ML22063A704

Shine Medical Technologies, LLC - Request for Additional Information Related to the Phased Approach

ML22063A704
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/06/2022
From:	Holly Cruz NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Cruz H
References
EPID L-2022-NEW-0004
Download: ML22063A704 (7)

Text

SHINE Medical Technologies, LLC May 5, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR ADDITIONAL INFORMATION RELATED TO THE PHASED STARTUP OPERATIONS APPLICATION SUPPLEMENT (EPID NO. L-2022-NEW-0004)

Dear Dr. Piefer:

By letter dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22027A353), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC), Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, related to its 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 phased startup operations application supplement, questions have arisen for which additional information is needed. The enclosed request for additional information (RAI) 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 phased startup operations application supplement, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RAI is Chapter 5, Cooling Systems.

It is requested that SHINE provide responses to the enclosed RAI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RAI, 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 RAI 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 additional 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 phased startup operations application supplement, additional RAIs 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) 415-1053, or by electronic mail at Holly.Cruz@nrc.gov.

Sincerely, Signed by Cruz, Holly on 05/05/22 Holly D. Cruz, Senior 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 w/enclosure: See next page

SHINE Medical Technologies, LLC Docket No. 50-608 cc:

Jeff Bartelme Mark Freitag Licensing Manager City Manager SHINE Technologies, LLC P.O. Box 5005 3400 Innovation Court Janesville, WI 53547-5005 Janesville, WI 53546 Bill McCoy Nathan Schleifer 1326 Putnam Avenue General Counsel Janesville, WI 53546 SHINE Technologies, LLC 3400 Innovation Court Alfred Lembrich Janesville, WI 53546 541 Miller Avenue Janesville, WI 53548 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 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 Shelley Warwick Environmental Analysis Specialist-South Team Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115

ML22063A704 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 3/31/2022 3/31/2022 5/5/2022 5/5/2022 OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING PHASED STARTUP OPERATIONS APPLICATION SUPPLEMENT TO OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22027A353), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC), Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, related to its 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 Part 50, Domestic Licensing of Production and Utilization Facilities.

During the NRC staffs review of SHINEs phased startup operations application supplement, questions have arisen for which additional information is needed. This enclosed request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted in connection with the operating license application and phased startup operations application supplement, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RAI is Chapter 5, Cooling Systems.

Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE operating license application and phased startup operations application supplement, using the applicable regulations, as well as the guidance contained in NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ADAMS Accession No. ML042430055), and NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (ADAMS Accession No. ML042430048). The NRC staff is also using the Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069), and Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A075).

Enclosure

As applicable, additional guidance cited in SHINEs FSAR or referenced in NUREG-1537, Parts 1 and 2, or the ISG Augmenting NUREG-1537, Parts 1 and 2, has been utilized during this review.

For the purposes of this review, the term reactor, as it appears in NUREG-1537, the ISG Augmenting NUREG-1537, and other relevant guidance can be interpreted to refer to SHINEs irradiation unit, irradiation facility, or radioisotope production facility, as appropriate within the context of the application and corresponding with the technology described by SHINE in its application. Similarly, for the purposes of this review, the term reactor fuel, as it appears in the relevant guidance listed above, may be interpreted to refer to SHINEs target solution.

Chapter 5 - Cooling Systems RCPS [Radioisotope Process Facility Cooling System] Analyses Section 5a2.3 of the phased startup operations application supplement states, in part:

The RPCS interface points with IU [irradiation unit] specific systems are isolated to support phased startup operation (i.e., interfaces with unit specific systems supporting IUs 3 through 8 are isolated during Phase 1 operation, interfaces with unit specific systems supporting IUs 6 through 8 are isolated during Phase 2 operation), as follows:

The RPCS supply and return interfaces with PCLS [primary closed loop cooling system] are each isolated with a manual valve and a blind flange or cap.

The RPCS supply and return interfaces with NDAS [neutron driver assembly system] cooling cabinets are each isolated with a manual valve and a blind flange or cap.

The RPCS supply and return interfaces with TOGS [target solution vessel (TSV) off-gas system] are each isolated with a manual valve and a blind flange or cap.

The RPCS supply and return interfaces with the RVZ1r [radiological ventilation zone 1 recirculating cooling subsystem] IU supplemental cooling are each isolated with a manual valve and a blind flange or cap.

NUREG-1537, Part 2, Section 5a2.3, Secondary Cooling System, describes, in part, that

[t]he secondary cooling system of an AHR should be designed to transfer reactor heat from the primary and possibly other cooling systems to the environment. The secondary cooling system should be designed for continuous operation at the licensed power level. Therefore, the secondary cooling system in these reactors must be designed to dissipate heat continuously. In this section of the SAR, the applicant should justify how any necessary heat dissipation is accomplished.

RAI 5-1 SHINE Design Criteria 26 Section 5a2.3.2 of the FSAR states that the RPCS cooling water will be maintained at a higher pressure than those systems with potential to contaminate the RPCS, which is referred to as a pressure cascade. Section 5a2.3 of the phased construction approach supplement describes modifications that will be made to the RPCS piping in order to isolate it from unit-specific systems that have not yet been installed.

Confirm that the pressure cascade will be maintained in each RPCS piping configuration employed in the phased construction approach.