ML20297A531
ML20297A531 | |
Person / Time | |
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Issue date: | 09/30/2020 |
From: | NRC/NRR/DANU/UNPL |
To: | |
Montgomery C | |
Shared Package | |
ML20297A599 | List: |
References | |
Download: ML20297A531 (54) | |
Text
New Facilities and NPUF Licensing:
What is on the Horizon?
TRTR Annual Conference September 30, 2020 Non-Power Production and Utilization Facility (NPUF)
Licensing Branch, U.S. NRC
Presenters
- Steve Lynch, Senior Project Manager, UNPL
- Duke Kennedy, Project Manager, UNPL
- Ed Helvenston, Project Manager, UNPL
- Molly-Kate Gavello, Project Manager, UNPL
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
Responsibilities, Support, and Coordination
- The Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU) is responsible, in part, for initial licensing activities associated with NPUFs licensed under 10 CFR Part 50.
- The following types of facilities may be licensed as commercial or research and development facilities under Sections 103 or 104 of the Atomic Energy Act, respectively:
- Non-Power Reactors, including advanced reactor technologies
- Subcritical Operating Assemblies
- Production Facilities
Responsibilities, Support, and Coordination
- Technical and safety considerations for NPUFs- particularly those used for the production of medical radioisotopes - share similarities with currently operating non-power reactors and fuel cycle facilities. As such, DANU relies on the expertise and support of organizations throughout the agency to support application reviews:
- Security
- Thermal Hydraulics
- Neutronics Analysis
- Chemical Hazards
- Accident Analysis
- Criticality Safety
- Radiation Protection
- Material Control and Accounting
- Fire Hazards
- Instrumentation and Control
- Quality Assurance Systems
- Environmental
- Electrical Power Systems
- Financial
- Siting and External Hazards
- Human Factors
Responsibilities, Support, and Coordination
- NPUF and Advanced Reactor staff also collaborate, share expertise, and build upon best practices for initial licensing reviews
- Use of focused review groups
- Leverage scaled review methodologies
- Exchange technical and licensing expertise
- Establish clear responsibilities to ensure responsiveness and timeliness
Supporting Advanced Reactor Development
- Designers may choose to construct and operate a small facility, such as a research or test reactor, prior to a full scale commercial facility based on factors such as data needs, cost, safety, and time
- Data obtained from a research or test reactor could be used to fulfill the testing requirements of 10 CFR 50.43(e) during subsequent application for a license, approval, or certification for a prototype or commercial reactor
- Any data obtained using a research and test reactor and subsequently used to support a commercial nuclear power plant design would need to meet quality assurance requirements set forth in 10 CFR Part 50 Appendix B
Licensing Pathways Supporting Advanced Reactor Development 9
Testing Supported by Non-Power Reactors Capabilities of structures, systems, and components demonstrated through a combination of testing, operating experiences, and operational programs, including:
- Separate Effects Tests
- Demonstrate adequacy of physical models to predict physical phenomena
- Integral Effects Tests
- Demonstrate interactions between different phenomena and system components and subsystems identified and predicted correctly
- Fuel and Materials Qualification Tests
- Demonstrate adequacy of performance of fuel and materials under operational conditions
- Pre-operational Tests
- Demonstrate capability of structures, systems, and components to meet performance requirements and design criteria
- Initial Startup Tests
- Demonstrate that the facility will operate in accordance with its design and is capable of responding as designed to anticipated transients and postulated accidents
Government Coordination and Legislation
- NRC staff coordinate other federal agencies, as well as local and state governments to support initial licensing application reviews
- Department of Energy
- National Nuclear Security Administration (NNSA)
- Food and Drug Administration
- National Aeronautics and Space Administration
Government Coordination and Legislation
- Important Legislation for Initial Licensing
- American Medical Isotopes Production Act
- Uranium lease and takeback program
- Established review schedules
- Updated licensing framework
- Nuclear Energy Innovation Capabilities Act
- Advanced Reactor Demonstration Program
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
Licensee and Current Radioisotope Applicant:
SHINE Medical Technologies
- Technology:
- Molybdenum-99 (Mo-99) produced by fissioning of low enriched uranium (LEU) solution using eight accelerator-driven subcritical operating assemblies licensed as utilization facilities under 10 CFR Part 50
- Mo-99 recovered by processing irradiated solution in three hot cells licensed as a production facility under 10 CFR Part 50
- Facility to be located in Janesville, Wisconsin
- Project Status:
- Operating license application submitted in July 2019 and accepted for review in October 2019
- Construction commenced in September 2019
- Docket Number: 05000608
Licensee and Prospective Radioisotope Applicant:
Northwest Medical Isotopes, LLC
- Technology
- Target manufacturing to be licensed under 10 CFR Part 70
- LEU targets irradiated at existing research reactors
- Irradiated targets returned to NWMI for processing in a 10 CFR Part 50 production facility
- Project Status
- Preparing operating license application Source: OSTR Webpage
- Docket Number: 05000609 15
Licensee and Prospective Radioisotope Applicant:
Niowave
- Technology
- Accelerator-driven subcritical operating assembly, target processing facility, and target fabrication facility
- Commercial licensing pathway is to be determined
- Project Status
- Currently conducting proof-of-concept technology demonstrations under an NRC materials license
- Developing a three-phase approach to begin commercial operation of a subcritical operating assembly, target processing facility, and target fabrication facility
- Docket Numbers: 03038770, 03038988, 04038369
Prospective Radioisotope Applicant:
Eden Radioisotopes
- Technology:
- 2-megawatt thermal reactor with hot cell and target fabrication facilities to produce medical radioisotopes
- 10 CFR Part 50 application expected for non-power reactor and hot cell facilities (would be licensed as a utilization facility and production facility, respectively)
- Target fabrication activities covered under 10 CFR Part 70
- Facility to be located in Eunice, New Mexico
- Project Status:
- Joint construction permit and operating license application, including target fabrication activities, expected in FY21
- NRC staff currently reviewing safeguards information handling and protection plan
- Project Number: 99902077
Prospective Radioisotope Applicant:
Atomic Alchemy
- Technology:
- Commercial non-power utilization facilities and production facility licensed under 10 CFR Part 50
- Four non-power, pool type reactors (utilization facilities)
- Chemical extraction and purification facility (production facility) to produce radioisotopes
- Project Status:
- Engaging in pre-application interactions
- Letter of Intent submitted to NRC in August 2019
- Project Number: 99902080
Prospective Advanced Reactor Applicant:
Abilene Christian University (ACU)
- Technology:
- Project Status:
- Graphite Moderated Fluoride
- Engaging in preapplication Salt Flowing Fluid Reactor interactions Designed for 1 MW Thermal
- Regulatory Engagement Plan and Power (Non-Power Molten Salt Letter of Intent submitted to NRC Reactor) in March and July 2020
- Facility to be located on or near
- Project Number: 99902088 ACU campus in Abilene, TX Source: ACU Regulatory Engagement Plan (ADAMS Accession No. ML20241A071)
Prospective Advanced Reactor Applicant:
University of Illinois at Urbana-Champaign
- Technology:
- High-temperature gas micro-reactor developed by Ultra Safe Nuclear Corporation
- Project Status:
- Submitted DOE-NE Advanced Reactor Demonstration Program Application
- Engaging in preapplication interactions
Broad Landscape of Advanced Reactor Designs:
Additional Interest in NPUF Applications Indicates vendor interested in submitting an application for an NPUF
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
Revision of NUREG-1537
- NUREG-1537, Guidelines for the Preparation and Review of Applications for the Licensing of Nonpower Reactors, originally published in 1996
- Updates
- Reflect changes in the regulations and law
- Address the NPUF Rule
- Incorporate interim staff guidance
- Benefit from 25 years of use
- Restructure into volumes
Revision of NUREG-1537 Revision of NUREG-1537 Non-Power Production and Utilization Facility License Renewal Rule
- Terminology
- Accident dose criterion
- Definition of testing facility
- Updates to the final safety analysis report
Revision of NUREG-1537 Interim Staff Guidance Augmenting NUREG-1537 for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors
- Part 1, Format and Content
- Part 2, Standard Review Plan and Acceptance Criteria
- Chapter 19, Environmental Review Draft Interim Staff Guidance on Instrumentation and Control Systems (Chapter 7)
Revision of NUREG-1537 NEIMA Section 106, Encouraging Private Investment in Research and Test Reactors
- New criteria based on cost recovery for determining whether a utilization facility is licensed as a commercial facility or a research and development facility
Revision of NUREG-1537 Proposed Guidance for Preparing and Reviewing a Molten Salt Non-Power Reactor Application (ORNL/TM-2020/1478)
- Appendix A, Format and Content
- Appendix B, Standard Review Plan and Acceptance Criteria
Revision of NUREG-1537
- New volume structure
- Volume 1: Heterogenous Reactors
- Volume 2: Aqueous Fueled Systems
- Volume 3: Production Facilities
- Volume 4: Environmental Review
- Volume 5: Liquid Fueled Molten Salt Reactors
- Each volume will have 2 parts:
- Format and Content
- Standard Review Plan and Acceptance Criteria
Guidance for Non-Power Molten Salt Reactors
- In response to the Nuclear Energy Innovation and Modernization Act (NEIMA), the NRC staff identified an opportunity to enhance its readiness to license non-power reactors that will use liquid fueled molten salt reactor (MSR) technology
- Under contract with NRC, Oak Ridge National Laboratory developed a report titled, Proposed Guidance for Preparing and Reviewing a Molten Salt Non-Power Reactor Application
Overview of the Report
- An information resource for stakeholders interested in licensing of non-power MSRs
- Based on NUREG-1537
- Focuses on the technical information needed to apply NUREG-1537 to a non-power MSR licensing application
Overview of the Report
- Covers topics including:
- Siting
- Design of structures, systems, and components
- Reactor description
- Reactor cooling systems
- Engineered safety features
- Instrumentation and control systems
- Auxiliary systems
- Radiation protection and waste management
- Accident analysis
- Technical specifications
Future Plans
- The NRC staff is considering endorsing the report for use by potential non-power MSR applicants by January 2021
- Subsequently, the NRC staff will consider incorporating appropriate information from the report in an existing NRC guidance document, such as the next revision of NUREG-1537, a process that would include a formal public comment period
- Any feedback is welcome
How to Get the Report
- Available on the NRCs Agencywide Documents Access and Management System (ADAMS) at Accession No. ML20219A771
- Posted on the NRCs public website on the advanced reactors page at https://www.nrc.gov/reactors/new-reactors/advanced.html under the heading, Advanced Reactor Reference Materials
- Contact me at william.kennedy@nrc.gov
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
NEIMA - Section 102
- Establish milestone schedules for completion of requested activities of the Commission for NPUFs 1
- Construction permits - 36 months
- Operating licenses - 36 months
- License amendments - 24 months
- Exemptions - 24 months
- Code reliefs - 24 months
- License transfers - 24 months
- https://www.nrc.gov/about-nrc/generic-schedules.html 1 Time it generically takes to issue a final safety evaluation for each activity after the acceptance review is completed
NEIMA - Section 103
- Directed the NRC to develop and implement strategies within the existing regulatory framework for licensing research and test reactors for the purpose of predictable, efficient, and timely reviews
- January 2020, report to Congress
- Use a combination of existing non-power reactor guidance and commercial advanced reactor guidance
- Issue guidance on non-power liquid fueled molten salt reactors
- Complete by January 2021
NEIMA - Section 106
- Section 106 of NEIMA amended Section 104c of the Atomic Energy Act of 1954 (AEA) to focus on how the costs to the licensee of owning and operating the facility are recovered rather than how much a licensee spends on commercial activities
- Prior to NEIMA, the AEA did not include such criteria, and the criterion on cost expenditures specified in 10 CFR 50.22 was used to determine whether a facility was licensed under Section 103 or Section 104 of the AEA
NEIMA - Section 106
- NRC staff developed a rulemaking plan to conform 10 CFR 50.22 with Section 106 of NEIMA
- Provided to the Commission in June 2020
- Recommended that existing NPUFs be able to choose to comply with the current cost expenditure criteria in 10 CFR 50.22 or the new cost recovery criteria in the AEA
- New facility operating licenses and renewed facility operating licenses will be subject to the new cost recovery criteria in the AEA
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
Pre-Submission
- A shared understanding between the prospective applicant and NRC staff of what to expect, and when to expect it, supports an effective application review
- Coordination may begin years before the submission of a license application
- Goals:
- Consistent expectations
- Identification and resolution of technical, policy, and licensing issues prior to application submission
- Support high-quality application preparation and effective review
Early Engagement
- Frequent and early engagement with NRC staff is the key to success
- May informally discuss project plans with UNPL project managers and Branch Chief
- Drop-in meetings are a tool for administrative discussions
- Include NRC management and necessary licensing and technical staff
- Introduction of licensee/applicant staff, proposed application, high-level discussion of proposed technology, regulations/guidance, and submission schedule
- Informs budget and resource planning
- Public meetings facilitate technical and licensing discussions
- Broader NRC staff attendance
- May be closed, when appropriate to discuss sensitive information
Letters of Intent
- Indicates an initial interest in submitting a license application to inform NRC staff budget and resource planning
- Includes a preliminary idea of the types and number of licensing actions to be requested within a proposed timeframe
Regulatory Engagement Plans
- Includes more detailed plans for pre-application engagement with NRC staff on proposed application(s)
- May include more detailed technical/licensing information, as well as proposed topical reports or other supporting licensing actions
Guidance for Preparing LOIs and REPs
- NEI 18.06, Guidelines for the Development of a Regulatory Engagement Plan, Revision 0 (developed for Advanced Reactors)
- RIS 2013-03, "Pre-Application Communication and Scheduling for Medical Radioisotope Facilities Intending to Produce Molybdenum-99" (ADAMS Accession No. ML13078A385)
- RIS 2017-08, Process for Scheduling and Allocating Resources for Fiscal Year 2020 through 2022 for the Review of New Licensing Applications for Light-Water Reactors and Non-Light-Water Reactors, dated December 21, 2017, ML17262B022 (developed for Advanced/Power Reactors)
Pre-Submission Activities
- Other pre-application submittals that may be identified in a LOI or REP include:
- Requests for interpretation of regulations
- White papers
- Topical reports
- Quality Assurance Program Description
- Safeguards Information Protection Plan
- Request(s) for approval of reviewing official
- Applicants for initial licenses may also consider engaging the NRC staff in a Pre-Application Readiness Assessment
Pre-Application Readiness Assessments
- NRC LIC-116, Preapplication Readiness Assessment, ML20104B698
- Separate from the acceptance review, allows early NRC feedback on draft application
- Should be conducted at least 6 months before the expected application submittal
- Goals of the readiness assessment include:
- Identify information gaps
- Identify major technical or policy issues
- Increase familiarity with content of application
- Discuss guidance and precedents (if any) used to prepare application
- Is there is sufficient technical information in scope and depth to allow NRC to begin detailed technical review?
- Does the application have any readily apparent information insufficiencies with respect to regulatory requirements or characterization of licensing basis?
- Acceptance review information requests are separate from request for additional information (RAI) process, and are intended to address completeness for docketing (and reduce RAIs)
Application Review Process Following acceptance review, NRC staff may use a number of tools to effectively resolve information gaps identified during the technical review, including:
- Regulatory Audits
- Help efficiently gain understanding, verify information, and/or identify information that will require docketing
- May be conducted on-site or virtually
- Public Meetings
- Requests for Additional Information (RAIs)
- May provide draft RAIs to ensure understanding
- NRC/applicant discussions of RAIs before and after transmittal (clarification calls)
New Facilities and NPUF Licensing:
What is on the Horizon?
- Responsibilities, Support, and Coordination
- Current and Prospective New NPUF Applicants
- Guidance Updates
- Review Process
- Student Opportunities
NRC Student Opportunities
- Nuclear Regulator Apprenticeship Network
- Temporary Summer Student Program
- Co-Operative Education Program
- Judicial Law Clerk Program
- Honor Law Graduate Program
Nuclear Regulator Apprenticeship Network
- Entry-level hiring cohort to recruit, hire, and develop college graduates
- Full-time 2-year training program
- Initial regulatory and technical training
- Apprenticeships across the NRC
- Transition to full-time technical positions
Temporary Summer Student Program
- Summer Internship in a specific branch
- Possibility to continue through the Co-Op Education Program
- Application is open now at usajobs.gov
- Closes 10/19/2020
Thank you for your attention, any questions?
Steve Lynch, U.S. NRC Duke Kennedy, U.S. NRC 301-415-1524 301-415-2313 Steven.Lynch@nrc.gov William.Kennedy@nrc.gov Ed Helvenston, U.S. NRC Molly-Kate Gavello, U.S. NRC 301-415-4067 301-415-0293 Edward.Helvenston@nrc.gov Molly-Kate.Gavello@nrc.gov