ML22304A055
| ML22304A055 | |
| Person / Time | |
|---|---|
| Issue date: | 04/24/2023 |
| From: | Andrea Keim NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| RG-1.028, Rev 6 DG-1403 | |
| Download: ML22304A055 (3) | |
Text
REGULATORY ANALYSIS DRAFT REGULATORY GUIDE DG-1.28 QUALITY ASSURANCE PROGRAM CRITERIA (DESIGN AND CONSTRICTION)
(Proposed Revision 6 for Regulatory Guide 1.28)
- 1. Introduction This document presents the results of a regulatory analysis of the U.S. Nuclear Regulatory Commissions (NRCs) determination of whether to issue Draft Regulatory Guide (DG) 1403, Quality Assurance Program Criteria (Design and Construction. The analysis provides the public with an insight in how the NRC arrives at a decision.
- 2. Statement of the Problem The NRC published Revision 5 of Regulatory Guide 1.28, Quality Assurance Program Criteria (Design and Construction), in October 2017. RG 1.28, Revision 5, approves the use of American Society of Mechanical Engineers (ASME) NQA-1b-2011 addenda to NQA 2008, NQA-1-2012 and NQA-1-2015, Quality Assurance Requirements for Nuclear Facility Applications, as industry guidance for establishing and implementing a quality assurance program for the design and construction of nuclear power plants and fuel reprocessing plants, in accordance with Title 10, of the Code of Federal Regulations, Part 50, Domestic Licensing of Production and Utilization Facilities (10 CFR Part 50), and 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, which refer to 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.
Since publication of Rev. 5, new and updated industry guidance has become available in the form of NQA-1-2017, NQA-1-2019, and NQA-1-2022, and the current version of Regulatory Guide 1.28, Rev. 5, does not reflect the updated guidance in these standards.
Revision 6 of RG 1.28 addresses this issue. Specifically, this proposed regulatory guide revision endorses, with certain clarifications and regulatory positions, the latest revisions of NQA-1, including NQA-1-2017, NQA-1-2019, and NQA-1-2022, as well as NEI 1405A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1.
- 3. Objective The objective of this regulatory action is to provide current NRC guidance on the development and implementation of quality assurance (QA) programs and approve for use recent revisions to industry guidance that NRC has identified as an acceptable method to demonstrate compliance with regulatory requirements in 10 CFR Part 50 and 10 CFR Part 52.
- 4. Identification and Analysis of Alternative Approaches The NRC staff considered the following alternative approaches:
- 1. Do not revise Regulatory Guide 1.28.
- 2. Withdraw Regulatory Guide 1.28.
- 3. Revise Regulatory Guide 1.28 to address the current methods and procedures.
Alternative 1: Do Not Revise Regulatory Guide 1.28 Under this alternative, the NRC would not revise or issue additional guidance, and the current guidance would be retained. This alternative is considered the no-action alternative and provides a baseline condition from which any other alternatives will be assessed.
If NRC takes no action, there would be no changes in costs or benefit to the public, licensees, or NRC. However, the no-action alternative would not address the identified issue with the current version of the regulatory guide. The NRC would continue to review each application on a case-by-case basis.
Alternative 2: Withdraw Regulatory Guide 1.28 Under this alternative the NRC would withdraw this regulatory guide. This would eliminate the issue identified above regarding the regulatory guide. It would also eliminate the only readily available description of the methods the NRC staff considers acceptable for demonstrating compliance with Appendix B to 10 CFR Part 50. By eliminating guidance for future applicants, the content of future applications could vary from applicant to applicant, thereby making the review of these applications more burdensome for the staff. The burden on applicants would also be greater under this alternative, because without specific guidance, it would impede the publics accessibility to the most current regulatory guidance.
Alternative 3: Revise Regulatory Guide 1.28 Under this alternative, the NRC would revise Regulatory Guide 1.28. This revision would extend the acceptance of the use of ASME NQA-1 to include the latest three revisions.
Specifically, the NRC staff performed a review and identified that differences exist between the previously endorsed industry guidance (the NQA-1b-2011 Addenda to NQA-1-2008, and NQA-1-2012 and NQA-1-2015) and the most recently issued industry guidance from the American Society of Mechanical Engineers (ASME) (NQA-1-2017, NQA-1-2019, and NQA-1-2022). The NRC completed a technical evaluation of the differences. Based on the results of the technical evaluation, under this alternative the NRC would revise RG 1.28 to include the updated supporting guidance and review practices. By doing so, the NRC would ensure that the RG guidance available in this area is current, and accurately reflects the staffs position.
The impact to the NRC would be the costs associated with preparing and issuing the regulatory guide revision. The impact to the public would be the voluntary costs associated with reviewing and providing comments to NRC during the public comment period. The value to NRC staff and its applicants would be the benefits associated with enhanced efficiency and effectiveness in using a common guidance document as the technical basis for license applications and other interactions between the NRC and its regulated entities.
- 5. Conclusion This regulatory guide revision endorses versions of a consensus standard and is consistent with the NRC policy of evaluating the latest versions of national consensus standards to determine their suitability for endorsement by regulatory guides. This approach complies with the NRCs Management Directive (MD) 6.5 - NRC Participation in the Development and Use of Consensus Standards.
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Based on this regulatory analysis, the NRC staff concludes that revision of Regulatory Guide 1.28 is warranted. The action will enhance reactor and fuel reprocessing safety by providing licensees and applicants with the latest guidance for QA program requirements.
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