ML25259A327
| ML25259A327 | |
| Person / Time | |
|---|---|
| Site: | 07100974 |
| Issue date: | 09/23/2025 |
| From: | Gerond George NRC/NMSS/DFM/IOB |
| To: | Vaughn S X-Energy |
| Shared Package | |
| ML25259A325 | List: |
| References | |
| Download: ML25259A327 (1) | |
Text
Mr. Stephen Vaughn Director, Reactor Licensing X-Energy, LLC 530 Gaither Road, Suite 700 Rockville, MD 20850
SUBJECT:
APPROVAL OF X-ENERGY, LLC QUALITY ASSURANCE PROGRAM FOR 10 CFR PART 71 TRANSPORTATION PACKAGE DESIGN
Dear Stephen Vaughn:
By letter dated June 19, 2025 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML25170A014), X-Energy, LLC. (hereafter referred to as X-Energy), requested approval of a quality assurance program (QAP) under the Title 10 of the Code of Federal Regulations (10 CFR ) Part 71, Packaging and Transportation of Radioactive Material. Specifically, X-Energy requested the U.S. Nuclear Regulatory Commission (NRC or Commission) for approval to apply its previously approved Appendix B to 10 CFR Part 50, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, Quality Assurance Program Description (QAPD) Topical Report, Revision 6, to 10 CFR Part 71 pursuant to 10 CFR 71.101(f) (ADAMS Accession No. ML24218A128).
Although normally a previously approved 10 CFR Part 50, Appendix B QAPD can be used for a 10 CFR Part 71 QAP under 10 CFR 71.101(f), in this case, X-Energys QAPD was approved with a limitation. Specifically, Limitation No. 1 in the NRCs safety evaluation of X-Energys QAPD Topical Report, Revision 6, states that X-Energys QAPD, Revision 6, is not approved for 10 CFR Part 71 activities. Because of this limitation, X-Energy has requested that NRC approve the QAP for 10 CFR Part 71, Subpart H, to supersede this limitation.
Only licensees, certificate holders, and applicants for a certificate of compliance (CoC) are eligible to have a QAP approved by the NRC under 10 CFR 71.101(c)(1) and (c)(2). The NRC notes that X-Energy is not yet a specific or general licensee, who can possess licensed material nor an applicant for a CoC for a transportation packaging approval and, pursuant to 10 CFR Part 71, it is not necessary to have an NRC-approved QAP prior to beginning packaging design activities. Historically, the NRC awaits until submission of a CoC application before approving a QAP that allows 10 CFR Part 71 fabrication activities.
In this instance, because X-Energy has stated their intention to submit a CoC application in the near term, the NRC will approve the previously approved 10 CFR Part 50 QAPD Revision 6, for activities conducted under 10 CFR Part 71with the following conditions in NRC Form 311:
1.
Activities conducted regarding transportation packaging are to be executed under September 23, 2025
S. Vaughn 2
applicable criteria of Appendix B to 10 CFR Part 50. Authorized activity includes design. Design activities are only authorized for new transportation packaging or those for which X-Energy is the CoC holder.
2.
Upon submittal of a CoC application for a transportation packaging to the NRC in accordance with the provisions of 10 CFR 71 subpart D, additional authorized activities under the applicable criteria of Appendix B to 10 CFR Part 50 that will be effective include, but are not limited to: procurement, fabrication, assembly, testing, modification, maintenance, repair, and use.
3.
This approval removes Limitation No. 1 imposed in the NRCs Final Safety Evaluation For X-Energys QAPD Topical Report, Revision 6, dated February 11, 2025.
This allows X-Energy to move forward with confidence that an acceptable QAP will be in place for designing transportation packages; and, for future transportation activities, effective upon X-Energys submittal of a CoC application.
If you have any questions or additional concerns regarding this communication, please contact Raju Patel at (301) 415-3511.
Sincerely, Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No: 71-0974
Enclosure:
NRC 311 QAP Approval Signed by George, Gerond on 09/23/25
ML25259A325 (pkg), ML25259A327 (ltr), ML25259A326 (form 311)
OFFICE:
NMSS/DFM NMSS/DFM OGC NLO NRR/DRO/NQVB NMSS/DFM NAME:
RPatel WWheatley ACoggins KKavanagh GGeorge DATE:
09/17/2025 09/17/2025 09/22/2025 09/22/2025 09/23/2025