[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Notices]
[Pages 70354-70356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28065]
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NUCLEAR REGULATORY COMMISSION
[NRC-2013-0254]
Conceptual Example of a Proposed Risk Management Regulatory
Framework Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Conceptual example of a proposed policy statement; request for
comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
document entitled: ``White Paper on a Conceptual Example of a Proposed
Risk Management Regulatory Framework Policy Statement'' (ADAMS
Accession No. ML13273A517) and requesting public comment. The
conceptual statement would set forth a possible Commission policy
regarding the use of a structured decision-making model that results in
risk-informed and performance-based defense-in-depth protections to:
Ensure appropriate personnel, barriers, and controls to prevent,
contain, and mitigate possible inadvertent exposure to radioactive
material according to the hazard present, the relevant scenarios, and
the associated uncertainties; and ensure that the risks resulting from
the failure of some or all of the established barriers and controls,
including human errors, are maintained acceptably low. The white paper
is an illustration of the staff's work in progress and is expected to
be modified as both internal and external review is solicited and
considered.
DATES: Please submit comments by January 10, 2014. Comments received
after this date will be considered if it is practical to do so, but the
NRC staff is able to ensure consideration only for comments received on
or before this date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0254. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. For technical questions, contact
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section
of this document.
Mail comments to: Cindy Bladey, Chief, Rules,
Announcements, and Directives Branch (RADB), Office of Administration,
Mail Stop: 3WFN-06-44M, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
For additional direction on accessing information and submitting
comments, see ``Accessing Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Mary Drouin, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone: 301-251-7574; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Accessing Information and Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC-2013-0254 when contacting the NRC
about the availability of information regarding this document. You may
access publicly-available information related to this document by any
of the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0254.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. The ADAMS accession number
for each document referenced in this document (if that document is
available in ADAMS) is provided the first time that a document is
referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2013-0254 in the subject line of your
comment submission, in order to ensure that the NRC is able to make
your
[[Page 70355]]
comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in you
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment submissions into ADAMS.
II. Discussion
As part of the NRC strategic plan's goal of ``openness,'' a white
paper on a Conceptual Example of a Proposed Risk Management Regulatory
Framework (RMRF) Policy Statement (ML13273A517) is being issued to both
inform public stakeholders of the work and to start soliciting
stakeholder feedback with regard to an NRC working group's early draft.
An NRC inter-office working group has been chartered to develop a
conceptual draft of a RMRF Policy Statement for Commission
consideration. The document is a work in progress and has been
developed to illustrate a potential organization, structure, and
content of a conceptual policy statement. It is expected that as the
Conceptual Example of a Proposed RMRF Policy Statement is modified that
additional notices, requesting public comment will be published in the
Federal Register. In early 2011, at the request of Chairman Gregory B.
Jaczko, Commissioner George Apostolakis lead a Risk Management Task
Force (RMTF) to evaluate how the agency should be regulating 10 to 15
years in the future. More specifically, the RMTF was chartered ``to
develop a strategic vision and options for adopting a more
comprehensive and holistic risk-informed, performance-based regulatory
approach for reactors, materials, waste, fuel cycle, and transportation
that would continue to ensure the safe and secure use of nuclear
material.'' The NUREG-2150, ``A Proposed Risk Management Regulatory
Framework,'' was published in April 2012 (ML12109A277). This report
describes the findings and recommendations of this evaluation. The
report provides findings and recommendations which are compiled into
two groups. The first group addresses agency-wide, more strategic
issues, recommending that ``The NRC should formally adopt the proposed
Risk Management Regulatory Framework through a Commission Policy
Statement.'' The second group addresses what changes would be needed in
specific program areas (e.g., power reactors and materials) in the next
several years to ensure that the framework is implemented.
The agency-wide findings of the RMTF are:
Finding: Whether used explicitly, as for power reactors,
or implicitly, as for materials programs, the concept of defense-in-
depth has served the NRC and the regulated industries well and
continues to be valuable today. However, it is not used consistently,
and there is no guidance on how much defense-in-depth is sufficient.
Finding: Risk assessments provide valuable and realistic
insights into potential exposure scenarios. In combination with other
technical analyses, risk assessments can inform decisions about
appropriate defense-in-depth measures.
Considering these findings, the RMTF proposes that ``The NRC should
formally adopt the proposed Risk Management Regulatory Framework
through a Commission Policy Statement.''
The RMTF notes that the proposed framework includes several
important benefits:
Updated knowledge from contemporary studies, such as risk
assessments, would be incorporated into the regulations and guidance,
thereby improving their realism and technical basis.
Implementation of a systematic approach would foster a
consistent regulatory decision-making process throughout the agency and
improve resource allocation.
Consistency in language and communication would be
improved across the agency and externally.
Support of issue resolution would be achieved in a
systematic, consistent, and efficient manner.
The RMTF also notes that implementation of the proposed framework
would also pose challenges:
A change would be required within the agency and
externally to increase understanding of the value and use of risk
concepts and risk management language.
The proposed risk-informed and performance-based concept
of defense-in-depth may require the development of additional decision
metrics and numerical guidelines.
The approach would likely require developing new or
revised risk-assessment consensus codes and standards.
A long-term commitment from the Commission and senior
agency management would be required for implementation.
To assist in the review and comment process, the NRC is requesting
the public address the specific questions listed below.
Overall Questions:
(1) Is there a need for such a policy statement? If so, why? If
not, why not?
(2) Do you see any benefits in such a policy statement? If so, what
are they? If not, why not?
(3) How could the proposed RMRF policy statement be made more
useful to licensees and/or certificate holders, applicants and other
stakeholders?
(4) Is the policy statement sufficiently flexible to address the
specific program area activities (e.g., reactor versus transportation)
with regard, for example, to the type of risk analyses, to the defense-
in-depth principles?
(5) What implementation challenges do you foresee?
(6) A policy statement generally states the Commission's
expectation regarding a particular subject. How to meet the
Commission's expectation is not included in the policy statement. If
approved by the Commission, the staff plans to develop associated
implementation guidance. What should be the scope and extent of this
guidance to be helpful? For example,
a. For program area of interest, what would be the appropriate
decision criteria for determining adequate defense-in-depth?
b. What specific issues or actions should the guidance address in
order to implement the policy statement for a particular program area
(of interest)?
(7) Does the proposed policy statement appropriately integrate
security considerations into the RMRF? If not, why not?''
Sections I and II
(8) Are these two sections (Background and Development of Risk
Management Regulatory Framework Policy Statement) informative? Do they
provide useful information in helping to clarify the need, purpose,
goals, etc. of the policy statement in Section III? What information is
not necessary and what type of information should be added, if any?
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Section III
(9) Is the purpose and goal of the proposed conceptual policy
statement clear? If not, where is clarification needed?
(10) Is the proposed conceptual RMRF policy statement useful in
clarifying the Commission's intent to use a risk-informed and
performance-based defense-in-depth approach in performing its
regulatory function? If not, what needs to be clarified?
Section II
(11) Should the current PRA policy statement (60 FR 42622, August
16, 1995) be replaced or subsumed/incorporated into this policy
statement?
(12) What would be the benefit? What would be the detriment?
Section III.B
(13) If subsumed, is the proposed manner of incorporating the PRA
statement reasonable? If not, why not?
(14) Should the policy statement establish a Commission expectation
that for all program areas, licensees and/or certificate holders are
expected to have a risk analysis that is commensurate with the activity
and technology?
Section III.A
(15) Do the proposed key elements in the RMRF process represent a
complete and reasonable set?
a. If not, what modifications should be made?
b. Are other elements needed to cover the full spectrum of
regulated activities?
c. Are the elements sufficient to develop a consistent
decisionmaking approach across all regulated activities?
Section III.C
(16) Should defense-in-depth be a key aspect of a RMRF? If not, why
not?
(17) Will such proposed draft policy statement be useful in
determining the extent of defense-in-depth needed in each program area?
(18) Is the approach proposed for characterizing defense-in-depth
clear? If not, where is clarification needed? Is the strategy
reasonable? If not, why not?
(19) Is the definition provided for defense-in-depth clear? If not,
why not?
(20) Are the key attributes identified reasonable and complete? If
not, why not?
(21) Are the basic levels of prevention and mitigation reasonable?
If not, why not?
(22) Are the definitions of prevention and mitigation clear and
reasonable? If not, why not?
a. Are they sufficiently flexible to support all program areas? If
not, where not?
b. Should and can these levels be further detailed (i.e., more
specific) and still be sufficiently flexible to support all program
areas?
(23) Is it reasonable to expect the levels of defense to be
independent such that failure of one level does not lead to failure of
subsequent levels? If not, why not?
a. Should the NRC accept different levels of rigor, or different
levels of confidence, in demonstrating that there is independence
between levels? Could the level of rigor vary depending upon the nature
of the activity and the risks associate with loss of independence?
b. Are there any other considerations that should be taken into
account in determining the acceptable level of rigor or confidence in
demonstrating independence between layers?
(24) Is it reasonable to expect the following with regards to
defense-in-depth:
a. Ensure appropriate barriers, controls, and personnel are
available to prevent and mitigate exposure to radioactive material
according to the hazard present, the credible scenarios, and the
associated uncertainties; and
b. Ensure that the risks resulting from the failure of some or all
of the established barriers and controls, including human errors, are
maintained acceptably low consistent with the applicable acceptance
guidelines.
c. Overall, ensure that each regulated activity has appropriate
defense-in-depth measures for prevention and mitigation of adverse
events and accidents.
d. If the expectations of a, b, or c are not reasonable, why not?
(25) Are the proposed defense-in-depth principles and decision
criteria complete? Are they useful in deciding the extent of defense-
in-depth needed in a program area? If not, how should they be improved?
Section III.D
(26) Are the proposed program area specific policy considerations
clear and complete? If not, what modifications should be made? Are
others needed to cover the full spectrum of regulated activities?
Dated at Rockville, Maryland, this 4th day of November, 2013.
For the Nuclear Regulatory Commission.
Richard P. Correia,
Director, Division of Risk Analysis, Office of Nuclear Regulatory
Research.
[FR Doc. 2013-28065 Filed 11-22-13; 8:45 am]
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