ML22143A814

Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information

ML22143A814
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/23/2022
From:	Jim Costedio SHINE Health. Illuminated
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2022-SMT-0058
Download: ML22143A814 (2)

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May 23, 2022 2022-SMT-0058 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

(2) SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Application for an Operating License Supplement No. 15, Submittal of the Phased Startup Operations Application Supplement, dated January 27, 2022 (ML22027A353)

(3) NRC letter to SHINE Technologies, LLC, SHINE Medical Technologies, LLC - Request for Additional Information Related to the Phased Startup Operations Application Supplement (EPID No. L-2022-NEW-0004), dated May 5, 2022 (ML22063A704)

SHINE Technologies, LLC Application for an Operating License Response to Request for Additional Information Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, Wisconsin (Reference 1). On January 27, 2022, SHINE submitted Supplement No. 15 to the application for an operating license describing the SHINE approach to initial facility startup and operations (Reference 2). The NRC staff determined that additional information was required to enable the staffs continued review of the SHINE application supplement (Reference 3).

Enclosure 1 provides the SHINE responses to the NRC staffs request for additional information.

If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on May 23, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 3400 Innovation Ct

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com

ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff determined that additional information was required (Reference 1) to enable the continued review of the SHINE Technologies, LLC (SHINE) operating license application (Reference 2) and subsequent Supplement No. 15 to the application for an operating license describing the SHINE approach to initial facility startup and operations (Reference 3). The following information is provided by SHINE in response to the NRC staffs request.

Chapter 5 - Cooling Systems 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.

SHINE Response SHINE confirms that the pressure cascade will be maintained in each radioisotope process facility cooling system (RPCS) piping configuration employed during the phased construction approach.

References

1. NRC letter to SHINE Technologies, LLC, SHINE Medical Technologies, LLC - Request for Additional Information Related to the Phased Startup Operations Application Supplement (EPID No. L-2022-NEW-0004), dated May 5, 2022 (ML22063A704)

2. SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

3. SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Application for an Operating License Supplement No. 15, Submittal of the Phased Startup Operations Application Supplement, dated January 27, 2022 (ML22027A353)

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