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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations 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 HISTAR 100 Cask System design by adding it to the list of NRC-approved cask designs in 72.214
as Certificate of Compliance No. 1008.
On December 7, 2018, Holtec International requested a renewal of the initial certificate and Amendment Nos.
1, 2, and 3 of the HISTAR 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 72.240b, 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 HISTAR 100 Cask System to unload spent fuel from these systems and return it to a spent fuel pool or reload 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 sitespecific 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
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would entail either 1 more environmental impacts than the preferred action from transferring the spent fuel now in the HISTAR 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 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 NRCs 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 HISTAR 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 20year 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,
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Question I, 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 HISTAR
100 Cask Systems after the initial 20year 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.
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.

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