[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Notices]
[Pages 66782-66785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28495]


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NUCLEAR REGULATORY COMMISSION


Plan for Using Risk Information in the Materials and Waste 
Arenas: Case Studies

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability.

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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 plan for using risk-informed approaches in the nuclear 
materials and waste arenas. The plan employs case studies to examine 
the use of risk information in the nuclear materials and waste arenas.
    The purpose of the case studies is: (1) To illustrate what has been 
done and what could be done in the materials and waste arenas to alter 
the regulatory approach in a risk-informed manner; and (2) to establish 
a framework for using a risk-informed approach in the materials and 
waste arenas. A draft of the plan was published in the Federal Register 
(65 FR 54323, September 7, 2000). On September 21, 2000, the NRC staff 
held a public meeting to communicate the draft plan to the public and 
to receive feedback. The meeting was open to the public and all 
interested parties were welcomed to attend and provide comments. The 
meeting was held from 9 a.m. to 12 noon in the U.S. Nuclear Regulatory 
Commission Auditorium in Rockville, Maryland. Based on the comments 
received at the public meeting and on comments from members of the 
Office of Nuclear Materials Safety and Safeguards Risk Steering Group, 
the NRC staff has revised and finalized the plan. The final plan is 
provided below in its entirety.

Plan for Using Risk Information in the Materials and Waste Arenas: 
Case Studies

1. Background

    In SECY-99-100, ``Framework for Risk-Informed Regulation in the 
Office of Nuclear Material Safety and Safeguards (NMSS),'' dated March 
31, 1999, the Nuclear Regulatory Commission (NRC) staff proposed a 
framework for risk-informed regulation in the materials and waste 
arenas. 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 the materials and waste arenas, 
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 and waste 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.

2. Purpose

    The purpose of the case studies is: (1) To illustrate what has been 
done and what could be done in the materials and waste arenas to alter 
the regulatory approach in a risk-informed manner; and (2) to establish 
a framework for using a risk-informed approach in the materials and 
waste arenas 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 materials and 
waste regulatory applications.
    The case studies will be used to begin the process of developing 
safety goals

[[Page 66783]]

for applications in the materials and waste arenas. 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. The case 
studies will also be used to check for and test any existing risk-
informed framework (e.g., defense-in-depth) in the material and waste 
arenas.
    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 
regulatory applications in the materials and waste arenas. 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.

3. Objectives

    Case studies will have the following objectives:

Objective 1: Produce a final version of screening criteria for the 
materials and waste arenas.
Objective 2: Illustrate how the application of risk information has 
improved or could improve a particular area of the regulatory process 
in the materials and waste arenas.
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.
Objective 4: Identify methods, data, and guidance needed to implement a 
risk-informed regulatory approach.

4. Draft Screening Criteria

    Draft screening criteria were published in Federal Register Notices 
announcing the April 2000 workshop and a September 2000 public meeting 
(65 FR 14323, 03/16/00, and 65 FR 54323, 09/07/00, respectively). On 
the basis of comments received at the workshop, the public meeting, 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 processess in which Agreement States 
are involed, 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) Does information (data) and analytical models exist that are of 
sufficient quality or could they be reasonably 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 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.

5. 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.
(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.
(4) If a case study can develop the risk-informed regulatory approach 
sufficient to define the methods, data, and guidance needed and the 
feasibility of developing them, the case study will meet Objective 4.

    When completed, the staff will present the results of the spectrum 
of case studies to the Commission.

6. 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 and other appropriate individuals (NRC 
and non-NRC) for perspectives and insights on the materials and waste 
regulatory history.
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

[[Page 66784]]

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 
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 materials and waste programs; also, 
possibly an area to look at chemical risk).
    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.

7. Draft Questions for Case Studies

7.1.  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?
7.2  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?
(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?
7.3  Questions Upon Developing 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?

ADDRESSES: Copies of this plan are available on the Internet at http://www.nrc.gov/NMSS/IMNS/riskassessment.html. Submit written requests for 
single copies of this plan to the U. S. Nuclear Regulatory Commission, 
Office of Nuclear Materials Safety and Safeguards, Risk Task Group, MS 
T-8-A-23, Washington, DC 20555-0001.

FOR FURTHER INFORMATION CONTACT: Marissa Bailey, Mail Stop T-8-A-23, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
Telephone: (301) 415-7648; Internet: <a href="/cdn-cgi/l/email-protection#0c414b4e4c425e4f224b435a"><span class="__cf_email__" data-cfemail="79343e3b39372b3a573e362f">[email protected]</span></a>.


[[Page 66785]]


    Dated at Rockville, MD, this 1st day of November 2000.

    For the Nuclear Regulatory Commission.
Lawrence E. Kokajko,
Section Chief, Risk Task Group, Office of Nuclear Material Safety and 
Safeguards.
[FR Doc. 00-28495 Filed 11-6-00; 8:45 am]
BILLING CODE 7590-01-P


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