ML22035A075
| ML22035A075 | |
| Person / Time | |
|---|---|
| Site: | 07007036 |
| Issue date: | 02/09/2022 |
| From: | Yawar Faraz NRC/NMSS/DFM/FFLB |
| To: | Peters W Niowave |
| Y FARAZ NRC/NMSS/DFM/FFLB 3014157220 | |
| References | |
| EPID L-2022-LRM-0012 | |
| Download: ML22035A075 (3) | |
Text
February 9, 2022 Dr. William Peters Radiation Safety Officer Niowave, Inc.
1012 North Walnut Street Lansing, Michigan 48906
SUBJECT:
ACKNOWLEDGEMENT OF RECEIPT OF REGULATORY ENGAGEMENT PLAN FROM NIOWAVE FOR A MEDICAL ISOTOPES FACILITY LICENSED UNDER 10 CFR PART 70 (ENTERPRISE PROJECT IDENTIFICATION NUMBER: L-2022-LRM-0012)
Dear Dr. Peters:
By letter dated December 3, 2021 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML22011A315), Niowave, Inc. (Niowave) provided the Office of Nuclear Material Safety and Safeguards (NMSS) of the U.S. Nuclear Regulatory Commission (NRC) its regulatory engagement plan (REP) for production of Molybdenum-99 (Mo-99) and other medical isotopes at its facilities located in Lansing, Michigan.
The REP described Niowaves medical isotopes production program in three phases. Phase I involves ongoing laboratory scale activities licensed by the NRCs Region III office. Phase II, for which Niowave submitted an application to the NRCs Region III office on October 1, 2021 (ADAMS Accession No. ML21288A118, non-public), involves a pilot facility processing less than a critical mass of special nuclear material to produce Mo-99. Phase III involves a full-scale Mo-99 production facility. By letter dated January 12, 2022 (ADAMS Accession No. ML22012A443), however, Niowave withdrew the amendment request dated October 1, 2021, for its Phase II pilot medical isotopes facility. At that time, Niowave verbally informed the NRC that, as a result of the withdrawal of the Phase II application, Niowave, may need to revise its plans for submitting future license applications to the NRC. To aid in NRC planning, it would be helpful for you to submit to the NRC any revised plans for submitting future applications. In addition, since this will be a first-of-a-kind application under 10 CFR Part 70, it would help expedite NRC review if you identified the specific regulatory requirements and guidance you intend to follow in the areas of safety, safeguards, security, and environment, including any acceptance criteria you will be using to develop your application documents.
As requested in your December 3, 2021 REP, we support conducting pre-application discussions in which we can discuss your plans and schedule for submitting a license application for a Mo-99 production facility and the specific regulatory requirements and guidance, including any acceptance criteria you will be using to develop your application, as well as the proposed contents of your application. Such discussions should also facilitate your efforts in preparing a complete and high-quality application that the NRC can accept for technical review, as well as facilitate the NRC staffs understanding of the key safety,
Dr. Peters 2
safeguards, security, and environmental aspects of your facility. To make the discussions meaningful and efficient, providing the NRC an annotated outline of the application you intend to submit would also be very useful. It would also help facilitate discussions at future pre-application meetings if you could provide the items mentioned in the final two sentences of previous paragraph before the said meeting.
Niowaves project under NMSS has been assigned Docket Number 07007036. Your request for pre-application engagement has been assigned Enterprise Project Identification Number (EPID)
L-2022-LRM-0012. Please reference this EPID number and Docket Number 07007036 in any future correspondence associated with this request.
In accordance with Title 10 of the Code of Federal Regulations, Section 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room, or from the Publicly Available Records component of the NRCs ADAMS. The ADAMS database is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html If you have any questions regarding this communication, please contact me by telephone at 301-415-7220, or via e-mail at Yawar.Faraz@nrc.gov.
Sincerely, Yawar H. Faraz, Senior Project Manager Fuel Facility Licensing Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 70-7036 cc: Dr. Terry Grimm, Chief Executive Officer and Senior Scientist, Niowave M. Postman, National Nuclear Security Administration, Department of Energy
Dr. Peters 3
SUBJECT:
ACKNOWLEDGEMENT OF RECEIPT OF REGULATORY ENGAGEMENT PLAN FROM NIOWAVE FOR A MEDICAL ISOTOPES FACILITY LICENSED UNDER 10 CFR PART 70 (ENTERPRISE PROJECT IDENTIFICATION NUMBER: L-2022-LRM-0012)
DOCUMENT DATE: February 9, 2022 Distribution:
DFM r/f JBorromeo, NRR JTobin, NMSS GMiller, NMSS ROrlikowski, RIII FTran, RIII TCampbell, OGC KRoach, OGC NMertz, OGC SHelton, NMSS CEngland, OGC RTaylor, NRR MShams, NRR MBalazik, NRR DDecker, OCA JRubenstone, NMSS LTran, NRR LSuggs, RII CWolf, OCA DMcIntyre, OPA JWiel, NMSS JLubinski, NMSS RLewis, NMSS RTaylor, NRR JQuintero, NMSS ADAMS Accession Number: ML22035A075 OFFICE NMSS/DFM/
FFLB/PM NMSS/DFM/
FFLB/LA OGC/LHE/
MFW NMSS/DFM/
FFLB/BC NAME YFaraz ELee NMertz JZimmerman DATE 02/04/2022 02/07/2022 02/08/2022 02/09/2022 OFFICIAL RECORD COPY