ML18169A411
| ML18169A411 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 06/20/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | |
| Lynch S | |
| References | |
| Download: ML18169A411 (20) | |
Text
American Nuclear Society 2018 Annual Meeting Driving the Future of Nuclear Technology Panel on Licensing of Medical Isotope Production Facilities U.S. Nuclear Regulatory Commission Activities Related to Domestic Molybdenum-99 Production Steven T. Lynch Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission June 20, 2018
Supporting Domestic 99Mo Production
- NRC is conducting efficient reviews of applications submitted in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR)
- Reviews support U.S. national security interests and nuclear nonproliferation policy objectives by contributing to the establishment of 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 2
Regulated Production Processes
- Target manufacturing
Preparation of low enriched uranium targets for irradiation
- Target irradiation
Nuclear reactors
Subcritical operating assemblies
Accelerators
- Target processing
Hot cell separation of 99Mo from low enriched uranium targets
- Medical uses of byproduct material
Generators for extracting technetium-99m (99mTc) from 99Mo 3
Medical Radioisotope Licensing Reviews
- Construction permit and operating license applications
Northwest Medical Isotopes (NWMI)
SHINE Medical Technologies (SHINE)
- License amendment requests anticipated from Oregon State University (OSU) and University of Missouri Research Reactor Center (MURR) in support of NWMI project
- Materials license, and subsequent amendments, issued to Niowave
- Licensing guidance issued for NorthStar RadioGenix generator system 4
- Acceptance and docketing of application
- Parallel development of safety evaluation report and environmental impact statement (or environmental assessment)
- Request(s) for additional information, as needed
- Potential contested hearing; mandatory hearing on adequacy of staff safety and environmental review
- Decision to grant or deny construction permit 5
Construction Permit Review Process
6 Development of Safety Evaluation Report Docketing of Application Issuance of Request(s) for Additional Information (RAIs)
Completion of Draft Safety Evaluation Report 0
8 ACRS Subcommittee Meetings Completion of Safety Evaluation Report 18 19 20 21 22 Receive Response(s) to RAIs 10 3
2 Issue Supplemental RAIs 9
16 Review Response(s) to RAIs Receive Response(s) to RAIs 17 Review Response(s) to RAIs 11 ACRS Full Committee Meeting Sample 22-month Safety Review Timeline
Environmental Review Draft EIS Published Final EIS Published 18-22 months*
6-7 months 11-15 months Federal Register Notice for Intent/Environmental Scoping Meeting Scoping comment period (>45 days)
Scoping summary report (>90 days)
Request for Additional Information (each round 90 days)
Environmental Analysis and Develop Draft EIS Comment period (45 days)
EIS update (120-150 days)
Public Scoping Meeting Public meeting
- estimated time of review based on historical data. Actual time of review may vary based on complexity of application.
Sample Environmental Review Timeline 7
Impacts to Review Schedule
- Quality of Application
Adherence to regulatory requirements
Technical completeness
Attention to detail (i.e., organization, format, etc.)
- Requests for Additional Information (RAIs)
Completeness, timeliness, and responsiveness to requests
Evaluation of new information
Number of requests for additional information
Number of rounds of RAIs
- Policy Questions
Commission involvement to resolve unique considerations
Number of subcommittee meetings
Follow-up 8
Other Scheduling Considerations
- Possible contested hearing(s)
- Mandatory hearing Cannot hold mandatory hearing until completion of Safety Evaluation Report, Environmental Impact Statement, ACRS Review, and contested hearing(s)
- Commission decision to issue or deny construction permit Decision on SHINE construction permit made 2 months following hearing Decisions on combined operating licenses made 2 - 5 months following mandatory hearing 9
NRC Review Methodology
- Since construction permit only allows construction, level of detail needed in application and staffs SER different than for combined operating license or operating license
- 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
- 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
Basis for Issuing Construction Permit
- The following findings must be made to issue a construction permit, based on 10 CFR 50.35:
Facility has been described, including the principal architectural and engineering criteria for the design
Further technical or design information may be reasonably left for later consideration in the FSAR
Safety features or components requiring research and development have been identified
Safety questions will be resolved prior to the completion of construction and the proposed facility can be constructed without undue risk to the health and safety of the public
- Staffs conclusions also based on the considerations in 10 CFR 50.40 and 50.50 12
- NWMI proposes to manufacture and process low enriched uranium (LEU) targets for 99Mo production in Columbia, Missouri
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
Irradiated targets returned to NWMI for processing in a 10 CFR Part 50 production facility
- NRC staff applied best practices to support 23-month review
Emphasis on most safety-significant technical aspects
Focused requests for additional information
Weekly status calls Northwest Medical Isotopes 13
- Construction permit application submitted in 2015
- Final environmental impact statement published in May 2017
- Advisory Committee Meeting on Reactor Safeguards full committee meeting held in November 2017
- Safety evaluation report completed in November 2017
- Commission held mandatory hearing in January 2018
Staff and applicant presented on unique licensing considerations
- Construction permit issued in May 2018 Status of NWMI Review 14
SHINE Medical Technologies, Inc.
- 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
- Construction permit issued in February 2016
Periodic reports on permit conditions
Annual financial reports
- Pre-construction and pre-application meetings scheduled in April and May 2018
Construction expected to begin in 2018
Operating license application expected in 2018
- Proposed site: Janesville, Wisconsin 15
Facility-Specific Permit Conditions
- SHINE and NWMI construction permits require the submission of periodic reports to verify certain design elements related to nuclear criticality safety and radiation protection
Criticality accident alarm system
Nuclear criticality safety evaluations
- The SHINE construction permit contains an additional condition requiring the submission of a periodic report to verify design information related to radiation protection
- The NWMI construction permit contains additional conditions related to the completion of a geotechnical investigation and implementation of its quality assurance program
- SHINE has submitted four periodic reports since the issuance of its construction permit
- NRC staff may request clarifying or more detailed information, if necessary, prior to the completion of construction 16
Annual Financial Reports
- In addition to financial qualifications during initial licensing, NRC requires certain licensees to submit annual financial reports
- While annual financial reports are submitted for informational purposes, NRC staff keeps reports available for future reviews of financial qualifications
- SHINE has submitted three annual financial reports since the issuance of its construction permit
- NRC staff may request additional or more detailed information regarding ability of licensees to continue the conduct of activities authorized by its construction permit 17
Reactor License Amendments at MURR
- First of two anticipated amendment requests related to General Atomics (GA) selective gas extraction (SGE) technology submitted in May 2017 If granted, would have allowed modification of reactor reflector and installation of supporting systems for LEU target irradiation Second amendment would have supported installation of SGE hot cells to process irradiated targets In an April 2018 press release, Nordion, Inc. announced withdrawal of support for medical radioisotope production project partnership with GA and MURR Consequently, GA terminated its contract with MURR, who subsequently withdrew its license amendment request to produce Mo-99 using the GA SGE process 18
Materials and Medical Use Licenses
- Materials license issued to Niowave in 2015
Production of small amounts of 99Mo through uranium fission using superconducting linacs for proof of concept
NRC staff has issued amendments increasing LEU possession limit and supporting irradiation of natural uranium targets
- NorthStar Medical Radioisotopes
Proposes to produce 99Mo from enriched molybdenum target irradiation
Developed RadioGenix 99mTc generator system compatible with lower specific activity 99Mo
NRC staff published licensing guidance for medical use applicants and licensees that possess RadioGenix system in February 2018
NRC staff currently considering updated information on generator system and potential changes to licensing guidance 19
Oversight, Infrastructure, and Support Activities
- Developing construction and operation inspection programs
Construction inspection program established in December 2015
Inspections commensurate with risk of facility, focusing on most safety-significant structures, systems, and components
- Updating regulatory framework
Published proposed rule to streamline license renewal in 2017
Supporting development of proposed rule for emergency planning
- Coordinating technical and licensing expertise through inter-office working group
- Providing updates on public website: