ML19269B764
| ML19269B764 | |
| Person / Time | |
|---|---|
| Issue date: | 03/01/2001 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| SJG1 | |
| Shared Package | |
| ML19269B755 | List: |
| References | |
| DG-3054 | |
| Download: ML19269B764 (4) | |
Text
REGULATORY ANALYSIS DRAFT REGULATORY GUIDE DG-3054 GUIDANCE FOR IMPLEMENTATION OF 10 CFR 72.48, CHANGES, TESTS, AND EXPERIMENTS (Proposed Revision 1 of Regulatory Guide 3.72, dated March 2001)
- 1.
Statement of the Problem The U.S. Nuclear Regulatory Commission (NRC) is considering revising Regulatory Guide (RG) 3.72, Guidance for Implementation of 10 CFR 72.48, Changes, tests, and experiments, to provide specific guidance for the implementation of 10 CFR 72.48 to certificate of compliance (CoC) holders for spent fuel storage casks (SFSCs), specific and general licensees of independent spent fuel storage installations (ISFSIs), and monitored retrievable storage (MRS) facilities.
The NRC published Revision 0 of RG 3.72 in March 2001.1 The RG provided acceptable guidance to the industry for complying with and implementing the requirements of 10 CFR 72.48, which allows general and specific licensees of ISFSI facilities, CoC holders for SFSCs, and MRS facilities to make changes to the facility or its procedures, or to conduct tests or experiments, without prior NRC approval provided specific criteria are met.
The NRC held several public meetings with industry and other stakeholders to identify industry experiences with 10 CFR 72.48 and Appendix B to Nuclear Energy Institute (NEI) 96-
- 07. The public discussions identified the following issues:
Appendix B to NEI 96-07 did not provide clear guidance on 10 CFR 72.48 that is tailored to general licensees, specific licensees, CoC holders, and MRS installations, which has led to confusion among the regulated industry; Enforcement actions against licensees and CoC holders for improper implementation of the 72.48 change management process pointed to misunderstandings of the 10 CFR 72.48 change process and how the change process should be implemented; Industry requested more specific guidance on how the NRC approves methods of evaluation, as described in the final safety analysis report (FSAR).
In response to these findings, NEI developed NEI 12-04, Guidelines for 10 CFR 72.48 Implementation, to provide users of the change control process with clear instructions on implementing 10 CFR 72.48. NEI developed NEI 12-04, Revision 2 in 2018 to be consistent with the guidance issued for 10 CFR 50.59 in NEI 96-07, Revision 1.2 NEI 96-07 is endorsed by RG 1.187, Revision 1, Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments.
1 Revision 0 of RG 3.72 endorsed NEI 96-07, Appendix B, Guidelines for 10 CFR 72.48 Implementation, dated March 2001.
2 Guidelines for 10 CFR 50.59 Implementation, NEI 96-07, Revision 1, Washington, DC, November 2000 (ADAMS Accession No. ML003771157).
Page 2 NEI 12-04, Revision 2 reflects updates and revisions to Appendix B to NEI-96-07, which are based on operating experience and NRCs lessons learned through licensing and oversight.
The DG-3054, by endorsing NEI 12-04, would provide a new approach for approvals of a method of evaluation (MOE), under 10 CFR 72.48, and be consistent with NEI 96-07, Revision 1, Guidelines for 10 CFR 50.59 Implementation.
- 2.
Objective This DG-3054 to RG 3.72, Revision 1, would endorse NEI 12-04, Revision 2, Guidelines for 10 CFR 72.48 Implementation, with exceptions and clarification. NEI 12-04, Revision 2 reflects updates and revisions to NEI 96-07, Appendix B that were made based on ISFSI operating experience and NRCs inspection findings. In addition, RG 3.72, Revision 1 would change the NRCs guidance on departures from an MOE and the NRCs approval of an MOE, as stated in Revision 0 to RG 3.72.
The staff determined that RG 3.72, Revision 1, would provide acceptable guidance with respect to which changes are permissible without prior-NRC approval. In addition, the revision would increase regulatory effectiveness and efficiency. For example, the efficiency in NRCs licensing and oversight activities would increase by, bringing consistency to the guidance for 10 CFR 72.48 and 10 CFR 50.59, and reducing the number of amendment requests from specific licensees and certificate holders, with no reduction in safety.
- 3.
Alternative Approaches The NRC staff considered the following alternative approaches:
- 1. Do not revise RG 3.72
- 2. Withdraw RG 3.72
- 3. Revise RG 3.72 to address the current methods and procedures.
Alternative 1: Do Not Revise RG 3.72, Revision 0 Under this alternative, the NRC would not revise RG 3.72, Revise 0 and the NRC would continue to find the existing guidance acceptable. This is considered the no-action alternative and is the baseline against which the impacts of other alternatives are measured.
This alternative would not impose costs on the public, licensees, CoC holders, or the NRC. Licensees and CoC holders would continue to prepare 72.48 evaluations to determine whether the proposed changes require submission of license amendments. However, the NRCs knowledge of the licensing and oversight processes, as well as the operational experiences and lessons learned from nearly 20 years of industry practice would not be available in the guidance, and there would continue to be inconsistencies between 10 CFR 72.48 and 10 CFR 50.69 guidance.
NRC inspections would continue to review 72.48 evaluations prepared by CoC holders and licensees to assess their compliance with regulations and make determinations based on the circumstances for each case.
Page 3 Alternative 2: Withdraw RG 3.72 Under this alternative, the NRC would withdraw RG 3.72, Revision 0 without replacing it.
Withdrawal of RG 3.72 would eliminate the existing guidance that describes the methods the NRC staff considers acceptable to demonstrate compliance with 10 CFR 72.48, Changes, tests, and experiments. Additionally, withdrawing the RG would eliminate guidance for CoC holders and licensees to use in evaluating MOEs and the change process, which may lead to additional time spent on inspections and enforcement actions and impose additional costs on both licensees and the NRC. Alternative 2 would likely result in CoC holders and specific licensees submitting more license amendments and exemptions for the NRCs technical review, which would not promote regulatory efficiency. For this reason, this alternative is not considered further in this analysis.
Alternative 3: Revise RG 3.72 Under this alternative, RG 3.72, Revision 1 would be revised to describe a method acceptable to the NRC for complying with and implementing the requirements of 10 CFR 72.48, which allows licensees of ISFSIs and MRS facilities, and CoC holders for SFSCs to make changes to the facility or its procedures, or to conduct tests or experiments, without prior NRC approval, provided the specific criteria of 10 CFR 72.48(c)(2) are met. The revision of RG 3.72 would allow CoC holders and specific licensees to apply MOEs used in establishing the design bases or described in the FSAR, as updated, across cask systems and CoCs, for which they are the design authority. The NRC staffs previous guidance on departures from an MOE and the NRCs approval of an MOE could restrict the use of an MOE described in the FSAR to a single CoC amendment.
The proposed changes to the NRCs guidance on departures from an MOE in RG 3.72, Revision 1 are expected to reduce the number of future license amendments submitted to the NRC, without a reduction in safety. Specifically, the proposed changes would reduce the number of licensing actions submitted by a design authority and the number of NRC technical review and approval of these submittals.3 The staff anticipates the impact on the industry of implementing the new guidance would be minimal and would be the voluntary costs of reviewing the issued RG 3.72, Revision 1 and the endorsed NEI 12-04, Revision 2 guidance. The impact to the NRC would be the costs associated with preparing and issuing the RG 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 benefit to NRC staff and its applicants would be enhanced efficiency and effectiveness in using a common guidance document as the technical basis for licensing actions.
Under Alternative 3, CoC holders and licensees would use MOEs that were previously approved by the NRC without seeking a license amendment, under certain conditions. 10 CFR Part 72 licensees and CoC holders could extend the use of previously approved MOEs to other certificates, when they are the vendor/authorized design authority and the NRC approved the MOE for the intended application, provided the conditions and the limitations associated with the approved MOE are met. However, a licensee or CoC holder must submit a proposed change as a license amendment when seeking to use an unapproved MOE, an MOE not approved for its 3
The NRC approval of a method of evaluation is limited to a single design authority for the intended application and does not provide for generic approval for use by all licensees and certificate holders.
Page 4 intended application, an MOE not meeting stated conditions and limitations, and when seeking to extend an MOE outside the single vendor/design authority. The benefit to the CoC holder and licensees is the reduction in the costs associated with the preparation and submission of amendment and exemption requests for ISFSIs and SFSCs. The benefit to the NRC is that the reduction in reviews of CoC amendment and exemption submittals, without a reduction in safety.
This Revision 1 to RG 3.72 would endorse guidance that describes an acceptable method of performing and documenting the 10 CFR 72.48 change control process, thereby enhancing regulatory stability. The revision to RG 3.72 would not be legally binding on the NRCs licensees or CoC holders and would not impose new requirements or change existing regulations.
Conclusion The NRC staff concludes that a revision of RG 3.72 (Alternative 3) is warranted. It focuses the resources of licensees, CoC holders, and the NRC staff on the proper evaluation of safety issues. Alternative 3 would incorporate the NRCs knowledge of the licensing and oversight processes, as well as the operational experiences and lessons learned from nearly 20 years of industry practice.