[Federal Register Volume 63, Number 161 (Thursday, August 20, 1998)] [Notices] [Pages 44659-44662] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-22412] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION Use of PRA in Plant-Specific Reactor Regulatory Activities: Final Regulatory Guide and Standard Review Plan Section; Availability The Nuclear Regulatory Commission has issued a new guide in its Regulatory Guide Series, along with its conforming section of the Standard Review Plan. Regulatory Guide 1.174, ``An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant- Specific Changes to the Licensing Basis,'' describes a method acceptable to the NRC staff for assessing the nature and impact of changes to a plant's licensing basis when the licensee chooses to support these changes with risk information. The accompanying Standard Review Plan Chapter 19, ``Use of Probabilistic Risk Assessment in Plant-Specific, Risk-Informed Decisionmaking: General Guidance,'' conforms to the guide to provide guidance to the NRC staff in reviewing such changes. In June 1997, the Nuclear Regulatory Commission issued for public comment a series of draft regulatory guides and Standard Review Plan sections and a draft NUREG document addressing the use of PRA in support of risk-informed regulatory activities. The preparation of these documents followed from the Commission's Policy Statement of August 16, 1995, on the use of PRA methods in nuclear regulatory activities (60 FR 42622). The draft guidance documents were being developed to provide acceptable approaches for using probabilistic risk assessment (PRA) information in support of plant-specific changes to plant licensing bases. The use of such PRA information and guidance by power reactor licensees is voluntary, and alternative approaches may be proposed. The Commission conducted a workshop on August 11-13, 1997, during the comment period, to provide an overview of the draft documents, to answer questions regarding their intended application, and to solicit comments and suggestions. Comments received from the workshop have been considered in preparing this final general regulatory guide (1.174) and its accompanying Standard Review Plan (Chapter 19) for risk-informed applications. Comments received from the workshop on application- specific guidance documents for technical specifications, inservice testing, and graded quality assurance are currently being considered. These guidance documents will be issued at a later date. Comments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time. Written comments may be submitted to the Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Single copies of regulatory guides, both active and draft, and draft NUREG documents may be obtained free of charge by writing the Reproduction and Distribution Services Section, OCIO, USNRC, Washington, DC 20555-0001; or by fax to (301) 415-2289; or by email to [email protected]. Active guides may also be purchased from the National Technical Information Service on a standing order basis. Details on this service may be obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161. Copies of active and draft guides and the Standard Review Plan are available for inspection or copying for a fee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; telephone (202) 634-3273; fax (202) 634-3343. Regulatory guides are not copyrighted, and Commission approval is not required to reproduce them. I. Background On August 16, 1995, the Commission published in the Federal Register a final policy statement on the Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities (60 FR 42622). The policy statement included the following policy regarding NRC's expanded use of PRA: 1. The use of PRA technology should be increased in all regulatory matters to the extent supported by the state-of-the-art in PRA methods and data and in a manner that complements the NRC's deterministic approach and supports the NRC's traditional defense-in-depth philosophy. 2. PRA and associated analyses (e.g., sensitivity studies, uncertainty analyses, and importance measures) should be used in regulatory matters, where practical within the bounds of the state-of- the-art, to reduce unnecessary conservatism associated with current regulatory requirements, regulatory guides, license commitments, and staff practices. Where appropriate, PRA should be used to support proposals for additional regulatory requirements in accordance with 10 CFR 50.109 (Backfit Rule). Appropriate procedures for including PRA in the process for changing regulatory requirements should be developed and followed. It is, of course, understood that the intent of this policy is that existing rules and regulations shall be complied with unless these rules and regulations are revised. 3. PRA evaluations in support of regulatory decisions should be as realistic as practicable and appropriate supporting data should be publicly available for review. 4. The Commission's safety goals for nuclear power plants and subsidiary numerical objectives are to be used with appropriate consideration of uncertainties in making regulatory judgments on the need for proposing and backfitting new generic requirements on nuclear power plant licensees. It was the Commission's intent that implementation of this policy statement would improve the regulatory process in three areas: 1. Enhancement of safety decision making by the use of PRA insights. 2. More efficient use of agency resources, and 3. Reduction in unnecessary burdens on licensees. [[Page 44660]] In parallel with the development of Commission policy on uses of risk assessment methods, the NRC developed an agency-wide implementation plan for applying PRA insights within the regulatory process (SECY-95-079). This implementation plan included tasks to develop a series of regulatory guides and standard review plans (SRPs) on general guidance, inservice inspection (ISI), inservice testing (IST), technical specifications (TS), and graded quality assurance (GQA). The general regulatory guide, Regulatory Guide 1.174, and its accompanying SRP section, Chapter 19, are intended to help implement the Commission's August 1995 policy on the use of risk information in the regulatory process. These two general documents are the first in the series of risk-informed guidance documents. Together, they provide the basic framework for an approach acceptable to the NRC staff for use by power reactor licensees in preparing proposals for plant-specific changes to their licensing bases using risk information. Alternative approaches may be proposed. Application-specific guidance documents for risk-informed technical specifications, inservice testing, and graded quality assurance are currently being revised to address the public comments that were received; these documents are scheduled to be issued later in 1998. Guidance for inservice inspection is also being developed on a later schedule. II. Public Comment Summary and Resolution The public comments on the draft regulatory guidance documents on risk-informed applications were due by September 30, 1997. In addition to comments received at the workshop, the NRC staff received approximately 40 sets of written comments. Some of the more extensive comments were provided by the Nuclear Energy Institute (NEI), in a letter dated September 29, 1997, which provided comments on behalf of the nuclear industry. In its letter, NEI commended the NRC staff for its efforts in developing the draft documents, stating that the industry recognized the significance of the drafts in articulating a framework for the use of risk information in regulatory decisionmaking and that the documents represent a milestone in the evolution of the regulatory process. In addition, the NEI letter expressed concern regarding four policy issues; NEI believes the resolution of these issues is essential to the continued viability and the expansion of risk-informed regulation. The issues cited by NEI were overall cost benefit, use of numerical acceptance guidelines, treatment of uncertainty, and PRA attributes and quality considerations. Each of these areas highlighted by NEI will be addressed in the following discussion of the principal issues. Comment letters were also received from the Electric Power Research Institute (EPRI), the American Society of Mechanical Engineers (ASME), the owners groups for the four reactor vendors (General Electric, Westinghouse, Combustion Engineering, and Babcock and Wilcox), one vendor (Westinghouse), 18 electric utilities, one national laboratory (Oak Ridge), five technical organizations, five other private industry organizations or individuals, and two anonymous commenters. The following discussion addresses the resolution of the principal issues raised by the commenters. A more complete discussion of the comments received overall is given in the attachment to a memorandum from Mr. Mark A. Cunningham (Chief, Probabilistic Risk Analysis Branch, Division of Systems Technology, Office of Nuclear Regulatory Research) to Mr. M. Wayne Hodges (Director, Division of Systems Technology, Office of Nuclear Regulatory Research) dated January 7, 1998, which is available in the NRC's Public Document Room. The discussion in the attachment covers the resolution of the NRC's specific requests for comments included in the Federal Register notice for the workshop (62 FR 34321), other issues raised by the commenters, and the principal issues discussed in this announcement. Principal Issues 1. Use of 10-4 Per Reactor-Year Core Damage Frequency as an Acceptance Guideline Issue: Comments were received indicating that the use of 10-4 per reactor-year core damage frequency (10-4/RY CDF) as an acceptance guideline was overly conservative, that the Commission's Safety Goal Policy quantitative health objectives (QHOs) would be more appropriate for use as goals, and that it was not clear how closely staff reviewers would hold applications to this numerical criteria. Resolution: Revised Section 2.2.4, ``Acceptance Guidelines,'' of Regulatory Guide 1.174 addresses the use of 10-4/RY CDF as a guideline in evaluating the acceptability of risk-informed applications. The use of 10-4/RY CDF as a subsidiary goal is consistent with past Commission guidance. The guidelines for assessing risk, contained in the regulatory guide and SRP, are based upon the QHOs in the Commission's Safety Goal Policy and upon previous Commission guidance related to implementation of the Safety Goal Policy and regulatory analysis guidelines (Revision 2 of NUREG/BR-0058, ``Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission,'' USNRC, November 1995). Specifically, the guideline value of 10-4/RY for CDF is based upon a June 15, 1990, memorandum from the Commission to the NRC staff on implementation of the Safety Goal Policy, which established a 10-5/RY CDF as a benchmark objective for accident prevention. The guideline value onCDF of 10-5/RY is based upon the guidance in the Commission's regulatory analysis guidelines, which establish 10-5/RY CDF as a cutoff below which the significance of safety issues is not large enough to warrant backfit analysis, assuming a reasonable accident mitigation capability. Accident mitigation capability is addressed via guidelines on large early release frequency (LERF). The guideline value of 10-5/ RY for LERF contained in Regulatory Guide 1.174 is based upon risk analysis results presented in NUREG-1150 (``Severe Accident Risks: An Assessment for Five U.S. Nuclear Power Plants,'' Vol. 3, USNRC, January 1991), which calculated offsite health risks for five nuclear power plants and compared them to the Safety Goal QHOs. Analyses for all five plants calculated health risks well below the QHOs. However, if the results of this analysis were adjusted so that the offsite health risks just met the early fatality QHO (the most limiting QHO), with allowance for the unanalyzed modes of operation (shutdown), and in some cases external events, a corresponding LERF value of 10-5/RY would result for those plants whose calculated offsite health risks are closest to the QHOs. Site-to-site variations in LERF were judged to be not a large factor (this was also confirmed in a study reported by the Advisory Committee for Reactor Safeguards in a September 19, 1997, letter to Chairman Jackson), and thus a single value for all plants is used. The guideline value of 10-6/RY for ``LERF is based upon the regulatory analysis guidelines that, when used in conjunction with the CDF guidelines discussed above, establish a cutoff below which the significance of safety issue is not large enough to warrant backfit analysis. Figures 3 and 4 of Section 2.2.4 in Regulatory Guide 1.174 illustrate acceptance guidelines for CDF and [[Page 44661]] LERF and indicate that for each of these metrics, three regions have been identified for use in screening the acceptability of proposed changes in licensing bases. Region III, shown in the figures and discussed in the text of Regulatory Guide 1.174, has been identified as representing a sufficiently low CDF or LERF increase that, in general, program changes associated with this region may be permitted without a detailed assessment of the baseline CDF/LERF. As discussed in Regulatory Guide 1.174, if there are indications that the baseline CDF or LERF is above the guideline values, additional evaluation would be needed even though the calculated changes in CDF or LERF were small and in Region III. In Section 2.2.5, ``Comparison of PRA Results with the Acceptance Guidelines,'' it is stated that the acceptance guidelines (lines separating the regions) are not to be interpreted in an overly prescriptive manner and that they are intended to provide an indication, in numerical terms, of what is considered acceptable. Graduated shading has been added to the guideline figures to indicate regions in which proposed changes will be subject to gradually more intensive NRC technical and management review. Regarding the use of the QHOs, it is stated that the use of the QHOs in lieu of LERF in support of risk-informed applications is an acceptable approach provided that appropriate consideration is given to the methods and assumptions used in the analysis and in the treatment of uncertainties. Also, in Section 2.2.6, ``Integrated Decisionmaking,'' it is noted that Level 3 PRA information can be submitted and will be considered in support of those cases in which increased NRC management attention is needed during the review (e.g., when the calculated CDF/LERF changes and baseline values are close to the acceptance guidelines). 2. Definition of Risk Neutral Issue: A number of comments were received indicating a need for a definition of risk neutral applications, and indicating that increased NRC management and technical review should not be required for risk increases below some threshold. Resolution: See responses to Issues Number 1 and 3 addressing very small increases in risk. 3. Allowance for Very Small Increases in Risk Issue: Comments stated that facilities with CDFs greater than 10-4/RY should be allowed small risk increases and that the level of effort and information required in submittals was excessive for small risk increases. Resolution: Section 2.2.4, ``Acceptance Guidelines,'' addresses the treatment of small increases in risk using the metrics of CDF and LERF. As noted in the discussion for Issue Number 1, this section has been revised and now includes a special category of application in which the estimated level of CDF/LERF increase associated with the application is sufficiently low that, in general, program changes associated with this region may be permitted without a detailed assessment of the baseline CDF/LERF. This category is displayed in Figures 3 and 4 of Section 2.2.4. 4. Treatment of Uncertainties Issue: Comments stated that the inclusion of uncertainty could lead to confusion regarding the decision criteria and that the use of PRA inherently takes care of uncertainty. Resolution: Several approaches were reconsidered for the treatment of uncertainties, and it was concluded that the approach described in Draft Regulatory Guide DG-1061 appeared to be the most practical and useful approach at this time, although the text needed to be clarified. Uncertainty is addressed in Section 2.2.5, ``Comparison of PRA Results with the Acceptance Guidelines,'' in Regulatory Guide 1.174. In this section, it is noted that it is important, when interpreting the results of a PRA, to develop an understanding of the impact of a specific assumption or choice of model on the prediction. PRA only inherently takes care of those uncertainties modeled in the analysis. Others must be qualitatively or quantitatively addressed. The impact of using alternative assumptions and models may be reasonably evaluated using appropriate sensitivity studies. The major sources of uncertainty should be understood, but it is not necessary, in all cases, to perform elaborate uncertainty evaluations (e.g, propagation of uncertainty distributions). 5. Quality of PRA Issue: Numerous comments were received indicating concern that the PRA standards included in Draft NUREG-1602, ``The Use of PRA in Risk- Informed Applications'' (USNRC, June 1997), were unnecessarily high for many risk-informed applications. The comments also indicated that the requirements for PRA quality were not clear and that graded levels of PRA quality should be provided for different applications. Resolution: The issue of PRA quality is addressed in the revised Section 2.2.3, ``Scope, Level of Detail, and Quality of the PRA,'' of Regulatory Guide 1.174. In this section it is stated that PRA quality should be commensurate with the application for which it is intended and with the role that PRA results would play in the integrated decision process. A PRA used in a risk-informed application should be performed in a manner that is consistent with accepted practices, and it should be commensurate with the scope and level of detail, which are also discussed in Section 2.2.3 of Regulatory Guide 1.174. The NRC has not developed its own formal standard nor endorsed an industry standard for PRA quality, but it supports such a standard and expects that one will be available in the future. Draft NUREG-1602 was cited in Draft Regulatory Guide DG-1061 as a potential reference for PRA methods that could be used to support regulatory decisionmaking. There were a number of comments indicating that the ``PRA standard'' represented by Draft NUREG-1602 was excessive for many risk-informed applications that did not require sophisticated or state-of-the-art methods. While Draft NUREG-1602 was not intended to be used universally as a PRA standard, it is acknowledged that it would be more useful to have a standard that addresses the differing needs for PRA scope and detail depending on the application. Accordingly, Draft NUREG-1602 is no longer referenced in Regulatory Guide 1.174, and a separate discussion on PRA quality has been added, including the use of peer reviews or PRA cross comparisons. PRA peer review activities such as those presently being done under various industry PRA certification programs are examples. Peer review, PRA certification, or cross comparison do not replace a staff review in its entirety, and licensees need to justify why the PRA is adequate for the proposed application. In the interim, until a consensus PRA standard is available, the NRC staff will evaluate PRAs submitted in support of specific applications using the guidelines given in Chapter 19 of the Standard Review Plan. 6. Low Safety Significant Components Monitoring Needs Issue: Comments indicated that the draft guidance placed too much importance on monitoring low safety significant components (LSSCs). The comments also indicated that monitoring performed under the Maintenance Rule should be acceptable for risk-informed programs. [[Page 44662]] Resolution: Section 2.3, ``Element 3: Define Implementation and Monitoring Program,'' has been revised to clarify the need for monitoring LSSCs. While details for monitoring LSSCs will be provided in the application-specific guidance documents, the following principal needs should be satisfied for all applications. Monitoring programs should be proposed that are capable of adequately tracking the performance of equipment that, when degraded, could alter the conclusions that were key to supporting the acceptance of the program. It follows that monitoring programs should be structured such that SSCs are monitored commensurate with their safety significance. Monitoring that is performed as a part of the Maintenance Rule implementation can be used when the monitoring performed under the Maintenance Rule is sufficient for the SSCs affected by the risk-informed application. 7. Shutdown and Temporary Plant Condition Issue: Several commenters noted that the guidelines proposed did not distinguish between power operation and shutdown and did not address temporary plant conditions. Separate guidelines for these conditions were suggested. Resolution: In response to these comments, Section 2.2.4 of Regulatory Guide 1.174 has been expanded to address the shutdown condition. Specific guidance for temporary plant conditions has not been added, but will be considered in a future update of the guide. 8. Documentation Needs Issue: Many commenters stated that the requirements in the drafts for documentation were excessive and unmanageable, particularly for proposals involving small changes in risk. It was also suggested that certain items of documentation should not be required to be submitted for the staff's initial review, provided that more complete documentation was maintained at the utility for review as necessary. Resolution: In response to the comments received, Section 3 of Regulatory Guide 1.174 has been reevaluated to determine whether all items listed in the draft were necessary. As a result, a number of documentation items, particularly with regard to the PRA, have been removed in the final regulatory guide, and the SRP has been revised to be consistent. 9. Overall Cost Benefit Issue: This issue was highlighted by NEI in its comment letter and was also included in a number of other comment letters. A concern was expressed that the resources required by licensees to prepare proposals and to subsequently implement NRC-approved risk-informed changes to the CLB would be too high considering the benefit in terms of burden reduction. Resolution: The question of how cost beneficial it would be for utilities to prepare proposals for risk-informed changes to their licensing bases and to implement such programs after review and approval by the NRC will only be fully answered after the industry and the NRC gain further experience in these types of programs. Certainly, the pilot plant program proposals, which are currently being reviewed for application to technical specifications, graded quality assurance, and inservice testing and inspection, will provide useful insights into the potential cost savings of these programs. While it is not the NRC's responsibility to ensure that such risk-informed programs are cost beneficial, it is believed that such programs can enhance safety by better focusing utility and NRC resources on the most important safety areas in reactors; this philosophy is consistent with the Commission's Policy Statement on the use of PRA methods in nuclear regulatory activities. During the preparation of this final regulatory guide and standard review plan section, attention was paid to areas in which needs for utility resources could be reduced, thus the cost beneficial aspects of the risk-informed process were improved while still maintaining an appropriate level of safety. Examples in Regulatory Guide 1.174 are Section 2.2.3, ``Scope, Level of Detail, and Quality of the PRA,'' which states that the level of detail required to support an application can vary depending on the application, and not all applications require an expensive, detailed PRA; Section 2.2.4, ``Acceptance Guidelines,'' identifies a special category of risk- informed proposal as having a sufficiently low estimated risk increase that, generally, the proposal would be considered without a detailed assessment of baseline CDF/LERF (i.e., Region III of Figures 3 and 4 in Regulatory Guide 1.174); and in Section 3, ``Documentation,'' where some of the items that were identified in the draft guide and SRP as being needed in program submittals have been removed since they were not believed necessary. (5 U.S.C. 552(a)) Dated at Rockville, MD, this 31st day of July 1998. For the Nuclear Regulatory Commission. Ashok C. Thadani, Director, Office of Nuclear Regulatory Research. [FR Doc. 98-22412 Filed 8-19-98; 8:45 am] BILLING CODE 7590-01-P