ML18138A389
| ML18138A389 | |
| Person / Time | |
|---|---|
| Issue date: | 05/16/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | |
| Lynch S, NRR/DLP, 415-1524 | |
| References | |
| Download: ML18138A389 (8) | |
Text
National Nuclear Security Administration Mo-99 Stakeholders Meeting Update on Licensing Reviews Supporting Domestic Molybdenum-99 Production Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission May 16, 2018
Medical Isotope 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 2
- 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 3
- 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 4
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 5
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 isotope 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 6
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 Mo-99 from molybdenum targets enriched in Mo-98
Developed RadioGenix Tc-99m generator system
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 7
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: