ML25260A045
| ML25260A045 | |
| Person / Time | |
|---|---|
| Site: | 99902028 |
| Issue date: | 11/14/2025 |
| From: | Aida Rivera-Varona Licensing Processes Branch |
| To: | Nichol M Nuclear Energy Institute |
| References | |
| EPID L-2025-LRO-0038, NEI 22-04 | |
| Download: ML25260A045 (1) | |
Text
NUCLEAR ENERGY INSTITUTES REPORT NO. 22-04, UTILIZATION OF ISO 9001 AND OTHER NON-NUCLEAR SUPPLIERS FOR SAFETY-RELATED APPLICATIONS (EPID: L-2025-LRO-0038)
Dear Mr. Nichol:
This letter acknowledges receipt of the Nuclear Energy Institutes (NEIs), May 22, 2025, letter to the U.S. Nuclear Regulatory Commission (NRC) submitting Revision 0 of NEI 22-04, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-related Applications,1 for the NRC staffs review and endorsement. The NEI letter and its attachment contain guidance to provide an alternative approach for suppliers of safety-related components to meeting the requirements of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
The NRC staff agrees with the high-level concepts outlined in your letter and has not identified any fundamental gaps with the NRCs ongoing and planned activities that would deter implementation of the proposal. The NRC is committed to an efficient, timely, and predictable process for the review of NEI 22-04. The NRC staff conducted an initial review of your request and identified some areas for discussion. On September 18, 20252, the NRC met with you and shared the following comments:
In your letter, you state that the increasing demand for nuclear-grade components needs an option for a more direct and scalable path. The NRC agrees that the methodology outlined in NEI 22-04, if approved, could provide such a path. However, the NRC cautions that achieving this outcome will require end users to possess a strong understanding of both Appendix B to 10 CFR Part 50 and ISO 9001, Quality Management Systems - Requirements, in order to effectively identify and address the gaps between the two frameworks.
1 Letter from M. Nichol to M. King, Request for Endorsement and Fee Exemption for NEI 22-04, Revision 0, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-related Applications, dated May 22, 2025, Agencywide Documents and Access Management System (ADAMS) Package Accession No. ML25162A176.
2 September 18, 2025 Public Meeting with NEI Representatives and NRC staff on NEI 22-04, Revision 0, "Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-related Applications ADAMS Accession No. ML25248A222.
November 14, 2025 Mr. Marcus Nichol Executive Director, New Nuclear Nuclear Energy Institute 1201 F St., NW Suite 1100 Washington, DC 20004-1218
SUBJECT:
U.S. NUCLEAR REGULATORY COMMISSIONS RESPONSE TO THE
M. Nichol
- On June 20, 2025,3 and September 2, 2025,4 the NRC received two letters from the nuclear industry expressing concerns and withholding support for the NRCs endorsement of NEI 22-04. The NRC staff believes it would be beneficial for NEI to further explore how these industry concerns might be addressed and resolved.
In SECY-03-0117, Approaches for Adopting More Widely Accepted International Quality Standards, the NRC discusses the use of ISO 9001-certified suppliers.
Specifically, the document notes that ISO 9001 outlines requirements for a quality management system intended to demonstrate an organizations ability to consistently provide products that meet customer and applicable regulatory requirements, while also enhancing customer satisfaction. ISO certification involves a formal accreditation and supplier certification process. In contrast, NEI 22-04 proposes a gap assessment approach that relies heavily on the knowledge and experience of those conducting the assessment. The NRC has noted that ISO 9001 certification offers a more robust and repeatable process, less prone to error, and therefore would be preferable to a gap assessment alone.
ISO has also developed a nuclear sector-specific standard, ISO 19443, Quality Management Systems - Specific Requirements for the Application of ISO 9001:2015 by Organizations in the Supply Chain of the Nuclear Energy Sector Supplying Products and Services Important to Nuclear Safety. NEI did not specifically address ISO 19443, citing the limited number of suppliers currently certified to this standard and the potential for remaining gaps between ISO 19443 and 10 CFR 50, Appendix B programs that would still necessitate a gap assessment. While the NRC staff understands NEIs rationale, it also notes that ISO 19443, having been developed specifically for nuclear applications, may be better suited to support the increasing demand for nuclear-grade components through a more direct and scalable path.
The NRC staff may identify further areas that require additional information or discussion as it conducts its detailed review. Should you have any questions on this matter, please contact please contact Ngola Otto at 301-415-6695 or via email at Ngola.Otto@nrc.gov.
Sincerely, Aida Rivera-Varona, Acting Director Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 99902028 3 Letter from E. Mayhorn to M. King, Nuclear Procurement Issues Corporation Steering Committee letter related to NEI 22-04, dated June 20, 2025, ADAMS Accession No. ML25175A185.
4 Letter from K. Hyam to G. Bowman, Preserving Nuclear Safety through Continued Use of ASME NQA-1-for Safety-Related Applications: A Response to NEI 22-04, dated September 2, 2025, ADAMS Accession No. ML25246C400.
Signed by Rivera-Varona, Aida on 11/14/25
ML25260A045 OFFICE NRR/DORL/LLPB/PM*
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NAME NOtto DHarrison KKavanagh JRankin DATE 09/25/2025 09/26/2025 09/26/2025 09/26/2025 OFFICE NRR/DRO/D NRR/DORL/D (A)*
NAME PMcKenna ARivera-Varona DATE 09/26/ 2025 11/14/2025