ML24222A646
| ML24222A646 | |
| Person / Time | |
|---|---|
| Site: | 99902098 |
| Issue date: | 08/09/2024 |
| From: | Cuadrado De Jesus S Office of Nuclear Reactor Regulation |
| To: | Bolin J General Atomics Electromagnetic System |
| References | |
| Download: ML24222A646 (1) | |
Text
From:
Samuel Cuadrado de Jesus To:
Bolin, John Cc:
Matthew Hiser; Rebecca Romero-Devore; Frankie Vega; Kerri Kavanagh; Josh Borromeo
Subject:
Transmittal of Requests for Additional Information - General Atomics-Electromagnetic Systems Fast Modular Reactor Quality Assurance Program Description Topical Report Rev 4 Date:
Friday, August 09, 2024 2:57:00 PM
- John,
The NRC staffs Request for Additional Information (RAIs) are below. This email serves as formal transmittal of the RAIs.
A response from GA-EMS is expected by September 12, 2024. If you need additional time to provide the responses to the RAIs, please do not hesitate to contact me. This email will be placed in ADAMS and will be declared public.
REQUEST FOR ADDITIONAL INFORMATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION GENERAL ATOMICS ELECTROMAGNETIC SYSTEMS TOPICAL REPORT - FAST MODULAR REACTOR QUALITY ASSURANCE PROGRAM DESCRIPTION DOCKET NO. 99902098 ISSUE DATE: 08/09/2024
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Background===
The following requests for additional information (RAIs) are based on the U.S. Nuclear Regulatory Commission (NRC) staffs ongoing review of General Atomics Electromagnetic Systems (GA-EMS) topical report (TR), Fast Modular Reactor Quality Assurance Program Description, Revision 4 (Agencywide Documents Access and Management System (ADAMS) Accession No.ML24179A337). This requested information is necessary to demonstrate GAEMSs compliance with the relevant requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants. The responses to these RAIs regarding quality assurance program controls will support the NRC staffs reasonable assurance determination.
The NRC staff reviewed the information presented in Revision 4 of the GA-EMS Quality Assurance Program Description (QAPD) TR against the quality assurance (QA) requirements in 10 CFR Part 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, using the guidance in NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, (or the SRP) Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants, Revision 1 (ML15037A441).
The SRP is not a substitute for the NRC regulations, and compliance with it is not required.
However, an applicant is required to identify differences between the design features, analytical techniques, and procedural measures proposed for its facility and the SRP acceptance criteria and evaluate how the proposed alternatives to the SRP acceptance criteria provide an acceptable method of complying with the NRC regulations.
Regulatory Basis The regulatory requirements related to quality assurance (QA) programs are set forth in 10 CFR 52.47, Contents of applications; technical information, 10 CFR 52.137, Contents of applications; technical information, and Appendix B to 10 CFR Part 50, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.
The regulations in 10 CFR 52.47 establish the technical information requirements for DC applications. Section 10 CFR 52.47(a)(19) requires that DC applications provide a description of the quality assurance program applied to the design of the SSCs of the facility. Further, 10 CFR 52.47(a)(19) requires that the description of the quality assurance program include a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 have been satisfied.
The regulations in 10 CFR 52.137 establish the technical information requirements for SDA applications. Specifically, 10 CFR 52.137(a) requires that an SDA application contain the technically relevant information in a final safety analysis report (FSAR) that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the structures, systems, and components (SSCs) and of the facility as a whole.
Additionally, 10 CFR 52.137(a)(19) states that the FSAR must include a description of the quality assurance program, applied to the design, and to be applied to the fabrication, construction, and testing, of the SSCs of the facility.
Appendix B to 10 CFR 50 sets forth the regulatory requirements for quality assurance programs for nuclear power plants, and establishes quality assurance requirements for design, fabrication, construction, and testing for SSCs for the facility. The description of the quality assurance program for a nuclear power plant must include a discussion of how the applicable requirements of Appendix B have been and will be satisfied, including a discussion of how the quality assurance program will be implemented. The pertinent requirements of Appendix B apply to all activities affecting the safety-related functions of those SSCs and include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying SSCs.
RAI 1
QAPD TR Section 3.2.6, NQA-1 Commitment/Exceptions, states: Section 401 (e) requires the date of certification expiration be included on the qualification record. GA-EMS considers the certification expiration date to be the date from the certification or recertification date plus the certification interval time and its inclusion on the qualification record is optional. The staff notes that NQA-1 Section 401 (g) addresses the certification expiration requirements. Explain why Section 401(e) is referenced rather than 401(g) for the certification expiration.
RAI 2
QAPD TR Section 3.7.2, NQA-1 Commitment/Exceptions," states: [in] accordance with the NRC-accepted NEI 14-05A Revision 1, when purchasing commercial-grade calibration and testing services from domestic and international calibration and testing laboratories accredited by an International Laboratory Accreditation Cooperation (ILAC) Mutual
Recognition Arrangement (MRA) signatory, suppliers of basic components may use the ILAC accreditation process in lieu of performing a commercial-grade survey as part of the commercial-grade dedication process provided the following standards are met:
The staff notes that there is no numbered list following this bulleted paragraph describing the standards that should be met. However, it appears that the items included below the referenced paragraph are the conditions that should be met for the use of the ILAC accreditation process in lieu of performing a commercial-grade survey. Clarify if it was the intent to reference the conditions that should be met and make the corrections in the QAPD.
RAI 3
The GA-EMS QAPD TR Section 1.1, Scope/Applicability, states: [the] QAPD applies to design-phase activities, including those in support of Standard Design Approval (SDA) and Design Certification (DC) activities affecting the quality and performance of safety-related structures, systems, and components of the FMR [].
The staff has identified the following areas that appear to be outside the scope of the proposed activities described in QAPD Section 1.1.
- 1. QAPD TR Section 3.3.4, "Setpoint Control. The staff notes that instrument and equipment setpoints are typically associated with operational phase activities which, according to Section 1.1 of the GA-EMS QAPD, fall outside the scope of this QAPD.
- 2. QAPD TR Section 3.1.3.3, Nuclear Quality Assurance Manager, states: [t]he NQA Manager reports to the corporate QA Director for the operations activities []. The staff notes that this statement references operational phase activities which, according to Section 1.1 of the GA-EMS QAPD, fall outside the scope of this QAPD.
Based on the scope provided in QAPD TR Section 1.1, remove the sections that do not apply or provide a justification of how they are within scope of this TR.
RAI 4
QAPD TR Section 3.2.4, "Issuance and Revision to Quality Assurance Program," states:
[r]egulations require that the Final Safety Analysis Report (FSAR) include, among other things, the managerial and administrative controls to be used to assure safe operation, including a discussion of how the applicable requirements of 10 CFR 50, Appendix B, will be satisfied. In order to comply with this requirement, the FSAR references the QAPD and, as a result, the requirements of 10 CFR 50.54(a) are satisfied by, and apply, to the QAPD.
Remove references to an FSAR and 10 CFR 50.54(a), as they are outside of the scope outlined in QAPD TR Section 1.1 and do not apply to GA-EMS as a nonlicensee or justify how they are within the scope of the TR.
RAI 5
QAPD TR Section 1, Introduction, states, in part, [a]s part of its Quality Management System (QMS), GA-EMS has established a Nuclear Quality Assurance (NQA) program responding to the requirements and intents of 10 CFR 50 Appendix B, 10 CFR 21, ASME-
ANSI N45.2 (including the seven daughter standards), ANSI/ASME NQA-1-2015 and all earlier editions endorsed by the NRC, ISO 9001 / AS9100, and Safety Standard IAEA 50-C-QA. The staff notes that the quality requirements and guidance for establishing and executing QA programs for design and construction of nuclear facilities are not necessarily the same between ASME-ANSI N45.2 (including the seven daughter standards) and ASME NQA-1-2015. Clarify which quality standard is the basis for the GA-EMS QAPD and explicitly state whether ASME-ANSI N45.2 (including the seven daughter" standards) or ASME NQA-1-2015 will be used.
OFFICE NRR/DANU/UAL1/PM NRR/DANU/UAL1/BC NRR/DRO/IQVB/BC NAME SCuadrado de Jesus MHiser KKavanagh DATE 08/07/2024 08/07/2024 08/06/2024
- Regards, Samuel Cuadrado de Jesús Project Manager Advanced Reactor Licensing Branch 1 (UAL1)
Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU)
U.S. Nuclear Regulatory Commission Phone: 301-415-2946 Samuel.CuadradoDeJesus@nrc.gov