ML21096A291
| ML21096A291 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/2021 |
| From: | Steven Lynch NRC/NRR/DANU/UNPL |
| To: | |
| Lynch S | |
| Shared Package | |
| ML21096A289 | List: |
| References | |
| Download: ML21096A291 (19) | |
Text
Technical Meeting on State of the Art Reactor Based Radioisotope and Radiopharmaceutical Production Insights on Adapting Licensing Frameworks to New Radioisotope Production Technologies Steven Lynch Non-Power Production and Utilization Facility Licensing Branch Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission March 2021
Non-Power Facility Licensing and Oversight
- U.S. Nuclear Regulatory Commission (NRC) responsible for 31 non-power reactors
Routine licensing actions
License renewal reviews
Digital instrumentation and control upgrades
Highly enriched uranium to low-enriched uranium fuel conversions
Inspection and operator licensing
- Licensing infrastructure and policy
Guidance development
American Nuclear Society standard committee participation
Advanced reactor licensing support
Rulemaking development and support
- International activities, including International Atomic Energy Agency support
- Initial licensing reviews for medical radioisotope facilities 2
Status of United States Supply
- Currently, limited domestically-produced molybdenum-99 (99Mo) supply
- The United States 99Mo policy objectives are to:
1)
Ensure a reliable supply of 99Mo 2)
Eliminate highly-enriched uranium use in 99Mo production, and 3)
Eliminate market subsidies
- Production encouraged by cost-sharing cooperative agreements between National Nuclear Security Administration and commercial partners 3
Supporting 99Mo Production
- NRC staff committed to efficient reviews of applications and inspections in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR)
- Licensing and oversight activities support U.S. national security interests and nuclear nonproliferation policy objectives of establishing a domestically-available and reliable supply of 99Mo without the use of highly-enriched uranium
- Applications include initial license and license amendment requests for facilities proposing to manufacture, irradiate, and process low enriched uranium and molybdenum targets
- Oversight activities focused on preparation for construction inspection 4
Regulated Production Processes
- Target manufacturing
Preparation of low enriched uranium (LEU) targets for irradiation
- Target irradiation
Nuclear reactors
Subcritical operating assemblies
Accelerators
- Target processing
Hot cell separation of 99Mo from irradiated LEU targets
- Medical uses of byproduct material
Generators for extracting technetium-99m from 99Mo 5
Similarities to Existing Facilities
- Safety considerations comparable to non-power reactors:
Fission heat removal Decay heat generation Fission gas release
- and fuel cycle facilities:
Target manufacturing Radiation protection Material processing Fission product buildup Accident scenarios Criticality control Chemical hazards 6
- Applications contain both general and technical information
- Construction permit application Environmental report Preliminary safety analysis report (PSAR)
- Operating license application Update to environmental report, as necessary Final safety analysis report (FSAR)
- Applications may be submitted separately or together
- Testing facilities and commercial facilities may request limited work authorization to allow certain construction activities prior to the issuance of a construction permit 7
Non-Power Licensing Process
Regulatory Guidance and Acceptance Criteria
- NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors
- Interim Staff Guidance Augmenting NUREG-1537
Radioisotope production facilities
Incorporates relevant non-reactor guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility, Rev. 1
- Other guidance (e.g., regulatory guides and ANSI/ANS standards) and engineering judgement used, as appropriate, to determine what is necessary for construction permit 8
NUREG-1537 Review Areas
- 1. The Facility/Introduction
- 2. Site Characteristics
- 3. Design of Structures, Systems, and Components
- 4. Facility Description
- 5. Coolant Systems
- 6. Engineered Safety Features
- 7. Instrumentation and Control
- 8. Electrical Power Systems
- 9. Auxiliary Systems 10.Experimental Facilities*
11.Radiation Protection and Waste Management 12.Conduct of Operations 13.Accident Analysis 14.Technical Specifications 15.Financial Qualifications 16.Other License Considerations*
17.Decommissioning*
18.Uranium Conversions*
19.Environmental Review
- May not be applicable to construction permit application for 99Mo facility 9
NRC Review Methodology
- For a construction permit application review, level of detail needed in application different than for an operating license application
- For the purposes of issuing a construction permit, the facility may be adequately described at a functional or conceptual level in the PSAR
- Applicants may defer providing many design and analysis details until the submission of its final safety analysis report (FSAR) with its operating license application
- Staffs review tailored to unique and novel technology described in construction permit application using appropriate regulatory guidance 10
Resolving Technical Issues of Preliminary Designs
- For technical areas requiring additional information, the staff has several options:
The staff may determine that such technical issues must be resolved prior to the issuance of a construction permit
The staff may determine that such information may be left until the submission of the FSAR
The staff may require that such technical issues be resolved prior to the completion of construction, but after the issuance of the construction permit
- In all cases, staff may issue requests for additional information
- In the second and third options, staff may track regulatory commitments or identify necessary license conditions 11
SHINE Operating License Application Review 99Mo produced by fissioning of low enriched uranium (LEU) solution using eight accelerator-driven subcritical operating assemblies 99Mo recovered by processing irradiated solution in three hot cells Facility to be located in Janesville, Wisconsin Operating license application submitted in July 2019 and accepted for review in October 2019 12
- NWMI proposes to manufacture and process LEU targets for 99Mo production
Target manufacturing
LEU targets irradiated at existing research reactors, including Oregon State University
Irradiated targets returned to NWMI for processing Northwest Medical Isotopes 13 Oregon State University TRIGA Reactor Source: OSTR Webpage
Prospective Applicants
- Niowave
Accelerator-driven subcritical operating assembly, target processing facility, and target fabrication facility
Currently conducting proof-of-concept technology demonstrations under an NRC materials license
- Eden Radioisotopes
2-megawatt thermal reactor with hot cell and target fabrication facilities to produce medical radioisotopes
Joint construction permit and operating license application, including target fabrication activities, under development
- Atomic Alchemy
Four non-power, pool type reactors and processing facility
Quality assurance program under review 14
Licensing Accomplishments
- Issued two construction permits
SHINE Medical Technologies (February 2016)
Northwest Medical Isotopes (May 2018)
Reviews completed in under two years from time of application docketing
- Published guidance in 2018 for medical use applicants and licensees possessing the NorthStar Medical Radioisotopes RadioGenix system
Supported first commercial domestic production of 99Mo since Cintichem ceased operations in 1989
- Issued license amendment to OSU in 2016 for demonstration of 99Mo production in small nuclear reactor with experimental uranium targets
- Issued materials license to Niowave in 2015
License amendments issued increased LEU possession limit and supported irradiation of natural uranium targets using superconducting linacs for proof of concept 15
Construction Inspection NRC staff developed IMC 2550 in 2015 for construction inspection of new non-power facilities, consisting of three inspection procedures:
IP 69020 for safety-related structures, systems, and components (SSCs)
IP 69021 for quality assurance program
IP 69022 for programmatic inspections Inspections commensurate with risk of facility, focusing on most safety-significant SSCs Formal construction activities began in October 2019 with the initial pouring of subgrade concrete. SHINE is moving toward completion of its weather-tight building in March 2021 16 SHINE Construction Site in February 2020
Reflecting Back
- For novel technologies, early interactions between NRC staff and applicants support efficient application processing and review
- Public pre-application meetings
Promote engagement between NRC and potential applicant
Inform the development of high-quality applications
Inform budgeting and resource allocation
Inform public of NRC process
- Best practices from construction permit application reviews:
Emphasis on most safety-significant technical aspects
Focused requests for additional information
Weekly status calls 17
And Looking Forward
- Continuing review of SHINE operating license application
- Updating licensing framework
- Anticipating technical and licensing challenges
- Engaging with potential construction permit applicants
- Supporting ongoing activities related to materials and medical use licensees
- Continuing interactions with construction permit holders on facility-specific conditions and annual reports 18
Impact of Medical Radioisotope Facility Reviews
- Experience gained from reviews supporting a more responsive and efficient technology-inclusive regulatory framework at the NRC
- Considering initial licensing of technologies beyond light water and non-power reactors
- Review of construction permit applications setting example for future advanced reactor reviews
- Success made possible through technical and licensing expertise provided by inter-office working group
- Updates on medical radioisotope facility activities available through NRC public website: