Organizational Infrastructure –Regulatory Authority
Mark A. Cunningham
NRRC Workshop on

Risk-Informed Decision Making: A Survey of U.S. Experience
Tokyo, Japan, June 1-2, 2017

Nuclear Risk Research Center, CRIEPIThe B. John Garrick Institute for the Risk Sciences

UCLA

Introduction
 Risk management implementation in a regulatory authority• Has important parallels to that in a licensee/operator organization (asdiscussed earlier)• Requires consideration of both strategic and tactical issues• Establishing policies• Defining intended staff functions• Issuing implementation guidance• Developing (or otherwise obtaining) expertise

Nuclear Risk Research Center, CRIEPI

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UCLA

Establishing policies
Characterization of the role of riskmanagement

USNRC model• PRA Policy Statement provides
fundamental principles• Regulatory standing• Policy• Rule• Applies to both licensees and staff• Broadly defines complementary role ofrisk analysis• Applicability to• Staff• Licensees• Relative to traditional engineering andregulatory practices• Safety Goal Policy Statement defines
acceptable level of safety/risk• Deterministic analysis• Defense in depth• Acceptance standards• Overall level of safety (safety goals)• Incremental safety changes• Risk benefit of additional requirements• Potential relaxations

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3The B. John Garrick Institute for the Risk Sciences

UCLA

Defining intended staff functions
Clear definition of staff functions

USNRC model• Reviewing licensee-generated riskanalyses• Generating risk information, insupport of:• Reviews licensee risk analysis
submittals• Performs risk analyses in particularareas• Judging significance of newinformation• Operating experience• Inspection findings• Research• Backfit analyses• Significance determination process• Taking regulatory actions• Determining need for additionalrequirements• Allocating (reallocating) staffresources• Relaxing requirements

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UCLA

Issuing implementation guidanceTranslate strategic policies into
practical tools

USNRC model• For licensees• For licensees• Regulatory guides• Acceptable topics• Submittal guidance• Standards for underlying risk modelsand data

• For regulatory staff• Standard review plans• Regulatory analysis guidelines (forbackfit analyses)• Inspection manual (including forsignificance determination process)• For regulatory staff• Reviews of licensee submittals• Guidance• Acceptance criteria• Staff-generated risk analyses• Guidance• Standards for underlying risk
models and data
• Acceptance criteria

Nuclear Risk Research Center, CRIEPI

5The B. John Garrick Institute for the Risk Sciences

UCLAExample of traditional licensee submittal(e.g., license amendment)Licensee

Regulatory Staff• Identify issue• Develop technical and regulatory
basis document• Develop submittal• Review submittal• Is it risk-informed?
• Should it be risk-informed?

• Issue questions• Respond to questions• Issue safety evaluation• Take implementation actions
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6The B. John Garrick Institute for the Risk SciencesUCLAExample of regulatory staff action(e.g., backfit analysis, significance determination)
Licensee

Regulatory staff• Identify issue• New rule or change to rule
• Inspection finding• Develop technical and regulatory
basis document• Issue for comment• Review and provide comments• Review comments and finalize
decision• Implement decision (generically)• Implement decision in facility
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UCLA

Developing expertiseStaff with necessary expertiseUSNRC model• Types of expertise• Centralized and extensive expertisein PRA methods• Within agency• Available under contract• Extensive contractor support inparticular areas• Location of expertise(organizationally)• Training programs• De-centralized expertise in PRAimplementation• License amendment reviews• Senior reactor analysts (regions)• Internal• External

Nuclear Risk Research Center, CRIEPI• Agency-maintained training
program

8The B. John Garrick Institute for the Risk Sciences

UCLA