitat Use

    Similar to gray wolves in North America, the Alexander Archipelago wolf uses a variety of habitat types and is considered a habitat generalist (Person and Ingle 1995, p. 30; Mech and Boitani 2003, p. xv). Person (2001, pp. 62-63) reported that radiocollared Alexander Archipelago wolves spent most of their time at low elevation during all seasons (95 percent of locations were below 1,312 feet [ft] [400 m] in elevation), but did not select for or against any habitat types except during the pup-rearing season. During the pup-rearing season, radiocollared wolves selected for open- and closed-canopy old-growth forests close to lakes and streams and avoided clearcuts and roads (Person 2001, p. 62), a selection pattern that is consistent with den site characteristics.

    Alexander Archipelago wolves den in root wads of large living or dead trees in low-elevation, old-growth forests near freshwater and away from logged stands and roads, when possible (Darimont and Paquet 2000, pp. 17-18; Person and Russell 2009, pp. 211, 217, 220). Of 25 wolf dens monitored in GMU 2, the majority (67 percent) were located adjacent to ponds or streams with active beaver colonies (Person and Russell 2009, p. 216). Although active dens have been located near clearcuts and roads, researchers postulate that those dens probably were used because suitable alternatives were not available (Person and Russell 2009, p. 220).

    Home range sizes of Alexander Archipelago wolves are variable depending on season and geographic location. Generally, home ranges are about 50 percent smaller during denning and pup-rearing periods compared to other times of year (Person 2001, p. 55), and are roughly four times larger on the mainland compared to the islands in southeastern Alaska (ADFG 2015c, p. 2). Person (2001, pp. 66, 84) found correlations between home range size, pack size, and the proportion of “critical winter deer habitat”; he thought that the relation between these three factors was indicative of a longer-term influence of habitat on deer density. We review space and habitat use of Alexander Archipelago wolf and Sitka black-tailed deer, the primary prey item consumed by wolves throughout most of their range, in detail in the Status Assessment (Service 2015, “Space and habitat use”).

    Summary of Species Information

    In summary, we find that the Alexander Archipelago wolf currently is distributed throughout most of southeastern Alaska and coastal British Columbia with a rangewide population estimate of 850-2,700 wolves. The majority of the range (67 percent) and the rangewide population (approximately 62 percent) occur in coastal British Columbia, where the population is stable or increasing. In southeastern Alaska, we found trend information only for the GMU 2 population (approximately 6 percent of the rangewide population) that indicates a decline of about 75 (SE = 15) percent since 1994, although variation around the point estimates (n = 4) was substantial. This apparent decline is consistent with low estimates of annual survival of wolves in GMU 2, with the primary source of mortality being harvest by humans. For the remainder of southeastern Alaska (about 32 percent of the rangewide population), trends of wolf populations are not known.

    Similar to the continental gray wolf, the Alexander Archipelago wolf has several life-history and ecological traits that contribute to its resiliency, or its ability to withstand stochastic disturbance events. These traits include high reproductive potential, ability to disperse long distances (over 100 km), use of a variety of habitats, and a diverse diet including terrestrial and marine prey. However, some of these traits are affected by the island geography and rugged terrain of most of southeastern Alaska and coastal British Columbia. Most notably, we found that demographic and genetic connectivity of some populations, specifically the GMU 2 population, is low, probably due to geographical disruptions to dispersal and gene flow. In addition, not all prey species occur throughout the range of the Alexander Archipelago wolf, and, therefore, some populations have a more limited diet than others despite the opportunistic food habits of wolves. Specifically, the GMU 2 wolf population is vulnerable to fluctuations in abundance of deer, the only ungulate species that occupies the area. We postulate that the insularity of this population, coupled with its reliance on one ungulate prey species, likely has contributed to its apparent recent decline, suggesting that, under current conditions, the traits associated with resiliency may not be sufficient for population stability in GMU 2.

    Summary of Information Pertaining to the Five Factors

    Section 4 of the Act (16 U.S.C. 1533) and implementing regulations (50 CFR 424) set forth procedures for adding species to, removing species from, or reclassifying species on the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, a species may be determined to be endangered or threatened based on any of the following five factors:

    (A) The present or threatened destruction, modification, or curtailment of its habitat or range;

    (B) Overutilization for commercial, recreational, scientific, or educational purposes;

    (C) Disease or predation;

    (D) The inadequacy of existing regulatory mechanisms; or

    (E) Other natural or manmade factors affecting its continued existence.

    In making this finding, information pertaining to the Alexander Archipelago wolf in relation to the five factors provided in section 4(a)(1) of the Act is discussed below. In considering what factors might constitute threats, we must look beyond the mere exposure of the species to the factor to determine whether the species responds to the factor in a way that causes actual impacts to the species. If there is exposure to a factor, but no response, or only a positive response, that factor is not a threat. If there is exposure and the species responds negatively, the factor may be a threat; we then attempt to determine if that factor rises to the level of a threat, meaning that it may drive or contribute to the risk of extinction of the species such that the species warrants listing as an endangered or threatened species as those terms are defined by the Act. This does not necessarily require empirical proof of a threat. The combination of exposure and some corroborating evidence of how the species is likely impacted could suffice. The mere identification of factors that could impact a species negatively is not sufficient to compel a finding that listing is appropriate, however; we require evidence that these factors are operative threats that act on the species to the point that the species meets the definition of an endangered or threatened species under the Act.

    In making our 12-month finding on the petition we considered and evaluated the best available scientific and commercial information.

    Factor A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    The Alexander Archipelago wolf uses a variety of habitats and, like other gray wolves, is considered to be a habitat generalist. Further, it is an opportunistic predator that eats ungulates, rodents, mustelids, fish, and marine mammals, typically killing live prey, but also feeding on carrion if fresh meat is not available or circumstances are desirable (e.g., large whale carcass). For these reasons and others (e.g., dispersal capability), we found that wolf populations often are resilient to changes in their habitat and prey. Nonetheless, we also recognize that the Alexander Archipelago wolf inhabits a distinct ecosystem, partially composed of island complexes, that may restrict wolf movement and prey availability of some populations, thereby increasing their vulnerability to changes in habitat.

    In this section, we review stressors to terrestrial and intertidal habitats used by the Alexander Archipelago wolf and its primary prey, specifically deer. We identified timber harvest as the principal stressor modifying wolf and deer habitat in southeastern Alaska and coastal British Columbia, and, therefore, we focus our assessment on this stressor by evaluating possible direct and indirect impacts to the wolf at the population and rangewide levels. We also consider possible effects of road development, oil development, and climate-related events on wolf habitat. We describe the information presented here in more detail in the Status Assessment (Service 2015, “Cause and effect analysis”).

    Timber Harvest

    Throughout most of the range of the Alexander Archipelago wolf, timber harvest has altered forested habitats, especially those at low elevations, that are used by wolves and their prey. Rangewide, we estimate that 19 percent of the productive old-growth forest has been logged, although it has not occurred uniformly across the landscape or over time. A higher percentage of productive old-growth forest has been logged in coastal British Columbia (24 percent) compared to southeastern Alaska (13 percent), although in both areas, most of the harvest has occurred since 1975 (85 percent and 66 percent, respectively). Within coastal British Columbia, the majority of harvest (66 percent of total harvest) has happened in Region 1, where 34 percent of the forest has been logged; in the coastal portions of Regions 2, 5, and 6, timber harvest has been comparatively lower, ranging from 12 to 17 percent of the productive forest in these regions. Similarly, in southeastern Alaska, logging has occurred disproportionately in GMU 2, where 23 percent of the forest has been logged (47 percent of all timber harvest in southeastern Alaska); in other GMUs, only 6 to 14 percent of the forest has been harvested. We discuss spatial and temporal patterns of timber harvest in more detail in the Status Assessment (Service 2015, “Timber harvest”).

    Owing to past timber harvest in southeastern Alaska and coastal British Columbia, portions of the landscape currently are undergoing succession and will continue to do so. Depending on site-specific conditions, it can take up to several hundred years for harvested stands to regain old-growth forest characteristics fully (Alaback 1982, p. 1939). During the intervening period, these young-growth stands undergo several successional stages that are relevant to herbivores such as deer. Briefly, for 10 to 15 years following clearcut logging, shrub and herb biomass production increases (Alaback 1982, p. 1941), providing short-term benefits to herbivores such as deer, which select for these stands under certain conditions (e.g., Gilbert 2015, p. 129). After 25 to 35 years, early seral stage plants give way to young-growth coniferous trees, and their canopies begin to close, intercepting sunlight and eliminating most understory vegetation. These young-growth stands offer little nutritional browse for deer and therefore tend to be selected against by deer (e.g., Gilbert 2015, pp. 129-130); this stage typically lasts for at least 50 to 60 years, at which point the understory layer begins to develop again (Alaback 1982, pp. 1938-1939). An understory of deciduous shrubs and herbs, similar to pre-harvest conditions, is re-established 140 to 160 years after harvest. Alternative young-growth treatments (e.g., thinning, pruning) are used to stimulate understory growth, but they often are applied at small spatial scales, and their efficacy in terms of deer use is unknown; regardless, to date, over 232 mi2 (600 km2) of young-growth has been treated in southeastern Alaska (summarized in Service 2015, “Timber harvest”).

    We expect timber harvesting to continue to occur throughout the range of the Alexander Archipelago wolf, although given current and predicted market conditions, the rate of future harvest is difficult to project. In southeastern Alaska, primarily in GMUs 2 and 3, some timber has been sold by the USFS already, but has not yet been cut. In addition, new timber sales currently are being planned for sale between 2015 and 2019, and most of this timber is expected to be sourced from GMUs 2 and 3; however, based on recent sales, it is unlikely that the planned harvest will be implemented fully due to lack of bidders. Also, we anticipate at least partial harvest of approximately 277 km2 of land in GMU 2 that was transferred recently from the Tongass National Forest to Sealaska Native Corporation. In coastal British Columbia, we estimate that an additional 17 percent of forest will be harvested by 2100 on Vancouver Island (Region 1) and an additional 39 percent on the mainland of coastal British Columbia; however, some of this timber volume would be harvested from old young-growth stands. See the Status Assessment for more details (Service 2015, “Future timber harvest”).

    Since 2013, the USFS has been developing a plan to transition timber harvest away from primarily logging old-growth and toward logging young-growth stands, although small amounts of old-growth likely will continue to be logged. An amendment to the current Tongass Land and Resource Management Plan is underway and is expected to be completed by the end of 2016. Although this transition is expected to reduce further modification of habitat used by wolves and deer, the amendment that outlines the transition is still in the planning phase.

    Potential Effects of Timber Harvest

    After reviewing the best available information, we determined that the only potential direct effect from timber harvest to Alexander Archipelago wolves is the modification of and disturbance at den sites. Although coastal wolves avoided using den sites located in or near logged stands, other landscape features such as gentle slope, low elevation, and proximity to freshwater had greater influence on den site use (Person and Russell 2009, pp. 217-219). Further, our review of the best available information did not indicate that denning near logged stands had fitness consequences to individual wolves or that wolf packs inhabiting territories with intensive timber harvest were less likely to breed due to reduced availability of denning habitat. Therefore, we conclude that modification of and disturbance at den sites as a result of timber harvest does not constitute a threat to the Alexander Archipelago wolf at the population or rangewide level.

    We then examined reduction in prey availability, specifically deer, as a potential indirect effect of timber harvest to the Alexander Archipelago wolf. Because deer selectively use habitats that minimize accumulation of deep snow in winter, including productive old-growth forest (e.g., Schoen and Kirchhoff, 1990, p. 374; Doerr et al. 2005, p. 322; Gilbert 2015, p. 129), populations of deer in areas of intensive timber harvest are expected to decline in the future as a result of long-term reduction in the carrying capacity of their winter habitat (e.g., Person 2001, p. 79; Gilbert et al. 2015, pp. 18-19). However, we found that most populations of Alexander Archipelago wolf likely will be resilient to predicted declines in deer abundance largely owing to their ability to feed on alternate ungulate prey species and non-ungulate species, including those that occur in intertidal and marine habitats (greater than 15 percent of the diet; see “Food Habits,” above) (Szepanski et al. 1999, p. 331; Darimont et al. 2004, p. 1871, Darimont et al. 2009, p. 130). Moreover, in our review of the best available information, we found nothing to suggest that these intertidal and marine species, non-ungulate prey, and other ungulate species within the range of the Alexander Archipelago wolf (i.e., moose, goat, elk) are affected significantly by timber harvest (Service 2015, “Response of wolves to timber harvest”). Therefore, we focus the remainder of this section on predicted response of wolves to reduction in deer numbers as a result of timber harvest and availability of alternate ungulate prey.

    In coastal British Columbia, where a greater proportion of productive old-growth forest has been harvested compared to southeastern Alaska, deer populations are stable (Regions 1, 2, and 5) or decreasing (Region 6) (BCMO 2015b, p. 1). Yet, corresponding wolf populations at the regional scale are stable or slightly increasing (Kuzyk and Hatter 2014, p. 881; BCMO 2015a, p. 1). We attribute the stability in wolf numbers, in part, to the availability of other ungulate species, specifically moose, mountain goat, and elk (Region 1 only), which primarily have stable populations and do not use habitats affected by timber harvest. Therefore, we presume that these wolf populations have adequate prey available and are not being affected significantly by changes in deer abundance as a result of timber harvest.

    Similarly, throughout most of southeastern Alaska, wolves have access to multiple ungulate prey species in addition to deer. Along the mainland (GMUs 1 and 5A), where deer densities are low naturally, moose and mountain goats are available, and, in GMU 3, moose occur on all of the larger islands and elk inhabit Etolin and Zarembo islands. Also, although we expect deer abundance in these GMUs to be lower in the future, deer will continue to be available to wolves; between 1954 and 2002, deer habitat capability was reduced by only 15 percent in parts of GMU 1 and by 13 to 23 percent in GMU 3 (Albert and Schoen 2007, p. 16). Thus, although we lack estimates of trend in these wolf populations, we postulate that they have sufficient prey to maintain stable populations and are not being impacted by timber harvest.

    Only one Alexander Archipelago wolf population, the GMU 2 population, relies solely on deer as an ungulate prey species and therefore it is more vulnerable to declines in deer numbers compared to all other populations. Additionally, timber harvest has occurred disproportionately in this area, more so than anywhere else in the range of the wolf except Vancouver Island (where the wolf population is stable). As a result, in GMU 2, deer are projected to decline by approximately 21 to 33 percent over the next 30 years, and, correspondingly, the wolf population is predicted to decline by an average of 8 to 14 percent (Gilbert et al. 2015, pp. 19, 43). Further, the GMU 2 wolf population already has been reduced by about 75 percent since 1994, although most of the apparent decline occurred over a 1-year period between 2013 and 2014 (see “Abundance and Trend,” above), suggesting that the cause of the decline was not specifically long-term reduction in deer carrying capacity, although it probably was a contributor. These findings indicate that for this wolf population, availability of non-ungulate prey does not appear to be able to compensate for declining deer populations, especially given other present stressors such as wolf harvest (see discussion under Factor B). Therefore, we conclude that timber harvest is affecting the GMU 2 wolf population by reducing its ungulate prey and likely will continue to do so in the future.

    In reviewing the best available information, we conclude that indirect effects from timber harvest likely are not having and will not have a significant effect on the Alexander Archipelago wolf at the rangewide level. Although timber harvest has reduced deer carrying capacity, which in turn is expected to cause declines in deer populations, wolves are opportunistic predators, feeding on a variety of prey species, including intertidal and marine species that are not impacted by timber harvest. In addition, the majority (about 94 percent) of the rangewide wolf population has access to ungulate prey species other than deer. Further, currently the wolf populations in coastal British Columbia, which constitute 62 percent of the rangewide population, are stable or slightly increasing despite intensive and extensive timber harvest.

    However, we also conclude that the GMU 2 wolf population likely is being affected and will continue to be affected by timber harvest, but that any effects will be restricted to the population level. This wolf population represents only 6 percent of the rangewide population, is largely insular and geographically peripheral to other populations, and appears to function as a sink population (see “Abundance and Trend” and “Dispersal and Connectivity,” above). For these reasons, we find that the demographic and genetic contributions of the GMU 2 wolf population to the rangewide population are low. Thus, although we expect deer and wolf populations to decline in GMU 2, in part as a result of timber harvest, we find that these declines will not result in a rangewide impact to the Alexander Archipelago wolf population.

    Road Development

    Road development has modified the landscape throughout the range of the Alexander Archipelago wolf. Most roads were constructed to support the timber industry, although some roads were built as a result of urbanization, especially in southern coastal British Columbia. Below, we briefly describe the existing road systems in southeastern Alaska and coastal British Columbia using all types of roads (e.g., sealed, unsealed) that are accessible with any motorized vehicle (e.g., passenger vehicle, all-terrain vehicle). See the Status Assessment for a more detailed description (Service 2015, “Road construction and management”).

    Across the range of the Alexander Archipelago wolf, the majority (86 percent) of roads are located in coastal British Columbia (approximately 41,943 mi [67,500 km] of roads), where mean road density is 0.76 mi per mi2 (0.47 km per km2), although road densities are notably lower in the northern part of the province (Regions 5 and 6, mean = 0.21-0.48 mi per km2 [0.13-0.30 km per km2]) compared to the southern part (Regions 1 and 2, mean = 0.85-0.89 mi per mi2 [0.53-0.55 km per km2]), largely owing to the urban areas of Vancouver and Victoria. In southeastern Alaska, nearly 6,835 mi [11,000 km] of roads exist within the range of the Alexander Archipelago wolf, resulting in a mean density of 0.37 mi per mi2 (0.23 km per km2). Most of these roads are located in GMU 2, where the mean road density is 1.00 mi per mi2 (0.62 km per km2), more than double that in all other GMUs, where the mean density ranges from 0.06 mi per mi2 (0.04 km per km2) (GMU 5A) to 0.42 mi per mi2 (0.26 km per km2) (GMU 3). Thus, most of the roads within the range of the Alexander Archipelago wolf are located in coastal British Columbia, especially in Regions 1 and 2, but the highest mean road density occurs in GMU 2 in southeastern Alaska, which is consistent with the high percentage of timber harvest in this area (see “Timber Harvest,” above). In addition, we anticipate that most future road development also will occur in GMU 2 (46 mi [74 km] of new road), with smaller additions to GMUs 1 and 3 (Service 2015, “Road construction and management”).

    Given that the Alexander Archipelago wolf is a habitat generalist, we find that destruction and modification of habitat due to road development likely is not affecting wolves at the population or rangewide level. In fact, wolves occasionally use roads as travel corridors between habitat patches (Person et al. 1996, p. 22). As reviewed above in “Timber Harvest,” we recognize that wolves used den sites located farther from roads compared to unused sites; however, other landscape features were more influential in den site selection, and proximity to roads did not appear to affect reproductive success or pup survival, which is thought to be high (Person et al. 1996, p. 9; Person and Russell 2009, pp. 217-219). Therefore, we conclude that roads are not a threat to the habitats used by the Alexander Archipelago wolf, although we address the access that they afford to hunters and trappers as a potential threat to some wolf populations under Factor B.

    Oil and Gas Development

    We reviewed potential loss of habitat due to oil and gas development as a stressor to the Alexander Archipelago wolf. We found no existing oil and gas projects within the range of the coastal wolf, although two small-scale exploration projects occurred in Regions 1 and 2 of coastal British Columbia, but neither project resulted in development. In addition, we considered a proposed oil pipeline project (i.e., Northern Gateway Project) intended to transport oil from Alberta to the central coast of British Columbia, covering about 746 mi (1,200 km) in distance. If the proposed project was approved and implemented, risk of oil spills on land and on the coast within the range of the Alexander Archipelago wolf would exist. However, given its diverse diet, terrestrial habitat use, and dispersal capability, we conclude that wolf populations would not be affected by the pipeline project even if an oil spill occurred because exposure would be low. Further, oil development occurs in portions of the range of the gray wolf (e.g., Trans Alaska Pipeline System) and is not thought to be impacting wolf populations negatively. We conclude that oil development is not a threat to the Alexander Archipelago wolf now and is not likely to become one in the future.

    Climate-Related Events

    We considered the role of climate and projected changes in climate as a potential stressor to the Alexander Archipelago wolf. We identified three possible mechanisms through which climate may be affecting habitats used by coastal wolves or their prey: (1) Frequency of severe winters and impacts to deer populations; (2) decreasing winter snow pack and impacts to yellow cedar; and (3) predicted hydrologic change and impacts to salmon productivity. We review each of these briefly here and in more detail in the Status Assessment (Service 2015, “Climate-related events”).

    Severe winters with deep snow accumulation can negatively affect deer populations by reducing availability of forage and by increasing energy expenditure associated with movement. Therefore, deer selectively use habitats in winter that accumulate less snow, such as those that are at low elevation, that are south-facing, or that can intercept snowfall (i.e., dense forest canopy). Timber harvest has reduced some of these preferred winter habitats. However, while acknowledging that severe winters can result in declines of local deer populations, we postulate that those declines are unlikely to affect wolves substantially at the population or rangewide level for several reasons.

    First, in southern coastal British Columbia where 24 percent of the rangewide wolf population occurs, persistent snowfall is rare except at high elevations. Second, in GMU 2, where wolves are limited to deer as ungulate prey and therefore are most vulnerable to declines in deer abundance, the climate is comparatively mild and severe winters are infrequent (Shanley et al. 2015, p. 6); Person (2001, p. 54) estimated that six winters per century may result in general declines in deer numbers in GMU 2. Lastly, climate projections indicate that precipitation as snow will decrease by up to 58 percent over the next 80 years (Shanley et al. 2015, pp. 5-6), reducing the likelihood of severe winters. Therefore, we conclude that winter severity, and associated interactions with timber harvest, is not a threat to the persistence of the Alexander Archipelago wolf at the population or rangewide level now or in the future.

    In contrast to deer response to harsh winter conditions, recent and ongoing decline in yellow cedar in southeastern Alaska is attributed to warmer winters and reduced snow cover (Hennon et al. 2012, p. 156). Although not all stands are affected or affected equally, the decline has impacted about 965 mi2 (2,500 km2) of forest (Hennon et al. 2012, p. 148), or less than 3 percent of the forested habitat within the range of the Alexander Archipelago wolf. In addition, yellow cedar is a minor component of the temperate rainforest, which is dominated by Sitka spruce and western hemlock and neither of these tree species appears to be impacted negatively by reduced snow cover (e.g., Schaberg et al. 2005, p. 2065). Therefore, we conclude that any effects (positive or negative) to the wolf as a result of loss of yellow cedar would be negligible given that it constitutes a small portion of the forest and that the wolf is a habitat generalist.

    Predicted hydrologic changes as a result of changes in climate are expected to reduce salmon productivity within the range of the Alexander Archipelago wolf (e.g., Edwards et al. 2013, p. 43; Shanley and Albert 2014, p. 2). Warmer winter temperatures and extreme flow events are predicted to reduce egg-to-fry survival of salmon, resulting in lower overall productivity. Although salmon compose 15 to 20 percent of the lifetime diet of Alexander Archipelago wolves in southeastern Alaska (Szepanski et al. 1999, pp. 330-331) and 0 to 16 percent of the wolf diet in coastal British Columbia (Darimont et al. 2004, p. 1871; Darimont et al. 2009, p. 13) (see “Food Habits,” above), we do not anticipate negative effects to them in response to projected declines in salmon productivity at the population or rangewide level owing to the opportunistic predatory behavior of wolves.

    Conservation Efforts To Reduce Habitat Destruction, Modification, or Curtailment of Its Range

    We are not aware of any nonregulatory conservation efforts, such as habitat conservation plans, or other voluntary actions that may help to ameliorate potential threats to the habitats used by the Alexander Archipelago wolf.

    Summary of Factor A

    Although several stressors such as timber harvest, road development, oil development, and climate-related events may be impacting some areas within the range of the Alexander Archipelago wolf, available information does not indicate that these impacts are affecting or are likely to affect the rangewide population. First and foremost, wolf populations in coastal British Columbia, where most (62 percent) of the rangewide population occurs, are stable or slightly increasing even though the landscape has been modified extensively. In fact, a higher proportion of the forested habitat has been logged (24 percent) and the mean road density (0.76 mi per mi2 [0.47 km per km2]) is higher in coastal British Columbia compared to southeastern Alaska (13 percent and 0.37 mi per mi2 [0.23 km per km2], respectively). Second, we found no direct effects of habitat-related stressors that resulted in lower fitness of Alexander Archipelago wolves, in large part because the wolf is a habitat generalist. Third, although deer populations likely will decline in the future as a result of timber harvest, we found that most wolf populations will be resilient to reduced deer abundance because they have access to alternate ungulate and non-ungulate prey that are not impacted significantly by timber harvest, road development, or other stressors that have altered or may alter habitat within the range of the wolf. Only the GMU 2 wolf population likely is being impacted and will continue to be impacted by reduced numbers of deer, the only ungulate prey available; however, we determined that this population does not contribute substantially to the other Alexander Archipelago wolf populations or the rangewide population. Therefore, we posit that most (94 percent) of the rangewide population of Alexander Archipelago wolf likely is not being affected and will not be affected in the future by loss or modification of habitat.

    We conclude, based on the best scientific and commercial information available, that the present or threatened destruction, modification, or curtailment of its habitat or range does not currently pose a threat to the Alexander Archipelago wolf at the rangewide level, nor is it likely to become a threat in the future.

    Factor B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    The Alexander Archipelago wolf is harvested by humans for commercial and subsistence purposes. Mortality of wolves due to harvest can be compensated for at the population or rangewide level through increased survival, reproduction, or immigration (i.e., compensatory mortality), or harvest mortality may be additive, causing overall survival rates and population growth to decline. The degree to which harvest is considered compensatory, partially compensatory, or at least partially additive is dependent on population characteristics such as age and sex structure, productivity, immigration, and density (e.g., Murray et al. 2010, pp. 2519-2520). Therefore, each wolf population (or group of populations) is different, and a universal rate of sustainable harvest does not exist. In our review, we found rates of human-caused mortality of gray wolf populations varying from 17 to 48 percent, with most being between 20 and 30 percent (Fuller et al. 2003, pp. 184-185; Adams et al. 2008, p. 22; Creel and Rotella 2010, p. 5; Sparkman et al. 2011, p. 5; Gude et al. 2012, pp. 113-116). For the Alexander Archipelago wolf in GMU 2, Person and Russell (2008, p. 1547) reported that total annual mortality greater than 38 percent was unsustainable and that natural mortality averaged about 4 percent (SE = 5) annually, suggesting that human-caused mortality should not exceed 34 percent annually. In our review, we did not find any other estimates of sustainable harvest rates specific to the coastal wolf.

    Across the range of the Alexander Archipelago wolf, hunting and trapping regulations, including reporting requirements, vary substantially. In southeastern Alaska, wolf harvest regulations are set by the Alaska Board of Game for all resident and nonresident hunters and trappers, and by the Federal Subsistence Board for federally-qualified subsistence users on Federal lands. In all GMUs, each hunter can harvest a maximum of five wolves, and trappers can harvest an unlimited number of wolves; all harvested wolves must be reported and sealed within a specified time following harvest. In GMU 2 only, an annual harvest guideline is applied; between 1997 and 2014, the harvest guideline was set as 25 to 30 percent of the most recent fall population estimate, and in 2015, this guideline was reduced to 20 percent in response to an apparent decline in the population (see “Abundance and Trend,” above). If the annual harvest guideline is exceeded, then an emergency order closing the hunting and trapping seasons is issued. In coastal British Columbia, the provincial government manages wolf harvest, following an established management plan. The hunting bag limit is three wolves per hunter annually, and, similar to southeastern Alaska, no trapping limit is set. In Regions 1 and 2, all wolf harvest is required to be reported, but no compulsory reporting program exists for Regions 5 and 6.

    In this section, we consider wolf harvest as a stressor to the Alexander Archipelago wolf at the population and rangewide levels. Given that harvest regulations and the biological circumstances (e.g., degree of insularity; see “Dispersal and Connectivity,” above) of each wolf population vary considerably, we examined possible effects of wolf harvest to each population by first considering the current condition of the population. If the population is stable or increasing, we presumed that wolves in that population are not being overharvested; if the population is declining or unknown, we assessed mean annual harvest rates based on reported wolf harvest. Because some wolves are harvested and not reported, even in areas where reporting is required, we then applied proportions of unreported harvest to reported harvest for a given year to estimate total harvest, where it was appropriate to do so. We used the population-level information collectively to evaluate impacts of total harvest to the rangewide population of the Alexander Archipelago wolf. We present our analyses and other information related to wolf harvest in southeastern Alaska and coastal British Columbia in more detail in the Status Assessment (Service 2015, “Wolf harvest”).

    In coastal British Columbia, populations of the Alexander Archipelago wolf are considered to be stable or slightly increasing (see “Abundance and Trend,” above), and, therefore, we presume that current harvest levels are not impacting those populations. Moreover, in Regions 1 and 2, where reporting is required, few wolves are being harvested on average relative to the estimated population size; in Region 1, approximately 8 percent of the population was harvested annually on average between 1997 and 2012, and in Region 2, the rate is even lower (4 percent). It is more difficult to assess harvest in Regions 5 and 6 because reporting is not required; nonetheless, based on the minimum number of wolves harvested annually from these regions, we estimated that 2 to 7 percent of the populations are harvested on average with considerable variation among years, which could be attributed to either reporting or harvest rates. Overall, we found no evidence indicating that harvest of wolves in coastal British Columbia is having a negative effect on the Alexander Archipelago wolf at the population level and is not likely to have one in the future.

    In southeastern Alaska, the GMU 2 wolf population apparently has declined considerably, especially in recent years, although the precision of individual point estimates was low and the confidence intervals overlapped (see “Abundance and Trend,” above). In our review, we found compelling evidence to suggest that wolf harvest likely contributed to this apparent decline. Although annual reported harvest of wolves in GMU 2 equated to only about 17 percent of the population on average between 1997 and 2014 (range = 6-33 percent), documented rates of unreported harvest (i.e., illegal harvest) over a similar time period were high (approximately 38 to 45 percent of total harvest) (Person and Russell 2008, p. 1545; ADFG 2015b, p. 4). Applying these unreported harvest rates, we estimate that mean total annual harvest was 29 percent with a range of 11 to 53 percent, suggesting that in some years, wolves in GMU 2 were being harvested at unsustainable rates; in fact, in 7 of 18 years, total wolf harvest exceeded 34 percent of the estimated population (following Person and Russell [2008, p. 1547], and accounting for natural mortality), suggesting that harvest likely contributed to or caused the apparent population decline. In addition, it is unlikely that increased reproduction and immigration alone could reverse the decline, at least in the short term, owing to this population's insularity (see “Dispersal and Connectivity,” above) and current low proportion of females (see “Abundance and Trend,” above). Thus, we conclude that wolf harvest has impacted the GMU 2 wolf population and, based on the best available information, likely will continue to do so in the near future, consistent with a projected overall population decline on average of 8 to 14 percent (Gilbert et al. 2015, pp. 43, 50), unless total harvest is curtailed.

    Trends in wolf populations in the remainder of southeastern Alaska are not known, and, therefore, to evaluate potential impact of wolf harvest to these populations, we reviewed reported wolf harvest in relation to population size and considered whether or not the high rates of unreported harvest in GMU 2 were applicable to populations in GMUs 1, 3, and 5A. Along the mainland (GMUs 1 and 5A) between 1997 and 2014, mean percent of the population harvested annually and reported was 19 percent (range = 11-27), with most of the harvest occurring in the southern portion of the mainland. In GMU 3, the same statistic was 21 percent, ranging from 8 to 37 percent, but with only 3 of 18 years exceeding 25 percent. Thus, if reported harvested rates from these areas are accurate, wolf harvest likely is not impacting wolf populations in GMUs 1, 3, and 5A because annual harvest rates typically are within sustainable limits identified for populations of gray wolf (roughly 20 to 30 percent), including the Alexander Archipelago wolf (approximately 34 percent) (Fuller et al. 2003, pp. 184-185; Adams et al. 2008, p. 22; Person and Russell 2008, p. 1547; Creel and Rotella 2010, p. 5; Sparkman et al. 2011, p. 5; Gude et al. 2012, pp. 113-116). In our review, we found evidence indicating that unreported harvest occasionally occurs in GMUs 1 and 3 (Service 2015, “Unreported harvest”), but we found nothing indicating that it is occurring at the high rates documented in GMU 2.

    Harvest rates of wolves in southeastern Alaska are associated with access afforded primarily by boat and motorized vehicle (85 percent of successful hunters and trappers) (ADFG 2012, ADFG 2015d). Therefore, we considered road density, ratio of shoreline to land area, and the total number of communities as proxies to access by wolf hunters and trappers and determined that GMU 2 is not representative of the mainland (GMUs 1 and 5A) or GMU 3 and that applying unreported harvest rates from GMU 2 to other wolf populations is not appropriate. Mean road density in GMU 2 (1.00 mi per mi2 [0.62 km per km2]) is more than twice that of all other GMUs (GMU 1 = 0.13 [0.08], GMU 3 = 0.42 [0.26], and GMU 5A = 0.06 [0.04]). Similarly, nearly all (13 of 15, 87 percent) of the Wildlife Analysis Areas (smaller spatial units that comprise each GMU) that exceed the recommended road density threshold for wolves (1.45 mi per mi2 [0.9 km per km2]) (Person and Russell 2008, p. 1548) are located in GMU 2; one each occurs in GMUs 1 and 3. In addition, the ratio of shoreline to land area, which serves as an indicator of boat acess, in GMU 2 (1.30 mi per mi2 [0.81 km per km2]) is greater than all other GMUs (GMU 1 = 0.29 [0.18], GMU 3 = 1.00 [0.62], and GMU 5A = 0.19 [0.12]). Lastly, although the human population size of GMU 2 is comparatively smaller than in the other GMUs, 14 communities are distributed throughout the unit, more than any other GMU (GMU 1 = 11, GMU 3 = 4, and GMU 5A = 1).

    Collectively, these data indicate that hunting and trapping access is greater in GMU 2 than in the rest of southeastern Alaska and that applying unreported harvest rates from GMU 2 to elsewhere is not supported. Therefore, although we recognize that some level of unreported harvest likely is occurring along the mainland of southeastern Alaska and in GMU 3, we do not know the rate at which it may be occurring, but we hypothesize that it likely is less than in GMU 2 because of reduced access. We expect wolf harvest rates in the future to be similar to those in the past because we have no basis from which to expect a change in hunter and trapper effort or success. Consequently, we think that reported wolf harvest rates for GMUs 1, 3, and 5A are reasonably accurate and that wolf harvest is not impacting these populations nor is it likely to do so in the future.

    In summary, we find that wolf harvest is not affecting most populations of the Alexander Archipelago wolf. In coastal British Columbia, wolf populations are stable or slightly increasing, suggesting that wolf harvest is not impacting those populations; in addition, mean annual harvest rates of those populations appear to be low (2 to 8 percent of the population based on the best available information). In southeastern Alaska, we determined that the GMU 2 wolf population is being affected by intermediate rates of reported harvest (annual mean = 17 percent) and high rates of unreported harvest (38 to 45 percent of total harvest), which have contributed to an apparent population decline that is projected to continue. We also find that wolf populations in GMUs 1, 3, and 5A experience intermediate rates of reported harvest, 19 to 21 percent of the populations annually, but that these populations likely do not experience high rates of unreported harvest like those estimated for GMU 2 because of comparatively low access to hunters and trappers. In addition, these GMUs are less geographically isolated than GMU 2 and likely have higher immigration rates of wolves. Therefore, based on the best available information, we conclude that wolf harvest of these populations (GMUs 1, 3, and 5A) is occurring at rates similar to or below sustainable harvest rates proposed for gray wolf (roughly 20 to 30 percent) and the Alexander Archipelago wolf (approximately 34 percent) (Fuller et al. 2003, pp. 184-185; Adams et al. 2008, p. 22; Person and Russell 2008, p. 1547; Creel and Rotella 2010, p. 5; Sparkman et al. 2011, p. 5; Gude et al. 2012, pp. 113-116).

    Although wolf harvest is affecting the GMU 2 wolf population and likely will continue to do so, we conclude that wolf harvest is not impacting the rangewide population of Alexander Archipelago wolf. The GMU 2 wolf population constitutes a small percentage of the rangewide population (6 percent), is largely insular and geographically peripheral to other populations, and appears to function as a sink population (see “Abundance and Trend” and “Dispersal and Connectivity,” above). Therefore, although we found that this population is experiencing unsustainable harvest rates in some years, owing largely to unreported harvest, we think that the condition of the GMU 2 population has a minor effect on the condition of the rangewide population. The best available information does not suggest that wolf harvest is having an impact on the rangewide population of Alexander Archipelago wolf, nor is it likely to have an impact in the future.

    Our review of the best available information does not suggest that overexploitation of the Alexander Archipelago wolf due to scientific or educational purposes is occurring or is likely to occur in the future.

    Conservation Efforts To Reduce Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    The ADFG has increased educational efforts with the public, especially hunters and trappers, in GMU 2 with the goal of improving communication and coordination regarding management of the wolf population. In recent years, the agency held public meetings, launched a newsletter, held a workshop for teachers, and engaged locals in wolf research. We do not know if these efforts ultimately will be effective at lowering rates of unreported harvest.

    We are not aware of any additional conservation efforts or other voluntary actions that may help to reduce overutilization for commercial, recreational, scientific, or educational purposes of the Alexander Archipelago wolf.

    Summary of Factor B

    We find that wolf harvest is not affecting most Alexander Archipelago wolf populations. In coastal British Columbia, wolf harvest rates are low and are not impacting wolves at the population level, as evidenced by stable or slightly increasing populations. In southeastern Alaska, we found that the GMU 2 wolf population is experiencing high rates of unreported harvest, which has contributed to an apparent population decline, and, therefore, we conclude that this population is being affected by wolf harvest and likely will continue to be affected. We determined that wolf harvest in the remainder of southeastern Alaska is occurring at rates that are unlikely to result in population-level declines. Overall, we found that wolf harvest is not having an effect on the Alexander Archipelago wolf at the rangewide level, although we recognize that the GMU 2 population likely is being harvested at unsustainable rates, especially given other stressors facing the population (e.g., reduced prey availability due to timber harvest). Thus, based on the best available information, we conclude that overexploitation for commercial, recreational, scientific, or educational purposes does not currently pose a threat to the Alexander Archipelago wolf throughout its range, nor is it likely to become a threat in the future.

    Factor C. Disease or Predation

    In this section, we briefly review disease and predation as stressors to the Alexander Archipelago wolf. We describe information presented here in more detail in the Status Assessment (Service 2015, “Disease”).

    Disease

    Several diseases have potential to affect Alexander Archipelago wolf populations, especially given their social behavior and pack structure (see “Social Organization,” above). Wolves are susceptible to a number of diseases that can cause mortality in the wild, including rabies, canine distemper, canine parvovirus, blastomycosis, tuberculosis, sarcoptic mange, and dog louse (Brand et al. 1995, pp. 419-422). However, we found few incidences of diseases reported in Alexander Archipelago wolves; these include dog louse in coastal British Columbia (Hatler et al. 2008, pp. 88-91) and potentially sarcoptic mange (reported in British Columbia, but it is unclear whether or not it occurred along the coast or inland; Miller et al. 2003, p. 183). Both dog louse and mange results in mortality only in extreme cases and usually in pups, and, therefore, it is unlikely that either disease is having or is expected to have a population- or rangewide-level effect on the Alexander Archipelago wolf.

    Although we found few reports of diseases in Alexander Archipelago wolves, we located records of rabies, canine distemper, and canine parvovirus in other species in southeastern Alaska and coastal British Columbia, suggesting that transmission is possible but unlikely given the low number of reported incidences. Only four individual bats have tested positive for rabies in southeastern Alaska since the 1970s; bats also are reported to carry rabies in British Columbia, but we do not know whether or not those bats occur on the coast or inland. Canine distemper and parvovirus have been found in domestic dogs on rare occasions; we found only one case of canine distemper, and information suggested that parvovirus has been documented but is rare due to the high percentage of dogs that are vaccinated for it. Nonetheless, we found no documented cases of rabies, canine distemper, or canine parvovirus in wolves from southeastern Alaska or coastal British Columbia.

    We acknowledge that diseases such as canine distemper and parvovirus have affected gray wolf populations in other parts of North America (Brand et al. 1995, p. 420 and references therein), but the best available information does not suggest that disease, or even the likelihood of disease in the future, is a threat to the Alexander Archipelago wolf. We conclude that, while some individual wolves may be affected by disease on rare occasions, disease is not having a population- or rangewide-level effect on the Alexander Archipelago wolf now or in the future.

    Predation

    Our review of the best available information did not indicate that predation is affecting or will affect the Alexander Archipelago wolf at the population or rangewide level. As top predators in the ecosystem, predation most likely would occur by another wolf as a result of inter- or intra-pack strife or other territorial behavior. The annual rate of natural mortality, which includes starvation, disease, and predation, was 0.04 (SE = 0.05) for radio-collared wolves in GMU 2 (Person and Russell 2008, p. 1545), indicating that predation is rare and is unlikely to be having a population or rangewide effect. Therefore, we conclude that predation is not a threat to the Alexander Archipelago wolf, nor is it likely to become one in the future.

    Conservation Efforts To Reduce Disease or Predation

    We are not aware of any conservation efforts or other voluntary actions that may help to reduce disease or predation of the Alexander Archipelago wolf.

    Summary of Factor C

    We identified several diseases with the potential to affect wolves and possible vectors for transmission, but we found only a few records of disease in individual Alexander Archipelago wolves, and, to the best of our knowledge, none resulted in mortality. Further, we found no evidence that disease is affecting the Alexander Archipelago wolf at the population or rangewide level. Therefore, we conclude that disease is not a threat to the Alexander Archipelago wolf and likely will not become a threat in the future.

    We also determined that the most likely predator of individual Alexander Archipelago wolves is other wolves and that this type of predation is a component of their social behavior and organization. Further, predation is rare and is unlikely to be having an effect at population or rangewide levels. Thus, we conclude that predation is not a threat to the Alexander Archipelago wolf, nor is it likely to become one in the future.

    Factor D. The Inadequacy of Existing Regulatory Mechanisms

    In this section, we review laws aimed to help reduce stressors to the Alexander Archipelago wolf and its habitats. However, because we did not find any stressors examined under Factors A, B, and C (described above) and Factor E (described below) to rise to the level of a threat to the Alexander Archipelago wolf rangewide, we also did not find the existing regulatory mechanisms authorized by these laws to be inadequate for the Alexander Archipelago wolf. In other words, we cannot find an existing regulatory mechanism to be inadequate if the stressor intended to be reduced by that regulatory mechanism is not considered a threat to the Alexander Archipelago wolf. Nonetheless, we briefly discuss relevant laws and regulations below.

    Southeastern Alaska National Forest Management Act (NFMA)

    The National Forest Management Act (NFMA; 16 U.S.C. 1600 et seq.) is the primary statute governing the administration of National Forests in the United States, including the Tongass National Forest. The stated objective of NFMA is to maintain viable, well-distributed wildlife populations on National Forest System lands. As such, the NFMA requires each National Forest to develop, implement, and periodically revise a land and resource management plan to guide activities on the forest. Therefore, in southeastern Alaska, regulation of timber harvest and associated activities is administered by the USFS under the current Tongass Land and Resource Management Plan that was signed and adopted in 2008.

    The 2008 Tongass Land and Resource Management Plan describes a conservation strategy that was developed originally as part of the 1997 Plan with the primary goal of achieving objectives under the NFMA. Specifically, the conservation strategy focused primarily on maintaining viable, well-distributed populations of old-growth dependent species on the Tongass National Forest, because these species were considered to be most vulnerable to timber harvest activities on the forest. The Alexander Archipelago wolf, as well as the Sitka black-tailed deer, was used to help design the conservation strategy. Primary components of the strategy include a forest-wide network of old-growth habitat reserves linked by connecting corridors of forested habitat, and a series of standards and guidelines that direct management of lands available for timber harvest and other activities outside of the reserves. We discuss these components in more detail in the Status Assessment (Service 2015, “Existing conservation mechanisms”).

    As part of the conservation strategy, we identified two elements specific to the Alexander Archipelago wolf (USFS 2008a, p. 4-95). The first addresses disturbance at and modification of active wolf dens, requiring buffers of 366 m (1,200 ft) around active dens (when known) to reduce risk of abandonment, although if a den is inactive for at least 2 years, this requirement is relaxed. The second pertains to elevated wolf mortality; in areas where wolf mortality concerns have been identified, a Wolf Habitat Management Program will be developed and implemented, in conjunction with ADFG; such a program might include road access management and changes to wolf harvest limit guidelines. However, this element, as outlined in the Plan, does not offer guidance on identifying how, when, or where wolf mortality concerns may exist, but instead it is left to the discretion of the agencies. The only other specific elements relevant to the Alexander Archipelago wolf in the strategy are those that relate to providing sufficient deer habitat capability, which is intended first to maintain sustainable wolf populations, then to consider meeting estimated human deer harvest demands. The strategy offers guidelines for determining whether deer habitat capability within a specific area is sufficient or not.

    We find the 2008 Tongass Land and Resource Management Plan, including the conservation strategy, not to be inadequate as a regulatory mechanism aimed to reduce stressors to the Alexander Archipelago wolf and its habitats. Although some parts of the Tongass National Forest have sustained high rates of logging in the past, the majority of it occurred prior to the enactment of the Plan and the conservation strategy. We think that the provisions included in the current Plan are sufficient to maintain habitat for wolves and their prey, especially given that none of the stressors evaluated under Factors A, B, C, and E constitutes a threat to the Alexander Archipelago wolf.

    However, we recognize that some elements of the Plan have not been implemented fully yet, as is required under the NFMA. For example, despite evidence of elevated mortality of wolves in GMU 2 (see discussion under Factor B, above), the USFS and ADFG have not developed and implemented a Wolf Habitat Management Program for GMU 2 to date. The reason for not doing so is because the agencies collectively have not determined that current rates of wolf mortality in GMU 2 necessitate concern for maintaining a sustainable wolf population. Although we think that a Wolf Habitat Management Program would benefit the GMU 2 wolf population, we do not view the lack of it as enough to deem the entire Plan, or the existing regulatory mechanisms driving it, to be inadequate for the Alexander Archipelago wolf rangewide. Thus, we conclude that the 2008 Tongass Land and Resource Management Plan is not inadequate to maintain high-quality habitat for the Alexander Archipelago wolf and its prey.

    Roadless Rule

    On January 12, 2001, the USFS published a final rule prohibiting road construction and timber harvesting in “inventoried roadless areas” on all National Forest System lands nationwide (hereafter Roadless Rule) (66 FR 3244). On the Tongass National Forest, 109 roadless areas have been inventoried, covering approximately 14,672 mi2 (38,000 km2), although only 463 mi2 (1,200 km2) of these areas have been described as “suitable forest land” for timber harvest (USFS 2008a, p. 7-42; USFS 2008b, pp. 3-444, 3-449). All of these roadless areas are located within the range of the Alexander Archipelago wolf. However, the Roadless Rule was challenged in court and currently a ruling has not been finalized and additional legal challenges are pending; in the meantime, the Tongass is subject to the provisions in the Roadless Rule, although the outcome of these legal challenges is uncertain. Thus, currently, the Roadless Rule protects 14,672 mi2 (38,000 km2) of land, including 463 mi2 (1,200 km2) of productive forest, from timber harvest, road construction, and other development, all of which is within the range of the Alexander Archipelago wolf.

    State Regulations

    The Alaska Board of Game sets wolf harvest regulations for all resident and nonresident hunters and trappers, and the ADFG implements those regulations. (However, for federally-qualified subsistence users, the Federal Subsistence Board sets regulations, and those regulations are applicable only on Federal lands.) Across most of southeastern Alaska, State regulations of wolf harvest appear not to be resulting in overutilization of the Alexander Archipelago wolf (see discussion under Factor B, above). However, in GMU 2, wolf harvest is having an effect on the population, which apparently has declined over the last 20 years (see “Abundance and Trend,” above). Although the population decline likely was caused by multiple stressors acting synergistically (see Cumulative Effects from Factors A through E, below), overharvest of wolves in some years was a primary contributor, suggesting that the wolf harvest regulations for GMU 2 have been allowing for greater numbers to be harvested than would be necessary to maintain a viable wolf population.

    In March 2014, ADFG and the USFS, Tongass National Forest, as the in-season manager for the Federal Subsistence Program, took emergency actions to close the wolf hunting and trapping seasons in GMU 2, yet the population still declined between fall 2013 and fall 2014, likely due to high levels of unreported harvest (38 to 45 percent of total harvest, summarized under Factor B, above). In early 2015, the agencies issued another emergency order and, in cooperation with the Alaska Board of Game, adopted a more conservative wolf harvest guideline for GMU 2, but an updated population estimate is not available yet, and, therefore, we do not know if the recent change in regulation has been effective at avoiding further population decline. Therefore, based on the best available information, we think that wolf harvest regulations in GMU 2 are inadequate to avoid exceeding sustainable harvest levels of Alexander Archipelago wolves, at least in some years. In order to avoid future unsustainable harvest of wolves in GMU 2, regulations should consider total harvest of wolves, including loss of wounded animals, not just reported harvest. Although we found that regulations governing wolf harvest in GMU 2 have been inadequate, we do not expect their inadequacy to impact the rangewide population of Alexander Archipelago wolf for reasons outlined under Factor B, above.

    The Alexander Archipelago wolf receives no special protection as an endangered species or species of concern by the State of Alaska (AS 16.20.180). However, in the draft State Wildlife Action Plan, which is not yet finalized, the Alexander Archipelago wolf is identified as a “species of greatest conservation need” because it is a species for which the State has high stewardship responsibility and it is culturally and ecologically important (ADFG 2015e, p. 154).

    Coastal British Columbia

    In coastal British Columbia, populations of the Alexander Archipelago wolf have been stable or slightly increasing for the last 15 years (see “Abundance and Trend,” above). Nonetheless, we identified several laws that ensure its continued protection such as the Forest and Range Practices Act (enacted in 2004), Wildlife Act of British Columbia (amended in 2008), Species at Risk Act, Federal Fisheries Act, Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), and other regional land use and management plans. We review these laws in more detail in the Status Assessment (Service 2015, “Existing conservation measures”).

    In 1999, the gray wolf was designated as “not at risk” by the Committee on the Status of Endangered Wildlife in Canada, because it has a widespread, large population with no evidence of a decline over the last 10 years (BCMO 2014, p. 2). In British Columbia, the gray wolf is ranked as “apparently secure” by the Conservation Data Centre and is on the provincial Yellow list, which indicates “secure.” We note here that Canada does not recognize the Alexander Archipelago wolf as a subspecies of gray wolf that occupies coastal British Columbia, and, therefore, these designations are applicable to the province or country scale.

    Summary of Factor D

    The laws described above regulate timber harvest and associated activities, protect habitat, minimize disturbance at den sites, and aim to ensure sustainable harvest of Alexander Archipelago wolves in southeastern Alaska and coastal British Columbia. As discussed under Factors A, B, C, and E, although we recognize that some stressors such as timber harvest and wolf harvest are having an impact on the GMU 2 wolf population, we have not identified any threat that would affect the taxon as a whole at the rangewide level. Therefore, we find that the existing regulatory mechanisms authorized by the laws described above are not inadequate for the rangewide population of the Alexander Archipelago wolf now and into the future.

    Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence

    In this section, we consider other natural or manmade factors that may be affecting the continued persistence of the Alexander Archipelago wolf and were not addressed in Factors A through D above. Specifically, we examined effects of small and isolated populations, hybridization with dogs, and overexploitation of salmon runs.

    Small and Isolated Population Effects

    In the petition, island endemism was proposed as a possible stressor to the Alexander Archipelago wolf. An endemic is a distinct, unique organism found within a restricted area or range; a restricted range may be an island, or group of islands, or a restricted region (Dawson et al. 2007, p. 1). Although small, isolated populations are more vulnerable to extinction than larger ones due to demographic stochasticity, environmental variability, genetic problems, and catastrophic events (Lande 1993, p. 921), endemism or “rarity” alone is not a stressor. Therefore, we instead considered possible effects associated with small and isolated populations of the Alexander Archipelago wolf.

    Several aspects of the life history of the Alexander Archipelago wolf result in it being resilient to effects associated with small and isolated populations. First, the coastal wolf is distributed across a broad range and is not concentrated in any one area, contributing to its ability to withstand catastrophic events, which typically occur at small scales (e.g., wind-caused disturbance) in southeastern Alaska and coastal British Columbia. Second, the Alexander Archipelago wolf is a habitat and diet generalist with high reproductive potential and high dispersal capability in most situations, making it robust to environmental and demographic variability. However, owing to the island geography and steep, rugged terrain within the range of the Alexander Archipelago wolf, some populations are small (fewer than 150 to 250 individuals, following Carroll et al. 2014, p. 76) and at least partially isolated, although most are not. Nonetheless, we focus the remainder of this section on possible genetic consequences to small, partially isolated populations of the Alexander Archipelago wolf.

    The primary genetic concern of small, isolated wolf populations is inbreeding, which, at extreme levels, can reduce litter size and increase incidence of skeletal effects (e.g., Liberg et al. 2005, p. 17; Raikkonen et al. 2009, p. 1025). We found only one study that examined inbreeding in the Alexander Archipelago wolf. Breed (2007, p. 18) tested for inbreeding using samples from Regions 5 and 6 in northern British Columbia and GMUs 1 and 2 in southern southeastern Alaska, and found that inbreeding coefficients were highest for wolves in GMU 1, followed by GMU 2, then by Regions 5 and 6. This finding was unexpected given that GMU 2 is the smaller, more isolated population, indicating that inbreeding likely is not affecting the GMU 2 population despite its comparatively small size and insularity. Further, we found no evidence of historic or recent genetic bottlenecking in the Alexander Archipelago wolf (Weckworth et al. 2005, p. 924; Breed 2007, p. 18), although Weckworth et al. (2011, p. 5) speculated that a severe bottleneck may have taken place long ago (over 100 generations).

    Therefore, while we recognize that some populations of the Alexander Archipelago wolf are small and insular (e.g., GMU 2 population), our review of the best available information does not suggest that these characteristics currently are having a measurable effect at the population or rangewide level. However, given that the GMU 2 population is expected to decline by an average of 8 to 14 percent over the next 30 years, inbreeding depression and genetic bottlenecking may be a concern for this population in the future, but we think that possible future genetic consequences experienced by the GMU 2 population will not have an effect on the taxon as a whole. Thus, we conclude that small and isolated population effects do not constitute a threat to the Alexander Archipelago wolf, nor are they likely to become a threat in the future.

    Hybridization With Dogs

    We reviewed hybridization with domestic dogs as a potential stressor to the Alexander Archipelago wolf. Based on microsatellite analyses, Munoz-Fuentes et al. (2010, p. 547) found that at least one hybridization event occurred in the mid-1980s on Vancouver Island, where wolves were probably extinct at one point in time, but then recolonized the island from the mainland. Although hybridization has been documented and is more likely to occur when wolf abundance is unusually low, most of the range of the Alexander Archipelago wolf is remote and unpopulated by humans, reducing the risk of interactions between wolves and domestic dogs. Therefore, we conclude that hybridization with dogs does not rise to the level of a threat at the population or rangewide level and is not likely to do so in the future.

    Overexploitation of Salmon Runs

    As suggested in the petition, we considered overexploitation of salmon runs and disease transmission from farmed Atlantic salmon (Salmo salar) in coastal British Columbia as a potential stressor to the Alexander Archipelago wolf (Atlantic salmon are not farmed in southeastern Alaska). The best available information does not indicate that the status of salmon runs in coastal British Columbia is having an effect on coastal wolves. First, Alexander Archipelago wolf populations in coastal British Columbia are stable or slightly increasing, suggesting that neither overexploitation of salmon runs nor disease transmission from introduced salmon are impacting the wolf populations. Second, in coastal British Columbia, only 0 to 16 percent of the diet of the Alexander Archipelago wolf is salmon (Darimont et al. 2004, p. 1871; Darimont et al. 2009, p. 130). Given the opportunistic food habits of the coastal wolf, we postulate that reduction or even near loss of salmon as a food resource may impact individual wolves in some years, but likely would not result in a population- or rangewide-level effect. Further, our review of the best available information does not suggest that this is happening or will happen, or that coastal wolves are acquiring diseases associated with farmed salmon. Therefore, we conclude that overexploitation of salmon runs and disease transmission from farmed salmon do not constitute a threat to the Alexander Archipelago wolf at the population or rangewide level and are not likely to do so in the future.

    Conservation Efforts To Reduce Other Natural or Manmade Factors Affecting Its Continued Existence

    We are not aware of any conservation efforts or other voluntary actions that may help to reduce effects associated with small and isolated populations, hybridation with dogs, overexploitation of salmon runs, disease transmission from farmed salmon, or any other natural or manmade that may be affecting the Alexander Archipelago wolf.

    Summary of Factor E

    We find that other natural or manmade factors are present within the range of the Alexander Archipelago wolf, but that none of these factors is having a population or rangewide effect on the Alexander Archipelago wolf. We acknowledge that some populations of the coastal wolf are small and partially isolated, and therefore are susceptible to genetic problems, but we found no evidence that inbreeding or bottlenecking has resulted in a population or rangewide impact to the Alexander Archipelago wolf. In addition, even though some populations are small in size, many populations of the Alexander Archipelago wolf exist and are well distributed on the landscape, greatly reducing impacts from any future catastrophic events to the rangewide population. We also found that the likelihood of hybridation with dogs is low and that any negative impacts associated with the status of salmon in coastal British Columbia are unfounded at this time; neither of these potential stressors is likely to affect the continued persistence of the Alexander Archipelago wolf at the population or rangewide level. Therefore, based on the best available information, we conclude that other natural or manmade factors do not pose a threat to the Alexander Archipelago wolf, nor are they likely to become threats in the future.

    Cumulative Effects From Factors A Through E

    The Alexander Archipelago wolf is faced with numerous stressors throughout its range, but none of these individually constitutes a threat to the taxon as a whole now or in the future. However, more than one stressor may act synergistically or compound with one another to impact the Alexander Archipelago wolf at the population or rangewide level. Some of the identified stressors described above have potential to impact wolves directly (e.g., wolf harvest), while others can affect wolves indirectly (e.g., reduction in ungulate prey availability as a result of timber harvest); further, not all stressors are present or equally present across the range of the Alexander Archipelago wolf.

    In this section, we consider cumulative effects of the stressors described in Factors A through E. If multiple factors are working together to impact the Alexander Archipelago wolf negatively, the cumulative effects should be manifested in measurable and consistent demographic change at the population or species level. Therefore, for most populations such as those in coastal British Columbia and in GMU 2, we relied on trend information to inform our assessment of cumulative effects. For populations lacking trend information (e.g., GMUs 1, 3, and 5A), we examined the severity, frequency, and certainty of stressors to those populations and relative to the populations for which we have trend information to evaluate cumulative effects. We then assess the populations collectively to draw conclusions about cumulative effects that may be impacting the rangewide population.

    In coastal British Columbia, Alexander Archipelago wolf populations are stable or slightly increasing (see “Abundance and Trend,” above), despite multiple stressors facing these populations at levels similar to or greater than most populations in southeastern Alaska. The stability of the wolf populations in coastal British Columbia over the last 15 years suggests that cumulative effects of stressors such as timber harvest, road development, and wolf harvest are not negatively impacting these populations.

    The GMU 2 population of the Alexander Archipelago wolf apparently experienced a gradual decline between 1994 and 2013, and then declined substantially between 2013 and 2014, although the overall decline is not statistically significant owing to the large variance surrounding the point estimates (see “Abundance and Trend,” above). Nonetheless, we found evidence that timber harvest (Factor A) and wolf harvest (Factor B) are impacting this population, and these two stressors probably have collectively caused the apparent decline. Given reductions in deer habitat capability as a result of extensive and intensive timber harvest, we expect the GMU 2 wolf population to be somewhat depressed and unable to sustain high rates of wolf harvest. However, in our review of the best available information, we found that high rates of unreported harvest are resulting in unsustainable total harvest of Alexander Archipelago wolves in GMU 2 and that roads constructed largely to support the timber industry are facilitating unsustainable rates of total wolf harvest. Based on a population model specific to GMU 2, Gilbert et al. (2015, p. 43) projected that the wolf population will decline by another 8 to 14 percent, on average, over the next 30 years, largely owing to compounding and residual effects of logging, but also wolf harvest, which results in direct mortality and has a more immediate impact on the population. These stressors and others such as climate related events (i.e., snowfall) are interacting with one another to impact the GMU 2 wolf population and are expected to continue to do so in the future provided that circumstances remain the same (e.g., high unreported harvest rates).

    In the remainder of southeastern Alaska where the Alexander Archipelago wolf occurs (i.e., GMUs 1, 3, and 5A), we lack trend and projected population estimates to inform our assessment of cumulative effects, and, therefore, we considered the intensity, frequency, and certainty of stressors present. We found that generally the stressors facing wolf populations in GMUs 1, 3, and 5A occur in slightly higher intensity compared to populations in coastal British Columbia (Regions 5 and 6), but significantly lower intensity than the GMU 2 population. In fact, the percent of logged forest and road densities are among the lowest in the range of the Alexander Archipelago wolf. Although wolf harvest rates were moderately high in GMUs 1, 3, and 5A, given the circumstances of these populations, we found no evidence to suggest that they were having a population-level effect. Importantly, our review of the best available information did not suggest that unreported harvest was occurring at high rates like in GMU 2, and hunter and trapper access was comparatively lower (i.e., road density, ratio of shoreline to land area). In addition, the populations in GMUs 1, 3, and 5A are most similar biologically to the coastal British Columbian populations; all of these wolf populations have access to a variety of ungulate prey and are not restricted to deer, and none is as isolated geographically as the GMU 2 population. We acknowledge that elements of GMU 3 are similar to those in GMU 2 (e.g., island geography), but ultimately we found that GMU 3 had more similarities to GMUs 1 and 5A and coastal British Columbia.

    Therefore, in considering all of the evidence collectively, we presume that Alexander Archipelago wolf populations in GMUs 1, 3, and 5A likely are stable and are not being impacted by cumulative effects of stressors because these populations face similar stressors as the populations in coastal British Columbia, which are stable or slightly increasing. The weight of the available information led us to make this presumption regarding the Alexander Archipelago wolf in GMUs 1, 3, and 5A, and we found no information to suggest otherwise. We think our reasoning is fair and supported by the best available information, although we recognize the uncertainties associated with it.

    In summary, we acknowledge that some of the stressors facing Alexander Archipelago wolves interact with one another, particularly timber harvest and wolf harvest, but we determined that all but one of the wolf populations do not exhibit impacts from cumulative effects of stressors. We found that about 62 percent of the rangewide population of the Alexander Archipelago wolf is stable (all of coastal British Columbia), and another 32 percent is presumed to be stable (GMUs 1, 3, and 5A), suggesting that approximately 94 percent of the rangewide population is not experiencing negative and cumulative effects from stressors, despite their presence. Therefore, we conclude that cumulative impacts of identified stressors do not rise to the level of a threat to the Alexander Archipelago wolf and are unlikely to do so in the future.

    Finding

    As required by the Act, we considered the five factors in assessing whether the Alexander Archipelago wolf is an endangered or threatened species throughout all of its range. We examined the best scientific and commercial information available regarding the past, present, and future threats faced by the Alexander Archipelago wolf. We reviewed the petition, information available in our files, and other available published and unpublished information, and we consulted with recognized wolf experts and other Federal, State, and tribal agencies. We prepared a Status Assessment that summarizes all of the best available science related to the Alexander Archipelago wolf and had it peer reviewed by three experts external to the Service and selected by a third-party contractor. We also contracted the University of Alaska Fairbanks to revise an existing population model for the GMU 2 wolf population, convened a 2-day workshop with experts to review the model inputs and structure, and had the final report reviewed by experts (Gilbert et al. 2015, entire). As part of our review, we brought together researchers with experience and expertise in gray wolves and the temperate coastal rainforest from across the Service to review and evaluate the best available scientific and commercial information.

    We examined a variety of potential threats facing the Alexander Archipelago wolf and its habitats, including timber harvest, road development, oil development, climate change, overexploitation, disease, and effects associated with small and isolated populations. To determine if these risk factors individually or collectively put the taxon in danger of extinction throughout its range, or are likely to do so in the foreseeable future, we first considered if the identified risk factors were causing a population decline or other demographic changes, or were likely to do so in the foreseeable future.

    Throughout most of its range, the Alexander Archipelago wolf is stable or slightly increasing or is presumed to be stable based on its demonstrated high resiliency to the magnitude of stressors present. In coastal British Columbia, which constitutes 67 percent of the range and 62 percent of the rangewide population, the Alexander Archipelago wolf has been stable or slightly increasing over the last 15 years. In mainland southeastern Alaska (GMUs 1 and 5A) and in GMU 3, approximately 29 percent of the range and 32 percent of the rangewide population, we determined that the circumstances of these wolf populations were most similar to those in coastal British Columbia, and, therefore, based on the best available information, we reasoned that the Alexander Archipelago wolf likely is stable in GMUs 1, 3, and 5A. In GMU 2, which includes only 4 percent of the range and 6 percent of the rangewide population, the Alexander Archipelago wolf has been declining since 1994, and is expected to continue declining by another 8 to 14 percent, on average, over the next 30 years. Nonetheless, we conclude that the Alexander Archipelago wolf is stable or slightly increasing in nearly all of its range (96 percent), representing 94 percent of the rangewide population of the taxon.

    We then identified and evaluated existing and potential stressors to the Alexander Archipelago wolf. We aimed to determine if these stressors are affecting the taxon as a whole currently or are likely to do so in the foreseeable future, are likely to increase or decrease, and may rise to the level of a threat to the taxon, rangewide or at the population level. Because the Alexander Archipelago wolf is broadly distributed across its range and is a habitat and diet generalist, we evaluated whether each identified stressor was expected to impact wolves directly or indirectly and whether wolves would be resilient to any impact.

    We examined several stressors that are not affecting the Alexander Archipelago wolf currently and are unlikely to occur at a magnitude and frequency in the future that would result in a population- or rangewide-level effect. We found that oil and gas development, disease, predation, effects associated with small and isolated populations, hybridization with domestic dogs, overexploitation of salmon runs, and disease transmission from farmed salmon are not threats to the Alexander Archipelago wolf (see discussions under Factors A, C, and E, above). Most of these stressors are undocumented and speculative, rarely occur, are spatially limited, or are not known to impact gray wolves in areas of overlap. Although disease is known to affect populations of gray wolves, we found few reports of disease in the Alexander Archipelago wolf, and none resulted in mortality. Therefore, based on the best available information, we conclude that none of these stressors is having a population- or rangewide-level effect on the Alexander Archipelago wolf, or is likely to do so in the foreseeable future.

    Within the range of the Alexander Archipelago wolf, changes in climate are occurring and are predicted to continue, likely resulting in improved conditions for wolves. Climate models for southeastern Alaska and coastal British Columbia project that precipitation as snow will decrease substantially in the future, which will improve winter conditions for deer, the primary prey species of wolves. Although severe winters likely will continue to occur and will affect deer populations, we expect them to occur less frequently. Therefore, based on the best available information, we conclude that the effects of climate change are not a threat to the Alexander Archipelago wolf, nor are they likely to become a threat in the foreseeable future.

    We reviewed timber harvest and associated road development as stressors to the Alexander Archipelago wolf and found that they are not affecting wolves directly, in large part because the wolf is a habitat generalist. Although wolves used den sites farther from logged stands and roads than unused sites, den site selection was more strongly influenced by natural features on the landscape such as slope, elevation, and proximity to freshwater. Further, we did not find evidence indicating that denning near logged stands and roads resulted in lower fitness of wolves. Thus, we conclude that timber harvest and associated road development are not affecting wolves at the population or rangewide levels by decreasing suitable denning habitat. We did not identify any other potential direct impacts to wolves as a result of timber harvest or road development, so next we examined potential indirect effects, specifically reduction of deer habitat capability.

    Although the Alexander Archipelago wolf is an opportunistic predator that feeds on a variety of marine, intertidal, and terrestrial species, ungulates compose at least half of the wolf's diet throughout its range, and deer is the most widespread and abundant ungulate available to wolves. Timber harvest has reduced deer habitat capability, which in turn is predicted to reduce deer populations, especially in areas that have been logged intensively. However, based largely on the stability of wolf populations in coastal British Columbia despite intensive timber harvest, we conclude that wolves are resilient to changes in deer populations provided that they have other ungulate prey species available to them. We found that nearly all of the Alexander Archipelago wolves (94 percent of the rangewide population) have access to alternate ungulate prey such as mountain goat, moose, and elk, and, based on wolf diet, Alexander Archipelago wolves are consuming these prey species in areas where they are available. We identified only one Alexander Archipelago wolf population as an exception.

    In GMU 2, deer is the only ungulate species available to wolves, and, therefore, wolves in this population have a more restricted ungulate diet and likely are being affected by cascading effects of timber harvest. Both deer and wolves are projected to decline in GMU 2 in the future, largely due to long-term reduction in deer habitat capability. However, we find that the GMU 2 population contributes little to the rangewide population because it constitutes only 4 percent of the range and 6 percent of the rangewide population, is largely insular and geographically peripheral, and appears to function as a sink population. Therefore, while we recognize that timber harvest and associated road development has modified a considerable portion of the range of the Alexander Archipelago wolf, and will continue to do so, we find that the taxon as a whole is not being affected negatively, in large part because the wolf is a habitat and diet generalist. Based on the best available information, we conclude that timber harvest and associated road development do not rise to the level of a threat to the Alexander Archipelago wolf, and are not likely to do so in the future.

    Throughout its range, the Alexander Archipelago wolf is harvested for commercial and subsistence purposes, and, therefore, we examined overutilization as a stressor at the population and rangewide levels. In coastal British Columbia, we presume that wolf harvest is not having an effect at the population level given that populations there are stable or slightly increasing. This presumption is supported by the comparatively low rates of reported wolf harvest in coastal British Columbia, although reporting of harvest is required only in Regions 1 and 2, and, therefore, we considered these rates as minimum values. Nonetheless, we found no information suggesting that wolf harvest in coastal British Columbia is affecting wolves at the population level, as evidenced by the stability of the populations.

    Within southeastern Alaska, where reporting is required, rates of reported harvest on average are similar across all populations (17 to 21 mean percent of population annually). However, in GMU 2, unreported harvest can be a substantial component of total harvest (38 to 45 percent), resulting in high rates of total harvest in some years, which likely has contributed to the apparent population decline in GMU 2. Although unreported harvest probably occurs in other parts of southeastern Alaska, our review of the best available information does not indicate that it is occurring at the same high rate as documented in GMU 2. Further, access by hunters and trappers is significantly greater in GMU 2 compared to elsewhere (see discussion under Factor B, above), and, therefore, we find that applying rates of unreported harvest from GMU 2 to other wolf populations in southeastern Alaska is not appropriate. Thus, based on the best available information, we think that wolf harvest in most of southeastern Alaska (i.e., GMUs 1, 3, and 5A) is not affecting wolves at the population level, but that total wolf harvest in GMU 2 likely has occurred, at least recently, at unsustainable rates, largely due to high rates of unreported harvest, and has contributed to or caused an apparent decline in the population. However, for the same reasons described above, we determined that negative population impacts in GMU 2 do not affect the rangewide population significantly, and, therefore, we conclude that wolf harvest is not having a rangewide-level effect. In conclusion, we find that overutilization is not a threat to the Alexander Archipelago wolf, nor is it likely to become a threat in the foreseeable future.

    In summary, we found that the Alexander Archipelago wolf experiences stressors throughout its range, but based on our consideration of the best available scientific and commercial information, we determined that the identified stressors, individually or collectively, do not pose a threat to the taxon at the rangewide level now or in the foreseeable future. We determined that many of the life-history traits and behaviors of the Alexander Archipelago wolf, such as its variable diet, lack of preferential use of habitats, and high reproductive potential, increase its ability to persist in highly modified habitats with numerous stressors. Only one population of the Alexander Archipelago wolf has declined and likely will continue to decline, but this population contributes little to the taxon as a whole, and, therefore, while we acknowledge the vulnerability of this population to stressors such as timber harvest and wolf harvest, we find that its status does not affect the rangewide status significantly. Further, we found that approximately 94 percent of the rangewide population of the Alexander Archipelago wolf is stable or increasing, or presumed with reasonable confidence to be stable. Therefore, based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the threats are not of sufficient imminence, intensity, or magnitude to indicate that the Alexander Archipelago wolf is in danger of extinction (endangered), or likely to become endangered within the foreseeable future (threatened), throughout all of its range.

    Significant Portion of the Range

    Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so throughout all or a significant portion of its range. The Act defines “endangered species” as any species which is “in danger of extinction throughout all or a significant portion of its range,” and “threatened species” as any species which is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment [DPS] of any species of vertebrate fish or wildlife which interbreeds when mature.” We published a final policy interpreting the phrase “significant portion of its range” (SPR) (79 FR 37578, July 1, 2014). The final policy states that (1) if a species is found to be endangered or threatened throughout a significant portion of its range, the entire species is listed as an endangered or a threatened species, respectively, and the Act's protections apply to all individuals of the species wherever found; (2) a portion of the range of a species is “significant” if the species is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range; (3) the range of a species is considered to be the general geographical area within which that species can be found at the time the Service or the National Marine Fisheries Service makes any particular status determination; and (4) if a vertebrate species is endangered or threatened throughout an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

    The SPR policy is applied to all status determinations, including analyses for the purposes of making listing, delisting, and reclassification determinations. The procedure for analyzing whether any portion is an SPR is similar, regardless of the type of status determination we are making. The first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we list the species as an endangered (or threatened) species and no SPR analysis will be required. If the species is neither in danger of extinction nor likely to become so throughout all of its range, we determine whether the species is in danger of extinction or likely to become so throughout a significant portion of its range. If it is, we list the species as an endangered or a threatened species, respectively; if it is not, we conclude that listing the species is not warranted.

    When we conduct an SPR analysis, we first identify any portions of the species' range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that are not reasonably likely to be significant and endangered or threatened. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is endangered or threatened throughout a significant portion of its range; rather, it is a step in determining whether a more detailed analysis of the issue is required. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are affecting it uniformly throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats apply only to portions of the range that clearly do not meet the biologically based definition of “significant” (i.e., the loss of that portion clearly would not be expected to increase the vulnerability to extinction of the entire species), those portions will not warrant further consideration.

    If we identify any portions that may be both (1) significant and (2) endangered or threatened, we engage in a more detailed analysis to determine whether these standards are indeed met. The identification of an SPR does not create a presumption, prejudgment, or other determination as to whether the species in that identified SPR is endangered or threatened. We must go through a separate analysis to determine whether the species is endangered or threatened in the SPR. To determine whether a species is endangered or threatened throughout an SPR, we will use the same standards and methodology that we use to determine if a species is endangered or threatened throughout its range.

    Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address the “significant” question first, or the status question first. Thus, if we determine that a portion of the range is not “significant,” we do not need to determine whether the species is endangered or threatened there; if we determine that the species is not endangered or threatened in a portion of its range, we do not need to determine if that portion is “significant.”

    We evaluated the current range of the Alexander Archipelago wolf to determine if there is any apparent geographic concentration of potential threats to the taxon. We examined potential threats from timber harvest, oil and gas development, road development, climate change, effects of small and isolated populations, hybridization with dogs, overexploitation of salmon runs, disease transmission from farmed salmon, overutilization, disease, and predation. We found that potential threats are concentrated in GMU 2, where they are substantially greater than in other portions of its range. We considered adjacent parts of the range that are contained in GMUs 1 and 3, but, based on the best available information, we did not find any concentrations of stressors in those parts that were similar in magnitude and frequency to the potential threats in GMU 2. Therefore, we then considered whether GMU 2 is “significant” based on the Service's SPR policy, which states that a portion of its range is “significant” if the taxon is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the taxon is so important that, without the members in that portion, the taxon would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range.

    We reviewed population and rangewide metrics in relation to GMU 2 to estimate the numerical contribution of GMU 2 to the viability of the Alexander Archipelago wolf. We determined that GMU 2 constitutes only 4 percent of the total range and 9 percent of the range below 1,312 ft (400 m) in elevation where these wolves spend most of their time (see “Space and Habitat Use,” above). In addition, based on the most current population estimate for GMU 2, which was assessed in 2014, we estimated that only 6 percent of the rangewide population occupies GMU 2. Recognizing the apparent recent decline in the GMU 2 population (see “Abundance and Trend,” above), we then estimated that in 2013, the GMU 2 population composed about 13 percent of the rangewide population. We expect wolf abundance to fluctuate annually at the population and rangewide scales, but generally in recent years, we find that the GMU 2 population composes a somewhat small percentage of the rangewide population. Therefore, we conclude that, numerically, the GMU 2 population contributes little to the viability of the taxon as a whole given that it composes a small percentage of the current rangewide population and it occupies a small percentage of the range of the Alexander Archipelago wolf.

    We then considered the biological contribution of the GMU 2 population to the viability of the Alexander Archipelago wolf. We found that given its insularity and peripheral geographic position compared to the rest of the range, the GMU 2 population contributes even less demographically and genetically than it does numerically. In fact, it appears to function as a sink population with gene flow and dispersal primarily occurring uni-directionally from other areas to GMU 2 (see “Dispersal and Connectivity,” above). Therefore, overall, we found that GMU 2 represents a small percentage of the range and rangewide population of the Alexander Archipelago wolf, it is insular and geographically peripheral, and it appears to be functioning as a sink population to the Alexander Archipelago wolf. We conclude that, although potential threats are concentrated in GMU 2, this portion's contribution to the viability of the taxon as a whole is not so important that, without the members of GMU 2, the Alexander Archipelago wolf would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range.

    Our review of the best available scientific and commercial information indicates that the Alexander Archipelago wolf is not in danger of extinction (endangered) nor likely to become endangered within the foreseeable future (threatened), throughout all or a significant portion of its range. Therefore, we find that listing the Alexander Archipelago wolf as an endangered or threatened species under the Act is not warranted at this time.

    Evaluation of the GMU 2 Population of the Alexander Archipelago Wolf as a Distinct Population Segment

    After determining that the Alexander Archipelago wolf is not endangered or threatened throughout all or a significant portion of its range and is not likely to become so in the foreseeable future, we then evaluate whether or not the GMU 2 wolf population meets the definition of a distinct population segment (DPS) under the Act, as requested in the petition.

    To interpret and implement the DPS provisions of the Act and Congressional guidance, we, in conjunction with the National Marine Fisheries Service, published the Policy Regarding the Recognition of Distinct Vertebrate Population Segments (DPS policy) in the Federal Register on February 7, 1996 (61 FR 4722). Under the DPS policy, two basic elements are considered in the decision regarding the establishment of a population of a vertebrate species as a possible DPS. We must first determine whether the population qualifies as a DPS; this requires a finding that the population is both: (1) Discrete in relation to the remainder of the taxon to which it belongs; and (2) biologically and ecologically significant to the taxon to which it belongs. If the population meets the first two criteria under the DPS policy, we then proceed to the third element in the process, which is to evaluate the population segment's conservation status in relation to the Act's standards for listing as an endangered or threatened species. These three elements are applied similarly for additions to or removals from the Federal Lists of Endangered and Threatened Wildlife and Plants.

    Discreteness

    In accordance with our DPS policy, we detail our analysis of whether a vertebrate population segment under consideration for listing may qualify as a DPS. As described above, we first evaluate the population segment's discreteness from the remainder of the taxon to which it belongs. Under the DPS policy, a population segment of a vertebrate taxon may be considered discrete if it satisfies either one of the following conditions:

    (1) It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors. Quantitative measures of genetic or morphological discontinuity may provide evidence of this separation.

    (2) It is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the Act.

    We found that the GMU 2 population is markedly separated as a consequence of physical, physiological, ecological, or behavioral factors from other populations of the Alexander Archipelago wolf. It occupies a portion of the Alexander Archipelago within the range of wolf that is physically separated from adjacent populations due to comparatively long and swift water crossings and the fact that few crossings are available to dispersing wolves. Although low levels of movement between the GMU 2 population segment and other populations likely occur (see “Dispersal and Connectivity,” above), the GMU 2 wolf population is largely insular and geographically peripheral to the rest of the range of the Alexander Archipelago wolf; further, the Service's DPS policy does not require absolute separation to be considered discrete.

    In addition, several studies have demonstrated that, based on genetic assignment tests, the GMU 2 wolf population forms a distinct genetic cluster when compared to other Alexander Archipelago wolves (Weckworth et al. 2005, pp. 923, 926; Breed 2007, p. 21). Further, estimates of the fixation index (F ST, the relative proportion of genetic variation explained by differences among populations) are markedly higher between the GMU 2 population and all other Alexander Archipelago wolf populations than comparisons between other populations (e.g., Weckworth et al. 2005, p. 923; Cronin et al. 2015, p. 7). Collectively, these findings indicate genetic discontinuity between wolves in GMU 2 and those in the rest of the range of the Alexander Archipelago wolf. We review these studies and others in more detail in the Status Assessment (Service 2015, “Genetic analyses”).

    We found that the GMU 2 population of the Alexander Archipelago wolf is markedly separated as a consequence of physical (geographic) features and due to genetic divergence from other populations of the taxon. Therefore, we conclude that it is discrete under the Service's DPS policy.

    Significance

    If a population is considered discrete under one or more of the conditions described in the Service's DPS policy, its biological and ecological significance will be considered in light of Congressional guidance that the authority to list DPSs be used “sparingly” while encouraging the conservation of genetic diversity. In making this determination, we consider available scientific evidence of the discrete population segment's importance to the taxon to which it belongs. As precise circumstances are likely to vary considerably from case to case, the DPS policy does not describe all the classes of information that might be used in determining the biological and ecological importance of a discrete population. However, the DPS policy describes four possible classes of information that provide evidence of a population segment's biological and ecological importance to the taxon to which it belongs. As specified in the DPS policy (61 FR 4722), this consideration of the population segment's significance may include, but is not limited to, the following:

    (1) Persistence of the discrete population segment in an ecological setting unusual or unique to the taxon;

    (2) Evidence that loss of the discrete population segment would result in a significant gap in the range of a taxon;

    (3) Evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historical range; or

    (4) Evidence that the discrete population segment differs markedly from other populations of the taxon in its genetic characteristics.

    Given our determination that the GMU 2 wolf population is discrete under the Service's DPS policy, we now evaluate the biological and ecological significance of the population relative to the taxon as a whole. A discrete population segment is considered significant under the DPS policy if it meets one of the four elements identified in the policy under significance (described above), or otherwise can be reasonably justified as being significant. Here, we evaluate the four potential factors suggested by our DPS policy in evaluating significance of the GMU 2 wolf population.

    Persistence of the Discrete Population Segment in an Ecological Setting Unusual or Unique to the Taxon

    We find that the GMU 2 population does not persist in an ecological setting that is unusual or unique to the Alexander Archipelago wolf. To evaluate this element, we considered whether or not the habitats used by Alexander Archipelago wolves in GMU 2 include unusual or unique features that are not used by or available to the taxon elsewhere in its range. We found that the Alexander Archipelago wolf is a habitat generalist, using a variety of habitats on the landscape and selecting only for those that occur below 1,312 ft (400 m) in elevation (see “Space and Habitat Use,” above). Throughout its range, habitats used by and available to the Alexander Archipelago wolf are similar with some variation from north to south and on the mainland and islands, but we found no unique or unusual features specific to GMU 2 that were not represented elsewhere in the range. Although karst is more prevalent in GMU 2, we found no evidence indicating that wolves selectively use karst; in addition, karst is present at low and high elevations in GMUs 1 and 3 (Carstensen 2007, p. 24).

    The GMU 2 wolf population has a more restricted ungulate diet, comprised only of deer, than other populations of the Alexander Archipelago wolf (see “Food Habits,” above). However, given that the coastal wolf is an opportunistic predator, feeding on intertidal, marine, freshwater, and terrestrial species, we find that differences in ungulate prey base are not ecologically unique or unusual. In addition, Alexander Archipelago wolves feed on deer throughout their range in equal or even higher proportions than wolves in GMU 2 (e.g., Szepanski et al. 1999, p. 331; Darimont et al. 2009, p. 130), demonstrating that a diet based largely on deer is not unusual or unique. Thus, compared to elsewhere in the range, we found nothing unique or unusual about the diet or ecological setting of wolves in GMU 2. Further, we did not identify any morphological, physiological, or behavioral characteristics of the GMU 2 wolf population that differ from those of other Alexander Archipelago wolf populations, which may have suggested a biological response to an unusual or unique ecological setting. Therefore, we conclude that the GMU 2 wolf population does not meet the definition of significance under this element, as outlined in the Service's DPS policy.

    Evidence That Loss of the Discrete Population Segment Would Result in a Significant Gap in the Range of a Taxon

    We find that loss of the GMU 2 population of the Alexander Archipelago wolf, when considered in relation to the taxon as a whole, would not result in a significant gap in the range of the taxon. It constitutes only 6 percent of the current rangewide population, only 4 percent of the range, and only 9 percent of the range below 1,312 (400 m) in elevation where the Alexander Archipelago wolf selectively occurs. In addition, the GMU 2 population is largely insular and geographically peripheral to other populations, and appears to function as a sink population (see “Abundance and Trend” and “Dispersal and Connectivity,” above). For these reasons, we found that the demographic and genetic contributions of the GMU 2 wolf population to the rangewide population are low and that loss of this population would have a minor effect on the rangewide population of the Alexander Archipelago wolf. Also, although rates of immigration to GMU 2 likely are low (see “Dispersal and Connectivity,” above), recolonization of GMU 2 certainly is possible, especially given the condition of the remainder of the rangewide population. Therefore, we conclude that the GMU 2 wolf population does not meet the definition of significance under this element, as outlined in the Service's DPS policy.

    Evidence That the Discrete Population Segment Represents the Only Surviving Natural Occurrence of a Taxon That May Be More Abundant Elsewhere as an Introduced Population Outside Its Historical Range

    The GMU 2 population does not represent the only surviving natural occurrence of the Alexander Archipelago wolf throughout the range of the taxon. Therefore, we conclude that the discrete population of the Alexander Archipelago wolf in GMU 2 does not meet the significance criterion of the DPS policy under this factor.

    Evidence That the Discrete Population Segment Differs Markedly From Other Populations of the Taxon in Its Genetic Characteristics

    We find that the GMU 2 population does not differ markedly from other Alexander Archipelago wolves in its genetic characteristics. As noted above in Discreteness, the GMU 2 population exhibits genetic discontinuities from other Alexander Archipelago wolves due to differences in allele and haplotype frequencies. However, those discontinuities are not indicative of rare or unique genetic characterisics within the GMU 2 population that are significant to the taxon. Rather, several studies indicate that the genetic diversity within the GMU 2 population is a subset of the genetic diversity found in other Alexander Archipelago wolves. For example, the GMU 2 population does not harbor unique haplotypes; only one haplotype was found in the GMU 2 population, and it was found in other Alexander Archipelago wolves including those from coastal British Columbia (Weckworth et al. 2010, p. 367; Weckworth et al. 2011, p. 2). In addition, the number and frequency of private alleles in the GMU 2 population is low compared to other Alexander Archipelago wolves (e.g., Breed 2007, p. 18). The lack of unique haplotypes and the low numbers of private alleles both indicate that the GMU 2 population has not been completely isolated historically from other Alexander Archipelago wolves. Finally, these genetic studies demonstrate that wolves in GMU 2 exhibit low genetic diversity (as measured through allelic richness, heterozygosity, and haplotype diversity) compared to other Alexander Archipelago wolves (Weckworth et al. 2005, p. 919; Breed 2007, p. 17; Weckworth et al. 2010, p. 366; Weckworth et al. 2011, p. 2).

    Collectively, results of these studies suggest that the genetic discontinuities observed in the GMU 2 population likely are the outcome of restricted gene flow and a loss of genetic diversity through genetic drift or founder effects. Therefore, although the GMU 2 population is considered discrete under the Service's DPS policy based on the available genetic data, it does not harbor genetic characteristics that are rare or unique to the Alexander Archipelago wolf and its genetic contribution to the taxon as a whole likely is minor. Moreover, while we found no genetic studies that have assessed adaptive genetic variation of the Alexander Archipelago wolf, the best available genetic data do not indicate that the GMU 2 population harbors significant adaptive variation, which is supported further by the fact that the GMU 2 population is not persisting in an unusual or unique ecological setting. Therefore, we conclude that the GMU 2 population does not meet the definition of significance under this element, as outlined in the Service's DPS policy.

    Summary of Significance

    We determine, based on a review of the best available information, that the GMU 2 population is not significant in relation to the remainder of the taxon. Therefore, this population does not qualify as a DPS under our 1996 DPS policy and is not a listable entity under the Act. Because we found that the population did not meet the significance element and, therefore, does not qualify as a DPS under the Service's DPS policy, we will not proceed with an evaluation of the status of the population under the Act.

    Determination of Distinct Population Segment

    Based on the best scientific and commercial information available, as described above, we find that, under the Service's DPS policy, the GMU 2 population is discrete, but is not significant to the taxon to which it belongs. Because the GMU 2 population is not both discrete and significant, it does not qualify as a DPS under the Act.

    Conclusion of 12-Month Finding

    Our review of the best available scientific and commercial information indicates that the Alexander Archipelago wolf is not in danger of extinction (endangered) nor likely to become endangered within the foreseeable future (threatened), throughout all or a significant portion of its range. Therefore, we find that listing the Alexander Archipelago wolf as an endangered or threatened species under the Act is not warranted at this time.

    We request that you submit any new information concerning the status of, or threats to, the Alexander Archipelago wolf to our Anchorage Fish and Wildlife Field Office (see ADDRESSES) whenever it becomes available. New information will help us monitor the Alexander Archipelago wolf and encourage its conservation. If an emergency situation develops for the Alexander Archipelago wolf, we will act to provide immediate protection.

    References Cited

    A complete list of references cited is available on the Internet at http://www.regulations.gov and upon request from the Anchorage Fish and Wildlife Field Office (see ADDRESSES).

    Authors

    The primary authors of this document are the staff members of the Anchorage Fish and Wildlife Field Office.

    Authority

    The authority for this section is section 4 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

    Dated: December 15, 2015. Stephen Guertin, Acting Director, Fish and Wildlife Service.
    [FR Doc. 2015-32473 Filed 1-5-16; 8:45 am] BILLING CODE 4333-15-P
    81 3 Wednesday, January 6, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service National Advisory Committee for Implementation of the National Forest System Land Management Planning Rule AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meetings.

    SUMMARY:

    The National Advisory Committee for Implementation of the National Forest System Land Management Planning Rule Committee (Committee) will meet in Sacramento, California. Attendees may also participate via webinar and conference call. The Committee operates in compliance with the Federal Advisory Committee Act (FACA) (Pub. L. 92-463). Additional information relating to the Committee, including the meeting summary/minutes, can be found by visiting the Committee's Web site at: http://www.fs.usda.gov/main/planningrule/committee.

    DATES:

    The meetings will be held in-person and via webinar/conference call on the following dates and times:

    • Thursday, January 14, 2016 from 9:00 a.m. to 5:00 p.m. PST • Friday, January 15, 2016 from 9:00 a.m. to 5:00 p.m. PST

    All meetings are subject to cancellation. For updated status of meetings prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Holiday Inn Capitol Plaza, 300 J Street, Sacramento, California. For anyone who would like to attend via webinar and/or conference call, please visit the Web site listed above or contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the USDA Forest Service Washington Office—Yates Building, 201 14th Street SW., Mail Stop 1104, Washington, DC 20250-1104. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Helwig, Committee Coordinator, by phone at 202-205-0892, or by email at [email protected]. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of this meeting is to provide:

    1. Continued deliberations on formulating advice for the Secretary,

    2. Discussion of Committee work group findings,

    3. Hearing public comments, and

    4. Administrative tasks.

    This meeting is open to the public. The agenda will include time for people to make oral comments of three minutes or less. Individuals wishing to make an oral comment should submit a request in writing by January 7, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Jennifer Helwig, USDA Forest Service, Ecosystem Management Coordination, 201 14th Street SW., Mail Stop 1104, Washington, DC 20250-1104, or by email at [email protected]. The agenda and summary of the meeting will be posted on the Committee's Web site within 21 days of the meeting.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: December 9, 2015. Brian Ferebee, Associate Deputy Chief, National Forest System.
    [FR Doc. 2015-33275 Filed 1-5-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection; Fire & Aviation Management Medical Qualifications Program AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with revisions to the information collection, Fire & Aviation Management Medical Qualifications Program.

    With this extension, the Agency has changed the name of the information collection to Fire & Aviation Management Medical Qualifications Program.

    DATES:

    Comments must be received in writing on or before March 9, 2015 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Comments concerning this notice should be addressed to Attention: Dr. Jennifer Symonds, USDA Forest Service, National Interagency Fire Center, 3833 South Development Avenue, Boise, Idaho 83705. Comments also may be submitted via facsimile to 208-387-5735 or by email to [email protected]

    The public may inspect comments received at the National Interagency Fire Center, during normal business hours. Visitors are encouraged to call ahead to facilitate entry to the building.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Jennifer Symonds, Forest Service Wildland Fire Medical Qualifications Program Manager, at 208-387-5978.

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    Title: Fire & Aviation Management Medical Qualifications Program.

    OMB Number: 0596-0164.

    Expiration Date of Approval: March 31, 2016.

    Type of Request: Extension with revisions.

    Abstract: The Protection Act of 1922 (16 U.S.C. 594) authorizes the Forest Service to fight fires on National Forest System lands. This information collection is an approved Forest Service collection. The collection covers the USDA Forest Service and the Department of the Interior, and contains the information collection activities and burden hours for both agencies.

    Wildland firefighters perform long hours of arduous labor in adverse environmental conditions. It is imperative that these firefighters be in sufficient physical condition to avoid injury to themselves or their coworkers. Federal employees and private individuals seeking employment as a firefighter with the Forest Service or the Department of Interior complete the health capability forms. This information collection covers the forms and burden hours associated with the private individuals who apply for firefighter positions with the aforementioned agencies.

    Form FS-5100-30, Work Capacity Test—Informed Consent. The form is signed by those deemed to be in sufficient health to undergo a Work Capacity Test. The Work Capacity Test determines the level of an individual's aerobic fitness, level of muscular strength, and muscle endurance. The consent form is necessary to ensure the individual taking the test is aware of the various testing levels (arduous, moderate, and light) and the risks involved. The individual indicates the following:

    • They have read the information on the form, the brochure “Work Capacity Test” and understand the purpose, instructions, and risks of the test;

    • They have read the information, understood, and truthfully answered the Health Screen Questionnaire; and

    • Test to be taken—pack test (arduous), field test (moderate), or walk test (light).

    Failure to collect this data could result in injuries or deaths during the “Work Capacity Test” and while working on wildland fires. The information provided by an applicant for Federal employment is stored in secured official files, maintained according to Agency regulations. The information gathered is not available from other sources.

    Estimate of Annual Burden: 5.5 Minutes.

    Type of Respondents: Individuals.

    Estimated Annual Number of Respondents: 20,271.

    Estimated Annual Number of Responses per Respondents: 1.

    Estimated Total Annual Burden on Respondents: 1,858 hours.

    Form FS-5100-31, Health Screening Questionnaire. Prospective firefighters must complete this form when seeking employment as a new firefighter with the Forest Service or Department of the Interior. This form collects the following information:

    • Name and Unit;

    • Medical history;

    • Current medical symptoms;

    • Other health issues; and

    • Cardiovascular risk factors.

    The information collected pertains to an individual's health status and health history in an effort to determine if any physical conditions exist that might result in injury or death during fitness testing or when fighting a wildfire. If Federal Agency officials determine, based on the collected information, that an individual may not be physically able to train for or take a Work Capacity Test; the agency will require the individual to undergo a physical examination by a physician.

    Failure to collect this data could result in injuries or deaths during the “Work Capacity Test” and while working on wildland fires. The information provided by an applicant for Federal employment is stored in secured official files, maintained according to Agency regulations. The information gathered is not available from other sources.

    Estimate of Annual Burden: 3 Minutes.

    Type of Respondents: Individuals.

    Estimated Annual Number of Respondents: 20,271.

    Estimated Annual Number of Responses per Respondents: 1.

    Estimated Total Annual Burden on Respondents: 1,014 hours.

    Form FS-5100-32, Arduous Duty Medical Exam. Federal employees and private individuals seeking employment as a firefighter with the Forest Service will complete the form every three years (years 0, 3, 6, etc.). The form collects the following information:

    • Name, Federal Employee Number (if applicable), Sex and Date of Birth;

    • Address, Email Address, and Telephone Number;

    • Physical Activity Level and Fire Experience with Home Unit and Forest;

    • Past Medical History;

    • Current medical symptoms; and

    • Other health issues.

    The information collected pertains to an individual's health status and health history in an effort to determine if any medical or physical conditions exist that might result in injury or death during fitness testing or when fighting a wildfire. If Federal Agency officials determine, based on the collected information, that an individual may not be medically or physically able to train for or take a Work Capacity Test or meet the Medical Standards of arduous duty fire positions, the individual may request a waiver.

    The information provided by a firefighter for Federal employment is stored in secured official files, maintained according to Agency regulations. The information gathered is not available from other sources.

    Estimate of Annual Burden: 30 Minutes.

    Type of Respondents: Individuals.

    Estimated Annual Number of Respondents: 9,810.

    Estimated Annual Number of Responses per Respondents: 1.

    Estimated Total Annual Burden on Respondents: 4,905 hours.

    Form FS-5100-33, Self-Certification Statement and Blood Pressure Check. Federal employees and private individuals seeking employment as a firefighter with the Forest Service will complete the form the years in which the individual does not complete an Arduous Duty Examination. The form collects the following information:

    • Name and Date of Birth;

    • Home Unit and Forest

    • Medical history;

    • Current medical symptoms; and

    • Other health issues.

    The information collected pertains to an individual's health status and health history in an effort to determine if any medical or physical conditions exist that might result in injury or death during fitness testing or when fighting a wildfire. If Federal Agency officials determine, based on the collected information, that an individual may not be medically or physically able to train for or take a Work Capacity Test or meet the Medical Standards of arduous duty fire positions, the individual may request a waiver.

    The information provided by a firefighter for Federal employment is stored in secured official files, maintained according to Agency regulations. The information gathered is not available from other sources.

    Estimate of Annual Burden: 3 Minutes.

    Type of Respondents: Individuals.

    Estimated Annual Number of Respondents: 9,810.

    Estimated Annual Number of Responses per Respondents: 1.

    Estimated Total Annual Burden on Respondents: 491 hours.

    Total Estimate of Annual Burden: 41.5 Minutes.

    Total Type of Respondents: Individuals.

    Total Estimated Annual Number of Respondents: 20,271.

    Total Estimated Annual Number of Responses per Respondents: 1.

    Total Estimated Total Annual Burden on Respondents: 8,268 hours.

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.

    Dated: December 17, 2015. James E. Hubbard, Deputy Chief, State & Private Forestry.
    [FR Doc. 2015-33273 Filed 1-5-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Utilities Service Rural Utilities Service Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice of intent to publish Fiscal Year 2016 application requirements and application deadlines for Rural Utilities Service Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes.

    SUMMARY:

    The Rural Utilities Service (RUS) is hereby giving notice that it intends to publish in the near future a notice of solicitation for Fiscal Year 2016 (the “Notice of Solicitation for Applications”) specifying the timeframe for the submission of applications and program requirements for cooperative and other not-for-profit lenders wishing to participate in RUS's program involving the guarantee of loans for eligible electrification and telephone purposes, as authorized by Section 313A of the Rural Electrification Act of 1936, as amended (7 U.S.C. 940c-1) (the “Act”) and 7 CFR part 1720 (the “Program Regulations”).

    DATES:

    It is anticipated that the Notice of Solicitation for Applications will be published in early 2016.

    ADDRESSES:

    For detailed information regarding this notice, contact Amy McWilliams, Management Analyst, Office of Portfolio Management and Risk Assessment, Electric Program, Rural Utilities Service, United States Department of Agriculture, 1400 Independence Avenue SW., Room 0226-S, Washington, DC 20250-1568. Telephone (202) 205-8663; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The proceeds of the guaranteed bonds will be used by the guaranteed lender to make loans to borrowers for electrification or telephone purposes eligible for assistance under the Act, the Program Regulations, and the Notice of Solicitation for Applications, or to refinance bonds or notes previously issued by the guaranteed lender for such purposes. The proceeds of the guaranteed bonds are not to be used by the guaranteed lender to directly or indirectly fund projects for the generation of electricity.

    In order to promote competition and facilitate its review process, RUS will only accept applications: (1) Prepared in accordance with the Act, the Program Regulations, and the program requirements to be published in the Notice of Solicitation for Applications, and (2) submitted during the application period to be established by the forthcoming Notice of Solicitation for Applications.

    Authority:

    7 U.S.C. 940c-1.

    Dated: December 30, 2015. Brandon McBride, Administrator, Rural Utilities Service.
    [FR Doc. 2015-33285 Filed 1-5-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-469-814 and A-570-898] Chlorinated Isocyanurates From Spain and the People's Republic of China: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective Date: January 6, 2016.

    SUMMARY:

    As a result of these sunset reviews, the Department of Commerce (the Department) finds that revocation of the antidumping duty orders on chlorinated isocyanurates (chlorinated isos) from Spain and the People's Republic of China (PRC) would be likely to lead to continuation or recurrence of dumping at the rates identified in the “Final Results of Review” section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Jacqueline Arrowsmith or Chien-Min Yang, AD/CVD Operations, Office 7, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-5255 and (202) 482-5484, respectively.

    SUPPLEMENTARY INFORMATION: Background

    The Department published the antidumping duty orders on chlorinated isos from Spain and the PRC on June 24, 2005.1 On September 1, 2015, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), the Department initiated sunset reviews of the antidumping duty orders on chlorinated isos from Spain and the PRC.2 On September 11, 2015, the Department received a notice of intent to participate from Clearon Corporation (Clearon), Occidental Chemical Corporation (OxyChem), and Bio-Lab, Inc. (Bio-Lab), (collectively, the petitioners), within the deadline specified in 19 CFR 351.218(d)(1)(i). Petitioners are manufacturers of a domestic like product in the United States and, accordingly, are domestic interested parties pursuant to section 771(9)(C) of the Act.

    1See Chlorinated Isocyanurates from Spain: Notice of Antidumping Duty Order, 70 FR 36562 (June 24, 2005) (“Spain Order”); see also Notice of Antidumping Duty Order: Chlorinated Isocyanurates from the People's Republic of China, 70 FR 36561 (June 24, 2005) (“PRC Order”).

    2See Initiation of Five-Year (“Sunset”) Review, 78 FR 60253 (October 1, 2013).

    On October 1, 2015, the Department received an adequate substantive response to the notice of initiation from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). The Department did not receive any responses from the respondent interested parties, i.e., chlorinated isos producers and exporters from Spain and the PRC. On the basis of the notice of intent to participate and adequate substantive response filed by the petitioners and the inadequate response from any respondent interested party, the Department conducted expedited sunset reviews of these orders pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C).

    Scope of the Orders

    The products covered by the orders are chlorinated isos, which are derivatives of cyanuric acid, described as chlorinated s-triazine triones. There are three primary chemical compositions of chlorinated isos: (1) Trichloroisocyanuric acid (Cl3(NCO)3), (2) sodium dichloroisocyanurate (dehydrate) (NaCl2 (NCO)3(2H2O), and (3) sodium dichloroisocyanurate (anhydrous) (Nacl2(NCO)3). The orders cover all chlorinated isos. A full description of the scope of the order is contained in the Issues and Decision Memorandum for the Expedited Sunset Reviews of the Antidumping Duty Orders on Chlorinated Isocyanurates from Spain and the People's Republic of China.

    Analysis of Comments Received

    The issues discussed in the Decision Memorandum 3 are the likelihood of continuation or recurrence of dumping, and the magnitude of the margins of dumping likely to prevail if these orders were revoked. Parties can find a complete discussion of all issues raised in this review and the corresponding recommendations in the Decision Memorandum which is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit in Room B8024 of the main Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the Internet at http://trade.gov/enforcement/. The signed Decision Memorandum and electronic versions of the Decision Memorandum are identical in content.

    3See Department Memorandum, “Issues and Decision Memorandum for the Expedited Sunset Reviews of the Antidumping Duty Orders on Chlorinated Isocyanurates from Spain and the People's Republic of China,” dated concurrently with this notice (Decision Memorandum).

    Final Results of Review

    Pursuant to sections 752(c)(1) and (3) of the Act, we determine that revocation of the antidumping orders of chlorinated isos from Spain and the PRC would be likely to lead to continuation or recurrence of dumping. Further, we determine that the magnitudes of the margins of dumping likely to prevail are as follows:

    Spain Exporter/producer Margin
  • (percent)
  • Argonesas Delsa S.A 24.83 All others 24.83
    PRC Exporter/producer Margin
  • (percent)
  • Hebei Jiheng Chemical Co 75.78 Nanning Chemical Industry Co., Ltd 285.63 Changzhou Clean Chemical Co., Ltd 137.69 Liaocheng Huaao Chemical Industry Co., Ltd 137.69 Sinochem Hebei Import & Export Corporation 137.69 Sinochem Shanghai Import & Export Corporation 137.69 PRC-wide Entity 285.63
    Administrative Protective Order

    This notice also serves as the only reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return of destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    The Department is issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.

    Dated: December 30, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-33290 Filed 1-5-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE356 Endangered Species; File No. 19716 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Robert Hardy, 100 8th Avenue Southeast Florida Fish and Wildlife Conservation Commission, Fish & Wildlife Research Institute, St Petersburg, FL 33701, has applied in due form for a permit to take loggerhead (Caretta caretta), green (Chelonia mydas), Kemp's ridley (Lepidochelys kempii), hawksbill (Eretmochelys imbricata), and leatherback (Dermochelys coriacea) sea turtles for purposes of scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before February 5, 2016.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 19716 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Arturo Herrera or Amy Hapeman, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    The applicant requests a five-year permit to locate and describe surface-pelagic drift communities of the Atlantic Ocean and Gulf of Mexico that serve as developmental habitat for surface-pelagic juvenile and neonate sea turtles, to quantify threats to pelagic sea turtles, and to gather information on their life-history, genetics, movements, behavior, and diet. Researchers would conduct vessel surveys to count and pursue for capture by dip net up to 300 loggerhead, 200 green, 60 hawksbill, 130 Kemp's ridley and 10 leatherback sea turtles annually. An additional 150 loggerheads and 440 leatherbacks could be harassed annually during vessel surveys but would not be pursued for capture. Depending on life stage and size, captured sea turtles would have the following procedures performed prior to release: Measure, weigh, oral swab, esophageal lavage, skin and scute biopsy, flipper and passive integrated transponder tag, and/or epoxy attachment of a satellite or VHF transmitter. Voided fecal samples also would be collected opportunistically.

    Dated: December 29, 2015. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-33182 Filed 1-5-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD607 Marine Mammals; File No. 18824 AGENCY:

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

    ACTION:

    Notice; issuance of permit.

    SUMMARY:

    Notice is hereby given that a permit has been issued to Briana Witteveen, Ph.D., University of Alaska, Fairbanks, Kodiak Seafood and Marine Science Center, 118 Trident Way, Kodiak, AK, 99615, to conduct research on humpback (Megaptera novaeangliae); killer (Orcinus orca); gray (Eschrichtius robustus); North Pacific Right (Eubaelana japonica); fin (Balaenoptera physalus); sei (B. borealis); minke whales (B. acutorostrata); blue (B. musculus); and sperm whales (Physeter macrocephalus). Additionally, harbor (Phocoena phocoena) and Dall's porpoises (P. dalli), Pacific white-sided dolphins (Lagenorhynchus obliquidens), Northern fur (Callorhinus ursinus) and harbor seals (Phoca vitulina), and Steller sea lions (Eumetopias jubatus) may be incidentally harassed.

    ADDRESSES:

    The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Skidmore or Courtney Smith, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On November 21, 2014, notice was published in the Federal Register (79 FR 69432) that a request for a permit to conduct research on the above listed species had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    The permit authorizes non-lethal take using vessels to: Collect identification photographs; record vocalizations; conduct biopsy sampling; collect prey parts and sloughed skin; attach suction-cup tags; and document behavioral response to acoustic deterrents. Research may occur year-round within the Gulf of Alaska. The purpose of this research is to improve understanding of the foraging behavior, prey use, and habitat overlap among sympatric whale species throughout their habitat. The permit is valid through December 1, 2020.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, issuance of this permit was based on a finding that such permit: (1) Was applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: December 29, 2015. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-33183 Filed 1-5-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 14-01] 36(b)(1) Arms Sales Notification AGENCY:

    Department of Defense, Defense Security Cooperation Agency.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 14-01 with attached Policy Justification and Sensitivity of Technology.

    Dated: December 31, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN06JA16.002 BILLING CODE 5001-06-C Transmittal No. 14-01 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Turkey

    (ii) Total Estimated Value:

    Major Defense Equipment * $62 million Other $ 8 million TOTAL $70 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase: Joint Direct Attack Munition (JDAM) tail kits comprised of 400 GBU-31(V)1 for use with Mk84 bombs, 200 GBU-31(V)3 for use with BLU-109 bombs, 300 GBU-38 for use with Mk82 bombs, 100 GBU-54 Laser JDAM kits for use with Mk82 bombs, 200 BLU-109 Hard Target Penetrator Warheads, and 1000 FMU-152A/B fuzes. Non-MDE includes containers, support equipment, spare and repair parts, integration, test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor engineering and technical support, and other related elements of logistics support.

    (iv) Military Department: Air Force (YAF)

    (v) Prior Related Cases, if any: FMS case YAD-$23M-24Jan13

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or

    Defense Services Proposed to be Sold: See Attached Annex

    (viii) Date Report Delivered to Congress: 02 DEC 2015

    * As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION Turkey—Joint Directed Attack Munitions (JDAM)

    The Government of Turkey has requested a possible sale of Joint Direct Attack Munition (JDAM) tail kits comprised of 400 GBU-31(V)1 for use with Mk84 bombs, 200 GBU-31(V)3 for use with BLU-109 bombs, 300 GBU-38 for use with Mk82 bombs, 100 GBU-54 Laser JDAM kits for use with Mk82 bombs, 200 BLU-109 Hard Target Penetrator Warheads, and 1000 FMU-152A/B fuzes. Non-MDE includes containers, support equipment, spare and repair parts, integration, test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor engineering and technical support, and other related elements of logistics support. The estimated cost is $70 million.

    Turkey is a partner of the United States in ensuring peace and stability in the region. It is vital to the U.S. national interest to assist our NATO ally in developing and maintaining a strong and ready self-defense capability. This proposed sale is consistent with those objectives.

    This sale will enhance the Turkish Air Force's ability to defend and provides a capability to contribute to future NATO operations. The proven reliability and compatibility of like-systems will foster increased interoperability between NATO and U.S. forces, and expand regional defenses to counter common threats to air, border, and shipping assets in the region. Turkey will have no difficulty absorbing these additional munitions into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractor will be the Boeing Company of St. Charles, Missouri. Any offset agreement will be defined in negotiations between the purchaser and the contractor.

    The number of U.S. government and contractor representatives to support this program will be determined during negotiations with the Government of Turkey.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 14-01 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology

    1. The Joint Direct Attack Munition (JDAM) is a guidance kit that converts free-fall bombs into precision-guided munitions. By adding a new tail section containing Inertial Navigation System (INS)/Global Positioning System (GPS) guidance to existing bombs, the cost-effective JDAM provides highly accurate weapon delivery in any flyable weather. The INS, using updates from the GPS, guides the bomb to the target via the use of movable tail fins. With the addition of a laser guidance nose kit, the JDAM is capable of engaging moving targets. The JDAM all-up-round (AUR) is Unclassified; technical data for JDAM is classified up to Secret.

    2. The GBU-31(v)1 is a 2000 pound class JDAM consisting of a JDAM tail kit, a Mk-84 warhead, and one of three fuze types: FMU-139, FMU-143, or FMU-152. A DSU-33 sensor can be added to the nose well of the weapon to give the GBU-31(v)1 JDAM AUR a height of burst (HOB) fusing option.

    3. The GBU-31(v)3 is a 2000 pound class JDAM consisting of a JDAM tail kit, a BLU-109 hard target penetrator warhead, and one of three fuze types: FMU-139, FMU-143, or FMU-152.

    4. The GBU-38 is a 500 pound class JDAM consisting of a JDAM tail kit, a Mk-82 warhead, and one of two fuze types: FMU-139 or FMU-152. A DSU-33 sensor can be added to the nose well of the weapon to give the GBU-38 JDAM AUR a HOB fusing option.

    5. The GBU-54 is a 500 pound class JDAM consisting of a JDAM tail kit, a Mk-82 warhead, and one of two fuze types: FMU-139 or FMU-152. A DSU-38/B adds a Precision Laser Guidance Set (PLGS) to the GBU-54 JDAM AUR, giving the weapon system optional semi-active laser guidance in addition to its current GPS/INS guidance.

    6. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    7. A determination has been made that the recipient country can provide the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.

    8. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Turkey.

    [FR Doc. 2015-33251 Filed 1-5-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 16-03] 36(b)(1) Arms Sales Notification AGENCY:

    Department of Defense, Defense Security Cooperation Agency.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-03 with attached Policy Justification and Sensitivity of Technology.

    Dated: December 31, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, <E T="03">Department of Defense</E>. BILLING CODE 5001-06-P EN06JA16.001 BILLING CODE 5001-06-C Transmittal No. 16-03 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(l) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Government of France

    (ii) Total Estimated Value:

    Major Defense Equipment* $355 million Other $295 million TOTAL $650 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE): Two (2) C-130J aircraft with Rolls Royce AE-2100D Turboprop Engines Two (2) KC-130J aircraft with Rolls Royce AE-2100D Turboprop Engines Four (4) Rolls Royce AE-2100D Turboprop Engines (spares) Non-Major Defense Equipment (Non-MDE): Six (6) AN/ALE 47 Electronic Countermeasure Dispensers (1 per aircraft, plus 2 spares) Six (6) AN/AAR-47A(V)2 Missile Warning Systems (1 per aircraft, plus 2 spares) Six (6) AN/ALR-56M Radar Warning Receivers (1 per aircraft, plus 2 spares) Ten (10) Embedded Global Positioning/Inertial Navigation Systems (2 per aircraft, plus 2 spares) Ten (10) AN/ARC-210 Radios (2 per aircraft, plus 2 spares) Ten (10) AN/ARC-164 UHF/VF Radios (2 per aircraft, plus 2 spares) Two (2) HF Voice Radios Ten (10) KY-100 Secure Voice Terminals (2 per aircraft, plus 2 spares) Ten (10) KYV-5 Secure Voice Equipment Units (2 per aircraft, plus 2 spares)

    Also provided are support and test equipment; publications and technical documentation; personnel training and training equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistical and program support.

    (iv) Military Department: Air Force (SAE)

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex

    (viii) Date Report Delivered to Congress: 10 NOV 2015

    *As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION France—C-130J aircraft

    The Government of France has requested a possible sale of:

    Major Defense Equipment (MDE): Two (2) C- 130J aircraft with Rolls Royce AE-2100D Turboprop Engines Two (2) KC-130J aircraft with Rolls Royce AE-2100D Turboprop Engines Four (4) Rolls Royce AE-2100D Turboprop Engines (spares) Non-Major Defense Equipment (Non-MDE): Six (6) AN/ALE 47 Electronic Countermeasure Dispensers (1 per aircraft, plus 2 spares) Six (6) AN/AAR-47A(V)2 Missile Warning Systems (1 per aircraft, plus 2 spares) Six (6) AN/ALR-56M Radar Warning Receivers (1 per aircraft, plus 2 spares) Ten (10) Embedded Global Positioning/Inertial Navigation Systems (2 per aircraft, plus 2 spares) Ten (10) AN/ARC-210 Radios (2 per aircraft, plus 2 spares) Ten (10) AN/ARC-164 UHF/VF Radios (2 per aircraft, plus 2 spares) Two (2) HF Voice Radios Ten (10) KY-100 Secure Voice Terminals (2 per aircraft, plus 2 spares) Ten (10) KYV-5 Secure Voice Equipment Units (2 per aircraft, plus 2 spares)

    Also provided are support and test equipment; publications and technical documentation; personnel training and training equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistical and program support. The estimated MDE value is $355 million. The total overall estimated value is $650 million.

    This proposed sale will contribute to the foreign policy and national security of the United States by improving the capability of a NATO ally. It is vital to U.S. national interests to assist the French Air Force to increase its airlift, air refueling, and air drop capabilities. These aircraft will provide these capabilities and will be used to support national, NATO, United Nations, and other coalition operations. Providing these aircraft to the French Air Force will greatly increase interoperability between the U.S. Air Force and the French Air Force, as well as other NATO allies.

    The C-130Js will provide critical transport, airdrop, and resupply to thousands of French troops in support of current and future operations. The KC-130Js will provide crucial air refueling capability to France's fighter aircraft, light transport aircraft, and helicopters. France will have no difficulty absorbing these aircraft into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    France requests that Lockheed Martin be the sole source provider for the C-130J aircraft. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale may require multiple trips for U.S. contractor representatives to France and potentially to deployed locations to provide initial launch, recovery, and maintenance support.

    Transmittal No. 16-03 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The AN/ALE-47 Counter-Measures Dispensing System (CMDS) is an integrated, threat-adaptive, software-programmable dispensing system capable of dispensing chaff, flares, and active radio frequency expendables. The threats countered by the CMDS include radar-directed anti-aircraft artillery (AAA), radar command-guided missiles, radar homing guided missiles, and infrared (IR) guided missiles. The system is internally mounted and may be operated as a stand-alone system or may be integrated with other on-board Electronic Warfare and avionics systems. The AN/ALE-47 uses threat data received over the aircraft interfaces to assess the threat situation and to determine a response. Expendable routines tailored to the immediate aircraft and threat environment may be dispensed using one of four operational modes. Hardware is UNCLASSIFIED. Technical data to include threat information files and documentation to be provided could be classified up to SECRET.

    2. The AN/AAR-47 missile warning system is a small, lightweight, passive, electro-optic, threat warning device used to detect surface-to-air missiles fired at helicopters and low-flying fixed-wing aircraft and automatically provide countermeasures, as well as audio and visual-sector warning messages to the aircrew. The basic system consists of multiple Optical Sensor Converter (OSC) units, a Computer Processor (CP) and a Control Indicator (Cl). The set of OSC units, which normally consist of four, is mounted on the aircraft exterior to provide omni-directional protection. The OSC detects the rocket plume of missiles and sends appropriate signals to the CP for processing. The CP analyses the data from each OSC and automatically deploys the appropriate countermeasures. The CI displays the incoming direction of the threat, so that the pilot can take appropriate action. Hardware is UNCLASSIFIED. Technical data to include threat information files and documentation to be provided could be classified up to SECRET.

    3. The AN/ALR-56M Advanced Radar Warning Receiver continuously detects and intercepts RF signals in certain frequency ranges and analyzes and separates threat signals from non-threat signals. It contributes to full-dimensional protection by providing individual aircraft probability of survival through improved aircrew situational awareness of the radar guided threat environment. The AN/ALR-56M is designed to provide improved performance in a dense signal environment and improved detection of modem threats signals. Hardware is UNCLASSIFIED. Technical data to include threat information files and documentation to be provided could be classified up to SECRET.

    4. The AN/ARC-210 multi-mode integrated communications system family offers a two-way secure, jam-resistant, voice and data communications via line-of-sight or satellite communications links in the very high frequency (VHF) and ultra-high frequency (UHF) spectrum. The RT1794C provides frequency hopping (HAVE QUICK I/II), Single Channel Ground and Airborne Radio Systems (SINCGARS), and embedded COMSEC products. The RT-1556 transceiver is capable of establishing two-way communication links within tactical aircraft environments. The ARC-210 can be tailored for integration on many user platforms and its modular architecture enables addition of specific capabilities depending on user's needs. Hardware is UNCLASSIFIED. Technical data and documentation to be provided is UNCLASSIFIED.

    5. The AN/ARC-164 is a modular, slice-constructed, solid-state, 10W UHF transmitter/receiver. It is standard equipment for the U.S. Air Force and U.S. Army with alternative console/panel mounts for each service, the RT-1168 and RT-1167 respectively. As well as MIL-STD-1553B and Have-Quick II, the latest AN/ARC-164 radios feature ANVIS Green A front panel lighting and an electronic fill port. The current AN/ARC-164 system is an F3 (Form, Fit, Function) replacement for older AN/ARC-164 systems and obsolete UHF radios such as the AN/ARC-51. This F3 replacement option eliminates platform Group A modification costs. Hardware is UNCLASSIFIED. Technical data and documentation to be provided is UNCLASSIFIED.

    6. KYV-5 COMSEC Module and the Split Remote Control Unit (SRCU) provide narrowband secure voice and data capability and perform all COMSEC, operator control and indication functions. Designed to secure Naval and Joint Service narrowband half-duplex communications over HF, VHF, and UHF SATCOM radios. A SRCU is available for applications where the front panel controls are not accessible. This may include the FYV-5M variant, to remain up to date and interoperable with the most current NATO standard at the time of aircraft delivery. Hardware is UNCLASSIFIED. Technical data and documentation to be provided is SECRET.

    7. The Advanced Narrowband Digital Voice Terminal (ANDVT) AIRTERM KY-100 is a piece of secure, tactical airborne terminal which provides secure transmission of voice and data over narrowband radio systems and provides an additional capability for transmission over wideband systems. AIRTERM is the airborne version of the MINTERM and is fully interoperable with the ANDVT family of equipment (MINTERM, KY-99A TACTERM AN/USC-43) and also with the VINSON (KY-57/58) equipment. This may include the KY-100M variant, to remain up to date and interoperable with the most current NATO standard at time of aircraft delivery. Hardware is UNCLASSIFIED. Technical data and documentation to be provided is SECRET.

    8. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    9. A determination has been made that the Government of France can provide substantially the same degree of protection for the sensitive technology being released as the United States Government. This sale is necessary in furtherance of the United States foreign policy and national security objectives outlined in the Policy Justification.

    10. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of France.

    [FR Doc. 2015-33265 Filed 1-5-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (“the Judicial Proceedings Panel” or “the Panel”). The meeting is open to the public.

    DATES:

    A meeting of the Judicial Proceedings Panel will be held on Friday, January 22, 2016. The Public Session will begin at 9:00 a.m. and end at 4:45 p.m.

    ADDRESSES:

    The Holiday Inn Arlington at Ballston, 4610 N. Fairfax Drive, Arlington, Virginia 22203.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Julie Carson, Judicial Proceedings Panel, One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, VA 22203. Email: [email protected]. Phone: (703) 693-3849. Web site: http://jpp.whs.mil.

    SUPPLEMENTARY INFORMATION:

    This public meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: In Section 576(a)(2) of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), as amended, Congress tasked the Judicial Proceedings Panel to conduct an independent review and assessment of judicial proceedings conducted under the Uniform Code of Military Justice (UCMJ) involving adult sexual assault and related offenses since the amendments made to the UCMJ by section 541 of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112-81; 125 Stat. 1404), for the purpose of developing recommendations for improvements to such proceedings. At this meeting, the Panel will deliberate on topics to be included in its upcoming annual report to Congress and the Secretary of Defense. The Panel will also hear presentations and analysis regarding indicators, trends, and patterns for military justice case data for sexual assault offenses from 2012 to 2014. The Panel is interested in written and oral comments from the public, including non-governmental organizations, relevant to these issues or any of the Panel's tasks.

    Agenda 9:00 a.m.-12:00 p.m. Panel Deliberations on Annual Report: Article 120, Retaliation, and Restitution & Compensation (Public meeting begins) 12:00 p.m.-1:00 p.m. Lunch 1:00 p.m.-4:30 p.m. Review of Military Justice Case Data for Sexual Assault Offenses: Presentations & Analysis from Dr. Cassia Spohn & JPP Staff 4:30 p.m.-4:45 p.m. Public Comment

    Availability of Materials for the Meeting: A copy of the January 22, 2016 public meeting agenda or any updates or changes to the agenda, to include individual speakers not identified at the time of this notice, as well as other materials provided to Panel members for use at the public meeting, may be obtained at the meeting or from the Panel's Web site at http://jpp.whs.mil.

    Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis.

    Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact the Judicial Proceedings Panel at [email protected] at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Procedures for Providing Public Comments: Pursuant to 41 CFR 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Panel about its mission and topics pertaining to this public session. Written comments must be received by the JPP at least five (5) business days prior to the meeting date so that they may be made available to the Judicial Proceedings Panel for their consideration prior to the meeting. Written comments should be submitted via email to the Judicial Proceedings Panel at [email protected] in the following formats: Adobe Acrobat or Microsoft Word. Please note that since the Judicial Proceedings Panel operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection. If members of the public are interested in making an oral statement, a written statement must be submitted along with a request to provide an oral statement. Oral presentations by members of the public will be permitted from 4:30 p.m. to 4:45 p.m. on January 22, 2016 in front of the Panel members. The number of oral presentations to be made will depend on the number of requests received from members of the public on a first-come basis. After reviewing the requests for oral presentation, the Chairperson and the Designated Federal Officer will, if they determine the statement to be relevant to the Panel's mission, allot five minutes to persons desiring to make an oral presentation.

    Committee's Designated Federal Officer: The Panel's Designated Federal Officer is Ms. Maria Fried, Department of Defense, Office of the General Counsel, 1600 Defense Pentagon, Room 3B747, Washington, DC 20301-1600.

    Dated: December 30, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-33202 Filed 1-5-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Board of Regents, Uniformed Services University of the Health Sciences; Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense; Uniformed Services University of the Health Sciences (“the University”).

    ACTION:

    Quarterly meeting notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following meeting of the Board of Regents, Uniformed Services University of the Health Sciences (“the Board”).

    DATES:

    Tuesday, February 2, 2016, from 8:00 a.m. to 10:50 a.m. (Open Session) and 10:50 a.m. to 11:20 a.m. (Closed Session).

    ADDRESSES:

    Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Everett Alvarez Jr. Board of Regents Room (D3001), Bethesda, Maryland 20814.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Nuetzi James, Designated Federal Officer, 4301 Jones Bridge Road, D3002, Bethesda, Maryland 20814; telephone 301-295-3066; email [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting notice is being published under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: The purpose of the meeting is to provide advice and recommendations to the Secretary of Defense through the Under Secretary of Defense for Personnel and Readiness, on academic and administrative matters critical to the full accreditation and successful operation of the University. These actions are necessary for the University to pursue its mission, which is to educate, train and comprehensively prepare uniformed services health professionals, officers, scientists and leaders to support the Military and Public Health Systems, the National Security and National Defense Strategies of the United States, and the readiness of our Uniformed Services.

    Agenda: The actions scheduled to occur include the approval of the minutes from the Board meeting held on November 3, 2015; recommendations regarding the awarding of post-baccalaureate degrees; recommendations regarding the approval of faculty appointments and promotions; and recommendations regarding award nominations. The University President will provide a report on recent actions affecting academic and operational aspects of the University. Member Reports will include an Academics Summary from the School of Medicine, Graduate School of Nursing, Postgraduate Dental College, University Faculty Senate, Graduate Medical Education and Senior Vice President. Member Reports will also include a Finance and Administration Summary from the Vice President for Finance and Administration, the University Brigade and The Henry M. Jackson Foundation for the Advancement of Military Medicine. The University Vice President for Research will provide a semiannual report on the University Office of Research; the University Inspector General (IG) will provide an update on IG issues involving the University; and a brief overview of the University Center for Global Health Engagement will be provided. A closed session will be held, after the open session, to discuss active investigations and personnel actions.

    Meeting Accessibility: Pursuant to Federal statute and regulations (5 U.S.C., Appendix, 5 U.S.C. 552b, and 41 CFR 102-3.140 through 102-3.165) and the availability of space, the meeting is open to the public from 8:00 a.m. to 10:50 a.m. Seating is on a first-come basis. Members of the public wishing to attend the meeting should contact Jennifer Nuetzi James five business days prior to the meeting, at the address and phone number noted in the FOR FURTHER INFORMATION CONTACT section.

    Pursuant to 5 U.S.C. 552b(c)(2, 5-7), the Department of Defense has determined that the portion of the meeting from 10:50 a.m. to 11:20 a.m. shall be closed to the public. The Under Secretary of Defense (Personnel and Readiness), in consultation with the Office of the DoD General Counsel, has determined in writing that a portion of the committee's meeting will be closed as the discussion will disclose sensitive personnel information, will include matters that relate solely to the internal personnel rules and practices of the agency, will involve allegations of a person having committed a crime or censuring an individual, and may disclose investigatory records compiled for law enforcement purposes.

    Written Statements: Pursuant to 41 CFR 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Board about its approved agenda pertaining to this meeting or at any time regarding the Board's mission. Individuals submitting a written statement must submit their statement to the Designated Federal Officer at the address listed in FOR FURTHER INFORMATION CONTACT. Written statements that do not pertain to a scheduled meeting of the Board may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at the planned meeting, then these statements must be received at least 5 calendar days prior to the meeting, otherwise, the comments may not be provided to or considered by the Board until a later date. The Designated Federal Officer will compile all timely submissions with the Board's Chair and ensure such submissions are provided to Board Members before the meeting.

    Dated: December 31, 2015. Aaron Siegel, Alternate OSD <E T="03">Federal Register</E> Liaison Officer, Department of Defense.
    [FR Doc. 2015-33243 Filed 1-5-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Savannah River Site AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Monday, January 25, 2016 1:00 p.m.-5:00 p.m. Tuesday, January 26, 2016 8:30 a.m.-5:00 p.m. ADDRESSES:

    New Ellenton Community Center, 212 Pine Hill Avenue, New Ellenton, SC 29809.

    FOR FURTHER INFORMATION CONTACT:

    James Giusti, Office of External Affairs, Department of Energy, Savannah River Operations Office, P.O. Box A, Aiken, SC 29802; Phone: (803) 952-7684.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda Monday, January 25, 2016 1:00 p.m. Opening and Agenda Review 1:20 p.m. Work Plan Update 1:30 p.m. Combined Committees Session Order of committees: • Facilities Disposition & Site Remediation • Administrative & Outreach • Nuclear Materials • Waste Management • Strategic & Legacy Management 4:45 p.m. Public Comments 5:00 p.m. Adjourn Tuesday, January 26, 2016 8:30 a.m. Opening, Chair Update, and Agenda Review 9:15 a.m. Agency Updates 10:00 a.m. Public Comments 10:15 a.m. Administrative & Outreach Committee Report 10:30 a.m. Break 10:45 a.m. Facilities Disposition & Site Remediation Committee Report 11:15 a.m. Public Comments 11:30 a.m. Lunch Break 1:00 p.m. Waste Management Committee Report 1:30 p.m. Nuclear Materials Committee Report 2:15 p.m. Public Comments 2:30 p.m. Break 2:45 p.m. Strategic & Legacy Management Committee Report 4:45 p.m. Announcement of 2016 Committee Chairs 5:00 p.m. Adjourn

    Public Participation: The EM SSAB, Savannah River Site, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Giusti at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact James Giusti's office at the address or telephone listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling James Giusti at the address or phone number listed above. Minutes will also be available at the following Web site: http://cab.srs.gov/srs-cab.html.

    Issued at Washington, DC, on December 31, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-33316 Filed 1-5-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [Certification Notice—237] Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of filing.

    SUMMARY:

    On December 17, 2015, CPV Towantic, LLC, as owner and operator of a new base load electric powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to § 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the Federal Register. 42 U.S.C. 8311(d) and 10 CFR 501.61(c).

    ADDRESSES:

    Copies of coal capability self-certification filings are available for public inspection, upon request, in the Office of Electricity Delivery and Energy Reliability, Mail Code OE-20, Room 8G-024, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Lawrence at (202) 586-5260.

    SUPPLEMENTARY INFORMATION:

    Title II of FUA, as amended (42 U.S.C. 8301 et seq.), provides that no new base load electric powerplant may be constructed or operated without the capability to use coal or another alternate fuel as a primary energy source. Pursuant to FUA in order to meet the requirement of coal capability, the owner or operator of such a facility proposing to use natural gas or petroleum as its primary energy source shall certify to the Secretary of Energy (Secretary) prior to construction, or prior to operation as a base load electric powerplant, that such powerplant has the capability to use coal or another alternate fuel. Such certification establishes compliance with FUA section 201(a) as of the date it is filed with the Secretary. 42 U.S.C. 8311.

    The following owner of a proposed new base load electric powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:

    OWNER: CPV Towantic, LLC CAPACITY: 785 megawatts (MW) PLANT LOCATION: CPV Towantic Energy Center, 16 Woodruff Hill Road, Oxford, CT 06478 IN-SERVICE DATE: May 1, 2018 Issued in Washington, DC, on December 30, 2015. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2015-33317 Filed 1-5-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-612-000] Greeley Energy Facility, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Greeley Energy Facility, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33232 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14739-000] Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On November 27, 2015, the Energy Resources USA Inc. filed an application for a preliminary permit under section 4(f) of the Federal Power Act proposing to study the feasibility of the proposed Coralville Dam Hydroelectric Project No. 14739-000, to be located at the existing Coralville Dam on the Iowa River, near the City of Coralville, in Johnson County, Iowa. The Coralville Dam is owned by the United States government and operated by the U.S. Army Corps of Engineers.

    The proposed project would consist of: (1) A new 90-foot by 13-foot by 18-foot concrete conduit; (2) a new 70-foot by 50-foot reinforced concrete powerhouse containing two 3.5-megawatt Kaplan hydropower turbine-generators having a total combined generating capacity of 7.0 megawatts; (3) one new 100-foot-long by 65-foot-wide tailrace; (4) a new 50-foot-long by 45-foot-wide substation; (5) a new 2-mile-long, 69-kilovolt transmission line; and (6) appurtenant facilities. The project would have an estimated annual generation of 34 gigawatt-hours.

    Applicant Contact: Mr. Ander Gonzalez, 2655 Le Jeune Road, Suite 804, Coral Gables, Florida 33134; telephone (954) 248-8425.

    FERC Contact: Tyrone A. Williams, (202) 502-6331.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14739-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14739) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33237 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the PJM Interconnection, L.L.C. (PJM):

    PJM Planning Committee January 7, 2016, 9:30 a.m.-12:00 p.m. (EST) PJM Transmission Expansion Advisory Committee January 7, 2016, 11:00 a.m.-3:00 p.m. (EST)

    The above-referenced meetings will be held at: PJM Conference and Training Center, PJM Interconnection, 2750 Monroe Boulevard, Audubon, PA 19403.

    The above-referenced meetings are open to stakeholders.

    Further information may be found at www.pjm.com.

    The discussions at the meetings described above may address matters at issue in the following proceedings:

    Docket No. ER14-972, PJM Interconnection, L.L.C. Docket No. ER14-1485, PJM Interconnection, L.L.C. Docket Nos. ER13-1944, et al., PJM Interconnection, L.L.C., et al. Docket No. ER15-1344, PJM Interconnection, L.L.C. Docket No. ER15-1387, PJM Interconnection, L.L.C. and Potomac Electric Power Company Docket No. ER15-2562, PJM Interconnection, L.L.C. Docket No. ER15-2563, PJM Interconnection, L.L.C. Docket No. EL15-18, Consolidated Edison Company of New York, Inc. v. PJM Interconnection, L.L.C. Docket No. EL15-41, Essential Power Rock Springs, LLC, et. al. v. PJM Interconnection, L.L.C. Docket Nos. ER13-1927, et al., PJM Interconnection, L.L.C., et al. Docket No. ER15-2114, PJM Interconnection, L.L.C. and Transource West Virginia, LLC Docket No. EL15-79, TransSource, LLC v. PJM Interconnection, L.L.C. Docket No. EL15-95, Delaware Public Service Commission, et. al., v. PJM Interconnection, L.L.C., et. al. Docket No. EL15-67, Linden VFT, LLC v. PJM Interconnection, L.L.C. Docket No. EL05-121, PJM Interconnection, L.L.C.

    For more information, contact the following:

    Jonathan Fernandez, Office of Energy Market Regulation, Federal Energy Regulatory Commission, (202) 502-6604, [email protected] Alina Halay, Office of Energy Market Regulation, Federal Energy Regulatory Commission, (202) 502-6474, [email protected] Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33236 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-645-000] RE Barren Ridge 1 LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of RE Barren Ridge 1 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33235 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-583-000] GDF SUEZ Energy Resources NA, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of GDF SUEZ Energy Resources NA, Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33231 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #3

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2799-013; ER10-2801-013; ER10-2385-007; ER11-3727-014; ER10-2262-005; ER12-2413-012; ER11-2062-018; ER10-2346-008; ER10-2812-012; ER10-1291-019; ER10-2843-011; ER11-2508-017; ER11-2863-010; ER11-4307-018; ER10-2347-007; ER10-2348-006; ER12-1711-014; ER10-2350-007; ER10-2846-013; ER12-261-017; ER10-3223-007; ER10-2351-007; ER10-2875-013; ER10-2368-006; ER10-2352-007; ER10-2264-006; ER10-1581-016; ER10-2353-008; ER10-2876-014; ER10-2878-013; ER10-2354-008; ER10-2355-008; ER10-2879-013; ER10-2384-007; ER10-2383-007; ER10-2880-013; ER11-2107-009; ER11-2108-009; ER10-2888-018; ER13-1745-008; ER13-1803-010; ER13-1788-008; ER16-10-001; ER13-1789-008; ER13-1790-010; ER10-2896-013.

    Applicants: Devon Power LLC, Dunkirk Power LLC, Elkhorn Ridge Wind, LLC, El Segundo Energy Center LLC, El Segundo Power, LLC, Energy Alternatives Wholesale, LLC, Energy Plus Holdings LLC, Forward WindPower LLC, GenConn Devon LLC, GenConn Energy LLC, GenConn Middletown LLC, GenOn Energy Management, LLC, GenOn Mid- Atlantic, LLC, Green Mountain Energy Company, Groen Wind, LLC, High Lonesome Mesa, LLC, High Plains Ranch II, LLC, Hillcrest Wind, LLC, Huntley Power LLC, Independence Energy Group LLC, Indian River Power LLC, Jeffers Wind 20, LLC, Keystone Power LLC, Laredo Ridge Wind, LLC, Larswind, LLC, Long Beach Generation LLC, Long Beach Peakers LLC, Lookout WindPower, LLC, Louisiana Generating LLC, Middletown Power LLC, Midway-Sunset Cogeneration Company, Midwest Generation, LLC, Montville Power LLC, Mountain Wind Power, LLC, Mountain Wind Power II LLC, NEO Freehold- Gen LLC, North Community Turbines LLC, North Wind Turbines LLC, Norwalk Power LLC, NRG Bowline LLC, NRG California South LP, NRG Canal LLC, NRG Chalk Point CT LLC, NRG Chalk Point LLC, NRG Delta LLC, NRG Energy Center Dover LLC.

    Description: Notice of Change in Status of NRG MBR Sellers [Part 2 of 3].

    Filed Date: 12/30/15.

    Accession Number: 20151230-5308.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-669-000.

    Applicants: GenConn Energy LLC.

    Description: Section 205(d) Rate Filing: Revised Market-Based Rate Tariff to be effective 12/31/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5313.

    Comments Due: 5 p.m. ET 1/20/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33225 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-632-000] Blythe Solar II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Blythe Solar II, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33233 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-582-000] ENGIE Retail, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of ENGIE Retail, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33230 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-581-000] ENGIE Portfolio Management, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of ENGIE Portfolio Management, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33229 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Supplemental Notice of Technical Conference Docket Nos. PJM Interconnection, L.L.C ER15-2562-000. ER15-2563-000. Consolidated Edison Company of New York, Inc. v. PJM Interconnection, L.L.C EL15-18-001. Linden VFT, LLC v. PJM Interconnection, L.L.C EL15-67-000. Delaware Public Service Commission and Maryland Public Service Commission v. PJM Interconnection, L.L.C EL15-95-000. PJM Interconnection, L.L.C ER14-972-003. PJM Interconnection, L.L.C ER14-1485-005. Not Consolidated.

    As noticed on December 4, 2015, the Commission has directed Commission staff to conduct a technical conference in the above-referenced proceedings. The technical conference is scheduled for January 12, 2016, at the Commission's headquarters at 888 First Street NE., Washington, DC 20426 between 10:00 a.m. and 4:00 p.m. (Eastern Time).

    In an order dated November 24, 2015,1 the Commission found that the assignment of cost allocation for the projects in the filings and complaints listed in the caption using PJM's solution-based distribution factor (DFAX) cost allocation method had not been shown to be just and reasonable and may be unjust, unreasonable, or unduly discriminatory or preferential. The Commission directed its staff to establish a technical conference to explore both whether there is a definable category of reliability projects within PJM for which the solution-based DFAX cost allocation method may not be just and reasonable, such as projects addressing reliability violations that are not related to flow on the planned transmission facility, and whether an alternative just and reasonable ex ante cost allocation method could be established for any such category of projects.

    1PJM Interconnection, L.L.C., et al., 153 FERC ¶ 61,245 (2015) (November 2015 Order).

    An agenda with the list of selected speakers and presentations is attached and will be available on the web calendar on the Commission's Web site, www.ferc.gov. A schedule for post-technical conference comments will be established at the technical conference.

    The technical conference is open to the public. The Chairman and Commissioners may attend and participate in the technical conference.

    Pre-registration through the Commission's Web site https://www.ferc.gov/whats-new/registration/01-12-16-form.asp is encouraged, to help ensure sufficient seating is available.

    This conference will also be transcribed. Interested persons may obtain a copy of the transcript for a fee by contacting Ace-Federal Reporters, Inc. at (202) 347-3700.

    In addition, there will be a free audio cast of the conference. Anyone wishing to listen to the meeting should send an email to Sarah McKinley at [email protected] by January 5, 2016, to request call-in information. Please reference “call information for PJM cost allocation technical conference” in the subject line of the email. The call-in information will be provided prior to the meeting.

    Persons listening to the technical conference may participate by submitting questions, either prior to or during the technical conference, by emailing [email protected]

    Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or call toll free 1-866-208-3372 (voice) or 202-502-8659 (TTY); or send a fax to 202-208-2106 with the required accommodations.

    For more information about this technical conference, please contact [email protected]; or Sarah McKinley, 202-502-8368, [email protected], regarding logistical issues.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33228 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2265-009; ER12-21-019; ER11-2211-008; ER11-2209-008; ER11-2210-008; ER11-2207-008; ER11-2206-008; ER13-1150-006; ER13-1151-006; ER10-2783-013; ER10-2784-013; ER11-2855-019; ER10-2791-014; ER10-2333-007; ER10-2792-014; ER14-1818-009; ER12-1238-006; ER10-2260-006; ER10-2261-006; ER10-2337-008; ER14-1668-005; ER14-1669-005; ER14-1674-005; ER14-1670-005; ER14-1671-005; ER14-1675-005; ER14-1673-005; ER14-1676-005; ER14-1677-005; ER14-1678-005; ER14-1679-005; ER14-1672-005; ER10-2795-013; ER10-2798-013; ER10-1575-012; ER10-2338-011; ER10-2340-011; ER12-1239-006; ER10-2336-007; ER10-2335-007; ER13-1991-007; ER13-1992-007.

    Applicants: NRG Power Marketing LLC, Agua Caliente Solar, LLC, Alta Wind I, LLC, Alta Wind II, LLC, Alta Wind III, LLC, Alta Wind IV, LLC, Alta Wind V, LLC, Alta Wind X, LLC, Alta Wind XI, LLC, Arthur Kill Power LLC, Astoria Gas Turbine Power LLC, Avenal Park LLC, Bayou Cove Peaking Power, LLC, Bendwind, LLC, Big Cajun I Peaking Power LLC, Boston Energy Trading and Marketing LLC, Broken Bow Wind, LLC, Cabrillo Power I LLC, Cabrillo Power II LLC, CL Power Sales Eight, L.L.C., Community Wind North 1 LLC, Community Wind North 2 LLC, Community Wind North 3 LLC, Community Wind North 5 LLC, Community Wind North 6 LLC, Community Wind North 7 LLC, Community Wind North 8 LLC, Community Wind North 9 LLC, Community Wind North 10 LLC, Community Wind North 11 LLC, Community Wind North 13 LLC, Community Wind North 15 LLC, Conemaugh Power LLC, Connecticut Jet Power LLC, Cottonwood Energy Company LP, CP Power Sales Nineteen, L.L.C., CP Power Sales Twenty, L.L.C., Crofton Bluffs Wind, LLC, DeGreeff DP, LLC, DeGreeffpa, LLC, Desert Sunlight 250, LLC, Desert Sunlight 250, LLC.

    Description: Notice of Change in Status of NRG MBR Sellers [Part 1 of 3].

    Filed Date: 12/30/15.

    Accession Number: 20151230-5304.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER10-2794-018; ER14-2672-003; ER12-1825-016.

    Applicants: EDF Trading North America, LLC, EDF Energy Services, LLC, EDF Industrial Power Services (CA), LLC.

    Description: Updated Market Power Analysis for the Southwest Power Pool Region of the EDF Sellers.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5191.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER10-2794-019; ER14-2672-004; ER12-1825-017.

    Applicants: EDF Trading North America, LLC, EDF Energy Services, LLC, EDF Industrial Power Services (CA), LLC.

    Description: Updated Market Power Analysis for the Southwest Region of the EDF Sellers.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5207.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER13-1562-005.

    Applicants: Catalina Solar Lessee, LLC.

    Description: Southwest Region Triennial Updated Market Power Analysis of Catalina Solar Lessee, LLC.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5347.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-758-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Correction Filing to 2015 Annual Allocation Update to be effective 1/1/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5141.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER15-2205-003.

    Applicants: Prairie Breeze Wind Energy III LLC.

    Description: Triennial Report of Prairie Breeze Wind Energy III LLC.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5222.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-2647-001.

    Applicants: Tres Amigas, LLC.

    Description: Compliance filing: Compliance to be effective 12/10/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5278.

    Comments Due: 5 p.m. ET 1/13/16.

    Docket Numbers: ER16-665-000.

    Applicants: Public Service Company of Colorado.

    Description: Section 205(d) Rate Filing: 2015-12-30_PSC-Brlngtn Mtr Agrmt-402 0.0.0 to be effective 2/29/2016.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5133.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-666-000.

    Applicants: Niagara Mohawk Power Corporation, New York Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: NPPC NYPA Amended Service Agreement No. 2177 to be effective 9/30/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5206.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-667-000.

    Applicants: Duke Energy Carolinas, LLC.

    Description: Section 205(d) Rate Filing: Amendments to SCPSA and CEPCI NITSA and Metering Agmts to be effective 1/1/2016.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5208.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-668-000.

    Applicants: PJM Interconnection, L.L.C., Ohio Power Company.

    Description: Section 205(d) Rate Filing: AEP submits 46th Revised Service Agreement No. 1336 to be effective 11/30/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5294.

    Comments Due: 5 p.m. ET 1/20/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33224 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-25-000] Startrans IO, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date

    On December 30, 2015, the Commission issued an order in Docket No. EL16-25-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of Startrans IO, LLC's proposed transmission revenue requirement reduction. Startrans, IO, LLC, 153 FERC ¶ 61,360 (2015).

    The refund effective date in Docket No. EL16-25-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33227 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-36-000] National Fuel Gas Supply Corporation; Notice of Request Under Blanket Authorization

    Take notice that on December 21, 2015 National Fuel Gas Supply Corporation (National Fuel), 6363 Main Street, Williamsville, New York 14221 filed a prior notice request pursuant to sections 157.205, 157.208, 157.210 and 157.216 of the Commission's regulations under the Natural Gas Act for authorization to construct and operate four sections of Line R34S totaling approximately 5.524 miles, and an approximately 0.153 mile section of Line R26S, both 12-inch-diameter pipelines located in Chautauqua and Cattaraugus Counties, New York, and abandon approximately 5.677 miles feet of 12-inch-diameter pipeline, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Any questions regarding this Application should be directed to Laura P. Berloth, Attorney for National Fuel, 6363 Main Street, Williamsville, New York 14221, by calling (716) 857-7001, or by email at [email protected]

    Any person may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention. Any person filing to intervene or the Commission's staff may, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) file a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (www.ferc.gov) under the “e-Filing” link. Persons unable to file electronically should submit original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33226 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-634-000] AltaGas Pomona Energy Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of AltaGas Pomona Energy Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 19, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected]. or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33234 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-58-000.

    Applicants: ReEnergy Sterling CT Limited Partnership.

    Description: Application for Authorization Pursuant to Section 203 of the Federal Power Act to Dispose of Jurisdictional Facilities, Request for Waivers, Expedited Consideration, and Confidential Treatment of ReEnergy Sterling CT Limited Partnership.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5335.

    Comments Due: 5 p.m. ET 1/19/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-2568-001.

    Applicants: Duke Energy Progress, LLC.

    Description: Compliance filing: Name Change Progress Rate Schedules to be effective 11/1/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5088.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER15-2568-002.

    Applicants: Duke Energy Progress, LLC.

    Description: Compliance filing: Name Change Progress SA to be effective 11/1/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5090.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER15-2569-001.

    Applicants: Duke Energy Florida, LLC.

    Description: Compliance filing: Name Change Rate Schedule Filing to be effective 11/1/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5044.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER15-2569-002.

    Applicants: Duke Energy Florida, LLC.

    Description: Compliance filing: Name Change Service Agreement Filing to be effective 11/1/2015.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5080.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-212-001.

    Applicants: Black Hills/Colorado Electric Utility Company, LP.

    Description: Tariff Amendment: Response Filing to be effective 1/1/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5287.

    Comments Due: 5 p.m. ET 1/19/16.

    Docket Numbers: ER16-217-001.

    Applicants: Black Hills/Colorado Electric Utility Co.

    Description: Tariff Amendment: Response Filing to be effective 1/1/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5288.

    Comments Due: 5 p.m. ET 1/19/16.

    Docket Numbers: ER16-652-000.

    Applicants: Roosevelt Wind Project, LLC.

    Description: Market-Based Triennial Review Filing: Roosevelt Wind Project Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5285.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-653-000.

    Applicants: Slate Creek Wind Project, LLC.

    Description: Market-Based Triennial Review Filing: Slate Creek Wind Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5286.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-654-000.

    Applicants: Spearville 3, LLC.

    Description: Market-Based Triennial Review Filing: Spearville 3 Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5289.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-655-000.

    Applicants: Spinning Spur Wind LLC.

    Description: Market-Based Triennial Review Filing: Spinning Spur Wind Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5290.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-656-000.

    Applicants: Oasis Power Partners, LLC.

    Description: Market-Based Triennial Review Filing: Oasis Power Partners Triennial Update to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5291.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-657-000.

    Applicants: Pacific Wind Lessee, LLC.

    Description: Market-Based Triennial Review Filing: Pacific Wind Lessee Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5292.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-658-000.

    Applicants: Shiloh Wind Project 2, LLC.

    Description: Market-Based Triennial Review Filing: Shiloh Wind Project 2 Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5293.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-659-000.

    Applicants: Shiloh III Lessee, LLC.

    Description: Market-Based Triennial Review Filing: Shiloh III Lessee Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5294.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-660-000.

    Applicants: Shiloh IV Lessee, LLC.

    Description: Market-Based Triennial Review Filing: Shiloh IV Lessee Triennial Filing to be effective 2/28/2016.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5295.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-661-000.

    Applicants: Appalachian Power Company.

    Description: Section 205(d) Rate Filing: OATT—Revise Attachment K, TCC and TNC Rate Update to be effective 12/31/9998.

    Filed Date: 12/29/15.

    Accession Number: 20151229-5304.

    Comments Due: 5 p.m. ET 1/19/16.

    Docket Numbers: ER16-662-000.

    Applicants: Duke Energy Progress, LLC.

    Description: Tariff Cancellation: DEP Cancellation Filing to be effective 2/28/2016.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5017.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-663-000.

    Applicants: Duke Energy Florida, LLC.

    Description: Tariff Cancellation: DEF Cancellation Filing to be effective 2/28/2016.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5018.

    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-664-000.

    Applicants: Midcontinent Independent System Operator, Inc., Entergy Services, Inc.

    Description: Section 205(d) Rate Filing: 2015-12-30_RS 40 Revised EMI-SMEPA JPZ to be effective 1/1/2016.

    Filed Date: 12/30/15.

    Accession Number: 20151230-5108

    Comments Due: 5 p.m. ET 1/20/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 30, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-33223 Filed 1-5-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0794; FRL-9940-41] Registration Review; Draft Human Health and Ecological Risk Assessments; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's draft human health and ecological risk assessments for the registration review of a group of pesticides identified individually in this document in the table in Unit III, and opens a public comment period. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed a comprehensive draft human health and ecological risk assessment for the identified pesticides. After reviewing comments received during the public comment period on each assessment, EPA may issue revised risk assessments and explain any changes to the draft risk assessments, and respond to substantive comments on the risk assessments. EPA may also request public input on risk mitigation before completing a proposed registration review decision for the identified pesticides. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    DATES:

    Comments must be received on or before March 7, 2016.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:

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

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

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.

    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 pesticide specific information contact: The Chemical Review Manager (CRM) identified in the table in Unit III.

    For general questions on the registration review program contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; email address: [email protected]

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager listed in the table in Unit III.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/commenting-epa-dockets#tips.

    3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document compared to the general population.

    II. Authority

    EPA is conducting its registration review of these pesticides pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

    III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide registrations for the pesticides listed in the table to ensure that they continue to satisfy the FIFRA standard for registration—that is, that these pesticides can still be used without unreasonable adverse effects on human health or the environment.

    Table—Draft Risk Assessments Being Made Available for Public Comment Registration review case name and No. Docket ID No. Chemical review manager and contact information Azoxystrobin, 7020 EPA-HQ-OPP-2009-0835 Veronica Dutch, [email protected], (703) 308-8585. Bensulfuron-methyl, 7216 EPA-HQ-OPP-2011-0663 Moana Appleyard, [email protected], (703) 308-8175. Bifenazate, 7609 EPA-HQ-OPP-2012-0633 Garland Waleko, [email protected], (703) 308-8049. Boric Acid and Sodium Borate Salts, 0024 EPA-HQ-OPP-2009-0306 Moana Appleyard, [email protected], (703) 308-8175. Ethephon, 0382 EPA-HQ-OPP-2010-0098 Marquea D. King, [email protected], (703) 305-7432. Hymexazol, 7016 EPA-HQ-OPP-2010-0127 Caitlin Newcamp, [email protected], (703) 347-0325. Lithium hypochlorite, 3084 EPA-HQ-OPP-2013-0606 Donna Kamarei, [email protected], (703) 347-0443. Pronamide, 0082 EPA-HQ-OPP-2009-0326 Wilhelmena Livingston, [email protected], (703) 308-8025.

    Azoxystrobin. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0835). Azoxystrobin is a systemic fungicide and antimicrobial registered for use on a variety of terrestrial food and feed crops, including vegetables, fruits and nuts; terrestrial non-food crops, including turf and ornamentals; and non-crop sites including additives for the manufacture of paint, rubber, paper products, textiles, and adhesives. The Agency has conducted draft human health and ecological risk assessments for the conventional and antimicrobial uses of azoxystrobin. A full endangered species assessment has not been completed for azoxystrobin at this time. For foliar applications, the ecological risk assessment identifies risks of concern for aquatic plants, freshwater fish, aquatic invertebrates, and mammals. For seed treatments, risks of concern are identified for birds and mammals. The conventional uses of azoxystrobin are associated with inhalation risks of concern for residential handlers and some occupational post-application scenarios even with maximum personal protective equipment (PPE). The antimicrobial uses of azoxystrobin are not associated with ecological risks of concern, but the human health risk assessment identifies potential risks of concern for residential and occupational handlers. Azoxystrobin has not been assessed under the endocrine disruptor screening program (EDSP) or for risks to pollinators.

    Bensulfuron-methyl. Draft Human Health Risk Assessment (EPA-HQ-OPP-2011-0663). Bensulfuron-methyl is a sulfonylurea herbicide that acts by inhibiting acetolactate synthase. Bensulfuron-methyl is registered for use to control broadleaf weeds and sedges in aquatic rice production. Tolerances have been established for crayfish, rice, and rice straw. There are no registered residential uses of bensulfuron-methyl. Bensulfuron- methyl was first registered in 1989, and a Final Work Plan was published in February 2012. The ecological risks of bensulfuron-methyl were assessed together with all other sulfonylureas in the Preliminary Ecological Risk Assessment for Registration Review of 22 Sulfonylurea Herbicides, published in September 2015. EPA conducted a human health risk assessment and did not identify any risks of concern for dietary, residential, occupational, or aggregate exposure. Bensulfuron-methyl was not on either initial list of chemicals to be screened under the EDSP, nor has an endangered species or pollinator assessment been conducted at this time.

    Bifenazate. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2012-0633). Bifenazate is a selective carbazate miticide/insecticide that is registered for use to control the motile stage of mites in agricultural and non-agricultural sites including on bearing and non-bearing fruit and vegetable crops, cotton, conifer plantations, ornamentals, and in greenhouses, as well as indoor and outdoor residential, commercial, institutional, and recreational areas. The human health non-occupational drift assessment was updated in registration review for bifenazate and found no risks of concern. In the recent June 2014, new use assessment, all dietary, residential, occupational, and aggregate risks were not of concern. In the ecological assessment, chronic risks of concern were identified for mammals and birds. There are acute risks identified for listed birds, freshwater fish, freshwater invertebrates, and estuarine and marine invertebrates. There is also potential acute and chronic risk to terrestrial invertebrates. Bifenazate was not on either initial list of chemicals to be screened under the EDSP, nor has an endangered species or pollinator assessment been conducted at this time.

    Boric Acid and Sodium Borate Salts. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0306). Boric acid and its sodium salts are inorganic compounds with registrations for use as active ingredients in insecticides, acaricides, herbicides, algaecides, fungicides, and wood and material preservatives. In small quantities, boron is an essential nutrient for aquatic vertebrates and invertebrates and plants. There is also evidence that boron is essential or, if not essential, beneficial in birds and mammals, in small quantities. Boric acid and its sodium salts are also present as inert ingredients in pesticide products and as ingredients in non-pesticide consumer products. The Agency issued a Final Work Plan for boric acid in October 2009. The ecological risk assessment identifies potential risks to terrestrial invertebrates, birds, mammals, reptiles, terrestrial-phase amphibians, aquatic organisms, and terrestrial plants. For birds and mammals, risk is primarily associated with the granular formulations and bait uses. For aquatic organisms, risk is primarily associated with discharge of swimming pool, hot tub, and spa effluent directly to surface waters, to storm drains, roadways, and potentially from storage of treated wood. For terrestrial plants, risk is primarily associated with discharge of effluent from swimming pools, hot tubs, and spas. The human health risk assessment did not identify risks of concern. Boric acid was not on either initial list of chemicals to be screened under the EDSP, nor has an endangered species or pollinator assessment been conducted at this time.

    Ethephon. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2010-0098). Ethephon, 2-chloroethylphosphonic acid, is an organophosphonate plant growth regulator intended to promote fruit ripening, abscission, flower induction, breaking of apical dominance (inhibition of the growth of lateral buds by the terminal bud of a shoot), and other plant responses through the release of ethylene gas, a natural plant hormone. EPA conducted a human health risk assessment and identified aggregate risks of concern for children ages 1-2 years old. EPA also conducted an ecological risk assessment and identified potential risks to birds, mammals, and non-target plants. A full endangered species assessment has not been completed for ethephon at this time. At this time, ethephon has not been evaluated for its potential to affect endocrine systems in mammals and wildlife, nor has an assessment of risks to pollinators been conducted.

    Hymexazol. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2010-0127). Hymexazol is a systemic fungicide for control of foliar and soil-borne plant diseases. There is only one existing registration as a commercial seed treatment for sugar beets. Hymexazol may be applied only using commercial seed treatment equipment. A Final Work Plan for hymexazol was published by the Agency in September 2010, and data were then required in a generic data call-in, dated October 2011. The reviews of the required data have been incorporated into the draft risk assessments. The Draft Human Health Risk Assessment identified no dietary risks of concern but identified potential risk to occupational workers (individuals treating/mixing seed and individuals doing multiple activities). The Draft Ecological Risk Assessment identified potential risks to mammals and birds. Hymexazol was not on either initial list of chemicals to be screened under the EDSP, and a complete endangered species assessment has not been conducted at this time.

    Lithium hypochlorite. Draft Ecological Risk Assessment (EPA-HQ-OPP-2013-0606). Lithium hypochlorite is an algicide, disinfectant, and fungicide. Its primary pesticidal use is to control algae, bacteria, and mildew in swimming pool water systems, hot tubs, and spas. EPA conducted a qualitative ecological risk assessment on the swimming pool uses of lithium hypochlorite as part of registration review. EPA previously conducted human health and ecological risk assessments at the time of the Reregistration Eligibility Decision (RED) for lithium hypochlorite in 1993. Lithium hypochlorite was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

    Pronamide. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0326). Pronamide, also called propyzamide, 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, is a selective, systemic, pre-and post-emergence herbicide registered for the control of grasses and broadleaf weeds in several food and feed crops as well as woody ornamentals, Christmas trees, grasses grown for seed or turf (sod), golf course turf, recreational area turf, and fallow land. EPA conducted a human health risk assessment and did not identify any risks of concern for dietary, residential, occupational, or aggregate exposure. EPA also conducted an ecological risk assessment and identified potential risks to birds, mammals, and plants. An endangered species and pollinator assessment has not been completed for pronamide at this time. Pronamide was evaluated for its potential to affect endocrine systems in mammals and wildlife and the results of the Agency's review are found in the weight of evidence review in this registration review docket.

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft human health and ecological risk assessments for the pesticides identified in this document. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to this draft risk assessment. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to the draft human health and ecological risk assessments. EPA may then issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments. In the Federal Register notice announcing the availability of the revised risk assessment, if the revised risk assessment indicates risks of concern, the Agency may provide a comment period for the public to submit suggestions for mitigating the risk identified in the revised risk assessment before developing a proposed registration review decision on the pesticides identified in this document.

    1. Other related information. Additional information on pesticides identified in this document is available on the Pesticide Registration Review Status Web page. Information on the Agency's registration review program and its implementing regulation is available at http://www.epa.gov/pesticide-reevaluation/registration-review-process.

    2. Information submission requirements. Anyone may submit data or information in response to this document. To be considered during a pesticide's registration review, the submitted data or information must meet the following requirements:

    • To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.

    • The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.

    • Submitters must clearly identify the source of any submitted data or information.

    • Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.

    As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: December 24, 2015. Richard P. Keigwin, Jr., Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2015-33298 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0393; FRL-9939-58] Registration Review Interim Decisions; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's interim registration review decision for the pesticides listed in Unit II of this notice. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without causing unreasonable adverse effects to human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    FOR FURTHER INFORMATION CONTACT:

    For pesticide specific information, contact the Chemical Review Manager identified in the table in Unit II for the pesticide of interest.

    For general information on the registration review program, contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; email address: [email protected]

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the pesticide specific contact person listed under FOR FURTHER INFORMATION CONTACT.

    B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0393, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. What action is the Agency taking?

    Pursuant to 40 CFR 155.58(c), this notice announces the availability of EPA's interim registration review decisions for the pesticides in the following table:

    Table—Registration Review Interim Decisions Registration review case name and No. Docket ID No. Contact and contact information 2-Propen-1-aminium, N,Ndimethyl-N-2-propenyl-, chloride, Homopolymer (Case 5024) EPA-HQ-OPP-2015-0255 Donna Kamarei, (703) 347-0443, [email protected]. Daminozide (Case 0032) EPA-HQ-OPP-2009-0242 Margaret Hathaway, (703) 305-5076, [email protected]. Dipropyl isocinchomeronate (Case 2215) EPA-HQ-OPP-2014-0578 Marianne Mannix, (703) 347-0275, [email protected]. Fenoxaprop-p-ethyl (Case 7209) EPA-HQ-OPP-2007-0437 Miguel Zavala, (703) 347-0504, [email protected]. Imazapyr (Case 3078) EPA-HQ-OPP-2014-0200 Matthew Manupella, (703) 347-0411, [email protected]. Isoxaben (Case 7219) EPA-HQ-OPP-2007-1038 Nathan Sell, (703) 347-8020, [email protected]. Paclobutrazol (Case 7002) EPA-HQ-OPP-2006-0109 Khue Nguyen, (703) 347-0248, [email protected]. Silica and Silcates (Case 4081) EPA-HQ-OPP-2007-1140 James Parker, (703) 306-0469, [email protected]. Sulfentrazone (Case 7231) EPA-HQ-OPP-2009-0624 Christina Scheltema, (703) 308-2201, [email protected]. Tributyltin Oxide (Case 2620) EPA-HQ-OPP-2014-0801 Sandra O'Neill, (703) 347-0141, [email protected].

    The registration review final decisions for several of these cases are dependent on the assessment of listed species and designated critical habitats under the Endangered Species Act (ESA), determinations on the potential for endocrine disruption, and/or evaluation of risks to pollinators.

    2-Propen-1-aminium, N, N-dimethyl-N-2-propenyl-, chloride, homopolymer (Interim Decision). The registration review docket for 2-propen-1-aminium, N, N-dimethyl-N-2-propenyl-, chloride, homopolymer opened in August 2015. The Agency did not receive any comments. There is one product containing this active ingredient; which is registered to control mollusks in potable water supplies. The Agency did not call-in any data in support of this registration review case. Additionally, the Agency did not conduct a human health or an environmental risk assessment since label instructions minimize exposure from the product's registered use. Based on the lack of potential exposure, the Agency is making a “no effect” determination for listed species. The final decision on the registration review for this case will occur after an Endocrine Disruption Screen Program (EDSP) Federal Food Drug and Cosmetic Act (FFDCA) section 408(p) determination is made.

    Daminozide (Interim Decision). EPA is announcing the availability of the daminozide interim registration review decision. Daminozide is a plant growth regulator (PGR) used to control the development of commercially grown container plants. It is used in nurseries, shade houses, and greenhouses and is applied as a foliage spray that is systemically distributed throughout the plant, a use pattern resulting in little or no potential for off-site drift. Daminozide has no registered food uses and no registered residential uses. EPA conducted both an ecological risk assessment and human health risk assessment for daminozide, and there were no human health risks of concern with registered daminozide uses. The Agency is not calling for mitigation for either ecological or human health risks from daminozide at this time. Except for ongoing ESA consultation, a pollinator risk assessment, and EDSP component of this registration review case, the Agency is proposing that no additional data and no further risk mitigation is needed for daminozide. The Agency's final registration review decision is dependent upon the assessment of risks to threatened and endangered species, pollinators, and an EDSP determination.

    Dipropyl isocinchomeronate (Interim Decision). This notice announces the publication of the registration review interim decision for dipropyl isocinchomeronate. Dipropyl isocinchomeronate is registered for use as an insect repellent for use on humans and companion animals to repel flies, gnats, and other flying and biting insects. It is never the sole active ingredient; it is always co-formulated with other insecticides/repellents to broaden their spectrum of repellency. The Agency has concluded that there are no human health risk concerns associated with the use of dipropyl isocinchomeronate. Based on the limited usage, diffusion over a large treatment area, and the low probability of non-target organism exposure, the Agency has not found any ecological risks of concern associated with dipropyl isocinchomeronate and is making a “no effect” determination for all federally listed species and a “no habitat modification” determination for all designated critical habitat for listed species. The Agency concludes that no risk reduction measures or additional data are needed at this time. Dipropyl isocinchomeronate has not been evaluated under the EDSP. The Agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine effects.

    Fenoxaprop-p-ethyl (Interim Decision). Fenoxaprop-p-ethyl (FPE) is a selective aryloxy phenoxy-propionate herbicide registered for use on barley, cotton, rice, soybeans, and wheat for post-emergence control of grassy weeds. Additional non-agricultural use sites include conservation reserves, ornamentals, rights-of-way, and turf. In this interim registration review decision for fenoxaprop-p-ethyl, EPA has determined that no additional data are required at this time; however, certain risk reduction measures are necessary at this time. To address potential risk to non-target terrestrial monocots, spray drift management language is required for all fenoxaprop-p-ethyl product registrations used on agricultural, wide area, or rights-of-way use sites. The Agency also is requiring the implementation of label language clarifying use rates, to which the registrants have already agreed. In addition, EPA is requiring label language to include recommended herbicide-resistance management measures. The final registration review decision for fenoxaprop-p-ethyl is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

    Imazapyr (Interim Decision). The registration review docket for imazapyr opened in June 2014. Imazapyr is a non-selective systemic herbicide registered for use as pre- and post-emergent treatments to control broad spectrum terrestrial and aquatic weeds including terrestrial annual and perennial grasses, broadleaf weeds, herbs, woody species, and riparian and emergent aquatic weed species. EPA published draft human health and ecological risk assessments at the time of the docket opening for a 60-day public comment period. In this imazapyr interim decision, the Agency has determined that no additional data are required and no changes to the affected registrations or their labeling are needed at this time. In this interim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of imazapyr, nor is it making an endangered species finding. EPA's registration review decision for imazapyr will depend upon the result of an EDSP FFDCA section 408(p) determination, complete pollinator determination, and ESA determination.

    Isoxaben (Interim Decision). Isoxaben is a pre-emergent benzamide herbicide registered for use to control broadleaf weeds. It is classified as a Group 21 herbicide that inhibits cell wall biosynthesis. It is registered for non-agricultural uses such as turf grass, ornamentals, and landscape mulch. It is also registered for agricultural use on bearing fruit and nut trees and vineyards. There are no human health risk concerns for isoxaben. However, there are potential ecological risks to aquatic and terrestrial plants and potential chronic risk to mammals. In this interim registration review decision for isoxaben, EPA has determined that no additional data are required at this time and that certain risk reduction measures are necessary, including uniform spray drift management and herbicide resistance management label language. The final registration review decision for isoxaben is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

    Paclobutrazol (Interim Decision). Paclobutrazol is a systemic PGR that slows vegetative growth by inhibiting cell elongation. Paclobutrazol is currently registered for use on turf grass (including in parks, athletic fields, golf courses, and rights-of-ways), on ornamentals, as a tree injection, as a soil injection/basal tree drench, and as a seed treatment for various vegetables. There are no registered residential uses of paclobutrazol. EPA conducted a risk assessment for both human health and ecological risk. No human health risks were identified. The ecological risk assessment indicated potential risks to birds, reptiles, and terrestrial-phase amphibians, mammals, terrestrial and aquatic plants, and other aquatic organisms. In the paclobutrazol interim decision, the Agency has determined that certain additional data are required and certain changes to product labeling to address risk from runoff are needed at this time. EPA is making no human health or environmental safety findings associated with the EDSP screening of paclobutrazol, nor is it making an endangered species finding. EPA's registration review decision for paclobutrazol will depend upon the result of an EDSP FFDCA section 408(p) determination, complete pollinator determination, and ESA determination.

    The silicates (silica gel and silicon dioxide) (Interim Decision). Silica gel and silicon dioxide are commonly referred to as the silicates, silica silicates or diatomaceous earth (DE) and are found in most soils. Silica gel and silicon dioxide are registered for use as insecticides on a variety of indoor and outdoor areas including crop and residential use sites to treat pests (including ants, boxelder bugs, cockroaches, crickets, slugs, flies, fleas, millipedes, silver-fish, sowbugs and ticks). EPA conducted an ecological risk assessment, including an endangered species assessment. EPA reached a “no effect” determination for all listed species, excluding 57 listed terrestrial invertebrate species, for which a “not likely to adversely affect” determination was made. EPA also concluded that there would be no modification of designated critical habitat. EPA engaged in informal consultation with the U.S. Fish and Wildlife Service (FWS) seeking concurrence on the “not likely to adversely affect” findings. FWS concurred with EPA's “not likely to adversely affect” determination, thus completing consultation. No human health risk assessment was conducted for silica gel and silicon dioxide because no toxicological endpoints were identified to conduct a human health risk assessment. No risk mitigation measures for human health or ecological effects are included in the silica gel and silicon dioxide registration review interim decision. This interim decision does not include the EDSP component of this registration review case. The Agency's final registration review decision will depend upon the result of an EDSP FFDCA section 408(p) determination.

    Sulfentrazone (Interim Decision). Sulfentrazone is a broad spectrum, pre-emergence, soil-directed proto porphyrinogen herbicide used to control a variety of weeds. It is registered for use on field crops, specialty vegetable crops, fruit trees, ornamentals, and turf grass. EPA completed quantitative human health and ecological risk assessments for sulfentrazone in 2014, and amended the ecological risk assessment in 2015. The Agency has risk concerns for pesticide handlers that can be adequately mitigated by requiring use of chemical-resistant gloves. In addition, there are potential risk concerns for terrestrial plants. In this interim registration review decision for sulfentrazone, EPA has determined that no additional data are required at this time and that certain risk reduction measures are necessary. These measures include uniform spray drift management language on sulfentrazone labels for products applied by spraying and herbicide resistance management language on all product labels. The Agency's final registration review decision is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

    Tributyltin oxide (Interim Decision). There are four EPA registrations for tributyltin oxide for rubber coatings on the sonar domes of nuclear submarines and for oceanographic conductivity sensors. Based on the lack of potential for dietary exposure and no residential uses, the Agency did not conduct a human health risk assessment. Exposure to aquatic organisms would occur only from the small amount of tributyltin oxide potentially leaching from sonar domes, and the Agency believes that risks to non-target, non-listed species are minimal. Tributyltin oxide use as an antifoulant on sonar domes is undergoing ESA consultation with the Department of Defense, EPA, and the Services for compounds covered under EPA's Uniform National Discharge Standards. No EDSP determination has been made at this time. Except for the EDSP component of the tributyltin oxide registration review case, the Agency is not requiring additional data and is not proposing any risk reduction measures for this case. The final decision on the registration review for tributyltin oxide will occur after the ESA consultation and the EDSP FFDCA section 408(p) determination have been made.

    Pursuant to 40 CFR 155.57, a registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA. EPA has considered the pesticides listed in light of the FIFRA standard for registration. The interim decision documents in the docket describe the Agency's rationale for issuing registration review interim decisions for these pesticides.

    In addition to the interim registration review decision document, the registration review docket for these pesticides also includes other relevant documents related to the registration review of these cases. The proposed interim registration review decisions were posted to the docket and the public was invited to submit any comments or new information. EPA has addressed the substantive comments or information received during the 60-day comment period in the interim decision document for each pesticide listed in this document.

    Pursuant to 40 CFR 155.58(c), the registration review case docket for each pesticide discussed in this notice will remain open until all actions required in the interim decision have been completed.

    Background on the registration review program is provided at: http://www2.epa.gov/pesticide-reevaluation. Links to earlier documents related to the registration review of this pesticide are provided in the Pesticide Chemical Search data base accessible at: http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: December 23, 2015. Richard P. Keigwin, Jr., Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2015-33300 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2015-0613; FRL-9940-96-OW] Proposed Information Collection Request; Comment Request; Title I of the Marine Protection, Research, and Sanctuaries Act AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR), “Title I of the Marine Protection, Research, and Sanctuaries Act” (EPA ICR No. 0824.06, OMB Control No. 2040-0008) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed renewal of the ICR (formerly known as “Ocean Dumping Regulations—reports and record keeping to obtain a permit, request designation, and report on permitted dumping activities”), which is currently expired. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before March 7, 2016.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OW-2015-0613, online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    David Redford, Oceans and Coastal Protection Division, Environmental Protection Agency, 4504T 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone 202-566-1288; fax number: 202-566-1546; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: Ocean dumping—the transportation of any material for the purpose of dumping in ocean waters—cannot occur unless a permit is issued under the Marine Protection, Research, and Sanctuaries Act (MPRSA). EPA is responsible for issuing ocean dumping permits for all materials except dredged material. The U.S. Army Corps of Engineers (USACE) is responsible for issuing ocean dumping permits for dredged material using EPA's environmental criteria. Ocean dumping permits for dredged material are subject to EPA review and concurrence. EPA is also responsible for designating and managing ocean sites for the disposal of wastes and other materials, and establishing Site Management and Monitoring Plans for ocean disposal sites. EPA collects or sponsors the collection of information for the purposes of permit issuance, reporting of emergency dumping to safety of life at sea, compliance with permit requirements, including specifically general permits for burial at sea and for transportation and disposal of vessels.

    EPA collects this information to ensure that ocean dumping is appropriately regulated and will not harm human health and the marine environment, based on applying the Ocean Dumping Criteria. The Ocean Dumping Criteria consider, among other things: The environmental impact of the dumping; the need for the dumping; the effect of the dumping on esthetic, recreational, or economic values; land-based alternatives to ocean dumping; and the adverse effects of the dumping on other uses of the ocean. The Ocean Dumping Criteria are codified in 40 CFR parts 227-228. To meet U.S. reporting obligation under the London Convention, EPA also reports some of this information in the annual United States Ocean Dumping Report.

    EPA uses ocean dumping information to make decisions regarding whether to issue or deny a permit. This information is also used to develop the conditions in ocean dumping permits issued by EPA in order to ensure consistency with the Ocean Dumping Criteria. EPA uses monitoring and reporting data from permittees to assess compliance with ocean dumping permits, including associated monitoring activities.

    Form numbers: None.

    Respondents/affected entities: Respondents/affected entities may include any private person or entity, or State, local or foreign governments.

    Respondent's obligation to respond: Required to obtain or retain a benefit, specifically permit authorization and/or compliance with permits required under MPRSA sections 102 and 104, 33 U.S.C. 1402 & 1404, and implementing regulations at 40 CFR parts 220-229.

    Estimated number of respondents: 2,767 respondents per year.

    Frequency of response: The frequency of response varies for application and reporting requirements for different permits. Other than the general permit for transportation and disposal of vessels, response is required once for each permit application, whether a single notification to EPA or a permit application. Depending on the type of MPRSA permit, a permit application would be required prior to expiration if the permittee seeks re-issuance: General permit (once every seven years); special permit (once every three years), and research permit (once every 18 months).

    Total estimated burden: The public reporting and recordkeeping burdens for this collection of information are estimated to be 3,207 hours per year. Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: Annual labor costs are estimated to be $153,300 and $195,857 for capital or operation & maintenance costs.

    Changes in estimates: EPA estimates an increase in the number of respondents from 21 to 2,767 with a corresponding decrease in total estimated burden from 27,004 to 3,207 hours as compared to the most recently approved ICR, which expired January 31, 1992. The estimated increase in the number of respondents is due to the significant increase in the number of entities using the burial at sea and vessel general permits, which were not widely used at the time of the earlier ICR. The estimated decrease in the total estimated burden is due to the implementation of the Ocean Dumping Ban Act of 1988, which led to the cessation of the dumping of sewage sludge and industrial wastes. The respondent burden for these special permits was high due the potentially significant impacts from dumping these wastes, and the data required from the respondents to ensure permit compliance.

    Benita Best-Wong, Director, Office of Wetlands, Oceans, and Watersheds.
    [FR Doc. 2015-33295 Filed 1-5-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1127] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before March 7, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1127.

    Title: First Responder Identification Information in the Uniform Licensing System (ULS).

    Form No.: FCC Form 601.

    Type of Review: Extension of a previously approved collection.

    Respondents: Business or other-for-profit; Not-for-profit institutions; State, local, or Tribal Government.

    Number of Respondents and Responses: 133,095 respondents; 13,310 responses.

    Estimated Time per Response: .25 hours.

    Frequency of Response: One-time reporting requirement.

    Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. 4(i), 154(i) and 0.191.

    Total Annual Burden: 3,327 hours.

    Total Annual Cost: None.

    Nature and Extent of Confidentiality: To protect the identities and locations of key first responder communications personnel, the Commission will treat emergency contact information submitted into ULS pursuant to the Public Notice, DA-09-243, as confidential and will not make such information publicly available.1 The contact information submitted into ULS by public safety licensees and non-public safety licensees designated as emergency first responders will be available only to Commission staff. Interested licensees should file their operational point of contact information in ULS in the form of a confidential pleading.

    1 47 CFR 0.457.

    Also, to protect the confidentiality, integrity and availability of the emergency contact information submitted pursuant to this collection, the Commission will ensure that the sensitive information is encrypted and properly stored.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: As part of its Universal Licensing System (ULS), the Commission seeks additional information from licensees. Specifically, the Commission seeks to request the following information from licensees:

    (1) Whether the Public Safety or Commercial Licensee is identified by a state, county, and/or local emergency authority to provide “first responder” emergency services;

    (2) What type of first responder the Public Safety or Commercial Licensee is identified as;

    (3) The identity, by name and contact information, of the Public Safety or Commercial Licensee's designated point-of-contact; and

    (4) The identity, by name and contact information, of the relevant state, county, and/or local emergency authority that designated the Public Safety or Commercial Licensee as a “first responder.”

    This information will assist the Commission in providing quality assistance to first responders in the event of an emergency. With this information, the Commission will be able to enhance its targeted assistance to first responders in the affected areas.

    Federal Communications Commission. Sheryl D. Todd, Deputy Secretary. Office of the Secretary.
    [FR Doc. 2015-33238 Filed 1-5-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0741] Information Collections Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before February 5, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the “Supplementary Information” section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <http://www.reginfo.gov/public/do/PRAMain>, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0741.

    Title: Technology Transitions, GN Docket No. 13-5, et al.

    Form Number: N/A.

    Type of Review: Revision of currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 5,357 respondents; 573,767 responses.

    Estimated Time per Response: 0.5-8 hours.

    Frequency of Response: On occasion reporting requirements; recordkeeping; third party disclosure.

    Total Annual Burden: 575,840 hours.

    Total Annual Cost: No cost.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority is contained in 47 U.S.C. 222 and 251.

    Nature and Extent of Confidentiality: The Commission is not requesting that the respondents submit confidential information to the FCC. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR 0.459 of the Commission's rules.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: Section 251 of the Communications Act of 1934, as amended, 47 U.S.C. 251, is designed to accelerate private sector development and deployment of telecommunications technologies and services by spurring competition. Section 222(e) is also designed to spur competition by prescribing requirements for the sharing of subscriber list information. These OMB collections are designed to help implement certain provisions of sections 222(e) and 251, and to eliminate operational barriers to competition in the telecommunications services market. Specifically, these OMB collections will be used to implement (1) local exchange carriers' (“LECs”) obligations to provide their competitors with dialing parity and non-discriminatory access to certain services and functionalities; (2) incumbent local exchange carriers' (“ILECs”) duty to make network information disclosures; and (3) numbering administration. The Commission estimates that the total annual burden of the entire collection, as revised, is 575,840 hours. This revision relates to a change in one of many components of the currently approved collection—specifically, certain reporting, recordkeeping and/or third party disclosure requirements under section 251(c)(5). In August 2015, the Commission adopted new rules concerning certain information collection requirements implemented under section 251(c)(5) of the Act, pertaining to network change disclosures. The changes to those rules apply specifically to a certain subset of network change disclosures, namely notices of planned copper retirements. The changes are designed to provide interconnecting entities adequate time to prepare their networks for the planned copper retirements and to ensure that consumers are able to make informed choices. There is also a change in the number of potential respondents to the rules promulgated under that section. The number of respondents as to the information collection requirements implemented under section 251(c)(5) of the Act, has changed from 1,300 to 750, a decrease of 550 respondents from the previous submission. Under section 251(f)(1) of the Act, rural telephone companies are exempt from the requirements of section 251(c) “until (i) such company has received a bona fide request for interconnection, services, or network elements, and (ii) the State commission determines . . . that such request is not unduly economically burdensome, is technically feasible, and is consistent with section 254. . . .” The Commission has determined that the number of potential respondents set forth in the previous submission inadvertently failed to take this exemption into account. There are 1,429 ILECs nationwide. Of those, 87 are non-rural ILECs and 1,342 are rural ILECs. The Commission estimates that of the 1,342 rural ILECs, 679 are entitled to the exemption and 663 are not entitled to the exemption and thus must comply with rules promulgated under section 251(c) of the Act, including the rules that are the subject of this information collection. Thus, the Commission estimates that there are 87 (non-rural) + 663 (rural) = 750 potential respondents. The Commission estimates that the revision does not result in any additional outlays of funds for hiring outside contractors or procuring equipment.

    Federal Communications Commission. Sheryl D. Todd, Deputy Secretary, Office of the Secretary.
    [FR Doc. 2015-33239 Filed 1-5-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [ DA 15-1343] Order Declares Wypoint Telecom, Inc.'s International Section 214 Authorization Terminated AGENCY:

    Federal Communications Commission

    ACTION:

    Notice.

    SUMMARY:

    In this document, we declare the international section 214 authorization granted to Wypoint Telecom, Inc. (“Wypoint” and formerly known as Sage VOIP Solutions, Inc.) terminated given Wypoint's inability to comply with an express condition for holding the authorization. We also conclude that Wypoint failed to comply with those requirements of the Communications Act of 1934 (the Act) and the Commission's rules that ensure that the Commission can contact and communicate with the authorization holder, which failures have prevented any way of addressing Wypoint's inability to comply with the condition of its authorization.

    DATES:

    November 20, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Cara Grayer, Telecommunications and Analysis Division, International Bureau, at (202) 418-2960 or [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 27, 2007, the International Bureau granted Wypoint an international section 214 authorization to provide global or limited global facilities-based service and global or limited global resale service in accordance with sections 63.18(e)(1) and 63.18(e)(2) of the Commission's rules. The International Bureau granted the application on the express condition that Wypoint abide by the commitments and undertakings contained in its Letter of Assurance (LOA) to the U.S. Department of Justice, U.S. Department of Homeland Security, and Federal Bureau of Investigation (collectively, the Agencies) dated July 11, 2007. We determine that Wypoint's section 214 authorization to provide international services issued under File No. ITC-214-20070601-00211 has terminated for Wypoint's inability to comply with an express condition for holding the section 214 international authorization. The International Bureau has afforded Wypoint with notice and opportunity to respond to the allegations in the Executive Branch May 9, 2014 Letter concerning Wypoint's non-compliance with the condition of its grant. Wypoint has not responded to any of our requests or requests from the Agencies. We find that Wypoint's failure to respond to our multiple requests demonstrates that it is unable to satisfy the LOA conditions concerning the availability of U.S. customer records, upon which the Agencies gave their non-objection to the grant of the authorization to Wypoint, and which were a condition of its section 214 authorization.

    Furthermore, after having received an international 214 authorization, a carrier “is responsible for the continuing accuracy of the certifications made in its application” and must promptly correct information no longer accurate, “and in any event, within thirty (30) days.” Wypoint's address is no longer valid and thus Wypoint has failed to inform the Commission of any changes in the continuing accuracy of its prior certifications, referencing the FCC file number of the original certification. Nor is there any record of Wypoint's having complied with section 413 of the Act and the Commission's rules requiring it to designate an agent for service after receiving its authorization on July 27, 2007. Finally, as part of its authorization, Wypoint “must file annual international telecommunications traffic and revenue as required by § 43.62.” Section 43.62(b) states that “[n]ot later than July 31 of each year, each person or entity that holds an authorization pursuant to section 214 to provide international telecommunications service shall report whether it provided international telecommunications services during the preceding calendar year.” Our records indicate that Wypoint failed to file an annual international telecommunications traffic and revenue report indicating whether or not Wypoint provided services in 2014, as required by section 43.62(b) of the Commission's rules. In these circumstances, and in light of Wypoint's failure to respond to the Commission's repeated inquiries, we conclude that this failure to comply with the basic requirements of the Commission's rules designed to ensure its ability to communicate with the holder of the authorization also warrants termination, wholly apart from demonstrating Wypoint's inability to satisfy the LOA conditions of its authorization.

    By this Order, we grant the Executive Branch agencies' request to the extent set forth in this Order. A copy of this Order was sent by return receipt requested, to Wypoint at its last known addresses.

    Further requests should be sent to Denise Coca, Chief, Telecommunications and Analysis Division, International Bureau via email at [email protected] and file it in File No. ITC-214-20121210-00323 via IBFS at http://licensing.fcc.gov/myibfs/pleading.do.

    Federal Communications Commission. Francis Gutierrez, Deputy Chief, Telecommunications and Analysis Division, International Bureau.
    [FR Doc. 2015-33271 Filed 1-5-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0392] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before March 7, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0392.

    Title: 47 CFR 1 Subpart J—Pole Attachment Complaint Procedures.

    Form Number: N/A.

    Type of Review: Extension of currently approved collection.

    Respondents: Businesses or other for-profit, and State, local or tribal government.

    Number of Respondents and Responses: 1,772 respondents; 1,772 responses.

    Estimated Time per Response: 0.5 to 100 hours.

    Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 224.

    Total Annual Burden: 2,629 hours.

    Total Annual Cost: $450,000.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality. However, respondents may request materials or information submitted to the Commission be withheld from public inspection under 47 CFR 0.459 of FCC rules.

    Needs and Uses: The rules and regulations contained in 47 CFR part 1 Subpart J provide complaint and enforcement procedures to ensure that telecommunications carriers and cable system operators have nondiscriminatory access to utility poles, ducts, conduits, and rights-of-way on rates, terms and conditions that are just and reasonable. They also provide complaint and enforcement procedures for incumbent local exchange carriers (as defined in 47 U.S.C. 251(h)) to ensure that the rates, terms, and conditions of their access to pole attachments are just and reasonable. The FCC will use the information collected under these rules to hear and resolve petitions for stay and complaints as mandated by Section 224 of the Communications Act of 1934, as amended. The information that is also filed is used to determine the merits of the petitions and complaints. Additionally, state certifications are used to make public notice of the states' authority to regulate rates, terms and conditions for pole attachments, and to determine the scope of the FCC's jurisdiction.

    Federal Communications Commission. Sheryl D. Todd, Deputy Secretary. Office of the Secretary.
    [FR Doc. 2015-33240 Filed 1-5-16; 8:45 am] BILLING CODE 6712-01-P
    GENERAL SERVICES ADMINISTRATION [Notice-CSE-2016-01; Docket No. 2016-0002; Sequence No. 1] Notice of the General Services Administration's Labor-Management Relations Council Meeting AGENCY:

    Office of Human Resources Management (OHRM), General Services Administration (GSA).

    ACTION:

    Notice of meeting.

    SUMMARY:

    The General Services Administration's Labor-Management Relations Council (GLMRC), a Federal Advisory Committee established in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C., App., and Executive Order 13522, plans to hold one meeting that is open to the public.

    DATES:

    The meeting will be held on Tuesday, January 26, 2016 from 9:30 a.m. to 4:30 p.m. and Wednesday, January 27, 2016 from 9:30 a.m. to 12:00 noon, Eastern Standard Time.

    ADDRESSES:

    The meeting will be held in Room 6044 of the General Services Administration's Headquarters Building, 1800 F Street NW., Washington, DC 20405. This site is accessible to individuals with disabilities.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula D. Lucak, GLMRC Designated Federal Officer (DFO), OHRM, General Services Administration, at telephone 202-969-7110, or email at [email protected]

    SUPPLEMENTARY INFORMATION: Background

    The GLMRC is a forum for managers and the exclusive representatives of the U.S. General Services Administration (GSA) employees, which are the two national labor unions. In this forum, managers and the Unions discuss Government operations to promote satisfactory labor relations and improve the productivity and effectiveness of GSA. The GLMRC serves as a complement to the existing collective bargaining process and allows managers and the Unions to collaborate in continuing to deliver the highest quality services to the public. The Council discusses workplace challenges and problems and recommends solutions that foster a more productive and cost-effective service to the taxpayer, through improving job satisfaction and employees' working conditions.

    Agenda

    The purpose of the meeting is for the GLMRC to discuss the Council's focus for the upcoming year and consider Agency initiatives. The topics to be discussed include Council metrics & GSA EVS results, GSA EEO program, and Council subcommittee updates.

    Meeting Access

    The meeting is open to the public. The meeting will be held in Room 6044 of the General Services Administration's Headquarters Building, 1800 F Street NW., Washington, DC 20405. This site is accessible to individuals with disabilities. In order to gain entry into the Federal building where the meeting is being held, public attendees who are Federal employees should bring their Federal employee identification cards, and members of the general public should bring their driver's license or other government-issued identification.

    Availability of Materials for the Meeting

    Please see the GLRMC Web site: http://www.gsa.gov/portal/content/225831 for any materials available in advance of the meeting and for meeting minutes that will be made available after the meeting. Detailed meeting minutes will be posted within 90 days of the meeting.

    Procedures for Providing Public Comments

    The public is invited to submit written comments for the meeting until 5:00 p.m. Eastern Time on the Monday prior to the meeting, by either of the following methods:

    Electronic or Paper Statements: Submit electronic statements to Ms. Paula Lucak, Designated Federal Officer, at [email protected]; or send paper statements in triplicate to Ms. Lucak at 1800 F Street NW., Suite 7003A, Washington, DC 20405. In general, public comments will be posted on the GLMRC Web site. All comments, including attachments and other supporting materials received, are part of the public record and subject to public disclosure.

    Any comments submitted in connection with the GLMRC meeting will be made available to the public under the provisions of the Federal Advisory Committee Act.

    Dated: December 30, 2015. Wade Hannum, Office of Human Resources Management, OHRM Director, Office of HR Strategy and Services, Center for Talent Engagement (COE4), General Services Administration.
    [FR Doc. 2015-33302 Filed 1-5-16; 8:45 am] BILLING CODE 6820-34-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 23, 2015. The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

    FOR FURTHER INFORMATION CONTACT:

    Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, [email protected], 301-796-7047, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of November 23, 2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee would be held on February 19, 2016. On page 72972, in the first column, the Agenda portion of the document is changed to read as follows:

    The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-33262 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4952] Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration's (FDA or Agency) Office of Minority Health (OMH), Office of Women's Health (OWH), the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) are announcing a public meeting seeking feedback and recommendations from patient groups, consumer groups, regulated industry, academia, and other interested parties on FDA's progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under the Food and Drug Administration Safety and Innovation Act (FDASIA).

    DATES:

    The public meeting will be held on February 29, 2016, from 9 a.m. to 4 p.m. The deadline for submitting comments regarding this meeting is April 29, 2016.

    ADDRESSES:

    The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (B & C), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2015-N-4952 for “FDASIA 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FDA will post the full agenda approximately 5 days before the meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.

    FOR FURTHER INFORMATION CONTACT:

    Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into law. Section 907 of FDASIA directed FDA to publish and provide to Congress a report “addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups, including sex, age, race, and ethnicity, is included in applications submitted to the Food and Drug Administration.” Section 907 of FDASIA also directed that 1 year after the publication of the report FDA publish and provide to Congress an action plan outlining “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, healthcare providers, and researchers” and to indicate the applicability of these recommendations to the types of medical products addressed in section 907. To fulfill these directives, an FDA-wide steering committee with representatives from CBER, CDER, CDRH, and the Office of the Commissioner (OC) conducted a detailed assessment of the 72 new drug, biologic, and medical device applications the Agency approved in 2011. In August 2013, FDA issued a report on the group's findings entitled “Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products.” In August 2014, FDA followed up with a report entitled “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” which contained 27 action items divided up into three overriding priorities: Data quality, subgroup participation, and data transparency.

    The purpose of the public meeting is to report on FDA's progress implementing the Action Plan, to discuss how stakeholders have been affected by these changes, and to solicit feedback and recommendations for further implementation from interested parties and stakeholders.

    Some questions we would like the public to comment on during the meeting include:

    1. What approaches have been successful in addressing key barriers to recruiting diverse clinical trial populations?

    2. What are your key limitations to conducting meaningful data analysis of underrepresented groups?

    3. What have you learned about best practices for recruiting a broad representation of subjects for clinical trials? Which practices have been successful and why? Which have not and why?

    4. What communication strategies have you successfully used that were also sensitive to the needs of underrepresented populations?

    5. What are potential methods FDA should consider using to effectively communicate meaningful information on demographic analyses to a diverse public?

    6. What are some of the actual or potential unintended consequences of data transparency you have encountered related to reporting demographic subgroup analysis?

    Stakeholders are invited to provide brief comments on these topics during the public comment portion of the meeting, but are not limited to discussing only the previous topics. Since the day-long meeting may not provide enough time to fully address all of these issues, we encourage interested groups to submit longer explanations and comments to the docket.

    II. Registration and Request for Oral Presentations

    FDA will try to accommodate all participant requests to speak; however, the duration of comments may be limited by time constraints. Those wishing to make oral presentations will be asked to send a brief summary of their comments and registration information (including name, title, firm name, address, telephone, email address, and fax number), and should register by February 1, 2016, by emailing [email protected]

    All other participants are asked to register online at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm by February 13, 2016, whether they plan to attend in person or listen to the meeting on a live Webcast. Registration is free and will be on a first-come, first-served basis. Onsite registration on the day of the meeting will be based on space availability. Information on how to access the Webcast will be posted approximately 5 days before the meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.

    If you need special accommodations due to a disability, please contact [email protected] at least 7 days in advance. Persons attending the public meeting are advised that FDA is not responsible for providing access to electrical outlets.

    Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-33261 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

    Name of Committee: Vaccines and Related Biological Products Advisory Committee.

    General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on March 4, 2016, from 8:30 a.m. to 3 p.m.

    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. For those unable to attend in person, the meeting will also be Web cast and will be available at the following link https://collaboration.fda.gov/vrbpac030416/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    Contact Person: Sujata Vijh or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240-402-7107 or 240-402-8158, email: [email protected] or [email protected] or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    Agenda: On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 19, 2016. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 10, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 11, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Sujata Vijh at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: December 31, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-33263 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; X01's BRAC Review.

    Date: January 14, 2016.

    Time: 1:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Joel A. Saydoff, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3205, MSC 9529, Bethesda, MD 20892-9529, 301-435-9223, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS)
    Dated: December 31, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-33256 Filed 1-5-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Development of Primer and Reference Tool to Assess Neonatal Abstinence Syndrome (1210).

    Date: January 15, 2016.

    Time: 11:00 a.m. to 2:30 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4238, MSC 9550, Bethesda, MD 20892-9550, 301-402-6626, [email protected]

    (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)
    Dated: December 31, 2015. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-33252 Filed 1-5-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Mental Health Special Emphasis Panel, Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders.

    Date: January 21, 2016.

    Time: 12:30 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Marcy Ellen Burstein, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6143, MSC 9606, Bethesda, MD 20892-9606, 301-443-9699, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel, Interventions.

    Date: January 28, 2016.

    Time: 2:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: David I. Sommers, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892-9606, 301-443-7861, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel, NAPLS Continuation.

    Date: January 29, 2016.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: David I. Sommers, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892-9606, 301-443-7861, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: December 31, 2015. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-33254 Filed 1-5-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Cell Biology Integrated Review Group; Development—2 Study Section.

    Date: February 1-2, 2016.

    Time: 8:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites DC Convention Center, 900 10th Street NW., Washington, DC 20001.

    Contact Person: Rass M. Shayiq, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435-2359, [email protected]

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neurobiology of Motivated Behavior Study Section.

    Date: February 4-5, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC 20037.

    Contact Person: Nicholas Gaiano, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5178, MSC 7844, Bethesda, MD 20892-7844, 301-435-1033, [email protected]

    Name of Community: Immunology Integrated Review Group; Cellular and Molecular Immunology—B Study Section.

    Date: February 4-5, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Betty Hayden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-1223, [email protected]

    Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Psychosocial Development, Risk and Prevention Study Section.

    Date: February 4-5, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC 20037.

    Contact Person: Anna L. Riley, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3114, MSC 7759, Bethesda, MD 20892, (301) 435-2889, [email protected]

    Name of Committee: Cell Biology Integrated Review Group; Membrane Biology and Protein Processing Study Section.

    Date: February 4-5, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Palomar, 2121 P Street NW., Washington, DC 20037.

    Contact Person: Janet M. Larkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5142, MSC 7840, Bethesda, MD 20892, 301-806-2765, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Musculoskeletal Tissue Engineering Study Section.

    Date: February 4-5, 2016.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Baljit S. Moonga, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7806, Bethesda, MD 20892, 301-435-1777, [email protected]

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Molecular Genetics B Study Section.

    Date: February 4-5, 2016.

    Time: 10:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Richard A. Currie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7840, Bethesda, MD 20892, (301) 435-1219, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: December 31, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-33255 Filed 1-5-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Mental Health.

    The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF MENTAL HEALTH, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors, National Institute of Mental Health.

    Date: February 3, 2016.

    Time: 8:45 a.m. to 5:45 p.m.

    Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

    Place: National Institutes of Health, Porter Neuroscience Research Center, GE620/630, Building 35A Convent Drive, Bethesda, MD 20892.

    Contact Person: Jennifer E. Mehren, Ph.D., Scientific Advisor, Division of Intramural Research Programs, National Institute of Mental Health, NIH, 35A Convent Drive, Room GE 412, Bethesda, MD 20892-3747, 301-496-3501, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: December 31, 2015. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-33253 Filed 1-5-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY:

    Substance Abuse and Mental Health Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809).

    A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines.

    If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.

    This notice is also available on the Internet at http://www.samhsa.gov/workplace.

    FOR FURTHER INFORMATION CONTACT:

    Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, Room 7-1051, One Choke Cherry Road, Rockville, Maryland 20857; 240-276-2600 (voice), 240-276-2610 (fax).

    SUPPLEMENTARY INFORMATION:

    The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.

    To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.

    Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.

    In accordance with the Mandatory Guidelines dated November 25, 2008 (73 FR 71858), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

    HHS-Certified Instrumented Initial Testing Facilities: Dynacare, 6628 50th Street NW., Edmonton, AB Canada T6B 2N7, 780-784-1190 (Formerly: Gamma-Dynacare Medical Laboratories) HHS-Certified Laboratories: ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585-429-2264 Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615-255-2400 (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc., Aegis Analytical Laboratories) Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-8989/800-433-3823 (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.) Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804-378-9130 (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.) Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock, AR 72209-7056, 501-202-2783 (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215-2802, 800-445-6917 DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-235-4890 Dynacare*, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-1630 (Formerly: Gamma-Dynacare Medical Laboratories) ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662-236-2609 Fortes Laboratories, Inc., 25749 SW Canyon Creek Road, Suite 600, Wilsonville, OR 97070, 503-486-1023 Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713-856-8288/800-800-2387 Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908-526-2400/800-437-4986 (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919-572-6900/800-833-3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group) Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866-827-8042/800-233-6339 (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center) LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913-888-3927/800-873-8845 (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.) MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651-636-7466/800-832-3244 MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232, 503-413-5295/800-950-5295 Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088, Testing for Veterans Affairs (VA) Employees Only National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661-322-4250/800-350-3515 One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888-747-3774 (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory) Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800-328-6942 (Formerly: Centinela Hospital Airport Toxicology Laboratory) Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509-755-8991/800-541-7891x7 Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-5840 Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800-729-6432 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories) Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610-631-4600/877-642-2216 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories) Quest Diagnostics Incorporated, 8401 Fallbrook Ave., West Hills, CA 91304, 818-737-6370 (Formerly: SmithKline Beecham Clinical Laboratories) Redwood Toxicology Laboratory, 3700650 Westwind Blvd., Santa Rosa, CA 95403, 800-255-2159 Southwest Laboratories, 4625 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040, 602-438-8507/800-279-0027 STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800-442-0438 US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for Department of Defense (DoD) Employees Only

    *The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.

    Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 30, 2010 (75 FR 22809). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program.

    Summer King, Statistician.
    [FR Doc. 2015-33222 Filed 1-5-16; 8:45 am] BILLING CODE 4160-20-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Substance Abuse and Mental Health Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276-1243.

    Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Proposed Project: Services Grant Program for Residential Treatment for Pregnant and Postpartum Women (PPW) Quarterly Progress Reports—NEW

    The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment, has developed a set of infrastructure development measures in which recipients of cooperative agreements will report on various benchmarks on a quarterly-annual basis. The infrastructure development measures are designed to collect information at the grantee-level and program-level.

    The draft infrastructure measures are based on the programmatic requirements conveyed in TI-14-005, Services Grant Program for Residential Treatment for Pregnant and Postpartum Women.

    The purpose of this program is to provide funding to improve treatment for low-income (according to federal poverty guidelines) women, age 18 and over, who are pregnant, postpartum (the period after childbirth up to 12 months), and their minor children, age 17 and under, who have limited access to quality health services.

    The pregnant and postpartum women program will implement parenting and treatment evidence-based practice models and a feedback loop developed to enable the grantee and the programs to identify barriers and test solutions through direct services. The expected outcomes of these grants will include decreases in the use and/or abuse of prescription drugs, alcohol, tobacco, illicit and other harmful drugs (e.g., inhalants) among pregnant and postpartum women; increases in safe and healthy pregnancies; improved birth outcomes; reduced perinatal and environmentally-related effects of maternal and/or paternal drug abuse on infants and children; improved mental and physical health of women and children; prevention of mental, emotional, and behavioral disorders among the children; improved parenting skills, family functioning, economic stability, and quality of life; decreased involvement in and exposure to crime, violence, and neglect; and decreased physical, emotional, and sexual abuse for all family members. Women, their adolescents/children (up to age 17), fathers, and other family members who are provided services through grant funds will inform the process to improve systems issues.

    Annual Data Collection Burden Data Collection Burden Instrument/activity Number of
  • respondents
  • Responses per
  • respondent
  • Total
  • responses
  • Hours per
  • response
  • Total hour
  • burden
  • Progress Report 25 4 100 8 800

    Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a copy at [email protected]. Written comments should be received by March 7, 2016.

    Summer King, Statistician.
    [FR Doc. 2015-33221 Filed 1-5-16; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning Certain Multifunction Printer Products AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Notice of final determination.

    SUMMARY:

    This document provides notice that U.S. Customs and Border Protection (“CBP”) has issued a final determination concerning the country of origin of certain multifunction printer products known as bizhub C3850FS multifunction digital printers (“bizhub MFP”). Based upon the facts presented, CBP has concluded that the country of origin of the bizhub MFP is Japan for purposes of U.S. Government procurement.

    DATES:

    The final determination was issued on December 23, 2015. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within February 5, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Antonio J. Rivera, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-0226.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that on December 23, 2015, pursuant to subpart B of part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin certain multifunction printer products known as bizhub C3850FS multifunction digital printers, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ 263561, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that the processing in Japan resulted in a substantial transformation. Therefore, the country of origin of the bizhub MFP is Japan for purposes of U.S. Government procurement.

    Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register.

    Dated: December 23, 2015. Myles B. Harmon, Acting Executive Director, Regulations and Rulings, Office of International Trade. Attachment HQ H263561 December 23, 2015 OT:RR:CTF:VS H263561 AJR CATEGORY: Origin Daniel E. Waltz, Esq., Squire Patton Boggs (US) LLP, 2550 M Street, NW., Washington, DC 20037 RE: U.S. Government Procurement; Country of Origin of Multifunction Printers; Substantial Transformation

    Dear Mr. Waltz: This is in response to your letter, dated March 23, 2015, requesting a final determination on behalf of Konica Minolta (“K/M”), pursuant to subpart B of part 177 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR part 177). Under these regulations, which implement Title III of the Trade Agreements Act of 1979 (“TAA”), as amended (19 U.S.C. 2511 et seq.), CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government.

    This final determination concerns the country of origin of K/M's bizhub C3850FS multifunction digital printers (“bizhub MFP(s)”). We note that K/M is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination.

    FACTS:

    K/M plans to sell its bizhub MFPs to the U.S. government. The bizhub MFPs are multifunction color machines that perform printing, copying, scanning, and faxing functions. According to K/M's counsel, the bizhub MFP was designed and developed in Japan, and its most important and complex components will be manufactured in Japan. The assembly process for the bizhub MFPs will start in Thailand and finish in Japan, assembling a total of 11 subassemblies into the final bizhub MFP product.

    Assembly Processes in Thailand:

    In Thailand, the following four subassemblies (collectively, “Subassemblies 1-4”) will be assembled into their final form within the bizhub MFP's frame:

    1. The Print Head will be produced in Thailand from five sub-components:

    • a G1 lens manufactured in Japan;

    • a G2 lens manufactured in Japan;

    • a polygonal motor manufactured in China;

    • a housing case manufactured in China; and,

    • a laser diode manufactured in Taiwan.

    According to K/M's counsel, while the quantity at which the G1 and G2 lenses are produced lowers their relative cost, the lenses are more complex than the other sub-components of the Print Head as noted by the higher skill and technology levels needed to produce them. The Print Head operates by reflecting a laser beam off of the lenses and onto the rotating polygonal mirrors in order to produce a copied image in the Latent Image Unit's photoconductor (“OPC”). The Print Head will be assembled into, and permanently integrated within, each bizhub MFP in Thailand.

    2. The Optical Lens will be manufactured in China from Chinese-origin materials. It operates by accurately collecting the light reflected from external documents onto its lens. It will be assembled into, and permanently integrated within, each bizhub MFP in Thailand.

    3. The Charge Coupled Device (“CCD”) Board will be manufactured in China. It separates the colors collected by the Optical Lens, and converts them into independent colors. It will be assembled into, and permanently integrated within, each bizhub MFP in Thailand.

    4. The Mechanical Control Board will be manufactured in Thailand. It controls the bizhub MFP's input and output process through an engine that feeds the paper. It will be assembled into, and permanently integrated within, each bizhub MFP in Thailand.

    Additionally, six subassemblies (collectively, “tested subassemblies”) will be assembled into the bizhub MFP for testing purposes, but then removed after testing, as follows:

    5. The Latent Image Unit will be produced in Thailand from three sub-components:

    • OPC drums manufactured in Japan;

    • a developer, with toner and carrier developing materials, manufactured in Japan; and,

    • an electrostatic charging roller manufactured in Japan.

    The OPC drums receive the laser beam. Then, the developing materials and electrostatic charging roller sense the image being transmitted by the laser, regulate its thickness and precision, and transfer it to the Image Transfer Belt. The Latent Image Unit will be installed within a bizhub MFP for testing purposes, and then removed, while in Thailand.

    6. The Image Transfer Belt Unit will be manufactured in China from three sub-components:

    • an image transfer belt manufactured in China;

    • a 1st image transfer roller manufactured in China; and,

    • a cleaning blade manufactured in China.

    It receives the single-color image from the Latent Image Unit and creates a multi-color image to transfer onto paper. The Image Transfer Belt Unit will be shipped to Thailand, where it will be installed within a bizhub MFP for testing purposes, and then removed.

    7. The 2nd Image Transfer Roller Unit will be manufactured in China. It supports the Image Transfer Belt Unit. The 2nd Image Transfer Roller Unit will be shipped to Thailand, where it will be installed within a bizhub MFP for testing purposes, and then removed.

    8. The Fusing Unit will be produced in Thailand from three sub-components:

    • a fusing belt manufactured in Japan;

    • a fusing roller manufactured in China; and,

    • a pressure sub-component manufactured in China.

    According to K/M's counsel, the fusing belt accounts for a significant percentage of the Fusing Unit's cost and is a key sub-component. The Fusing Unit will be installed within a bizhub MFP for testing purposes, and then removed, while in Thailand.

    9. The Hard Disk Drive (“HDD”) will be manufactured in China or Thailand. It will be installed within a bizhub MFP for testing purposes, and then removed, while in Thailand.

    10. The Power Supply Unit will be manufactured in China. It will be shipped to Thailand, where it will be installed within a bizhub MFP for testing purposes, and then removed.

    Assembly Process in Japan:

    Once the tested subassemblies are removed, the bizhub MFPs as assembled with Subassemblies 1-4 will be shipped to Japan without the tested subassemblies. Instead of shipping the tested subassemblies, six separate but identical subassemblies (collectively, “Subassemblies 5-10,” as described above) will be shipped to Japan for final assembly. In Japan, these integrated and unintegrated subassemblies will be assembled to completion with the following subassembly:

    11. The MFP Board will be manufactured from Japanese materials, and installed with Japanese-developed software, in Japan. According to K/M”s counsel, it constitutes the machine's “brain”, integrating the printer and copier functions, and converting electric signals to digital signals, which are sent to the Print Head to create the image. It will be assembled into, and permanently integrated within, each bizhub MFP in Japan.

    The finished bizhub MFP will be tested, adjusted, and calibrated in Japan before shipment to the U.S. The testing conducted in Japan includes electronically adjusting the laser position and intensity of the laser diode's beam in the Print Head, and electronically and physically adjusting the Latent Image Unit to calibrate the unit's position and imaging accuracy. According to K/M's counsel, the testing conducted in Japan requires skilled workmanship, involving more complex and precise tests than the initial testing and adjustments conducted in Thailand.

    ISSUE:

    What is the country of origin of the bizhub MFP for purposes of U.S. Government procurement?

    LAW AND ANALYSIS:

    Pursuant to Subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511 et seq.), CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government.

    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):

    An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.

    See also 19 CFR 177.22(a).

    To determine whether the combining of parts or materials constitutes a substantial transformation, the determinative issue is the extent of operations performed and whether the parts lose their identity and become an integral part of the new article. Belcrest Linens v. United States, 573 F. Supp. 1149 (Ct. Int'l Trade 1983), aff'd, 741 F.2d 1368 (Fed. Cir. 1984). Assembly operations that are minimal or simple, as opposed to complex or meaningful, will generally not result in a substantial transformation. See C.S.D. 80-111, C.S.D. 85-25, C.S.D. 89-110, C.S.D. 89-118, C.S.D. 90-51, and C.S.D. 90-97. CBP will make these decisions on a case-by-case basis, considering the totality of the circumstances. The country of origin of the article's components, the extent of the processing that occurs within a given country, and whether such processing renders a product with a new name, character, and use are primary considerations in such cases. Additionally, facts such as resources expended on product design and development, extent and nature of post-assembly inspection procedures, and worker skill required during the actual manufacturing process will be considered when analyzing whether a substantial transformation has occurred; however, no one such factor is determinative.

    In various cases concerning similar merchandise, CBP has held that complex and meaningful assembly operations involving a large number of components will generally result in a substantial transformation. In Headquarters Ruling Letter (“HQ”) 562936, dated March 17, 2004, CBP addressed the country of origin of certain MFPs assembled in Japan of various Japanese- and Chinese-origin parts. CBP determined that the MFP was a product of Japan based on the fact that a “substantial portion of the printer's individual components and subassemblies [were] of Japanese origin.” Furthermore, CBP noted that some of the Japanese components and subassemblies were essential parts of the finished article, and other Japanese parts, including the reader scanner unit and the control panel unit, were critical to the production of the printer. Finally, CBP noted that the Japanese processing operations were complex and meaningful, that required “the assembly of a large number of components, and render[ed] a new and distinct article of commerce that possesse[d] a new name, character, and use.”

    In HQ H025106, dated June 11, 2008, CBP addressed the country of origin of certain photocopying machines, which had photocopying, printing, faxing, and scanning functions. The machines were comprised of a scanning unit, controller unit subassembly, laser scanning unit, photoconductor unit, developer unit, transfer unit, and fusing unit. Three of these components were assembled into the machine's frame in China, and the rest were assembled into the frame in Japan, where the machines were completed. CBP noted that though the developer unit and transfer unit were assembled in China, enough of the subassemblies and individual components (e.g. the transfer belt and photoconductor unit, among others) were from Japan, with the photoconductor being made of entirely Japanese parts. It also noted that though the developer unit would be assembled in China, two of the unit's key components were from Japan; and while the transfer unit would be partially assembled in China, the transfer belt was from Japan. CBP also noted that there were a large variety of adjustments that were made to the subassemblies in Japan, using advanced equipment and firmware. As a result, CBP held that the country of origin of the machines was Japan because the Japanese and foreign origin parts were substantially transformed into the machines through the product assembly that took place in Japan. See also HQ H020516, dated November 7, 2008 (holding that the country of origin of certain MFPs was Japan, using the same reasoning as HQ 562936 and HQ H025106, and also noting that the MFPs were designed and developed in Japan).

    Based on the facts presented, we note that though the assembly of the bizhub MFP will take place in Japan and Thailand, there are also operations that contribute to this assembly which will take place in China. In situations like these, no one country imparts the dominant portion of the work conducted. Nonetheless, based upon the applicable legal standard, we determine that, the frame and subassemblies of the bizhub MFP that will be imported into Japan will be substantially transformed in Japan such that Japan will be the country of origin for purposes of U.S. Government procurement. In making this determination, we note that only four of the bizhub MFP's subassemblies (i.e. Subassemblies 1-4) will be assembled into the bizhub MFP's frame in Thailand, while the remaining seven subassemblies (i.e. Subassemblies 5-10, plus the MFP Board) will be assembled into, and permanently integrated within, the bizhub MFP in Japan. Further, we note that the MFP Board (the “brain” of the bizhub MFP) will be manufactured from all Japanese parts, will be integrated into the bizhub MFP in Japan, and accounts for a significant percentage of total subassemblies cost. Although many of the individual subassemblies will be assembled outside of Japan, we note sufficient use of Japanese sub-components in producing these subassemblies, such as the fusing belt that will be used to make the Fusing Unit, and the OPC drums, developer, and electrostatic roller that will be used to make the Latent Image Unit. As a result, the Japanese subassemblies and sub-components collectively attribute a significant percentage of the total subassemblies cost. Moreover, though we note the importance of the subassemblies and sub-components from Thailand and China, these subassemblies and sub-components will be integrated into a product that was designed and developed in Japan, and will be operated by Japanese-developed software that will also be installed onto the bizhub MFP in Japan. See HQ H198875, dated June 5, 2012 (noting that a foreign HDD that was integrated into an MFP in Singapore and installed with Japanese software in Singapore contributed to the reason that the HDD was substantially transformed into the MFP in Singapore). In this case, K/M incurred significant resources in Japan by developing and designing the MFP product, and its proprietary software, in Japan. Finally, the assembly operations that occur in Japan will be sufficiently complex and meaningful. Through the product assembly, as well as the testing and adjustment operations, the individual subassemblies and sub-components of Japanese and foreign-origin will be subsumed into a new and distinct article of commerce that has a new name, character, and use. Therefore, under the totality of the circumstances, we find that the country of origin of the bizhub MFP will be Japan for purposes of U.S. Government procurement.

    HOLDING:

    Based on the facts provided, the country where the last substantial transformation will take places is Japan. As such, the bizhub MFPs will be considered products of Japan for purposes of U.S. Government procurement.

    Notice of this final determination will be given in the Federal Register, as required by 19 CFR 177.29. Any party-at-interest other than the party which requested this final determination may request, pursuant to 19 CFR 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 CFR 177.30, any party-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade.

    Sincerely, Myles B. Harmon, Acting Executive Director Regulations and Rulings Office of International Trade
    [FR Doc. 2015-33245 Filed 1-5-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Revocation of Customs Brokers' Licenses AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Revocation of customs brokers' licenses.

    SUMMARY:

    This document provides notice of the revocation of customs brokers' licenses by operation of law.

    FOR FURTHER INFORMATION CONTACT:

    Julia D. Peterson, Branch Chief, Broker Management, Office of International Trade, (202) 863-6601, [email protected]

    SUPPLEMENTARY INFORMATION:

    This document provides notice that, pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and section 111.30(d) of title 19 of the Code of Federal Regulations (19 CFR 111.30(d)), the following customs brokers' licenses were revoked by operation of law, without prejudice, for failure to file a triennial status report. A list of revoked customs brokers' licenses appears, below, in alphabetical order by name, and the names are grouped according to the ports of issuance.

    Last/Company name First name License Port of issuance Harris Lisa 17048 Anchorage. Sherman Cynthia 12763 Anchorage. Canty Jeremain 21800 Atlanta. Crist Diane 23021 Atlanta. Davis Lisa 20146 Atlanta. Dean Sandra 23851 Atlanta. Duru Chioma 28256 Atlanta. Godfrey Kimberly 12089 Atlanta. Hodgkins Kristen 23043 Atlanta. Johnson Stephen 16226 Atlanta. Kelly Merrill Elizabeth 24351 Atlanta. Leverett Wesley 27943 Atlanta. Nicholson Caroline 24052 Atlanta. Spencer Schulz Elizabeth M 09658 Atlanta. Wahl Mark 28257 Atlanta. Wang Yueh 28079 Atlanta. Willeby Natalie Renee 15042 Atlanta. Williams Aria 29979 Atlanta. Williamson Heather 16752 Atlanta. Bratt Thomas 04409 Baltimore. Brennan Frank 10364 Baltimore. Campion Samueleis Jennifer 22259 Baltimore. Connolly Henry 09745 Baltimore. Dash Joseph 03433 Baltimore. DiCarlo Susan 11689 Baltimore. Duckett Dina 13012 Baltimore. Gilmer Jimmie 10299 Baltimore. H.C. Bennett Company 14423 Baltimore. Ian International, Inc 11886 Baltimore. Kraus International Shipping Co 22112 Baltimore. Leslie Robert 05236 Baltimore. Morgan James 12466 Baltimore. Stitt Marsha 09739 Baltimore. Blaisdell Philip G 20063 Boston. Ciampa Rosemary 16662 Boston. Doucette Lawrence B 09020 Boston. Gamblin Glenn George 12091 Boston. Gomez Roger 04073 Boston. Hellenbeck Margaret M 16661 Boston. Hooks John H 06162 Boston. Houston Paul 06400 Boston. Import Export Compliance, Inc 28217 Boston. LaRoque Paul Kevin 03189 Boston. Lasko Dennis M 17501 Boston. MacKenzie Kathleen Irene 16553 Boston. Murphy Barry 10543 Boston. Nickole Kellie Rose 10451 Boston. Powell Paul Atkin 03687 Boston. Votze Janet C 11236 Boston. Walsh Pamela 16919 Boston. World Express Inc. 09651 Boston. Barrette Robert 24206 Buffalo. Behr Donald 09125 Buffalo. Bondi Victor 04929 Buffalo. Brocato Joyce 09093 Buffalo. Burke Michele 16850 Buffalo. Cain Timothy 21447 Buffalo. Deane (Bishop) Jennifer 23291 Buffalo. Ferrell Martha 14676 Buffalo. Fremont, Lancaster, LLC 28977 Buffalo. Fyke Logistics (USA), Inc 28352 Buffalo. Giumentaro Joseph 16516 Buffalo. Great Lakes Customs Brokerage, Inc 14150 Buffalo. Hemstock Kathleen 17193 Buffalo. Hormell Deborah 14768 Buffalo. King Deborah 13218 Buffalo. Levitt Glenn 09337 Buffalo. MacGillivray Karen 20554 Buffalo. Mccaw Rita 09154 Buffalo. McLeod Joan 09048 Buffalo. Osborne Andrew 28962 Buffalo. Perrelli John 15585 Buffalo. Roulley Douglas 09324 Buffalo. Stroupe Charles 09685 Buffalo. Szewczyk Pearl 20851 Buffalo. Wald Franklin 06653 Buffalo. Westmoreland Patricia 21083 Buffalo. Brunell Gary 06822 Champlain. Burl Wayne R 04338 Champlain. Casey William 02863 Champlain. Columbe Gloria 07639 Champlain. Deloria Dawn 20859 Champlain. Perkins Mary C 15335 Champlain. Saunders Ralph 05392 Champlain. Willette Randall 06796 Champlain. Blitch Keri 15292 Charleston. Enfinger Katrina 11677 Charleston. Fain Angelic 15295 Charleston. Fitzpatrick Amy 12760 Charleston. Inman Jessica 21030 Charleston. Sadler-Magliacane Debbie 11477 Charleston. Thompson Theresa 14147 Charleston. Walters Willis 11393 Charleston. West Glennis 14474 Charleston. Barlas Georgia 17055 Charlotte. Flock Deborah 13907 Charlotte. Nelson John R. 21288 Charlotte. Stults Pamela N 15175 Charlotte. Stutts, III Kenneth 29379 Charlotte. Arthur Essie N 14007 Chicago. Benson Allison V 11591 Chicago. Blaha Jane E 15460 Chicago. Cahill Raymond 16066 Chicago. Chew Ken H 16052 Chicago. Cieslak Dennis D 28858 Chicago. Denehy Robert K 14909 Chicago. Dompke Leroy J 05562 Chicago. Fluger Carol A 11256 Chicago. Frye Jeffrey 11879 Chicago. Garcia Joe T 05420 Chicago. Gosling Sandra M 23429 Chicago. Heinke Lynn M 14621 Chicago. Henneghan-Bernet Annare 15505 Chicago. Koelling Bruce G 10825 Chicago. Lentz Arthur F 07708 Chicago. Leviton Fred G 16431 Chicago. McGrath James P 05968 Chicago. Neary James A 17172 Chicago. Silberman Gail E 15263 Chicago. Stradley Janis L 14317 Chicago. Bennett Diana Kay 16580 Cleveland. Freese Thomas 28740 Cleveland. Groh Peter 09797 Cleveland. Hagarman Connie 09880 Cleveland. Haury Joshua 23797 Cleveland. Hoppes Laura 13877 Cleveland. International Compliance Experts, LLC 27461 Cleveland. McKeever Kenneth Duane 27503 Cleveland. Milklosovic Bradley John 30029 Cleveland. Neal Todd 20176 Cleveland. Ortiz Henry 10402 Cleveland. Peters Kathy 13372 Cleveland. Radomirov Bridgette 23682 Cleveland. Segovia Amanda 23583 Cleveland. Sireci Joan 15649 Cleveland. Sorenson Robert 13514 Cleveland. Chester Jimmy 20567 Dallas. Ellershaw Sharon 10305 Dallas. Lauritzen Michael 17115 Dallas. McElvany Douglas Keith 10046 Dallas. Reed Douglas 21284 Dallas. Renner Carl 21342 Dallas. Speegle Joseph M 13038 Dallas. Trojacek Connie Dolores 22501 Dallas. Acosta Juan J 15089 El Paso. Delgado Jeanette Victoria 15614 El Paso. Dotson Lorna Yvonne 15777 El Paso. Guzman Gerardo 21814 El Paso. Ogaz Juan Antonio 14799 El Paso. Ralin Peter Leonard 07137 El Paso. Suarez Arturo 12152 El Paso. Bell Cynthia 11339 Great Falls. Brett Howard 17097 Great Falls. Calhoun Stephen 17444 Great Falls. Chester Shans 12276 Great Falls. Crellin Stephanie 12550 Great Falls. Palmer Michael 04901 Great Falls. Parker Irina 23180 Great Falls. Rasmussen Jeannine 12009 Great Falls. Rode Marie 12790 Great Falls. Rotter Kurt 16766 Great Falls. Smedley Marsha 15986 Great Falls. Wasden Benjamin 22206 Great Falls. Aucoin Samuel 22019 Honolulu. Fujimori Bert 04766 Honolulu. BuitronEl Ricardo A 14409 Houston. Carranza Elvia Irene 24300 Houston. Edward Berlin E 07817 Houston. Gastler Jacklyn 11013 Houston. K2 Customs Brokers, LLC 30009 Houston. Leidy Susan L 14713 Houston. Marinis Steven J 05577 Houston. McClellan Lavone W 07787 Houston. Nygard Karen Elaine 07524 Houston. Pohutsky Lori J 09580 Houston. Stewart Harold Wade 04313 Houston. Thompson, Jr. Eugene E 10979 Houston. Travis Cynthia B 11562 Houston. Warner Robert Bruce 05531 Houston. Carrasco Gonzalo 16478 Laredo. Del Rio Rafael Beltran 28908 Laredo. Gonzalo Carrasco C.H.B., Inc 20897 Laredo. International Express Brokers, Inc 21640 Laredo. Munoz Esteban 05243 Laredo. Pohler Randy 14458 Laredo. Ronald E. Guerra, Inc 05526 Laredo. Sumner Gregory Joe 13935 Laredo. Abramovic Felice 17443 Los Angeles. Abella Joel 22608 Los Angeles. Adams Lorraine 07380 Los Angeles. Allen Thomas 10660 Los Angeles. Beteta Martin E. Berrera 16102 Los Angeles. Brownfield Jon 05981 Los Angeles. Burns Karen M 11353 Los Angeles. Byler Timothy 13929 Los Angeles. Carandang-Webster Mila 07016 Los Angeles. Cawiezel Sharon 07151 Los Angeles. Chang Goang Yih 13617 Los Angeles. Choi David 24195 Los Angeles. Chung Jin 29679 Los Angeles. Cook Calvin M 06979 Los Angeles. Crow Maria 21383 Los Angeles. Danache Charles 04183 Los Angeles. Dependable Global Express, Inc 23369 Los Angeles. Dew Michael 15068 Los Angeles. Ficklin Terrence 27409 Los Angeles. Fischer Lewis Leland 14505 Los Angeles. Hagedorn Linda M. 05523 Los Angeles. Hampton Madrienne 22905 Los Angeles. Han Qi 27433 Los Angeles. Heck Dennis 01042 Los Angeles. Henry Hiram 12779 Los Angeles. Hofer Marion 14056 Los Angeles. Hu Edith 13202 Los Angeles. Huynh Phuong 09389 Los Angeles. Imbrogulio John 14144 Los Angeles. Krieger Ian H 07232 Los Angeles. Law Kyran 22480 Los Angeles. Lee Jeffrey 23311 Los Angeles. Lee Linda 11143 Los Angeles. Lee Soo 07095 Los Angeles. Li Christopher 11323 Los Angeles. Li Valerie 11709 Los Angeles. Liang Philip 13628 Los Angeles. Loza Sally 05963 Los Angeles. McGaughey Deborah 10924 Los Angeles. Michaels Douglas 14482 Los Angeles. Milne Mark 05671 Los Angeles. Min Robert 11948 Los Angeles. Montgomery Randall 09926 Los Angeles. Monto Joseph 04792 Los Angeles. Neal Scott 22424 Los Angeles. Nee Howard 28518 Los Angeles. Pirgyi Diana 22906 Los Angeles. Plumtree Angelina 21491 Los Angeles. Rae Alan 04239 Los Angeles. Reep Denise 20645 Los Angeles. Schafer Customs Brokerage, Inc 27648 Los Angeles. Shay Shane 15196 Los Angeles. Sieren-Smith Bridget 23312 Los Angeles. Snitwongse Chanpen 06669 Los Angeles. Song Deok 24184 Los Angeles. Taslitt Victory 16023 Los Angeles. Tirsch Wendy 22056 Los Angeles. Tomlin Robert 13995 Los Angeles. VAB Services, Inc 28853 Los Angeles. Valente Giovanni 21221 Los Angeles. Walden Michael 16717 Los Angeles. Walters Michele 14044 Los Angeles. Wismann Enrique M 06707 Los Angeles. Yetter Jesse 29429 Los Angeles. Ziegler Natalie 13179 Los Angeles. Ziskrout Philip 04171 Los Angeles. Crowley Logistics, Inc 27721 Miami. Espinet Gilbert 16810 Miami. Garcia Jan 27681 Miami. Gelbert Norman E 09505 Miami. Lopez Eva M 22551 Miami. Mearsheimer Mark 14217 Miami. Roque Cynthia 28543 Miami. Saltalamacchia Felix 15967 Miami. Stair Peter J 22720 Miami. Turner David L 14884 Miami. Vinals Mercedes 22150 Miami. Woolf Eric F 16242 Miami. Blachowski Mark 13694 Milwaukee. Chou Hung-Liang 11936 Milwaukee. Johnston Donna 21327 Milwaukee. Konruff Dustin 29975 Milwaukee. Morris Freddie 06858 Milwaukee. Pinter Mark 12587 Milwaukee. Rutland Robert 12223 Milwaukee. Schwalbe Vincent 28705 Milwaukee. Becnel David Martin 17553 New Orleans. Bourque Michael 29150 New Orleans. Dunbar John Scott 21770 New Orleans. Krupp David 16970 New Orleans. Noto-Diaz Donna 17408 New Orleans. Wegener Paul F 03476 New Orleans. Aguirre Ricardo 09544 New York. Alpi USA, Inc 15052 New York. Bayer Charles 23910 New York. Bernstein Steven 03765 New York. Brandvold Kirstin 13480 New York. Braun Linda 23184 New York. C.W. Logistics Corp 23699 New York. Castilla Judith 06912 New York. Castro Salvatore 12659 New York. Chakedis James 05191 New York. Chen Zhen 28625 New York. Chiaramonte Charles 11868 New York. Chiu Christina 21475 New York. Cruz Fidel 14678 New York. Cunningham Nancy 05895 New York. David Vincent Associates, Inc 15541 New York. Deresh Steven 07097 New York. Dobson Marla 10038 New York. Dockery Maureen 10887 New York. Encarnacion Aurelio 05720 New York. Espinal Yanilcia 23319 New York. Evans William 05325 New York. Fanok Jeffrey 10611 New York. Firpo Laura 10015 New York. Galvin John 09320 New York. Gavin Sambrook Terry 10581 New York. Geary Chad 22487 New York. Guengue Nancy 20576 New York. Gyomory Barbara 10016 New York. Hagedorn William 07305 New York. Highgrace International Corp 13612 New York. Hodges Mary 08069 New York. Horsky Tereza 22971 New York. Imperiale Lisa Ann 20313 New York. Jackson Tracey 22297 New York. Joh Justin 28317 New York. La Russo Patrick 04548 New York. Lee Diana 27777 New York. Lee John 13727 New York. Li Venching 28398 New York. Liebgott Charles 05771 New York. Luzzo Robert 20084 New York. McCooey Patrick 10420 New York. Myers James 03848 New York. Palazzolo Florence 06934 New York. Poli Gregory 10980 New York. Rodriguez Dominic 10705 New York. Rose Alan 05736 New York. Saunders Fred 11471 New York. Scibelli Gennaro 02583 New York. Seltzer Irwin 13301 New York. Semins John 07830 New York.