ML18263A306
| ML18263A306 | |
| Person / Time | |
|---|---|
| Issue date: | 09/21/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | |
| Lynch S, NRR/DLP, 415-1524 | |
| Shared Package | |
| ML18264A306 -Pkg. | List: |
| References | |
| Download: ML18263A306 (20) | |
Text
2018 Mo-99 Topical Meeting on Molybdenum-99 Production Technology Development Licensing and Oversight Enhancements and Preparations for 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 September 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 targets for irradiation
- Target irradiation
Nuclear reactors
Subcritical operating assemblies
Accelerators
- Target processing
Hot cell separation of 99Mo from irradiated low enriched uranium (LEU) targets
- Medical uses of byproduct material
Generators for extracting technetium-99m from 99Mo 3
Medical Radioisotope Licensing and Oversight
- 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 Medical Radioisotopes RadioGenix generator system
- Inspection preparation for anticipated construction of SHINE and NWMI facilities 4
- 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
- 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 5
10 CFR Part 50 Licensing Process
- Similar review process for construction permit and operating license applications:
Acceptance and docketing review Parallel safety and environmental reviews o Construction permit: preparation of safety evaluation report (SER) and environmental impact statement (EIS) (or environmental assessment) o Operating license: preparation of SER and supplemental EIS (or environmental assessment)
Request(s) for additional information, as needed Advisory Committee on Reactor Safeguards (ACRS) review Hearing(s) o Construction permit and operating license: potential for contested hearing(s) o Construction permit: mandatory hearing on sufficiency of staff safety and environmental reviews Decision to grant or deny permit or license 6
10 CFR Part 50 Licensing Process
- Safety reviews for construction permit and operating license applications conducted in accordance with Commissions regulations
- The level of detail needed in a construction permit application and NRC staffs SER different than for combined operating license or operating license The PSAR includes preliminary design of the facility, while the FSAR includes final design of the facility, as well as plans and programs not provided in PSAR
- Staffs review tailored to unique and novel technology described in construction permit application using appropriate regulatory guidance NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance Augmenting NUREG-1537 Other guidance (e.g., regulatory guides and industry standards) and engineering judgment used, as appropriate 7
NRC Safety Review Methodology
Resolving Technical Issues
- For technical areas requiring additional information, the NRC 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 8
9 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 NRC Staff Safety Review Timeline
- Legislation, regulations, and guidance National Environmental Policy Act NRC Environmental Regulations (10 CFR Part 51)
Applications reviewed using Interim Staff Guidance Augmenting NUREG-1537
- Applicant submits environmental report for construction permit and operating license applications
- Construction permit application environmental review includes:
Environmental scoping period; site audit; and preparation of draft and final EIS (or environmental assessment)
- Operating license application environmental review includes preparation of either Supplemental EIS or environmental assessment Supplemental EIS updates prior review and describes matters that differ or reflect significant new information since publication of EIS Review considers changes in facility design; operation; natural or physical environment; and regulatory environment 10 Environmental Review Process
Environmental Review Draft EIS Published Final EIS Published Total Review Time: 18-22 months*
6-7 months 11-15 months Federal Register Notice for Intent/Environmental Scoping Meeting Scoping comment period Scoping summary report Requests for Additional Information Environmental Analysis and Develop Draft EIS Comment period EIS update 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 11
Impacts on Review Schedule
- Quality of application
Adherence to regulatory requirements
Technical completeness
Attention to detail (i.e., organization, format, etc.)
- Requests for additional information (RAIs)
Complexity and novelty of technology
Completeness, timeliness, and responsiveness to requests
Number of RAIs and need for follow-up
Evaluation of new information
- Policy questions
Commission involvement to resolve unique considerations
Number of subcommittee meetings
Follow-up items 12
Other Scheduling Considerations
- Possible contested hearing for construction permit and operating license applications
- Mandatory hearing only for construction permit application Cannot hold mandatory hearing until completion of Safety Evaluation Report, Environmental Impact Statement, ACRS Review, and any contested hearing
- Commission decision to issue or deny construction permit Decisions on construction permits made 2 - 4 months following mandatory hearing 13
Licensing Accomplishments
- Issued first two construction permits for non-power utilization or production facilities since 1985
SHINE Medical Technologies (February 2016)
Northwest Medical Radioisotopes (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 14
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 15
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 16
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
- Another SHINE construction permit condition requires the submission of a periodic report to verify design information related to radiation protection
- Other NWMI construction permit conditions require the completion of a geotechnical investigation and quality assurance program implementation
- SHINE has submitted five 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 17
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 18
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 FSAR submission
Information shared through public meetings, site visits, and electronic reading rooms
- Reviewing previous construction inspection reports 19
Impact of Medical Radioisotope Facility Reviews
- Experience gained from medical radioisotope facility reviews is supporting the creation of a more responsive and efficient technology-inclusive regulatory framework at the NRC
- 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
- Stay up-to-date on medical radioisotope facility activities through NRC public website: