[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
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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
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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: [email protected].
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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]
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