[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?

[[Page 70356]]

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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