ML25143A040
| ML25143A040 | |
| Person / Time | |
|---|---|
| Issue date: | 05/28/2025 |
| From: | John Lubinski Office of Nuclear Material Safety and Safeguards |
| To: | Craig Erlanger, Jack Giessner, Shana Helton, Mark King, Andrea Kock, Julio Lara, John Marshall, John Monninger, Christopher Regan, Dafna Silberfeld Region 1 Administrator, Region 2 Administrator, Region 3 Administrator, Region 4 Administrator, Division of Decommissioning, Uranium Recovery and Waste Programs, Division of Fuel Management, NRC/NMSS/DMSST, NRC/NMSS/DREFS, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response |
| References | |
| Download: ML25143A040 (1) | |
Text
MEMORANDUM TO:
FROM:
SUBJECT:
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 28, 2025 Those on the Attached List John W. Lubinski, Director Office of Nuclear Material Safety and Safeguards LICENSING EFFICIENCY EXPECTATIONS We have an urgent need to improve our licensing processes to meet the Nation's increasing energy demands. This memorandum establishes (and in some cases re-emphasizes) my expectations, effective immediately, to improve the efficiency, predictability, and timeliness of the materials licensing programs. My expectations are informed by the U.S. Nuclear Regulatory Commission's (NRC's) updated mission statement and associated guidance 1, the NRC's Principles of Good Regulation, and ongoing efforts of the Material Licensing Efficiencies and Processes (M-LEAP) team. These expectations shall be captured in future revisions to business-line instructions for licensing staff. I appreciate the improvements staff are already implementing in response to the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy Act of 2024 (ADVANCE Act). We must continue to implement these improvements and engage with the regulated community to identify further efficiencies in our processes.
This memorandum states my expectations for safety focus, cost and schedule of reviews, and immediate implementation of near-term efficiencies.
FOCUS LICENSING REVIEWS ON SAFETY In licensing reviews, staff safety evaluations should be to the point, concise, and only contain the minimum information needed to support the regulatory conclusions. I expect staff reviews and safety evaluations to be more streamlined and focused only on the information necessary to make a regulatory finding, being mindful that guidance is just guidance and there are multiple ways to meet the regulations.
CONTACT: Shana Helton, NMSS/DFM 301-287-9104 1 "SECY-25-0031: Enclosure 1 - Mission Statement Implementation Guidance" (Agencywide Documents Access and Management System [ADAMS] Accession Number ML25106A353)
M. King, et al.
2 Over time, the level of detail in both license applications and in NRC safety evaluation reports has grown substantially. While the increased level of detail may have some benefits for knowledge management, this is a trend that does not support efficient and timely licensing.
Agency tools such as Nuclepedia may be used for knowledge transfer when needed. Staff should seek only the minimum amount of information needed from applicants to satisfy NRC requirements and ensure safety.
In determining what information is needed to make a regulatory decision, I expect staff to adhere to prior expectations on reasonable assurance and level of detail needed in an application, being mindful of backfit principles.2 The Commission has given clear direction in SRM-SECY-19-0036, "In any licensing review or other regulatory decision, the staff should apply risk-informed principles when strict, prescriptive application of deterministic criteria such as the single failure criterion is unnecessary to provide for reasonable assurance of adequate protection of public health and safety." If an applicant can demonstrate safety with their approach, staff should consider exemptions when needed to give relief to unnecessary regulatory requirements.
If there is disagreement on what is needed to make a finding on reasonable assurance, staff must promptly raise issues to the division and office level as soon as possible, consistent with best practices of enterprise risk management. As noted in Management Directive (MD) 4.4, "Business Line Leads (BLLs), Product Line Leads (PLLs), and partner office leads are responsible for identifying and managing risks in their respective areas and communicating appropriately those risks that could impact them in accomplishing their strategic objectives, or the agency meeting its mission."3 This places a responsibility on all staff involved in licensing reviews to identify project risks, communicate them with management promptly, and suggest ways to resolve or mitigate those risks. As staff is communicating review issues, they should highlight the different viewpoints, including those of the applicant. Additionally, staff must apply the NRC's Be riskSMART framework to ensure appropriate safety focus, identification of what may go right/wrong, and how best to mitigate risks.
Finally, staff must ensure appropriate knowledge transfer occurs so that our licensing reviews do not re-review facets of the review where NRC has previously made a regulatory decision.
Staff should discuss licensing precedents and seek views of the applicants during the pre application stage of the review, to ensure that the review team understands how NRC previously found reasonable assurance on related issues. If a prior decision must be revisited, staff should only do so by using the backfit process, or (in cases where backfit does not explicitly apply) a backfit-like process. This will ensure that staff considers whether the safety significance of an issue merits further cost. If additional review time and/or changes to the facility/design application are not needed for adequate protection, staff should not focus review efforts in those areas.
REDUCE SCHEDULE AND COST OF LICENSING REVIEWS As we meet the rising workload demand, we must scrutinize our non-casework activities and apply our add/shed/defer framework to appropriately set our priorities. Timely cqmpletion of licensing reviews must be prioritized over work that is budgeted in the Part 171 fee category.
2 "Key Principles for Nuclear Material Safety and Safeguards Review" (ML19015A290), "Development of a Methodology to Enhance Effectiveness in Regulatory Decisionmaking Related to Materials Licensees" (ML21005A298) 3 MD 4.4 "Enterprise Risk Management and Internal Control" (ML17312B109)
M. King, et al.
3 Licensing and inspection activities should not be delayed if qualified staff working on Part 171 activities can be re-assigned to work on licensing and inspection activities. I anticipate that prioritizing, to the maximum extent practicable, direct licensing and inspection activities (i.e.,
work that is budgeted in the Part 170 fee category) will enable acceleration of licensing reviews.
Additionally, several business lines in the materials program are exploring the use of templates for Safety Evaluation Reports (SERs), I expect these efforts to be accelerated and implemented as soon as possible to support this reduction in schedules and cost of licensing reviews.
Therefore, effective immediately, the Office of Nuclear Material Safety and Safeguards (NMSS) will reflect in license acceptance letters that schedules are aggressive, and resources are minimized based on the scope of review activities needed for the application. In all cases, the estimates will be at least 15 percent below the Nuclear Energy Innovation and Modernization Act (NEIMA) generic milestone schedules (GMS),4 or historical average, whichever is shorter.
This reduction is supported by our recent assessment of the historical data to update the GMS which indicated that in most cases, licensing was completed faster than the GMS. Additionally, we have already begun implementing efficiencies in all materials licensing processes, which I expect will reduce cost and schedule5. Review schedules and costs that do not meet these expectations must be approved by the division director.
This reduction in cost and schedule is to be implemented immediately and reflected in acceptance letters. Additionally, the acceptance letters must clearly communicate to the applicant the assumptions underlying the cost and schedule, including factors such as the availability of the applicant to have licensing audits and discuss review issues, quality of any needed supplemental information, and timeliness in responding to staff requests for additional information.
IMMEDIATELY IMPLEMENT NEAR-TERM EFFICIENCIES Pre-application Engagement Pre-application engagement encourages two-way dialog with a goal to maximize openness and transparency. While voluntary, pre-application engagement often benefits applicants by increasing the quality of an application, minimizing the need for supplemental information during the acceptance review, and ensuring NRC has the resources available to conduct the review.
All materials business lines have sought to optimize this stage of the licensing review, and these practices shall be implemented immediately.
Key to success in these discussions is having open, candid conversations about potential review issues and what the potential resolutions to those challenges may look like. In the past, staff may have held back from sharing their thoughts because they were concerned about appearing to consult the applicant. There is, however, a difference between consulting, which we do not do, and clearly stating our regulatory needs, which we must do. The recently issued NRC Mission Statement Guidance states that we have an opportunity to reshape the way the 4 NEIMA generic milestones, https://www.nrc.gov/about-nrc/generic-schedules.html does not apply to Nuclear Materials Users (NMU).
5 Review schedules and resources may need to be further reduced to comply with future requirements.
M. King, et al.
4 NRC operates. Three best practices in this guidance are especially relevant for staff behavior during pre-application engagement:
Take the initiative to use alternate paths when the normal approach does not provide a benefit commensurate with the resource investment. Examples include discussions with applicants about submitted or staff-initiated exemptions on a case-by-case basis.
Use preapplication engagement to understand unique technical issues, align on regulatory paths, and identify efficiencies for the licensing review.
During meetings with applicants and licensees, openly express questions and concerns, clearly communicate the safety or security basis, and discuss options under the regulatory framework.
I'm encouraged by the progress we are making in this area. For example:
Nuclear Materials Users enhanced the medical uses licensee toolkit website to address emerging medical technologies, including information that NRC staff will use to make licensing determinations.
Fuel Facilities has piloted an enhanced pre-application process involving time-limited reviews of draft licensing chapters, which resulted in substantial savings (>50 percent compared to typical review times) to the estimated schedule and cost.
Spent Fuel Storage and Transportation approved a new transport package design in under 1 year (significantly ahead of schedule), a schedule that was largely possible due to open exchanges that modeled the behaviors above during the preapplication.
Decommissioning and Low-Level Waste has used pre-submittal public meetings and audits for new applicants as well as prior to new requests from existing licensees and have reduced review timelines by several months as well as significantly reducing requests for additional information.
The Environmental Center of Expertise streamlined its consultation initiation process, increased pre-application and outreach meetings with Tribal governments interested in the NRC's regulatory activities. These actions have strengthened working relationships between the NRC, Tribal governments, and applicants, resulting in earlier resolution of project concerns. For example, for the Clinch River Environmental Assessment, the NRC staff built upon the relationships forged with Tribal governments during previous environmental reviews in the same area and, which likely contributed to the fact that no major concerns, challenges, or delays were raised during the Tribal consultation.
Draft Safety Evaluation Reports I expect staff to complete draft SERs prior to issuing any requests for additional information (RAls). RAls must be risk-informed and safety-focused and must be limited to seeking that information that is needed to fill a gap in a draft safety evaluation where staff is unable to make a safety finding. This practice is consistent with the NRC mission statement implementation guidance, which states:
Start activities with an early assessment of the safety or security significance of the matter, including an analysis of the impact and consequences. This means that safety and security are the starting point for all decisions. Safety and security are the foundation to achieve our mission and should be our core principle in every decision-making process.
M. King, et al.
5 The draft SER is an early assessment of the significance of review issues and should be used as the starting point to guide staff needs for further information from applicants.
Current instructions address the draft SER development ("DUWP 10-11-Review Process for New Uranium Recovery License Applications" (ML20269A112) and "LIC-FM-1, Overview and Expectations of the Certification and Licensing Process, Revision 1" (ML22130A658) non public. NMU licensing process uses a form to guide RAI development and to document its evaluation and usually does not generate full safety evaluation reports. Staff must adhere to these instructions and conduct staff training (and enhance the guidance, as needed, to address the best practices and lessons learned) to ensure consistent application.
RETURN ON INVESTMENT In addition to focusing on increased efficiency in direct licensing activities, we need to continue to focus on efficiencies in licensing support. The licensing support product line contributes to Part 171 annual fees for licensees. Only those activities that directly benefit licensing should be contributing to the annual fee. We have been using the add/shed/defer process to balance priorities, but we need to go beyond what we are currently doing and truly scrutinize all the activities underway for licensing support activities, and whether the activity is needed today, whether it adds to licensing efficiency, or whether the work may be shed If the return on investment is not realized as a project progresses, efforts on that project must be shed.
Efficiencies that are realized and do benefit direct licensing activities need to be proceduralized for posterity - and the cost savings from implementing those efficiencies should be captured in projected budget estimates.
M. King, et al.
6 MEMORANDUM TO THOSE ON THE A TT ACHED LIST DATED: MAY 28, 2025
SUBJECT:
LICENSING EFFICIENCY EXPECTATIONS Mike King, Acting Director, Office of Nuclear Reactor Regulation Craig Erlanger, Director, Office of Nuclear Security and Incident Response Andrea L. Kock, Regional Administrator, Region I Julio Lara, Acting Regional Administrator, Region II John B. Giessner, Regional Administrator, Region Ill John D. Monninger, Regional Administrator, Region IV Jane Marshall, Director, Division of Decommissioning, Uranium Recovery, and Waste Programs, NMSS Shana Helton, Director, Division of Fuel Management, NMSS Dafna Silberfeld, Acting Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Christopher Regan, Director, Division of Rulemaking, Environmental, and Financial Support, NMSS RidsNrrMailCenter Resource RidsNsirMailCenter Resource RidsRgn1 MailCenter Resource RidsRgn2MailCenter Resource RidsRgn3MailCenter Resource RidsRgn4MailCenter Resource
ML25143A040 OFFICE NMSS/DFM NMSS NMSS NAME SHelton THerrera JLubinski DATE 05/27/2025 05/27/2025 05/28/2025