ML19149A230
| ML19149A230 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 05/29/2019 |
| From: | Riti T Nuclear Energy Institute |
| To: | Division of Operating Reactor Licensing |
| Parker C, 415-1603 | |
| References | |
| L-2019-PMP-0002 | |
| Download: ML19149A230 (22) | |
Text
©2019 Nuclear Energy Institute Tim Riti Senior Project Manager, Regulatory Affairs Low Safety Significance Issue Resolution (LSSIR)
May 29, 2019
©2019 Nuclear Energy Institute 2 Industry recognizes the importance of maintaining compliance with requirements.
At the same time, we believe that safety significance can be used to inform the resolution of issues where there is not a clear violation, as well as to inform the methods used to restore compliance.
We agree with the staff that, in some cases, there is an inappropriate expenditure of industry and NRC resources and attention to issues of low safety significance.
A process is necessary that will ensure that safety significance is evaluated early in the life cycle of a regulatory issue, and that issue resolution flows logically from that evaluation.
Introduction
©2019 Nuclear Energy Institute 3 Insights regarding foundational characteristics of the LSSIR process Insights regarding opportunities for use of the LSSIR process Insights regarding characteristics of an effective safety significance evaluation tool (SSET)
Overview of Presentation
©2019 Nuclear Energy Institute 4
©2019 Nuclear Energy Institute 5 Initial area of focus
©2019 Nuclear Energy Institute 6 Process needs to allow for evaluation of safety significance early in the life cycle of the issue - before the expenditure of substantial resources.
Where appropriate, issues of low safety significance, that are not a matter of compliance (lower left quadrant), should be dispositioned via no further action, with durable documentation.
Process should provide a mechanism for staff to promptly escalate issues to aid in determining both: (1) whether the SSET should be applied, and, if so, (2) whether additional resources should be devoted to an issue based on safety significance.
Foundational Characteristics of LSSIR Process
©2019 Nuclear Energy Institute 7 Decisions regarding regulatory status are necessary to determine whether the issue falls on the left or right half of the diagram.
Compliance can be objectively evaluated, without the need for significant interpretation; and without directly or indirectly imposing current guidance or positions on licensees that were not applicable when licensing decisions were made, and which the licensee has not formally committed to meeting.
Where multiple reasonable interpretations of a requirement are possible, presumption should be as-built condition of the plant conforms to applicable design criteria and licensing basis requirements.
Guiding Principles - Compliance
©2019 Nuclear Energy Institute 8
Is there a requirement that is clearly applicable to the issue being evaluated (i.e., specific regulation, order, technical specification, license condition)?
Is the most prescriptive requirement at issue a GDC or PDC?
Does the staffs compliance position rely on the use of guidance or standards issued after the licensing basis was established?
Is there a genuine issue of material fact that is in dispute between the NRC and licensee (i.e.,
dispute on the facts, as opposed to a dispute over the licensing basis)?
Does the staffs position rely on a subjective interpretation of a requirement (i.e., are multiple, reasonable interpretations of a requirement possible)?
Questions Concerning Compliance (examples)
©2019 Nuclear Energy Institute 9 Processes Recommended for Initial Focus IMC-0612, Appendix B, Issue Screening LIC-101 Appendix B, Guide for Processing License Amendments (e.g. forward fitting considerations)
COM-106, Control of Task Interface Agreements Management Directive 8.18, NRC Generic Communications Program Management Directive 6.4, Generic Issues Program Others Updates to Regulatory Guidance (e.g. Regulatory Guides, NUREGs)
Operating Experience Smart Sample (OpESS) Program Opportunities for Use (examples)
©2019 Nuclear Energy Institute 10 IMC-0612, Appendix B, Issue Screening Example #1
©2019 Nuclear Energy Institute 11 IMC-0612, Appendix B, Issue Screening Example #1 (cont.)
Is information required to determine if a violation exists?
YES Low Safety Significance?
YES Opportunity to disposition with No Further Action and document versus issuing a URI.
©2019 Nuclear Energy Institute 12 If the current forward fitting position is maintained, the LSSIR process should be applied NRC staff guidance is subject to Backfitting Rule if:
Staff intends positions in guidance to become legally binding on a licensee (through further NRC action); or The Staffs expectation that the licensee will adopt positions in the guidance is the basis for resolution of a safety or regulatory issue.
Example #2: Forward-fitting
©2019 Nuclear Energy Institute 13 In contrast to the scenarios presented on the previous slide, the NRCs 2010 letter explained that there are also guidance documents that the staff intends only to be forward-fit.
Such guidance would apply only to:
1.
Future applicants; and 2.
Applications from existing licensees for license amendments or exemptions, and other requests for dispensation from compliance with otherwise-applicable requirements (e.g., an application to use an alternative under 10 CFR 50.55a).
Example #2: Forward-fitting (cont.)
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With respect to #2 from the previous slide, the NRCs 2010 letter went on to explain that when a licensee voluntarily requests approval from the NRC to modify its licensing basis, the NRC staff may condition its approval on the licensees agreement to conform to new or revised agency guidance, so long as:
The new or revised guidance relates directly to the licensees voluntary request; and The specific subject-matter of the new or revised guidance is an essential consideration in the NRC staffs determination of the acceptability of the licensees voluntary request Example #2: Forward-fitting (cont.)
If the existing forward-fitting concept remains in place, then the SSET could be applied to determine whether the proposed forward-fit is an essential consideration in the NRC staffs determination of the acceptability of the licensees voluntary request.
If the subject-matter of the new or revised guidance does not pass the SSET screening, then it should not be considered essential to the staffs determination and should not be forward-fit onto a licensee.
©2019 Nuclear Energy Institute 15 Assessing Safety Significance
©2019 Nuclear Energy Institute 16
SSET is used to separate the top and bottom halves of the NRCs diagram and should be capable of being applied across various regulatory contexts (inspection, licensing/forward-fitting, generic issue management, etc.).
SSET should be relatively simple and utilize qualitative criteria, with quantitative insights used when available.
SSET should be aimed at determining whether an issue could be safety-significant, either from the standpoint of the absolute or incremental risk posed by the issue.
Foundational Characteristics of the Safety-Significance Evaluation Tool (SSET)
©2019 Nuclear Energy Institute 17 Assessing Safety Significance Considerations Fundamental Criteria Potential Consequence Qualitative Likelihood Considerations Scope of issue Potential for mitigating actions or compensatory measures associated with temporary conditions Qualitative Potentially Safety Significant Quantitative Considerations Consider NUREG/BR-0058 safety goal screening criteria Consider TEC-002 for refined semi-qualitative and quantitative risk criteria Evaluate the change or delta risk between options or different resolutions Potentially Safety Significant Proceed with Issue Disposition Document Decision Not Safety Significant
©2019 Nuclear Energy Institute 18 A qualitative assessment is essential to drive an initial evaluation of safety across a wide variety of potential issues Not all issues are amenable to quantification or application of existing models/tools Fundamental Criteria Likelihood and Potential Consequence both need to be considered High for an issue to be identified as Potentially Safety Significant
Is the potential consequence high when considered in the context of a holistic assessment of consequences?
Assessing Qualitative Safety Significance
©2019 Nuclear Energy Institute 19 Considerations Scope of the issue (focused issue, SSC, safety function, single or multiple sites) could represent an influencing factor on the fundamental criteria If the issue involves a temporary condition, mitigation actions or compensatory measures can be qualitatively considered Assessing Qualitative Safety Significance
©2019 Nuclear Energy Institute 20 Potential Guiding questions Could the qualitative likelihood, or change in likelihood resulting from an issue, challenge regulatory thresholds of significance?
Could the potential consequence exist during multiple plant states or conditions?
Would operator action or emergency response actions be required to mitigate the potential consequence?
Could the issue impact multiple facilities?
Issues that are limited in scope to a specific site will likely not have potential significant consequence Assessing Qualitative Safety Significance
©2019 Nuclear Energy Institute 21 When issues of non-compliance are discovered, safety significance assessments can be used to inform approaches to achieve compliance (e.g. simplified or expedited licensing review process to change licensing basis)
Ensure time and resources for potential solutions are commensurate with safety significance Looking Ahead
©2019 Nuclear Energy Institute 22 We appreciate the NRCs reflection on how issues have been addressed in the past and for looking at ways to improve safety focus by reducing the time and effort spent on issues of low safety significance.
Conclusion