Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2015-08-18.xml --- 80 159 Tuesday, August 18, 2015 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50000-50008 2015-20358 2015-20359 Agricultural Marketing Agricultural Marketing Service PROPOSED RULES Farmer's Market Promotion Program; Withdrawal, 49930 2015-20384 Walnuts Grown in California: Increased Assessment Rate, 49930-49933 2015-20395 Agriculture Agriculture Department See Agricultural Marketing Service See Rural Housing Service Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare and Medicaid Programs:

CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements; Correction, 49973-49974 2015-20336 Coast Guard Coast Guard RULES Safety Zones: Eighth Coast Guard District Annual and Recurring Events, 49911-49913 2015-20250 Special Local Regulations: Tennessee River 647.0 to 648.0; Knoxville, TN, 49909-49911 2015-20406 PROPOSED RULES Special Local Regulations: Tennessee River 463.0 to 467.0; Chattanooga, TN, 49968-49970 2015-20403 NOTICES Meetings:

Commercial Fishing Safety Advisory Committee, 50017-50018 2015-20378 Nationwide Differential Global Positioning System, 50018-50020 2015-20401 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration Consumer Product Consumer Product Safety Commission NOTICES Settlement Agreements and Orders: Johnson Health Tech Co. Ltd. and Johnson Health Tech North America, Inc., 49991-49994 2015-20332 Defense Department Defense Department See Engineers Corps See Navy Department NOTICES Charter Renewals:

Department of Defense Federal Advisory Committees, 49996-49997 2015-20293 Meetings: National Commission on the Future of the Army, 49994-49995 2015-20362 Drug Drug Enforcement Administration NOTICES Decisions and Orders: Arthur H. Bell, D.O., 50035-50041 2015-20353 Decisions And Orders: Devra Hamilton, N.P., 50034-50035 2015-20348 Decisions and Orders: Jeffrey S. Holverson, M.D., 50033-50034 2015-20346 John R. Kregenow, D.D.S, 50029-50031 2015-20352 Matthew Valentine/Liar Catchers, 50042-50043 2015-20344 Nicholas Nardacci, M.D., 50032-50033 2015-20350 Ronald A.

Green, M.D., 50031-50032 2015-20349 Victor B. Williams, M.D., 50029 2015-20351 Importers of Controlled Substances; Applications: Cody Laboratories, Inc., Cody, WY, 50032 2015-20278 Manufacturers of Controlled Substances; Applications: Alltech Associates, Inc., Deerfield, IL, 50041-50042 2015-20283 Austin Pharma LLC, Round Rock, TX, 50043 2015-20284 IRIX Manufacturing, Inc., Greenville, SC, 50035 2015-20285 Energy Department Energy Department PROPOSED RULES Energy Efficiency Program for Consumer Products:

Energy Conservation Standards for Fluorescent Lamp Ballasts, 49933-49934 2015-20381 NOTICES Charter Renewals: High Energy Physics Advisory Panel, 49997 2015-20354 Engineers Engineers Corps NOTICES Nationwide Differential Global Positioning System, 50018-50020 2015-20401 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Missouri, Controlling Emissions During Episodes of High Air Pollution Potential, 49913-49916 2015-20249 PROPOSED RULES Air Quality State Implementation Plans;

Approvals and Promulgations: Clean Air Act Redesignation Substitute for the Houston-Galveston-Brazoria 1-hour Ozone Nonattainment Area; Texas, 49970-49973 2015-20024 NOTICES Work Plan Chemical Problem Formulation and Initial Assessment and Data Needs Assessment Documents for Flame Retardant Clusters, 49997-49999 2015-20370 Federal Aviation Federal Aviation Administration RULES Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Flight Envelope Protection, High-Speed Limiting, 49892-49893 2015-20299 Gulfstream Aerospace Corporation Model GVII-G500 Airplanes;

Electronic Flight Control System: Control Surface Position Awareness, 49893-49895 2015-20296 PROPOSED RULES Special Conditions: Cessna Airplane Company Model 680A Airplane, Side-Facing Seats Equipped with Airbag Systems, 49938-49945 2015-20300 Gulfstream Model GVII-G500 Airplanes, Automatic Speed Protection for Design Dive Speed, 49936-49938 2015-20297 Gulfstream Model GVII-G500 Airplanes, Side-Stick Controllers; Controllability and Maneuverability, 49934-49936 2015-20298 NOTICES Petitions for Exemptions;

Summaries: Ameriflight, 50068 2015-20253 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 49999-50000 2015-20275 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 50000 2015-20321 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Control and Management of Resident Canada Geese, 50021-50023 2015-20335 Wolf-Livestock Demonstration Project Grant Program, 50024-50025 2015-20334 Environmental Impact Statements;

Availability, etc.: Silvio O. Conte National Fish and Wildlife Refuge Draft Comprehensive Conservation Plan, 50023-50024 2015-20184 Food and Drug Food and Drug Administration RULES Medical Devices: Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device, 49895-49897 2015-20317 NOTICES Guidance: Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2, 50014-50015 2015-20316 Providing Submissions in Electronic Format:

Postmarketing Safety Reports for Vaccines, 50013-50014 2015-20312 Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, 50008-50009 2015-20308 Uncomplicated Gonorrhea: Developing Drugs for Treatment, 50009-50010 2015-20306 Requests for Nominations: Pilot Program for Medical Device Reporting on Malfunctions, 50010-50013 2015-20309 Foreign Trade Foreign-Trade Zones Board NOTICES Approvals of Subzone Status:

Toyota Motor Manufacturing Alabama, Inc., Huntsville, AL, 49985 2015-20386 Production Activities: Toyota Motor Manufacturing Alabama, Inc.; Foreign-Trade Zone 83, Huntsville, AL, 49986 2015-20389 Production Authority Applications: Coleman Co., Inc., Subzone 119I, Sauk Rapids, MN, 49986 2015-20385 Subzone Applications: Swisscosmet Corp., Foreign-Trade Zone 79, Tampa, FL, 49985-49986 2015-20388 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 50015-50016 2015-20357 Homeland Homeland Security Department See Coast Guard See U.S. Customs and Border Protection Indian Affairs Indian Affairs Bureau PROPOSED RULES Grants to Tribally Controlled Colleges and Universities and Dine College, 49946-49955 2015-20242 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See National Park Service International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Woven Electric Blankets from the People's Republic of China; Final Results of Sunset Review, 49987 2015-20393 Multilayered Wood Flooring from the People's Republic of China, 49986-49987 2015-20390 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Hot-Rolled Steel Flat Products from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom, 50028-50029 2015-20266 Prestressed Concrete Steel Wire Strand from China;

Scheduling of Expedited Five-Year Review, 50026-50027 2015-20301 Investigations; Determinations, Modifications, and Rulings, etc.: Ironing Tables from China, 50027-50028 2015-20318 Meetings; Sunshine Act, 50027 2015-20503 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Motor Vehicle Title Information System, 50043-50044 2015-20048 Proposed Consent Decrees under CERCLA, 50044-50045 2015-20307 Labor Department Labor Department See Occupational Safety and Health Administration See Workers Compensation Programs Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Authorization for Release of Medical Information for Black Lung Benefits, 50045-50046 2015-20314 Cadmium in General Industry Standard, 50046-50047 2015-20315 National Archives National Archives and Records Administration NOTICES Records Management: General Records Schedule; GRS Transmittal 24, 50047-50048 2015-20363 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Decisions of Inconsequential Noncompliance:

Mack Trucks, Inc., 50069-50070 2015-20310 National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 50016-50017 2015-20328 National Institute of Allergy and Infectious Diseases, 50016 2015-20330 National Institute of Biomedical Imaging and Bioengineering, 50017 2015-20329 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Large Coastal and Small Coastal Atlantic Shark Management Measures, 50074-50102 2015-19914 Revisions to Framework Adjustment 53 to the Northeast Multispecies Fishery Management Plan and Sector Annual Catch Entitlements:

Updated Annual Catch Limits for Sectors and the Common Pool for Fishing Year 2015, 49917-49929 2015-20303 PROPOSED RULES Atlantic Highly Migratory Species: Atlantic Shark Commercial Fishing Season, 49974-49984 2015-19915 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 49988 2015-20331 Meetings: Groundfish Operational Assessment, 49989 2015-20322 Gulf of Mexico Fishery Management Council, 49989-49990 2015-20311 Mid-Atlantic Fishery Management Council, 49988 2015-20339 New England Fishery Management Council, 2015-20338 49988-49991 2015-20340 2015-20341 South Atlantic Fishery Management Council, 49991 2015-20337 National Park National Park Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Community Harvest Assessments for Alaskan National Parks and Preserves, 50026 2015-20404 National Science National Science Foundation NOTICES Antarctic Conservation Act Permit Applications, 2015-20304 50048-50049 2015-20305 Navy Navy Department NOTICES Meetings: U.S. Naval Academy Board of Visitors, 49997 2015-20376 Nuclear Regulatory Nuclear Regulatory Commission RULES Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System, Certificate of Compliance No. 1014, Amendment No. 8, Revision 1, 49887-49892 2015-20141 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Personal Qualification Statement—Licensee, 50050-50051 2015-20360 Meetings: Advisory Committee on the Medical Uses of Isotopes, 50049-50050 2015-20364 Occupational Safety Health Adm Occupational Safety and Health Administration RULES State Plans for Occupational Safety and Health, 49897-49909 2015-19225 PROPOSED RULES State Plans for Occupational Safety and Health, 49956-49968 2015-19226 Overseas Overseas Private Investment Corporation NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 50051-50052 2015-20223 Meetings; Sunshine Act, 50051 2015-20466 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Hazardous Materials, 50070-50071 2015-20274 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 50052-50053 2015-20246 2015-20247 Rural Housing Service Rural Housing Service NOTICES Applications: Multifamily Preservation and Revitalization Demonstration Program for Fiscal Year 2015, 49985 2015-20399 Securities Securities and Exchange Commission RULES Pay Ratio Disclosure, 50104-50187 2015-19600 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 2015-20327 50056-50057, 50064-50065 2015-20324 2015-20325 Applications: Principal ETMF Trust, et al., 50055-50056 2015-20326 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 50061-50064 2015-20281 BATS Y-Exchange, Inc., 50059-50061 2015-20280 BOX Options Exchange, LLC, 50057-50059 2015-20279 EDGA Exchange, Inc., 50053-50055 2015-20282 Small Business Small Business Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 50065 2015-20291 Disaster Declarations: Missouri, 50066 2015-20287 South Dakota, 50065 2015-20290 West Virginia, 50066 2015-20288 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Application for Immigration Visa and Alien Registration, 50067-50068 2015-20261 Local U.S. Citizen Skills/Resources Survey, 50066-50067 2015-20239 Culturally Significant Objects Imported for Exhibition:

Carlo Crivelli Exhibitions, 50068 2015-20423 Transportation Department Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration NOTICES Nationwide Differential Global Positioning System, 50018-50020 2015-20401 Treasury Treasury Department NOTICES Online Marketplace Lending; Public Input on Expanding Access to Credit, 50071-50072 2015-20394 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Biometric Identity, 50020-50021 2015-20400 Workers' Workers Compensation Programs Office PROPOSED RULES Longshore and Harbor Workers' Compensation Act: Transmission of Documents and Information, 49945-49946 2015-20422 NOTICES Requests for Nominations: Advisory Board on Toxic Substances and Worker Health, 50047 2015-20408 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 50074-50102 2015-19914 Part III Securities and Exchange Commission, 50104-50187 2015-19600 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.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 80 159 Tuesday, August 18, 2015 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2014-0233] RIN 3150-AJ47 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System, Certificate of Compliance No. 1014, Amendment No. 8, Revision 1 AGENCY:

Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The U.S. Nuclear Regulatory Commission

(NRC)is amending its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to add Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012), to the Certificate of Compliance

(CoC)No. 1014. Amendment No. 8, Revision 1, changes burnup/cooling time limits for thimble plug devices, changes Metamic-HT material testing requirements, changes Metamic-HT material minimum guaranteed values, and updates fuel definitions to allow boiling water reactor fuel affected by certain corrosion mechanisms with specific guidelines to be classified as undamaged fuel. DATES: This final rule is effective on February 16, 2016. ADDRESSES: Please refer to Docket ID NRC-2014-0233 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-2014-0233. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: *Carol.Gallagher@nrc.gov.* For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • *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 *pdr.resource@nrc.gov.* 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 O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Vanessa Cox, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-8342; email: *Vanessa.Cox@nrc.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Discussion of Changes III. Public Comment Analysis IV. Voluntary Consensus Standards V. Agreement State Compatibility VI. Plain Writing VII. Environmental Assessment and Finding of No Significant Environmental Impact VIII. Paperwork Reduction Act Statement IX. Regulatory Analysis X. Regulatory Flexibility Certification XI. Backfitting and Issue Finality XII. Congressional Review Act XIII. Availability of Documents I. Background Section 218(a) of the Nuclear Waste Policy Act

(NWPA)of 1982, as amended, requires that “the Secretary [of the 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 [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

(SNF)in NRC-approved casks under a general license by publishing a final rule in part 72 of Title 10 of the *Code of Federal Regulations* (10 CFR), which added a new subpart K within 10 CFR part 72 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 on May 1, 2000 (65 FR 25241), that approved the Holtec International HI-STORM 100 Cask System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1014. The NRC published a direct final rule on this revision to this amendment in the **Federal Register** on February 5, 2015 (80 FR 6430). The NRC also concurrently published a companion proposed rule on February 5, 2015 (80 FR 6466). The NRC received at least one significant adverse comment on the proposed rule; therefore, the NRC withdrew the direct final rule on April 20, 2015 (80 FR 21639), and is proceeding, in this document, to address the comments on the proposed rule (see Section III, “Public Comment Analysis,” of this document). II. Discussion of Changes By letter dated August 21, 2013, and as supplemented on December 20, 2013, and February 28, 2014, Holtec International submitted a revision request for the Holtec International HI-STORM 100 Cask System, CoC No. 1014, Amendment No. 8. As a revision, the CoC will supersede the previous version of the CoC and Technical Specifications

(TSs)that were effective May 2, 2012, as corrected on November 16, 2012, in their entirety. Amendment No. 8, Revision 1, changes burnup/cooling time limits for thimble plug devices, changes Metamic-HT material testing requirements, changes Metamic-HT material minimum guaranteed values, and updates fuel definitions to allow boiling water reactor fuel affected by certain corrosion mechanisms within specific guidelines to be classified as undamaged fuel. As documented in the safety evaluation report (SER), the NRC staff performed a detailed safety evaluation of the 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 not be significant. This revision does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 8, Revision 1, would remain well within the 10 CFR part 20 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 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 exposure and no significant increase in the potential for or consequences of radiological accidents. This final rule revises the Holtec International HI-STORM 100 Cask System listing in 10 CFR 72.214 by adding Amendment No. 8, 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 Holtec International 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 final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load SNF into the Holtec International HI-STORM 100 Cask Systems that meets the criteria of Amendment No. 8, Revision 1, to CoC No. 1014 under 10 CFR 72.212. III. Public Comment Analysis The NRC received 16 comments from private citizens on the companion proposed rule to the direct final rule published on February 5, 2015. The NRC has not made any changes to the TSs or SER as a result of the public comments that the NRC has received. The NRC has, however, extended the effective date of the CoC in response to a comment. Summary of Comments The NRC received 16 comments on the companion proposed rule, many raising multiple and overlapping issues. Because the NRC received at least one significant adverse comment on the proposed rule (raising issues that the NRC deemed serious enough to warrant a substantive response to clarify the record), the NRC withdrew the direct final rule and is responding to the comments here. Other comments were not considered to be significant adverse comments because, in most instances, they were beyond the scope of this rulemaking. Nonetheless, in addition to responding to the issues raised in the significant adverse comments, the NRC is also taking this opportunity to respond to some of the issues raised in the comments that are beyond the scope of this rulemaking in order to clarify information about the CoC rulemaking process related to the comments received. The comments are summarized by issue and the NRC's responses follow. Issue 1—Storage of Spent Nuclear Fuel Several comments objected to the storage of SNF at the Indian Point nuclear plant and its proximity to New York City, and other comments objected to the storage of SNF, at any location, without a final repository approved. NRC Response The concern of SNF storage at the Indian Point nuclear plant, as well as the concern regarding the need for a final repository, are generic in nature and are not applicable to the HI-STORM Cask System, Amendment No. 8, Revision 1. This rulemaking is limited to allowing persons who hold a general license under 10 CFR 72.210 to load SNF into the Holtec International HI-STORM 100 Cask Systems if doing so meets the criteria of Amendment No. 8, Revision 1, to CoC No. 1014 under 10 CFR 72.212. Issue 2—Change in Definition Some comments also questioned the NRC's approval that SNF with certain types of corrosion fit within the definition of undamaged fuel. Some comments indicated that there was no explanation for this change in the definition. Another comment identified the concern with the change in the definition of undamaged fuel, as well as concerns with a variety of issues surrounding the manufacturing and use of this Holtec CoC cask system. NRC Response The inclusion of certain types of SNF corrosion in the undamaged fuel definition was addressed in detail in the NRC staff's SER which was referenced in the direct final rule published on February 5, 2015 (80 FR 6430), as was the staff's basis for determining that this CoC, as revised, complies with the NRC's regulations in 10 CFR part 72 and therefore, the revision ensures adequate protection of public health and safety. While these comments oppose the rule, they do not raise relevant or specific issues that were not previously addressed or considered by the NRC staff. Issue 3—Other Agencies One comment questioned why the NRC did not include other agencies in its Environmental Assessment (EA). NRC Response As explained in the direct final rule published on February 5, 2015 (80 FR 6430), the NRC determined that “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 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 exposure and no significant increase in the potential for or consequences of radiological accidents.” Therefore, no consultation was deemed necessary. Issue 4—Time Allowed for Comments Several comments objected to the time allowed by the NRC to provide comments on the companion proposed rule. NRC Response These comments do not provide any specific adverse comments on the companion proposed rule. Instead the comments cite concerns with the process used to issue the certificates. The NRC has determined that the amount of time provided for the submission of comments on a rule of this nature is reasonable, and the comments provide no specific details that would result in a change to that determination. Issue 5—Implementation Period Although not commenting on the technical details of the rule, one commenter requested that the NRC consider a 180-day implementation period for the revision to HI-STORM 100 Cask System, Amendment No. 8, to allow general licensees time to incorporate any applicable administrative changes. NRC Response The NRC determined that this comment is significant and adverse as defined in Section II, “Procedural Background,” of the direct final rule, because the comment raises an issue serious enough to warrant a substantive response to clarify or complete the record. A revision to a CoC amendment supersedes that specific amendment. Therefore, as the commenter indicates, any general licensee using the system authorized by this specific CoC amendment would have to update their records pursuant to 10 CFR 72.212(b)(5) to that of the revised system by the effective date of this revision. At the time the application was submitted, according to the applicant, no casks subject to the amendment had been manufactured, and therefore, this was not an issue. However, as of February 5, 2015, upon publication of the direct final rule, several canisters manufactured under CoC No. 1014, Amendment No. 8 have been purchased and delivered to Exelon Generation Company, LLC (Exelon Generation), at its Dresden Nuclear Power Plant. Given this change in circumstance, the NRC is revising the effective date of the revision to Amendment No. 8 of CoC 1014 to February 16, 2016,180 days from August 18, 2015, thereby providing more time for the general licensee to prepare the necessary paperwork pursuant to 10 CFR 72.212 before this revision becomes effective. Because this revision will supersede Amendment No. 8 in its entirety, the general licensee will have to be in compliance with 10 CFR 72.212 once this revision becomes effective. IV. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are 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 final rule, the NRC will revise the Holtec International HI-STORM 100 Cask System design listing in 10 CFR 72.214. This action does not constitute the establishment of a standard that contains generally applicable requirements. V. 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 final rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that 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 via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State. VI. 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). VII. 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 International HI-STORM 100 Cask System design listing within the “List of approved spent fuel storage casks” to revise Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012), of CoC No. 1014 by adding Amendment No. 8, Revision 1. Under the National Environmental Policy Act 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 is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment. B. The Need for the Action This final rule revises an amendment of the CoC for the Holtec International HI-STORM 100 Cask System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 8, Revision 1, changes burnup/cooling time limits for thimble plug devices, changes Metamic-HT material testing requirements, changes Metamic-HT material minimum guaranteed values, and updates fuel definitions to allow boiling water reactor fuel affected by certain corrosion mechanisms within specific guidelines to be classified as undamaged fuel. 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 environmental assessment for the 1990 final rule. The environmental assessment for this CoC addition tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act. The Holtec International HI-STORM 100 Cask System is 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 (ISFSI), 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 containment, shielding, and criticality control. If there is no loss of containment, shielding, or criticality control, the environmental impacts would not be significant. This revision does not reflect a significant change in design or fabrication of the cask. In addition, because there are no significant design or production process changes, any resulting occupational exposures or offsite dose rates from the implementation of Amendment No. 8, Revision 1, would remain well within the 10 CFR part 20 limits. Therefore, the proposed CoC changes will not result in either radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment 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 from radiological accidents. The NRC staff documented its safety findings in the SER for this revision. D. Alternative to the Action The alternative to this action is to deny approval of the changes in Amendment No. 8, Revision 1, and terminate the final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load SNF into the Holtec International HI-STORM 100 Cask System in accordance with the changes described in proposed Amendment No. 8, 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, a separate exemption request, thereby increasing the administrative burden on the NRC and the cost to each licensee. Therefore, the environmental impacts would be the same or less than the action. E. Alternative Use of Resources Approval of Amendment No. 8, Revision 1, of 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 environmental assessment. G. Finding of No Significant Impact The environmental impacts of the action have been reviewed under the requirements in 10 CFR part 51. Based on the foregoing environmental assessment, the NRC concludes that this final rule entitled, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System, Certificate of Compliance No. 1014, Amendment No. 8, Revision 1,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this final rule. VIII. Paperwork Reduction Act Statement This rule does not contain any information collection requirements and, therefore, is not subject to the requirements of 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 current valid Office of Management and Budget control number. IX. 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 SNF under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store SNF 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 contained 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 Holtec International HI-STORM 100 Cask System design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214. On August 21, 2013, and as supplemented on December 20, 2013, and February 28, 2014, Holtec International submitted a revision request for the HI-STORM 100 Cask System, CoC No. 1014, Amendment No. 8, as described in Section II, “Discussion of Changes,” of this document. The alternative to this action is to withhold approval of the changes requested in Amendment No. 8, Revision 1, and require any 10 CFR part 72 general licensee seeking to load SNF into the Holtec International HI-STORM 100 Cask System under the changes described in Amendment No. 8, 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 on the NRC and the costs to each affected licensee. Approval of this final rule is consistent with previous NRC actions. Further, as documented in the SER and the EA, the final rule will have no adverse effect on public health and safety or the environment. This 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 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. 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 final rule affects only nuclear power plant licensees and Holtec International. These entities do not fall within the scope of 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. 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 final rule. Therefore, a backfit analysis is not required. This final rule revises CoC No. 1014 for the Holtec International HI-STORM 100 Cask System, as currently listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” Amendment No. 8, Revision 1, changes burnup/cooling time limits for thimble plug devices, changes Metamic-HT material testing requirements, changes Metamic-HT material minimum guaranteed values, and updates fuel definitions to allow boiling water reactor fuel affected by certain corrosion mechanisms within specific guidelines to be classified as undamaged fuel. At the time the application was submitted, Holtec International indicated that no casks had been manufactured under this revision, but as of publication of the direct final rule, casks had been manufactured and delivered to a general licensee. Although Holtec International has manufactured some casks under the existing CoC No. 1014, Amendment No. 8 that is being revised by this final rule, Holtec International, as the vendor, is not subject to backfitting protection under 10 CFR 72.62. Moreover, Holtec International requested the change and has requested to apply it to the existing casks manufactured under Amendment No. 8. Therefore, even if the vendor were deemed to be an entity protected from backfitting, this request represents a voluntary change and is not backfitting for Holtec International. Under 10 CFR 72.62, general licensees are entities that are protected from backfitting, and in this instance, Holtec International has provided casks under CoC No. 1014, Amendment No. 8, to one general licensee. 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. 8, now must be evaluated under 10 CFR 72.212 consistent with the revisions in CoC No. 1014 Amendment 8, Revision 1, this change in the evaluation method and criteria constitutes a change in a procedure required to operate an ISFSI and, therefore, would constitute backfitting under 10 CFR 72.62(a)(2). However, in this instance, the general licensee voluntarily indicated its willingness to comply with the revised CoC, as long as the general licensee is provided adequate time to implement the revised CoC (see ADAMS No. ML15170A439). This final rule accommodates that request by extending the effective date for the final rule to February 16, 2016, 180 days from August 18, 2015. Therefore, although the general licensee is an entity protected from backfitting, this request represents a voluntary change and is not backfitting for this general licensee. In addition, the changes in CoC No. 1014, Amendment No. 8, Revision 1 do not apply to casks which were manufactured to other amendments of CoC No. 1014, and, therefore, have no effect on current ISFSI licensees using casks which were manufactured to other amendments of CoC No. 1014. For these reasons, NRC approval of CoC No. 1014, Amendment No. 8, Revision 1, does not constitute backfitting for users of the HI-STORM 100 Cask System which were manufactured to other amendments of CoC No. 1014, under 10 CFR 72.62, 10 CFR 50.109(a)(1), or the issue finality provisions applicable to combined licenses in 10 CFR part 52. For the reasons set forth above, no backfit analysis or additional documentation addressing the issue finality criteria in 10 CFR part 52 has been prepared by the NRC. XII. Congressional Review Act In accordance with the Congressional Review Act of 1996 (5 U.S.C. 801-808), the NRC has determined that this action is not a rule as defined in the Congressional Review Act. XIII. 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. CoC No. 1014, Amendment No. 8, Revision 1 ML14262A478 Safety Evaluation Report ML14262A476 Technical Specifications, Appendix A ML14262A480 Technical Specifications, Appendix B ML14262A479 Application (portions are non-public/proprietary) ML13235A082 December 20, 2013, Application Supplement ML14009A271 February 28, 2014, Application Supplement ML14064A344 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-2014-0233. 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-2014-0233);

(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, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, 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; and 5 U.S.C. 552 and 553, the NRC is adopting 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 1969 (42 U.S.C. 4332); Nuclear Waste 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. 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); superseded by Revision 1 Effective Date: February 16, 2016. Amendment Number 8, Revision 1 Effective Date: February 16, 2016. Amendment Number 9 Effective Date: March 11, 2014. 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 4th day of August, 2015. For the Nuclear Regulatory Commission. Michael R. Johnson, Acting Executive Director for Operation. [FR Doc. 2015-20141 Filed 8-17-15; 8:45 am]

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