ML21194A088

Direct Final Rule - Holtec International Certificate of Compliance No. 1008, Renewal of Initial Issue and Amendment Nos. 1, 2, and 3

ML21194A088
Person / Time
Site:	07201008
Issue date:	09/15/2021
From:	Margaret Doane NRC/EDO
To:
Cox V
Shared Package
ML21194A075	List: ML21194A088 ML21194A089 ML21194A154
References
NRC-2021-0135, RIN 3150-AK68
Download: ML21194A088 (25)

Text

[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Part 72

[NRC-2021-0135]

RIN 3150-AK68 List of Approved Spent Fuel Storage Casks: Holtec International HI-STAR 100 Cask System, Certificate of Compliance No. 1008, Renewal of Initial Certificate and Amendment Nos. 1, 2, and 3 AGENCY: Nuclear Regulatory Commission.

ACTION: Direct final rule.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Holtec International HI-STAR 100 Cask System listing within the List of approved spent fuel storage casks to renew, for an additional 40 years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008. The renewal of the initial certificate and Amendment Nos. 1, 2, and 3 revises the certificate of compliances conditions and technical specifications to address aging management activities related to the structures, systems, and components of the dry storage system to ensure that these will maintain their intended functions during the period of extended storage operations.

DATES: This direct final rule is effective December 15, 2021, unless significant adverse comments are received by November 1,2021. If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so,

but the NRC is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

ADDRESSES: Submit your comments, identified by Docket ID NRC-2021-0135, at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

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: Kristina Banovac, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-7116, email:

Kristina.Banovac@nrc.gov and 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. Discussion of Changes V. Voluntary Consensus Standards VI. Agreement State Compatibility VII. Plain Writing VIII. Environmental Assessment and Finding of No Significant Impact IX. Paperwork Reduction Act Statement X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality 2

XIII. Congressional Review Act XIV. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2021-0135 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 https://www.regulations.gov and search for Docket ID NRC-2021-0135. Address questions about NRC dockets to Dawn Forder, telephone: 301-415-3407, email: Dawn.Forder@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• NRCs Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select Begin Web-based ADAMS Search. For problems with ADAMS, please contact the NRCs 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.

• Attention: The PDR, where you may examine and order copies of public documents, is currently closed. You may submit your request to the PDR via email at 3

pdr.resource@nrc.gov or call 1-800-397-4209 between 8:00 a.m. and 4:00 p.m. (EST),

Monday through Friday, except Federal holidays.

B. Submitting Comments Please include Docket ID NRC-2021-0135 in your comment submission. The NRC requests that you submit comments through the Federal rulemaking website at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

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 https://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 rule is limited to the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 to Certificate of Compliance No. 1008 and does not include other aspects of the Holtec International HI-STAR 100 Cask System design. The NRC is using the direct final rule procedure to issue this renewal because it represents a limited and routine change to an existing certificate of compliance that is expected to be non-controversial.

4

Adequate protection of public health and safety continues to be reasonably assured.

The amendment to the rule will become effective on December 15, 2021. However, if the NRC receives any significant adverse comment on this direct final rule by November 1, 2021, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rules 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 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.

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.

5

3) The comment causes the NRC to make a change (other than editorial) to the rule, certificate of compliance, or technical specifications.

III. Background Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended, requires that [t]he 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 Nuclear Waste Policy Act states, in part, that [t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule 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 September 3, 1999 (64 FR 48259) that approved the HI-STAR 100 Cask System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1008.

6

IV. Discussion of Changes On December 7, 2018, Holtec International submitted a request to the NRC to renew, for an additional 40 years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 for the HI-STAR 100 Cask System. Holtec International supplemented its request on June 28, 2019, October 10, 2019, December 12, 2019, June 1, 2020, June 11, 2020, November 13, 2020, and November 24, 2020.

The renewal of the initial certificate and Amendment Nos. 1, 2, and 3 were conducted in accordance with the renewal provisions in § 72.240. This section of the NRC spent fuel storage regulations authorizes NRC staff to include any additional certificate conditions it deems necessary to ensure the safe operation of the cask during the certificates renewal period. The NRC included three additional conditions to the renewal of the initial certificate of compliance and Amendment Nos. 1, 2, and 3:

• The submittal of an updated final safety analysis report (UFSAR) to address aging management activities resulting from the renewal of the certificate of compliance. This condition ensures that the UFSAR changes are made in a timely fashion to enable general licensees using the storage system during the period of extended operation to develop and implement necessary procedures.

• The requirement that general licensees initiating or using spent fuel dry storage operations with the HI-STAR 100 Cask System ensure that their evaluations are included in the reports required by § 72.212, Conditions of general license issued under § 72.210. These reports will include appropriate considerations for the period of extended operation, a review of the UFSAR changes resulting from the certificate of compliance 7

renewal, and a review of the NRC safety evaluation report (SER) related to the certificate of compliance renewal.

• The requirement that future amendments and revisions to this certificate of compliance include evaluations of the impacts to aging management activities to ensure that they remain adequate for any changes to the structures, systems, and components (SSCs).

The NRC made one corresponding change to the technical specifications for the initial certificate of compliance and Amendment Nos. 1, 2, and 3 on the aging management program. The change added a new section, which ensures that general licensees using the storage system develop procedures to address aging management activities required in the period of extended operation.

As documented in the preliminary SER, the NRC performed a safety evaluation of the proposed certificate of compliance renewal request. The NRC determined that this renewal does not change the cask design or fabrication requirements in the proposed certificate of compliance renewal request. The NRC determined that the design of the cask would continue to maintain confinement, shielding, and criticality control in the event of each evaluated accident condition. In addition, any resulting occupational exposure or offsite dose rates from the renewal of the initial certificate of compliance and Amendment Nos. 1, 2, and 3 would remain well within the limits specified by 10 CFR part 20, Standards for Protection Against Radiation. Thus, the NRC found there will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents.

In its SER for the renewal of the HI-STAR 100 Cask System, the NRC has determined that if the conditions specified in the certificate of compliance to implement these 8

regulations are met, adequate protection of public health and safety will continue to be reasonably assured.

This direct final rule revises the HI-STAR 100 Cask System listing in § 72.214 by renewing, for 40 more years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008. The renewal consists of the changes previously described, as set forth in the renewed initial certificate and amendments and their revised technical specifications. The revised technical specifications are identified in the SER.

V. 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 direct final rule, the NRC revises the Holtec International HI-STAR 100 Cask System Cask System design listed in § 72.214, List of approved spent fuel storage casks. This action does not constitute the establishment of a standard that contains generally applicable requirements.

VI. Agreement State Compatibility Under the Agreement State Program Policy Statement approved by the Commission on October 2, 2017, and published in the Federal Register on October 18, 2017 (82 FR 48535), this rule is classified as Compatibility Category NRC -

Areas of Exclusive NRC Regulatory Authority. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the 9

Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR chapter I.

Therefore, compatibility is not required for program elements in this category. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category NRC does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular States administrative procedure laws.

VII. Plain Writing The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, Plain Language in Government Writing, published June 10, 1998 (63 FR 31885).

VIII. Environmental Assessment and Finding of No Significant Impact Under the National Environmental Policy Act of 1969, as amended, and the NRCs regulations in 10 CFR part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, the NRC has determined that this direct final 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.

A. The Action The action is to amend § 72.214 to revise the Holtec International HI-STAR 100 Cask System listing within the List of approved spent fuel storage casks to renew, for 10

an additional 40 years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008.

B. The Need for the Action This direct final rule renews the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 for the Holtec International HI-STAR 100 Cask System design within the list of approved spent fuel storage casks to allow power reactor licensees to store spent fuel at reactor sites in casks with the approved modifications under a general license. Specifically, this rule extends the expiration date for the Holtec International HI-STAR 100 Cask System certificate for an additional 40 years, allowing a power reactor licensee to continue using it under general license provisions in an independent spent fuel storage installation to store spent fuel in dry casks in accordance with 10 CFR part 72.

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 analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 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 of 1969, as amended. As required by § 72.240, applications for renewal of a spent fuel storage certificate of compliance design are required to demonstrate that SSCs important to safety will continue to perform their intended function for the requested renewal term. As discussed in the NRC staffs SER for the renewal of the 11

initial certificate and Amendment Nos. 1, 2, and 3, the NRC staff has approved conditions in the renewed initial certificate and Amendment Nos. 1, 2, and 3 requiring the general licensee to implement the aging management activities described in the renewal application and incorporated into the UFSAR. These conditions ensure that the Holtec International HI-STAR 100 Cask System will continue to perform its intended safety functions and provide reasonable assurance of adequate protection of public health and safety throughout the renewal period.

Incremental impacts from continued use of the HI-STAR 100 Cask System under a general license for an additional 40 years are not considered significant. When the general licensee follows all procedures and administrative controls, including the conditions established because of this renewal, no effluents are expected from the sealed dry cask systems. Activities associated with cask loading and decontamination may result in some small incremental liquid and gaseous effluents, but these activities will be conducted under 10 CFR parts 50 and 52 reactor operating licenses, and effluents will be controlled within existing reactor site technical specifications. Because reactor sites are relatively large, any incremental offsite doses due to direct radiation exposure from the spent fuel storage casks are expected to be small, and when combined with the contribution from reactor operations, well within the annual dose equivalent of 0.25 mSv (25 mrem) limit to the whole body specified in § 72.104.

Incremental impacts on collective occupational exposures due to dry cask spent fuel storage are expected to be only a small fraction of the exposures from operation of the nuclear power station.

The HI-STAR 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 12

surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation 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.

During the promulgation of the amendments that added subpart K to 10 CFR part 72 (55 FR 29181; July 18, 1990), the NRC staff assessed the public health consequences of dry cask storage accidents and sabotage events. In the supporting analyses for these amendments, the NRC staff determined that a release from a dry cask storage system would be comparable in magnitude to a release from the same quantity of fuel in a spent fuel storage pool. As a result of these evaluations, the NRC staff determined that, because of the physical characteristics of the storage casks and conditions of storage that include specific security provisions, the potential risk to public health and safety due to accidents or sabotage is very small.

Considering the specific design requirements for each accident or sabotage condition, the design of the cask would maintain confinement, shielding, and criticality control. If confinement, shielding, and criticality control are maintained, the environmental impacts from an accident would be insignificant.

There are no changes to cask design or fabrication requirements in the renewed initial certificate or Amendment Nos. 1, 2, and 3. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 would remain well within the 10 CFR part 20 limits.

Decommissioning of dry cask spent fuel storage systems under a general license would be carried out as part of a power reactor's site decommissioning plan. In general, decommissioning would consist of removing the spent fuel from the site, 13

decontaminating cask surfaces, and decontaminating and dismantling the independent spent fuel storage installation where the casks were deployed. Under normal and off-normal operating conditions, no residual contamination is expected to be left behind on supporting structures. The incremental impacts associated with decommissioning dry cask storage installations are expected to represent a small fraction of the impacts of decommissioning an entire nuclear power station.

In summary, the proposed 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. Compliance with the requirements of 10 CFR parts 20 and 72 would provide reasonable assurance that adequate protection of public health and safety will continue.

The NRC, in its SER for the renewal of the HI-STAR 100 Cask System, has determined if the conditions specified in the certificate of compliance to implement these regulations are met, adequate protection of public health and safety will continue to be reasonably assured.

Based on the previously stated assessments and its SER for the requested renewal of the HI-STAR 100 Cask System certificates, the NRC has determined that the expiration date of this system in 10 CFR 72.214 can be safely extended for an additional 40 years, and that commercial nuclear power reactor licensees can continue using the system during this period under a general license without significant impacts on the human environment.

D. Alternative to the Action The alternative to this action is to deny approval of the renewal and not issue the direct final rule. Under this alternative, the NRC would either 1) require general licensees using the HI-STAR 100 Cask System to unload the spent fuel from these 14

systems and either return it to a spent fuel pool or re-load it into a different dry storage cask system listed in § 72.214; or 2) require that users of the existing HI-STAR 100 Cask System request site-specific licensing proceedings to continue storage in these systems.

The environmental impacts of requiring the licensee to unload the spent fuel and either return it to the spent fuel pool or re-load it into another NRC-approved cask system would result in increased radiological doses to workers. These increased doses would be due primarily to direct radiation from the casks while the workers unloaded, transferred, and re-loaded the spent fuel. These activities would consist of transferring the dry storage canisters to a cask-handling building, opening the canister lid welds, returning the canister to a spent fuel pool or dry transfer facility, removing the fuel assemblies, and re-loading them, either into a spent fuel pool storage rack or another NRC-approved dry storage system. In addition to the increased occupational doses to workers, these activities may also result in additional liquid or gaseous effluents.

Alternatively, users of the dry cask storage system would need to apply for a site-specific license. Under this option for implementing the no-action alternative, interested licensees would have to prepare, and the NRC would have to review, each separate license application, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

In summary, the no-action alternative would entail either 1) more environmental impacts than the preferred action from transferring the spent fuel now in the HI-STAR 100 Cask System; or 2) cost and administrative impacts from multiple licensing actions that, in aggregate, are likely to be the same as, or more likely greater than, the preferred action.

15

E. Alternative Use of Resources Renewal of the initial certificate and Amendment Nos. 1, 2, and 3 to Certificate of Compliance No. 1008 would result in no irreversible commitment 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 the National Environmental Policy Act of 1969, as amended, and the NRCs regulations in subpart A of 10 CFR part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule, List of Approved Spent Fuel Storage Casks: Holtec International HI-STAR 100 Cask System, Certificate of Compliance No. 1008, Renewal of Initial Certificate and Amendment Nos. 1, 2, and 3, 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 direct final rule.

IX. Paperwork Reduction Act Statement This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Existing collections of information were approved by the Office of Management and Budget, approval number 3150-0132.

16

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

X. Regulatory Flexibility Certification Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec 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 (§ 2.810).

XI. Regulatory Analysis On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if 1) it notifies the NRC in advance; 2) the spent fuel is stored under the conditions specified in the casks certificate of compliance; and 3) the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On September 3, 1999 (64 FR 48259), the NRC issued an amendment to 10 CFR part 72 that approved the HI-STAR 100 Cask System design by adding it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1008.

17

On December 7, 2018, Holtec International requested a renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of the HI-STAR 100 Cask System for an additional 40 years beyond the initial certificate term. Holtec International supplemented its request on June 28, 2019, October 10, 2019, December 12, 2019, June 1, 2020, June 11, 2020, November 13, 2020, and November 24, 2020. Because Holtec International filed its renewal application at least 30 days before the certificate expiration date of October 4, 2019, pursuant to the timely renewal provisions in § 72.240(b), the initial issuance of the certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 did not expire.

The alternative to this action is to deny approval of the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 and end this direct final rule. Under this alternative, the NRC would either 1) require general licensees using the HI-STAR 100 Cask System to unload spent fuel from these systems and return it to a spent fuel pool or re-load it into a different dry storage cask system listed in 10 CFR 72.214; or 2) require that users of the existing HI-STAR 100 Cask System request site-specific licensing proceedings to continue storage in these systems.

Therefore, the no-action alternative would result in a significant burden on licensees and an additional inspection or licensing caseload on the NRC. In addition, the no-action alternative would entail either 1) more environmental impacts than the preferred action from transferring the spent fuel now in the HI-STAR 100 Cask System; or 2) cost and administrative impacts from multiple licensing actions that, in aggregate, are likely to be the same as, or more likely greater than, the preferred action.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the preliminary SER and environmental assessment, this direct final rule will have no adverse effect on public health and safety or the environment. This 18

direct final rule has no significant identifiable impact or benefit on other government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory; therefore, this action is recommended.

XII. Backfitting and Issue Finality The NRC has determined that the backfit rule (§ 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Certificate of Compliance No. 1008 for the Holtec International HI-STAR 100 Cask System, as currently listed in § 72.214, to extend the expiration date of the initial certificate and Amendment Nos. 1, 2, and 3 by 40 years. The renewed initial certificate and Amendment Nos. 1, 2, and 3 consist of the changes previously described, as set forth in the renewed certificate of compliance and technical specifications.

Extending the effective date of the initial certificate and Amendment Nos. 1, 2, and 3 for 40 more years and requiring the implementation of aging management activities does not impose any modification or addition to the design of a cask systems SSCs, or to the procedures or organization required to operate the system during the initial 20-year storage period of the system, as authorized by the current certificate.

General licensees that have loaded these casks, or that load these casks in the future under the specifications of the applicable certificate, may continue to store spent fuel in these systems for the initial 20-year storage period consistent with the original certificate.

The aging management activities required to be implemented by this renewal are only required after the storage cask systems initial 20-year service period ends. As explained in the 2011 final rule that amended 10 CFR part 72 (76 FR 8872, Question I),

19

the general licensees authority to use a particular storage cask design under an approved certificate of compliance terminates 20 years after the date that the general licensee first loads the particular cask with spent fuel, unless the casks certificate of compliance is renewed. Because this rulemaking renews the initial certificate and Amendment Nos. 1, 2, and 3, and renewal is a separate licensing action voluntarily implemented by vendors, the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 is not an imposition of new or changed requirements from which these licensees would otherwise be protected by the backfitting provisions in § 72.62.

Even if renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 could be considered a backfit, Holtec International, as the holder of the certificate of compliance and vendor of the casks, is not protected by the backfitting provisions in § 72.62.

Unlike a vendor, general licensees using the existing systems subject to this renewal would be protected by the backfitting provisions in § 72.62 if the renewal constituted new or changed requirements applicable during the initial 20-year storage period. But, as previously explained, renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 does not impose such requirements. The general licensee using the initial certificate or Amendment Nos. 1, 2, or 3 of Certificate of Compliance No. 1008 may continue storing material in their respective cask systems for the initial 20-year storage period identified in the applicable certificate or amendment with no changes. If general licensees choose to continue to store spent fuel in HI-STAR 100 Cask Systems after the initial 20-year period, these general licensees will be required to implement aging management activities for any cask systems subject to a renewed certificate of compliance, but such continued use is voluntary.

20

For these reasons, renewing the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008, and imposing the additional conditions previously discussed, does not constitute backfitting under § 72.62, or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

XIII. Congressional Review Act This direct final rule is not a rule as defined in the Congressional Review Act.

XIV. Availability of Documents The documents identified in the following table are available to interested persons as indicated.

DOCUMENT ADAMS ACCESSION NO.

Holtec International HI-STAR 100 Storage System, Certificate of Compliance No. 1008 ML18345A178 (package)

Renewal Application, dated December 7, 2018 Holtec International Response to the Request for Supplemental Information on the Renewal of the ML19184A232 (package)

HI-STAR 100 Storage System, Certificate of Compliance No. 1008, dated June 28, 2019 Holtec International Submittal of Supplemental Information Related to Request for Supplemental Information on the Renewal of the HI-STAR 100 ML19288A089 (package)

Storage System, Certificate of Compliance No. 1008, dated October 10, 2019 Holtec International HI-STAR 100 Storage System, Certificate of Compliance No. 1008 ML19350A576 Renewal, Updated Non-Proprietary Documents, dated December 12, 2019 Holtec International Response to the Request for Additional Information on the Renewal of the HI-ML20153A768 (package)

STAR 100 Storage System, Certificate of Compliance No. 1008, dated June 1, 2020 21

Holtec International Response to the Request for Additional Information on the Renewal of the HI-ML20163A713 (package)

STAR 100 Storage System, Certificate of Compliance No. 1008, dated June 11, 2020 Holtec International Response to the Request for Clarification of Additional Information on the Renewal of the HI-STAR 100 Storage System, ML20318A321 (package)

Certificate of Compliance No. 1008, dated November 13, 2020 Holtec International Response to the Request for Clarification of Additional Information on the Renewal of the HI-STAR 100 Storage System, ML20329A321 (package)

Certificate of Compliance No. 1008, Updated Attachment, dated November 24, 2020 User Need Memorandum for Rulemaking for Certificate of Compliance No. 1008 Renewal, ML21168A352 Initial Issue, Amendment Numbers 1, 2, and 3 to HI-STAR 100 Cask System, dated June 28, 2021 Proposed Certificate of Compliance No. 1008, ML21168A353 Renewed Amendment No. 0 Proposed Technical Specifications (Appendix A) for Certificate of Compliance No. 1008, Renewed ML21168A354 Amendment No. 0 Proposed Technical Specifications (Appendix B) for Certificate of Compliance No. 1008, Renewed ML21168A355 Amendment No. 0 Proposed Certificate of Compliance No. 1008, ML21168A356 Renewed Amendment No. 1 Proposed Technical Specifications (Appendix A) for Certificate of Compliance No. 1008, Renewed ML21168A357 Amendment No. 1 Proposed Technical Specifications (Appendix B) for Certificate of Compliance No. 1008, Renewed ML21168A358 Amendment No. 1 Proposed Certificate of Compliance No. 1008, ML21168A359 Renewed Amendment No. 2 Proposed Technical Specifications (Appendix A) for Certificate of Compliance No. 1008, Renewed ML21168A360 Amendment No. 2 Proposed Technical Specifications (Appendix B) for Certificate of Compliance No. 1008, Renewed ML21168A361 Amendment No. 2 Proposed Certificate of Compliance No. 1008, ML21168A362 Renewed Amendment No. 3 22

Proposed Technical Specifications (Appendix A) for Certificate of Compliance No. 1008, Renewed ML21168A363 Amendment No. 3 Proposed Technical Specifications (Appendix B) for Certificate of Compliance No. 1008, Renewed ML21168A364 Amendment No. 3 Preliminary Safety Evaluation Report for Renewed Certificate of Compliance No. 1008, ML21168A365 Amendment Nos. 0, 1, 2, and 3 The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2021-0135.

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 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:

23

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. 1008 is revised to read as follows:

§ 72.214 List of approved spent fuel storage casks.

Certificate Number: 1008.

Initial Certificate Effective Date: October 4, 1999, superseded by Renewed Initial Certificate, on December 15, 2021.

Amendment Number 1 Effective Date: December 26, 2000, superseded by Renewed Amendment Number 1, on December 15, 2021.

Amendment Number 2 Effective Date: May 29, 2001, superseded by Renewed Amendment Number 2, on December 15, 2021.

Amendment Number 3 Effective Date: November 5, 2019, superseded by Renewed Amendment Number 3, on December 15, 2021.

SAR Submitted by: Holtec International.

SAR

Title:

Final Safety Analysis Report for the HI-STAR 100 Cask System.

Docket Number: 72-1008.

Certificate Expiration Date: October 4, 2019.

Renewed Certificate Expiration Date: October 4, 2059.

Model Number: HI-STAR 100 (MPC-24, MPC-32, MPC-68, MPC-68F).

24

Dated: September 15, 2021.

For the Nuclear Regulatory Commission.

/RA/

Margaret M. Doane, Executive Director for Operations.

25