[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Pages 72220-72223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30098]


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NUCLEAR REGULATORY COMMISSION

[NRC-2011-0269]


Incorporation of Risk Management Concepts in Regulatory Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Request for public comments.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) 
is considering development of a strategic vision to better incorporate 
risk management concepts into its regulatory programs. To continue 
NRC's longstanding goal to move toward more risk-informed, performance-
based approaches in its regulatory programs, Chairman Gregory Jaczko 
has chartered a task force headed by Commissioner George Apostolakis to 
develop a strategic vision and options for adopting a more 
comprehensive and holistic risk-informed, performance-based regulatory 
approach that would continue to ensure the safe and secure use of 
nuclear material. As part of this initiative, the task force is seeking 
comments from external stakeholders on a series of questions that will 
provide input for the task force to consider in its work.

DATES: Submit comments by January 6, 2012. Comments received after this 
date will be considered, if it is practical to do so, but the 
Commission is able to ensure consideration only for comments received 
on or before this date.

ADDRESSES: Please include Docket ID NRC-2011-0269 in the subject line 
of your comments. For additional instructions on submitting comments 
and instructions on accessing documents related to this action, see 
``Submitting Comments and Accessing Information'' in the SUPPLEMENTARY 
INFORMATION section of this document. You may submit comments by any 
one of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2011-0269. Address questions about NRC dockets to Carol Gallagher, 
telephone: (301) 492-3668; email: [email protected].
     Mail comments to: Cindy Bladey, Chief, Rules, 
Announcements, and Directives Branch (RADB), Office of

[[Page 72221]]

Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001.
     Fax comments to: RADB at (301) 492-3446.

FOR FURTHER INFORMATION CONTACT: Christiana Lui, Risk Management Task 
Force, Office of Commissioner Apostolakis, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001; telephone: (301) 415-1801, 
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information
II. Background
III. Why Risk Management and Why Now
IV. The Role of Stakeholder Input
V. Paperwork Reduction Act Statement

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their comments to remove any 
identifying or contact information, and therefore, they should not 
include any information in their comments that they do not want 
publicly disclosed.
    You can access publicly available documents related to this 
document using the following methods:
     NRC's Public Document Room (PDR): The public may examine 
and have copied, for a fee, publicly available documents at the NRC's 
PDR, O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland 20852.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): Publicly available documents created or received at the NRC 
are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, 
which provides text and image files of the NRC's public documents. If 
you do not have access to ADAMS or if there are problems in accessing 
the documents located in ADAMS, contact the NRC's PDR reference staff 
at 1-800-397-4209, (301) 415-4737, or by email to [email protected]. 
This Risk Management Survey is available electronically under ADAMS 
Accession Number ML112870118.
     Federal Rulemaking Web site: Public comments and 
supporting materials related to this notice can be found at http://www.regulations.gov by searching on Docket ID NRC-2011-0269.

II. Background

    The NRC has a longstanding goal to move toward more risk-informed, 
performance-based approaches in its regulatory programs. In 1995, the 
Commission finalized and published its policy on how risk assessment 
would be used in agency decisionmaking (see http://www.nrc.gov/reading-rm/doc-collections/commission/policy/60fr42622.pdf). In the late 1990s-
early 2000s timeframe, the NRC staff undertook a number of initiatives 
to better incorporate risk insights and performance considerations into 
its regulatory programs. These initiatives resulted in fundamental 
changes to how the NRC conducts its licensing, inspection and 
rulemaking programs. The Commission has also directed the NRC staff to 
solicit input from industry and other stakeholders on performance-based 
initiatives, including areas that are not amenable to risk-informed 
approaches, to supplement the NRC's traditional deterministic system of 
licensing and oversight. It should be noted that deterministic \1\ and 
prescriptive \2\ regulatory requirements were based mostly on 
experience, testing programs and expert judgment, considering factors 
such as engineering margins and the principle of defense-in-depth. 
These requirements are viewed as being successful in establishing and 
maintaining adequate safety margins for NRC-licensed activities. The 
NRC has recognized that deterministic and prescriptive approaches can 
limit the flexibility of both the regulated industries and the NRC to 
respond to lessons learned from operating experience and support the 
adoption of improved designs or processes.
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    \1\ A deterministic approach to regulation establishes 
requirements for engineering margin and for quality assurance in 
design, manufacture, and construction. In addition, it assumes that 
adverse conditions can exist and establishes a specific set of 
design basis events and related acceptance criteria for specific 
systems, structures, and components based on historical information, 
engineering judgment, and desired safety margins. An example is a 
defined load on a structure (e.g., from wind, seismic events, or 
pipe rupture) and an engineering analysis to show that the structure 
maintains its integrity.
    \2\ A prescriptive requirement specifies particular features, 
actions, or programmatic elements to be included in the design or 
process, as the means for achieving a desired objective. An example 
is a requirement for specific equipment (e.g., pumps, valves, heat 
exchangers) needed to accomplish a particular function (e.g., remove 
a defined heat load).
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    The NRC has as one of its primary safety goal strategies the use of 
sound science and state-of-the-art methods to establish, where 
appropriate, risk-informed and performance-based regulations. The NRC 
issued SECY-98-144, ``White Paper on Risk-Informed and Performance-
Based Regulation'' (see http://www.nrc.gov/reading-rm/doc-collections/commission/secys/1998/secy1998-144/1998-144scy.pdf), to define the 
terminology and expectations for evaluating and implementing the 
initiatives related to risk-informed, performance-based approaches. The 
paper defines a performance-based approach as follows:

    A performance-based regulatory approach is one that establishes 
performance and results as the primary basis for regulatory 
decisionmaking, and incorporates the following attributes:
    (1) Measurable (or calculable) parameters (i.e., direct 
measurement of the physical parameter of interest or of related 
parameters that can be used to calculate the parameter of interest) 
exist to monitor system, including facility and licensee, 
performance,
    (2) objective criteria to assess performance are established 
based on risk insights, deterministic analyses and/or performance 
history,
    (3) licensees have flexibility to determine how to meet the 
established performance criteria in ways that will encourage and 
reward improved outcomes; and
    (4) a framework exists in which the failure to meet a 
performance criterion, while undesirable, will not in and of itself 
constitute or result in an immediate safety concern.\3\
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    \3\ Using the previous example (footnote 2), a performance-based 
approach might provide additional flexibility to a licensee on plant 
equipment and configurations used to accomplish a safety function 
(e.g., removing a heat load), but the performance criteria could not 
be the actual loss of a safety function that would result in the 
release of radioactive materials.

Performance-based approaches can be pursued either independently or in 
combination with risk-informed approaches. The NRC staff and the 
Commission continued to make progress on developing policies and 
guidance related to performance-based approaches and subsequently 
issued documents such as SECY-00-191, ``High Level Guidelines for 
Performance-Based Activities'' (see http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2000/secy2000-0191/2000-0191scy.pdf); and 
NUREG/BR-0303, ``Guidance for Performance-Based Regulation'' (see 
http://www.nrc.gov/reading-rm/doc-collections/nuregs/brochures/br0303/
).

[[Page 72222]]

    Risk and performance considerations for materials and fuel cycle 
licensees were documented in SECY-99-062, ``Nuclear Byproduct Material 
Risk Review'' (see http://www.nrc.gov/reading-rm/doc-collections/commission/secys/1999/secy1999-062/1999-062scy.pdf); SECY-99-100, 
``Framework for Risk-Informed Regulation in the Office of Nuclear 
Material Safety and Safeguards'' (see http://www.nrc.gov/reading-rm/doc-collections/commission/secys/1999/secy1999-100/1999-100scy.pdf); 
SECY-00-0048, ``Nuclear Byproduct Material Risk Review'' (see http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2000/secy2000-0048/2000-0048scy.pdf); and the Phase II Byproduct Material Review 
(ADAMS Accession No. ML012430396).
    Perhaps the most significant programmatic adoption of risk-informed 
and performance-based considerations in the reactor area took place 
with implementation of the Reactor Oversight Process (ROP) in April of 
2000. The ROP replaced the previous Systematic Assessment of Licensee 
Performance (SALP) program with explicit consideration of risk and 
performance considerations. The normal ``baseline'' inspection program 
is focused on the more risk-important areas of plant operations. In 
addition, events or conditions at plants are assessed for significance 
using probabilistic risk models. The results of such assessments are 
used to direct additional oversight to plants with more significant 
findings. A more recent reactor initiative that adopts a risk-informed 
and performance-based approach is the incorporation of the National 
Fire Protection Association (NFPA) standard NFPA 805, ``Performance-
Based Standard for Fire Protection for Light-Water Reactor Electric 
Generating Plants'' into NRC's regulations (Federal Register, 69 FR 
33536; June 16, 2004; see http://edocket.access.gpo.gov/2004/pdf/04-13522.pdf). NFPA 805 provides deterministic requirements that are very 
similar to those in NRC's traditional fire protection regulations, and 
also includes performance-based methods for evaluating plant 
configurations that provide a comparable and equivalent level of safety 
intended by the conservative deterministic requirements. The 
performance-based methods allow engineering analyses to demonstrate 
that the changes in overall plant risk that result from these plant 
configurations is acceptably small and that fire protection defense-in-
depth is maintained.\4\ Defense-in-depth as applied to fire protection 
means that an appropriate balance is maintained between: (1) Preventing 
fires from starting; (2) timely detection and extinguishing of fires 
that might occur; and (3) protection of SSCs important to safety from a 
fire that is not promptly extinguished. The adoption of NFPA 805 
provides a licensee with flexibility regarding how to implement its 
fire protection program while maintaining an acceptable level of fire 
safety.
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    \4\ Building upon the guidance in Regulatory Guide 1.174, ``An 
Approach for Using Probabilistic Risk Assessment in Risk-Informed 
Decisions on Plant-Specific Changes to the Licensing Basis,'' 
Regulatory Guide 1.205, ``Risk-Informed, Performance-Based Fire 
Protection for Existing Light-Water Nuclear Power Plants,'' states:
    Prior NRC review and approval is not required for individual 
changes that result in a risk increase less than 1x10-7/
year (yr) for CDF [core damage frequency] and less than 
1x10-8/yr for LERF [large early release frequency]. The 
proposed change must also be consistent with the defense-in-depth 
philosophy and must maintain sufficient safety margins. The change 
may be implemented following completion of the plant change 
evaluation.
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    In the materials area, the NUREG-1556 series, Volumes 1-21, 
``Consolidated Guidance About Materials Licensees'' (see http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/) was 
developed in the late 1990's to pull together into one place the 
various guidance documents written over the years for the wide variety 
of materials licensees. These documents allow license applicants to 
find the applicable regulations, guidance and acceptance criteria used 
in granting a materials license. Operational experience (performance) 
and risk insights guided the development of these documents. Over time 
the guidance in NUREG-1556 has been revised to further incorporate risk 
insights, performance considerations and changing technology. A new 
revision to the series is under development to address security and 
other issues.
    The materials inspection program was fundamentally revised in 
2001--both in terms of approach and frequency--in the Phase II 
Byproduct Material Review. The inspection approach was modified to 
emphasize licensee knowledge and performance of NRC-licensed activities 
over document review. Inspectors now review a licensee's program 
against focus areas that reflect those attributes which are considered 
to be most risk-significant. If a licensee's performance against a 
given focus element during the inspection is considered to be 
acceptable, the inspector moves on to the next focus element. 
Performance concerns or questions lead an inspector to go deeper into 
that area. In addition, inspection frequencies were revised based on 
risk insights from the NUREG/CR-6642 effort as well as licensee 
performance over time.

III. Why Risk Management and Why Now

    The initiatives identified above have been successful in making the 
NRC's regulatory programs less deterministic and prescriptive and more 
risk-informed and performance-based. The risk-informed approach has 
provided the NRC the ability to make regulatory decision making more 
systematic, more objective, more consistent, and more transparent. In 
addition, it has allowed the NRC to better focus its licensing and 
inspection efforts on the most risk-significant areas and has provided 
flexibility in addressing technological change, thus increasing 
effectiveness and efficiency. However, current projections for flat or 
declining budgets for the foreseeable future may necessitate NRC to 
adjust the way it does business to continue to fulfill its mission.
    Accordingly, a task force headed by Commissioner George Apostolakis 
is developing 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 (ADAMS Accession No. ML110680621). The task force was afforded 
the flexibility to provide options ranging from a complement to or 
alternative to the existing regulatory framework. The task force is 
expected to complete its work by May 2012.
    One of the approaches being considered by the task force is risk 
management. Risk management is being widely used in various sectors, 
including government agencies, financial institutions and technology 
companies, to address the kinds of challenges the NRC faces and that 
the task force must address. In a 2008 report, the Government 
Accountability Office (GAO) stated that:

    Using principles of risk management can help policymakers reach 
informed decisions regarding the best ways to prioritize investments 
in security programs so that these investments target the areas of 
greatest need. Broadly defined, risk management is a strategic 
process for helping policymakers make decisions about assessing 
risk, allocating finite resources, and taking actions under 
conditions of uncertainty.

    While the GAO report was focused on homeland security issues, the 
task force

[[Page 72223]]

believes that risk management concepts may represent a logical 
evolution from the risk-informed, performance-based philosophy that has 
governed many NRC regulatory activities for more than a decade and may 
be particularly effective in addressing the challenges that the NRC 
faces in the years to come. Risk management concepts and approaches 
vary, but generally include the following:

 Identification and framing of the issue
 Identification of options
 Analysis
 Deliberation for integrated decisionmaking
 Implementation
 Performance monitoring and feedback.

    Risk management allows for various approaches to consideration of 
risk in decisionmaking, including both quantitative and qualitative 
tools, which is essential in the broad range of NRC regulatory 
programs. It may also provide program managers with a more systematic 
approach to resource allocation, whether in budget formulation, 
response to events or licensing decisions.

IV. The Role of Stakeholder Input

    This effort could not be successful without meaningful stakeholder 
input. The task force is soliciting the views of both internal and 
external stakeholders to assist them in developing sound and effective 
long-term strategies. The process of interaction with internal 
stakeholders is ongoing. However, this Federal Register notice is 
intended to solicit the views of external stakeholders on the options 
and specific actions that the NRC might undertake in moving toward a 
more comprehensive and holistic risk management approach for its 
regulatory programs.
    The task force is seeking stakeholder input on the following 
questions to assist in its work. The task force will use the comments 
received to inform its deliberations, and its report will address the 
key issues raised in the comments which are relevant to task force 
activities. However, the task force does not plan to prepare a detailed 
response to individual comments or prepare an analysis of comments.
    1. Do you believe there is a common understanding and usage of the 
terms risk-informed, performance-based, and defense-in-depth within the 
NRC, industry, and other stakeholders? Which terms are especially 
unclear?
    2. What are the relevant lessons learned from the previous 
successful and unsuccessful risk-informed and performance-based 
initiatives?
    3. What are the relevant lessons learned from the previous 
successful and unsuccessful deterministic regulatory actions?
    4. What are the key characteristics for a holistic risk management 
regulatory structure for reactors, materials, waste, fuel cycle, and 
security?
    5. Should the traditional deterministic approaches be integrated 
into a risk management regulatory structure? If so, how?
    6. What are the challenges in accomplishing the goal of a holistic 
risk management regulatory structure? How could these challenges be 
overcome?
    7. What is a reasonable time period for a transition to a risk 
management regulatory structure?
    8. From your perspective, what particular areas or issues might 
benefit the most by transitioning to a risk management regulatory 
approach?

V. Paperwork Reduction Act Statement

    This survey contains information collections that are subject to 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These 
information collections were approved by the Office of Management and 
Budget, approval number 3150-0197, which expires August 31, 2012.
    The burden to the public for these voluntary information 
collections is estimated to be 2 hours per response. The information 
gathered will be used to incorporate risk management concepts into 
NRC's regulatory programs. Send comments regarding this burden estimate 
to the Information Services Branch (T-5 F53), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet electronic mail 
to [email protected]; and to the Desk Officer, Chad 
Whiteman, Office of Information and Regulatory Affairs, NEOB-10202, 
(3150-0197), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.
    The task force requests comments on these questions by January 6, 
2012 to assist in its efforts.

    For the Nuclear Regulatory Commission.

    Dated at Rockville, Maryland, this 15th day of November, 2011.
Christiana Lui,
Risk Management Task Force, Office of Commissioner Apostolakis.
[FR Doc. 2011-30098 Filed 11-21-11; 8:45 am]
BILLING CODE 7590-01-P