Interim Enforcement Policy for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder-Generated Changes

<RULE> NUCLEAR REGULATORY COMMISSION <CFR>10 CFR Part 72</CFR> <DEPDOC>[NRC-2025-0064]</DEPDOC> <SUBJECT>Interim Enforcement Policy for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder-Generated Changes</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Nuclear Regulatory Commission. <HD SOURCE="HED">ACTION:</HD> Policy statement; issuance. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The U.S. Nuclear Regulatory Commission (NRC) is issuing an Interim Enforcement Policy (IEP) titled, “Enforcement Discretion for General Licensee Adoption of CoC Holder-Generated Changes.” This IEP allows enforcement discretion for certain general licensee violations related to their adoption of a change generated by the Certificate of Compliance holder. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The policy statement is effective on August 15, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Please refer to Docket ID NRC-2025-0064 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: • <E T="03">Federal Rulemaking Website:</E> Go to <E T="03">https://www.regulations.gov</E> and search for Docket ID NRC-2025-0064. Address questions about NRC dockets to Helen Chang; telephone: 301-415-3228; email: <E T="03">Helen.Chang@nrc.gov</E> . For technical questions contact the individual listed in the <E T="02">FOR FURTHER INFORMATION CONTACT</E> section of this document. • <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E> You may obtain publicly available documents online in the ADAMS Public Documents collection at <E T="03">https://www.nrc.gov/reading-rm/adams.html</E> . 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 <E T="03">PDR.Resource@nrc.gov</E> . For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section. • <E T="03">NRC's PDR:</E> The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to <E T="03">PDR.Resource@nrc.gov</E> or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. ET, Monday through Friday, except Federal holidays. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Gerond A. George, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-3882, email: <E T="03">Gerond.George@nrc.gov,</E> U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> The Certificate of Compliance (CoC or certificate) is the NRC approved design for each dry cask storage system. Title 10 of the <E T="03">Code of Federal Regulations</E> (10 CFR) 72.48, “Changes, tests, and experiments,” establishes the conditions under which a general or specific licensee, and a spent fuel storage cask certificate holder may make changes to their independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation facility (MRS), spent fuel storage cask design, or procedures, and under which they may conduct tests or experiments, without prior NRC approval. In addition to the 10 CFR 72.48 change review process, paragraph (b)(7) of 10 CFR 72.212, “Conditions of general license issued under 10 CFR 72.210,” also requires the general licensee to evaluate any changes to written evaluations required by paragraphs (b)(5) and (6) of 10 CFR 72.212, using the requirements of 10 CFR 72.48(c). Moreover, there are various provisions in 10 CFR 72.212, such as paragraphs (a)(2), (b)(3), (b)(5)(i), and (b)(11), that require general licensees to ensure they use casks that conform to the terms, conditions and specifications of a CoC listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” Therefore, if a general licensee wishes to adopt a change initiated by the CoC holder under the CoC holder's 10 CFR 72.48 change authority, the general licensee must perform a separate 10 CFR 72.48 review as required by the regulations. Additionally, if a general licensee adopts a CoC holder's change made under 10 CFR 72.48 and that change is later determined to be noncompliant, the general licensee would also be in noncompliance with provisions of 10 CFR 72.48 and 10 CFR 72.212. The NRC is implementing a more efficient process in which the staff addresses CoC holders' apparent violations of the 10 CFR 72.48 change control process without pursuing an enforcement action against the general licensee for an apparent violation that is strictly due to the general licensee's adoption of a noncompliant change made under § 72.48 by the CoC holder. The NRC is also implementing a more efficient process for general licensees to review and adopt changes made by a CoC holder, pursuant to the CoC holder's § 72.48 change authority, as long as the general licensee does not need to make any site-specific technical changes. Accordingly, the staff is considering rulemaking, including potential interpretation of the applicable regulations, and revision of the implementation guidance. <HD SOURCE="HD1">II. Discussion</HD> <HD SOURCE="HD2">A. Rulemaking</HD> The NRC published a final rule on October 4, 1999 (64 FR 53582) that revised 10 CFR 72.48 to clarify the specific types of changes, tests, and experiments conducted at a licensed facility or by a certificate holder that require evaluation, and revised the criteria that licensees and certificate holders must use to determine when NRC approval is needed before such changes, tests, or experiments can be implemented. The Commission approved the publication of the final rule in SECY-99-130, “Final Rule—Revisions to Requirements of 10 CFR parts 50 and 72 Concerning Changes, Tests, and Experiments.” The preamble to the final rule for 10 CFR 50.59 and 10 CFR 72.48 stated the following in Section O.1, “Part 72 Changes,” provided on page 53601: “The Commission envisioned that a general licensee who wants to adopt a change to the design of a spent fuel storage cask it possesses—which change was previously made to the generic design by the certificate holder under the provisions of § 72.48—would be required to perform a separate evaluation under the provisions of § 72.48 to determine the suitability of the change for itself.” As indicated by the rule and supported by the preamble, both the CoC holder and general licensee are required to perform an evaluation when implementing a change made by a CoC holder pursuant to § 72.48. The NRC staff may request that the Commission revise its regulations or interpretation of existing regulations to establish that CoC holders and general licensees have different obligations. The NRC staff may seek this change because both entities have separate quality assurance programs, and the NRC staff performs inspections of each change control process on a regular basis, which would provide reasonable assurance of safety and increase regulatory efficiency. Specifically, the efficiency will be realized by streamlining the inspections associated with the evaluation of the changes to focus (1) on CoC holders and (2) on general licensees only to the extent the general licensees make site-specific, technical changes. <HD SOURCE="HD2">B. Summary</HD> This IEP allows staff to exercise enforcement discretion for certain general licensee violations of 10 CFR 72.48 and 10 CFR 72.212 related to the general licensee's adoption of a CoC holder-generated modification. This IEP also allows for better efficiency and reliability of spent fuel storage cask inspection oversight, while still providing adequate protection of public health and safety. The NRC is issuing this IEP due to the NRC's operational experience with its inspection and oversight of general licensees' adoption of CoC holders' § 72.48 changes. Certificate holders are NRC-regulated entities that are required to (1) ensure their storage casks meet NRC requirements and the Certificate of Compliance and (2) perform design changes in accordance with § 72.48; the NRC inspects their processes. In addition, the NRC recognizes that a general licensee who wants to adopt a change to the design of a spent fuel storage cask it possesses—where the change was previously made by the certificate holder under the provisions of § 72.48—must perform a review of that change for their site under a variety of other processes other than § 72.48, including those set forth in paragraphs (b)(5) and (6) of § 72.212, and in the general licensee quality assurance program. The combination of these review and oversight processes, together with other existing inspection and oversight processes, provide confidence that the general licensee has appropriately considered changes made by CoC holders and appropriately evaluated the potential safety implications of implementing those <FP>changes at its site. For these reasons, the NRC determined that this IEP continues to provide adequate protection of public health and safety while enabling the safe and secure use of civilian nuclear energy technologies. This approach also aligns with the NRC's mission statement and the Principles of Good Regulation.</FP> Following issuance of the IEP, the NRC will explore a rulemaking solution to eliminate the requirement that a GL must always perform a 10 CFR part 72.48 evaluation when adopting CoC holder-generated changes. The NRC plans to review the regulations in 10 CFR part 72 and guidance documents to determine whether rulemaking, including potential interpretation of the applicable regulations, and/or ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 31k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━