List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12, 63814-63817 [2018-26878]

Download as PDF 63814 Proposed Rules Federal Register Vol. 83, No. 238 Wednesday, December 12, 2018 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC–2018–0221] RIN 3150–AK18 List of Approved Spent Fuel Storage Casks: Holtec International HI–STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12 Nuclear Regulatory Commission. ACTION: Proposed rule. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI– STORM 100 Multipurpose Canister Cask System (HI–STORM 100 System) listing within the ‘‘List of approved spent fuel storage casks’’ to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes. DATES: Submit comments by January 11, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC 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: • Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC–2018–0221. Address questions about NRC dockets to Carol Gallagher; telephone: 301–415–3463; email: Carol.Gallagher@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document. amozie on DSK3GDR082PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 17:18 Dec 11, 2018 Jkt 247001 • Email comments to: Rulemaking.Comments@nrc.gov. 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: YenJu Chen, Office of Nuclear Material Safety and Safeguards; telephone: 301– 415–1018; email: Yen-Ju.Chen@nrc.gov or Vanessa Cox, Office of Nuclear Material Safety and Safeguards; telephone: 301–415–8342; email: Vanessa.Cox@nrc.gov. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. SUPPLEMENTARY INFORMATION: Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Plain Writing V. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC–2018– 0221 when contacting the NRC about the availability of information for this action. You may obtain publiclyavailable information related to this action by any of the following methods: • Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC–2018–0221. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publiclyavailable documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/ PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 adams.html. To begin the search, 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 O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. B. Submitting Comments Please include Docket ID NRC–2018– 0221 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. Rulemaking Procedure This proposed rule is limited to the changes contained in Amendment Nos. 11 and 12 to Certificate of Compliance 1014 and does not include other aspects of the Holtec International HI–STORM 100 System design. Because the NRC considers this action to be noncontroversial, 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 (FR). The direct final rule will become effective on February 25, 2019. However, if the NRC receives significant adverse comments on this proposed rule by January 11, 2019, then the NRC will publish a document that withdraws the E:\FR\FM\12DEP1.SGM 12DEP1 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules 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-andcomment 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. For procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the FR. III. 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 in NRC-approved casks under a general license by publishing a final rule that 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 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 System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1014. 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. 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. ADAMS accession No./web link/ Federal Register citation amozie on DSK3GDR082PROD with PROPOSALS1 Document Subpart K of 10 CFR part 72, ‘‘General License for Storage of Spent Fuel at Power Reactor Sites’’ ..................................... 10 CFR part 72, ‘‘List of Approved Spent Fuel Storage Casks: Holtec HI–STORM 100 Addition’’ .......................................... Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System Amendment Request 1014–11’’ dated January 29, 2016. Letter from Holtec International to NRC, ‘‘Supporting Information for License Amendment Request 11 (1014–11) to the HI– STORM 100 CoC’’ dated February 16, 2016. (This letter contains five enclosures, and Enclosures 1 through 4 are proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Transmittal of Requests for Supplemental Information Responses Supporting HI– STORM 100 License Amendment Request 1014–11’’ dated June 6, 2016. Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s Requests for Additional Information for HI– STORM 100 License Amendment Request 1014–11’’ dated December 22, 2016. Letter from Holtec International to NRC, ‘‘Modification to Requested Changes on HI–STORM 100 Amendment 11 Request’’ dated April 22, 2016. Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s 2nd Round Requests for Additional Information for HI–STORM 100 License Amendment Request 1014–11’’ dated September 8, 2017. Letter from Holtec International to NRC, ‘‘Submittal of Supplemental Information on NRC’s Requests for Additional Information for HI–STORM 100 License Amendment Request 1014–11’’ dated November 10, 2017. (This package contains nine attachments, and Attachments 1, 6, 7, and 8 are proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Submittal of Revised Supplemental Information on NRC’s Requests for Additional Information for HI–STORM 100 License Amendment Request 1014–11’’ dated December 21, 2017. User Need Memorandum for Rulemaking for the Holtec International HI–STORM 100 Cask System, Amendment 11 .......... Proposed Certificate of Compliance 1014, Amendment 11, Certificate of Compliance for Spent Fuel Storage Casks ........... Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A .......................................... Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B .............. Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A–100U ............................... Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B–100U .... Certificate of Compliance 1014, Amendment 11, Preliminary Safety Evaluation Report .......................................................... VerDate Sep<11>2014 17:18 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00002 Fmt 4702 63815 Sfmt 4702 E:\FR\FM\12DEP1.SGM 12DEP1 55 FR 29181 65 FR 25241 ML16029A528 ML16069A246 ML16159A344 ML17005A236 ML16113A394 ML17261A159 ML17325A555 ML17362A113 ML18141A568 ML18141A561 ML18141A562 ML18141A563 ML18141A564 ML18141A565 ML18141A567 63816 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules ADAMS accession No./web link/ Federal Register citation Document Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System Amendment Request 1014–12’’ dated June 14, 2016. Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System Amendment Request 1014–12 Supporting Calculation Packages’’ dated July 22, 2016. (This package contains four attachments, and Attachments 1 through 3 are proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘HI–STORM 100 Amendment 12 Responses to Requests for Supplemental Information’’ dated November 4, 2016. (This package contains five attachments, and Attachment 4 is proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s Requests Additional Information for HI– STORM 100 License Amendment Request 1014–12’’ dated August 25, 2017. (This package contains 13 attachments, and Attachments 1, 5, 7, 8, 9, 10, 11, and 12 are proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s 2nd Round Requests Additional Information for HI–STORM 100 License Amendment Request 1014–11’’ dated September 8, 2017. (This package contains seven attachments, and Attachments 1, 5, and 6 are proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Submittal of Supplemental Information on NRC’s Requests for Additional Information for HI–STORM 100 License Amendment Request 1014–12’’ dated November 10, 2017. (This package contains six attachments, and Attachment 1 is proprietary information and not publicly available.). Letter from Holtec International to NRC, ‘‘Submittal of Revised Supplemental Information on NRC’s Requests for Additional Information for HI–STORM 100 License Amendment Request 1014–12’’ dated December 22, 2017. User Need Memorandum for Rulemaking for the Holtec International HI–STORM 100 Cask System, Amendment 12 .......... Proposed Certificate of Compliance 1014, Amendment 12, Certificate of Compliance for Spent Fuel Storage Casks ........... Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A .......................................... Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B .............. Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A–100U ............................... Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B–100U .... Certificate of Compliance 1014, Amendment 12, Preliminary Safety Evaluation Report .......................................................... The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC–2018–0221. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC–2018–0221); (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 amozie on DSK3GDR082PROD with PROPOSALS1 Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, 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: VerDate Sep<11>2014 17:18 Dec 11, 2018 Jkt 247001 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 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. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 ML16169A363 ML16210A133 ML16313A216 ML17251A739 ML17261A159 ML17326A174 ML17362A130 ML18087A056 ML18087A057 ML18087A058 ML18087A059 ML18087A060 ML18087A061 ML18087A062 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 Amendment Number 8, 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, superseded by Amendment Number 9, Revision 1, on March 21, 2016. Amendment Number 9, Revision 1, Effective Date: March 21, 2016, as corrected (ADAMS Accession No. ML17236A451). Amendment Number 10 Effective Date: May 31, 2016, as corrected (ADAMS Accession No. ML17236A452). Amendment Number 11 Effective Date: February 25, 2019. Amendment Number 12 Effective Date: February 25, 2019. Safety Analysis Report Submitted by: Holtec International. Safety Analysis Report Title: Final Safety Analysis Report for the HI– STORM 100 Cask System. Docket Number: 72–1014. E:\FR\FM\12DEP1.SGM 12DEP1 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules consider comments made at the public meeting in its review of the Rule. Certificate Expiration Date: May 31, 2020. Model Number: HI–STORM 100. * * * * * Dated at Rockville, Maryland, this 29th day of November 2018. For the Nuclear Regulatory Commission. Margaret M. Doane, Executive Director for Operations. [FR Doc. 2018–26878 Filed 12–11–18; 8:45 am] BILLING CODE 7590–01–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 93 RIN 2120–AK39 Notification of Replacement Public Meeting on Requirement for Helicopters To Use the New York North Shore Helicopter Route Federal Aviation Administration (FAA), DOT. ACTION: Notification of public meeting. AGENCY: Due to inclement weather on November 15, 2018, the FAA announces a replacement public meeting to solicit feedback concerning the New York North Shore Helicopter Rule (‘‘the Rule’’). This meeting is being held pursuant to Section 182 of the FAA Reauthorization Act of 2018. The Rule requires civil helicopter pilots operating under Visual Flight Rules (VFR), whose route of flight takes them over the north shore of Long Island between the Visual Point Lloyd Harbor (VPLYD) waypoint and Orient Point (VPOLT), to use the North Shore Helicopter Route. DATES: The public meeting will be held on Thursday, December 13, 2018. ADDRESSES: The public meeting will be held at Vaugh College, 8601 23rd Avenue, Flushing NY 11369. The meeting is 7:00 p.m.–9:00 p.m. EST. FOR FURTHER INFORMATION CONTACT: Christopher Bailey, Office of Rulemaking, Federal Aviation Administration; telephone (202) 267– 4158; email Christopher.Bailey@faa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: amozie on DSK3GDR082PROD with PROPOSALS1 Purpose of the Public Meeting The purpose of the public meeting is for the FAA to obtain feedback relevant to the Rule at subpart H of part 93, which requires civil helicopter pilots operating under VFR, whose route of flight takes them over the north shore of Long Island between the VPLYD waypoint and VPOLT, to use the North Shore Helicopter Route. The FAA will VerDate Sep<11>2014 17:18 Dec 11, 2018 Jkt 247001 Public Participation and Meeting Procedures The meeting will use a workshop format. FAA will have several stations covering a number of relevant aspects of the Rule. Each station will be staffed by an FAA representative who is able to answer questions regarding that subject. There will also be a station where the public can submit a written statement or have their oral comment transcribed. No formal presentations will be made. Section 182 of the FAA Reauthorization Act of 2018 also calls for a written comment period on the North Shore Helicopter Rule. See docket number FAA–2018–0954 to submit written comments. Sign and oral interpretation can be made available at the meeting, as well as an assistive listening device, if requested 3 calendar days before the meeting. The meeting will be open to all persons on a space-available basis. There will be no admission fee or other charge to attend and participate. Issued in Washington, DC, on December 7, 2018. Brandon Roberts, Deputy Executive Director, Office of Rulemaking. [FR Doc. 2018–26934 Filed 12–10–18; 4:15 pm] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 [Docket No. FDA–2018–N–2732] RIN 0910–AH57 Definition of the Term ‘‘Biological Product’’ AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines ‘‘biological product’’ to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms ‘‘protein’’ and ‘‘chemically synthesized polypeptide.’’ Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino SUMMARY: PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 63817 acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated. DATES: Submit either electronic or written comments on the proposed rule by February 25, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 25, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions.’’) Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\12DEP1.SGM 12DEP1

Agencies

[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Proposed Rules]
[Pages 63814-63817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26878]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / 
Proposed Rules

[[Page 63814]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 72

[NRC-2018-0221]
RIN 3150-AK18


List of Approved Spent Fuel Storage Casks: Holtec International 
HI-STORM 100 Multipurpose Canister Cask System, Certificate of 
Compliance No. 1014, Amendment Nos. 11 and 12

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 HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 
100 System) listing within the ``List of approved spent fuel storage 
casks'' to include Amendment Nos. 11 and 12 to Certificate of 
Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise 
multiple items in the Technical Specifications for multi-purpose 
canister models listed under Certificate of Compliance No. 1014; most 
of these revisions involve changes to the authorized contents. In 
addition, Amendment No. 11 makes several other editorial changes.

DATES: Submit comments by January 11, 2019. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
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:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0221. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact 
the individuals 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: Yen-Ju Chen, Office of Nuclear 
Material Safety and Safeguards; telephone: 301-415-1018; email: [email protected] or Vanessa Cox, Office of Nuclear Material Safety and 
Safeguards; telephone: 301-415-8342; email: [email protected]. Both 
are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Obtaining Information and Submitting Comments
II. Rulemaking Procedure
III. Background
IV. Plain Writing
V. Availability of Documents

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2018-0221 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 Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0221.
     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 ``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-2018-0221 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. Rulemaking Procedure

    This proposed rule is limited to the changes contained in Amendment 
Nos. 11 and 12 to Certificate of Compliance 1014 and does not include 
other aspects of the Holtec International HI-STORM 100 System design. 
Because the NRC considers this action to be non-controversial, 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 (FR). The direct final rule will become effective on February 
25, 2019. However, if the NRC receives significant adverse comments on 
this proposed rule by January 11, 2019, then the NRC will publish a 
document that withdraws the

[[Page 63815]]

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

III. 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 in NRC-approved casks under a general license by 
publishing a final rule that 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 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 System design and added it to the list of NRC-approved cask 
designs in Sec.  72.214 as Certificate of Compliance No. 1014.

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. 
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.

------------------------------------------------------------------------
                                               ADAMS accession No./web
                  Document                      link/ Federal Register
                                                       citation
------------------------------------------------------------------------
Subpart K of 10 CFR part 72, ``General       55 FR 29181
 License for Storage of Spent Fuel at Power
 Reactor Sites''.
10 CFR part 72, ``List of Approved Spent     65 FR 25241
 Fuel Storage Casks: Holtec HI-STORM 100
 Addition''.
Letter from Holtec International to NRC,     ML16029A528
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-11'' dated January
 29, 2016.
Letter from Holtec International to NRC,     ML16069A246
 ``Supporting Information for License
 Amendment Request 11 (1014-11) to the HI-
 STORM 100 CoC'' dated February 16, 2016.
 (This letter contains five enclosures, and
 Enclosures 1 through 4 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML16159A344
 ``Transmittal of Requests for Supplemental
 Information Responses Supporting HI-STORM
 100 License Amendment Request 1014-11''
 dated June 6, 2016.
Letter from Holtec International to NRC,     ML17005A236
 ``Submittal of Responses to NRC's Requests
 for Additional Information for HI-STORM
 100 License Amendment Request 1014-11''
 dated December 22, 2016.
Letter from Holtec International to NRC,     ML16113A394
 ``Modification to Requested Changes on HI-
 STORM 100 Amendment 11 Request'' dated
 April 22, 2016.
Letter from Holtec International to NRC,     ML17261A159
 ``Submittal of Responses to NRC's 2nd
 Round Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-11'' dated September 8, 2017.
Letter from Holtec International to NRC,     ML17325A555
 ``Submittal of Supplemental Information on
 NRC's Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-11'' dated November 10, 2017. (This
 package contains nine attachments, and
 Attachments 1, 6, 7, and 8 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17362A113
 ``Submittal of Revised Supplemental
 Information on NRC's Requests for
 Additional Information for HI-STORM 100
 License Amendment Request 1014-11'' dated
 December 21, 2017.
User Need Memorandum for Rulemaking for the  ML18141A568
 Holtec International HI-STORM 100 Cask
 System, Amendment 11.
Proposed Certificate of Compliance 1014,     ML18141A561
 Amendment 11, Certificate of Compliance
 for Spent Fuel Storage Casks.
Proposed Certificate of Compliance 1014,     ML18141A562
 Amendment 11, Technical Specifications,
 Appendix A.
Proposed Certificate of Compliance 1014,     ML18141A563
 Amendment 11, Approved Contents and Design
 Features, Appendix B.
Proposed Certificate of Compliance 1014,     ML18141A564
 Amendment 11, Technical Specifications,
 Appendix A-100U.
Proposed Certificate of Compliance 1014,     ML18141A565
 Amendment 11, Approved Contents and Design
 Features, Appendix B-100U.
Certificate of Compliance 1014, Amendment    ML18141A567
 11, Preliminary Safety Evaluation Report.

[[Page 63816]]

 
Letter from Holtec International to NRC,     ML16169A363
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-12'' dated June 14,
 2016.
Letter from Holtec International to NRC,     ML16210A133
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-12 Supporting
 Calculation Packages'' dated July 22,
 2016. (This package contains four
 attachments, and Attachments 1 through 3
 are proprietary information and not
 publicly available.).
Letter from Holtec International to NRC,     ML16313A216
 ``HI-STORM 100 Amendment 12 Responses to
 Requests for Supplemental Information''
 dated November 4, 2016. (This package
 contains five attachments, and Attachment
 4 is proprietary information and not
 publicly available.).
Letter from Holtec International to NRC,     ML17251A739
 ``Submittal of Responses to NRC's Requests
 Additional Information for HI-STORM 100
 License Amendment Request 1014-12'' dated
 August 25, 2017. (This package contains 13
 attachments, and Attachments 1, 5, 7, 8,
 9, 10, 11, and 12 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17261A159
 ``Submittal of Responses to NRC's 2nd
 Round Requests Additional Information for
 HI-STORM 100 License Amendment Request
 1014-11'' dated September 8, 2017. (This
 package contains seven attachments, and
 Attachments 1, 5, and 6 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17326A174
 ``Submittal of Supplemental Information on
 NRC's Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-12'' dated November 10, 2017. (This
 package contains six attachments, and
 Attachment 1 is proprietary information
 and not publicly available.).
Letter from Holtec International to NRC,     ML17362A130
 ``Submittal of Revised Supplemental
 Information on NRC's Requests for
 Additional Information for HI-STORM 100
 License Amendment Request 1014-12'' dated
 December 22, 2017.
User Need Memorandum for Rulemaking for the  ML18087A056
 Holtec International HI-STORM 100 Cask
 System, Amendment 12.
Proposed Certificate of Compliance 1014,     ML18087A057
 Amendment 12, Certificate of Compliance
 for Spent Fuel Storage Casks.
Proposed Certificate of Compliance 1014,     ML18087A058
 Amendment 12, Technical Specifications,
 Appendix A.
Proposed Certificate of Compliance 1014,     ML18087A059
 Amendment 12, Approved Contents and Design
 Features, Appendix B.
Proposed Certificate of Compliance 1014,     ML18087A060
 Amendment 12, Technical Specifications,
 Appendix A-100U.
Proposed Certificate of Compliance 1014,     ML18087A061
 Amendment 12, Approved Contents and Design
 Features, Appendix B-100U.
Certificate of Compliance 1014, Amendment    ML18087A062
 12, Preliminary Safety Evaluation Report.
------------------------------------------------------------------------

    The NRC may post materials related to this document, including 
public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0221. The Federal 
Rulemaking website allows you to receive alerts when changes or 
additions occur in a docket folder. To subscribe: (1) Navigate to the 
docket folder (NRC-2018-0221); (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, 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

0
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.

0
2. In Sec.  72.214, Certificate of Compliance 1014 is revised to read 
as follows:


Sec.  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 
Amendment Number 8, 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, superseded by 
Amendment Number 9, Revision 1, on March 21, 2016.
    Amendment Number 9, Revision 1, Effective Date: March 21, 2016, as 
corrected (ADAMS Accession No. ML17236A451).
    Amendment Number 10 Effective Date: May 31, 2016, as corrected 
(ADAMS Accession No. ML17236A452).
    Amendment Number 11 Effective Date: February 25, 2019.
    Amendment Number 12 Effective Date: February 25, 2019.
    Safety Analysis Report Submitted by: Holtec International.
    Safety Analysis Report Title: Final Safety Analysis Report for the 
HI-STORM 100 Cask System.
    Docket Number: 72-1014.

[[Page 63817]]

    Certificate Expiration Date: May 31, 2020.
    Model Number: HI-STORM 100.
* * * * *

    Dated at Rockville, Maryland, this 29th day of November 2018.

    For the Nuclear Regulatory Commission.
Margaret M. Doane,
Executive Director for Operations.
[FR Doc. 2018-26878 Filed 12-11-18; 8:45 am]
 BILLING CODE 7590-01-P