[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
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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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