00-3803. Public Workshop on Performance-Based Regulatory Approaches

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of Workshop.

SUMMARY:

On Monday, January 24, 2000 (65 FR 3615), the Nuclear Regulatory Commission (NRC) issued a Federal Register Notice (FRN) titled, “High-Level Guidelines for Performance-Based Activities.” In that notice the NRC requested comments on its proposed high-level guidelines for developing performance-based activities, and noticed a public workshop to obtain stakeholder input. An agenda for that workshop has subsequently been developed and is provided herein. In addition, because of minor editorial and formatting errors, a corrected version of the January 24, 2000 FRN is reproduced here.

FOR FURTHER INFORMATION CONTACT:

N. Prasad Kadambi, [phone], Internet: [e-mail] of the Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

Background

In the Staff Requirements Memorandum (SRM) to SECY-99-176, “Plans for Pursuing Performance-Based Initiatives,” issued on September 13, 1999, the Commission directed the staff to develop high-level guidelines to identify and assess the viability of candidate performance-based activities. Among other things, the Commission directed the staff to develop the guidelines with input from stakeholders and program offices, and to include discussion on how risk information might assist in the development of performance-based initiatives.

This FRN focuses on the staff's efforts to develop high-level guidelines for performance-based initiatives applicable to all NRC licensees. The development and use of these guidelines will be coordinated (including public meetings and workshops) with the efforts to risk-inform 10 CFR part 50 and other regulations.

Public Meeting

The staff plans to hold a public meeting to obtain feedback on the proposed high-level guidelines for performance-based activities. The public meeting is scheduled for March 1, 2000, between 9 a.m. and 4 p.m., in the auditorium at the NRC headquarters (Two White Flint North, 11545 Rockville Pike, Rockville, Maryland, 20852). The public should be aware that another meeting concerning efforts to risk-inform 10 CFR part 50 is scheduled on February 24, 2000. That meeting, focused on reactors, will also consider performance-based revisions to 10 CFR Part 50 based on the high-level guidelines discussed in this FRN.

The meeting being noticed here will focus on the application of high-level guidelines to all regulatory activities (of which 10 CFR part 50 would be a part) so as to make them more performance-based. This meeting is scheduled to occur about 3 weeks prior to the expiration of the comment period mentioned above. This will allow for an exchange of views among stakeholders and the NRC staff. This interaction should be beneficial to the meeting participants in the development of written public comments.

This meeting is open to the general public to observe or to participate by making remarks. To register for attendance or to present prepared remarks, please contact N. Prasad Kadambi, USNRC, telephone: [phone]; facsimile: [phone]; internet: [e-mail].

Discussion

The high-level guidelines identified in this FRN are intended to be applied to future regulatory initiatives. As the effort to risk-inform regulatory activities (for example, in the reactors and materials areas) is performed, the high-level guidelines will be used to identify activities which can be made more performance-based. It should be noted that regulatory activities that cannot be made risk-informed could still be made more performance-based. In addition, candidates for performance-based activities may also be identified as a result of other mechanisms such as proposed changes arising from stakeholder input or from petitions for rulemaking as identified in the Rulemaking Activity Plan.

The fundamental basis for developing these guidelines has been the SRM to SECY-98-144, “White Paper on Risk-Informed and Performance-Based Regulation,” http://www.nrc.gov/​NRC/​COMMISSION/​SRM/​1998-144srm.html, in which the Commission provided a context and definition for performance-based approaches incorporating the following points:

• A regulation can be either prescriptive or performance-based.
• A performance-based regulatory approach establishes performance and results as the primary basis for regulatory decision-making.
• Four attributes are identified which characterize a performance-based approach. These attributes, as discussed below, form an important part of the high-level guidelines which are being proposed herein.
• A performance-based approach can be implemented with or without the use of risk insights.

The proposed high-level guidelines are to be used to evaluate potential performance-based regulatory initiatives. When the guidelines are finalized, they will be incorporated into NRC procedures and policy documents used by staff in conducting day-to-day activities (e.g. Management Directives). These regulatory initiatives will complement and build upon what is accomplished through risk-informed initiatives, including the effort to risk-inform 10 CFR part 50. Further, with successive application of the guidelines, it is anticipated that the staff will be able to reassess the utility of the guidelines such that they will evolve and improve over time.

High-Level Guidelines

The following proposed guidelines are designed such that they can be applied in the reactor, materials, and waste arenas. The nature of the regulated activity would determine which guidelines apply and the extent of the application.

I. Guidelines To Assess Viability

The NRC will apply the following guidelines (which are based on the four attributes in the White Paper) to assess whether a more performance-based approach is viable for any given new regulatory initiative. This assessment would be applied on a case-by-case basis and would be based on an integrated consideration of the individual guidelines. The guidelines are listed below:

A. Measurable (or calculable) parameters to monitor acceptable plant and licensee performance exist or can be developed.

a. For regulatory application, a parameter measured directly is preferred, although a calculation may also be acceptable; it should also be directly related to the safety objective of the regulatory activity being considered. For example, the sub-cooling margin available in the reactor coolant must be calculated from the coolant's pressure and temperature, which are monitored directly.

b. Preferable parameters are those which licensees can readily access, or are currently accessing, in real time. For example, monitoring of radiological effluents at some facilities is done in real time. However, parameters monitored periodically to address postulated or design basis conditions, such as monitoring occupational radiological doses, may also be used.

B. Objective criteria to assess performance exist or can be developed. Objective criteria are established based on risk insights, deterministic analyses and/or performance history.

C. Licensees would have flexibility in meeting the established performance criteria when a performance-based approach is adopted. Programs and processes used to achieve the established performance criteria would be at the licensee's discretion.

D. A framework exists or can be developed such that performance criteria, if not met, will not result in an immediate safety concern.

a. A sufficient safety margin exists.

b. Time is available for taking corrective action to avoid the safety concern.

c. The licensee is capable of detecting and correcting performance degradation.

II. Guidelines To Assess Performance-Based Regulatory Improvement

If a more performance-based approach is deemed to be viable based on the guidelines in (I) above, then the regulatory activity would be evaluated against the following set of guidelines to determine whether, on balance, after an integrated consideration of these guidelines, there are opportunities for regulatory improvement:

A. Maintain safety, protect the environment and the common defense and security. The level of conservatism and uncertainty in the supporting analyses would be assessed to ensure adequate safety margins.

B. Increase public confidence. An assessment would be made to determine if the emphasis on results and objective criteria (characteristics of a performance-based approach) can increase public confidence.

C. Increase effectiveness, efficiency and realism of the NRC activities and decision-making.

D. Reduce unnecessary regulatory burden.

E. A reasonable test shows an overall net benefit results from moving to a performance-based approach.

a. A reasonable test would begin with a qualitative approach to evaluate whether there is merit in changing the existing regulatory framework. When this question is approached from the perspective of existing practices in a mature industry, stakeholder support for change may need to be obtained.

b. If stakeholder input indicates that a change in regulatory practice is likely to be expensive, a much closer examination of the benefits would be warranted before such a change is pursued.

c. A simplified definition of the overall net benefit (such as net reduction in worker radiation exposure) may be appropriate for weighing the immediate implications of a proposed change.

F. The performance-based approach can be incorporated into the regulatory framework.

a. The regulatory framework includes the regulation in the Code of Federal Regulations, the associated Regulatory Guide, NUREG, Standard Review Plan, Technical Specification, or inspection guidance.

b. A feasible performance-based approach would be one which can be directed specifically at changing one, some, or all of these components.

G. The performance-based approach would accommodate new technology.

a. The incentive to consider a performance-based approach may arise from development of new technologies (such as advanced non-destructive evaluation techniques) as well as difficulty stemming from technological changes in finding spare components and parts.

b. Advanced technologies may provide more economical solutions to a regulatory issue, justifying consideration of a performance-based approach.

III. Guidelines To Assess Consistency with Other Regulatory Principles.

A. A proposed change to a more performance-based approach is consistent and coherent with other overriding goals, principles and approaches involving the NRC's regulatory process.

a. The main sources of these principles are the Principles of Good Regulation, the Probabilistic Risk Assessment (PRA) Policy Statement, the Regulatory Guide 1.174, “An Approach for Using PRA in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis,” and the NRC's Strategic Plan.

b. Consistent with the high-level at which the guidance described above has been articulated, specific factors which need to be addressed in each case (such as defense in depth and treatment of uncertainties) would depend on the particular regulatory issues involved.

Additional Information

The staff's proposed high-level guidelines reflect a measure of specificity designed to stimulate reactions, concerns, and views on the more detailed consideration or underpinnings of a set of high-level guidelines. In no way should this specificity be construed as an indication that the NRC has established any firm position regarding these guidelines. The NRC invites advice and recommendations from all interested persons on all aspects of its proposal. In addition, comments and supporting reasons are particularly requested in the following areas:

(1) Clarity and specificity of the guidelines;

a. Are the proposed guidelines appropriate and clear?

b. Are there additional guidelines that would improve clarity and specificity?

c. How does the “high-level” nature of the guidelines affect the clarity and specificity of the guidelines?

(2) Implementation of the guidelines;

a. What guidelines, if any, are mandatory for an activity to qualify as a performance-based initiative?

b. What is the best way to implement these guidelines?

c. How should the Backfit Rule apply to the implementation of performance-based approaches?

d. Should these guidelines be applied to all types of activity, e.g., should they be applied to petitions for rulemaking?

e. Should these guidelines only be applied to new regulatory initiatives?

f. Will these guidelines be effective in determining whether we can make a regulatory initiative more performance-based? The staff proposes that these guidelines be added to our Management Directives such that whenever the NRC is involved in a rulemaking, or changing a regulatory guide or branch technical position, etc., we will consider the option of making it more performance-based.

(3) Establishment of objective performance criteria;

a. In moving to performance-based requirements, should the current level of conservatism be maintained or should introduction of more realism be attempted?

b. What level of conservatism (safety margin) needs to be built into a performance criterion to avoid facing an immediate safety concern if the criterion is not met?

c. Recognizing that performance criteria can be set at different levels in a hierarchy (e.g., component, train, system, release, dose), on what basis is an appropriate level in the hierarchy selected for setting performance-based requirements, and what is the appropriate level of conservatism for each tier in the hierarchy?

d. Who would be responsible for proposing and justifying the acceptance limits and adequacy of objective criteria?

e. What are examples of performance-based objectives that are not amenable to risk analyses such as PRA or Integrated Safety Assessment?

f. In the context of risk-informed regulation, to what extent should performance criteria account for potential risk from beyond-design-basis accidents (i.e., severe accidents)?

(4) Identification and use of measurable (or calculable) parameters;

a. How and by whom are performance parameters to be determined?

b. How do you decide what a relevant performance parameter is?

c. How much uncertainty can be tolerated in the measurable or calculated parameters?

(5) Pilot projects;

a. Would undertaking pilot projects in the reactor, materials, and waste arenas provide beneficial experience before finalizing the guidelines?

b. What should be the relationship between any such pilot projects and those being implemented to risk-inform the regulations?

Agenda

9 A.M.—Welcome, ground rules, introductions, agenda overview—F.X. Cameron, Facilitator

9:15 A.M.—Overview of NRC performance-based regulatory initiative—P. Kadambi, Office of Nuclear Regulatory Research—Participant and audience questions

9:45 A.M.—Experience of other agencies with performance-based regulatory approaches—Participant and audience questions

10:15 A.M.—Break

10:30 A.M.—What is the nature of performance-based regulation? What are its objectives? What is the relationship between performance-based initiatives and risk-informed initiatives? Participant discussion

11:45 A.M.—Lunch

1 P.M.—Summary of morning discussion and introduction of new participants. What criteria should be used to select guidelines? Views on NRC's proposed guidelines (see subject FRN)—Participant discussion

2:30 P.M.—Implementation issues: What process should be used to implement the guidelines for performance-based regulatory approaches? What is the relationship between the guidelines and ongoing NRC performance-based regulatory approaches? What is the role of regulatory guidance, and inspection and enforcement in implementing performance-based regulatory initiatives? Should a pilot program be established before full scale application? Participant discussion

3:15 P.M.—Break

3:30 P.M.—Summary of day's discussion and review of specific NRC information needs. See FRN “Additional Information.” Discussion of future actions—Participant discussion

4 P.M.—Adjourn

Dated at Rockville, Maryland, this 11th day of February 2000.

For the Nuclear Regulatory Commission.

Charles E. Rossi,

Director, Division of Systems Analysis and Regulatory Effectiveness, Office Of Nuclear Regulatory Research.