**NRC INSPECTION MANUAL**IRAB

INSPECTION MANUAL CHAPTER 0609

SIGNIFICANCE DETERMINATION PROCESS

Effective Date:  11/09/2020

0609-01	PURPOSE

The Significance Determination Process (SDP) uses risk insights and other relevant information, as appropriate, to assist U.S. Nuclear Regulatory Commission (NRC) staff in determining the safety or security significance of inspection findings identified within the seven cornerstones of safety at operating reactors.  The SDP is a risk-informed process and the resulting safety or security significance of findings, combined with the results of the risk-informed performance indicator program, is used to determine a licensee’s level of safety performance and the level of NRC engagement with the licensee in accordance with Inspection Manual Chapter (IMC) 0305, “Operating Reactor Assessment Program.”  Each appendix to IMC 0609 supports a cornerstone(s) associated with the strategic performance areas as defined in Management Directive (MD) 8.13, “Reactor Oversight Process,” and the baseline inspection program as outlined in IMC 2515, “Light-Water Reactor Inspection Program - Operations Phase,” and IMC 2201, “Security and Safeguard Inspection Program for Commercial Power Reactors.”

This document will be used in conjunction with IMC 0609, Attachment 1, “Significance and Enforcement Review Panel (SERP) Process,” and IMC 0609, Attachment 5, “Inspection Finding Review Board.”  These procedures are intended to ensure the SDP is efficient through appropriate management oversight and planning of the disposition of potentially greater-than-Green (GTG) inspection findings.

0609-02	OBJECTIVES

02.01	To characterize the safety or security significance of inspection findings for the NRC Reactor Oversight Process (ROP), using best available information, as appropriate.

02.02	To provide all stakeholders an objective and common framework for communicating the potential safety or security significance of inspection findings.

02.03	To provide a basis for timely assessment and/or enforcement actions associated with an inspection finding.

02.04	To provide inspectors with plant-specific risk information for use in risk-informing the inspection program.

0609-03	APPLICABILITY

03.01	The SDP tools described in appendices to this IMC are applicable to inspection findings identified through the implementation of the NRC inspection program described in IMC 2515 and IMC 2201.  Before determining safety or security significance of an inspection finding, each performance deficiency shall be screened and determined to be “more than minor” using the guidance provided in IMC 0612, Appendix B, “Additional Issue Screening Guidance,” and Appendix E, “Examples of Minor Issues,” as applicable.  Violations with no associated performance deficiency are not inspection findings and therefore are not evaluated by the SDP.  In addition, safety significant degraded conditions with no associated performance deficiency are not evaluated by the SDP.  However, these degraded conditions may need to be addressed by other NRC processes (e.g., the backfit process, Generic Safety Issue Program, or rulemaking).

03.02	IMC 0612, Appendix B also includes the Very Low Safety Significance Issue Resolution (VLSSIR) process as part of issue screening.  Inspectors can use the VLSSIR process to discontinue evaluation of an issue involving a current licensing basis question in which the issue cannot be resolved without a significant level of effort and an expenditure of resources the agency has chosen not to utilize because the issue is expected to be of very low safety significance if found to be valid.  The VLSSIR process uses IMC 0609 to determine if an issue is of very low safety significance even though it has not yet been established whether there is an associated performance deficiency.  If the issue does not proceed to a “detailed risk evaluation,” or a Phase 2 evaluation when relevant, or Appendix M, then the issue would have insufficient safety significance.

03.03	A subtle yet extremely important and fundamental tenet of the SDP framework is that deficient licensee performance (as later described and documented as the inspection finding) is the proximate cause of the degraded condition(s).  As such, the degraded condition in and of itself (e.g., a non-functional safety-related pump) is not the deficient licensee performance.  Rather, the deficient licensee performance (e.g., failure to develop an adequate maintenance procedure) is the proximate cause that led to the particular degraded condition(s).  The SDP is designed to estimate the safety or security significance of a degraded condition(s) that was caused by deficient licensee performance above the baseline risk profile (see IMC 0308, Attachment 3, “Significance Determination Process Basis Document,” for more details).

03.04	Nothing in this guidance relieves any licensee from fully complying with Technical Specifications, licensing basis commitments, or other applicable regulatory requirements.  Continued compliance with regulatory requirements maintains the requisite defense-in-depth and safety margins necessary to achieve adequate protection of public health and safety.

03.05	The safety significance of reactor events caused or complicated by equipment malfunction and/or operator error are initially assessed by NRC staff in accordance with IMC 0309, “Reactive Inspection Decision Basis for Reactors,” and MD 8.3, “NRC Incident Investigation Program.”  Although the outcome of this risk evaluation may provide useful risk insights to NRC staff for event response or follow-up, it was not designed to determine the safety or security significance of inspection findings.  Since the SDP is used to evaluate the safety or security significance of degraded conditions caused by deficient licensee performance, including those that manifest themselves during events, inspection findings associated with a reactor event shall be processed in accordance with IMC 0609 and its associated attachments and appendices.

03.06	For AP1000 units constructed under 10 CFR Part 52, a finding will be made by the Commission in accordance with 10 CFR 52.103(g) signifying that construction inspections, tests, and analyses have been performed and verified, and all acceptance criteria have been met.  Following the 52.103(g) finding, this IMC and attachments will be used to disposition inspection findings associated with operational programs, IMC 2514 startup testing, initial test program activities (if any) beyond the 52.103(g) finding, and findings resulting from inspection of ITAAC subject to a hearing.  If the finding is related to the development or implementation of a security program, this IMC and attachments are also applicable prior to the 52.103(g) finding.

0609-04	DEFINITIONS

04.01	Applicable definitions are located in IMC 0612, “Issue Screening,” and supporting technical and program bases are located in IMC 0308, Attachment 3, “Significance Determination Process Basis Document.”

04.02	Inspection findings are assigned a color representing the safety significance of the finding.  The following definitions (04.02.a thru 04.02.d) include the quantitative and qualitative descriptions for each color and need to be applied appropriately to each SDP appendix listed at the end of this document.  The symbol “Δ,” as used in the quantitative SDP appendices that use core damage frequency (CDF) and large early release frequency (LERF) as metrics, refers to the difference between the CDF (or LERF) resulting from the degraded condition(s) caused by deficient licensee performance and the nominal CDF (or LERF) of the facility.  In other words, the quantitative SDP appendices estimate the increase in risk resulting from a degraded condition(s) caused by deficient licensee performance above a baseline risk profile.  A graphical representation of the quantitative significance of findings is displayed in Exhibit 1.

a. Red (high safety or security significance) is quantitatively greater than 104 ΔCDF or 105 ΔLERF.  Qualitatively, a Red significance indicates a decline in licensee performance that is associated with an unacceptable loss of safety margin.  Sufficient safety margin still exists to prevent undue risk to public health and safety.

b.	Yellow (substantial safety or security significance) is quantitatively greater than 105 and less than or equal to 104 ΔCDF or greater than 106 and less than or equal to 105 ΔLERF.  Qualitatively, a Yellow significance indicates a decline in licensee performance that is still acceptable with cornerstone objectives met, but with significant reduction in safety margin.

c.	White (low to moderate safety or security significance) is quantitatively greater than 106 and less than or equal to 105 ΔCDF or greater than 107 and less than or equal to 106 ΔLERF.  Qualitatively, a White significance indicates an acceptable level of performance by the licensee, but outside the nominal risk range.  Cornerstone objectives are met with minimal reduction in safety margin.

d. Green (very low safety or security significance) is quantitatively less than or equal to 106 ΔCDF or 107 ΔLERF.  Qualitatively, a Green significance indicates that licensee performance is acceptable and cornerstone objectives are fully met with nominal risk and deviation.

04.03	Risk-Based – An approach to regulatory decision-making that is solely based on the quantitative results of a risk assessment.

04.04	Risk-Informed – An approach to regulatory decision-making that considers both quantitative and qualitative risk insights and other relevant information, as appropriate.

04.05	SDP Timeliness – For potentially GTG inspection findings, the time it takes from identification (see IMC 0307, Appendix A, Section 03.03 for additional details) to the date a final significance determination is issued.  The goal for SDP timeliness is to complete all final significance determinations within 255 days from the identification date.  To effectively monitor the SDP timeliness goal, an associated metric is included in IMC 0307, Appendix A, “Reactor Oversight Process Self-Assessment Metrics and Data Trending.”  This metric takes into account that certain inspection findings may take additional time due to their complexity and/or potential high degree of risk significance.  Exhibit 3 to IMC 0609, Attachment 5, “Inspection Finding Review Board,” outlines the entire process from the identification of an issue to the final significance determination with an estimate of the time necessary to complete each step.

04.06	Best Available Information – Information that is accessible, applicable, and ready for use at the time of the review to determine the safety significance of the inspection finding.  It is important that the NRC make appropriate and timely decisions on inspection findings in order to ensure that findings are appropriately considered in the assessment process and to communicate the results of inspection findings to the public in a timely manner.  To accomplish this, it is expected that both licensees and the NRC will use information that is most reflective of the circumstances associated with the inspection finding and is available at the time of the significance determination.

04.07	Exposure time – The period of time the failed or degraded structure, system, or component (SSC) being assessed was unable to perform a probabilistic risk assessment (PRA) function (T).  If the exact time when the SSC became PRA non-functional is not known, one half of the time that has passed since the time the SSC was last definitively demonstrated to be PRA functional is used (T/2).  Any repair time in which the SSC was unable to perform a PRA function is always included in the exposure time.  The exposure time used for the SDP may be different than the reportability or Technical Specification inoperability times.  Additional information about the determination of exposure time is included in the Risk Assessment Standardization Project (RASP) Handbook.

0609-05	RESPONSIBILITIES AND AUTHORITIES

All NRC inspectors are required to assess the significance of inspection findings in accordance with the guidance provided in this IMC.  General and specific responsibilities are listed below.

In order to improve the efficiency and effectiveness of the SDP, it is essential that the Sponsor (as defined in IMC 0609, Attachment 1, Section 02.03), who also serves as Chair of the Inspection Finding Review Board (IFRB), be the voice of the NRC when communicating with licensee management on the disposition of potentially GTG inspection findings.  All management level communications should be directed to the Sponsor, consistent with 

IMC 0609, Attachment 5.

For security inspection findings that involve complexities and are not clear, the Security Information Forum (SIF) can be used in place of the IFRB.  The SIF provides a forum for regional and headquarters staff (Office of the General Counsel, Office of Enforcement (OE), and Office of Nuclear Reactor Regulation (NRR)) to solicit input from each other regarding a number of security inspection-related issues, including potentially GTG security findings.  A designated division-level manager should be appointed as the single point of contact for the issue and the overall process for dispositioning the issue should otherwise follow the Inspection Finding Resolution Management process.

05.01	Director, NRR

a. Provide overall program direction for the ROP.

b. Develop and direct the implementation of policies, programs, and procedures for regional application of the SDP guidance.

c. Assess the effectiveness, uniformity, and completeness of regional implementation of the SDP.

05.02	Director, Office of Nuclear Security and Incident Response (NSIR)

a. Provide overall program direction for the emergency preparedness and security cornerstones of the ROP.

b. Develop and direct the implementation of policies, programs, and procedures for regional application of the emergency preparedness and security SDP guidance.

c. Provide oversight and representatives as necessary to support the SERP in order to ensure consistent and timely application of the process.

d. Support the development, maintenance, and periodic implementation of appropriate training to ensure both technical staff and SERP decision-makers understand the program and process guidance.

05.03	Director, Division of Reactor Oversight (DRO) (NRR)

a. Approve all revisions to SDP procedures and direct the development of future SDP procedures and improvements through periodic revisions based on new risk insights and feedback from users.

b. Provide oversight and representatives as necessary to support the SERP in order to ensure consistent and timely application of the process.

c. Develop, maintain, and periodically provide appropriate training to ensure both technical staff and SERP decision-makers understand the program and process guidance, risk analysis techniques, and the treatment of uncertainty.  

05.04	Director, Division of Risk Assessment (DRA) (NRR)

a. Recommends improvements to all SDP tools using a probabilistic risk framework and approves changes to plant-specific risk insight information used by the SDP, based on new risk insights and feedback from users.

b. Provide oversight and representatives as necessary to support the SERP in order to ensure consistent and timely application of the process.

c. Support the development, maintenance, and periodic implementation of appropriate training to ensure both technical staff and SERP decision-makers understand the program and process guidance, risk analysis techniques, and the treatment of uncertainty.

d. Provide risk analysts with a general expectation that balances the amount of time and resources allocated in determining the safety significance of an inspection finding and the goal of providing a timely response.

05.05	Director, OE

a. Ensure consistent application of the enforcement process to violations of NRC regulations with the appropriate focus on the significance of the inspection finding.

b. Provide representatives as necessary to support the SERP in order to ensure consistent application of the enforcement process.

c. Coordinate with NRR (and NSIR when necessary) when revising agency documents used for communicating to the licensee about apparent violations and final determinations associated with the ROP.

d. Support the development, maintenance, and periodic implementation of appropriate training to ensure both technical staff and SERP decision-makers understand the program and process guidance, risk analysis techniques, and the treatment of uncertainty.

05.06	Director, Office of Nuclear Regulatory Research (RES)

a. Based on user need requests, provide support in the development and refinement of the SDP tools and research activities (e.g., SAPHIRE, SPAR models, NUREGs, NUREG/CRs) to enhance the overall implementation of the SDP.

b. Provide representatives, when requested, to support the SERP.

05.07	Regional Administrators

a. Provide program direction for management and implementation of the SDP to activities performed by the Regional Office.

b. Maintain overall responsibility for, and apply regional resources as necessary, to determine the significance of specific inspection findings in a timely manner, using best available information consistent with the SDP timeliness goal and associated SDP timeliness metrics.

05.08	Director, Division of Reactor Projects and Division of Reactor Safety.

a. Provide oversight and representatives as necessary to support the SERP in order to ensure consistent and timely application of the process.

b. Support the development, maintenance, and periodic implementation of appropriate training to ensure both technical staff and SERP decision-makers understand the program and process guidance, risk analysis techniques, and the treatment of uncertainty.

c. Provide regional staff with a general expectation to balance the amount of time and resources allocated in determining the safety significance of an inspection finding and the goal of providing a timely response.

d. Communicate with licensee management on potentially GTG inspection findings consistent with the IFRB process outlined in IMC 0609, Attachment 5.

05.09	Senior Reactor Analysts (SRAs).

a. Support NRC objectives related to the utilization of risk insights in the reactor inspection program, the SDP, and other risk-informed applications in the ROP.

b. Provide regional management with updates on the expected amount of resources needed to appropriately characterize the safety significance of an inspection finding.

c. Support the specific objectives as presented in Attachment 3 to this IMC.

0609-06	SIGNIFICANCE AND ENFORCEMENT REVIEW PANEL PROCEDURES

The following basic process is described in detail in IMC 0609, Attachment 1, “Significance and Enforcement Review Panel Process.”

06.01	Development of and Initial Characterization of Inspection Findings.  Initial significance determination is normally performed by the inspector using IMC 0609, Attachment 4, “Initial Characterization of Findings,” and the applicable appendix of IMC 0609.  Once an inspection finding is determined to not initially screen as Green, convening the IFRB shall be considered to ensure alignment on the performance deficiency, the inspection finding, any proposed violation(s), and the actions and timeframes to determine the preliminary significance.  Detailed risk information need not be developed in advance of the IFRB.  Refer to IMC 0609, Attachment 5, “Inspection Finding Review Board,” for additional guidance.

06.02	Preliminary Significance Review and Decision.  Any finding with a pending significance (see IMC 0612 for definition) of White, Yellow, Red, or GTG, shall be reviewed and decided by the SERP.  The result of the SERP review and decision represents the staff’s preliminary safety significance characterization.  However, when a pending White, Yellow, or Red finding is determined to be Green by the SERP, this will represent a final determination and characterized as such in the inspection report.

06.03	Planning SERP.  The purpose of the Planning SERP is to ensure the SERP decision-makers achieve alignment on the overall approach to characterize the significance of inspection findings that are more complex in nature and to coordinate headquarters expertise and resources.  Since the SERP decision-makers are involved, the Planning SERP is reserved for cases in which the Sponsor is planning to propose a GTG, White, Yellow, or Red significance characterization.

Guidelines for conducting a Planning SERP are detailed in IMC 0609, Attachment 1.

06.04	Obtaining Licensee Perspectives on Significance Determination.  After the IFRB approves the performance deficiency for an inspection finding that did not screen to Green, the IFRB Chair will notify licensee senior management that the NRC will be performing additional reviews and analysis to determine significance.  The Chair will also communicate the desire for timely, open, and constructive dialogue using best available information, emphasizing the Chair’s focal point role in the process.  If the preliminary significance assessment of a finding is White, Yellow, Red, or GTG, the licensee will be given the opportunity to provide additional information and perspectives at a public Regulatory Conference or in a written response on the docket.  This opportunity will be offered in the cover letter of the inspection report or in the preliminary significance determination letter.

06.05	Final Significance Review and Decision.  If the licensee accepts the staff’s preliminary significance determination and does not intend to present additional information, the staff will issue a final significance determination letter.  If the licensee provides information on the docket by letter or participates in a Regulatory Conference, the staff will convene a Post-Regulatory Conference Review prior to making a final significance decision.  If after considering the licensee’s additional information, the SERP determines that a preliminary White, Yellow, Red, or GTG finding is of Green significance, this is the final determination and will be communicated in the final significance determination letter.

In the case where the staff has issued a preliminary significance determination of GTG and the licensee has not or cannot provide sufficient information to better inform the staff’s significance determination in a reasonable period of time, the SERP will reconvene and make its final determination based on the best available information.  The SERP’s conclusion and rationale will be documented in the final significance determination letter.

06.06	Office of Investigation (OI) and Department of Justice (DOJ).  Some inspection findings may involve a formal OI or DOJ investigation.  When an inspection finding involves a formal OI/DOJ investigation and it is known that the results of the investigation will not impact further evaluation of the finding’s significance and/or follow-up inspection, the finding shall be resolved using the normal SDP process.  If the OI/DOJ investigation does impact the timely resolution of the finding, the guidance for a Planning SERP shall be implemented.

0609-07	PROCESS FOR LICENSEE APPEAL OF A STAFF SDP DETERMINATION

If a licensee disagrees with the staff’s final determination of significance, the licensee may appeal the determination as described in IMC 0609, Attachment 2, “Process for Appealing NRC Characterization of Inspection Findings (SDP Appeal Process).”  Any such review must meet the requirements stated in the Prerequisites and Limitations sections of Attachment 2 to merit further staff consideration.

0609-08	SDP DEVELOPMENT AND FEEDBACK PROCESS

08.01	SDP Development.  The development of a new SDP or significant modification of an existing SDP should follow the general process used for original SDP development.  This process should include the following general steps:

a. The draft of the new or significantly modified SDP should receive a thorough internal stakeholder review from both the regions and headquarters via periodic meetings, site visits, surveys, etc.  Early external stakeholder input should also be solicited through public meetings (or closed meetings if discussions involve sensitive security-related information).

b. A feasibility review should be performed, as deemed necessary, by the lead organization (e.g., NRR or NSIR) to assess the adequacy of the proposed new or significantly modified SDP.  This review should specifically involve regional representation and should test the SDP (preferably with real examples, though hypothetical inspection findings and violations may be used).  Based on the results of the feasibility review, a pilot should be considered to evaluate the robustness of the proposed SDP and to ensure that appropriate outcomes are achieved.  The feasibility and/or pilot results should be documented in the applicable SDP technical basis document.

c. Upon reconciliation of both internal and external feedback from the feasibility review and/or pilot, appropriate training on the new or significantly modified SDP should be provided to NRC staff.

d. After items 08.01a – c have been completed, the final SDP will be issued consistent with the requirements in IMC 0040, “Preparing, Revising, and Issuing Documents for the NRC Inspection Manual.”  Before issuance, staff should determine whether Commission notification or approval is necessary, in accordance with Management Directive 8.13.

08.02	SDP Feedback and Improvement.  IMC 0801, “Reactor Oversight Process Feedback Program,” describes in detail the feedback process and feedback form used by the Office of NRR/Division of Reactor Oversight, to document problems, concerns, or difficulties encountered during implementation of the ROP guidance.

0609-09	REFERENCES

1. IMC 0611, “Power Reactor Inspection Reports”

2. IMC 0612, Appendix B, “Additional Issue Screening Guidance”

3. IMC 0308, Attachment 3, “Significance Determination Process Basis Document”

4. IMC 0609, Attachment 1, “The Significance and Enforcement Review Panel Process”

5. IMC 0609, Attachment 2, “Process for Appealing NRC Characterization of Inspection Findings (SDP Appeal Process)”

6. IMC 0609, Attachment 3, “Senior Reactor Analyst Support Objectives”

7. IMC 0609, Attachment 4, “Initial Characterization of Findings”

8. IMC 0609, Attachment 5, “Inspection Finding Review Board”

9. IMC 0609, Appendix A, “Significance Determination Process for Findings At-Power”

10. IMC 0609, Appendix M, “Significance Determination Process Using Qualitative Criteria”

11. IMC 0040, “Preparing, Revising, and Issuing Documents for the NRC Inspection Manual”

12. SECY-99-007, “Recommendations for Reactor Oversight Process Improvements”

13. SECY-99-007A, “Recommendations for Reactor Oversight Process Improvements (Follow-up to SECY-99-007)”

14. SECY-00-0049, “Results of the Revised Reactor Oversight Process Pilot Program”

15. Staff Requirements - COMSECY-14-0030 – Proposed Suspension of the Reactor Oversight Process Self-Assessment for Calendar Year 2014

END

Exhibits:

Exhibit 1		Graphical Representation of the Quantitative Significance of Inspection Findings

Attachments:

	Attachment 1	Significance and Enforcement Review Panel Process

	Attachment 2	Process for Appealing NRC Characterization of Inspection Findings

	(SDP Appeal Process)

	Attachment 3	Senior Reactor Analyst (SRA) and Risk Analyst Support Expectations

	Attachment 4	Initial Characterization of Findings

	Attachment 5	Inspection Finding Review Board

Appendices:

	Appendix A		Significance Determination Process for Findings At-Power

	Appendix B		Emergency Preparedness SDP

	Appendix C		Occupational Radiation Safety SDP

	Appendix D		Public Radiation Safety SDP

	Appendix E		Part I, Baseline Security SDP for Power Reactors and 

				Part II, Force-on-Force Security SDP for Power Reactors

			Part III, Construction Fitness-for-Duty Significance Determination Process for New Reactors 

			Part IV, Cyber Security Significance Determination Process for Power Reactors

	Appendix F		Fire Protection SDP

	Appendix G		Shutdown Operations SDP

	Appendix H		Containment Integrity SDP

	Appendix I		Licensed Operator Requalification SDP

	Appendix J		Steam Generator Tube Integrity SDP

	Appendix K		Maintenance Risk Assessment and Risk Management SDP

	Appendix L		Significance Determination Process for B.5.b

	Appendix M		Significance Determination Process Using Qualitative Criteria

Issue Date:  11/09/20	1	0609

Exhibit 1

Graphical Representation of the Quantitative Significance of Inspection Findings

NOTE:  Not applicable to all safety cornerstones and IMC 0609 appendices

Issue Date:  11/09/20	Exh 1-1	0609

Attachment 1

Revision History - IMC 0609

Issue Date:  11/09/20	Att1-4	0609

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