ML12276A072

Regulatory Analysis for Draft Regulatory Guide DG-1300, Quality Assurance Program Requirements (Operations)(Proposed Rev.3 of Rg 1.33, Dated January 2013)

ML12276A072
Person / Time
Issue date:	01/25/2013
From:	Office of Nuclear Regulatory Research
To:
Rodriguez-Luccioni H
Shared Package
ML12276A061	List: ML12276A071 ML12276A072 ML12276A076
References
DG-1300 RG-1.033, Rev 3
Download: ML12276A072 (3)

Text

REGULATORY ANALYSIS DRAFT REGULATORY GUIDE DG-1300 Quality Assurance Program Requirements (Operations)

(Proposed Revision 3 of Regulatory Guide 1.33, dated January 2013)

1. Statement of the Problem The U.S. Nuclear Regulatory Commission (NRC) published Revision 2 of Regulatory Guide 1.33, Quality Assurance Program Requirements (Operation), in February 1978 to provide licensees and applicants with agency-approved guidance for complying with the then-current version of Title 10, of the Code of Federal Regulations, Part 50, Licensing of Production and Utilization Facilities (10 CFR Part 50). The current version of Regulatory Guide 1.33 is outdated because it endorses ANS 3.2/ANSI 18.7-1976, which required numerous clarifications or modifications of the standard in the RGs Regulatory Position statement. Over time, licensees obtained NRC approval to use various alternate positions to Revision 2 of RG 1.33. In addition, since the issuance of Revision 2 of RG 1.33, American Society of Mechanical Engineers (ASME) NQA-1 has been revised. NQA-1 adopts many of the acceptable NRC alternate positions. The NRC has endorsed ANSI/ASME NQA-1, Quality Assurance Program Requirements for Nuclear Power Plants, in 10 CFR 50.55a, Codes and standards. ANSI/ANS 3.2-2012 reflects the changes in NQA-1, and the alternate positions approved by the NRC. Therefore, Revision 2 of Regulatory Guide 1.33 does not provide current guidance for applicants submitting an application for licensing of new plants in accordance with the provisions of 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.

2. Objective The objective of this regulatory action is to update NRC guidance and provide applicants with a method to demonstrate compliance with the provisions of the regulations in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, of the Code of Federal Regulations, §50.34(b)(6)(ii),

Contents of applications; technical information, and10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, (10 CFR Part 52) §52.79(a)(27), Contents of applications; technical information in final safety analysis report. Both sections require compliance with 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, which, in part, requires the establishment QA controls for the implementation of managerial and administrative controls to assure safe operation.

The industry has made significant improvements to ANS 3.2/ANSI 18.7-1976 since 1978 when RG 1.33, Revision 2, endorsed the standard. In addition, the industry has: coordinated the update with its associated standard, NQA-1; reduced the standards focus on programs, incorporated requirements that were previously regulatory positions for subjects requiring independent review and audits of selected aspects of operation phase activities; clarified in the standard those activities that are considered safety-related and should be treated as a requirement; and consolidated guidance for rules of practice and preparation of instructions and procedures.

Therefore, revision of this regulatory guidance is necessary to make licensing reviews more efficient and effective, and to make applicants and licensees aware of the endorsement of ANSI/ANS 3.2-2012.

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Revising this regulatory guide to endorse portions of a consensus standard 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 will also comply with the requirement in the National Technology Transfer and Advancement Act of 1995, P.L. 104-113, that Federal agencies use voluntary consensus standards in lieu of government-developed requirements unless impractical or contrary to law.

3. Alternative Approaches The NRC staff considered the following alternative approaches:

1. Do not revise Regulatory Guide 1.33

2. Withdraw Regulatory Guide 1.33

3. Revise Regulatory Guide 1.33 to address the current methods and procedures.

Alternative 1: Do Not Revise Regulatory Guide 1.33 Under this alternative, the NRC would not revise [or issue additional] guidance and the current guidance would be retained. If NRC does not take action, there would not be any changes in costs or benefit to the public, licensees or NRC. However, the no-action alternative would not address identified concerns with the current version of the regulatory guide. This alternative is considered the no-action alternative and provides a baseline condition from which any other alternatives will be assessed.

Alternative 2: Withdraw Regulatory Guide 1.33 Under this alternative the NRC would withdraw this regulatory guide. This would eliminate the current conflict that exists between the current regulatory guide and the newer regulations. It would also eliminate the only readily available description of the methods the NRC staff considers acceptable for demonstrating compliance with 10 CFR 50.34(b)(6)(ii). Although this alternative would be less costly than the proposed alternative, it would impede the publics accessibility to the most current guidance information.

Alternative 3: Revise Regulatory Guide 1.33 Under this alternative, the NRC would revise Regulatory Guide 1.33. This revision would incorporate the latest information considering the need for guidance to support new plant applications submitted to the NRC for review and approval in accordance with the provisions of 10 CFR Part 52, the existing NRC endorsement of the ANSI/ASME NQA-1, Quality Assurance Program Requirements for Nuclear Power Plants, consensus standard, prior alternates approved by the NRC for licensee use, other supporting guidance, and existing NRC 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.

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Conclusion Based on this regulatory analysis, the NRC staff recommends revision of Regulatory Guide 1.33.

The staff concludes that the proposed action will enhance use of existing NRC approved methods and standards currently accepted by the NRC and will provide guidance for new plant applications submitted for revise and approval in accordance with 10 CFR Part 52.

Backfit Rule Concerns Any revision to this regulatory guide is not being imposed upon current licensees and may be voluntarily used by existing licensees. In addition, this proposed revision to this regulatory guide is issued in conformance with all applicable internal NRC policies and procedures governing backfitting.

Accordingly, the NRC staff issuance of this regulatory guide revision is not considered backfitting, as defined in 10 CFR 50.109(a)(1), 10 CFR 70.76(a)(1), 10 CFR 72.62(a), or 10 CFR 76.76(a)(1) nor is it deemed to be in conflict with any of the issue finality provisions in 10 CFR Part 52.

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