ML25118A058
| ML25118A058 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 04/25/2025 |
| From: | Mccullum R Nuclear Energy Institute |
| To: | Shana Helton Office of Nuclear Material Safety and Safeguards |
| References | |
| NRC-025-0064, PR-72, 90FR14917 00001 | |
| Download: ML25118A058 (1) | |
Text
From:
Shana Helton To:
Yoira Diaz Sanabria; Lisa Regner Cc:
Gerond George; Cinthya Roman
Subject:
FYI: Interim Enforcement Policy (IEP) for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder Generated Changes (Docket ID NRC-2025-0064)
Date:
Friday, April 25, 2025 2:39:36 PM Attachments:
04-25-25_Interim Enforcement Policy for GL Adoption of CoC Holder Generated Changes (Docket ID NRC-2025-0064).pdf FYI
From: McCULLUM, Rodney <rxm@nei.org>
Sent: Friday, April 25, 2025 2:17 PM To: Shana Helton <Shana.Helton@nrc.gov>
Cc: Mirela Gavrilas <Mirela.Gavrilas@nrc.gov>; John Lubinski <John.Lubinski@nrc.gov>; Brooke Clark
<Brooke.Clark@nrc.gov>; Carrie Safford <Carrie.Safford@nrc.gov>; David Pelton
<David.Pelton@nrc.gov>; Mike King <Michael.King2@nrc.gov>
Subject:
[External_Sender] Interim Enforcement Policy (IEP) for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder Generated Changes (Docket ID NRC-2025-0064)
THE ATTACHMENT CONTAINS THE COMPLETE CONTENTS OF THE LETTER
April 25, 2025 Ms. Shana Helton Director, Division of Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
Subject:
Interim Enforcement Policy (IEP) for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder Generated Changes, 90 Federal Register 14,917, April 7 2025 (Docket ID NRC-2025-0064)
Submitted via Regulations.gov
Dear Ms. Helton,
On behalf of our members, the Nuclear Energy Institute (NEI)[1] writes to express our appreciation for NRCs responsiveness to our February 28, 2025, letter providing comments on Enforcement Guidance Memorandum (EGM) 25-001, Enforcement Guidance for Dispositioning Noncompliances Related to a General Licensees Use of Certain Non-Qualified Spent Fuel Casks.[2] This letter provides our comments on NRCs proposed
Interim Enforcement Policy (IEP), Interim Enforcement Policy for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder-Generated Changes.[3]
Given that thousands of hours of NRC staff and industry time have already been expended addressing the issue without improving safety, we believe that NRC staff should expedite resolution of this issue to provide regulatory predictability. Prompt issuance of the IEP and withdrawal of EGM 25-001 would achieve that objective. However, an even more expeditious, efficient and equally viable path would be for NRC to close this issue by reaffirming its longstanding position and endorsement of industry guidance explaining how these programs are implemented and withdraw EGM 25-001. Licensees are tracking the progress of the IEP and will continue to act in a manner consistent with the regulatory position presented in the draft IEP and consistent with longstanding industry practice until an agency position is finalized. Finally, as NRC proceeds, it is of utmost importance that staff present a more complete picture of the regulatory history of this issue. To facilitate this, we offer the following comments on the IEP.
In conclusion, industry agrees with NRCs stated intent to implement a more efficient regulatory process to resolve this issue. If the NRC staff determines that pursing Commission approval of the approach used to close this issue is necessary, we respectfully request that the Commission be provided with a complete description of the regulatory history of this issue - including the endorsement history of NEI 12-04 (and Appendix B to NEI 96-07 before it). Again, we believe this regulatory history and the language of 10 CFR 72.48 would allow a solution path that reaffirms the approach provided in the existing NRC-endorsed industry guidance, without the need for additional resource-intensive rulemaking.
Regardless of the closure pathway chosen by the agency, we look forward to working with staff to implement any additional actions necessary to effectively and effciently resolve this matter.
If you have any questions regarding this request, please contact me at rxm@nei.org.
Sincerely, Rod McCullum Senior Director, Decommissioning and Used Fuel
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[1] The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.
[2] NEI, Letter from J. Uhle (NEI) to J. Lubinski (NRC), Enforcement Guidance Memorandum 25-001, Enforcement Guidance for Dispositioning Noncompliances Related to a General Licensees Use of Certain Non-Qualified Spent Fuel Casks, (Feb. 28, 2025)
(ML25083A106).
[3] 90 Fed. Reg. 14917 (April 7, 2025).
Rodney McCullum Sr. Director, Decommissionin and Used Fuel Phone: 202.739.8082 Email: rxm@nei.org April 25, 2025 Ms. Shana Helton Director, Division of Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
Subject:
Interim Enforcement Policy (IEP) for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder Generated Changes, 90 Federal Register 14,917, April 7 2025 (Docket ID NRC-2025-0064)
Submitted via Regulations.gov
Dear Ms. Helton,
On behalf of our members, the Nuclear Energy Institute (NEI)1 writes to express our appreciation for NRCs responsiveness to our February 28, 2025, letter providing comments on Enforcement Guidance Memorandum (EGM) 25-001, Enforcement Guidance for Dispositioning Noncompliances Related to a General Licensees Use of Certain Non-Qualified Spent Fuel Casks.2 This letter provides our comments on NRCs proposed Interim Enforcement Policy (IEP), Interim Enforcement Policy for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder-Generated Changes.3 Given that thousands of hours of NRC staff and industry time have already been expended addressing the issue without improving safety, we believe that NRC staff should expedite resolution of this issue to provide regulatory predictability. Prompt issuance of the IEP and withdrawal of EGM 25-001 would achieve that objective. However, an even more expeditious, efficient and equally viable path would be for NRC to close this issue by reaffirming its longstanding position and endorsement of industry guidance explaining how these programs are implemented and withdraw EGM 25-001. Licensees are tracking the progress of the IEP and will continue to act in a manner consistent with the regulatory position presented 1 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.
2 NEI, Letter from J. Uhle (NEI) to J. Lubinski (NRC), Enforcement Guidance Memorandum 25-001, Enforcement Guidance for Dispositioning Noncompliances Related to a General Licensees Use of Certain Non-Qualified Spent Fuel Casks, (Feb. 28, 2025)(ML25083A106).
3 90 Fed. Reg. 14917 (April 7, 2025).
Ms. Shana Helton April 25, 2025 Page 2 Nuclear Energy Institute in the draft IEP and consistent with longstanding industry practice until an agency position is finalized.
Finally, as NRC proceeds, it is of utmost importance that staff present a more complete picture of the regulatory history of this issue. To facilitate this, we offer the following comments on the IEP.
- 1. The IEP reaches the correct conclusion about how 10 CFR 72.48 should be applied to general licensees.
NEI agrees with the position articulated in the IEP that the NRC should address apparent violations of the 10 CFR 72.48 change control process by a Certificate of Compliance holder (CoC holder), without pursuing separate enforcement actions against general licensees for alleged violations of section 72.48 that are due to the general licensees adoption of a noncompliant change made by the CoC holder. We also agree that an efficient process whereby general licensees can adopt changes made by a CoC holder pursuant to section 72.48, as long as the general licensee does not need to make any site-specific technical changes is essential to efficient and effective implementation of 10 CFR 72.48.4
- 2. The approach for applying 10 CFR 72.48 to general licensees described in the IEP is not new.
As explained in our comments on EGM 25-001, the position reflected in the IEP is precisely the approach that has been endorsed by the NRC and consistently followed by the industry for the past 24 years.5 Specifically, the longstanding NRC-endorsed guidance in NEI 12-04 (and its predecessor, Appendix B to NEI 96-07) clearly and repeatedly states that general licensees may adopt changes made to cask designs by CoC holders without undertaking a duplicative 10 CFR 72.48 evaluation, provided that the change does not affect site-specific reports, procedures, calculations, or equipment required by 10 CFR 72.212.6 This position is also reflected in the relevant NRC inspection procedure.7 Without acknowledging the long history of endorsement of NEI 12-04 and Appendix B to NEI 96-07, the IEP takes the position that the approach prescribed in those documents for adoption of CoC holder changes by general licensees - and which the NRC seeks to implement under the IEP - is inconsistent the requirements of 10 CFR 72.48.8 Thus, the draft IEP seems to reach the conclusion that the NRC has endorsed an method of compliance for nearly two-and-a-half decades that, in fact, violates 10 CFR 72.48.
4 Id. at 14918.
5 NRC, Guidance for Implementation of 10 CFR 72.48, Changes, Tests, and Experiments, Regulatory Guide 3.72, Revision 1 (Sept. 2020); see also NRC, Guidance for Implementation of 10 CFR 72.48, Changes, Tests, and Experiments, Regulatory Guide 3.72 (March 2001).
6 See NEI, Guidelines for 10 CFR 72.48 Implementation, NEI 12-04, Revision 2 (Sept. 2018)(NEI 12-04), at sections 2.5, 3.1.5.1, 3.1.5.3, and 4.7.
7 See NRC, Inspection Procedure 60857, Review of 10 CFR 72.48 Evaluations, Jan. 1, 2021, at section 03.01 ([F]or general licensees, the inspectors should review a list of CoC holder performed 10 CFR 72.48 CTEs and confirm that an adoption of the change did not affect the site-specific procedures and/or 10 CFR 72.212, Conditions of general license issued under 72.210 evaluation and, therefore, would require that the change be evaluated through the 10 CFR 72.48 process.).
8 [I]f a general licensee wishes to adopt a change initiated by the CoC holder under the CoC holders 10 CFR 72.48 change authority, then a general licensee must perform a separate 10 CFR 72.48 review as required by the regulations. Additionally, if a general licensee adopts a CoC holders change made under 10 CFR 72.48 and that change is later determined to be non-compliant, the general licensee would also be in noncompliance with provisions of 10 CFR 72.48 and 72.212. 90 Fed. Reg. 14918.
Ms. Shana Helton April 25, 2025 Page 3 Nuclear Energy Institute
- 3. Continued adherence to the approach provided in NEI 12-04 and suggested in the IEP does not compel changes to 10 CFR 72.48.
Paragraph (c) of section 72.48 provides criteria to be used by CoC holders and licensees to determine whether NRC approval is required prior to incorporating a proposed change, test, or experiment. Given that general licensees are relying upon dry cask storage systems (DSS) approved through the CoC process, paragraph 72.48(c)(2) requires that such licensees request that a CoC holder obtain a CoC amendment pursuant to section 72.244 prior to implementing a proposed change, test, or experiment that would meet any of the criteria provided in 72.48(c)(2)(i)-(viii). The requirement for general licensees to request that a CoC holder request a CoC amendment is clearly applicable to situations where the general licensee initiates and desires to implement a change, test, or experiment that has not been evaluated by the CoC holder. However, the general licensees responsibilities under section 72.48 in situations where the CoC holder has already implemented such changes to a dry cask system after performing a 72.48 evaluation is not explicitly addressed in section 72.48. The interpretation of the general licensees responsibilities in this situation provided in NEI 12-04 and endorsed by the NRC in Regulatory Guide 3.72 is a reasonable interpretation of the text of section 72.48 and is consistent with the overall general licensing framework established in Part 72.
Further, although requirements cannot be imposed in the preamble to final regulations, we understand that such language can provide guidance on how to properly interpret such regulations. Like EGM 25-001, the IEP points to language in the preamble of the 1999 final rule promulgating section 72.48 to support its interpretation. That language states:
The Commission envisioned that a general licensee who wants to adopt a change to the design of a spent fuel storage cask it possesseswhich change was previously made to the generic design by the certificate holder under the provisions of § 72.48would be required to perform a separate evaluation under the provisions of § 72.48 to determine the suitability of the change for itself.9 While this statement communicates the Commissions vision when it developed the 1998 proposed rule that preceded the 1999 final rule, it is not revisited or further explained in describing the provisions promulgated in the 1999 final rule.10 More importantly, the Commission did not articulate what the separate evaluation a general licensee was to use to determine the suitability of the [CoC holders]
change for itself should entail.
The NRC staff interpretation of both the language of 10 CFR 72.48 and the 1999 preamble language soon after the rule was finalized clearly did not view either as compelling the conclusion regarding 9 NRC, Changes, Tests, and Experiments: Final Rule, 64 Fed. Reg. 53582, 53601-602 (Oct. 4, 1999).
10 This language is contained in Section O.1. Part 72 Changes of the preamble to the 1999 final rule. The introduction to that section explains that [t]his section discusses the changes offered in the proposed rule on part 72, then discusses the comments received and the resolution and final rule language. 64 Fed. Reg. 53601. The language quoted in the IEP appears immediately under the subheading Changes Presented in the Proposed Rule.
Ms. Shana Helton April 25, 2025 Page 4 Nuclear Energy Institute noncompliance with 10 CFR 72.48 articulated in the IEP. Specifically, in March 2001 the NRC endorsed Appendix B to NEI 96-07 in Regulatory Guide 3.72.11 And it did so with full knowledge of the preamble language, which was quoted in section B4.1.7 of Appendix B. This endorsement appropriately provided the necessary clarity on this issue, incorporating a rational approach that a general licensees review of changes incorporated by a CoC holder focused on the site-specific impacts of such changes.
- 4. NRCs subsequent endorsement of NEI 12-04 specifically addressed consistency with the preamble of the 1999 final rule.
Revision 1 to Regulatory Guide 3.72 was issued in September 2020.12 Revision 1 endorses NEI 12-04, Revision 2, Guidelines for 10 CFR 72.48 Implementation. NEI 12-04, Revision 2 updated and revised Appendix B to NEI 96-07, but did not significantly change, the guidance previously provided on general licensee adoption of changes made and evaluated by the CoC holder. There was much discussion between the industry and NRC regarding endorsement of NEI 12-04, Revision 2. For example, in an August 2016 letter, NEI described 11 fundamental and key issues that required resolution to facilitate the endorsement of NEI 12-04. Among these issues was Fundamental Issue number 2 - General licensee processing of CoC holder 72.48s.13 Specifically, NEIs August 2016 letter responded to NRCs comments on previous iterations of NEI 12-04. Those comments expressed the NRCs view that the position articulated in those previous iterations of NEI 12-04, which simply repeated the NRC-endorsed guidance in Appendix B to NEI 96-07, was inconsistent with the 1999 preamble language. In response to those comments, NEI suggested several revisions to NEI 12-04.
The NRC responded to NEIs proposed resolution in a March 2017 letter.14 In that letter, the NRC stated,
[t]he staff finds the addition of the three-part categorization and the proposal to add a flow chart should address the staffs concerns on Issue 2 because it provides the process and categories of changes that apply to general licensees.15 Revision 1 to Regulatory Guide 3.72 was issued in September 2020 and endorsed NEI 12-04, Revision 2 as generally acceptable for use in complying with the requirements of 10 CFR 72.48 with certain exceptions and clarifications. None of those exceptions or clarifications addressed issues that are relevant to the issues addressed in the IEP.
As demonstrated above, the NRC has consistently interpreted 10 CFR 72.48 as allowing the approach suggested as the agencys desired resolution path in the IEP through its longstanding endorsement of both Appendix B to NEI 96-07 and NEI 12-04. The agency did so with full awareness of the preamble 11 NRC, Guidance for Implementation of 10 CFR 72.48, Changes, Tests, and Experiments, Regulatory Guide 3.72, (March 2001).
12 NRC, Guidance for Implementation of 10 CFR 72.48, Changes, Tests, and Experiments, Regulatory Guide 3.72, Revision 1 (Sept. 2020).
13 Letter from R. McCullum (NEI) to P.A. Silva (NRC), Industry Summary of Meeting with the NRC Pertaining to NEI 12-04, Guidelines for 10 CFR 72.48 Implementation, Revision 0, Dated August 2012, (Aug. 8, 2016), at Enclosure pg. 1.
14 Letter from P.A. Silva (NRC) to R. McCullum (NEI), U.S. Nuclear Regulatory Commission Response to Industry Summary Meeting Conducted to Discuss Fundamental Issues Regarding Nuclear Energy Institute Submittal: Guidelines for Title 10 of the Code of Federal Regulations 72.48 Implementation, Revision 0, (March 3, 2017).
15 Id. at Enclosure, pg. 2.
Ms. Shana Helton April 25, 2025 Page 5 Nuclear Energy Institute language accompanying the 1999 final rule, and after explicitly evaluating the consistency of that language with the method of compliance currently provided in Revision 2 of NEI 12-04.
In conclusion, industry agrees with NRCs stated intent to implement a more efficient regulatory process to resolve this issue. If the NRC staff determines that pursing Commission approval of the approach used to close this issue is necessary, we respectfully request that the Commission be provided with a complete description of the regulatory history of this issue - including the endorsement history of NEI 12-04 (and Appendix B to NEI 96-07 before it). Again, we believe this regulatory history and the language of 10 CFR 72.48 would allow a solution path that reaffirms the approach provided in the existing NRC-endorsed industry guidance, without the need for additional resource-intensive rulemaking.
Regardless of the closure pathway chosen by the agency, we look forward to working with staff to implement any additional actions necessary to effectively and effciently resolve this matter.
If you have any questions regarding this request, please contact me at rxm@nei.org.
Sincerely, Rod McCullum Senior Director, Decommissioning and Used Fuel C:
Mirela Gavrilas, Executive Director for Operations John Lubinski, Office of Nuclear Material Safety and Safeguards Brooke Clark, Office of the General Counsel Carrie Safford, Office of the Secretary David Pelton, Office of Enforcement Mike King, Office of Nuclear Reactor Regulation