[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]
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