ML25330A003
| ML25330A003 | |
| Person / Time | |
|---|---|
| Site: | 99902041 |
| Issue date: | 12/17/2025 |
| From: | Ngola Otto Licensing Processes Branch |
| To: | Marshall M Licensing Processes Branch |
| References | |
| EPID L-2025-LRO-0038 NEI 22-04 | |
| Download: ML25330A003 (0) | |
Text
December 17, 2025 MEMORANDUM TO: Michael L. Marshall, Jr., Chief (Acting)
Licensing Projects Branch Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation FROM:
Ngola A. Otto, Project Manager
/RA/
Licensing Projects Branch Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation
SUBJECT:
SUMMARY
OF SEPTEMBER 18, 2025, MEETING WITH NUCLEAR ENERGY INSTITUTE REPRESENTATIVES AND THE U.S. NUCLEAR REGULATORY COMMISSION STAFF ON NEI 22-04, REVISION 0, UTILIZATION OF ISO 9001 AND OTHER NON-NUCLEAR SUPPLIERS FOR SAFETY-RELATED APPLICATIONS (EPID L-2025-LRO-0038)
On September 18, 2025, the U.S. Nuclear Regulatory Commission (NRC) staff held a hybrid public meeting at NRC headquarters and via Microsoft Teams with representatives from the Nuclear Energy Institute (NEI). Other industry representatives also attended the meeting remotely. The purpose of this meeting was for the NRC staff to get clarification from NEI regarding its submittal of the NEI 22-04, Revision 0, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-related Applications, May 2025 (Agencywide Documents Access and Management System (ADAMS) No. ML25162A176) and to provide preliminary feedback before issuance of its response letter. The meeting notice dated September 5, 2025, is available in the ADAMS at Accession No. ML25248A222 and the list of attendees is enclosed.
During meeting the NRC staff and NEI representatives discussed four main topic areas, which are described in the NRCs response letter dated November 14, 2025 (ML25260A045). Specific NRC staffs questions pertained to the need for an alternate process, rationale, overall motivation, supply chain, NQA-1 suppliers, commercial grade dedication (CGD), and not using the approved 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, process. The NEI representatives explained that CGD is not adequate for many components, therefore NEI 22-04 would provide for a larger scale of suppliers. In addition, very few suppliers in the United States use ISO 19443 and NEI 22-04 would be expandable to ISO 19443. There were other clarifications provided regarding how NEI 22-04 would work with the NQA-I program and the Title 10 of the Code of Federal Regulation (10 CFR) Part 21, Reporting of Defects and Noncompliance, process.
CONTACT: Ngola Otto, NRR/DORL 301-415-6695 Nuclear Procurement Issues Corporation (NUPIC) representatives expressed concerns regarding NEI 22-04 and explained that they were not involved in the decisions pertaining to NEI 22-04. In June 2025, NUPIC sent a letter (ML25175A185) to the NRCs Acting Director of the Office of Nuclear Reactor Regulation expressing nonsupport for NEI 22-04. The chair of the American Society of Mechanical Engineers committee also expressed some concerns regarding NEI 22-04. There were several questions and comments from members of the industry and the public. The NRC plans to meet with NEI in the near term to discuss the process for review of NEI 22-04, Revision 0. No regulatory decisions and commitments were made at the meeting.
Docket No. 99902041
Enclosure:
List of Attendees
Enclosure List of Attendees Meeting between Nuclear Energy Institute and the U.S. Nuclear Regulatory Commission on NEI 22-04, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-related Applications September 18, 2025 1:00 pm - 2:00 pm NAME ORGANIZATION Marcus Nichol Nuclear Energy Institute (NEI)
Mark Richter NEI A Keim U. S. Nuclear Regulatory Commission (NRC)
Kerri Kavanagh NRC Yamir Diaz-Castillo NRC Yiu Law NRC Jeremy Groom NRC Phil McKenna NRC Josh Borromeo NRC Aida Rivera-Varona NRC Mehdi Reisi Fard NRC Stephen Philpott NRC Ngola Otto NRC Jennie Rankin NRC Eric Nour NRC Frankie Vega NRC Carolyn Lauron NRC Abbt Matheus Tim Czuba Roger Mills Milton Concepcion Constellation Nuclear Joe Pennington Steve Unikewicz NAME ORGANIZATION Phil Pfeiffer Richard Knott Pascal Ancion Mark Coren Kris Cummings Musicale Leanne Shular Quality Assurance Amy Tyson Jim Nikola Mineka Taltoan Monika Thiede Robert Symes Michael L Hedden Abhijit sengupta Neel N Shukla Marc Tannenbaum Thomas J Vogan Urvish Savani Quality Assurance Howard LeCompte Michael Wautlet Maurizio V. Tuse Niko McMurray Joel M. Davis Joshua Hart Don Bentley Andrés Torralba Piqueras Pat Scouten Taunia Jean Sandquist Adrienne Lindsay Hudson NAME ORGANIZATION Justin Youngblood Aixa Belen-Ojeda X-energy Brent Hamilton Thomas Marcille Kate Matt Fredrick Brian Stanley E Griffin GE Vernova Doug Crawford Antares Deric Tilson BTI Leslie Casey Jake Dolecki Douglas VanTassell Tudor Comsa Lara Chern Patrick Donnelly TP Tanja Nikacevic Memarie Burke Guy Robinson Joshua Luppert Kyle Ulassin Alber French Chanson MKS
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ML25330A003 (Summary)
- via email OFFICE NRR/DORL/LLPB/PM*
NRR/DORL/LLPB/LA*
NRR/DRO/IQVB/BC*
NRR/DORL/LLPB/BC*
NAME NOtto DHarrison KKavanagh MMarshall(A)
DATE 12/3/2025 12/4/2025 12/10/2025 12/16/2025 OFFICE NRR/DORL/LLPB/PM*
NAME NOtto DATE 12/17/2025