ML18340A276
| ML18340A276 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/19/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | Piefer G SHINE Medical Technologies |
| Lynch S, NRR/DLP 415-1544 | |
| References | |
| EPID L-2017-PMP-0014 | |
| Download: ML18340A276 (4) | |
Text
December 19, 2018 Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, INC. - ACKNOWLEDGMENT OF RECEIPT OF REQUEST FOR CONFIRMATION OF APPLICABLE FINANCIAL PROTECTION REQUIREMENTS (EPID NO. L-2017-PMP-0014)
Dear Dr. Piefer:
By letter dated August 27, 2018 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18239A219), SHINE Medical Technologies, Inc. (SHINE) presented an analysis of the statutory and regulatory financial protection requirements contained in Section 170 of the Atomic Energy Act of 1954, as amended (AEA), and Title 10 of the Code of Federal Regulations (10 CFR) Part 140, Financial Protection Requirements and Indemnity Agreements, respectively. Based on its analysis, SHINE indicated that it plans to obtain and maintain financial protection in the amount of $1.5 million and execute and maintain an indemnification agreement with the U.S. Nuclear Regulatory Commission (NRC). In its letter, SHINE requested that the NRC staff confirm that this proposed amount of financial protection is acceptable.
The NRC issued Construction Permit No. CPMIF-001 on February 29, 2016, finding, in part, that SHINE was financially qualified to design and construct its proposed facility in accordance with the Commissions regulations set forth in 10 CFR Chapter I based on the information provided in SHINEs preliminary safety analysis report supporting its construction permit application.
However, the NRC staffs financial qualifications review for a construction permit is limited to estimates of construction costs, estimates of fuel cycle costs, and sources of funds to cover these costs as required by 10 CFR 50.33, Contents of applications; general information, paragraph (f)(1). At the time of the issuance of the construction permit, SHINE had not requested to possess special nuclear material (SNM). Therefore, consistent with Section 170 of the AEA, the NRC staff deferred evaluation of information related to financial protection to such a time when SHINE applies for either an operating license or a license under 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, to possess SNM. Further, the SHINE construction permit includes a condition that an operating license will not be issued by the Commission unless SHINE submits proof of financial protection and executes an indemnity agreement with the NRC in accordance with Section 170 of the AEA.
The proposed SHINE Medical Isotope Production Facility comprises an irradiation facility and a radioisotope production facility (RPF) for the irradiation and processing of SNM to produce medical radioisotopes, such as molybdenum-99. The irradiation facility would consist of eight subcritical operating assemblies (or irradiation units), which would each be licensed under Section 103 of the AEA as a non-reactor utilization facility, as that term is defined in 10 CFR
50.2, Definitions. The RPF would consist of three hot cell structures, which would together be licensed as a single production facility, as that term is defined in 10 CFR 50.2.
In reviewing SHINEs analysis of financial protection requirements, the NRC staff acknowledges that the current requirements in 10 CFR Part 140 do not specifically address the amounts of financial protection required for SHINEs proposed non-reactor utilization facilities and production facility. However, consistent with Section 170 of the AEA, if an operating license were issued to SHINE, it would include a condition requiring that SHINE have and maintain financial protection of such type and in such amount as determined by the Commission to cover public liability claims. Such an operating license issued to SHINE would be further conditioned to require that SHINE execute and maintain an indemnification agreement as required by the NRC.
While the Commission has not yet determined what type and amount of financial protection would be adequate for the proposed SHINE Medical Isotope Production Facility, the NRC staff is reviewing SHINEs financial protection analysis as part of a larger effort to determine the appropriate amount(s) of financial protection for all potential non-reactor technologies to be licensed under 10 CFR Part 50 for the purposes of producing medical radioisotopes such as molybdenum-99. The results of the NRC staffs review will be presented to the Commission for approval.
The NRC staff recognizes the importance of ensuring certainty and predictability in its regulatory framework to support the timely licensing of facilities used for medical radioisotope production such as the proposed SHINE Medical Isotope Production Facility, and is working to determine the appropriate amount(s) of financial protection for these facilities so as to not delay the issuance of their operating licenses. The NRC staff will share the status of its efforts with SHINE through formal written correspondence, meetings, or informal e-mail and telephone communication, as necessary and appropriate.
If you have any questions, please contact Steven Lynch at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely,
/RA/
Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Licensing Projects Office of Nuclear Reactor Regulation Docket No. 50-608 cc: See next page
SHINE External Stakeholder Mailing List Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter P.O. Box 118300 University of Florida Gainesville, FL 32611 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546
- concurred via email NRR-088 OFFICE NRR/DLP/PRLB/PM NRR/DLP/LA*
NRR/DLP/PFPB/BC NAME SLynch*
NParker ABowers DATE 12/06/2018 12/7/2018 12/18/2018 OFFICE OGC*
NRR/DLP/PRLB/BC NRR/DLP/PRLB/PM NAME JWachutka AAdams SLynch DATE 12/12/2018 12/19/2018 12/19/2018