ML19325D290

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Building a Smarter Fuel Cycle Draft Comment Resolution Table
ML19325D290
Person / Time
Issue date: 11/21/2019
From:
Office of Nuclear Material Safety and Safeguards
To:
Harrison D
References
Download: ML19325D290 (14)


Text

Building a Smarter Fuel Cycle Licensing Program -

Comment Resolution Table

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness Effective communication of the Reliability PM with licensee staff and Communication/Openness Solicit input from each licensee management is identified in the Continue the practice of soliciting input from regarding milestones that should be fuel cycle Licensing Review licensees regarding the milestones for specific established for each application. Handbook (LRH) as a vital activity. applications, consistent with Suggestion #6, Future 1

Milestones may vary based on the The expectation to work with the revisions of the procedures and/or instructions complexity of the licensing action licensee in establishing milestones governing the fuel cycle licensing program and and estimated timeline. for an application is established in associated knowledge management training should the LRH. This suggestion is closely ensure this practice is maintained.

tied to Suggestion #6.

Openness The LRH already notes that the PM Clarity should communicate technical Communication/Openness reviewer estimated hours for the Consider sharing standard metrics Continue sharing standard metrics and hours review at the completion of the from Web Based Licensing along estimates with licensees. Future revisions of the 2 acceptance review. Including the with the hours estimated in the procedures and instructions governing the fuel cycle information in the acceptance acceptance letter. licensing program should ensure this practice is review letter has been maintained.

implemented by fuel cycle PMs and should continue.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness Communication/Openness PMs should initiate a telephone call (or other Consider updating the status of the communication means; e-mail) with each licensee at review as it progresses (i.e., an agreed upon periodicity and/or specific action encourage routine status calls Effective communication of the review phase, dependent on the level of activity at between NRC and licensee). PM with licensee staff and the licensee, to update the status of licensing actions.

3 Licensees are planning capital management is identified in the For large applications, this may involve routine status projects, so the status of the reviews fuel cycle LRH as a vital activity. calls focused solely on that application. Future will allow them to keep their revisions of the procedures/instructions governing management informed. the fuel cycle licensing program and associated knowledge management training should ensure this practice is maintained.

Consider a meeting with the Efficiency applicant during the acceptance Clarity This process (either during pre-review to better understand the application or the acceptance Review Efficiency/Effectiveness unique aspects of the licensees phase) could increase the initial PMs should discuss a meeting with the licensee to request and provide for early cost to the licensee, but better understand the licensing action during the pre-4 identification of complexities or efficiencies may be realized over application phase or the acceptance review phase.

unique aspects of the review and the course of the review. This Holding this meeting should be dependent on the provide for early identification of suggestion is similar to Suggestion level of complexity of the licensing action.

complexities or unique aspects of #27.

the review.

Efficiency Process/Metrics This process was recently Continue evaluating each review for potential time implemented by fuel cycle PMs savings. Provide an allowance within the review and should continue when Consider if multiple steps of the metrics to exempt earlier due dates for combined appropriate. However, the licensing process can be combined steps if overall efficiency is achieved (i.e., be outcome 5 internal review metrics may dis-for simple actions (e.g., acceptance -oriented). Future revisions of the incentivize combining steps if it and approval letters). procedures/instructions governing the fuel cycle results in missing a metric. This licensing program should ensure that PMs continue suggestion is similar to Suggestion to be aware of this option and that metrics do not

  1. 28.

obstruct this efficiency.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness Expands upon Suggestion #1, but Establish and share licensing specific to the support offices/

Communication/Openness milestones for most submittals to COEs. A representative from OGC Incorporate guidance for PMs to coordinate with include all offices and centers of discussed this comment during licensees on key review milestones (cf. Suggestion 6 excellence (COEs) involved. For the public meeting on August 8,

  1. 1). However, such milestones should not identify example, clarify when NRCs Office 2019. Key review milestones unique milestones for inputs or reviews by specific of General Counsel (OGC) is involved typically do not go to the level of staff, branch, division, COE, or office.

with the review of a licensing action. detail of providing specific office/COE review timeframes.

Efficiency Review Efficiency/Effectiveness The LRH recommends scheduling Continue optimizing the timing of site visits and a site visit shortly after draft RAIs leverage virtual audits/visits using available Site visits are valuable, and the are developed and the RAIs technology, as appropriate. Staff from supporting timing of the visits should optimize provided to the licensee in offices (e.g., NSIR and OGC, as appropriate) involved the effort of NRCs review (prior to preparation for the visit. The in a review should also be included in site visits. Also, 7

and/or after submittal) and with scheduling of site visits could be consider the timing of the site visit, such as holding a respect to requests for additional especially valuable for large meeting at the site as part of a pre-application information (RAIs). applications, such as major license meeting or when draft RAIs are developed. Future amendments, license renewals, revisions of the procedures governing the fuel cycle and new applications. licensing program should ensure this practice is maintained.

Clarity The LRH states that the regulatory Efficiency basis for the RAI should be Good Practices addressed. The importance of Develop a template for RAIs to further ensure that providing regulatory bases for RAIs should have clear regulatory regulatory bases for RAIs are consistently provided.

RAIs has been communicated to 8 bases, perhaps a uniform template Include the template in future revisions of the the staff. There is a job aid is needed. procedures/instructions governing the fuel cycle developed for the spent fuel licensing program and provide to the staff as a job reviews that could be leveraged to aid.

address this suggestion, especially in establishing a template for RAIs.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Efficiency The LRH allows holding clarifying calls for draft RAIs. These calls serve to: ensure the draft RAI questions are understood, the Review Efficiency/Effectiveness regulatory basis for the question is PMs should arrange discussions of draft RAIs with the clear, clarify the type and amount Consider if RAIs should be discussed licensee at an established milestone and for larger of information the staff needs, with the licensee in draft form to applications to consider scheduling a site visit minimize the likelihood of multiple confirm understanding of the (consistent with Suggestion #7) at this stage. For rounds of RAIs, and improve the request and also consider holding a large applications or complex RAIs, the PMs should 9 efficiency of the licensing process.

discussion when the licensee has also arrange discussions with the licensee to ensure Similar calls can be used for draft developed a draft response to the response fully addresses the staff request. Future RAI responses. This suggestion is ensure the response is appropriately revisions of the procedures/instructions governing also related to Suggestion #7 in addressing the staff request. the fuel cycle licensing program and associated that a site visit could be knowledge management training should ensure this coordinated at the draft RAI stage practice is maintained.

for larger applications to ensure full understanding of the RAIs and/or proposed licensee responses.

Clarity Process/Metrics Develop a tool to enable tracking and establishing metrics for RAIs, including RAIs developed in a phase The Nuclear Energy Innovation manner, and setting expectations for timeliness of Consider when the clock should and Modernization Act (NEIMA) RAIs. The RAI phased approach and considerations 10 start on NRCs metrics surrounding direction will likely influence how will also be captured within the RAI business line RAIs.

this item is addressed. instruction that is currently under development.

30-day response time - WBL issue - track metric from individual RAI

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Clarity There is existing guidance in the Efficiency LRH that allows RAI clarification calls (cf. Suggestion #9) without needing to be public Process/Metrics Consider if the requirement to meetings, as long as they stay The RAI business line instruction effort initiated by notice a public meeting 10-days in within the bounds of clarifying the 11 this working group (cf. Suggestion # 16) should advance limits the benefit of meaning and intent of the RAIs.

include guidance on RAI clarification calls and when discussing draft RAIs. This can be very beneficial at the it needs to be a public meeting is required.

draft RAI stage to ensure the final RAIs are clearly communicated and understood by the licensee/applicant.

Efficiency This expectation is already captured in the LRH (cf.

Suggestion #9) in which the calls are expected to minimize the likelihood of multiple rounds of RAIs, and improve the efficiency of the licensing process. Further, the LRH states that RAIs should not be Good Practices submitted if the information is Continue emphasizing the tools that are available to Reduce the likelihood of multiple available elsewhere or can be facilitate achieving the goal of a single round of RAIs.

12 rounds of RAIs. inferred from other information. Future revisions of the procedures/instructions Clarifying calls can be used to governing the fuel cycle licensing program should address or confirm such ensure this practice is maintained.

information instead of using formal RAIs. Current review guidance also indicates that RAIs should be developed from gaps in a draft SER. Addressing Suggestion #7 and #9 would also support achieving this goal.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Reliability Review Efficiency/Effectiveness The importance of providing for Efficiency Knowledge/Awareness continuity of reviews has been Emphasize and institutionalize the development of communicated to the staff and draft inputs early in reviews. Guidance and training guidance on this topic has recently should ensure PMs request draft deliverables at been incorporated into the LRH.

specific interim milestones to better ensure staff The staff agrees that continuity effort is captured. Future revisions of the procedures should be more uniformly The continuity of licensing process and instructions governing the fuel cycle licensing achieved. In addition, current quality and efficiency must be program should ensure this practice is maintained.

13 staff review guidance states the maintained despite staff and/or Aspects of knowledge management and training of draft SER inputs should be management turnover. incoming new staff need to continue to be developed early in the review considered, such as technical mentoring and teaming process (by the timing of the draft new staff up with more senior staff in performing RAIs), which ensures more reviews. Aspects supporting efficiency and efficient development of RAIs effectiveness during management turnover include (supporting Comment #s 7, 9, and maintaining briefing books on the various licensees,

12) and provides more effective their facilities and processes, and the fuel cycle turnover.

regulatory and licensing aspects.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Reliability Depending on the type of staff The current approved license Efficiency review (e.g., programmatic, provides a basis for acceptance sampling, etc.), some reviews may review and limited NRC review for be able to focus solely on the license renewals. This renewal areas of change. However, other Process/Metrics &

application identifies program aspects, such as sampling type Knowledge/Awareness changes since last renewal. As such, reviews, may involve additional Clarify how technical reviewers should focus their license renewals should focus only sampling to confirm the accepted reviews for a license renewal. This may be captured on safety significant areas of 14 methods are being implemented in guidance developed strictly for license renewals change. This may result in needing appropriately. Even in these (cf. Suggestion #23) or as part of a job aid. In no review for specific areas in which aspects of the review there should addition, developing such guidance or reviewer job there are no changes to that be more emphasis, though not aids could be informed based by reviewing recent program and no new/revised entirely, on areas that have renewals and identifying associated lessons learned.

requirements. Also, consider a changed since the recent renewal.

holistic review with industry input Implementation of Suggestion #23 on recent renewals to identify should directly address this lessons learned.

suggestion as well.

Efficiency Process/Metrics A key concept, that is directly Incorporate into review guidance the use of implementable by fuel cycle for integrated, multi-disciplined, review teams, especially larger team reviews, is the use of for larger scope applications. To be successful (i.e.,

Consider incorporating concepts integrated teams throughout the efficient and effective) the guidance needs to ensure from the recently issued NRR LIC- review, starting at pre-application review teams hold regular team meetings throughout 206, Integrated Risk-Informed phase, and the use of relative risk 15 the review (including pre-application, acceptance, Decision-Making for Licensing insights in planning and draft SER, RAI, and final SER phases, as appropriate)

Reviews, into the fuel cycle conducting the review. LIC-206 is to ensure understanding of the application and licensing program. available at:

consideration of relative risk insights in planning the https://www.nrc.gov/docs/ML190 review, the scope and focus of individual review 3/ML19031C861.pdf.

areas, identifying unique considerations, and in conducting the reviews.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness It is preferred to develop stand-Consider developing an instruction Efficiency alone guidance for the various for the Fuel Facility Business Line on aspects of the review that can be Communication/Openness &

license amendments like NRRs LIC- made publicly available without Review Efficiency/Effectiveness 101, License Amendment Review redaction (as would be needed for Develop and make publicly available procedures Procedures. This would take the the LRH). The staff has already and/or instructions governing the various aspects of 16 relevant information out of the begun the development of a the fuel cycle licensing program and invite internal desk guide (fuel cycle LRH) business line instruction for the stakeholder input and feedback for consideration in and place it into a publicly available RAI process, which needs to be the development process. A business line instruction document that is applicable to all coordinated and integrated with for the RAI process has already been initiated during staff performing work under the spent fuel instruction this effort.

Fuel Facility Business Line. improvement efforts (cf.

Suggestion #32)

Develop a tool to track licensing Efficiency As NRR is also involved in actions in accordance with the new implementing NEIMA, approaches Process/Metrics 17 metrics associated with the Nuclear should be consistent with, and Develop implementing tools to address the NEIMA Energy Innovation and incorporate lessons learned from, requirements Modernization Act (NEIMA). NRR implementation.

Reliability This process was recently Ensure internal work requests implemented by fuel cycle PMs Good Practices identify the appropriate technical and should continue. This Continue effort developing and utilizing accurate staff and that resource estimates suggestion ties to better planning internal work requests. Future revisions of the 18 are consistent with the projected of reviews and ties to numerous procedures and instructions governing the fuel cycle scope, focus, and level of detail of other suggestions (e.g., licensing program should ensure this practice is each review area. Suggestions #2, #21, #29, and maintained.

  1. 30).
  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Reliability Seminars should consider Training on the licensing program, Clarity including: How do technical Knowledge/Awareness that highlights recent changes and Efficiency reviewers perform reviews? What There are already seminars being conducted. This 19 longstanding fundamentals, should are the basics? What job aids and continual learning and reinforcing good practices be provided for fuel cycle PMs and guidance exists? Are there should continue to be used to maintain and expand technical reviewers opportunities for on-the-job capability and awareness of the staff.

training?

Reliability The current approach is to follow Clarity aspects of NUREG-1520, but there Efficiency is no specific guidance on which aspects to follow. This is not an Review Efficiency/Effectiveness A standard review plan is needed for efficient approach, especially as Develop appropriate review guidance, such as: SRP, 20 reviews of greater than critical mass new reviewers join the instruction, review roadmap to NUREG-1520 (SRP),

licensees. organization. An old draft guide job aid, etc.

exists, however it was not finalized. This could be a starting point for any new guidance or job aid.

Clarity Current guidance does not explicitly require documenting this level of specificity of the staff reviews. This documentation Good Practices Document the scope and focus of could be especially valuable in ISA Augment guidance to ensure the specific scope, 21 licensing reviews in the Safety reviews and other areas involving focus, and depth of review and approach used for the Evaluation Report (SER). sampling approaches (cf.

review (e.g., sampling) are documented in the SER.

Suggestion #14) and inform future reviewers of areas previously reviewed (or by implication not reviewed).

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Efficiency NRR is considering implementation of this practice.

Process/Metrics Lessons learned from these Need to determine the usefulness of such an activities should be incorporated Consider an electronic interface with approach for the typical application. This may be a 22 into any action considered by licensees for RAIs, dashboards, etc. longer-term item that builds off lessons learned from DFM. The main benefit may be NRR and past NRO use to consider for implementing, achieved for larger or more consistent with Suggestion #15, for large applications.

complicated reviews or new types of applications.

Reliability Review Efficiency/Effectiveness Clarity Implementation of this suggestion Similar to Suggestion #20, develop the appropriate Develop a business line instruction 23 Efficiency would directly address Suggestion type of guidance for license renewal applications, on license renewals.

  1. 14 such as: SRP, instruction, review roadmap to NUREG-1520 (SRP), job aid, etc.

Reliability Many of the cited reference Consider the development of a Knowledge/Awareness Clarity examples are available to the licensing manual to create a Develop a roadmap for each type of license that Efficiency staff, though often scattered catalog of fuel cycle licensing identifies the appropriate guidance, job aids, and across multiple locations and 24 guidance (e.g., NUREGs, Policy & guidance. Consider creating an unique catalogue of platforms (e.g., sharepoint, Procedures, Branch technical references (or cross-reference lists) for each licensee ADAMS, internal website) and not Positions, generic communications, or license type that is maintained by the appropriate consistently profiled in ADAMS (cf.

qualifications). PM and made easily available to the staff.

Suggestion #25).

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Reliability The LRH states that the PM should Clarity participate in frequent Efficiency communications with regional Consider ways to better facilitate Independence counterparts regarding licensing inspector involvement with the activities at their facilities and licensing process. How does an provides an opportunity for Knowledge/Awareness &

inspector raise a concern about a inspector insights being shared at Process/Metrics section of the license application? the draft SER stage. It is not clear Provide further guidance and training in effectively Can a central depository be that PMs routinely seek inspector incorporating inspector participation and insights at 25 developed for the current version of insights into licensing actions.

various stages of a licensing action, especially for each license application? Are Further, there is not much large applications. This participation should not be at licensing basis documents uniformly material related to inspector the end of the review, but as early as possible in the profiled in ADAMS consistently? direct involvement in the licensing review, including at the pre-application stage.

Can lessons be learned from NRR in review process. A similar how they maintain the licensing recommendation was provided basis documents? during the Westinghouse Lessons Learned activity. Some aspects of this suggestion are similar to Suggestion #24 Reliability Knowledge/Awareness Clarity This is a broad suggestion to Champion and institutionalize post-review lessons Can any efficiencies be gained that Efficiency leverage on-going efforts of learned activities of new or complex applications with focus on the review of an continual learning, review lessons the aim of informing future new and novel application to: fabricate pebble bed learned, and self-assessments to application reviews. Further guidance improvement 26 reactor fuel; or produce medical proactively prepare for new activities to incorporate lessons learned and isotopes? What about for technologies and applications. knowledge management. In addition, initiate early amendments of current licensees to This could build off efforts related efforts to develop guidance and/or roadmaps for produce accident tolerant fuel?

to Suggestion #24. projected new applications (including new technologies) based on past experiences.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action For the pre-application phase set Clarity While this approach (either during expectations for holding early team Efficiency pre-application or the acceptance meetings of likely technical phase) could increase the initial Good Practices reviewers and PMs to: understand cost to the license and might PMs should discuss with the licensee about holding a proposed application, establish risk- require a slightly longer timeframe meeting to better understand the licensing action informed consideration in setting and metric if done at the during the pre-application phase or the acceptance early scope and focus of review, and acceptance review phase, 27 review phase. This could involve a site visit for those identify unique review efficiencies would likely be reviewers unfamiliar with the process(es) involved in considerations. Also, consider realized over the course of the the application. Forming an integrated review team having a site visit (e.g., as part of a review. This suggestion is similar and holding periodic meetings is dependent on the pre-application meeting with the to Suggestion #4 and aspects, such scope and level of complexity of the licensing action.

licensee, especially for reviewers as site visits and team reviews, (including NSIR, OGC, et al) overlap with Suggestions #7 and unfamiliar with the facility. #15.

Efficiency Process/Metrics Provide a recognized path for short duration, straightforward reviews that do not need to include For reviews that are expected to be This process was recently an acceptance review phase (or a minimal acceptance of short duration (e.g., < 60 days) implemented by fuel cycle PMs review). For example, license changes that are solely and straightforward, forego the and should continue when administrative or simple changes. Continue acceptance review phase (or have a appropriate. However, the evaluating each review for potential time savings and minimal acceptance review (e.g., 2 28 internal review metrics may dis- provide an allowance within the review metrics to days) with only a teleconference incentivize combining steps if it exempt earlier due dates for combined steps if noting acceptance) and perform the results in missing a metric. This overall efficiency is achieved (i.e., be outcome -

technical review using an suggestion is similar to Suggestion oriented). Future revisions of the established timeliness metric for

  1. 5. procedures/instructions governing the fuel cycle such reviews instead.

licensing program should ensure that PMs continue to be aware of this option and that metrics do not obstruct this efficiency.

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness Communication/Openness &

Reliability Process/Metrics Clarity Incorporate into review guidance and improve the Improve early processing, Efficiency This suggestion ties to better processing of reviews so that there is early alignment alignment, and documentation in planning and documenting of on the expected focus, scope, and level of detail of establishing the expected focus, review effort and ties to reviews. The improvements will also include early 29 scope, and level of detail of reviews. numerous other suggestions (e.g., documentation (including branch chief acceptance)

Make this information available to Suggestions #2, #18, #21, and within the PM process and communicated with the the licensee/applicant. #30). licensee/applicant. This will also then need to include a review revision process that includes the justification for changing these previously agreed upon aspects of the reviews.

Develop process and technical job Reliability Implementing this suggestion aids that augment the process and Clarity Process/Metrics &

would involve nearly every technical staff guidance at a lower Efficiency Knowledge/Awareness technical staff lead and many lead level that incorporates: review In concert with Suggestion #31, develop process and PMs to fully capture its scope and area/discipline lessons learned and technical job aids to support risk-informed reviews breadth. However, it could be 30 insights; typical considerations for and decisionmaking. Develop process and technical initiated for what are considered determining the focus, scope and job aids within each of the review disciplines and for the most significant areas of the level of effort for different types of different types of applications. It is recognize that this typically more significant applications; considerations in may need to be implemented in a progressive and applications. This suggestion is review sampling approaches (if prioritized manner over a long period.

closely related to Suggestion #31.

appropriate).

  1. Suggestion Primary PGR Additional NRC Considerations Resolution Grouping

& Proposed Action Openness Knowledge/Awareness Reliability In concert with Suggestion #30, develop process and Clarity technical job aids to support risk-informed reviews Efficiency and decisionmaking. Consider job aids that provide Consistent with NRC staff Innovative example questions to ask to ensure every aspect of a Idea #68, develop a set of risk review is appropriately risk-informed. For example, factors and their impacts (i.e., during pre-application and acceptance review 31 considerations) associated with questions to aid in identifying the scope, focus, and specific tasks of a review; including level of detail of each review area and likely complex schedule risk and aspects of the review that might challenge the review/decisionmaking risks. schedule; during development of RAIs in determining the means for seeking information by call or formal request, the significance of information needed, and if the RAI should be elevated for management awareness.

Reliability Process/Metrics Given the recent merger of the Clarity Combine, where appropriate, and make consistent divisions addressing fuel cycle Efficiency the staff review procedures/instructions, as time and facilities and spent fuel, staff review This suggestion is being further resources are available. As an example, the initial guidance, procedures, and evaluated and addressed by a activities on developing a business line instruction on 32 instructions should be harmonized newly formed DFM integration RAIs (cf. Suggestion #16) will be integrated with the and best practices within each of the team, which will address all lessons learned activities being addressed within the prior divisions implemented in a working group proposed actions.

prior spent fuel division. An expected outcome is the coherent manner within the new development of a single RAI instruction that can be division.

applied consistently across both business lines.