ML20099F354
ML20099F354 | |
Person / Time | |
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Site: | 07003103 |
Issue date: | 04/30/2020 |
From: | Jacob Zimmerman NRC/NMSS/DFM/FFLB |
To: | Andrea Kock Division of Fuel Management |
KMSturzebecher NMSS/DFM/FFL 415.8534 | |
Shared Package | |
ML20099F352 | List: |
References | |
Download: ML20099F354 (39) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 30, 2020 MEMORANDUM TO: Andrea Kock, Director Division of Fuel Management Office of Nuclear Material Safety and Safeguards FROM: Jacob I. Zimmerman, Chief Fuel Facility Licensing Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
SUBJECT:
WORKING GROUP RECOMMENDATIONS FOR BUILDING A SMARTER FUEL CYCLE LICENSING PROGRAM On April 26, 2019, the Division of Fuel Cycle Safety, Safeguards, and the Environment (FCSE),
issued a Charter (Agencywide Documents Access and Management System [ADAMS] Package Accession No. ML19115A011) to collect and evaluate stakeholder input on improving the efficiency and effectiveness of the fuel cycle licensing program. The enclosed working group report provides the deliverable required by the Charter. This report includes specific recommendations for each of the stakeholder suggestions and the qualitative prioritization of the proposed actions.
The anticipated next step is to develop an implementation plan that recommends how to address the interrelated suggestions and will include projected implementation timelines and resources. This plan will further inform division management decision-making in determining which, when, and how to implement the working group recommendations and the associated budget planning activities.
Enclosure:
Report for Building a Smarter Fuel Cycle Licensing Program CONTACT: Donnie Harrison, NMSS/DFM 301-415-2470 Enclosure
ML20099F352 (Pkg) ML20099F354 (Memo)
- concurred by e-mail OFFICE DFM/FFLB/ DFM/NARAB DFM/NARAB NRR/DORL DFM/SLS DFM/FFLB/BC PM STAFF JDowns* ASmith* DChung* SLee* DHarrison* JZimmerman DATE 04/03/2020 04/02/2020 04/02/2020 04/03/2020 04/06/2020 04/30/2020 RECOMMENDATIONS FOR BUILDING A SMARTER FUEL CYCLE LICENSING PROGRAM PURPOSE This report proposes recommendations to improve the fuel cycle licensing program. The U.S.
Nuclear Regulatory Commission (NRC) staff developed these recommendations based on suggestions from both internal and external stakeholders. In providing these recommendations, this report completes the activities tasked under the Working Group (WG) Charter, dated April 26, 2019 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML19115A016).
SUMMARY
While both the NRC staff and stakeholders largely consider the fuel cycle licensing program effective, both also recognize that further improvements could be gained. Through stakeholder correspondence and interactions, NRC staff insights, and input received during multiple public meetings, the WG collected thirty-two suggestions. Five of these suggestions have aspects that were considered separately by the WG, resulting in a total of thirty-seven suggestions being evaluated. The suggestions are wide-ranging, from relatively simple considerations, such as more frequent communication between the licensee/applicant and the NRC project manager; to relatively extensive actions, such as developing job aids for each aspect of the NRC staff review effort for various types of licensing actions. These suggestions, the associated WG evaluations, and the recommended actions are provided as Table 1 in the Attachment to this report. The WG has developed recommendations that are consistent with NRC's Principles of Good Regulation (PGR) (i.e., Independence, Openness, Efficiency, Clarity, and Reliability as defined in ADAMS Accession No. ML14135A076). These recommendations will continue to ensure the fuel cycle licensing program accomplishes its mission and strategic goals.
The WG evaluated the suggestions using a screening and prioritization process to bin the individual suggestions as high, medium, or low priority. This process first identified suggestions that are already established expectations and good practices. Based on their potential to reinforce certain PGR (e.g., clarity and openness) and/or improve the efficiency and effectiveness of reviews, the WG categorized these suggestions as high priority. The remaining suggestions were qualitatively evaluated for their potential to improve the efficiency and effectiveness of the fuel cycle licensing program in achieving the NRC mission. The WG then qualitatively evaluated the resources and time expected to implement each suggestion. The WG recommends that some suggestions, even though they may take significant resources and time to implement, be implemented in a phased manner. Table 2 of the Attachment to this report provides the prioritization of the recommendations for each suggestion.
The suggestions are grouped into three focus areas in the Recommendations and Priorities section of this report:
- 1. Guidance and Tool Development (3 high priority, 9 medium priority, and 3 low priority)
- 2. Planning and Processing (8 high priority, 3 medium priority, and 1 low priority)
- 3. Performance and Documentation (9 high priority, 1 medium priority, and 0 low priority)
Enclosure
In addition, the WG determined it was more appropriate to address some aspects of the Charter during the implementation of suggestions, rather than during the evaluation and prioritization phase. These items are also discussed in the Recommendations and Priorities section of this report as additional considerations for implementation.
Through this initiative, the WG achieved the objective of the Charter by identifying, evaluating, and prioritizing thirty-seven suggestions for improving the fuel cycle licensing program. A wide range of suggestions was received from both internal and external stakeholders. The WG concludes that all suggestions are consistent with NRC's PGR, and therefore recommends that all the suggestions except one be implemented. The WG concluded that implementation of the suggestions will improve the fuel cycle licensing program in accomplishing its mission and strategic goals.
BACKGROUND The fuel cycle licensing program applies to applications to construct, modify, or operate nuclear fuel cycle facilities licensed by the NRC under Title 10 of the Code of Federal Regulations (10 CFR) Part 40, Domestic Licensing of Source Material, and Part 70, Domestic Licensing of Special Nuclear Material. These include: nuclear fuel fabrication facilities, uranium enrichment facilities, uranium conversion facilities, greater than critical mass (GTCM) facilities, and medical isotope production facilities. The NRC staffs licensing reviews and decisions are performed using the concept of reasonable assurance of adequate protection. The guidance documents used in the fuel cycle licensing program include:
- Division of Fuel Cycle Safety, Safeguards, and Environmental Review [FCSE] 1 Licensing Review Handbook (LRH) (not publicly available), which assists project managers (PMs), technical reviewers (TRs), and supervisors by describing the steps, responsibilities, and expectations for performing licensing-related actions.
- NUREG-1520, Standard Review Plan (SRP) for License Applications for Fuel Cycle Facilities, (ADAMS Package Accession No. ML15176A258), which is a comprehensive and integrated document that identifies methods and approaches acceptable for meeting the NRC requirements and provides guidance to the NRC staff who perform reviews of applications to construct, modify, or operate nuclear fuel cycle facilities. NUREG-1520 addresses each of the technical disciplines involved in a review, including: the responsibilities of the NRC technical reviewer, the matters that they review, the Commissions regulations pertinent to the specific technical matters, the acceptance criteria used by the NRC staff, and the findings and conclusions that are appropriate to summarize the review.
In addition, on January 15, 2019, the Director of the Office of Nuclear Material Safety and Safeguards (NMSS) issued a memorandum to the NMSS staff on key principles for NMSS reviews (ADAMS Accession No. ML19015A290). The memorandum states that the scope of NMSS staff reviews should be adjusted in the following ways:
1 In October 2019, the Division of Fuel Cycle Safety, Safeguards, and Environmental Review merged with the Division of Spent Fuel Management to form the Division of Fuel Management.
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- Focus NMSS staff resources and expertise on the most safety-significant portions of a licensing decision;
- Focus NMSS staff effort on reaching adequate protection or other regulatory conclusions based on reasonable assurance with respect to system performance, rather than an individual component; and
- Enable the NMSS staff to acknowledge that a new technology may be safer than an existing technology, although operating experience with that new technology may be lacking and the new technology may not meet the regulatory review standards developed for the existing technology.
The memorandum states that [i]n line with this discussion of our optimal review approach to licensing actions, I have asked the division directors to engage you in discussions on the need for continued innovation and transformation in our work, including enhancing our use of risk insights in making a finding of reasonable assurance. The enclosure to the memorandum includes additional information on reasonable assurance of adequate protection and describes various principles that should be considered in establishing the scope of licensing reviews, as well as performing and documenting the results of these reviews. Expectations for completing licensing actions for fuel cycle facilities in accordance with this memorandum were provided by the Director of the Division of Fuel Management (DFM) on January 24, 2020 (ADAMS Accession No. ML20010D837).
DISCUSSION As stated in the memorandum approving the WG Charter (ADAMS Accession No. ML19115A017), the overarching objective of the WG is to perform a review of the Fuel Cycle Licensing Program for the purpose of improving the effectiveness and efficiency of the program. The memorandum further states that the purpose of the WG is to conduct a holistic assessment of the Fuel Cycle Licensing Program to make recommendations on improving both the effectiveness and efficiency of the program while further integrating risk-informed insights. To ensure that the WG benefited from recent risk-informed initiatives in other divisions and offices, the Charter identified specific NRC staff from the Division of Spent Fuel Management and Office of Nuclear Reactor Regulation (NRR) as members of the WG.
Although incremental changes to the fuel cycle licensing program have occurred, including a recent update of the LRH, the WG was specifically tasked to look for areas of transformation and innovation in the program while adhering to the PGR, which focus the NRC staff on ensuring safety and security.
Approach to Identifying Suggestions The Charter specifically tasked the WG to solicit and assess feedback from internal stakeholders and a broad range of external stakeholders. The Charter also directed the WG to specifically review and consider a number of reference materials, including:
- The January 15, 2019, NMSS Office Director memorandum (ADAMS Accession No. ML19015A290);
- Associated licensing review guidance documents, such as the LRH and NUREG-1520;
- Findings from other related lessons learned and improvement activities, such as the Westinghouse Columbia Fuel Fabrication Facility Lessons Learned reports (ADAMS Accession No. ML16330A642);
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- Suggestions provided by external stakeholders during the development of the Charter, such as the NEI letter dated April 12, 2019 (ADAMS Accession No. ML19114A288) and the URENCO USA letter dated April 24, 2019. (ADAMS Accession No. ML19115A349); and
- Input and feedback from internal and external stakeholders.
As additional documents were identified (e.g., a recently issued NRR instruction), these documents were shared among the WG members for detailed consideration. In addition, the WG received suggestions via correspondence from external stakeholders. The documents and correspondence reviewed and considered by the WG are identified in the References section of this report.
Stakeholder input and feedback was vital to this initiative. To gather suggestions, five public meetings were held with interested stakeholders from April through November of 2019. These public interactions were coordinated with the similar initiative being pursued for the fuel cycle inspection program to ensure broad representation of potentially interested stakeholders.
References to the public engagement activities can be found in the Public Meetings section of this report. In addition, insights and perspectives were received from fuel cycle project managers and technical reviewers via a brainstorming activity, one-on-one discussions, and suggestions received through the NRC staff innovation panel. Through this multi-faceted approach, the WG collected thirty-seven suggestions for improving the efficiency and effectiveness of the fuel cycle licensing program.
A. Approach to Prioritizing Suggestions The WG evaluated each suggestion to determine its potential for improving the fuel cycle licensing program. Table 1 in the Attachment presents the thirty-seven suggestions along with the associated PGR, additional considerations identified by the WG, the WGs recommended actions, and the priority determined by the WG.
The WG determined that only one suggestion should not be pursued further. That suggestion, Suggestion #6b, is related to providing information to the licensee/applicant on when, and the review metrics for, the Office of General Counsel (OGC) staff involvement in a review of a licensing action. While the WG agrees that general schedules should be provided to applicants/licensees, the WG did not agree that internal agency decisions such as what offices to involve in a review and the metrics for input from various members of a project, should be shared with the applicant/licensee. This is the only suggestion that the WG determined should not be pursued further.
To prioritize the suggestions, the WG devised a multi-step process. The approach considered if the action(s) needed to address the suggestion: was already an established expectation, would improve achieving the NRCs mission, would result in licensing review efficiencies, and could be implemented effectively, considering both the time and resources it would likely take to implement the actions. The steps are described below.
Step 1: Determine if there is existing guidance or processes that already establishes an expectation that addresses the suggestion.
The first step identified suggestions that are already captured as an expectation or good practice within existing guidance or processes. The WG developed recommendations for 4
these suggestions taking into account the likely reason for the suggestion. Two common reasons identified by the WG are:
- The commenter was not aware of the NRC internal (i.e., non-public) processes or guidance, or
- There was an indication of the need to reinforce existing expectations and good practices.
The WG determined that some suggestions, especially those from external stakeholders, may have arisen because certain information (e.g., guidance documents) is not publicly available. For these suggestions, the WG recommends that materials be put in a form that can be shared publicly. Other suggestions indicate that, while guidance to address the suggestion exists, some NRC staff may not always implement the guidance as expected or leverage allowances within the guidance (e.g., good practices). For these suggestions, the WG recommends performing on-going knowledge management and training activities, including process and technical review seminars, job-specific training, and mentoring.
Twelve suggestions were identified in this step as already being an established expectation.
While some of these suggestions may improve the efficiency and effectiveness of the fuel cycle licensing program, many are primarily associated with improving other aspects of the PGR, such as openness, clarity, and reliability. Based on these aspects of the PGR, the twelve suggestions were categorized as high priority and screened during this step.
Step 2: Consider the potential improvement in achieving the NRCs mission and improving the efficiency of the licensing program.
In the second step, the WG qualitatively evaluated the impact of the remaining twenty-five suggestions on mission effectiveness and efficiency. The WG first considered the potential improvement in achieving the NRCs mission, vision, and associated strategic goals, objectives, and strategies, as defined by the NRC Strategic Plan (ADAMS Accession No. ML18032A561). The WG then evaluated the potential improvement in the efficiency (a specific element of the PGR) of the licensing program if the suggestion was implemented.
The WG qualitatively scored each of the suggestions as high, medium, or low in each area.
Together, these two qualitative criteria form the second step of the screening process.
Step 3: Consider the likely resources and timing for NRC implementation of each suggestion.
In the third step, the WG qualitatively evaluated the suggestions considering the anticipated time and resources required to implement the specific suggestion. The timing and resource evaluations considered each suggestion individually; that is, the WG did not consider additional efficiencies or impacts from implementing multiple suggestions simultaneously.
For timing, the WG qualitatively scored the suggestions as: high (minimal time, e.g., within 6 months), medium (some time, e.g., within 1 year), or low (significant time, e.g., greater than 1 year). For resources, the WG qualitatively scored the suggestions as: high (minimal resources, e.g., less than 0.5 FTE), medium (some resources, e.g., less than 1 FTE or contracting expenses), or low (significant resources, e.g., greater than 1FTE and/or contracting expenses).
During the performance of this step, the WG recognized that some suggestions may warrant phased implementation to fully achieve the intent of the suggestion. For example, 5
Suggestion #30 suggested developing process and technical job aids based on lessons learned to guide all aspects of a review and for all types of applications. This suggestion could be better implemented in a progressive, phased manner. Some of these types of suggestions, while potentially scoring medium or low in resources and/or timing, are parenthetically indicated in Table 2 of the Attachment to this report as phased. Other suggestions that are indicated as medium or low in this step might also be considered for implementation in a phased manner or as resources allow.
Step 4: Final Prioritization The results of the second and third steps were used by the WG to establish an overall prioritization of the twenty-five suggestions that had not been previously prioritized as high in Step 1. This process resulted in: eight suggestions prioritized as high, thirteen suggestions prioritized as medium, and four suggestions prioritized as low. The WG recommends that the suggestions prioritized as low only be pursued after accomplishing the high priority suggestions and/or as resources become available. Table 2 of the Attachment to this report presents the WGs qualitative evaluation results and the final prioritization for each suggestion.
RECOMMENDATIONS and PRIORITIES All the suggestions were subsequently grouped into three focus areas based on the primary means of implementation recommended by the WG. The matrix below identifies the specific suggestions by their primary implementation area and priority.
MATRIX OF SUGGESTIONS BY PRIMARY IMPLEMENTATION AREA & PRIORITY High Priority Medium Priority Low Priority Focus Area Suggestions Suggestions Suggestions Guidance and 14, 15, 20, 23, 24, 25a, 25b, 19, 31, 32 10, 16, 17 Tool Development 26, 30 Planning and 1, 2, 3, 4, 6a, 7b, 18, 27 5, 28, 29 6b Processing Performance and 7a, 8, 9a, 9b, 11, 12, 13a, 22 Documentation 13b, 21 A. Guidance and Tool Development A total of fifteen suggestions are primarily focused on improving or developing guidance and tools to further enhance the licensing program. Of these, three suggestions are considered high priority and all three suggestions (#s 19, 31, and 32) are already being implemented. Nine suggestions are considered medium priority and three suggestions are considered low priority.
The priority grouping of the fifteen suggestions is as follows:
High Priority Suggestions
- 19 Providing training/seminars on the licensing program that highlights recent changes and long-standing fundamentals, including job aids, on-the job-training opportunities, etc.
- 31 Developing a job aid to support considering review phase risk factors and their impacts (i.e., risk considerations associated within specific phases of a review; including schedule risk and review/decision-making risks).
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- 32 Harmonizing the NRC staff review guidance, procedures, instructions, and best practices within each of the prior divisions into the new, merged DFM.
Medium Priority Suggestions
- 14 Clarifying the focus of license renewal application reviews and performing a holistic review (e.g., table top exercise) with industry to identify additional lessons learned.
- 15 Incorporating concepts of NRR LIC-206, Integrated Risk-informed Decision-Making for Licensing Reviews, into the fuel cycle licensing program guidance, in particularly the use of integrated review teams.
- 20 Developing guidance (e.g., SRP or job aid) for reviews of GTCM license applications.
- 23 Developing a business line instruction for license renewals.
- 24 Developing a catalog/roadmap for each type of license that identifies all the related fuel cycle licensing guidance (e.g., NUREGs, Branch Technical Positions, etc.).
- 25a Enhancing guidance to facilitate inspector insights and involvement in the licensing review process.
- 25b Developing a central repository for the current version of each license application and creating guidance/templates for uniformly profiling licensing basis documents in ADAMS.
- 26 Institutionalizing post-review lessons learned activities of new or complex applications to improve guidance and inform future new and novel application reviews.
- 30 Developing lower level process and technical job aids that incorporate risk insights and provides review discipline lessons learned, considerations in establishing the focus, scope, and level of effort for various types of applications, considerations in review sampling, etc.
Low Priority Suggestions
- 10 Establishing RAI timeliness metric considerations for application reviews in which RAIs are developed in a phased manner.
- 16 Moving the relevant information on performing license amendment reviews that is in non-public guidance into a business line instruction that is made publicly available.
- 17 Developing an automated tool to track licensing actions in accordance with NEIMA.
B. Review Planning and Processing A total of twelve suggestions are primarily focused on review planning and processing (i.e.,
activities prior to a licensing action, such as pre-application meetings through the early processing phase of a licensing action through the acceptance for review phase). Of these, eight suggestions are considered high priority, including four suggestions (#s 1, 2, 3, and 6a) that are already established expectations. Three suggestions are considered medium priority.
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One suggestion is considered low priority. The priority grouping of the twelve suggestions is as follows:
High Priority Suggestions
- 1 Soliciting input from each licensee/applicant regarding milestones that should be established for each application review.
- 2 Sharing metrics and estimated level of effort with the licensee/applicant.
- 3 Updating the status of the review as it progresses, including the use of routine status calls between the NRC and licensee/applicant.
- 4 Meeting with the licensee/applicant during the acceptance review phase to better understand the unique aspects of the licensees/applicants request and identify complexities or unique aspects of the review.
- 6a Coordinating and sharing with the licensee/applicant the license application review milestones, considering the involvement of all support offices and centers of excellence (COEs).
- 7b Holding a site visit, especially for major license amendments, license renewals, and new applications, during the pre-application or acceptance review phases that includes all expected reviewers.
- 18 Ensuring internal work requests identify the appropriate NRC staff and that resource estimates are consistent with the projected scope, focus, and level of detail of each review area.
- 27 Enhancing the understanding of a proposed application by holding a meeting with the licensee/applicant, and possibly a site visit of expected core reviewers, during the pre-application phase and holding early integrated review team meetings to identify risk-informed considerations in setting the scope and focus of the review and identify any unique review considerations.
Medium Priority Suggestions
- 5 Encouraging combining multiple steps (e.g., acceptance and approval letters) of the review process for simple actions.
- 28 Revising guidance and associated metrics to allow combining review steps (e.g.,
acceptance review and formal NRC staff review) for expected short-duration and straight-forward license application reviews.
- 29 Improving, and incorporating into review guidance, the early processing, alignment, and documentation of the expected focus, scope, and level of detail of reviews and sharing this information with the licensee/applicant.
Low Priority Suggestions 8
- 6b Clarifying (and sharing milestones with licensees/applicants for) when OGC staff are involved in a licensing action review.
C. Review Performance and Documentation A total of ten suggestions were determined by the WG to be focused on review performance and documentation (i.e., from formal initiation of the technical review through the request for additional information phase through documentation of the final SER). Of these, nine suggestions are considered high priority, including seven suggestions (#s 7a, 8, 9a, 11, 12, 13a, and 13b) that are already established expectations. One suggestion is considered medium priority. No suggestions are considered low priority. The priority grouping of the fourteen suggestions is as follows:
High Priority Suggestions
- 7a Holding a site visit, especially for major license amendments, license renewals, and new applications, at the draft RAI phase involving the pertinent reviewers.
- 8 Ensuring RAIs have a clear regulatory basis and leveraging existing job aids and templates to meet this expectation.
- 9a Discussing RAIs with the licensee/applicant in draft form to confirm understanding of the request and anticipated level of effort needed to develop the response.
- 9b Holding discussions with the licensee/applicant when a draft response to a RAI is developed to ensure the response appropriately addresses the NRC staff request.
- 11 Ensuring clarification calls with the licensee/applicant to support clarity and understanding of RAIs is not disincentivized by meeting notice metrics.
- 12 Using the tools (e.g., job aids and templates) available to the NRC staff to minimize the potential for multiple rounds of RAIs.
- 13a Ensuring the continuity of the quality, effectiveness, and efficiency of the licensing review process during NRC staff turnover.
- 13b Ensuring the continuity of the quality, effectiveness and efficiency of the licensing review process during NRC management turnover.
- 21 Providing guidance to ensure the Safety Evaluation Report (SER) documents the scope and focus of NRC staff reviews of licensing actions.
Medium Priority Suggestions
- 22 Using an electronic interface with licensees/applicants, including in support of review planning and implementation, such as for the RAI phase.
Low Priority Suggestions NONE 9
D. Additional Implementation Considerations The WG identified many suggestions that are interrelated or significantly overlap in scope. As a result, implementation of many suggestions should be integrated. For example, Suggestion #1 is related to soliciting input from the licensee/applicant in establishing review milestones for a licensing action. This suggestion significantly overlaps with Suggestion #6, which is related to establishing and sharing milestones with the licensee/applicant. Any action taken in this area should consider both suggestions together. Another example of interrelated suggestions involves twelve different suggestions (Suggestion #s 7, 8, 9a, 9b, 10, 11, 12, 13, 16, 22, 31, and
- 32) that have aspects that the WG identified as involving the RAI process. Implementation planning for improving the RAI process should consider all these suggestions in developing the path forward.
Finally, there are a few considerations and tasks identified in the Charter that the WG determined would be more appropriate to address during any implementation activities derived from this report. These additional considerations are discussed below, along with the recommended actions for the implementation phase.
Section II, Development of Implementation Metrics The Charter directed the WG to develop metrics that would measure the effectives and efficiency of the implementation of the recommendations. At the time of this report the WG has not identified specific implementation metrics for each suggestion. Given the significant number of suggestions, the WG concluded that, where appropriate, implementation metrics should be established as part of an implementation plan. The metrics should consider: the scope of the suggestion(s), the expected level of long-term improvement in efficiency and effectiveness (or other PGR), the implementation approach (e.g., in a progressive phased manner, addressing related suggestions together, etc.), and the time and resources necessary for implementation.
The NEI letter dated April 12, 2019, also addressed the need for implementation metrics as part of determining the success of the WG initiative and stated that this area warranted future dialogue as the initiative moved forward (i.e., General Comment 3). The WG concluded that engaging stakeholders, like NEI, after NRC management has approved the specific suggestions to implement will foster a more effective discussion of metrics.
Section III, Task E, Perform Table Top Exercises The Charter directed the WG to perform, as appropriate, table top exercises of recent license amendments and license renewals to identify best practices, lessons learned, and insights into additional areas for improvements. The Charter also directed the WG to consider table top exercises for some potential improvements to determine their likely impact on program efficiency and effectiveness. In order to gather, evaluate, and address the numerous suggestions, the WG concluded that conducting table top exercises did not align with the scope and intent of this effort. However, the WG recognizes that future table top exercises may be beneficial for evaluating significant proposed changes to guidance. As an example, the industry-provided Suggestion #14 essentially proposes conducting a table top exercise of recent license renewal applications to gain lessons learned, which could lead to improvements in NRC staff guidance and licensee submittals. The WG prioritized this suggestion as a medium priority. Since the next fuel facility license renewal application is not expected for several years, there is an opportunity to pursue such an endeavor, assuming continued interest and available resources.
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Section III, Task G, Improvement or Development of New Performance Metrics The Charter also directed the WG to develop recommendations for improving existing performance metrics and/or develop new performance metrics. The WG concluded that this task is embedded in a number of on-going NRC initiatives (e.g., NEIMA tracking and reporting related to Suggestion #s 10 and 17) and/or is expected to be part of the implementation of other specific suggestions. For example, the combining of steps of the licensing review process for straight-forward, short-duration reviews, as envisioned by Suggestion #s 5 and 28 would, by necessity, require milestones and performance metrics specific to the application. As a result, the WG did not provide any additional recommendations regarding performance metrics beyond what is captured within the proposed implementation actions of the associated suggestions.
CONCLUSIONS Through this initiative, the WG achieved the objective of the Charter by identifying, evaluating, and prioritizing thirty-seven suggestions for improving the fuel cycle licensing program. A wide range of suggestions were received from both internal and external stakeholders via numerous interactions and correspondence. Many of these suggestions directly address the efficiency and effectiveness of the program, while other suggestions address the other PGR, such as openness, reliability, and clarity. Overall, the WG determined that the suggestions and recommended actions are largely consistent with NRC's PGR and their implementation will continue to ensure that the fuel cycle licensing program will accomplish its mission and strategic goals. As provided in Table 1 of the Attachment, the WG recommended specific actions for thirty-six of the thirty-seven suggestions. A total of sixty-seven recommended actions were identified by the WG. This completes the activities of the WG tasked under the Charter.
REFERENCES Office of the Federal Register, Title 10 of the Code of Federal Regulations (10 CFR) Part 40, Domestic Licensing of Source Material.
Office of the Federal Register, Title 10 of the Code of Federal Regulations (10 CFR) Part 70, Domestic Licensing of Special Nuclear Material.
NEI, Industry Comments on U.S. Nuclear Regulatory Commission Draft Working Group Charters on Building Smarter Licensing and Inspection Programs for Fuel Cycle Facilities Discussed During April 2, 2019 NRC Public Meeting, April 12, 2019. (ADAMS Accession No. ML19114A288)
NEI, Industry Comments on Near Final Fuel Cycle Smarter Program Working Group Reports Post March 5, 2020 NRC Public Meeting, March 17, 2020. (ADAMS Accession No. ML20097E050)
NMSS, Key Principles for Nuclear Material Safety and Safeguards Reviews, January 15, 2019.
(ADAMS Accession No. ML19015A290)
NMSS, Process Improvement Project: Fuel Cycle Licensing Action Process Final Report, November 9, 2010. (not publicly available) 11
NMSS/DFM, Licensing Process Expectations, January 24, 2020. (ADAMS Accession No. ML20010D837)
NMSS/FCSE, Licensing Review Handbook, Revision 7, November 2018. (not publicly available)
NMSS/FCSE, Westinghouse Lessons Learned Report, January 30, 2017. (ADAMS Accession No. ML16330A642)
NMSS/FCSE, Westinghouse Additional Insights Report, March 31, 2017. (not publicly available)
NMSS/FCSE, Working Group Charter for Building A Smarter Fuel Cycle Licensing Program, April 26, 2019. (ADAMS Accession No. ML19115A016)
NMSS/FCSE, Memorandum from Michael F. King to Jacob I. Zimmerman, Approval of the Working Group Charter for Building A Smarter Fuel Cycle Licensing Program, April 26, 2019.
(ADAMS Accession No. ML19115A017)
NMSS/SFM Division Instruction, SFM-2, Revision 2, Safety Evaluation Reports, September 17, 2015. (not publicly available)
NMSS/SFST Office Instruction, SFST-3, Revision 4, Requests for Additional information, August 19, 2010. (not publicly available)
NMSS/SFST Office Instruction, SFST-4, Revision 4, SFST Licensing Process, April 14, 2009.
(not publicly available)
NRC, Achieving Modern Risk-Informed Regulation, SECY-18-0060, May 23, 2018. (ADAMS Package Accession No. ML18110A186)
NRC, Strategic Plan - Fiscal Years 2018-2022, NUREG-1614, Volume 7. (ADAMS Accession No. ML18032A561)
NRC, Principles of Good Regulations. (ADAMS Accession No. ML14135A076)
NRC, Standard Review Plan for License Applications for Fuel Cycle Facilities - Final Report, NUREG-1520, Revision 2, June 2015. (ADAMS Package Accession No. ML15176A258)
NRR Office Instruction, LIC-101, Revision 5, License Amendment Review Procedures, January 16, 2017. (ADAMS Accession No. ML16061A451)
NRR Office Instruction, LIC-107, Revision 2, Procedures for Handling License Transfers, June 5, 2017. (ADAMS Accession No. ML17031A006)
NRR Office Instruction, LIC-109, Revision 2, Acceptance Review Procedures, January 16, 2017. (ADAMS Accession No. ML16144A521)
NRR Office Instruction, LIC-115, Revision 0, Processing Requests for Additional Information, November 6, 2019. (ADAMS Accession No. ML19242B237) 12
NRR Office Instruction, LIC-206, Revision 0, Integrated Risk-Informed Decision-Making for Licensing Reviews, June 10, 2019. (ADAMS Accession No. ML19031C861)
URENCO USA, UUSA Comments on the NRC Proposed Charters, April 24, 2019. (ADAMS Accession No. ML19115A349)
PUBLIC MEETINGS April 2, 2019, Public Meeting with Industry on Cumulative Effects of Regulation - Summary of Meeting. (ADAMS Accession No. ML19106A349)
May 21, 2019, Public Meeting on Building a Smarter Fuel Licensing and Oversight Program -
Summary of Meeting. (ADAMS Accession No. ML19163A267)
August 8, 2019, Public Meeting on Building a Smarter Fuel Cycle Inspection and Licensing Program - Summary of Meeting. (ADAMS Accession No. ML19227A158)
September 25, 2019, Public Meeting with Industry on Cumulative Effects of Regulation and Fuel Cycle Regulatory Activities - Summary of Meeting. (ADAMS Accession No. ML19274D398)
November 15, 2019, Public Meeting on Building a Smarter Fuel Licensing and Oversight Program - Summary of Meeting. (ADAMS Accession No. ML19338C823)
March 5, 2020, Public Meeting on Building a Smarter Fuel Licensing and Oversight Program -.
Agenda and Presentation Materials. (ADAMS Accession No. ML20057F413 and ML20065H300) 13
ATTACHMENT REPORT TABLES 14
ATTACHMENT Table 1 - SUGGESTION EVALUATION AND PRIORITY Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 1 NEI (April 12, 2019 Openness The fuel cycle Licensing Review PMs should continue the practice of HIGH Letter; Specific Reliability Handbook (LRH) already sets the soliciting input from licensees/applicants Comment I.4 and I.5), expectation that the project manager regarding the milestones for specific NRC staff input, and (PM) will work with the licensee/applicant applications and sharing the established public meeting in establishing milestones for an milestones with the licensee/applicant, discussions application. The LRH also identifies consistent with Suggestion #6a.
The current process for effective communication of the PM with RECOMMENDED ACTIONS:
the NRCs timeliness licensee/applicant staff and management 1- Include topic in on-going knowledge metrics for licensing as a vital activity. management training.
actions should be This suggestion is closely tied to 2- As appropriate, convert licensing action analyzed for efficiency Suggestion #6a. process guidance into publicly available and effectiveness. instructions.
Specifically, solicit input from each licensee/applicant regarding milestones that should be established for each application.
Milestones may vary based on the complexity of the licensing action and estimated timeline.
2 Industry public meeting Openness The LRH already notes that the PM PMs should continue sharing standard HIGH discussions and NRC Clarity should communicate the estimated hours metrics and review hour estimates with staff input for the review at the completion of the licensees/applicants.
Consider sharing standard acceptance review and, consistent with RECOMMENDED ACTIONS:
metrics from Web Based Suggestion #1, the PM should interact 1- Include topic in on-going knowledge Licensing (WBL) along with the licensee/applicant on management training.
with the hours estimated establishing review milestones. Including 2- As appropriate, convert licensing action in the acceptance letter. the information in the acceptance review process guidance into publicly available letter as currently implemented by fuel instructions.
cycle PMs should continue.
A-1
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 3 Industry public meeting Openness The LRH already establishes the The review guidance (e.g., the LRH or HIGH discussions and NRC expectation for effective communication other means) should be enhanced to staff input of the PM with licensee/applicant staff establish the good practice and Consider updating the and management and identifies it as a expectations associated with establishing status of the review as it vital activity. While periodic status calls regular status calls with progresses (i.e., between the PM and licensee/applicant licensees/applicants. Associated training encourage routine status are an established good practice, for PMs should also emphasize the need calls between NRC and especially for large or more complex to have agreed upon periodic status licensee/applicant). applications, the LRH does not explicitly interactions (via teleconference, e-mail, or Licensees/applicants are address this type of interaction or other communication means) with the planning capital projects, recommend establishing the periodicity licensee/applicant, considering the level of so the status of the of these interactions with the activity at the licensee/applicant. For large reviews will allow them to licensee/applicant. applications, this may involve routine keep their management status interactions focused solely on the informed. application.
RECOMMENDED ACTIONS:
1- Clarify the guidance that the PMs should hold periodic general status interactions with their licensee(s)/applicant(s) and to also hold periodic specific status interactions for large licensing actions.
2- Include topic in on-going knowledge management training.
3- As appropriate, convert licensing action process guidance into publicly available instructions.
A-2
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 4 Industry public meeting Efficiency The LRH states that pre-application The review guidance should be improved HIGH discussions and NRC Clarity public meetings should be encouraged to make it clear that when new, large, staff input for new licensing actions, particularly for unique, or complex license applications Consider a meeting with new licenses or new processes for are being considered by the the applicant during the existing licenses. However, the guidance licensee/applicant that the PM discuss acceptance review to is not oriented on understanding the with the licensee/applicant about holding a better understand the unique aspects or complexities of the meeting to better understand the licensing unique aspects of the licensees/applicants request. There is action during the pre-application phase licensees/applicants also no similar discussion for the and/or the acceptance review phase.
request and provide for acceptance review phase. When considering whether to hold this early identification of This suggestion is similar to Suggestion type meeting the PM should consider the complexities or unique #27 and relates to improving early staff level of complexity of the licensing action.
aspects of the review. alignment associated with Suggestion RECOMMENDED ACTIONS:
- 29. 1- Enhance the review guidance for PMs to expand the intent and focus of pre-application meetings, leverage job aids supporting early interactions for improving review planning (see Suggestion #s 27 and 29) and provide the option to hold such meetings during the acceptance review phase.
2- Include topic in on-going knowledge management training.
3- As appropriate, convert licensing action process guidance into publicly available instructions.
A-3
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 5 NEI (April 12, 2019 Efficiency This approach was recently implemented The review guidance should be revised to MEDIUM Letter; General for a review and should continue to be encourage PMs to seek opportunities to Comment 2b) and NRC used when appropriate, though it is not improve review efficiencies by allowing staff input identified within the LRH as an option. flexibility within the review metrics (e.g., to Combine the NRC This suggestion is similar to Suggestion exempt earlier due dates for combined acceptance and approval #28. steps) if overall efficiency is achieved (i.e.,
letters in one letter to the The current review metrics may dis- becomes outcome-oriented). The process licensee/applicant in the incentivize this approach if it results in and planning tools should be modified to case of simple license missing an established metric (e.g., support this flexibility.
amendment requests. acceptance review within 60 days). If RECOMMENDED ACTIONS:
implemented, the licensing planning and 1- In concert with Suggestion #28, revise tracking tool (i.e., WBL) would also need the review guidance related to work to be modified, which would involve planning and metrics to encourage review contractor expenses. efficiency approaches, such as combining review process steps for simple reviews that result in overall improvement in the review schedule.
2- Enhance the WBL tool to allow process steps to be combined (e.g., acceptance review and final SER) or skipped and the ability to adjust the metrics in these situations as long as the overall review is completed on an accelerated schedule.
6 NEI (April 12, 2019 Openness a) This suggestion is consistent with a) RECOMMENDED ACTION: a) HIGH Letter; Specific Suggestion #1, but is specific to the 1- Implement Suggestion #1, ensuring its Comment I.5), NRC staff inclusion of support offices and COEs. implementation addresses the entirety of input, and public The established practice is to share the review, including all offices and COEs meeting discussions overall review milestones, but not to involved in the review.
a) Establish and share identify specific office or COE licensing milestones for milestones.
most submittals to include all offices and centers of excellence (COEs) involved.
A-4
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation b) Clarify (and share b) A representative from OGC discussed b) While Suggestion #s 1 and 6a are b) LOW -
milestones for) when this aspect of the suggestion during the recommended to be implemented related NO NRCs Office of General public meeting on August 8, 2019. to establishing and sharing milestones ACTION Counsel (OGC) is Key review milestones typically do not go with the licensee/applicant for the whole involved with the review of to the level of detail of providing specific review, there is no expectation to share a licensing action. office/COE review timeframes, but rather unique milestones for inputs or reviews by addresses the overall performance of the specific staff, branch, division, COE, or review by the NRC. office.
The LRH provides guidance to the PM NO ACTION on the typical aspects that do not require (e.g., purely administrative) or do require OGC review (e.g., new licenses and license renewals).
7 Industry public meeting Efficiency Site visits are valuable for staff unfamiliar PMs should continue the good practice of HIGH discussions and NRC with the facility or processes and for all coordinating a site visit at the appropriate staff input staff to gain a fuller understanding of an time of review and should include Site visits are valuable, application, especially for new, large supporting offices (e.g., NSIR and OGC),
and the timing of the visits (e.g., major license amendments, license as appropriate.
should optimize the NRCs renewals, and new applications) and The ability to leverage virtual audits/visits review unique/complex applications. using available technology, should also be a) with respect to requests a) The LRH already recommends recognized as an option.
for additional information scheduling a site visit shortly after draft Also, consider the timing of the site visit:
(RAIs). RAIs are developed and the RAIs are a) RECOMMENDED ACTIONS:
provided to the licensee/applicant in 1- Include topic in on-going knowledge preparation for the visit. management training.
2- Further enhance the review guidance to ensure support office staff associated with a review are considered for a site visit and that opportunities to leverage available technology to perform a virtual audit/visit is utilized when appropriate.
3- As appropriate, convert licensing action process guidance into publicly available instructions.
A-5
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation b) prior to and/or after b) The LRH does not address holding b) RECOMMENDED ACTION: HIGH submittal (e.g., pre- site visits at earlier phases and states it 1- Provide additional review guidance, and application through early is generally scheduled after draft RAIs associated training, to encourage holding review phase). have been developed. a meeting at the site as part of a pre-application meeting or early in the review, especially for new, large, or unique/complex actions to gain insights and understanding of the scope of the application and of any unique or complex aspects.
8 NEI (April 12, 2019 Clarity The LRH already establishes the RECOMMENDED ACTIONS: HIGH Letter; Specific Efficiency expectation that RAIs have a clear 1- Develop a job aid and/or template (or Comment I.4), NRC staff regulatory basis, the guidance could be refine the Spent Fuel job aid and input, and public further enhanced by including templates template) for RAIs to further ensure meeting discussions and job aids. consistency in providing the regulatory The current process for The importance of providing regulatory bases for RAIs provided and incorporate it the RAI process should be bases for RAIs has been communicated into the review guidance.
analyzed for efficiency to the staff. 2- Provide knowledge management and and effectiveness. A job aid developed for the spent fuel refresher training on when RAIs are Specifically, the reviews could be leveraged to address needed or not needed and on the expectation should be this suggestion, especially in establishing expectation that RAIs provide a clear established that an RAI a template for RAIs. regulatory basis.
have a clear regulatory 3- As appropriate, convert licensing action basis. Consider if a process guidance into publicly available uniform template is instructions.
needed.
A-6
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 9 NEI (April 12, 2019 Efficiency The LRH already establishes a good PMs should continue the practice of HIGH Letter; Specific practice to provide draft RAIs to the arranging discussions of draft RAIs with Comment I.4), NRC staff licensee/applicant to ensure the licensee/applicant and for larger input, and public understanding. This expectation was applications should consider scheduling a meeting discussions reinforced by the January 2020 DFM site visit (consistent with Suggestion #7a).
The current process for licensing expectations memorandum. a) RECOMMENDED ACTIONS:
the RAI process should be These calls are expected to minimize the 1- Enhance the review guidance to be analyzed for efficiency likelihood of multiple rounds of RAIs and more specific about the focus of the draft and effectiveness. improve the efficiency of the licensing RAI clarifying calls to include discussions a) Specifically, the process. on the scope, significance, and level of expectation that an RAI be This suggestion is also related to effort expected of the licensee/applicant in provided to the licensee Suggestion #7a in that the LRH suggests responding to the request.
first in draft form. Consider holding a site visit after providing draft 2- Provide knowledge management and if RAIs should be RAIs for larger applications to ensure full refresher training on the use and purpose discussed with the understanding. of clarifying calls with the licensee/applicant in draft a) While, the LRH allows RAI clarifying licensee/applicant on draft RAIs.
form to confirm calls, the purpose is narrowly set as 3- As appropriate, convert licensing action understanding of the ensuring understanding of the request process guidance into publicly available request, its significance to and ensure a comprehensive response. instructions.
the application, and the The guidance could be more specific by expected level of stating that these calls serve to also effort/detail needed to clarify at a high level: the scope, address the issue. significance, and level of effort expected by the staff request.
b) In addition, also b) While the LRH has a sentence that b) RECOMMENDED ACTION: HIGH consider holding a states a call should be scheduled with 1- Provide more complete guidance and discussion when the the licensee/applicant to discuss the associated training for the PMs to arrange licensee/applicant has proposed RAI responses, no other discussions with the licensee/applicant, developed a draft guidance is provided. It is not clear that especially for large applications or response to ensure the this good practice is implemented complex RAIs, when the response is appropriately consistently, on a regular basis, or when licensee/applicant has developed draft addressing the staff a draft response has been developed. RAIs to ensure the response fully request. addresses the staff request.
A-7
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 10 NRC staff input Clarity While the LRH states that the typical RECOMMENDED ACTIONS: LOW Consider when the clock licensee/applicant is given 30 to 60 days 1- Enhance the licensing planning and should start on NRCs from the date of the RAI letter, tracking tool (i.e., WBL) for the RAI portion metrics surrounding RAIs. considering the complexity of the of the review, in particular for the potential application and review, there is no stated for RAIs developed in a staggered or metric for the staff in developing the phased manner.
RAIs. Further, such a metric would be 2- Ensure metrics established for different for different types of timeliness of RAIs are consistent with, or applications. considered when, NEIMA metrics are The Nuclear Energy Innovation and established (see Suggestion #17).
Modernization Act (NEIMA) actions will likely influence how this item is addressed (see Suggestion #17).
When implemented, the licensing planning and tracking tool (i.e., WBL) would likely need to be modified, which would involve contractor expenses.
11 NRC staff input Clarity The LRH already establishes the good RECOMMENDED ACTIONS: HIGH Consider if the Efficiency practice of holding RAI clarification calls 1- Include topic in on-going knowledge requirement to notice a (see Suggestion #9) without it needing to management training.
public meeting 10-days in be a public meeting as long as the calls 2- As appropriate, convert licensing action advance limits the benefit stay within the bounds of clarifying the process guidance into publicly available of discussing draft RAIs. meaning and intent of the RAIs. This can instructions.
be very beneficial at the draft RAI stage to ensure the final RAIs are clearly communicated and understood by the licensee/applicant.
A-8
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 12 NEI (April 12, 2019 Efficiency The LRH already establishes the good RECOMMENDED ACTIONS: HIGH Letter; General practice of developing the draft SER at 1- Implement Suggestion #s 7 and 9.
Comment 2a and the same time as the development of the 2- Incorporate into guidance the Specific Comment I.4), RAIs, which are associated with gaps in expectation that division management be NRC staff input, and the draft SER. The LRH further states engaged for subsequent rounds of RAIs.
public meeting that the review team should seek a 3- Include topic in on-going knowledge discussions single round of RAIs and subsequent management training.
RAIs should only be rounds or follow-on RAIs should be 4- As appropriate, convert licensing action issued once the draft SER avoided as much as possible. However, process guidance into publicly available is written with each RAI it is recognized that at times multiple instructions.
addressing a gap in the rounds of RAIs may occur due to draft SER. This should application complexities or other issues.
help minimize additional As such, while there is an expectation to RAI rounds and would pursue high-quality reviews and RAIs represent a significant, that would limit follow-on or new RAIs, it well-understood milestone is not appropriate to establish an a priori in the review. Consider limit to the rounds of RAIs for a review.
limiting the number of Addressing Suggestion #s 7 and 9 would rounds of RAIs for certain also support achieving this goal of types of licensing actions. minimizing additional rounds of RAIs.
A-9
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 13 NEI (April 12, 2019 Reliability a) The LRH already establishes the a) The importance of continuity of reviews a) HIGH Letter; Specific Efficiency expectation for effective PM and has been communicated to the staff.
Comment I.6) technical reviewer turnover, including the Effective PM and technical reviewer Licensing Process development of a transition plan and turnover should continue to be an area of Continuity: Based on turnover package. In addition, the LRH emphasis, including the use of transition industrys experience, states the draft SER inputs should be plans.
some processes and developed early in the review process RECOMMENDED ACTIONS:
assurances need to be put (i.e., by the timing of the draft RAIs), 1- Implement Suggestion #s 7, 9, and 12 in place to ensure which ensures more efficient related to developing draft SER inputs at continuity of quality and development of RAIs (supporting the RAI stage.
efficiency of the licensing Suggestion #s 7, 9, and 12) and also 2- Include topic in on-going knowledge process during a licensing mitigates some impacts of staff turnover. management training, specifically the use action. This is particularly Further, in skill areas where there is of transition plans and turnover packages.
problematic with limited capability (e.g., no backup), 3- Identify and increase the capability for protracted and more proactive actions need to be taken to critical skill areas where there is limited complex licensing actions, develop staff through mentoring, capability through technical mentoring, e.g., renewals where teaming, cross-training, double- teaming, cross-training, double-additional documentation encumbering positions, etc. encumbering positions, etc.
of status, next steps and other information to ensure a smooth transition from one staff or manager to another is needed.
Need to address:
a) staff turnover.
A-10
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation b) management turnover. b) While it is an implicit expectation and b) Steps should be taken to minimize the b) HIGH a good practice to have effective impacts of management turnover for management (i.e., branch chiefs and currently active licensing action reviews.
above) turnover, there is no direct RECOMMENDED ACTIONS:
guidance describing the elements of 1- Develop a more formalized expectation effective management turnover, and process related to the conduct of especially in the context of the continuity management turnover (e.g., establishing a of licensing action reviews. management transition plan) that includes Maintaining briefing books on the various the status, actions, and discussions licensees/applicants, types of facilities, related to significant licensing issues and and associated regulations, as well as actions.
up-to-date files describing the significant 2- Develop a more formalized expectation licensing actions, could mitigate some that ensures continual up-to-date impacts of management turnover. information is available for new managers, including: briefing books on the various licensees/applicants, their facilities and processes, licensing actions, issues, and the fuel cycle regulatory and licensing aspects. Consider the best means of maintaining this information up to date, such as being an established expectation of specific licensee/applicant PMs.
A-11
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 14 Industry public meeting Clarity Depending on the type of staff review RECOMMENDED ACTIONS: MEDIUM discussions Reliability (e.g., programmatic, sampling, etc.), 1- Develop guidance (in concert with The current approved some reviews may be able to focus Suggestion #23) or a job aid (e.g., check license provides a basis solely on the areas of change. However, list, questions etc.) specific to license for acceptance review and other aspects, such as sampling type renewals that describes what technical limited NRC review for reviews, may involve additional sampling reviewers should consider in determining license renewals. This to confirm the accepted methods are the proper scope, focus, and level of detail renewal application being implemented appropriately. Even for their review (see Suggestion #29).
identifies program these aspects should focus primarily on 2- The above effort (and implementation changes since last areas of change. of Suggestion #23) should also include renewal. As such, license Implementation of Suggestion #23, internal lessons learned activities renewals should focus which is related to developing guidance associated with recent license renewal only on safety significant specific to license renewal, should reviews and a broader holistic review, areas of change. This may directly address this suggestion and such as a table top exercise, that includes result in needing no should use a holistic review with industry PMs, technical staff, and licensees.
review for specific areas in to enhance the guidance development.
which there are no changes to that program and no new/revised requirements. Also, consider a holistic review with industry input (e.g.,
table top exercise) on recent renewals to identify lessons learned.
A-12
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 15 NEI (April 12, 2019 Efficiency A key concept that is directly RECOMMENDED ACTIONS: MEDIUM Letter; Specific implementable for larger team reviews is 1- Incorporate into review guidance the Comment I.1), NRC staff the use of integrated teams throughout use of integrated, multi-disciplined, review input, and public the review. teams, especially for larger scope meeting discussions To be successful (i.e., efficient and applications, leveraging existing guidance The review level is effective) the guidance for an integrated (e.g., LIC -206) and concepts such as adjusted based on review effort needs to ensure review tiger-team reviews, as appropriate, that available relative margin teams hold regular team meetings work together either throughout the entire and the level of detail in throughout the review (including pre- review or through specific phases of a the licensee/applicant application, acceptance, draft SER, RAI, review (e.g., review scoping).
submittal [and the staff and final SER phases, as appropriate) to 2- Develop job aids that inform the overall level of review] should ensure understanding of the application and individual review scope, focus, and depend on that items and consideration of relative risk insights level of detail. This job aid should consider level of safety and risk in planning the review from an holistic a number of factors, including: type of significance. Consider perspective, the scope and focus of application, scope of regulations, incorporating concepts individual review areas, identifying changes, prior application reviews, margin from the recently issued unique considerations, and in conducting of safety, significance, uniqueness, NRR LIC-206, Integrated the reviews. The NRR integrated team complexity, precedence, etc.
Risk-Informed Decision- review guidance, LIC-206, is available at:
Making for Licensing https://www.nrc.gov/docs/ML1903/ML19 Reviews, into the fuel 031C861.pdf.
cycle licensing program.
A-13
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 16 Industry public meeting Openness It is preferred to develop stand-alone The main focus of this suggestion is in LOW discussions and NRC guidance for the various aspects of the taking the review guidance (i.e., the LRH) staff input review that can be made publicly that is not currently publicly available and Consider developing an available without redaction (as would be converting the appropriate portions of that instruction for the Fuel needed for the LRH). The staff has guidance into a format (instructions or Facility Business Line on already begun the development of an guidance) that can be made publicly license amendments like instruction for the RAI process, which available.
NRRs LIC-101, License needs to be coordinated and integrated RECOMMENDED ACTIONS:
Amendment Review with spent fuel instruction improvement 1- Convert portions of existing review Procedures. This would efforts (see Suggestion #32) guidance (e.g., instructions specific to the take the relevant development and resolution of RAIs) that information out of the is not currently publicly available into internal desk guide (fuel appropriate process-specific instructions cycle LRH) and place it or guidance that can be made publicly into a publicly available available.
document that is 2- Incorporate additional improvements to applicable to all staff the converted guidance based on the performing work under the implementation of related other Fuel Facility Business suggestions of this working group report.
Line.
17 NRC staff input Reliability There is already a working group RECOMMENDED ACTION: LOW Develop an automated associated with the DFM merger that is 1- Ensure that the revised WBL planning tool to track licensing considering improvements to the WBL and tracking tool is able to address the actions in accordance with planning and tracking tool(s). NEIMA requirements.
the new metrics The licensing tracking tool needs to be associated with the modified to enable this capability, which Nuclear Energy Innovation will involve contractor expenses.
and Modernization Act (NEIMA).
A-14
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 18 NRC staff input and Reliability Portions of this suggestion were recently RECOMMENDED ACTION: HIGH public meeting implemented by fuel cycle PMs and 1- Continue efforts associated with risk-discussions should continue. Aspects of ensuring informing the licensing action reviews Ensure internal work resources are consistent with through development of the assignment requests identify the established scope, focus, and level of and alignment job aid/instruction and appropriate technical staff detail of review should be further incorporate this guidance into the review and that resource enhanced using risk-informed guidance.
estimates are consistent considerations. In particular, work on the with the projected scope, item in the NMSS transformation action focus, and level of detail plan related to questions to consider of each review area. during assignment and alignment on an activity should address this suggestion.
This suggestion ties to better planning of reviews and ties to numerous other suggestions (e.g., Suggestion #s 2, 4, 15, 21, 27, 30, and 31).
19 NRC staff input Reliability This suggestion is already being There are already seminars being HIGH Training on the licensing Clarity performed and is expected to continue conducted.
program, that highlights Efficiency and expand in scope. Future seminars RECOMMENDED ACTION:
recent changes and should consider including: How do 1- This continual learning and reinforcing longstanding specific technical reviewers perform their of good practices should continue to be a fundamentals, should be reviews? What are the review basics? high priority and used to maintain and provided for fuel cycle What job aids and guidance exists? expand capability and awareness of the PMs and technical staff.
reviewers 20 NRC staff input Reliability The current approach to these reviews is Guidance specific to critical mass MEDIUM A standard review plan is Clarity to follow aspects of NUREG-1520, but licensing would clarify and improve the needed for reviews of Efficiency there is no specific guidance on which consistency and efficiency of these greater than critical mass aspects to follow. This is not an efficient reviews.
licensees/applicants. approach, especially as new reviewers RECOMMENDED ACTION:
join the organization. An old draft guide 1- Develop appropriate review guidance, exists, however it was not finalized. This specific to the review of critical mass could be a starting point for any new license applications. The guidance could guidance or job aid. take the form of a SRP, instruction, review This suggestion was also a roadmap to NUREG-1520 (SRP), job aid, recommendation of the lean six sigma etc.
activity performed in 2010.
A-15
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 21 NRC staff input Clarity Current guidance does not explicitly RECOMMENDED ACTION: HIGH Document the scope and require documenting this level of 1- Augment review guidance and provide focus of licensing reviews specificity of the staff reviews. This associated training to ensure the specific in the Safety Evaluation documentation could be especially scope, focus, level of depth and approach Report (SER). valuable in ISA reviews and other areas (e.g., sampling) used for the review are involving sampling approaches (see documented in the SER.
Suggestion #14) and inform future reviewers of areas previously reviewed (or by implication not reviewed).
22 NRC staff input Efficiency NRR is considering implementation of This may be a longer-term item that builds MEDIUM Consider an electronic this practice. Lessons learned from these off lessons learned from NRR and past interface with activities should be incorporated into any NRO.
licensees/applicants for action considered by DFM. The main RECOMMENDED ACTIONS:
RAIs, dashboards, etc. benefit may be achieved for larger or 1- Establish a working group to evaluate more complicated reviews or new types the need and benefit of using a RAI and/or of applications. dashboard electronic interface for large-scope licensing action reviews.
2- Incorporate in review guidance or instructions the allowance for the use of this technology, as appropriate.
23 NRC staff input Reliability Implementation of this suggestion would RECOMMENDED ACTIONS: MEDIUM Develop a business line Clarity directly address Suggestion #14 1- Similar to Suggestion #20, and in instruction on license Efficiency concert with Suggestion #14, develop the renewals. appropriate type of guidance for license renewal applications, such as: SRP, instruction, review roadmap to NUREG-1520 (SRP), instruction, job aid, etc.
2- The above effort (and implementation of Suggestion #23) should also include internal lessons learned activities associated with recent license renewal reviews and a broader holistic review, such as a table top exercise, that includes PMs, technical staff, and licensees/applicants.
A-16
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 24 NRC staff input Reliability Many of the cited reference examples RECOMMENDED ACTION: MEDIUM Consider the development Clarity are available to the staff, though often 1- In concert with Suggestion #25b, of a licensing manual to Efficiency scattered across multiple locations and develop a roadmap for each type of create a catalog of fuel platforms (e.g., SharePoint, ADAMS, license that identifies the appropriate cycle licensing guidance internal website) and not consistently regulations, guidance, procedures, job (e.g., NUREGs, Policy & profiled in ADAMS. aids, etc. Consider creating a unique Procedures, Branch This suggestion also relates to catalogue of references (or cross-technical Positions, Suggestion #25b. reference lists) for each licensee/applicant generic communications, or license type that is maintained by the qualifications). appropriate PM and made easily available to the staff (e.g., SharePoint).
25 NRC staff input Reliability a) The LRH states that the PM should a) The review guidance should be a) a) Consider ways to better Clarity participate in frequent communications enhanced to establish the good practice MEDIUM facilitate inspector Efficiency with regional counterparts regarding and expectations associated with gaining involvement with the Independence licensing activities at their facilities and the insights of inspectors in performing licensing process. How provides an opportunity for inspector licensing action reviews.
does an inspector raise a insights being shared at the draft SER RECOMMENDED ACTION:
concern about a section of stage. It is not clear that PMs routinely 1- Incorporate into guidance that the PMs the license application? seek inspector insights into licensing should facilitate inspector involvement in actions. Further, there is not much the licensing process to gain their insights guidance related to inspector direct at various stages of a licensing action, involvement in the licensing review especially for large applications. This process. participation should not only be at the end A similar recommendation was provided of the review to ensure conditions etc. are during the Westinghouse Lessons understood and inspectable, but should Learned activity. also be early in the review to gain inspector observations that might aid in understanding and focusing aspects of the review. This interaction could be valuable for scoping and planning purposes at the pre-application and acceptance review stages.
A-17
ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation b) Can a central b) Developing a central depository and b) RECOMMENDED ACTIONS: b) depository be developed common profiling of licensing basis 1- Consistent with Suggestion #24, MEDIUM for the current version of documents is similar to Suggestion #24. Consider creating a unique catalogue of each license application? references (or cross-reference lists),
Are licensing basis including licensing basis documents, for documents uniformly each licensee/applicant that is maintained profiled in ADAMS by the appropriate PM and made easily consistently? Can lessons available to the staff (e.g., SharePoint).
be learned from NRR in 2- Ensure licensing basis documents are how they maintain the consistently profiled in ADAMS (e.g., use licensing basis of a template for the various types of documents? licensing basis documents).
26 NRC staff input Reliability This is a broad suggestion to leverage Lessons learned from previous large- MEDIUM Can any efficiencies be Clarity on-going efforts of continual learning, scope applications that are new or novel gained that focus on the Efficiency review lessons learned, and self- should be performed to support review review of an application assessments to proactively prepare for improvements for future new types of to: fabricate pebble bed new technologies and applications. applications.
reactor fuel; or produce RECOMMENDED ACTIONS:
medical isotopes? What 1- Ensure current guidance is sufficient for about for amendments of expected near-term new applications, current such as pebble bed fuel fabrication and licensees/applicants to medical isotope production.
produce accident tolerant 2- Establish the expectation via guidance, fuel? procedure, or internal expectations memorandum that a lessons learned activity (or for smaller scope applications a hot wash) should be performed following the review of unique or complex applications to capture review insights and proposed improvements to guidance.
3- Integrate the lessons learned activity results into the DFM knowledge management and training activities.
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ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 27 NRC staff input Clarity This suggestion ties to better planning Continue activities to risk-inform the HIGH For the pre-application Efficiency and documenting of review effort and scope, focus, and level of detail of phase set expectations for ties to numerous other suggestions (e.g., reviews.
holding early team Suggestion #s 2, 4, 15, 18, 21, 29, 30, RECOMMENDED ACTION:
meetings of likely and 31). In particular, this action closely 1- In concert with Suggest # 31 et al, technical reviewers and aligns with Suggestion #29 and is improve the review guidance for the early PMs to: understand already being addressed per an action in phases of review planning so that there is proposed application, the NMSS transformation action plan a holistic approach in gaining early establish risk-informed (see Suggestion #31) that involves alignment on the expected scope, focus, considerations in setting developing questions to support and level of detail of reviews, considering early scope and focus of assignment and alignment meetings. any unique aspects of the review. The review in a holistic While this approach (either during pre- improvements should also include early manner, and identify application or the acceptance phase) documentation (including branch chief unique review could increase the initial cost to the acceptance) within the PM process and considerations. Also, licensee/applicant and might require a communicated with the licensee/applicant.
consider having a site visit slightly longer timeframe and metric if The process will also need to include a (e.g., as part of a pre- done at the acceptance review phase, review revision process that includes the application meeting with efficiencies would likely be realized over justification for changing these previously the licensee/applicant, the course of the review. agreed upon aspects of the reviews.
especially for reviewers (including NSIR, OGC, et al) unfamiliar with the facility.
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ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 28 NRC staff input Efficiency This approach was recently implemented The review guidance should be revised to MEDIUM For reviews that are for a review and should continue to be encourage PMs to seek opportunities for expected to be of short used when appropriate, though it is not improve review efficiencies by allowing duration (e.g., < 60 days) identified within the LRH as an option. flexibility within the review metrics (e.g., to and straightforward, This suggestion is similar to Suggestion exempt earlier due dates for combined forego the acceptance #5. steps) if overall efficiency is achieved (i.e.,
review phase (or have a The current review metrics may dis- be outcome-oriented). The process and minimal acceptance incentivize this approach if it results in planning tools should be modified to review (e.g., 2 days) with missing an established metric (e.g., support this flexibility, such as providing a only a teleconference acceptance review within 60 days). If recognized path for short duration, noting acceptance) and implemented, the licensing planning and straightforward reviews that do not need perform the technical tracking tool (i.e., WBL) would also need an acceptance review phase (or minimal review using an to be modified, which would involve acceptance review), such as applications established timeliness contractor expenses. that are solely administrative changes.
metric for such reviews RECOMMENDED ACTIONS:
instead. 1- In concert with Suggestion #5, revise the review guidance related to work planning and metrics to encourage review efficiency approaches, such as combining review process steps for simple reviews that result in overall improvement in the review schedule.
2- Enhance the WBL tool to allow process steps to be combined (e.g., acceptance review and final SER) or skipped and the ability to adjust the metrics in these situations as long as the overall review is completed on an accelerated schedule.
and that metrics do not obstruct this efficiency.
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ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 29 NRC staff input Openness This suggestion ties to better planning Continue activities to risk-inform the MEDIUM Improve early processing, Reliability and documenting of review effort and scope, focus, and level of detail of alignment, and Clarity ties to numerous other suggestions (e.g., reviews.
documentation in Efficiency Suggestion #s 2, 4, 15, 18, 21, 27, 30, RECOMMENDED ACTION:
establishing the expected and 31). In particular, an action in the 1- In concert with Suggest # 31 et al, focus, scope, and level of NMSS transformation action plan (see improve review guidance for the early detail of reviews. Make Suggestion #31) involves developing phases of review planning so that there is this information available questions to support assignment and early alignment on the expected focus, to the licensee/applicant. alignment meetings. As such, activities scope, and level of detail of reviews. The have already been initiated to address improvements should also include early this suggestion. For example, a draft set documentation (including branch chief of high-level questions have been acceptance) within the PM process and developed to support review team early communicated with the licensee/applicant.
scoping activities. The process will also need to include a review revision process that includes the justification for changing these previously agreed upon aspects of the reviews.
30 NRC staff input Reliability A working group has been formed to It is recognized that this action may need MEDIUM Develop process and Clarity initiate work to address this suggestion. to be implemented in a phased and technical job aids that Efficiency To capture the full scope and breadth of prioritized manner over a longer period as augment the process and the suggestion would involve nearly resources become available.
technical staff guidance at every technical staff lead and many lead RECOMMENDED ACTIONS:
a lower level that PMs. However, it could be initiated for 1- Identify the highest priority areas and incorporates: review what are considered the most significant applications to develop process and area/discipline lessons areas of the typically more significant technical job aids that will also be used to learned and insights; applications and then continued to other develop templates for future activities.
typical considerations for areas and application types as resources 2- In concert with Suggestion #31, determining the focus, become available. This suggestion is develop process and technical job aids to scope and level of effort closely related to Suggestion #31. support risk-informing the reviews and for different types of decision making. The process and applications; technical job aids should address each considerations in review review discipline for each type of sampling approaches (if application, as resources become appropriate). available.
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ATTACHMENT Principle of
- Suggestion and Origin Good Additional NRC Considerations WG Recommendation Priority Regulation 31 NRC staff input Openness This suggestion was identified by NRC Continue activities to risk-inform review HIGH Develop a set of risk Reliability Innovation Panel Idea #68. One aspect tasks.
factors and their impacts Clarity (early alignment on activities) is RECOMMENDED ACTION:
(i.e., considerations) Efficiency associated with an action in the NMSS 1- In concert with Suggestions #s 29 and associated with specific transformation action plan and is also 30, develop process and technical job aids tasks of a review; related to Suggestion # 29. Activities to support risk-informed reviews and including schedule risk have already been initiated to address decision making as resources are and review/decision- this suggestion. For example, a draft set available. Consider job aids that provide making risks. of high-level questions have been questions to ask to ensure every aspect of developed to support review team early a review is appropriately risk-informed.
scoping activities. For example, during pre-application and acceptance review, develop questions to aid in identifying the scope, focus, and level of detail of each review area and likely complex aspects of the review that might challenge the schedule; during development of RAIs, develop questions to aid in determining the best means for seeking information by call or formal request, the significance of information needed, and if the RAI should be elevated for management awareness.
32 NRC staff input Reliability This suggestion has already been Continue merger activities related to HIGH Given the recent merger Clarity identified as needing to be addressed as harmonizing guidance and good practices of the divisions addressing Efficiency part of the DFM merger activities and in DFM guidance and instructions.
fuel cycle facilities and activities are already underway to RECOMMENDED ACTION:
spent fuel, staff review harmonize and incorporate good 1- Harmonize, incorporate good practices, guidance, procedures, practices into review procedures and and combine, where appropriate, the staff and instructions should be instructions. As an example, the initial review procedures and instructions within harmonized and best activities on developing an instruction on DFM.
practices within each of RAIs (see Suggestion #16) should be the prior divisions integrated with the RAI lessons learned implemented in a coherent activities being addressed within the manner within the new prior spent fuel division. A potential division. outcome is the development of a single RAI instruction that can be applied consistently across both business lines.
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ATTACHMENT Table 2 - PRIORITIZATION OF SUGGESTIONS Step 1 Step 2 Step 3 Overall Suggestion Mission Efficiency Timing Resource Priority Already Improvement Gain Effectiveness Effectiveness (H, M, L)
Expected (H, M, L) (H, M, L) (H, M, L) (H, M, L) 1 Yes H 2 Yes H 3 Yes H 4 M-H M-H H H H 5 M M M M M 6a Yes H 6b L L L L L 7a Yes H 7b M-H M-H H H H 8 Yes H 9a Yes H 9b M-H M-H H H H 10 L L M M L 11 Yes H 12 Yes H 13a Yes H 13b Yes H 14 M M L M M 15 H M M (Phased) L M 16 L L M (Phased) M L 17 L L M M L 18 M M-H H H H 19 Yes H 20 H M-H M M M 21 M-H M-H H H H 22 M M-H M M M 23 M M L H M 24 M H M M M 25a M-H M-H L M M 25b M H M M M 26 H H L (Phased) M M 27 M-H M-H H H H 28 M M H M M 29 M-H M-H M M M 30 M-H L-H L (Phased) L M 31 H H H H H 32 H H M (Phased) M H Table Entry Key: HIGH (H) MEDIUM (M) LOW (L)
Mission Improvement Significant Improvement Some Improvement Minimal Improvement Efficiency Gain Significant Gain Some Gain Minimal Gain Timing Effectiveness Near-Term (< 6 months) Mid-Term (6 months to year) Long-Term (> 1 year)
Resource Effectiveness Minimal (< 0.5 FTE) Some (0.5 - 1 FTE / contact $) Significant (> 1 FTE / contract $)
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