[Federal Register Volume 65, Number 174 (Thursday, September 7, 2000)]
[Notices]
[Pages 54323-54326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22956]


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NUCLEAR REGULATORY COMMISSION


Notice of Public Meeting to Present Draft Plan for Using Risk 
Information in NMSS--Case Studies

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of meeting.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff is 
developing an approach for using risk information in the nuclear 
materials regulatory process. As part of this effort, the NRC staff has 
developed a draft plan for using risk-informed approaches in the Office 
of Nuclear Material Safety and Safeguards (NMSS). The plan includes 
case studies to examine the use of risk information in NMSS. The 
purpose of the case studies is (1) to illustrate what has been done and 
what could be done in NMSS to alter the regulatory approach in a risk-
informed manner, and (2) to establish a framework for using a risk-
informed approach in NMSS. The purpose of the meeting is to communicate 
the draft plan to the public and receive feedback. The meeting is open 
to the public and all interested parties may attend and provide 
comments.

DATES: The meeting will be held on September 21, 2000, from 9 a.m. to 
12 noon, in the U.S. Nuclear Regulatory

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Commission Auditorium, 11545 Rockville Pike, Rockville, MD 20852.

FOR FURTHER INFORMATION, CONTACT: Marissa Bailey, Mail Stop T-8-A-23, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
Telephone: (301) 415-8531; Internet: [email protected].

SUPPLEMENTARY INFORMATION:

Draft Plan for Using Risk Information in NMSS--Case Studies

Background

    In SECY-99-100, ``Framework for Risk-informed Regulation in the 
Office of Nuclear Material Safety and Safeguards,'' dated March 31, 
1999, the NRC staff proposed a framework for risk-informed regulation 
in NMSS. On June 28, 1999, the Commission approved the staff's 
proposal. In the associated staff requirements memorandum, the 
Commission approved the staff's recommendation to implement a five-step 
process consisting of: (1) Identifying candidate regulatory 
applications that are amenable to expanded use of risk assessment 
information; (2) making a decision on how to modify a regulation or 
regulated activity; (3) changing current regulatory approaches; (4) 
implementing risk-informed approaches; and (5) developing or adapting 
existing tools and techniques of risk analysis to the regulation of 
nuclear materials safety and safeguards.
    Step one of the five-step process will be accomplished by applying 
screening criteria to regulatory application areas as a means to 
identify the candidate regulatory applications. To be a candidate for 
expanded use of risk information in NMSS, regulatory application areas 
must meet the screening criteria.
    As part of the staff's effort to use an enhanced public 
participatory process in developing the framework, the staff held a 
public workshop in Washington, DC, on April 25 and 26, 2000. The staff 
published draft screening criteria in a Federal Register Notice (65 FR 
14323, March 16, 2000) announcing the workshop. The purpose of the 
first part of the workshop was to solicit public comment on the draft 
screening criteria and their applications. The purpose of the second 
part of the workshop was to solicit public input for the process of 
developing safety goals for nuclear materials applications.
    The workshop included participation by representatives from NRC, 
Environmental Protection Agency, Department of Energy, Occupational 
Safety and Health Administration, Organization of Agreement States, 
Health Physics Society, Nuclear Energy Institute, environmental and 
citizen groups, licensees, and private consultants. A consensus among 
the workshop participants was that case studies and iterative 
investigations would be useful for the following purposes: (1) To test 
the screening criteria, (2) to show how the application of risk 
information has affected or could affect a particular area of the 
regulatory process, and (3) to develop safety goal parameters and a 
first draft of safety goals for each area.

Purpose

    The purpose of the case studies is (1) to illustrate what has been 
done and what could be done in NMSS to alter the regulatory approach in 
a risk-informed manner, and (2) to establish a framework for using a 
risk-informed approach in NMSS by testing the draft screening criteria, 
and determining the feasibility of safety goals. Once the screening 
criteria have been tested using a spectrum of case studies, the 
criteria can be modified as appropriate, placed in final form, and 
established as part of the framework for prioritizing the use of risk 
information in NMSS regulatory applications.
    The case studies will also be used to begin the process of 
developing safety goals for NMSS applications. Specifically, safety 
goal parameters (e.g., public, worker, acute fatality, latent fatality, 
injury, property damage, environment damage, safeguards, absolute vs. 
relative) should be identified in each study. Each case study will 
determine the feasibility of safety goals in that area. If feasible, a 
first draft of safety goals will be developed.
    All case studies will have these general objectives. However, 
certain case studies may have specialized objectives. For example, as 
one type of test of the screening criteria, a case study will be chosen 
in an area that the staff intuitively feels might not pass the 
screening criteria. These additional objectives are discussed in the 
case study outline which is included in this plan.
    The intent of the case studies is not to reopen or reassess 
previous decisions made by the staff and the Commission. The 
information gained by performing the case studies may impact future 
decisions to be made by the staff and the Commission.
    Questions have been developed for each case study to answer. 
Answering these questions will guide the case studies to meet the 
objectives outlined below. Each case study will be of limited scope, 
but collectively, the case studies will cover a broad spectrum of NMSS 
regulatory applications. The case studies have been selected in areas 
that the staff believes would specifically help in establishing a 
framework, as well as areas that would help to set the groundwork for 
establishing safety goals.

Objectives

    Case studies will have the following objectives: (1) Objective 1--
Produce a final version of the NMSS screening criteria. (2) Objective 
2--Illustrate how the application of risk information has improved or 
could improve a particular area of the NMSS regulatory process. (3) 
Objective 3--Determine the feasibility of safety goals in a particular 
area. If feasible, develop safety goal parameters, and a first draft of 
safety goals. If infeasible, document the reasons.

Draft Screening Criteria

    Draft screening criteria were published in the Federal Register 
Notice (65 FR 14323, March 16, 2000) announcing the April 2000 
workshop. On the basis of comments received at the workshop and 
discussions with the NMSS Risk Steering Group, the criteria have been 
revised. The revised draft screening criteria are as follows:
    1. Would a risk-informed regulatory approach help to resolve a 
question with respect to maintaining or improving the activity's 
safety?
    2. Could a risk-informed regulatory approach improve the efficiency 
or the effectiveness of the NRC \1\ regulatory process?
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    \1\ For those regulatory processes in which Agreement States are 
involved, this criterion is applicable to Agreement States.
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    3. Could a risk-informed regulatory approach reduce unnecessary 
regulatory burden for the applicant or licensee?
    4. Would a risk-informed approach help to effectively communicate a 
regulatory decision or situation?
    If the answer to any of the above is yes, proceed to additional 
criteria; if not, the activity is considered to be screened out.
    5. Do information (data) and analytical models exist that are of 
sufficient quality or could they be developed to support risk-informing 
a regulatory activity?
    If the answer to criterion 5 is yes, proceed to additional 
criteria; if not, the activity is considered to be screened out.
    6. Can startup and implementation of a risk-informed approach be 
realized at a reasonable cost to the NRC, \1\ applicant or licensee, 
and/or the public, and provide a net benefit? The net benefit

[[Page 54325]]

will be considered to apply to the public, the applicant or licensee, 
and the NRC. \1\ The benefit to be considered can be improvement of 
public health and safety, improved protection of the environment, 
improved regulatory efficiency and effectiveness, improved 
communication to the public, and/or reduced regulatory burden (which 
translates to reduced cost to the public.)
    If the answer to criterion 6 is yes, proceed to additional 
criteria; if not, the activity is considered to be screened out.
    7. Do other factors exist (e.g., legislative, judicial, adverse 
stakeholder reaction) which would preclude changing the regulatory 
approach in an area, and therefore, limit the utility of implementing a 
risk-informed approach?
    If the answer to criterion 7 is no, a risk-informed approach may be 
implemented; if the answer is yes, the activity may be given additional 
consideration or be screened out.

Measures of Success

    Success of the case studies will be measured by the following: (1) 
If, based on the testing of the draft screening criteria, final 
screening criteria are established, the case studies will, 
collectively, meet Objective 1; (2) if a case study can illustrate how 
the application of risk information has affected or could affect and 
improve a particular area of the regulatory process, the case study 
will meet Objective 2; and (3) if a case study can determine the 
feasibility of establishing safety goals, and if feasible, develop the 
necessary safety goal parameters and a first draft of goals, the case 
study will meet Objective 3.
    When completed, the staff will present the results of the spectrum 
of case studies to the Commission.

Case Study Outline

    I. Revise draft screening criteria based on workshop and other 
suggestions (completed prior to September 21, 2000, meeting).
    II. Meet with the NRC historian.
    III. Review tables from the NRC-EPA risk harmonization effort and 
other sources such as the National Academy of Sciences study to uncover 
any implicit objectives (goals) under the existing regulatory 
framework. Glean insights on any potential underlying safety goals.
    IV. Case Study Areas.
    A. Gas Chromatographs (new and old designs, the line between 
general licenses and specific licenses for almost identical devices is 
unclear--illustrate how the application of risk information could 
improve a particular area of the regulatory process)
    B. Fixed Gauges (some are specifically licensed, and others are 
under a general license; regulatory criteria for general versus 
specific license are not based on risk--illustrate how the application 
of risk information could improve a particular area of the regulatory 
process; also, this could be a test case for a safety goal on property 
damage)
    C. Site Decommissioning--the study may focus on certain well 
decommissioning incidents and certain selected sites (elements of 
implied safety goals may be found in Commission decisions)
    D. Uranium Recovery Facilities (gaps in the regulations may be 
found; helpful in testing the screening criteria; if determined to be a 
good candidate for using risk, develop and use risk information for new 
Part 41 rulemaking effort)
    E. Radioactive Material Transportation (elements of existing, 
implicit safety goals may be found in Commission decisions; public 
confidence and communication issue)
    F. Part 76 (decide to use expanded risk information for gaseous 
diffusion plants or document the reasons why risk information will not 
improve the regulatory process in this area--contrast with new Part 70 
approach; this decision-making process will be a good test for the 
draft screening criteria and will help establish consistency in 
applying risk information across NMSS programs; also, possibly an area 
to look at chemical risks.)
    G. Spent Fuel Interim Storage (study probabilistic hazards analysis 
exemptions and proposed rulemaking--implicit safety goals may be found; 
public confidence issues and burden considerations)
    H. Static Eliminators (public confidence issue; risk communication 
issue--regulatory changes were made even though perceived risk was low)
    V. Case Study Structure.
    A. Develop a set of questions for all case studies to answer.
    B. Select a case-specific contact in each NMSS Division; obtain 
agreement with the Divisions on participation.
    C. Public meeting to announce our plan for case studies (September 
21, 2000).
    D. Make any necessary revisions to plan based on input from public 
meeting.
    E. Develop detailed approach and timeline for each case study 
including the need and level of involvement of contractor support.
    F. Begin work on case studies.
    G. Test screening criteria for each case study.
    H. Answer all questions for each case study.
    I. Meet with case-specific stakeholders as input to case studies.
    J. Develop recommendations for safety goals (will be done in 
parallel with above).
    K. Document results.
    L. Conduct public meeting to present results of case studies.
    M. Inform Commission of results.
    VI. Assess the Outcome and Develop a Plan to Move Forward.

Draft Questions for Case Studies

    A. Screening criteria analysis/risk analysis questions:
    1. What risk information is currently available in this area? (Have 
any specific risk studies been done?)
    2. What is the quality of the study? (Is it of sufficient quality 
to support decision-making?)
    3. What additional studies would be needed to support decision-
making and at what cost?
    4. How is/was risk information used and considered by the NRC and 
licensee in this area?
    5. What is the societal benefit of this regulated activity?
    6. What is the public perception/acceptance of risk in this area?
    7. What was the outcome when this application was put through the 
draft screening criteria? Did this application pass any of the 
screening criteria? Does the outcome seem reasonable? Why or why not?
    B. Safety goal analysis questions:
    1. What is the basis for the current regulations in this area 
(e.g., legislative requirements, international compatibility, 
historical events, public confidence, undetermined, etc.)?
    2. Are there any explicit safety goals or implicit safety goals 
embedded in the regulations, statements of consideration, or other 
documents (an example would be the acceptance of a regulatory exemption 
based in part on a risk analysis and the outcome)?
    3. What was the basis for the development of the strategic goals, 
performance goals, measures and metrics? How are they relevant/
applicable to the area being studied and how do they relate/compare 
with the regulatory requirements? How would they relate to safety goals 
in this area?
    4. Are there any safety goals, limits, or other criteria implied by 
decisions or evaluations that have been made that are relevant to this 
area?
    5. If safety goals were to be developed in this area, would tools/
data be available for measurement?

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    6. Who are/were the populations at risk?
    7. What are/were, and what could be/have been, the various 
consequences to the populations at risk?
    8. What parameters should be considered for the safety goals (e.g., 
workers vs. public, individual vs. societal, accidents vs. normal 
operations, acute vs. latent fatality or serious injury, environmental 
and property damage)?
    9. On the basis of the answers to the questions above, would it be 
feasible to develop safety goals in this regulatory area?
    10. What methods, data results, safety goals, or regulatory 
requirements would be necessary to make it possible to risk-inform 
similar cases?
    C. Questions upon development of draft safety goals:
    1. Are the current regulations sufficient in that they reflect the 
objectives of the draft goals? Would major changes be required?
    2. Would the regulations need to be tightened?
    3. Are the regulations overly conservative and/or too prescriptive 
with respect to the goals?
    4. If these were the safety goals, what decisions would be made?
    5. Would these goals be acceptable to the public?
    The meeting will include a presentation of the draft plan and an 
opportunity for interested government agencies, organizations, and 
individuals to provide comments on the draft plan. Persons who wish to 
attend the meeting should contact Marissa Bailey no later than 
September 19, 2000.

    Dated at Rockville, MD, this 31st day of August, 2000.

    For the Nuclear Regulatory Commission
Lawrence E. Kokajko,
Section Chief, Risk Task Group, Office of Nuclear Material Safety and 
Safeguards.
[FR Doc. 00-22956 Filed 9-6-00; 8:45 am]
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