[Federal Register Volume 65, Number 33 (Thursday, February 17, 2000)]
[Proposed Rules]
[Pages 8072-8074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3803]


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NUCLEAR REGULATORY COMMISSION

10 CFR Ch. I


Public Workshop on Performance-Based Regulatory Approaches

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of Workshop.

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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, (301) 415-5896, 
Internet: [email protected] 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: 
(301) 415-5896; facsimile: (301) 415-5160; internet: [email protected].

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

[[Page 8073]]

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.

[[Page 8074]]

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.
[FR Doc. 00-3803 Filed 2-16-00; 8:45 am]
BILLING CODE 7590-01-P