[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Proposed Rules]
[Pages 3615-3617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1572]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / 
Proposed Rules

[[Page 3615]]



NUCLEAR REGULATORY COMMISSION

10 CFR Chapter I


High-Level Guidelines for Performance-Based Activities

AGENCY:  Nuclear Regulatory Commission.

ACTION:  Request for comments.

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SUMMARY:  The Nuclear Regulatory Commission (NRC) is requesting public 
comment on its proposed high-level guidelines for developing 
performance-based activities. The guidelines would be used to assess 
NRC regulatory activities for performance-based approaches. 
Specifically, the guidelines are designed to assess whether candidate 
regulatory activities are amenable to a performance-based approach; 
identify those regulatory activities that should utilize performance-
based approaches based on opportunities for regulatory improvement; and 
ensure consistency with the NRC's existing high-level regulatory goals 
and principles. Before it uses these proposed high-level guidelines, 
the staff plans to hold public meetings to obtain stakeholder input and 
to meet with the Advisory Committee on Reactor Safeguards (ACRS) and/or 
Advisory Committee on Nuclear Waste (ACNW) to obtain their feedback on 
the guidelines.

DATES:  The comment period expires March 24, 2000. Comments received 
after this date will be considered if it is practical to do so, but the 
Commission is able to assure consideration only for comments received 
on or before this date.

ADDRESSES:  Written comments may be sent to: David L. Meyer, Chief, 
Rules and Directives Branch, U.S. Nuclear Regulatory Commission, Mail 
Stop T-6D59, Washington, DC 20555-0001. Hand deliver comments to 11545 
Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on 
federal workdays.
    You may also provide comments via the NRC's interactive rulemaking 
website through the NRC home page (http://www.nrc.gov). This site 
provides the capability to upload comments as files (any format), if 
your web browser supports that function. For information about the 
interactive rulemaking website, contact Ms. Carol Gallagher, (301) 415-
5905 (e-mail: <a href="/cdn-cgi/l/email-protection#adeeeceaedc3dfce83cac2db"><span class="__cf_email__" data-cfemail="eba8aaacab859988c58c849d">[email protected]</span></a>).
    Documents created or received at the NRC after November 1, 1999, 
are also available electronically at the NRC's Public Electronic 
Reading Room on the Internet at http://www.nrc.gov/NRC/ADAMS/index.html. From this site, the public can gain entry into the NRC's 
Agencywide Document Access and Management System (ADAMS), which 
provides text and image files of NRC's public documents. For more 
information, contact the NRC Public Document Room (PDR) Reference staff 
at 202-634-3273 or toll-free at 1-800-397-4209, or by email at 
<a href="/cdn-cgi/l/email-protection#463622340628342568212930"><span class="__cf_email__" data-cfemail="c5b5a1b785abb7a6eba2aab3">[email protected]</span></a>.

FOR FURTHER INFORMATION CONTACT:  N. Prasad Kadambi, (301) 415-5896, 
Internet: <a href="/cdn-cgi/l/email-protection#305e405b705e42531e575f46"><span class="__cf_email__" data-cfemail="fc928c97bc928e9fd29b938a">[email protected]</span></a> 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 Federal Register Notice (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 9:00 a.m. and 
4:00 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 15 days 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; however, advance registration by 
February 1, 2000 is recommended. To register for attendance or to 
present prepared remarks, please contact N. Prasad Kadambi, USNRC, 
telephone: (301) 415-5896; facsimile: (301) 415-5160; internet: 
<a href="/cdn-cgi/l/email-protection#432d3328032d31206d242c35"><span class="__cf_email__" data-cfemail="f799879cb7998594d9909881">[email protected]</span></a>.

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

[[Page 3616]]

rulemaking as identified in the Rulemaking Activity Plan.
    The fundamental basis for developing these guidelines has been the 
SRM to SECY-98--44, ``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:
    <bullet> A regulation can be either prescriptive or performance-
based.
    <bullet> A performance-based regulatory approach establishes 
performance and results as the primary basis for regulatory decision 
making.
    <bullet> 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.
    <bullet> 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 being proposed 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.
A. 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:
    <bullet> Measurable (or calculable) parameters to monitor 
acceptable plant and licensee performance exist or can be developed.
    <bullet> 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.
    <bullet> 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.
    <bullet> Objective criteria to assess performance exist or can be 
developed.
    <bullet> Objective criteria are established based on risk insights, 
deterministic analyses and/or performance history.
    <bullet> Licensees would have flexibility in meeting the 
established performance criteria when a performance-based approach is 
adopted.
    <bullet> Programs and processes used to achieve the established 
performance criteria would be at the licensee's discretion.
    <bullet> A framework exists or can be developed such that 
performance criteria, if not met, will not result in an immediate 
safety concern.
    <bullet> A sufficient safety margin exists.
    <bullet> Time is available for taking corrective action to avoid 
the safety concern.
    <bullet> The licensee is capable of detecting and correcting 
performance degradation.
B. Guidelines to Assess Performance-Based Regulatory Improvement
    If a more performance-based approach is deemed to be viable based 
on the guidelines in (A) 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:
    <bullet> Maintain safety, protect the environment and the common 
defense and security.
    <bullet> The level of conservatism and uncertainty in the 
supporting analyses would be assessed to ensure adequate safety 
margins.
    <bullet> Increase public confidence.
    <bullet> 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.
    <bullet> Increase effectiveness, efficiency and realism of the NRC 
activities and decision-making.
    <bullet> Reduce unnecessary regulatory burden.
    <bullet> A reasonable test shows an overall net benefit results 
from moving to a performance-based approach.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> The performance-based approach can be incorporated into 
the regulatory framework.
    <bullet> 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. 
A feasible performance-based approach would be one which can be 
directed specifically at changing one, some, or all of these 
components.
    <bullet> The performance-based approach would accommodate new 
technology.
    <bullet> 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.
    <bullet> Advanced technologies may provide more economical 
solutions to a regulatory issue, justifying consideration of a 
performance-based approach.
C. Guidelines to Assure Consistency With Other Regulatory Principles
    A proposed change to a more performance-based approach needs to be 
consistent and coherent with other overriding goals, principles and 
approaches involving the NRC's regulatory process. The main sources of 
these principles are the Principles of Good Regulation, the 
Probabilistic Risk Assessment (PRA) Policy Statement, the

[[Page 3617]]

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. 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?

    Dated at Rockville, Maryland, this 14th day of January, 2000.

    For the Nuclear Regulatory Commission.
Charles E. Rossi,
Director Division of Systems Analysis and Regulatory Effectiveness, 
Office of Nuclear Regulatory Research.
[FR Doc. 00-1572 Filed 1-21-00; 8:45 am]
BILLING CODE 7590-01-P


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