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POLICY ISSUE
INFORMATION
SECY-04-0197
October 25, 2004
FOR: |
The Commissioners |
FROM: |
Luis A. Reyes
Executive Director for Operations |
SUBJECT: |
UPDATE OF THE RISK-INFORMED REGULATION IMPLEMENTATION PLAN |
PURPOSE:
To present the Commission with the latest update of the Risk-Informed Regulation
Implementation Plan (RIRIP), in accordance with a staff requirements memorandum (SRM)
dated January 4, 2001.
SUMMARY:
This paper provides a summary of the agency's significant risk-informing accomplishments
since the previous version of the RIRIP (Attachment 1 ), as well as providing the latest update of
the RIRIP (Attachment 2 ), which details activities designed to support the agency's Strategic
Plan and the Probabilistic Risk Assessment (PRA) Policy Statement.
This paper also summarizes the significant risk-informing activities to be conducted over the
next 6 months. These activities are in the areas of fire protection, risk-informing the acceptance
criteria for emergency core cooling systems for light-water nuclear power reactors (10 CFR
50.46), the coherence program, PRA quality, the risk-informed (regulatory) environment, new
reactor licensing, the reactor oversight process, dry cask storage, high-level waste, and risk-informed requirements for fuel cycle safety.
BACKGROUND:
In a January 2000 memorandum to the Commission, the staff outlined a strategy for
implementing risk-informed regulation. The strategy evolved into the initial version of the RIRIP, which the staff provided to the Commission in March 2000. The Commission reviewed
the plan and, after a briefing by the staff in March, directed the staff in April 2000 to include in
the next update of the implementation plan an internal communications plan, staff training
requirements, and a discussion of internal and external factors that may impede risk-informed
regulation. The first complete version of the implementation plan was issued in October 2000.
In an SRM dated January 4, 2001, the Commission asked the staff to provide a more detailed
communication plan, to prioritize activities, to identify necessary resources and tools, to address
how performance-based regulatory approaches will be integrated into the process of risk-informing regulations, and to identify critical-path activities and their crosscutting dimensions.
In response to the SRM, the December 2001 update of the RIRIP, specifically Part 2, included
expanded arena chapters that describe the staff's progress in prioritizing the various implementation activities and identifying the necessary resources and tools, critical-path
activities, and activities that have crosscutting dimensions. The arena chapters also described
arena-specific activities related to communication with both internal and external stakeholders.
DISCUSSION:
Attachment 1 is a Table of Accomplishments which describes the agency's risk-informing
accomplishments since the last update. Key risk-informing activities to be conducted at the
agency over the next 6 months, along with a brief background of each, are described in the
paragraphs below.
Attachment 2 is the RIRIP which discusses the agency's actions to risk-inform its regulatory
activities and describes each of the activities identified as supporting the goals and strategies of
the agency's Strategic Plan and the Probabilistic Risk Assessment (PRA) Policy Statement. It
is divided into two parts.
Part 1 describes the plan's relationship to the PRA Policy Statement and its relevance to the
NRC's Strategic Plan for Fiscal Years (FY) 2000 - 2005. Part 1 also discusses key features of
the traditional deterministic approach that should be preserved in establishing risk-informed
regulatory programs, since risk information will be used to complement the traditional approach.
In addition, Part 1 provides draft guidance that the staff has used to select candidate
requirements, practices, and processes to risk-inform.
Part 2 describes the staff's risk-informed regulation activities, with chapters addressing the
Reactor Safety arena and the Materials and Waste Safety arenas. Each chapter is currently
organized around the strategies defined in the Strategic Plan for FY 2000 - 2005 as they relate
to risk-informed regulation in the given arena. Each chapter describes the implementation
activities for each strategy and identifies significant milestones, training, and communication-related considerations for each activity. Relationships among implementation activities are
described and critical-path items are identified. Gantt charts for some of the implementation
activities are also provided to illustrate the relationships among tasks within activities.
In August 2004, the agency issued a revised Strategic Plan for FY 2004 - 2009. This new plan
established five goals and the associated strategies that the agency will use to achieve each
goal. Specifically, these five goals are safety, security, openness, effectiveness, and
management. In response, the staff is in the process of restructuring the RIRIP to make future
updates consistent with the five new goals in the agency's revised Strategic Plan. Toward that
end, this RIRIP update also lists and prioritizes the primary and secondary performance goals
and strategies identified in the Strategic Plan as they relate to each activity in the RIRIP. The
specific priority associated with each activity was determined through the NRC's Planning,
Budgeting and Performance (PBPM) process for FY 2006. This restructuring will continue as
the staff refines the planned activities in the next RIRIP update to reflect any changes in the
agency's priorities resulting from the issuance of the revised Strategic Plan.
Reactor Safety Arena
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Fire Protection (RS-MS8-6): The staff completed the rulemaking to endorse an
alternative performance-based and risk-informed fire protection standard for nuclear
power plants. The staff worked with the National Fire Protection Association (NFPA) to
develop NFPA Standard 805, which was issued in April 2001. The final rule to
incorporate NFPA 805 in Title 10, Part 50, of the Code of Federal Regulations (10 CFR
Part 50) was published in the Federal Register in June 2004. The staff is working with
the industry to complete development of the implementation guidance for NFPA 805,
which will be endorsed by the NRC in a regulatory guide.
-
Change Technical Requirements for 10 CFR 50.46 (RS-MS8-3): In response to an
SRM dated July 1, 2004, regarding SECY-04-0037, the staff is currently working on a
proposed rulemaking to risk-inform the requirements of 10 CFR 50.46, "Acceptance
criteria for emergency core cooling systems for light-water nuclear power reactors." The
staff is scheduled to complete a proposed rule by December 2004. As part of this work,
the staff also completed the preliminary frequency estimates for a loss-of-coolant
accident (LOCA). The results of this effort were provided in SECY-04-0060 in April
2004. The staff expects to complete the work on revised LOCA break size frequency
estimates by December 2004.
-
Coherence Program (RS-EER1-8): In response to an SRM dated February 8, 2002, ,
the staff developed a plan for improving coherence among risk-informed activities. The
goals of this plan were to develop a program demonstrating that the reactor regulations
and staff processes are built on a unified safety concept and are properly integrated so
that they complement one another. Each part of the plan has taken advantage of and
built on ongoing staff activities. The staff issued the plan for internal management
review but, due to redirection of resources to address higher priorities, the plan was not
implemented. However, the staff continued with specific efforts (e.g.,10 CFR 50.46 and
50.69) to address regulatory structure convergence with our risk-informed process. The
staff currently plans to issue a revised coherence program plan for internal
management review in December 2004.
-
PRA Quality (RS-EER1-9): The staff is working on the implementation of the action plan
for the Phased Approach to Achieving Appropriate PRA Quality and Completeness,
documented in SECY-04-0118. This work includes identifying the current risk-informed
applications, specifying the PRA needs for these applications, developing a prioritization
process for staff review, and developing a Phase 2 schedule. The staff expects to
complete these tasks by December 2004.
-
Develop standards with National Standards Committees (RS-EER1-2): In
December 2003, the American Nuclear Society (ANS) issued the "American National
Standard External Events PRA Methodology," ANSI/ANS-58.21-2003. The staff
reviewed the standard and developed a preliminary position, which will be documented
in Appendix C to Regulatory Guide (RG) 1.200, "An Approach for Determining the
Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed
Activities." A preliminary draft of Appendix C to RG 1.200 was issued in August 2004 to
solicit early feedback from stakeholders on the staff's initial assessment of the ANS
standard. Revision 1 to RG 1.200, which will include Appendix C, is scheduled for public
review and comment in midyear 2005.
-
Assess Adequacy of PRA Results (RS-EER1-7): The staff issued RG 1.200, "An
Approach for Determining the Technical Adequacy of Probabilistic Risk Assessment
Results for Risk-Informed Activities," for trial use in February 2004. The American
Society of Mechanical Engineers (ASME) is updating the "Standard for Probabilistic Risk
Assessment for Nuclear Power Plant Applications" (ASME RA-S-2002) and plans to
issue Revision 1 in early 2005. The Nuclear Energy Institute (NEI) plans to update and
issue its self-assessment process (NEI-00-02) based on Revision 1 to the ASME
standard shortly thereafter. The staff plans to update RG 1.200 to reflect the lessons
learned from the industry pilots during the trial period, Revision 1 of the ASME standard,
and Revision 1 to NEI-00-02 (all which are expected to be completed by April 2005).
Pilot studies at the Columbia Generating Station and Limerick are in progress. The
three remaining pilot studies at Surry, San Onofre, and South Texas Project (STP) are
expected to be completed by December 2004.
-
Assess Adequacy of PRA Results (RS-EER1-7): The PRA standards, RG 1.174 and
RG 1.200, allow the analyst to use supplementary approaches to account for scope
items or technical requirements that are not addressed in its PRA. In risk-informed
decision-making, an understanding of the key uncertainties is a fundamental piece of
the process. The staff has initiated efforts to develop guidance on the following topics:
-
Acceptable approaches to supplement a PRA that is not of a full scope, or has
deficiencies in some elements which includes the appropriate use of bounding
analyses, screening methods, or qualitative approaches
-
Identification and performance of sensitivity studies
-
How to use the results from the uncertainty analyses in the decision-making
process, including the role and definition of defense-in-depth
-
A draft guidance is expected to be completed for staff review by December 2004.
-
Methods for Calculating Risk (RS-EER1-3): The staff is preparing Draft Regulatory
Guide (DG) 1136, "Guidance for Demonstrating the Feasibility and Reliability of
Operator Manual Actions in Response to Fire," which will accompany the revision of
Section III.G.2 of Appendix R to 10 CFR Part 50. DG 1136 will provide detailed
guidance on how to implement the feasibility and reliability criteria developed by the staff
for the post-fire manual actions as part of the revision of Appendix R Section III.G.2.
DG 1136 will be sent to the Commission in December 2004 with the proposed rule.
-
Creating a Risk-Informed Environment (RS-EER1-1): A report documenting the findings
from Phase 2 has been completed. The report clearly lays out the critical elements of a
risk-informed environment and approaches for establishing those elements in the
reactor program. A plan has been developed for implementing changes in the reactor
program to enhance the current environment for risk-informed regulation. The plan was
presented to the leadership team in the NRC's Office of Nuclear Reactor Regulation
(NRR) in July 2004. The NRR leadership team is currently considering which of the
initiatives proposed in the plan to pursue in FY 2005.
-
New Plant Licensing (RS-MS8-10): In SECY-03-0059, "NRC Advanced Reactor
Research Program," dated April 18, 2003 (ADAMS Accession #ML023310534), the staff
discussed its plan for developing a technology-neutral framework for new plant
licensing. In SECY-04-0103, "Status of Response to the June 26, 2003, Staff
Requirements Memorandum on Policy Issues Related to Licensing Non-Light-Water
Reactor Designs," dated June 23, 2004 (ADAMS Accession #ML041140521), the staff
indicated that a draft framework would be issued for public review and comment and
would be provided to the Commission in December 2004. This framework will provide
guidance and criteria for the staff to use in developing technology-neutral requirements.
The staff has had continual interactions with both internal and external stakeholders,
including Advanced Reactor Steering Committee briefings, briefings of agency
management in NRR, the NRC's Offices of Nuclear Regulatory Research (RES) and
the General Counsel (OGC), the Advisory Committee on Reactor Safeguards (ACRS),
and public meetings.
-
Assessing Fire Safety (RS-EER1-4): The staff, in coordination with the Electric Power
Research Institute (EPRI), is developing risk-informed methods to estimate fire risk.
This will include demonstration studies that will develop insights and guidance for fire
risk analysis (FRA). The staff expects to complete a report on the development of
methods from the two pressurized-water reactor (PWR) pilot plants by April 2005. A
licensee with a boiling-water reactor (BWR) plant has agreed to participate in these
studies, and NRC and EPRI staff began work in May 2004.
-
Risk Management Technical Specifications (RMTS) (RS-MS8-5): The staff continues to
work on the eight RMTS initiatives to risk-inform the standard technical specifications
(STS) and make them more consistent with the Maintenance Rule [10 CFR 50.65(a)(4)].
The major activities in this area are summarized below:
-
Initiative 1, Modified End States: This initiative would allow (after a risk
assessment) some systems to enter hot shutdown rather than cold shutdown to
repair equipment. The safety evaluation reports (SER) have been issued for the
Combustion Engineering Owners Group (CEOG) and Boiling-Water Reactor
Owners Group (BWROG) topical reports, and the industry has proposed
technical specification changes which are under staff review. The staff provided
comments on the draft implementation guidance for the Combustion Engineering
(CE) STS change, TSTF-422, in July 2004, and the issues are currently being
resolved. TSTF-422 is expected to be available through the Consolidated Line
Item Improvement Process (CLIIP) in December 2004.
-
Initiative 4, Risk-Informed Completion Times: Contingent on the results of a
plant configuration risk assessment, this initiative would permit a temporary
extension of the existing completion time within a limiting condition for operation
(LCO) using a quantitative implementation of 10 CFR 50.65(a)(4). The staff
provided requests for additional information (RAIs) concerning the Risk
Management Guidance Document, the CE pilot proposal, TSTF-424, and the
STP pilot proposal. The industry will respond to the RAIs and update the RMTS
Risk Management Guidance, CE TSTF-424, and the STP pilot proposals by
December 2004.
-
Initiative 5, Relocation of Surveillance Frequencies: This initiative would permit
surveillance frequencies to be determined in and relocated to a licensee-controlled technical specification (TS) program. Limerick has submitted the pilot
plant license amendment request. The industry is developing an Initiative 5b
methodology, and will submit a methodology document and the associated
proposed technical specification changes, TSTF-425, in December 2004.
-
Initiative 6, Modification of LCO 3.0.3, Actions and Completion Times: For
specific systems, this initiative would convert default or explicit entry into the
LCO 3.0.3 shutdown track to a predetermined completion time for corrective
action, prior to beginning shutdown. The staff approved and issued the SER on
the CE topical report on July 9, 2004. The industry will submit a proposed CE
TSTF-426 in the near future, and staff approval is scheduled for December
2004.
-
Initiative 7, Non-TS Support System Impact in TS System Operability: This
initiative would permit a risk-informed delay time prior to entering LCO actions for
inoperability due to loss of support function provided by equipment outside of
tech specs; TSTF-372 addresses snubber inoperability and TSTF-427 addresses
hazard barrier inoperability. The staff approved and issued the safety evaluation
for TSTF-372 in September 2004 and is scheduled to make TSTF-372 available
via the CLIIP in December 2004. The safety evaluation for TSTF-427 is
scheduled to be issued in October 2005, with availability via CLIIP in December
2005.
-
Pressurized Thermal Shock Rule Revision (RS-MS8-7): In December 2002, RES
forwarded to NRR a draft staff report, "Technical Basis for Revision of the Pressurized
Thermal Shock (PTS) Screening Criteria in the PTS Rule (10 CFR 50.61)." This report
documents the results of a multiyear study reevaluating the technical basis of
10 CFR 50.61. The draft report is currently being peer-reviewed and will be modified to
reflect the comments. The results will be published as a final report in December 2004.
The draft results from this project confirm that the calculations which provide the basis
for the current PTS rule contain significant unnecessary conservatisms. These new
results suggest that PTS will not limit the safe operational life of any currently operating
PWR even for operational durations now being considered for license extension.
-
Assessing Steam Generator Performance (RS-MS8-9): The staff is developing an
improved PRA model for use in determining the frequency of containment bypass
events that result from steam generator (SG) tube failures induced by severe accident
conditions. This work utilizes materials and thermal-hydraulic analyses that have been
underway for several years. The improved PRA model will be used in a trial application
to calculate the frequency of SG containment bypass events at a pilot plant in December
2004, and will be improved based on lessons learned during that application. The
results from further applications of the improved model will be used to evaluate the
acceptability of existing requirements and guidance in effectively limiting the risk
associated with containment bypass events.
-
Methods for Calculating Risk (RS-EER1-3): The weakness of available data for human
reliability analysis (HRA) is one of the biggest concerns expressed by practitioners and
decision-makers. Furthermore, NRC activities supported by human factors (HF)
research are constrained by the lack of a database that analysts could draw on when
addressing various regulatory issues. To address this need, the staff is developing a
Human Event Repository and Analysis (HERA) database. Previous efforts had focused
on developing a structure for collecting human performance information in a format
suitable to HRA and HF applications regardless of the specific tool or method that an
analyst uses. Currently, the staff is populating the HERA database with human events
found in licensee event reports and is developing quantification processes allowing the
use of these data to estimate human failure event probabilities. The HERA data
collection and coding activity is closely coordinated with the component database called
"Integrated Data Collection and Coding System." A draft report on the development and
use of HERA will be completed for NRC peer review by December 2004.
-
Methods for Calculating Risk (RS-EER1-3): In July 2004, the staff issued draft
NUREG-1792, "Good Practices for Implementing Human Reliability Analysis (HRA),
Draft Report for Comment." The HRA good practices were developed as part of the
NRC activities for addressing PRA quality issues and provide guidance for implementing
RG 1.200. NUREG-1792 provides a technical basis for performing an HRA or for
formulating questions to evaluate the quality of HRA. NUREG-1792 will be revised to
address public comments and will be published by April 2005.
-
Reactor Oversight Process (RS-MS3-1): During FY 2004, the staff developed the
Mitigating Systems Performance Index (MSPI) in support of the reactor oversight
program and piloted it in 20 plants. MSPI will monitor risk associated with changes in
performance of selected mitigating systems, accounting for plant-specific design and
performance data. The MSPI addresses known problems with the existing safety
system unavailability performance indicator and provides a measure of both system
reliability and availability. The pilot program exercised the MSPI guidance, did validation
and verification, and performed temporary instruction inspections. The final staff report
documenting development of the MSPI, including results from the pilot program, is
expected to be published in early 2005.
Waste Safety and Materials Safety Arenas
-
PRA of Dry Cask Storage (WS-MS1-1): In support of the Commission's policies on risk-informing the regulatory process and performance goals, the staff is working to develop
probabilistic risk assessment methods and quantify the risk of dry storage of spent
nuclear fuel. These studies (Phases I and II) are intended to provide: (a) methods to
quantify the risk of dry cask storage of spent nuclear fuel, (b) insights into decision-making and how to improve 10 CFR Part 72 regulatory activities, and (c) analytical tools
that can be used to implement future waste safety goals and risk-informed regulatory
activities.
-
Phase I: In February 2003, RES completed a draft pilot PRA of dry cask storage
with a specific cask design. RES is currently revising the draft report to
incorporate peer review comments. The staff plans to discuss this study with the
joint ACRS/Advisory Committee on Nuclear Waste (ACNW) subcommittee in
April 2005 and will publish the final pilot PRA in 2006.
-
Phase II: Additional studies will be identified in November 2004 to broaden the
application of the pilot PRA method. The pilot PRA method and additional
studies will enable the NRC's Office of Nuclear Materials Safety and Safeguards
(NMSS) Spent Fuel Project Office (SFPO) to (1) develop a framework for
evaluating potential PRAs performed by industry to support specific licensing
actions and (2) develop generic insights that can be used with other parallel risk-informing efforts in SFPO. RES and SFPO expect to complete the additional
studies in FY 2005 and FY 2006. An expected outcome is an enhanced
regulatory focus on risk-important dry cask safety issues. This will maintain
safety, enhance efficiency and effectiveness in SFPO, and potentially reduce
unnecessary regulatory burden in the dry cask storage industry.
-
Develop Framework for Risk-Informing the NMSS Regulatory Process (MS-EER1-1):
The staff has developed a risk-informed framework for regulating the materials and
waste arena. The staff plans to transition from developmental work to trial application of
the proposed systematic risk-informing decision-making approach on routine materials
and waste activities. Beginning in October 2004, staff will start selecting activities to
explore during trial applications on how a risk-informed approach could be used to make
a decision in licensing casework, inspection activities, rulemaking, and guidance
development.
-
Risk-Inform High-Level Waste (HLW) Framework (WS-MS1-3): The HLW program staff
will continue to use risk information and insights to risk-inform its many pre-licensing
activities and prepare for the review of a license application that the U.S. Department of
Energy (DOE) plans to submit for a repository at Yucca Mountain. The staff will
continue to risk-inform its review of DOE's issue resolution agreement submittals by
using the Risk Insights Baseline Report, forwarded to the Commission on April 29, 2004,
as a reference to understand the risk significance of the technical issues addressed by
the agreements and to focus the staff's review on the more risk-significant aspects of
the submittals.
-
Risk-Inform High-Level Waste (HLW) Framework (WS-MS1-3): To support a risk-informed license application review, the staff will continue to refine the Risk Insights
Baseline for the potential Yucca Mountain repository as new risk information becomes
available. Currently, the staff is completing a series of focused risk analyses to
strengthen the quantitative information supporting the risk insights and to better
understand uncertainties in the risk insights. The staff plans to review its Risk Insights
Baseline in light of the new risk information before receiving a license application from
DOE.
-
Revise Part 70 (MS-MS2-3): The staff will continue reviewing the implementation of the
upgrade to 10 CFR Part 70 Subpart H. The staff will ensure that licensees are meeting
the Commission's objectives for a risk-informed and performance-based regulatory
approach for fuel cycle safety by requiring licensees to (1) perform an integrated safety
analysis (ISA) to identify significant potential accidents at the facility and the items relied
on for safety and (2) implement measures to ensure that the items relied on for safety
are available and reliable to perform their functions when needed. Internal staff
guidance will be completed in nine ISA areas.
RESOURCES:
In response to the Commission's direction regarding the October 2000 version of the RIRIP, the
plan lists the priority rating of each risk-informed regulation implementation activity. These
priorities were determined through the PBPM process. As part of the FY 2006 PBPM process,
the program offices developed a common prioritization methodology and used it to produce a
prioritized listing of planned activities. The offices continued to use the common prioritization
methodology to plan, budget, and implement RIRIP activities. As with other staff activities,
changes in priorities of the risk-informed regulation implementation activities will continue to be
made consistent with the PBPM process to reflect changes to the agency budget and priorities.
No additional funds are required and all activities are budgeted.
COORDINATION
The Office of the Chief Financial Officer has reviewed this paper for resource implications and
has no objections. The Office of the General Counsel has also reviewed this paper and has no
legal objections.
|
/RA Martin J. Virgilio Acting For/
Luis A. Reyes
Executive Director for Operations |
CONTACTS: |
Dean Overland, RES/DRAA
301-415-6702
Arthur Salomon, RES/DRAA
301-415-6552 |
|