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Code · REGISTER · 2015-09-08 · PROPOSED RULES · Agency Agency for International Development PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Agricultural Marketing Agricultural Marketing Service NOTICES Mee · Unknown

Unknown. Direct final rule; confirmation of effective date

5,981 words·~27 min read·/register/2015/09/08/2015-22053·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2015-09-08.xml --- 80 173 Tuesday, September 8, 2015 Contents Agency Agency for International Development PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Agricultural Marketing Agricultural Marketing Service NOTICES Meetings: National Organic Standards Board, 53759 2015-21736 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service See Rural Business-Cooperative Service PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Climate Change, Global Food Security, and the U.S.
Food System Assessment Report; Public Comment Period, 53764 2015-22668 Privacy Act; Systems of Records, 53759-53764 2015-22085 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53797-53802 2015-22529 2015-22549 2015-22550 Statement of Organization, Functions, and Delegations of Authority; Corrections, 53799 2015-22535 Vapor Containment Performance Protocol for Closed System Transfer Devices Used during Pharmacy Compounding and Administration of Hazardous Drugs, 53802-53803 2015-22525 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53803 2015-22530 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53804-53807 2015-22041 2015-22495 2015-22571 Civil Rights Civil Rights Commission NOTICES Meetings; Sunshine Act, 53773 2015-22652 Coast Guard Coast Guard PROPOSED RULES Safety Zones: Jacksonville Sea and Sky Spectacular, Atlantic Ocean; Jacksonville Beach, FL, 53754-53756 2015-22581 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Defense Department Defense Department RULES Federal Acquisition Regulations:
Inflation Adjustment of Acquisition-Related Thresholds; Correction, 53753 2015-22060 PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Defense Personal Property Program, 53786-53787 2015-22524 Meetings: Uniform Formulary Beneficiary Advisory Panel, 53787 2015-22068 Education Department Education Department PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Meetings: President's Board of Advisors on Historically Black Colleges and Universities, 53787-53789 2015-22541 Energy Department Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Meetings:
Environmental Management Advisory Board, 53789 2015-22534 Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53789-53790 2015-22538 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Feather River Air Quality Management District; Correction, 53739 2015-21939 Approval and Promulgation of State Implementation Plans:
Alaska; Transportation Conformity State Implementation Plan, 53735-53739 2015-21938 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Alaska; Transportation Conformity State Implementation Plan, 53757 2015-21936 Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles; Phase 2, 53756-53757 2015-22028 Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources, 54146-54169 2015-20768 NOTICES Cross-Media Electronic Reporting:
Authorized Program Revision Approval, Alabama, 53793-53794 2015-22063 Authorized Program Revision Approval, Mississippi, 53794 2015-22528 Federal Aviation Federal Aviation Administration RULES Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 53694-53704 2015-22009 2015-22010 2015-22011 2015-22012 Federal Communications Federal Communications Commission RULES Reorganization of the Enforcement Bureau's Field Operations, 53747-53753 2015-21963 PROPOSED RULES Petitions for Reconsideration of Action in Rulemaking Proceeding, 53757 C1--2015--21763 Federal Deposit Federal Deposit Insurance Corporation NOTICES Termination of Receivership:
American National Bank, Parma, OH, 53796 2015-22563 Bank of Florida—Tampa Bay, Tampa, FL, 53796 2015-22564 Chipola Community Bank, Marianna, FL, 53795 2015-22568 First National Bank of Anthony, Anthony, KS, 53795 2015-22561 NorhWest Bank and Trust, Acworth, GA, 53796 2015-22565 Paramount Bank, Farmington Hills, MI, 53795 2015-22566 Southern Community Bank, Fayetteville, GA, 53794-53795 2015-22562 Westside Community Bank, University Place, WA, 53795 2015-22567 Federal Energy Federal Energy Regulatory Commission NOTICES Applications:
Colorado Interstate Gas Co., LLC, Wyoming Interstate Co., LLC, 53792-53793 2015-22514 Pacific Gas and Electric Co, 53791-53792 2015-22516 Combined Filings, 53790, 53793 2015-22508 2015-22509 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Midwest Electric Power, Inc., 53790-53791 2015-22510 Staff Attendances, 53792 2015-22515 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 53796 2015-22519 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 53797 2015-22518 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Environmental Impact Considerations, 53807-53810 2015-22507 Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product -- Responses to Frequently Asked Questions; Second Edition, 53810-53811 2015-22494 Forest Forest Service NOTICES Meetings: Rogue and Umpqua Resource Advisory Committee, 53764-53765 2015-22527 General Services General Services Administration RULES Federal Acquisition Regulations: Inflation Adjustment of Acquisition-Related Thresholds;
Correction, 53753 2015-22060 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See Indian Health Service See National Institutes of Health RULES National Institute on Minority Health and Health Disparities Research Endowments, 53739-53747 2015-22018 PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Nondiscrimination in Health Programs and Activities, 54172-54221 2015-22043 Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53811-53812 2015-22545 Homeland Homeland Security Department See Coast Guard PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Housing Housing and Urban Development Department RULES On-Site Completion of Construction of Manufactured Homes, 53712-53732 2015-21774 Streamlining Administrative Regulations for Public Housing; Revisions to Public Housing Flat Rents, 53709-53712 2015-22022 NOTICES Fair Market Rents for the Housing Choice Voucher Program:
Moderate Rehabilitation Single Room Occupancy Program and Other Programs Fiscal Year 2016, 53817-53886 2015-22023 Indian Health Indian Health Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions, 53812-53813 2015-22532 Interior Interior Department See National Park Service See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service RULES Integrated Hedging Transactions of Qualifying Debt, 53732-53735 2015-22554 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53919, 53922-53923 2015-22584 2015-22588 Meetings: Taxpayer Advocacy Panel Joint Committee, 53918 2015-22580 Taxpayer Advocacy Panel Notices and Correspondence Project Committee, 53921 2015-22591 Taxpayer Advocacy Panel Special Projects Committee, 53921-53922 2015-22578 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 53919 2015-22585 Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee, 53923 2015-22582 Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 53922 2015-22590 Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 53919-53920 2015-22583 Members of Senior Executive Service Performance Review Boards, 53920-53921 2015-22577 Privacy Act;
Systems of Records, 54064-54143 2015-21980 International Trade Adm International Trade Administration NOTICES Aerospace Executive Service Trade Mission at Singapore Airshow, 53773-53775 2015-22072 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Audio Processing Hardware and Software Products Containing Same, 53887-53888 2015-22575 Certain Toner Supply Containers and Components Thereof, 53889 2015-22526 Chloropicrin from China, 53888 2015-22061 Crepe Paper from China, 53888 2015-22056 Justice Department Justice Department PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Acquisition 360 Survey, 53891 2015-22523 Request for Recognition of a Non-profit Religious, Charitable, Social Service, or Similar Organization, 53889-53890 2015-22052 Proposed Consent Decrees under CERCLA, 53890 2015-22520 Proposed Consent Decrees under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, etc., 53890-53891 2015-22531 Labor Department Labor Department PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NASA National Aeronautics and Space Administration RULES Federal Acquisition Regulations:
Inflation Adjustment of Acquisition-Related Thresholds; Correction, 53753 2015-22060 PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53891-53892 2015-22512 National Highway National Highway Traffic Safety Administration PROPOSED RULES Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles; Phase 2, 53756-53757 2015-22028 NOTICES Inconsequential Noncompliance;
Petitions: Baby Jogger, LLC, 53914-53915 2015-22573 Maserati S.p.A and Maserati North America, Inc., 53912-53913 2015-22569 Mitsubishi Motors North America, Inc., 53911-53912 2015-22572 National Institute National Institute of Standards and Technology NOTICES Meetings: Manufacturing Extension Partnership Advisory Board, 53775 2015-22544 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 53814-53815 2015-22504 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 53813-53816 2015-22498 2015-22499 2015-22500 2015-22501 2015-22502 National Center for Complementary and Integrative Health, 53814 2015-22503 National Institute of Biomedical Imaging and Bioengineering, 53817 2015-22497 National Institute of Diabetes and Digestive and Kidney Diseases, 53816-53817 2015-22496 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings:
Fisheries of the Gulf of Mexico -- Southeast Data, Assessment, and Review, 53776-53777 2015-22539 Pacific Islands Fisheries, 53775-53776 2015-22536 Western Pacific Management Council, 53776 2015-22540 Takes of Marine Mammals Incidental to Specified Activities: Rehabilitation of Jetty A at the Mouth of the Columbia River, 53777-53786 2015-22069 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Breach Management Plan, Fire Island National Seashore, NY, 53886-53887 2015-22560 Meetings:
Subsistence Resource Commission for the Cape Krusenstern National Monument; Amendments, 53886 2015-22559 National Science National Science Foundation PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1, 53691-53694 2015-22053 NOTICES Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 53897-53902 2015-21795 License Amendment Applications:
Entergy Operations, Inc., Waterford Steam Electric Station, Unit 3, 53892-53896 2015-22553 Meetings: Advisory Committee on the Medical Uses of Isotopes, 53896-53897 2015-22552 Meetings; Sunshine Act, 53902 2015-22613 Standard Review Plans: Quality Assurance Program Description—Design Certification, Early Site Permit and New License Applicants, 53902-53903 2015-22555 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 53903-53904 2015-22505 2015-22506 Rural Business Rural Business-Cooperative Service NOTICES Grant Applications:
Delta Health Care Services, 53765-53773 2015-22546 Securities Securities and Exchange Commission NOTICES Limited Exemption Orders: Greenbacker Renewable Energy Co., LLC, 53905-53906 2015-22492 Meetings: Advisory Committee on Small and Emerging Companies, 53904-53905 2015-22533 Self-Regulatory Organizations; Proposed Rule Changes: ISE Gemini, LLC, 53906-53911 2015-22493 NYSE Arca, Inc., 53905, 53911 2015-22490 2015-22491 Social Social Security Administration PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 State Department State Department RULES Schedule of Fees for Consular Services:
Department of State and Overseas Embassies and Consulates; Passport and Citizenship Services Fee Changes, 53704-53709 2015-22054 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53887 2015-22551 Surface Transportation Surface Transportation Board PROPOSED RULES Amtrak Emergency Routing Orders, 53758 2015-22543 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Statutory Authority to Preserve Rail Service, 53917-53918 2015-22522 Statutory Licensing and Consolidation Authority, 53915-53917 2015-22521 Construction and Operation Exemptions: Six County Association of Governments, Rail Line between Levan and Salina, UT, 53915 2015-22537 Transportation Department Transportation Department See Federal Aviation Administration See National Highway Traffic Safety Administration See Surface Transportation Board PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 Treasury Treasury Department See Internal Revenue Service Veteran Affairs Veterans Affairs Department PROPOSED RULES Federal Policy for the Protection of Human Subjects, 53933-54061 2015-21756 NOTICES Fund Availability:
Grants for Transportation of Veterans in Highly Rural Areas, 53923-53928 2015-22576 Requests for Nominations: Research Advisory Committee on Gulf War Veterans' Illnesses, 53928-53929 2015-22057 Separate Parts In This Issue Part II Agency for International Development, 53933-54061 2015-21756 Agriculture Department, 53933-54061 2015-21756 Commerce Department, 53933-54061 2015-21756 Defense Department, 53933-54061 2015-21756 Education Department, 53933-54061 2015-21756 Energy Department, 53933-54061 2015-21756 Environmental Protection Agency, 53933-54061 2015-21756 Health and Human Services Department, 53933-54061 2015-21756 Homeland Security Department, 53933-54061 2015-21756 Justice Department, 53933-54061 2015-21756 Labor Department, 53933-54061 2015-21756 National Aeronautics and Space Administration, 53933-54061 2015-21756 National Science Foundation, 53933-54061 2015-21756 Social Security Administration, 53933-54061 2015-21756 Transportation Department, 53933-54061 2015-21756 Veterans Affairs Department, 53933-54061 2015-21756 Part III Treasury Department, Internal Revenue Service, 54064-54143 2015-21980 Part IV Environmental Protection Agency, 54146-54169 2015-20768 Part V Health and Human Services Department, 54172-54221 2015-22043 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. 80 173 Tuesday, September 8, 2015 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0067] RIN 3150-AJ58 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1 AGENCY:
Nuclear Regulatory Commission. ACTION: Direct final rule; confirmation of effective date. SUMMARY: The U.S. Nuclear Regulatory Commission
(NRC)is confirming the effective date of September 8, 2015, for the direct final rule that was published in the **Federal Register** on June 23, 2015. This direct final rule amended the NRC's spent fuel storage regulations by revising the Holtec International, Inc. (Holtec), HI-STORM (Holtec International Storage Module) Underground Maximum Capacity
(UMAX)Canister Storage System listing within the “List of approved spent fuel storage casks” to add Amendment No. 1 to Certificate of Compliance
(CoC)No. 1040. Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the cavity enclosure containers
(CECs)surrounding the casks with 3000 psi concrete; strengthening the multi-purpose canister
(MPC)guides, and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design. DATES: *Effective date:* The effective date of September 8, 2015, for the direct final rule published June 23, 2015 (80 FR 35829), is confirmed. ADDRESSES: Please refer to Docket ID NRC-2015-0067 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-2015-0067. 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.* • *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: Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3781; email: *Solomon.Sahle@nrc.gov.* SUPPLEMENTARY INFORMATION: I. Discussion On June 23, 2015 (80 FR 35829), the NRC published a direct final rule amending its regulations in § 72.214 of Title 10 of the *Code of Federal Regulations* (10 CFR) by revising the Holtec HI-STORM UMAX Canister Storage System listing within the “List of approved spent fuel storage casks” to add Amendment No. 1 to CoC No. 1040. Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the CECs surrounding the casks with 3000 psi concrete; strengthening the MPC guides, and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design. II. Public Comments on the Companion Proposed Rule In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on September 8, 2015. The NRC received 10 comment submittals on the companion proposed rule (80 FR 35872). Electronic copies of these comments can be obtained from the Federal Rulemaking Web site, *http://www.regulations.gov,* by searching for Docket ID NRC-2015-0067. The comments are also available in ADAMS under Accession Nos. ML15210A145, ML15210A150, ML15210A151, ML15210A155, ML15210A169, ML15210A164, ML15210A166, ML15210A177, ML15210A181, and ML15210A184. For the reasons discussed in more detail in Section III, “Public Comment Analysis,” of this document, none of the comments received are considered significant adverse comments as defined in NUREG/BR-0053, Revision 6, “United States Nuclear Regulatory Commission Regulations Handbook” (ADAMS Accession No. ML052720461). III. Public Comment Analysis The NRC received 10 comment submittals on the proposed rule, many raising multiple and overlapping issues. As explained in the June 23, 2015, direct final rule (80 FR 35829), the NRC would withdraw the direct final rule only if it received a “significant adverse comment.” This 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 (TSs). The NRC determined that none of the comments submitted on this direct final rule met any of these criteria. The comments either were already addressed by the NRC staff's safety evaluation report
(SER)(ADAMS Accession No. ML15070A149), or were beyond the scope of this rulemaking. The NRC has not made any changes to the direct final rule as a result of the public comments. However, the NRC is taking this opportunity to respond to some of the comments in an effort to clarify information about the 10 CFR part 72 CoC rulemaking process. For rulemakings amending or revising a CoC, the scope of the rulemaking is limited to the specific changes requested by the applicant in the request for the amendment or amendment revision. Therefore, comments about the system or spent fuel storage in general that are not applicable to the changes requested by the applicant are outside the scope of this rulemaking. Comments about details of the particular system that is the subject of the rulemaking, but that are not being addressed by the specific changes requested, have already been resolved in prior rulemakings. Persons who have questions or concerns about prior rulemakings and the resulting final rules may consider the NRC's process for petitions for rulemaking under 10 CFR 2.802. Additionally, safety concerns about any NRC-regulated activity may be reported to the NRC in accordance with the guidance posted on the NRC's Web site at *http://www.nrc.gov/about-nrc/regulatory/allegations/safety-concern.html.* This Web page provides information on how to notify the NRC of emergency or non-emergency issues. The NRC identified the following issues raised in the comments, and the NRC's responses to these issues follow.
(1)Potential Supersonic Shear Earthquakes and Site Specific Seismic Standards Several commenters raised concerns regarding the ability of this CoC system to withstand seismic events, particularly if the system were to be used at specific sites with known seismic activity, such as San Onofre Nuclear Generating Station (SONGS). These commenters stated that Holtec casks have not been tested for newly discovered potential Supersonic Shear Earthquakes, which might result in a rupture after Supersonic Shear Earthquake Events. According to the comments, cask venting can be blocked after a tsunami leading to cask failure. NRC Response These comments are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule, but instead raise concerns with the general 10 CFR part 72 requirements and process for certification of the CoC systems. This rule adds Amendment No. 1 to the HI-STORM UMAX Canister Storage System, CoC No. 1040. Applicants submitting CoC's for approval are required to document a design bases for their CoC or amendment CoC, which includes seismic parameters. Under 10 CFR 72.212(b)(6), general licensees (power reactors seeking to use those CoC systems at their specific sites) are required to conduct a review of the CoC's Final Safety Analysis Report
(FSAR)and the related NRC SER prior to use of the general license to ensure that the reactor site parameters, including analyses of earthquake intensity, are enveloped by the cask design bases considered in these reports. This rulemaking makes no determination regarding the acceptability of this amended system for use at any specific site. Nor does this rule seek to change the existing generic nature of CoC approvals or the technical qualifications outlined for CoC approval, as currently envisioned in 10 CFR part 72. Commenters with concerns regarding the existing 10 CFR part 72 regulations for technical review and approval of CoC systems could consider filing a petition for rulemaking under 10 CFR 2.802.
(2)Wind Effect on Underground Cask Maximum Heat Load Commenters stated that according to NUREG-2174 “Impact of Variation in Environmental Conditions on the Thermal Performance of Dry Storage Casks” (ADAMS Accession No. ML15054A207), low-speed wind conditions increased the peak cladding temperature on underground systems, and asked whether this was considered in the development of the heat load limits of the HI-STORM UMAX Canister Storage System. NRC Response The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule. The NRC evaluated and approved the HI-STORM UMAX Canister Storage System heat loads in the initial CoC certification, and this is provided in its SER (ADAMS Accession No. ML15093A510). The Amendment No. 1 application requested no thermal changes that required NRC evaluation.
(3)MPC Seismic Evaluation A commenter stated that the thin stainless steel MPC canisters are subject to pitting and corrosion (particularly from marine environments like chloride-induced stress corrosion cracking). According to the comment, since cracks may initiate during the initial licensing period in these canisters, cracking canisters should be included in the seismic analysis for MPC's stored while in the HI-STORM UMAX Canister Storage System since it would be of more concern in high risk seismic areas as proposed for this UMAX Amendment. NRC Response The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule. The NRC has evaluated the design of the HI-STORM UMAX Canister Storage System and has determined that the design is robust, and contains a number of layers of acceptable confinement systems in compliance with 10 CFR part 72 requirements. Furthermore, the NRC has evaluated the susceptibility to and effects of stress corrosion cracking and other corrosion mechanisms on safety significant systems for spent nuclear fuel
(SNF)dry cask storage
(DCS)systems during an initial certification period. The NRC staff has determined that the HI-STORM UMAX Canister Storage System, when used within the requirements of the proposed CoC, will safely store SNF and prevent radiation releases and exposure consistent with regulatory requirements, including seismic requirements. This evaluation is documented in the NRC staff's SERs (ADAMS Accession Nos. ML15070A149 and ML14202A031).
(4)Transfer Cask Commenters ask if the transfer casks were approved for storage of an MPC in case of a failed MPC. NRC Response To the extent that this comment raises a concern with the availability of a transfer cask, it raises an issue that was addressed in the NRC's evaluation of this amendment and fails to cite any specific information that would alter the NRC's conclusions. In this case, the transfer cask utilized in the HI-STORM UMAX Canister Storage System is described in the HI-STORM Flood/Wind (F/W) Multipurpose Canister
(MPC)Storage System FSAR (ADAMS Accession No. ML15177A336). The HI-STORM UMAX transfer cask is authorized to transfer intact MPC's in accordance with the CoC No. 1040 TSs.
(5)Failed Canister Remediation A commenter asked if there is a plan to remediate a failed canister. NRC Response The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises a concern with the general 10 CFR part 72 requirement and process for certification of the CoC systems. Implementing corrective actions in the event of a failed MPC is the responsibility of the general licensee and those corrective actions are not incorporated into CoC No. 1040.
(6)MPC Thickness Commenters questioned the maximum MPC thickness allowed in this amendment, noting that although the FSAR indicated 0.5″ as the maximum thickness, Holtec has proposed using a thickness of 0.625 at San Onofre (SONGS). The commenters raised concerns regarding the implications of such a change outside of a license amendment where it could be properly evaluated to determine if the change in limiting parameters will affect seismic, thermal, weight, dimensions and other critical analyses. NRC Response The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of the CoC systems. The nominal MPC thickness for the canisters certified under CoC No. 1040, Amendment No. 1 is 0.5″. The NRC has no knowledge of a Holtec proposal to increase the thickness of an MPC to 0.625″. If presented with an amendment request to do so, the NRC will evaluate it in accordance with 10 CFR part 72 requirements.
(7)Definition of “Long-term” Commenters requested the NRC require a definition of “long-term” in the FSAR. NRC Response The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises general concerns regarding terminology. The definitions required by the NRC to support the evaluation and approval of CoC No. 1040, Amendment No. 1, are provided in Appendix A of the CoC, Technical Specifications for the HI-STORM UMAX Canister Storage System. “Long-term” is a general descriptive term that is not required to support any regulatory or technical evaluation, and thus is not required to be more formally defined.
(8)Definition of Underground Commenters requested the NRC define the term “underground” as used in this system. The comments raised concerns that a structure that is only partially underground, but covered on the side with an “earthen berm,” could still be considered “underground” for compliance with this CoC. NRC Response The comments regarding the need to define the term “underground” as used in the HI-STORM UMAX Canister Storage System are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule, but instead raise concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. In this instance, Holtec has provided and analyzed specific structure placement parameters, and the NRC has evaluated these parameters that bound the placement of such a system in the ground. Pursuant to the regulatory requirements in 10 CFR 72.212(b), any general licensee that seeks to use this system must determine that the design and construction of the system, structures, and components are bounded by the conditions of the CoC by analyzing the generic parameters provided and analyzed in the FSAR and SER to ensure that its site specific parameters are enveloped by the cask design bases established in these reports. The NRC is aware of the SONGS proposed configuration submitted to the California Coastal Commission and is closely monitoring this issue. The NRC will continue to ensure that the facility constructed at SONGS meets the requirements of the CoC and TS of the specific DCS system selected by Southern California Edison.
(9)Heat Load Charts One commenter stated that the FSAR indicates that changes to storage cell kW heat loads were made and requested that the NRC determine if this was evaluated in the amendment request. The comment also requested clarification on the placement configuration of SNF assemblies in the MPC, as well as the rationale for the heat load configuration. NRC Response This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The comment is addressing revision bars that are incorporated into the HI-STORM UMAX Canister Storage System FSAR, Revision 2 (ADAMS Accession No. ML14202A031). The tables referenced in the comment were revised due to changes made during the original HI-STORM UMAX Canister Storage System evaluation; 10 CFR 72.248(a)(1) requires that an updated FSAR reflecting any changes made during the NRC review process be submitted within 90 days after an approval of the cask design. The loading patterns were evaluated and approved by the NRC staff in its initial SER (ADAMS Accession No. ML15093A510). The Amendment No. 1 application required no further changes to these tables requiring NRC evaluation.
(10)MPC Inspection A commenter requested that the NRC clarify that the MPC leak test inspection, that is used to verify the integrity of the confinement boundary, is performed before the MPC is loaded with fuel. NRC Response This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The HI- STORM F/W MPC Canister System FSAR clearly identifies the purpose of the MPC leak detection requirement as a post fabrication certification test that is only required to be performed one time.
(11)Assumption of No Fuel Cladding Degradation After Dry Storage Is Not Substantiated Some commenters raised an issue with Holtec's claim that there is no credible mechanism for gross fuel cladding degradation of fuel classified as undamaged during storage in the HI-STORM UMAX Canister Storage System. NRC Response These comments are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule. Instead, these comments raise issues that would be addressed during any renewal application review. The NRC has determined that fuel cladding degradation is not an issue during the initial 20-year certification period, but instead, is an issue that would have to be addressed if a CoC holder requested renewal of the CoC for a period beyond the initial 20 years. If a renewal application is filed, NRC regulations require that the application include programs to manage the effects of aging, including necessary monitoring and inspection programs. Those programs would have to be reviewed and determined acceptable by the NRC before any CoC renewal is approved.
(12)Vertical Ventilated Module Needs Substantiation for Expected Lifespan Commenters questioned Holtec's claims of a design life of 60 years, a service life of 100 years and a licensed life of 40 years. Since no substantiation was provided for these claims, the commenters requested the claims be removed from the FSAR. NRC Response This issue is outside of the scope of this rulemaking because the term of a certificate is determined in the original certification, not in amendments to that certification. This rulemaking seeks to add Amendment No. 1 to CoC No. 1040. In this case, the UMAX CoC was approved on March 6, 2015 (80 FR 12073), for an initial 20-year term. This 20-year term will also apply to Amendment No. 1. Use of this system beyond the expiration date of 20 years would require an evaluation of a renewal application for this CoC which would be addressed in a subsequent rulemaking process.
(13)Concrete Inspection and Inspection Limitations Some commenters questioned whether the HI-STORM UMAX Canister Storage System design provided a safe and accessible method to perform inspections within the license period given that high seismic risk areas are more likely to cause cracking or other structural changes, and indicated that such an evaluation should be part of the NRC's review process. NRC Response This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The NRC has determined that concrete degradation is not an issue requiring inspection during the initial 20-year certification period, but instead, is an issue that would have to be addressed if a CoC holder requested renewal of the CoC for a period beyond the initial 20 years. If a renewal application is filed, NRC regulations require that the application include programs to manage the effects of aging, including necessary monitoring and inspection programs. Those programs would have to be reviewed and determined acceptable by the NRC before any CoC renewal is approved.
(14)High Burnup Fuel Commenters also raised questions regarding the long-term acceptability of the extended storage of high burnup fuel (HBF). NRC Response To the extent these comments raise issues about the storage of HBF in the CoC for the first 20 years, these comments are outside the scope of this rulemaking. The NRC has evaluated the acceptability of storage of HBF for the initial 20-year certification term for the HI-STORM UMAX Canister Storage System during its review of the initial certificate. As documented in the NRC staff's SER under Docket ID NRC-2014-0120, the NRC staff has determined that the use of the HI-STORM UMAX Canister Storage System, including storage of HBF, will be conducted in compliance with the applicable regulations of 10 CFR part 72, and the CoC should be approved for the initial 20-year term. This amendment does not impact the analysis conducted by the NRC staff during the initial certification of this system. Additionally, to the extent these comments raise concerns regarding the storage of HBF beyond the initial term of 20 years, the comments are also outside the scope of this rulemaking. A request to store HBF beyond the initial 20 years provided in the certification of this system will require the applicant to submit a license renewal application with the inclusion of Aging Management Programs addressing HBF. In that regard, a demonstration project is being planned by the U.S. Department of Energy to provide confirmatory data on the performance of HBF in DCS. The NRC plans to evaluate the data obtained from the project to confirm the accuracy of current models that are relied upon for authorizing the storage of HBF for extended storage periods beyond the initial 20-year certification term. The NRC staff has concluded that the comments received on the companion proposed rule for the Holtec HI-STORM UMAX Canister Storage System, CoC No. 1040, Amendment No. 1, are not significant adverse comments as defined in NUREG/BR-0053, Revision 6, “United States Nuclear Regulatory Commission Regulations Handbook.” Therefore, this rule will become effective as scheduled. Dated at Rockville, Maryland, this 1st day of September, 2015. For the Nuclear Regulatory Commission. Cindy Bladey, Chief, Rules, Announcements, and Directives Branch, Division of Administrative Services, Office of Administration. [FR Doc. 2015-22053 Filed 9-4-15; 8:45 am]
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