ML22075A336
| ML22075A336 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 03/21/2022 |
| From: | Michael Balazik NRC/NRR/DANU/UNPL |
| To: | Piefer G SHINE Technologies |
| Gavello M; 301-415-0293 | |
| References | |
| CPMIF-001, EPID L-2019-NEW-0004 | |
| Download: ML22075A336 (7) | |
Text
March 21, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO THE ELECTRICAL POWER SYSTEMS (EPID NO. L-2019-NEW-0004)
Dear Dr. Piefer:
By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of SHINEs operating license application, questions have arisen for which confirmatory information is needed. The enclosed request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report, submitted in connection with the operating license application, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RCI is Chapter 8, Electrical Power Systems.
It is requested that SHINE provide responses to the enclosed RCI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RCI, the NRC staff is available to meet with SHINE to clarify the scope of information and level of detail expected to be included in the RCI response. SHINE may coordinate the scheduling and agendas for any such meetings with the responsible project manager assigned to this project.
In accordance with 10 CFR 50.30(b), Oath or affirmation, SHINE must execute its response in a signed original document under oath or affirmation. The response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in the response that is considered sensitive or proprietary, that SHINE seeks to have withheld from the public, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to safeguards should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements. Following receipt of the confirmatory information, the NRC staff will continue its evaluation of the subject chapters and technical areas of the SHINE operating license application.
G. Piefer As the NRC staff continues its review of SHINEs operating license application, additional RCIs for other chapters and technical areas may be developed. The NRC staff will transmit any further questions to SHINE under separate correspondence.
If SHINE has any questions, or needs additional time to respond to this request, please contact me at 301-415-2856, or by electronic mail at Michael.Balazik@nrc.gov.
Sincerely, Michael Balazik, Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001
Enclosure:
As stated cc: See next page Signed by Balazik, Michael on 03/21/22
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme, Director of Licensing SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Nathan Schleifer, General Counsel SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Christopher Landers, Director Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Avenue, 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 Attention: Amber Johnson Department of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 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
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO THE ELECTRICAL POWER SYSTEMS (EPID NO. L-2019-NEW-0004) DATED: MARCH 21, 2022 DISTRIBUTION:
PUBLIC JBorromeo, NRR MBalazik, NRR NParker, NRR MGavello, NRR HCruz, NRR SAnderson, NRR JCintron-Rivera, NRR SRay, NRR JJohnston, NRR ADAMS Accession Number: ML22075A336 NRR-088 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/DD (A)
NRR/DANU/PM NAME MBalazik NParker JBorromeo SAnderson MBalazik DATE 03/18/2022 03/18/2022 03/21/2022 03/21/2022 03/21/2022 OFFICIAL RECORD COPY
Enclosure OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR CONFIRMATORY INFORMATION REGARDING OPERATING LICENSE APPLICATION FOR SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of the SHINE operating license application, and the review of documents during the audit, questions have arisen for which confirmatory information is needed.
This request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. Specific chapters and technical areas of the SHINE operating license application covered by this RCI include the following:
Chapter 8, Electrical Power Systems Applicable Regulatory Requirements and Guidance Documents Section 50.34, Contents of applications; technical information, paragraph (b) of 10 CFR states, in part, that [t]he final safety analysis report shall include information that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the structures, systems, and components and of the facility as a whole. As part of presenting its design bases, SHINE has established the following principal design criteria relevant to its electrical power systems:
Criterion 4 - Environmental and dynamic effects Safety-related [structures systems and components] (SSCs) are designed to perform their functions with the environmental conditions associated with normal operation, maintenance, testing, and postulated accidents. These SSCs are appropriately protected against dynamic effects and from external events and conditions outside the facility.
2 Criterion 27 - Electric power systems An on-site electric power system and an off-site electric power system are provided to permit functioning of safety-related SSCs. The safety functions are to provide sufficient capacity and capability to assure that:
- 1) target solution design limits and primary system boundary design limits are not exceeded as a result of anticipated transients, and
- 2) confinement integrity and other vital functions are maintained in the event of postulated accidents.
The on-site uninterruptible electric power supply and distribution system has sufficient independence, redundancy, and testability to perform its safety functions assuming a single failure.
Provisions are included to minimize the probability of losing electric power from the uninterruptible power supply as a result of or coincident with, the loss of power from the off-site electric power system.
Criterion 28 - Inspection and testing of electric power systems The safety-related electric power systems are designed to permit appropriate periodic inspection and testing of important areas and features, such as wiring, insulation, connections, and switchboards, to assess the continuity of the systems and the condition of their components. The systems are designed with a capability to test periodically:
- 1) the operability and functional performance of the components of the systems, such as on-site power sources, relays, switches, and buses; and
- 2) the operability of the systems as a whole and, under conditions as close to design as practical, the full operation sequence that brings the systems into operation, including operation of applicable portions of the protection system, and the transfer of power among the on-site and off-site power supplies.
Section 50.34(b)(2) of 10 CFR requires a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, with technical justification therefore, upon which such requirements have been established, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.
Section 50.34(b)(2)(ii) of 10 CFR states, in part, that for facilities other than nuclear reactors, such items as theelectrical systemsshall be discussed insofar as they are pertinent.
RCI 8-11 FSAR Section 8a2.2, Emergency Electrical Power Systems, states, in part, The UPSS [uninterruptable electric power supply system] consists of a 125-volt direct current (VDC) battery subsystem, inverters, bypass transformers, distribution panels, and other distribution equipment necessary to feed safety-related alternating current (AC) and direct current (DC) loads and select nonsafety-related AC and DC loads. FSAR Section 8a2.2.1, Uninterruptible Electrical Power
3 Supply System Design Basis, states, in part, that the UPSS is designed, fabricated, erected, tested, operated, and maintained to quality standards commensurate with the importance of the safety functions to be performed. The onsite safety functions are to provide sufficient capacity and capability per Criterion 27.
The NRC staff finds that that the licensee does not provide a description in the FSAR of the safety classification of UPSS subcomponents, (e.g., cables, connectors, etc.,).
Confirm that the UPSS subcomponents used to support safety-related loads in FSAR Table 8a2.2-1, UPSS Load List, are designated as safety-related. If the UPSS subcomponents are not safety-related, provide an explanation of how the subcomponents meets Criterion 27 for capability and demonstrate how the subcomponent will perform its safety function, (i.e., identify relevant standards).