ML18333A275
| ML18333A275 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | |
| Montgomery C | |
| Shared Package | |
| ML18333A271 | List: |
| References | |
| Download: ML18333A275 (13) | |
Text
2018 Test, Research, and Training Reactors Annual Conference Medical Radioisotope Facility Application Reviews and Construction Inspection Steven Lynch Research and Test Reactors Licensing Branch Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission October 2018
Supporting Domestic 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 molybdenum-99 (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 of utilization and production facilities 2
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 3
Similarities to Non-power Reactors
- Safety considerations comparable 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 4
Medical Radioisotope Licensing and Oversight
- Construction permit and operating license applications
Northwest Medical Isotopes (NWMI)
SHINE Medical Technologies (SHINE)
- License amendment requests supporting NWMI production project
Oregon State University (OSU)
University of Missouri Research Reactor Center (MURR)
- Materials license and medical use applications
Niowave, Inc.
NorthStar Medical Radioisotopes RadioGenix generator system
- Inspection preparation for anticipated construction of SHINE and NWMI facilities 5
- NWMI proposes to manufacture and process LEU targets for 99Mo production
Target manufacturing to be licensed under Title 10 of the Code of Federal Regulations (10 CFR) Part 70
LEU targets irradiated at existing research reactors, including OSU and MURR
Irradiated targets returned to NWMI for processing in a 10 CFR Part 50 production facility
- Proposed site: Columbia, Missouri Northwest Medical Isotopes 6
Oregon State University TRIGA Reactor Source: OSTR Webpage
SHINE Medical Technologies
- SHINE proposes to fission LEU target solution in 8 irradiation units licensed as 10 CFR Part 50 utilization facilities
- SHINE proposes to recover 99Mo by processing irradiated target solution in hot cells licensed as a 10 CFR Part 50 production facility
- Proposed site: Janesville, Wisconsin
- Pre-construction and pre-application meetings held in April, May, June, and August 2018 7
SHINE 99Mo Production Process Source: SHINE Webpage
Licensing Accomplishments
- Issued two construction permits for non-power production or utilization facilities
SHINE Medical Technologies (February 2016)
Northwest Medical Isotopes (May 2018)
Reviews completed in under two years from time of application docketing
- Published guidance in February 2018 for medical use applicants and licensees possessing the NorthStar Medical Radioisotopes RadioGenix system
Supports first anticipated 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 8
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 9
And Looking Forward
- Anticipating operating license application reviews and construction inspection activities expected to begin in fiscal year 2019
- Updating licensing framework
- Anticipating technical and licensing challenges
- Engaging with potential construction permit applicants
- Supporting ongoing activities related to materials and medical use licensees
- Preparing for license amendment requests from existing research reactor licensees supporting the NWMI production project
- Continuing interactions with construction permit holders on facility-specific conditions and annual reports 10
Construction Inspection Preparation
- Developing construction and operation inspection programs
Construction inspection program established in December 2015
Inspections to be commensurate with risk of facility, focusing on most safety-significant structures, systems, and components (SSCs)
- Updating construction inspection manual chapter
- Planning for initial construction inspections related to quality assurance and civil engineering
- Working with licensees to identify most safety-significant SSCs to prioritize and focus construction inspections ahead of final safety analysis report submission
Information shared through public meetings, site visits, and electronic reading rooms
- Reviewing previous construction inspection reports 11
Assumptions
NRC staff familiarity with proposed technology
Efficiencies gained from initial use of review guidance
Decrease in level of effort for environmental review
Increase in level of effort for safety review Factors impacting level of effort estimates
Complexity of review
Quality and completeness of application
Number of requests for additional information and need for follow-up
Use of NRC staff vs. contract resources to complete review
Number of Advisory Committee on Reactor Safeguards meetings
Potential for contested hearing 12 Estimated Level of Effort for Operating License Application Reviews Low-Complexity Review Base-Complexity Review High-Complexity Review Review Hours 13,000 22,000 34,000 Increase in Review Hours from Construction Permit Application 1,400 5,400 17,000 Challenges and uncertainty in estimates
First-of-a-kind technology and licensing reviews
Lack of similar reviews for comparison
Limited information on new and/or different information in operating license applications Cost considerations
2018 professional hourly rate is $275
Estimates do not include fee-billable construction inspection costs
Estimates do not include non-fee-billable overhead associated with:
Policy paper development
Rulemaking
Guidance development
Staff training
Impact of Medical Radioisotope Facility Reviews
- Experience gained from reviews supporting a more responsive and efficient technology-inclusive regulatory framework at the NRC
- Leading initial licensing activities at NRC by considering 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: