ML22213A049

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

ML22213A049
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/01/2022
From:	Jim Costedio SHINE Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2022-SMT-0081
Download: ML22213A049 (3)

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August 1, 2022 2022-SMT-0081 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 Confirmatory Information Related to Radiation Protection Program and Waste Management (EPID No. L-2019-NEW-0004), dated July 27, 2022 (ML22206A208)

SHINE Technologies, LLC Application for an Operating License Response to Request for Confirmatory 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 confirmatory 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 confirmatory 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 August 1, 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 COMFIRMATORY INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff determined that confirmatory 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.

RCI 11-1 By letter dated, May 23, 2022 (ML22094A114), the NRC staff issued audit questions to SHINE related to phased startup and operations approach. The NRC staff was seeking to better understand the radiation environments that workers would be exposed to when working in an empty irradiation unit (IU) cell adjacent to an operating IU cell to ensure occupational doses were ALARA. During a review of information made available during the audit, SHINE provided information in response to the NRC staff audit questions 10 and 11.

1. Confirm that the radiological dose estimates are as follows:

a. The average dose rate in an empty IU cell adjacent to an operating IU cell is approximately 15 millirem per hour (mrem/hr) below the normal light water pool height and less than 5 mrem/hr above the light water pool height. The dose rate in the empty IU cell is approximately 60 mrem/hr at the height of the target solution vessel near the south wall.

b. The maximum dose rate in an adjacent target solution vessel off-gas system cell is expected to be approximately 60 mrem/hr.

c. The maximum dose rate in an adjacent primary cooling room is expected to be approximately 5 mrem/hr.

d. During installation of the iodine and xenon purification and packaging system components, the adjacent cell can be operating, and the dose rate is expected to be approximately 5 mrem/hr.

2. Confirm that radiation protection surveys, and ALARA work planning practices will be implemented to maintain occupational doses ALARA.

SHINE Response SHINE confirms the radiological dose estimates in items 1.a. through 1.d. of RCI 11-1 are accurate. Additionally, SHINE confirms that radiation protection surveys and as low as Page 1 of 2

reasonably achievable (ALARA) work planning practices will be implemented to maintain occupational doses ALARA.

References

1. NRC letter to SHINE Technologies, LLC, SHINE Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management (EPID No. L-2019-NEW-0004), dated July 27, 2022 (ML22206A208)

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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